CAHB Newsletter
 
CAHB Newsletter covers breaking news and information about health and biosciences, as well as the Center's activities. Although the Newsletter covers all of the US, special emphasis is given to the news in the Bay Area, including Stanford University, Silicon Valley, and the cities of Palo Alto, and Menlo Park.
 
We welcome your contributions, which will help make the Newsletter a success. Happy reading and best wishes!
 

 
October 2011 Volume 1 Number 1
 
 
Announcement




3rd international workshop on humanized mice was held on October 28 - 31, 2011 with supported by CAHB. One of the board member of us, Mr. Nomura, gave an opening remark for it. In addition, Central Institute for Experimental Animals which is our related organization was the main sponsor for the conference. Please find the program from here.











December 2004 Volume 1 Number 9
 
Announcement
We, Center for the Advancement of Health and Biosciences (CAHB), are pleased to announce that the year 2004 was a successful start-up year for our two main activities, holding of Health & Bioscience Forum and publication of CAHB Newsletter. We would like to express our great appreciation to those of you who contributed to our activities to be successful. The success would never have been achieved without you.
 
Wish you a happy and prospective year 2005!
Hiroaki Masuda: hmasuda@cahb.org
 
Forum Report
Our sixth monthly Health & Bioscience Forum was held on December 16th, 2004. Dr. Hiroyuki Nakai from Department of Pediatrics, Stanford University School of Medicine, talked about “Adeno-associated virus (AAV) vectors – amazing vehicles for gene delivery in vivo”.
 
Here is an abstract of his talk -- Technologies for gene therapy and cell therapy have recently merged together establishing promising therapeutics for various diseases and powerful research tools for medical and biological sciences. Among various gene delivery vehicles (i.e., vectors), recombinant adenoassociated virus (AAV) vector is one of the most promising vectors for therapeutic gene delivery into living animals and humans. AAV vectors are produced from nonpathogenic viruses (therefore, believed to be safe) and mediate long-term stable therapeutic gene expression in various target tissues. In addition, recent advances in understanding biology of vectors (vectorology) have further potentiated this vector system. Now it is possible to stably express exogenous genes of interest in the entire liver, entire skeletal muscle system, and entire heart muscle etc. by a single peripheral vein injection of this vector. This one hour talk:
1) discussed the attractiveness of the AAV vector system;
2) concisely summarized complicated mechanisms of stable AAV vector transduction in vivo (how AAV vectors can persistently express     exogenously delivered genes in animals);
3) presented our recent interesting findings on AAV vector integration into host chromosomes in animals.

We had more than ten attendees with diverse backgrounds from medicine to engineering, and the academe to industry. For more information about the forum, please visit http://www.cahb.org/forum.html.

Hiroaki Masuda: hmasuda@cahb.org
 
Top 10 Bio News (December 2004)
1. Doctors Say Avoid Pfizer's Bextra
Doctors writing in a prominent medical journal on Dec. 17, 2004 recommended that physicians stop prescribing Pfizer Inc.'s Bextra painkiller, just as a large study found the drug maker's sister drug, Celebrex, doubled risk of heart attacks. A letter by three top doctors published in The New England Journal of Medicine said that in light of Vioxx and negative signs on Bextra, Bextra should be avoided.
 
2. Genentech, ImClone Shares Rise
Shares of Genentech, OSI Pharmaceuticals Inc. and ImClone Systems Inc. surged before the bell on Dec. 17 after rival AstraZeneca said its lung cancer drug Iressa failed to show survival benefits in a major clinical study.
 
3. Genencor Expands Oncology Pipeline with Product Candidates From the National Cancer Institute (NCI)
Palo Alto-based Genencor International, Inc. announced that it has signed an exclusive worldwide patent license agreement giving it the right to develop and commercialize two therapeutic product candidates for cancer from the Public Health Service (PHS) and the National Cancer Institute (NCI). The two proteins, BL22 and HA22, are recombinant immunotoxins that
 
4. AVANIR Announces Submission of Rolling NDA for Neurodex
San Diego-based AVANIR Pharmaceuticals announced it has begun submission of a New Drug Application (NDA) seeking marketing approval of Neurodex, an investigational drug for the treatment of pseudobulbar affect. The U.S. Food and Drug Administration offered a "rolling" review for Neurodex and also indicated that Neurodex would qualify for a priority review when the submission is complete.
 
5. OSI Pharmaceuticals Comments on Recently Filed Class Action Lawsuits
OSI Pharmaceuticals, Inc. announced that it has been made aware of several class action lawsuits filed against the Company alleging that the Company issued false and misleading statements concerning the survival benefit associated with the Company's flagship product Tarceva and the size of Tarceva's potential market upon U.S. Food and Drug Administration (FDA) approval of the drug. The Company continues to believe in the potential of its flagship product, Tarceva, to become a major product in the treatment of human cancer.
 
6. Mylan Gets FDA OK for Generic Darvon
Pittsburgh-based Mylan Laboratories Inc. reported that the Food and Drug Administration approved its abbreviated new drug application for a generic version of Pharma Inc.'s opioid painkiller Darvon. The approval is for a 65 milligram capsule version of the drug and Mylan said it will begin shipping the product immediately
 
7. FDA approves Eligard six-month formulation for prostate cancer
Canada-based QLT Inc.announced today that the company has received approval from the U.S. Food and Drug Administration for Eligard 45mg (leuprolide acetate for injectable suspension) six-month formulation, for the palliative treatment of advanced prostate cancer. Eligard is a member of a class of drugs known as luteinizing hormone-releasing hormone agonists, also called LHRH agonists. It works by lowering the levels of testosterone in the body, which may result in a reduction of symptoms related to the disease.
 
8. Roche and The University of Vermont Grant Cell Therapeutics, Inc. Exclusive Worldwide License to a New Class of     Anticancer Compounds
The University of Vermont, and Cell Therapeutics Europe, a subsidiary of Cell Therapeutics, Inc. have entered into an exclusive worldwide, royalty-bearing license to a new class of platinum-containing, anticancer drug candidates, called bisplatinum compounds. Under the terms of the agreement, CTI has development and commercialization rights to the compounds. At the same time, Roche has granted CTI a worldwide license for bisplatinum compounds under its patents.
 
9. WHO urges countries to prepare against bird flu threat
With up to 50 million people expected to die from the next influenza pandemic, the World Health Organisation (WHO) is to convene a meeting of international experts in Geneva to plan how best to meet the threat. Although it cannot predict when the next pandemic will strike, the WHO said the arrival of the avian influenza or "bird flu" virus, which is now widely entrenched in Asia, signals "the world has moved closer to the next pandemic." While it is impossible to accurately forecast the magnitude of the next pandemic, we do know that much of the world is unprepared for a pandemic of any size.
 
10. Hepatitis C Drug Available in Japan
Schering-Plough Corp. and Enzon Pharmaceuticals Inc. reported Friday that hepatitis C treatment PEG-Intron is now available in Japan following its inclusion on the country's health insurance reimbursement price listing. Enzon receives royalties from worldwide sales of the drug, which is marketed by Schering-Plough Corp. The companies said PEG-Intron is now available for use in combination with hepatitis C treatment Rebetol in Japan. It was approved for marketing in Japan in October 2004. The companies said hepatitis C is the leading cause of chronic liver disease in Japan, affecting up to 2 million people and resulting in about 30,000 deaths a year.
 
Paul Candelaria: paul@cahb.org
 
USA Topics
On An Impending Global Flu Outbreak
Governments must brace for a future flu outbreak because one will strike inevitably, the World Health Organization said Wednesday, Dec. 15, 2004.
 
"Influenza pandemics are natural phenomenon, like earthquakes," said Klaus Stohr, coordinator of the global flu program at the WHO. "The problem is bad preparedness."
 
Influenza is highly contagious and has killed millions over the past 100 years. It has traditionally moved in cycles, and some scientists say a major outbreak is already overdue.
 
The 1918-1919 Spanish Flu outbreak killed up to 40 million people around the world, many more than World War I. There also were major outbreaks in 1957-58 and 1968-1969 that killed more than a million people each. The most virulent strains hit about every 30 years.
 
WHO has warned that 7 million could die in a new outbreak and that governments must do more to prepare - and try to cut the death toll.
 
"We're living on borrowed time," said Stohr. "But that gives us a chance to do things we should perhaps have done before."
 
Besides developing vaccines to combat new, potentially deadly flu strains, health authorities worldwide must boost surveillance, said WHO. The agency also called for better emergency plans that can be put in place fast if there is a pandemic - with clear quarantine rules and screening of departing passengers at airports, for example.
 
"Vaccines are often mentioned as the first line, but they are not," said Stohr. "They are just one pillar of the response."
 
The three flu pandemics that hit in the last century, and the ones that came before them, spread around the world before health officials had the chance to even identify the strain - let alone make and distribute vaccines to combat it.
 
Fears of a new global outbreak have been spurred by last year's epidemic of severe acute respiratory syndrome, or SARS, which struck hardest in Asia. The flu-like disease killed nearly 800 people worldwide.
 
Worries also have been stoked by bird flu, which swept through farms across Asia this year, ravaging the poultry industry as more than 100 million birds were culled in an effort to stop the spread of the virus.
 
The disease also jumped to humans, killing 12 people in Thailand and 20 in Vietnam. There is no concrete evidence yet of human-to-human transmission, but experts fear the virus could mutate to a form that could spread among humans, sparking the next global pandemic.
 
WHO also wants governments to boost cooperation between medical and veterinary authorities because of fears that animal flu could jump the species barrier.
 
Paul Candelaria: paul@cahb.org
 
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November 2004 Volume 1 Number 8
 
Announcement
 
Health & Bioscience Forum
Seventh Monthly Lecture Series
 
“Adeno-Associated Virus (AAV) Vectors”
- Amazing vehicles for gene delivery in vivo -
 
Hiroyuki Nakai, M.D. Ph.D.
Senior Research Scientist and Principal Investigator
Department of Pediatrics
Stanford University School of Medicine
 
Date: December 16, 2004 (Thursday)
Time: 6:30 p.m. – 8:00 p.m.
Place: 525 Middlefield Road, Suite 100
Menlo Park, CA 94025
 
Light refreshment will be served
 
 
Forum Report
Our sixth monthly Health & Bioscience Forum was held on November 15th, 2004. This time, we had two distinctive speakers; Dr. Yoshiyuki Shiroyanagi from Tokyo Women’s Medical University, Japan and Dr. Kazuo Ohashi from Nara Medical University, Japan. The topic of the forum was “Frontier of Regenerative Medicine”.
 
Dr. Shiroyanagi talked on “Urothelium regeneration using viable cultured urothelial cell sheets grafted on demucosalized gastric flaps”. Here is an abstract of his talk; Bladder reconstruction using gastrointestinal flaps may induce severe complications, including lithiasis, urinary tract infection and electrolyte imbalance. The majority of these complications are related to intestinal mucosa. We have hypothesized that the replacement of gastrointestinal mucosa with urothelial cells could reduce clinical complications. The purpose of this study was to examine whether intact urothelial cell sheets harvested from new temperature-responsive cell culture systems without proteolytic enzyme treatment would be autografted successfully onto demucosalized gastric flaps in a dog model to promote improved regeneration of native-like urothelium. Urothelial cell sheets were autografted onto dog demucosalized gastric flaps successfully, generating a multilayered urothelium in vivo. The novel intact cell sheet grafting method rapidly produces native-like epithelium in vivo. This versatile technology should prove useful in urinary tract tissue engineering and surgical reconstructions.
 
Dr. Ohashi talked on “Liver Tissue Engineering at Extrahepatic Sites as a Potential New Therapy for Genetic Liver Diseases”. Here is an abstract of his talk; Liver tissue engineering using hepatocyte transplantation has been proposed as an alternative to whole-organ transplantation or liver directed gene therapy to correct various types of hepatic insufficiency. Hepatocytes are not sustained when transplanted under the kidney capsule of syngenic mice. However, when we transplanted hepatocytes with the extracellular matrix components extracted from Engelbreth-Holm-Swarm (EHS-gel), hepatocytes survived for at least 140 days and formed small liver tissues.Liver engineering in hemophilia A mice reconstituted 5-10% of normal clotting activity enough to reduce the bleeding time and have a therapeutic benefit. On the other hand, the subcutaneous space did not support the persistent survival of hepatocytes with EHSgel matrix. We hypothesized that establishing a local
 
vascular network at the transplantation site would reduce graft loss. To do this, we provided a potent angiogenic agent prior to hepatocyte transplantation into the subcutaneous space. With this procedure, persistent survival was achieved for the length of the experiment (120 days). To establish that these engineered liver tissues also retained their native regeneration potential in vivo, we induced two different modes of proliferative stimulus to the naïve liver, and confirmed that hepatocytes within the extrahepatic tissues regenerated with similar activity as naïve liver. In conclusion, our studies demonstrate that liver tissues can be engineered and maintained at extra-hepatic sites, retain their capacity for regeneration in vivo, and can be used to successfully treat genetic disorders. We had more than ten attendees with diverse backgrounds from medicine to engineering to investment. For more information about the forum, please visit http://www.cahb.org/forum.html.

Hiroaki Masuda:hmasuda@cahb.org
 
Top 10 Bio News (November 2004)
1. Schering-Plough Announces CLARITIN RediTabs Now Available in Japan
Schering-Plough Corporation announced that Schering-Plough K.K., the company's subsidiary in Japan, has introduced CLARITIN (loratadine) RediTabs, an instantly dissolving nonsedating antihistamine tablet. It is available by prescription in Japan for the treatment of allergic rhinitis (AR), chronic idiopathic urticaria (CIU), or hives of unknown cause, and itching associated with skin diseases in adults and children 15 years of age and above.
 
2. Neurobiological Technologies, Inc. to Present at the Wall Street Analyst Forum
California-based Neurobiological Technologies, Inc, a biotechnology company engaged in the business of acquiring and developing central nervous system (CNS) related drug candidates, announced that its President and Chief Executive Officer, Paul Freiman, will present a corporate overview at The Wall Street Analyst Forum in New York City at 11:00 a.m. on December 1, 2004. Listeners are encouraged to visit the website at least 15 minutes prior to the beginning of the scheduled presentation to register and to download and install any necessary audio software. The presentation will be available for 90 days after the event.
 
3. Cord Blood Registry Sees FDA Regulation as Good for Consumers and Industry
Beginning in May 2005, cord blood banks must meet new federal safety standards mandated by the Food and Drug Administration (FDA). Since 1997, Californiabased Cord Blood Registry (CBR), the nation's leading newborn stem cell bank, has been preparing for these new regulations, which will set the baseline standards for all cord blood banks. The blood remaining in the umbilical cord after it has been clamped and cut, "cord blood," has proven to be a rich source of stem cells, and a growing number of expectant parents are taking advantage of this once-in-a-lifetime chance by arranging to collect and bank their newborns' stem cells as a type of "biological insurance" to help protect their families' future health.
 
4. Nationally Renowned Surgeon Notes Increase in Patient Demand for Artificial Spinal Disc
With the FDA's recent approval of an artificial disc that makes spinal fusion "a thing of the past”, one nationally renowned spine surgeon is receiving a flood of phone calls from patients interested in seeking relief from chronic back pain. Rick Delamarter, M.D., medical director of The Spine Institute at Saint John's Health Center in Santa Monica, California, is one of only a handful of surgeons authorized by the FDA to perform a state-of-the-art surgical procedure where patients are fitted with an artificial spinal disc to replace one that has become damaged or diseased. Delamarter has performed more lumbar (lower back) and cervical artificial disc replacements than any other surgeon in the United States to date.
 
5. Nanogen Issued Patent for Device That Combines Optical Waveguides and Molecular Diagnostics
San Diego-based Nanogen, Inc., developer of advanced diagnostic products, announced today that it was issued U.S. Patent No. 6,821,729, "Device for Molecular Biological Analysis and Diagnostics Including Waveguides," by the U.S. Patent and Trademark Office. The patent covers methods and technologies for coupling optical waveguides with a DNA microarray used for performing biological operations and illuminating it at an angle that allows the size and complexity of the diagnostic instrument to be reduced.
 
6. Kosan NSCLC Phase II Trial Discontinued, Breast and Prostate Phase II Trials Advance
Hayward-based Kosan Biosciences announced that its Phase II clinical trial of KOS-862 in non-small cell lung cancer (NSCLC) has been discontinued, while Phase II clinical trials in both breast and prostate cancers continue to advance. The KOS-862 trial in non-small cell lung cancer was terminated as the trial did not meet the primary objective of tumor response in the first step of the two-stage Simon trial design.
Roche and Kosan entered into a global alliance for the co-development and commercialization of KOS-862 and its back up compounds in September 2002.
 
7. Federal Funding Provided for Non-embryonic Stem Cell Research
Case Western Reserve University, The Cleveland Clinic Foundation (CCF) and University Hospitals of Cleveland (UHC) have been awarded $4.5 million in seed funding to establish the National Center for Regenerative Medicine as part of the omnibus appropriation bill approved by Congress this week. Additional funding for the center is expected over the next five years. The center's research facilities, will enable new non-embryonic stem cell research discoveries by faculty to be translated into therapies that can be used to treat thousands of patients each year. In addition, the center's education programs will train personnel to perform groundbreaking research and deliver the world's foremost patient care.
 
8. Riverain Medical Introduces Artificial Intelligence System for Chest X-Ray Early Lung Cancer Detection
Ohio-based Riverain Medical has introduced the first and only artificial intelligence system with FDA PMA approval for early-stage Lung Cancer detection. In clinical trials, radiologists working with RapidScreen's computer aided detection technology demonstrated a 23% increase in detection efficiency for lung nodules ranging from 9 to 14mm in size. Detecting and treating more lung cancers in the earliest stage has the potential to save 54,000 lives annually. According to The American Cancer Society, Lung Cancer is the number one cancer killer in the United States. In the U.S. alone, an estimated 160,000 lives are lost each year to lung cancer -- more than colon, breast, and prostate cancer combined.
 
9. Genentech Again Named the No. 1 Employer in Science Magazine Survey
Genentech, Inc. announced that it has been named by Science magazine as "the top employer and most admired company in the biotechnology and pharmaceutical industries" for the third consecutive year. The honor is the result of a survey sponsored by Science magazine, along with the American Association for the Advancement of Science, and conducted by Senn-Delaney Culture Diagnostics and Measurement (SDCDM).
 
10. WHO Warns of Bird Flu Pandemic
The World Health Organization has issued a dramatic warning that bird flu will trigger an international pandemic that could kill up to seven million people. The influenza pandemic could occur anywhere from next week to the coming years. Even with the best case scenario, the most optimistic scenario, the pandemic will cause a public health emergency with estimates which will put the number of deaths in the range of two and seven million. Scientists are busy working on vaccines for bird flu and other viruses. Two U.S. companies have said they plan to test experimental bird flu vaccines from January.

Paul Candelaria:paul@cahb.org
 
USA Topics
New Law Coming That Will Affect U.S. Patent and Trademark Office
The provisions of the omnibus appropriations bill (H.R. 4818) will go beyond mere filing fee increases. The bill is likely to be signed by President Bush and becomes effective in mid-December, 2004. Unless an unlikely success is achieved in last-minute attempts to amend the provisions affecting the Patent and Trademark Office, the current form of these provisions will become the law of the land. An outline of the major themes of these provisions is:
 
  • Fee increases. The bill includes a broad-based and significant increase in fees. All persons who file and prosecute patent applications in the United States needs to conduct an analysis of their current and projected portfolios to determine the full impact of the bill. While the fee increases are broad-based, some areas are hit harder than others. For example, the cost of an appeal, from start to finish, will be more than doubles under the appropriations bill. The fees for filing an appeal and taking it through oral hearing will skyrocket to $2000.00. This could absorb a significant portion of a patent budget if the appeal process is a primary component of the overall prosecution strategy.
  • Establishment of a Multi-track Fee System. For the first time, patent applicants must now pay filing, search and examination fees. Each of these fees must be paid upon filing of an application. So, it can be said that the new "filing fee" includes all three of these fees. And the increase in the "filing fee" is significant -- over 25% for large entities. The 21st Century Strategic Plan, created by the Patent and Trademark Office, discusses a market-driven examination system that "permits applicants to have freedom of choice in the processing of their applications." The break-out of separate search and examination fees appears to be a step in this direction.
  • Fee Refunds. The bill authorizes the Director to promulgate regulations providing for the refund of the search fee in two situations: where an applicant files a written declaration of expressed abandonment before an examination is made, and where an applicant provides a search report that meets the conditions prescribed by the Director.
  • Outsourcing of Prior Art Searches. The outsourcing of searches is a major component of the 21st Century Strategic Plan and the bill includes provisions to initiate the program. Congress was very cautious with this program, however, writing several key protections into the bill. For example, the bill requires that the Director conduct a pilot study of limited time and scope to ensure appropriate quality of external searches. Dual layers of reports (the Director and the Patent Public Advisory Committee) must be submitted to Congress on the pilot study, and the bill includes a provision that allows Congress to easily kill the program by passage of a separate law. Also, the outsourcing provisions ensure that, when and if commercial entities are used for prior art searches, only US companies and US citizens are used.
  • Incentive to File Patent Applications Electronically. The bill includes, for the first time, an economic incentive to file applications electronically -- but the incentive is extremely narrow in scope, applying only to small entities and non-provisional applications. Under the bill, small entities will get a 75% discount (compared to 50%) on the filing fee (this only applies to the true filing fee, and does not apply to the search and examination fees) for a non-provisional application. This amounts to a savings of $75.00. Is this enough of an incentive to increase usage of the electronic filing system? Considering the relative costs of the entire prosecution system, the savings does not appear to be significant. Interestingly, the cost of filing a nonprovisional application, including the electronic filing discount, still exceeds the old small entity filing fee.
 
In a related development prior to Thanksgiving 2004, the Intellectual Property Coalition, has sent a letter asking the House Appropriations committee to oppose raising patent fees unless those fees are kept at the Patent and Trademark Office (PTO) for operating expenses. The letter, signed by the American Intellectual Property Law Association, the Intellectual Property Owners Association, and six others, was sent to the chairmen and ranking members of the House Committee on Appropriations and its Subcommittee on Commerce, Justice, and State, the Judiciary, and Related Agencies.
 
The Senate is expected to debate the FY2005 Commerce-Justice-State appropriations bill (S. 2809), incorporating a one-year, 30 percent PTO fee increase, as part of an omnibus appropriations package. The letter urges House Appropriators either to seek inclusion of language in conference negotiations that would allow the PTO to keep all of the fees generated by its work or to drop entirely the proposed fee increase.
 
An increase in PTO application fees without an end to diversion of those funds would be particularly onerous to the biotechnology industry. In fact, the vast majority of biotech organizations are small start-up companies that have yet to bring a product to market, but have 370 promising biotech medicines in the clinical pipeline. For these companies, patents are their sole assets, making the role of the PTO critical to the biotechnology industry.
 
The letter affirms the need for a stable funding stream for the PTO, which the one-year fee increase will not ensure. Already, the average time it takes to get a patent is more than 27 months (and more for some technologies) and the quality of patent examinations has suffered under inadequate funding. The letter also strongly asserts the coalition’s opposition to a fee increase without an end to fee diversion. The Senate CJS Appropriations bill as currently drafted is unacceptable to the PTO user community and totally ignores the premise that initially secured the user community’s support of a fee increase ending the 12-year practice of fee diversion.

Paul Candelaria:paul@cahb.org
 
What is BioSpace?
Part 6 – BioGarden (New Jersey)
As of November 2004, BioGarden consists of 131 organizations, bioscience and pharmaceutical companies, industry service and supply companies, research institutes, non-profit organizations, and universities in the State of New Jersey. Selected are:
 
Aventis Pharmaceuticals, Inc. (Biotechnology and Pharmaceutical, Bridgewater, New Jersey) is now a part of Sanofi-Aventis group, the world’s third largest pharmaceutical company, ranking number one in Europe. The group is developing leading positions in seven major therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, vaccines.
 
Covance (Contact Research Organization, Princeton, New Jersey) is a recognized industry leader with expertise and experience in every phase of drug development and the ability to conduct drug trials around the world. It is one of the world's largest and most comprehensive drug development services companies with 2003 revenues of $940 million, global operations in more than 15 countries, and 6,500 employees worldwide.
 
Johnson & Johnson (Pharmaceutical, New Brunswick, New Jersey) is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical and medical devices and diagnostics markets since the Company's founding in 1886. It has more than 200 operating companies in 57 countries around the world employing 109,200 employees and selling products in more than 175 countries.
 
Merck & Co., Inc. (Pharmaceutical, Whitehouse Station, New Jersey) is a leading research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products and services. Merck's research has produced vaccines and medicines to treat cardiovascular, gastrointestinal and infectious diseases, arthritis, glaucoma, and symptomatic benign prostate enlargement and products to treat animal parasites and crop pests.
For more information and news update, visit BioCorridor website http://www.biospace.com/hotbed.cfm?RegionID=820.

Hiroaki Masuda: masuda@cahb.org
 
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September & October 2004 Volume 1 Number 6 & 7
 
Announcement
There will be no monthly health & biosciences forum in October. Next forum will be held in mid November. Stay tuned at http://www.cahb.org/forum.html for update.
 
Forum Report
Our fifth monthly Health & Bioscience Forum was held on August 27th, 2004. The speaker was Naoya Tsurushita, Ph.D., Director, Protein Engineering, Protein Design Lab, CA. He talked on “Engineering Antibodies for Human Therapeutics “.
 
Since the introduction of the hybridoma technology in 1975, monoclonal antibodies have rapidly become one of the most important tools in bioscience, with utility extending to therapy of human diseases. The use of monoclonal antibodies as therapeutics, however, was initially hampered by the fact that murine (and other rodent) antibodies proved to be highly immunogenic in humans. Therefore, major research efforts have focused on elimination, or at least reduction, of the immunogenicity of rodent monoclonal antibodies in humans. The humanization technology has ultimately made it possible to eliminate the immunogenicity of rodent antibodies in humans and opened a door to the application of monoclonal antibodies for treatment of human diseases. In addition, recent advances in antibody engineering have provided an opportunity to improve the efficacy of monoclonal antibodies as therapeutics. In this presentation, I will describe how antibody engineering, such as humanization and Fc engineering, has contributed to the development of antibodybased human therapeutics and discuss on the future direction of the research in antibody engineering.
 
We had about 20 attendees with diverse backgrounds from medicine to engineering to Japanese local government. Lively conversations continued after the presentation, over fresh sushi. For more information about the forum, please visit http://www.cahb.org/forum.html.

Hiroaki Masuda: hmasuda@cahb.org
 
Top 10 Bio News (September & October 2004)
1. Roche and Protein Design Labs (PDL) announced a worldwide agreement
Roche and Protein Design Labs (PDL) recently announced a worldwide agreement to co-develop and commercialize Zenapax(R) (daclizumab) for asthma and related respiratory diseases, based on recent positive phase II data in patients with moderate to severe asthma. Under terms of the agreement, PDL will receive a $17.5 million upfront payment as well as up to $187.5 million in development and commercialization milestones for successful further development of daclizumab. Both companies will globally co-develop daclizumab in asthma, share development expenses and co-promote the product in the US. Outside the US, PDL will receive royalties on net sales of the product in asthma.
 
2. Medarex and diaDexus Expand Collaboration For Development Of Fully Human Antibody Therapeutics
Medarex, Inc. and diaDexus, Inc. today announced an expansion of their existing collaboration for the research and development of fully human antibody therapeutics against novel cancer targets provided by diaDexus. Under the terms of this expansion, diaDexus and Medarex expect to develop antibodies against three novel cancer targets outside of the lung cancer field, which is the focus of the original collaboration between Medarex and diaDexus announced in January 2003. The two companies expect to share the cost of development and commercialization as well as potential profits resulting from any products developed through this collaboration.
 
3. Nymox Has Global Patent Rights to Use of Statin Drugs for the Treatment and Prevention of Alzheimer's Disease
Statins offer hope for a readily available treatment for the prevention of Alzheimer's disease according to Dr. Michael Munzar, Medical Director of Nymox Pharmaceutical Corporation. Statins are a class of cholesterol-lowering drugs that are the biggest-selling prescription pills in pharmaceutical history with estimated 2004 global sales of up to $26 billion. Alzheimer's disease is the leading cause of dementia in the elderly, afflicting an estimated 4.5 million people in the U.S alone. Nymox holds U.S. and global patent rights for the use of statin drugs for the prevention and treatment of AD.
 
4. Genentech Announces October 6 Webcast Discussion Of Earnings And Other Business Results
Genentech, Inc., a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs, will announce its 2004 3rd quarter earnings on Wednesday, October 6, 2004, after the markets close.
 
The announcement will be followed by a live webcast at 2:15 p.m. Pacific Time of a discussion by Genentech management of the earnings and other business results. The webcast can be accessed on Genentech's web site at http://www.gene.com/ and will be archived and available for replay until 5:00 p.m. Pacific Time on October 20, 2004.
 
An audio replay of the webcast will be available beginning at 5:15 p.m. Pacific Time on October 6, 2004 through 5:15 p.m. Pacific Time on October 13, 2004. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-9291 (international); Conference ID number is 128648.
 
5. Abbott To Present At Banc of America Securities And Merrill Lynch Conferences
Abbott Laboratories will present at two investor conferences next week: the Banc of America Securities 34th Annual Investment Conference and the Merrill Lynch Global Drug, Biotech & Medical Devices Conference. Thomas Freyman, executive vice president and chief financial officer, will present on the company at the Banc of America conference at noon Central time on Sept. 20, 2004, in San Francisco. In addition, John Thomas, divisional vice president, will make a company presentation at the Merrill Lynch conference on Sept. 22, 2004, at 11 a.m. Central time in London.
 
6. Third Wave Files Patent Infringement Suit Against Stratagene
Third Wave Technologies Inc. announced that it has filed suit against Stratagene Corp. of La Jolla, Calif., for infringement of Third Wave's patents covering its invasive cleavage structure chemistry. The suit was filed in U.S. District Court in Madison, Wisconsin, and seeks a permanent injunction against Stratagene that would prevent the sale of that company's probe-based quantitative PCR and RT-PCR reagents.
 
The patent infringement suit against Stratagene has been filed in the same court that heard a similar suit brought by Third Wave against EraGen Biosciences Inc. of Madison, Wisconsin. The court issued a ruling in that case confirming Third Wave's interpretation of the patent claims at issue. That suit was subsequently settled with Eragen's removal from the market of the products in question.
 
7. Xechem Receives a Broad U.S. Patent for Second Generation Paclitaxel
Xechem International, Inc. announced that it has received its eighth U.S. patent related to Paclitaxel (TAXOL(R)). The United States Patent and Trademark Office has granted Xechem a broad patent # 6,765,015 B2 with 37 claims for the second generation paclitaxel. This patent award extends the validity of the patents granted in China, Australia, New Zealand and seven European countries including Austria, Belgium, Ireland, France, Germany, Switzerland and the United Kingdom. Xechem now has over 20 international and domestic patents covering Paclitaxel and next it's generation taxane analogs. Paclitaxel was developed by the National Cancer Institute, National Institutes of Health and first marketed by Bristol Myers Squibb under the trade name TAXOL(R) for the treatment of ovarian cancer, thereafter breast cancer and Kaposi's Sarcoma.
 
8. Schatz & Nobel Announce Class Action Lawsuit Against Nektar Therapeutics
The law firm of Schatz & Nobel, P.C., which has significant experience representing investors in prosecuting claims of securities fraud, announces that a lawsuit seeking class action status has been filed in the United States District Court for the Northern District of California on behalf of all persons who purchased the securities of Nektar Therapeutics between March 4, 2004 and August 4, 2004, including anybody who purchased shares in the March 9, 2004 stock offering. The complaint alleges that Nektar issued a series of material misrepresentations to the market between March 5, 2004 and August 4, 2004.
 
9. Bankrupt biotech company gives up facility
Genteric Inc. intends to shutter the doors to its state-ofthe-art facility in Alameda, California, by October 1st. The 7-year-old biotechnology company lost a battle with its landlord and ended up in bankruptcy court. The company, which is researching ways to deliver vaccines for common diseases through a pill rather than by injection, plans to sell the bulk of its equipment through an auction held by DoveBid on Sept. 15. If the auction and a deal with its landlord are approved by the bankruptcy court, Genteric will use the proceeds to pay off creditors and then end its lease.
 
10. Vaccine Producer Aventis Pasteur Warned by FDA to Address Deficiencies at French Plant
The U.S. Food and Drug Administration warned vaccine producer Aventis Pasteur SA earlier this month it could face regulatory action, including license suspension, if prompt corrections were not made to quality control problems found at one of its French manufacturing plants. Released by the FDA Tuesday, the letter said the company, now a unit of drug giant Sanofi-Aventis, had not sufficiently addressed quality control issues found by FDA inspectors at its Lyon, France, manufacturing plant. The inspections occurred before the Sanofi-Synthelabo and Aventis merger earlier this summer.

Paul Candelaria: paul@cahb.org
 
USA Topics
Congressman Greenwood as BIO President
Congressman James C. Greenwood was recently named President of the Biotechnology Industry Organization (BIO).
 
The industry group represents more than 1,000 small and large companies, as well as academic and research centers which use biotechnology to develop medical, agricultural, industrial and environmental products. BIO has members in all 50 U.S. states and 33 other nations.
 
BIO Chairman and Alkermes CEO Richard Pops said, after a comprehensive search from a pool of top-level candidates, Jim Greenwood was the Board of Directors’ unanimous choice to lead BIO because of his commitment to improving people’s lives through science and technology and his personal leadership skills. He inherits one of the youngest but strongest and most vibrant trade groups in Washington.
 
BIO, under Jim Greenwood’s leadership, is now well positioned and ready to be an even more persuasive voice for thousands of researchers, many from small innovative companies, as well as encouraging a regulatory climate in Washington that will help our industry bring even more cutting- edge health products to patients and consumers around the world.
 
Given my seniority in Congress, and my role on the Energy & Commerce Committee, had virtually any other organization approached me, I would have politely declined to interview. However, I passionately believe in the promise of biotechnology to find cures and treatments for the diseases that force parents to watch their children suffer and die, and children to endure their parents・disintegration into the clutches of Parkinson’s and Alzheimer’s diseases, Greenwood said, continuing, the research and the science that BIO’s members represent hold so much potential: regenerative medicine to enable us to repair our organs and spinal cords, biotech crops and foods which can help feed the hungry, and biofuels to help save the environment.
 
Greenwood has represented the Eighth District of Pennsylvania in the U.S. House of Representatives since 1993 and serves on the Energy and Commerce and Education and the Workforce Committees. He previously served in the Pennsylvania House and Senate.
 
Since 2001, Greenwood has served as Chairman of the Energy and Commerce Subcommittee on Oversight and Investigations. In this position, he has investigated and held hearings on a wide array of issues including corporate governance issues at Enron and WorldCom, bioterrorism, and the security of our ports and borders.
 
Greenwood has been a leader on education and juvenile justice issues. He has also authored several pieces of critical legislation to ensure that Americans have access to the best health care in the world, including the Help Efficient, Affordable, Low Cost, Timely Healthcare (HEALTH) Act to provide reasonable limits on non-economic damages in medical liability lawsuits to preserve patient’s access to healthcare.
 
Greenwood has been active on environmental issues and has worked to increase communication among leaders to address international environmental issues, serving as President of Global Legislators Organization for a Balanced Environment (GLOBE) International. He is also a founder and co-chair of the House Oceans Caucus.
 
Congresswoman Anna Eshoo of Palo Alto, California commented, Congressman Greenwood has been a valued colleague and classmate whom I've had the privilege to partner with on many successful legislative initiatives. The Congress’ loss is BIO’s gain. Jim brings a wealth of knowledge, experience and wisdom to BIO and I'm very proud of him.
 
In addition, the National Multiple Sclerosis Society (NMSS) commented that throughout his career, Representative Greenwood has been a strong voice for the needs of patients. While we are sad to see him leave Congress," said NMSS CEO General Mike Dugan, "we are gratified that someone with his balanced perspective has been chosen to lead this important biotechnology industry group. We wish him well and look forward to working with him in his new role.
 
Greenwood will be taking over from Carl B. Feldbaum who has headed BIO since its establishment in July of 1993. BIO has grown from 16 employees and a $2.1 million budget to almost a 100 member staff with a $40 million budget. Membership has increased from 350 companies to over 1,000. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.
 
Feldbaum, who announced in February that he would retire this year, said, Jim Greenwood has the broad social perspective, the passion, ability and experience to lead BIO superbly in the future. I could not be more enthusiastic in passing this baton to our industry’s next generation of leadership.

Paul Candelaria: paul@cahb.org
 
What is BioSpace?
Part 6 – BioCorridor (Wisconsin, Minnesota, Michigan, Missouri, Iowa, Ohio, Indiana, and Illinois)
Because of the dramatic growth and success of the life science industry in Wisconsin, Minnesota, Michigan, Missouri, Iowa, Ohio, Indiana, and Illinois, BioSpace has decided to launch the BioCorridor™ Hotbed Campaign. This marketing campaign for the Midwest Life Science Community will assist the cluster in attracting and retaining valuable resources.
 
As of Oct 2004, BioCorridor consists of 202 organizations including bioscience and pharmaceutical companies, industry service and supply companies, research institutes, non-profit organizations, and universities. Selected are:
 
Abbott Laboratories (Pharmaceutical and Medical Products, Abbott Park, Illinois) was founded by a young Chicago physician, Dr. Wallace Calvin Abbott, in 1888, Abbott Laboratories has evolved into a diversified health care company that discovers, develops, manufactures and markets innovative products and services that span the continuum of care – from prevention and diagnosis to treatment and cure.
 
  • Dowpharma (Pharmaceutical, Midland, Michigan) serves the pharmaceutical and biopharmaceutical industries with innovative technology, products, and services for clients in drug discovery, development, manufacturing, and delivery. Services include process development, route selection, methods development, custom solubilization, including BioAqueous* solubilization services, chiral capabilities, and associated analytical services, biotargeted radiopharmaceuticals development through ChelaMed radiopharmaceutical services, as well as manufacturing and scale-up from feasibility, through clinical trials, to commercial manufacturing. Dowpharma currently manufactures small molecule Active Pharmaceutical Ingredients (APIs) and intermediates, oligonucleotides, cGMP polymers, peptides and therapeutic proteins from microbial fermentation, including Pfenex Expression Technology, a Pseudomonas based system, and plant-based systems.
  • Eli Lilly and Company (Pharmaceutical, Indianapolis, Indiana) is a leader in the pharmaceutical industry. The company employs more than 46,000 people worldwide and markets its medicines in 138 countries. Their medicines treat depression, schizophrenia, attention deficit hyperactivity disorder, diabetes, cancer, osteoporosis and many other diseases.
  • MPI Research (Contract Research Organization, Mattawan, Michigan) exists to provide comprehensive non-clinical research that meets the requirements of pharmaceutical, animal health and chemical companies as well as governmental agencies.
  • Pfizer (Pharmaceutical) is a global pharmaceutical company, headquartered in New York. Pfizer discovers, develops, manufactures, and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands. Although Pfizer is headquartered in New York, it has three branches in BioCorridor region;

    • - Ann Arbor, MI . . . A culturally, economically, and socially diverse university town, home to the University of Michigan and three major medical centers. Residents there enjoy an easy pace of living, in a city that's easy to get around in, and one that boasts numerous outdoor recreational activities.
    • - Kalamazoo, MI . . . In the language of the Potawatomi Indians who first lived here, Kalamazoo means "boiling water." To its current residents and our Kalamazoo colleagues, the Greater Kalamazoo area means an ocean of fresh cold-water lakes and streams; a calendar full of festivals, sports and outdoor activities; a steady diet of fine restaurants, wineries and breweries; as well as museums, schools, and colleges that will stimulate your mind.
    • - St. Louis, MO . . . Known as the Gateway to the West, St. Louis is a diverse, vibrant metropolitan area of 2.5 million, with a broad-based economy. Residents enjoy professional sports teams, a world-class symphony orchestra, botanical gardens, and numerous other outdoor activities. Additionally, scientists have the opportunity to collaborate with researchers at Washington University School of Medicine.
  • Roche Protein Expression Group (Biotechnology, Indianapolis, Indiana) leverages 25 years of protein production experience to produce high quality preparative amounts of protein. Part of Roche Diagnostics, RPEG is a full-service protein production facility offering custom cell-free protein expression including activation of Kinases, expression in the presence of ligands and selective labeling.
  • Takeda Pharmaceuticals North America (Pharmaceutical, Lincolnshire, Illinois) a wholly owned subsidiary of Takeda Chemical Industries, Ltd. Takeda Chemical Industries is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the industry's leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by developing superior pharmaceutical products.
For more information and news update, visit BioCorridor website http://www.biospace.com/hotbed.cfm?RegionID=619.

Hiroaki Masuda: masuda@cahb.org
 
Bio-Novelty
Fusion or differentiation
Ms. Helen Blau is the one of the famous professors in Stanford University. She is the first woman professor who graduated from Stanford University. Her major is pharmacology and has been dedicating skeletal muscle study. She applied the gene therapy for Duchene muscular dystrophy (DMD) patients for the first time in the world. She is now dedicating the role of bone marrow stem cells (BMSC) research for skeletal muscle. Taken her several papers together, I can conclude her research is fusion theory or differentiation theory of BMSC.
 
Theise ND and Krause DS reported that BMSC differentiated into hepatocytes and neuron by using Ychromosome method in 2000 (Hepatology. 2000 Jan;31(1):235-40). They demonstrated that Y-positive hepatocytes, up to 2.2% of total hepatocytes, were identified in one animal at seven days post transplantation and in all animals sacrificed two months or longer post transplantation. They concluded that hepatocytes could be derived from bone marrow cells after irradiation without severe acute injury. The small subpopulation of CD34(+)line(-) bone marrow cells was also reported to be capable of such hepatic engraftment.
 
In contrast, Wagers AJ and Weissman IL reported that BMSC did not differentiate into other cells (Science. 2002 Sep 27;297(5590):2256-9. Epub 2002 Sep 05, Cell. 2004 Mar 5;116(5):639-48). In 2003, Weissman IL concluded that those produced cells that Klaus reported to be outcomes from the differentiation were just fusion cells. There has been intense debate between two parties.
 
In her conclusion, Helen Blau stated that BMSC could differentiate into other cells and fusion cells from BMSC could differentiate into the cells that BMSC fused if stimulation was added to some extent. Her theory is a kind of combination theory between Klaus and Weissman. Supported by the enormous data, her theory seems to convince the audience at the Stanford University.

Toshihiko Nishimura: toshi@cahb.org
 
Top
 
August 2004 - Volume 1 - Number 5
 
Announcement
 
Health & Bioscience Forum
Fifth Monthly Lecture Series
 
“Engineering Antibodies for Human Therapeutics”
 
Speaker
Naoya Tsurushita, Ph.D.
Director, Protein Engineering
Protein Design Lab
 
Date: August 27, 2004 (Friday)
Time: 6:30 p.m. - 8:00 p.m.
Place: 525 Middlefield Road, Suite 100
Menlo Park, CA 94025
 
Networking Time: 6:00-6:30, 8:00-8:30 p.m.
Light refreshment will be served
 
 
Forum Report
 
Our fourth monthly Health & Bioscience Forum was held on July 29th, 2004. The speaker was Kosuke Ishii, Professor of Mechanical Engineering, Stanford University. He talked on “Customer Value Chain Analysis (CVCA) - Key to Success in Medical Device Development“. CVCA is a methodological tool that aids design teams in the product definition phase to identify pertinent stakeholders, their relationships, and their role in the product’s life cycle.

We had about 30 attendees with diverse backgrounds from medicine to news media. Lively conversations continued after the presentation, over fresh sushi. For more information about the forum, please visit http://www.cahb.org/forum.html.

Hiroaki Masuda: hmasuda@cahb.org
 
Top 10 Bio News (August 2004)
1. Senate Panel OKs Bill To Create Facility At Cal State Hayward
Assemblywoman Ellen Corbett's uncompromising desire to create a biotechnology center at California State University in Hayward, continued to gain support, the latest coming from a state subcommittee. The Senate Appropriations Committee last week signed off on Bill 1885, which calls for the creation of such a center at Cal State Hayward. For the past year, the assemblywoman has spearheaded efforts to bring the East Bay Biotechnology Center to Cal State Hayward.
 
2. Venture Capitalists Return To Startups: Eighty-five Biotech Companies Attracted $923 Million
The life-sciences sector, which includes biotechnology and medical devices, continued to remain near historical highs, as it has for the past eight quarters. Investments in that sector totaled $1.41 billion, or 25% of the quarter's venture capital. However, eighty-five biotech companies attracted $923 million, down from the $968 million that went into 77 biotech companies in the first quarter of 2004. Meanwhile, funding for 70 medical- device companies jumped 40% to $485 million; that compares with the $344 million that went to 56 companies in the first quarter of the year.
 
3. Adeza Biomedical Corporation Files Registration Statement for Proposed IPO
Sunnyvale-based, Adeza Biomedical Corporation announced today that it has filed a registration statement relating to the proposed initial public offering of its common stock with the U.S. Securities and Exchange Commission. All of the shares are to be sold by Adeza. The number of shares to be offered and the price range for the offering have not yet been determined. Adeza's principal product is a patented diagnostic test, the Fetal Fibronectin Test, that utilizes a single-use, disposable cassette and is analyzed on Adeza's patented TLiIQ(R) System. This product is approved by the FDA for broad use in assessing the risk of preterm birth.
 
4. FDA Approves Eli Lilly and Company's Alimta For The Second-Line Treatment Of Advanced Lung Cancer
Eli Lilly and Company's anti-cancer drug Alimta received its second U.S. approval in 2004. The FDA granted accelerated approval for the treatment of locally advanced or metastatic non-small cell lung cancer in previously treated patients. In February, Alimta was approved, in combination with cisplatin (a common chemotherapy agent), for the treatment of malignant pleural mesothelioma, a cancer often associated with asbestos exposure.
 
5. Othera Pharmaceuticals Closes $13 Million In Venture Capital Financing
Othera Pharmaceuticals Inc., a privately-held ophthalmic pharmaceutical company developing proprietary drugs to treat or prevent the three leading causes of blindness, announced today that it has raised $13 million in a Series B financing to fund further clinical development of its ophthalmic drug pipeline. The financing was led by NewSpring Ventures, Commerce Health Ventures, and included investments from Johnson & Johnson Development Corporation and Liberty Venture Partners.
 
6. Science Recreates Mad Cow Disease
Scientists have produced a prion protein that can trigger the development of a neurological disorder in mice that is similar to mad cow disease, according to a new study supported by the National Institute on Aging (NIA), a part of the National Institutes of Health. The findings demonstrate that prions, an unusual class of infectious proteins, can make copies of themselves without the presence of viral DNA or RNA, damage brain tissue, and cause neurological diseases. The work by Nobel Laureate Stanley B. Prusiner, M.D., and colleagues at the University of California, San Francisco produced prion protein fragments in bacteria, folded them into larger protein structures called amyloid fibrils, and then injected them into the brains of susceptible mice. The mice began exhibiting symptoms of disease in their central nervous systems between 380 and 660 days after they were given the synthetic prion proteins.
 
7. Bio-Rad Purchases MJ GeneWorks
Hercules, California-based Bio-Rad Laboratories, Inc., a manufacturer and distributor of life science research products and clinical diagnostics, announced today that it has completed the purchase of MJ GeneWorks, Inc., and its subsidiaries, including MJ Research, Inc., for approximately $32 million in cash. The sale is effective immediately. MJ Research, based in Waltham, Massachusetts, is a life science company that specializes in premium instruments and consumables used in modern biological research, including thermal cycling instrumentation and reagents used to amplify DNA. MJ Research pioneered the use of Peltier-effect technology and has introduced a number of other innovations in the thermal-cycling field.
 
8. Merck & Co., Inc. Executes Exclusive Patent License and Collaborative Research and Development Agreement with
    Kyorin Pharmaceutical
Merck & Co., Inc. announced that it has entered into an exclusive patent license and collaborative research and development agreement in the infectious diseases field with Kyorin Pharmaceutical Co., Ltd. of Tokyo, Japan. Under the terms of this latest agreement, Kyorin grants Merck an exclusive worldwide license, excluding Japan, for the development, manufacture and sale of any products that result from the collaboration. Merck will make milestone payments to Kyorin and pay royalties based on product sales. Merck is a global research- driven pharmaceutical products company.
 
9. Galileo Genomics Purchases Illumina BeadStation Platforms to Fine Map Candidate Regions For at Least Five Disease
    Gene Discovery Programs
San Diego-based Illumina, Inc. and Galileo Genomics Inc. today announced that they have signed a collaborative agreement with a value exceeding $1.5 million. Under the terms of the agreement, Galileo has purchased two Illumina BeadStation 500GX genotyping systems for use in fine mapping candidate regions in a minimum of five disease gene discovery programs. The resulting information will be used to produce GeneMaps, comprised of multiple interacting genes unequivocally associated with disease, which will be used for the development of innovative therapeutics, diagnostics and pharmacogenomics services. Illumina is also licensing the diagnostic rights to Galileo's osteoarthritis gene discovery program.
 
10. Simova Updates On Phase I Human Clinical Testing Of SARS Vaccine
Sinovac Biotech Ltd. announces that all 36 subjects of the Phase I human clinical trial for its inactivated SARS vaccine have now been vaccinated with either SARS vaccine or placebo. The final 12 subjects in the second group of 18 volunteers have received the vaccination, 6 subjects on July 28 and 6 subjects on August 4, 2004. No adverse side-effects have been observed. As previously announced, the first 6 of this second group of 18 volunteers in the SARS vaccine trial were injected on July 15, 2004. These subjects together comprise the second group of 18 second group of 18 volunteers, which has been injected with either the high-dosage SARS vaccine or a placebo.

Paul Candelaria: paul@cahb.org
 
USA Topics
Stock Scheme Pushed Up Share Price Of Biotech Company
Stock scheme is being disguised as wrong number
An old stock scam with a new gimmick is ensnaring investors and has pushed up the share price of a biotech company, prompting the Securities and Exchange Commission to warn the public.
 
The classic "pump-and-dump" scheme, in which promoters hype a stock to build up its price and then sell their shares before the price plummets has been updated.
 
People checking their cell phone voice mail and home answering machines are finding a message from a woman who has apparently misdialed and, unaware of her mistake, left a stock tip for a friend. The well-crafted subterfuge even has the woman making chewing noises and apologizing for eating. The stock the woman tells her friend to buy is one sold on lightly regulated and thinly traded exchanges, called the pink sheets and the Over-the-Counter Bulletin Board.
 
A Manhattan Beach, California attorney, who represents one of the companies, said that the SEC staff attorney who is working on this case told him that there are five companies that are being touted this way, and none of the companies seemingly know anything about it. The SEC declined to identify the companies being promoted through the scheme and said that, "Right now we don't know who it is and we don't know if the companies are behind this or not."
 
The SEC is scheduled to make a formal announcement about the scam and ask for the public's help to locate the source of the messages. It is not a crime to talk up a stock or be compensated to do so. But it could be fraud and a violation of federal securities law if an investment professional does not tell potential investors about being paid to promote a stock and uses tactics that manipulate the markets.
 
For example, on August 11, 2004, just under 380,000 shares of Texas-based X Biotech Company were traded, and the stock closed at $2.17. The next day, 2.34 million shares were bought and sold, and the stock closed at $2.85. By Tuesday, the volume reached 5.69 million, and the stock closed at $4.38, more than double its price just four trading days earlier. It fell back 20.8 percent Wednesday to close at $3.47 on volume of 2.92 million.

Paul Candelaria: paul@cahb.org
 
What is BioSpace?
Part 5 - BioCapital (Maryland, Virginia, Delaware, and Washington, DC)
Recognizing the Maryland, Virginia, Delaware and Washington, DC area as an international life sciences hub, BioCapital has been one of the most active hotbeds in BioSpace.
 
As of Aug 2004, BioCapital consists of 66 organizations including bioscience and pharmaceutical companies, industry service and supply companies, research institutes, non-profit organizations, and universities. Located in the capital of the US government, two well-known national institutions are listed in BioCapital:
 
  • Food and Drug Administration (FDA) is a team of professionals working to protect, promote and enhance the health of the American people. FDA is responsible for ensuring that: Foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe.
  • National Institutes of Health (NIH) begun as a one-room Laboratory of Hygiene in 1887, NIH is one of the world's foremost biomedical research centers, and the Federal focal point for biomedical research in the U.S. Its mission is to uncover new knowledge that will lead to better health for everyone. The NIH comprises the office of the Director and 27 Institutes and Centers with 18,000 employees. $27B has been funded in FY2003 Congressional Appropriations. This photo (© NIH) shows the "Shannon Building," serving as NIH headquarters in the heart of the campus in Bethesda, Maryland.
Leading companies in bioscience and pharmaceutical industry are in the participant list as well.
 
  • AstraZeneca Pharmaceuticals LP is one of the top five pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. Headquartered in Wilmington, Delaware (USA) and 60,000 employees worldwide.
  • Baxter BioScience Corporation, MD business provides biopharmaceuticals derived from human plasma or recombinant technology to treat hemophilia, immune deficiencies and other blood-related disorders. It also provides vaccines for the prevention and treatment of certain infectious diseases, as well as bio-surgery products.
  • Eli Lilly and Company creates and delivers innovative medicines that enable people to live longer, healthier and more active lives, and markets in 146 countries, with more than 43,000 employees worldwide.
  • QIAGEN Sciences, Inc. is the market and technology leader in nucleic acid sample handling, separation and purification, established in 1986. It is committed to the global biotechnology market, with more than 1,600 employees in twelve countries.
  • Celera Genomics Corporation is engaged principally in integrating advanced technologies to discover and develop new therapeutics. It intends to leverage its capabilities in proteomics, bioinformatics and genomics to identify and validate drug targets and diagnostic marker candidates, and to discover novel therapeutic candidates.
 
BioCapital “Interactive Media Campaign”, conducted from 2001 to 2003, was a remarkable multi-media program designed to heighten awareness surrounding both the participating organizations and the BioCapital community. Utilizing BioSpace’s high visibility, the campaign provided two years of highly focused branding, directly reaching the vertical audience ”for less than the cost of one display ad in a Sunday newspaper”. A combination of advertising, marketing and industry awareness initiatives, the campaign consisted of two key elements below:
 
BioCapital “Interactive Media Campaign”, conducted from 2001 to 2003, was a remarkable multi-media program designed to heighten awareness surrounding both the participating organizations and the BioCapital community. Utilizing BioSpace’s high visibility, the campaign provided two years of highly focused branding, directly reaching the vertical audience ”for less than the cost of one display ad in a Sunday newspaper”. A combination of advertising, marketing and industry awareness initiatives, the campaign consisted of two key elements below:
 
1) BioCapital Map: Participant company’s building, logo and location relative to other companies in the BioCapital community is displayed on BioCapital Map. The map, recognized as a global branding tool is distributed industry wide over a two-year period at events, in media kits and by request.
 
2) A web-based interactive functionality: The BioCapital Map is duplicated on the BioSpace.com website, where your position on the map is linked to a detailed company profile. The profile consists of news and information regarding the organization and career opportunities posted on BioSpace. It is also linked to the company's website. This profile provides a highly visible presence to BioSpace.com's audience of over one million unique visitors per month.
 
For more information and news update, visit BioCapital website http://www.biospace.com/hotbed.cfm?RegionID=9.

Noriko Oki: oki@cahb.org
 
Top
 
July 2004 - Volume 1 - Number 4
 
Announcement
 
Health & Bioscience Forum
Seventh Monthly Lecture Series
 
“Customer Value Chain Analysis”
- Key to Success in Medical Device Development -
 
Speaker:
Kosuke Ishii, Ph.D.
Professor of Mechanical Engineering
Stanford University
 
Date: July 29, 2004 (Thursday)
Time: 6:30 p.m. – 8:00 p.m.
Place: 525 Middlefield Road, Suite 100
Menlo Park, CA 94025
 
Networking Time: 6:00-6:30, 8:00-8:30 p.m.
Light refreshment will be served
 
 
Top 10 Bio News (July 2004)
1. Draft Of Dog Genome Sequence Unveiled In US, Available Worldwide
US researchers have unveiled the first draft of the dog genome sequence, making it available around the world, the US National Human Genome Research Institute (NHGRI) said. A team of researchers picked a boxer dog out of 120 canines representing 60 breeds because of little variation in its genome sequence, making it the best reference for canines.
 
2. Mayo Clinic Use Human Antibody To Cure Malignant Melanoma In Mice
Mayo Clinic researchers have manipulated a human antibody to induce an anti-tumor response in living mice that consistently curbs, and often cures malignant melanoma, one of the most lethal forms of skin cancer and the most common cancer of young adults. Cancer immunotherapy refers to scientist-controlled manipulations of the immune system to kill cancer cells without the toxic side effects of chemotherapy or radiation.
 
3. Mouse Brain Stem Cells Capable Of Converting Into Blood Vessel Cells
Adult stem cells in the brains of mice possess a broader differentiation potential than previously thought and may be capable of developing into other cell types including those involved in the formation of new blood vessels, according to a new study supported by the National Institute on Aging (NIA), a part of the National Institutes of Health. The finding could help resolve a critical question about these promising, but still mystifying cells.
 
4. Technology That Reduces Infectious Prions "Mad Cow Disease" From Blood Unveiled At International Transfusion     Meeting
Pall Corporation unveiled an innovative, proprietary technology that reduces prions from blood prior to a transfusion at the annual meeting of the International Society for Blood Transfusion (ISBT). The soon to be released Leukotrap(R) Affinity Prion Reduction Filter will provide the dual benefit of reducing harmful white blood cells while also reducing infectious prions, the rogue proteins that cause variant Creutzfeldt-Jakob Disease (vCJD).
 
5. Bayer To Acquire Roche Holding's Roche Consumer Health for $3 Billion
Bayer announced that it has agreed to acquire Roche Consumer Health. By acquiring this business, Bayer will become one of the top three over-the-counter (OTC) consumer health companies worldwide. Additionally, Bayer will acquire Roche's 50 percent share of the 1997 Bayer/Roche joint venture in the U.S., (an element not included in Roche's original offering) and five Roche production sites in Grenzach (Germany), Gaillard (France), Pilar (Argentina), Casablanca (Morocco) and Jakarta (Indonesia). The OTC business of the Japanese company Chugai, in which Roche has a majority stake, is not included. The acquired business has yearly sales of around EUR 1 billion.
 
6. Novavax HIV Vaccine Programs and its Five-Year Contract Cancelled
Novavax, Inc. today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), has cancelled its five-year contract for the development of human immunodeficiency virus (HIV) vaccine candidates due to programmatic considerations for "the government's convenience." Novavax had been the prime contractor, with Emory University, Tulane University, and the University of Pittsburgh as subcontractors.
 
7. New Method Enables Researchers To Make Human SARS Antibodies Quickly
Human antibodies that thwart the SARS virus in mice can be mass-produced quickly using a new laboratory technique developed by an international research team collaborating with the National Institute of Allergy and Infectious Diseases (NIAID). The new technique could become an important tool for developing a cocktail of SARS-specific antibodies that might help protect people recently exposed to the SARS virus or at high risk of exposure.
 
8. U.S. Congress OKs $5.6B For Bioweapons Vaccines
Enough new-generation anthrax vaccine to dose 25 million people: That's first on the government's shopping list under a massive new program to develop and stockpile antidotes to biological and chemical weapons. Called Project BioShield, the $5.6 billion program passed the House on a 414-2 vote July 14, 2004. The Senate passed it in May and President Bush's signature is guaranteed. Federal health officials have their wish-list ready: antidotes for botulism and anthrax, a safer smallpox vaccine, and a long-awaited children's version of an anti-radiation pill.
 
9. Pfizer Chief Says He Expects to Win Appeal of China's Decision to Overturn Viagra Patent
Pfizer Inc., the U.S. maker of Viagra, expects to win an appeal of a recent decision by Chinese regulators to overturn the company's patent there, according to the company's top executive. Hank McKinnell, Pfizer chairman said overturning the ruling would have little effect on Pfizer's bottom line. However, the move would be welcomed by foreign investors wary of China's stance on intellectual property rights, he said.
 
10. Quigley Receives U.S. Patent For Its Topical Treatment For Radiation Dermatitis
The Quigley Corporation announced that it has received a patent for QR-335, its topical treatment designed to potentially prevent and relieve the effects of radiation dermatitis. The U.S. Patent, No. 6,753,325 B2 is entitled Topical Compositions and Methods for Treatment of Adverse Effects of Ionizing Radiation. A pre-clinical "proof of concept" study on pigskin is currently being planned, since pigs are an established animal model for the testing of likely human skin reactions.

Paul Candelaria: paul@cahb.org
 
USA Topics
Biotech Outsourcing – the next big wave
The Indian industry is planning an outsourcing encore. This time, it is slated to happen in the biotech sector. Currently valued at $120 million, biotech outsourcing in India is quickly turning out into a major money spinner for companies involved in contract and clinical research activities. Out of this, $50 million is raised from contract research and the rest from clinical research.
 
Added to that, a new concept called research process outsourcing (RPO), is finding its feet as well. Five years ago, outsourcing was a word alien for the industry but things have changed. Biotech outsourcing from India is growing at a rate of 75% and experts are predicting that the business would touch $1 billion in the next five years.
 
Globally, $40 billion is the R&D outsourcing expenditure in the pharmaceutical industry on an annual basis. In comparison, India's contribution at this stage would seem minimal, but taking into consideration India's scientific talent pool, it may not be that tough for it to break into the $1 billion club.
 
India had snared a 3% share of the global IT outsourcing market, and the biotech industry is aiming for exactly that. It is expected that India along with Russia and the East European block will become outsourcing destinations of the world and among these nations, India hold the edge due to its superior communication skills and IT talent.

Paul Candelaria: paul@cahb.org
 
What is BioSpace?
Part 4 - Bio NC (North Carolina)
North Carolina is one of the east-coast states, surrounded by Virginia on the North, Tennessee on the West and South Carolina on the South. According to the 2000 U.S. Census, about 8.2 million people call North Carolina home. That makes the state the 11th most populous in the nation. Raleigh has the State Capitol, but the largest city in NC is Charlotte as below.
 
<Top 5 cities ranked by population>
• Charlotte—540,828
• Raleigh—276,093
• Greensboro—223,891
• Durham—187,035
• Winston-Salem—185,776
 
Biotech NC consists of 108 organizations including universities, research institutes and companies (as of July 2004). The development of this area largely relies on colleges and universities. These academic organizations throughout North Carolina provide a strong foundation for the state's growing bioscience community through research, technology transfer, teaching and public service. Some of the campuses with extensive bioscience activities include:
 
• Duke University
• East Carolina University
• North Carolina Central University
• North Carolina State University
• University of North Carolina at Chapel Hill
• University of North Carolina at Charlotte
• University of North Carolina at Greensboro
• University of North Carolina at Wilmington
• Wake Forest University School of Medicine
 
Role of The North Carolina Biotechnology Center, which is a private, non-profit corporation established in 1981 by the state's General Assembly, cannot be neglected. The Center's mission is to provide long-term economic benefit to North Carolina through support of biotechnology research, development and commercialization statewide. The Center does not, however, perform laboratory research.
 
With the help of its working partners and the financial support of the General Assembly, the Center has made targeted investments in biotechnology that have been leveraged into substantial gains for the state. Selected accomplishments include:
 
  • Providing $10.6 million in financial assistance to 70 early stage biotechnology companies, which have gone on to raise more than $500 million from other sources.
  • Working to recruit, retain and expand biotechnology companies including Biogen Idec, Diosynth RTP and Novozymes, collectively responsible for 1,000s of highpaying jobs.
  • Investing more than $50 million to recruit 46 outstanding faculties, purchase multi-user research equipment, and sponsor more than 450 research projects at North Carolina universities. For every $1 invested in research projects by the Biotechnology Center, the universities have gained about $14 in federal grants.
  • Preparing more than 1,100 teachers in North Carolina to teach about biotechnology. In turn, they have given lessons and labs to 100,000's of students.
  • Tripling enrollment in the biosciences at the state's six historically minority universities by granting $8 million in special appropriations to improve the institutions' biotechnology programs.
 
In addition, a number of non-academic research facilities in the state contribute to North Carolina's high caliber of bioscience research:
 
  • National Institute of Environmental Health Sciences:
    The only one of the National Institutes of Health located outside of Washington. The Institute helped to identify the first breast cancer gene, BRCA1. Dr. Martin Rodbell, co-recipient of the 1994 Nobel Prize in Medicine, called the Institute home
  • National Institute of Environmental Health Sciences:
    The only one of the National Institutes of Health located outside of Washington. The Institute helped to identify the first breast cancer gene, BRCA1. Dr. Martin Rodbell, co-recipient of the 1994 Nobel Prize in Medicine, called the Institute home
  • Environmental Protection Agency
    The Agency's largest complex outside of Washington is home to a one-third of its research activity
  • Microelectronics and Supercomputing Center of North Carolina
    Provides molecular and protein modeling capabilities, among other resources
  • North Carolina Supercomputing Center
    The Supercomputing Center is developing the North Carolina BioGrid to give life science researchers fast access to genetic data

Noriko Oki: oki@cahb.org
 
Potpourri
ABC
“He is ABC”, said my Chinese friend. I have worked in Stanford University for six years. I have seven colleagues including three Chinese medical doctors. Guohua was an associate professor in Gowangchow, Linfang was a chief resident in Shanghai, and Daoming was also a chief resident in Peiging. They are not ABC, but CBC. ABC stands for America Born Chinese and CBC is China Born Chinese. The Chinese can tell themselves between ABC and CBC. Maybe I can tell by the accent of their spoken English. It’s so hard for me to understand CBC’s speaking. On the other hand ABC’s English is much clearer and more understandable than American. Chinese are diligent and so they may learn very carefully how to speak English if they are born in USA as ABC.
 
There are many China towns all over the world. Wherever we travel, we can find a China town in a city. Why? Once a Chinese leads a life in a place and he/she tries to call his/her family and his/her relatives. One Chinese does so and others do the same things. They can, then, build a Chinese community and have a China town there. As of today the population in Mainland China is more than 1.3 billion that is more than 20 % of the world’s population. If we calculate the population of all the Chinese in the world not only in Mainland China but also the Chinese out side of main land, the number will be more than 2 billion.
 
The mayor in San Francisco was a Chinese who was ABC. The current president is George Bush, but in the close future I can guess that we will see a Chinese president in United States of America. He/She must be ABC.

Toshihiko Nishimura: toshi@cahb.org
 
Acknowledgment
 
Publication of CAHB Newsletter is made possible by CLEA International, Inc., a subsidiary of CLEA Japan, Inc. This photo shows its Yaotsu breeding facility in Gifu prefecture, Japan, for common marmosets. Central Institute for Experimental Animals (CIEA), a not-for-profit organization in Japan, also greatly supports CAHB activity.

CLEA Japan, Inc. http://www.clea-japan.com/

CIEA http://www.rash2.com/CIEA.htm
 
Top
 
June 2004 - Volume 1 - Number 3
 
Announcement
There will be no monthly health & bioscience forum in June. Next forum will be held in late July. Stay tuned at http://www.cahb.org/forum.html.
 
Top 10 Bio News (May – June 2004)
1. Accumetrics Secures Funding Led by Essex Woodlands Ventures
San Diego-based Accumetrics, Inc., maker of the VerifyNow line of diagnostic tests, announced that it has raised $13.5 million in equity financing from a syndicate of private, corporate and venture investors led by Essex Woodlands Health Ventures. Other investors in the round are PTV Sciences, KB Partners and Telegraph Hill Partners. The company specializes in point-of-care tests to evaluate the effectiveness of antiplatelet therapy, a mainstay of treatment for patients with cardiovascular disease.
 
2. University of Toronto Study Links Tumors and Proteins
Protein long thought to be involved in repairing DNA that is damaged during normal metabolic processes is linked to tumor suppression, says a new University of Toronto study. The researchers discovered that reduction or loss of a protein called Mus81 led to the development of lymphomas and other tumors in mice. The research is published in the June 18 edition of Science, and demonstrates Mus81’s role in preventing cancer and illustrates that, contrary to popular belief, it is not necessary for processing Holliday Junctions.
 
3. Roche Submits Application To U.S. FDA For New Formulation Of Invirase
Roche announced the submission of a New Drug Application to the U.S. Food and Drug Administration for approval to market a new 500 mg tablet formulation of its HIV protease inhibitor Invirase(R) (saquinavir mesylate). The new formulation is smaller in size than the currently available 200 mg Invirase capsule and, if approved, will reduce pill count for each dose by more than half. A filing for approval to market the new formulation in the European Union will be submitted to the European Medicines Agency within days of the U.S.
filing.
 
4. Sanko Junyaku to Launch Diagnostic Test Kit for Hepatocellular Carcinoma
Sanko Junyaku Co., Fujirebio Inc., and Eisai Co., announced that Sanko Junyaku will launch on August 3, 2004, Lumipulse Pivka-II Eisai, a test kit (in vitro diagnostics) to determine Des-Carboxy-Prothrombin. The test kit will be used for Lumipulse, automatic chemiluminescent enzyme immunoassay system developed and marketed by Fujirebio.
 
5. Renowned UCLA Molecular Biologist Named to NeoStem Advisory Board
NeoStem, a company committed to pioneering adult stem cell therapeutics, announced today that Richard A. Gatti, M.D., Co-Director of the Molecular Pathology Laboratory at UCLA, has been named to the firm's Medical Advisory Board. Dr. Gatti is currently a distinguished professor of Pathology and Laboratory Medicine. He is a world-renowned molecular geneticist and immunologist and a pioneer in transplantation medicine.
 
6. Stanford Researchers Eye New Chip's Potential as an Artificial Retina
Researchers at the Stanford have developed a prototype for a new kind of implantable chip they believe could be adapted to serve as both a prosthetic retina for people who suffer from a common form of age-related blindness and as a drug-delivery system that could treat conditions such as Parkinson's disease. Where other types of chips use electricity to stimulate nerves, this one instead tickles cells with minute amounts of chemicals. Because nerve cells normally communicate with each other by releasing chemicals known as neurotransmitters, the new device points to a more effective way of treating very delicate tissues, such as those in the eye and in the brain.
 
7. Interleukin Receives Patent For Pharmacogenetic Tests For Asthma
Interleukin Genetics reported that it was awarded Patent No. 6,746,839 B1 by the U.S. Patent and Trademark Office for methods and kits that use specific genetic markers to assist in the diagnosis and management of an obstructive airway disease, such as asthma.
 
8. AGY Therapeutics At 11th Annual Euro-Biotech Forum
South San Francisco-based AGY Therapeutics Inc. announced that Cynthia J. Ladd, the company's president, made a presentation at Windhover Information's 11th Annual Euro-Biotech Forum last June 22nd in the Salon Napoleon at the Hotel Inter-Continental in Paris. She provided an update on progress in AGY's drug development programs made through the application of its proprietary central nervous system discovery and technology. The company's lead development program is for functional recovery after a stroke, which has a product candidate targeted to enter clinical trials in early 2005.
 
9. Pall Corporation To Reduce Potential Risk Of Mad Cow Disease
Innovations in membrane filtration developed at Pall Corporation will help reduce potential BSE (Bovine Spongiform Encephalopathy) contamination in biologicals and biotherapeutics. BSE is one of a family of invariably fatal, progressive, neuro-degenerative diseases widely believed to be caused by infectious proteins known as prions. Recent data demonstrate that Pall membrane technologies, validated to remove a host of viral and bacterial pathogens, can also remove prions for a range of applications. These include removing prions from animal growth factors and serum that are used to manufacture drug therapies, as well as prion clearance from breathing filters used in medical procedures and from blood prior to transfusions.
 
10. Cardima Meets With FDA Regarding Revelation Tx Microcatheter
Cardima today announced that it met with the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) on June 18th, in response to the FDA's encouragement for Cardima to meet with FDA representatives subsequent to the issuance of the FDA's letter stating that Cardima's Revelation Tx Microcatheter system pre-market approval application (PMA) was NOT approvable.

Paul Candelaria:
paul@cahb.org
 
USA Topics
New Research Shows That "Mighty Mouse" Gene Found In Humans.
 
By studying the genes of an unusually muscular child, scientists have identified a gene in human which has also been used to create "mighty mice" in the lab. The discovery means that successful therapies for degenerative muscle diseases in mice that target this gene might be also effective in humans.
 
Subject of the research is a boy, whose mother is a professional sprinter. He is so strong that at the age of just four and a half he can hold a three-kilogram weight in each hand with his arms outstretched horizontally. The international team of scientists has shown that the boy has a single mutation in the gene for a protein called myostatin. This gene has previously been examined in mice, and blocking it can make mice twice as brawny as normal. However, until now no one knew its effects in humans.
 
"The idea was if we could find ways to interfere with myostatin function, perhaps we could slow down muscle loss in muscle wasting diseases and hopefully increase lifespan," explains the main researcher at Johns Hopkins University in Maryland. "But a major question was, will this work in humans?" he says. The new study confirms that the so-called "mighty mouse" gene does have the same effects in humans.
 
Sequencing the myostatin gene of the boy and his mother revealed both had a single change in the gene's DNA sequence. Where the mother had only one copy of the mutant gene, the boy had two. The mutation affects the way that the RNA made from the gene is spliced and gives a misformed protein. Myostatin is normally made by muscle cells and circulates in the blood, acting on muscle only. The current view is that it may act on a group of muscle stem cells called satellite cells. These cells are activated in response to injury and regenerate muscle cells. Myostatin acts to keep them in some kind of a quiescent state.
 
The New Scientist Journal was told that there's definitely sufficient evidence to demonstrate, at least, there might be a therapeutic benefit for humans.

Paul Candelaria: paul@cahb.org
 
What is BioSpace?
Part 3 – Biotech Beach –
Biotech Beach covers Greater Los Angeles and San Diego areas and their surroundings in Southern California. At the time of this publication (6/25/2004), 275 companies, organizations, and universities are participating in the Biotech Beach hotbed community. Selected are:
 
  • Allergan, Inc. (Pharmaceutical, Irvine, CA)
    A global specialty pharmaceutical company that develops and commercializes pharmaceutical products for the eye care, neuromodulator, skin care and other specialty markets. There are more than 5,000 employees worldwide, four R&D facilities, and three manufacturing plants. There are 39 products targeting 50 diseases area for clinical trials.
  • Chugai Pharma USA, LLC. (Biotechnology, San Diego, CA) Established in 1995 as an independently operated, wholly owned subsidiary of Chugai Pharmaceutical Co., Ltd. Major areas of focus are cardiovascular disease and cancer. There is 1 product targeting 1 disease area for clinical trials.
  • Invitrogen Corporation (Genomics Carlsbad, CA)
    Invitrogen develops, manufactures and markets research tools in kit form, and provides other research products and services to over 20,000 biotechnology and biopharmaceutical researchers and companies worldwide.
  • Merck Research Laboratories (Human Therapeutics, San Diego, CA)
    One of three major neuroscience research units of Merck & Co. It has emerged from the acquisition of a biotechnology company, SIBIA Neurosciences, Inc., in 1999.
  • Prometheus Laboratories Inc. (Drug Discovery, Pharmaceuticals, San Diego, CA)
    A specialty pharmaceutical company integrating therapeutics and clinical information services for gastrointestinal, rheumatological, and other autoimmune diseases and disorders. There are 8 products targeting 14 diseases area for clinical trials.

The full directory can be found at the BioSpace web page at http://biospace.com/company_region.cfm?RegionID=12.
 
A list of upcoming events in Biotech Beach in 2004
  • BioImmersion: Biotech For Non-Science Professionals
    7/14/04 to 7/16/04
  • Strategic Research Institute - BioAsia-Pacific Strategic Alliances And Dealmaking: Opportunities And Challenges In Asia Biotech/Pharma Market
    8/2/04 to 8/3/04
  • American Urological Association (AUA): Western Section Annual Meeting
    8/22/04 to 8/27/04
  • Clinical Data Management Intensive Workshop
    9/11/04 to 11/20/04
  • Marcus Evans: PharmaTech Summit
    9/13/04 to 9/15/04
  • Biotech Beach 2004
    9/23/04 to 9/23/04
  • IBC's Preclinical Development Forum: From Discovery To Clinic
    10/4/04 to 10/6/04
  • BioNetwork 2004
    10/4/04 to 10/6/06
  • Burrill & Company: The Biotech Meeting At Laguna Niguel
    10/10/04 to 10/12/04
  • IBC's Assays & Cellular Targets (ACT)
    10/18/04 to 10/21/04
  • CBI's Validation Processes
    11/4/04 to 11/5/04
  • CBI's Optimizing Clinical Trials Efficiency
    11/4/04 to 11/5/04
  • CBI's LC/MS: Applications For Drug Discovery And Development
    11/8/04 to 11/9/04
  • Cambridge Healthtech Institute: Green Fluorescent Proteins
    11/14/04 to 11/16/04
  • Cambridge Healthtech Institute: In Vivo Molecular Imaging
    11/16/04 to 11/17/04
More information about the upcoming events can be found at http://biospace.com/calendar/calendar_region_list.cfm?RegionID=12

Hiroaki Masuda: hmasuda@cahb.org
 
Bio-Novelty
West Nile Virus
The news that the avian flu killed tremendous number of chickens in South Korea and Japan were reported in early 2004. Globalization can bring us many kinds of industrial products and foods from all over the world in a few days after they are collected in their original countries, which are good facets of globalization. However, like the avian flu case, we are in 24 hours exposed to the very dangerous situation when we can be infected by the pathogens that we never see before in the past in that area. SARS, avian flu, and WNV are the examples. This is very serious and we should keep in mind in this alert.
 
Background
WNV is an arbovirus first isolated in Uganda, Africa in 1937, and is endemic in entire Africa, Europe, Asia and the Middle Eastern Hemisphere. The first case of WNV was detected in the Western Hemisphere in 1999 in New York and has since spread to much of the United States. Last year in 2003, 9858 human cases and 262 deaths were reported, and animal or human infection was demonstrated in all the states except four states, which are Oregon, Washington, Alaska and Hawaii, far from New York. In California we had three human cases last year.
 
Clinical Illness
The spectrum of the disease caused by WNVranges from asymptomatic infection (79%), which is most common, mild illness (20%) known as “WNV fever” to severe infection (1%) manifesting as encephalitis.
  • Mild illness shows a mild fever, “WNV fever” and the incubation of clinical disease is from 3 to 14 days. A febrile illness of sudden onset often accompanied by: malaise, vomiting, myalgia, anorexia, eye pain, rash, nausea, headache, and lympadenopathy.
  • Severe infection results in severe neurological disease. Advanced age is the most significant risk factor for development of severe neurological disease and encephalitis is more common than meningitis.
 
Diagnosis
The WNV immunoflourescent assay (IFA) and enzyme immunoassay (EIA) tests measure IgM/IgG anitibodies and IgM anitibodies, respectively. These tests are positive in most infected people within 8 days of symptom onset.
 
Treatment
Treatment is supportive, often involving hospitalization. Ribavirin in high doses and IFN α and 2β may be good based on in vitro data. Prevention is the best way of treatment. We need to protect us and our family from mosquito’s bite. It’s better to stay in during dawn, dusk and in the early evening-peak mosquito biting times. Wear long sleeved shirts, and apply insect repellant containing DEET.
 
Useful information can be obtained from:
http://www.westnile.ca.gov/
http://www.cdc.gov/westnile/

Toshihiko Nishimura: toshi@cahb.org
 
Acknowledgment
 
Publication of CAHB Newsletter is made possible by CLEA International, Inc., a subsidiary of CLEA Japan, Inc. This photo shows an aerial view of its Ishibe breeding facility in Shiga prefecture, Japan, for experimental mice and rats. Central Institute for Experimental Animals (CIEA), a non-profit organization in Japan, also greatly supports CAHB activity.

CLEA Japan, Inc. http://www.clea-japan.com/

CIEA http://www.rash2.com/CIEA.htm
 
Top
 
May 2004 - Volume 1 - Number 2
 
Announcement
There will be no monthly health & bioscience forum in May. Next forum will be held in late June. Stay tuned at http://www.cahb.org/forum.html.
 
Forum Report
 
Our third monthly Health & Bioscience forum was held on April 30th, 2004. The speaker was John Faul, Assistant Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Stanford University Medical Center. He talked on “Sleep and Vascular Disease” and his presentation generated a lively discussion among all attendees with diverse backgrounds from medicine to investments. Lively conversations continued after the presentation, over Indian dishes.

Hope the dogs have sound sleep!

Hiroaki Masuda: hmasuda@cahb.org
 
Top 10 Bio News (April – May 2004)
 
  • Approval From USDA For Rapid Enfer BSE Test
    Abbott Laboratories announced that the United States Department of Agriculture (USDA) has given Abbott permission to sell and distribute its bovine spongiform encephalopathy (BSE) test. The rapid Enfer BSE test provides results within hours, is easy to use and addresses the workflow needs of USDA- approved screening laboratories.
  • Three Companies Announced Tarceva to Extend Survival of Patients
    OSI Pharmaceuticals, Genentech and Roche announced that a Phase III study of Tarceva, an investigational HER1/EGFR-inhibitor agent in previously treated patients with non-small cell lung cancer, met its primary endpoint of improving overall survival, with patients receiving Tarceva living longer than those in the placebo arm of the study.
  • VC Investment Up
    For the first quarter of 2004, VC investment in the U.S. in start-ups focusing on healthcare industry nearly doubled to $1.8 billion from $940 million in the first quarter of 2003. Those firms, which include biotech companies, healthcare service firms and makers of medical devices, garnered 36% of all total new investment.
  • Abbott Laboratories in Redwood City
    Abbott Laboratories will bring its West Coast research and development headquarters to nearby Redwood City. The city’s planning commission approved recently the project’s planned development application, allowing works to begin on more specific architectural and design details. The project’s size requires that the city make changes to its zoning and planning codes. The commission endorsed those changes again during a recent meeting, but the City Council must also agree before construction can begin.
  • Gene Mutation Predicts AstraZeneca's Cancer Drug's Success
    A quick genetic screen may be able to tell doctors which lung cancer patients will benefit from new, targeted cancer drugs that have dramatic effects but only in a few people. Researchers found a specific DNA mutation in people who were virtually cured of their cancer by a new drug called Iressa, made by AstraZeneca.
  • Researchers Close In On How Gene Changes Lead To New Traits
    Howard Hughes Medical Institute researchers at Stanford University are closer to understanding one of evolution's biggest questions: How do genetic changes contribute to the generation of new traits in naturally occurring species? By studying related populations of small fish, called sticklebacks, the scientists have learned how a variety of animals might have lost their hindlimbs during evolution.
  • Researchers Uncover Genes Involved In Early Stages Of Alzheimer's Disease
    Researchers at Oregon Health & Science University (OHSU) have identified a set of genes that appear to be involved in the development of Alzheimer's disease. They hope this information will help scientists create methods for early detection for the disease and for the development of therapeutic strategies to delay or even stop its progression.
  • Tercica, Inc. Licenses Patent Rights To rhIGF-1 From Fujisawa
    South San Francisco-based Tercica, Inc. announced today that it has signed an agreement with Fujisawa Pharmaceuticals under which Tercica has been granted a non-exclusive license to patent rights pertaining to the use of recombinant human Insulin-Like Growth Factor-I (rhIGF-I) for the treatment of certain forms of extreme insulin resistance, including Type A insulin resistant diabetes.
  • Alzheimer Urine Test Premarket Approval Application Suitable For Filing
    Nymox Pharmaceutical Corporation announced that its Premarket Approval (PMA) application with the FDA for the company's Alzheimer urine test (AlzheimAlert) was found acceptable for filing.
  • Dolly Scientists To Clone Embryos
    The scientists who cloned Dolly the sheep are applying for a license to clone human embryos. Professor Ian Wilmut, of the Roslin Institute in Edinburgh, wants to use cloned human embryos to study motor neurone disease (MND). His application to the Human Fertilisation and Embryology Authority is expected to provoke criticism that testing human embryos is immoral.

Paul Candelaria: paul@cahb.org
 
USA Topics
A Short History of Google
Internet search engine leader Google, Inc. filed its longawaited IPO plans on April 29, 2004 setting the stage for the company to make its stock market debut — a move that could still be months away. Without specifying a price per share, Google said it hopes to raise $2.7 billion with an initial public offering that's created the biggest high-tech buzz since the dot-com bubble burst four years ago.
 
Although Google's stock won't be sold for several more months, the filing represents a significant milestone in the 5 1/2-year-old company's evolution from a fun-loving startup to a corporate adolescent that will be held more accountable for how it manages its money.
 
According to Google news, company founders Larry Page and Sergey Brin first met as Stanford University graduate students in 1995. Larry was a 24-year-old University of Michigan alumnus on a weekend visit; Sergey, 23, was among a group of students assigned to show him around. They argued about every topic they discussed. Their strong opinions and divergent viewpoints would eventually find common ground in a unique approach to solving one of computing's biggest challenges: retrieving relevant information from a massive set of data.
 
By January of 1996, Larry and Sergey had begun collaboration on a search engine called BackRub, named for its unique ability to analyze the "back links" pointing to a given website. Larry, who had always enjoyed tinkering with machinery and had gained some notoriety for building a working printer out of Lego took on the task of creating a new kind of server environment that used low-end PCs instead of big expensive machines. Afflicted by the perennial shortage of cash common to graduate students everywhere, the pair took to haunting the department's loading docks in hopes of tracking down newly arrived computers that they could borrow for their network. A year later, their unique approach to link analysis was earning BackRub a growing reputation among those who had seen it and the new search technology began to build as word spread around campus.
 
Larry and Sergey continued working to perfect their technology through the first half of 1998. They bought a terabyte of disks at bargain prices and built their own computer housings in Larry's dorm room, which became Google's first data center. Meanwhile Sergey set up a business office, and the two began calling on potential partners who might want to license a search technology better than any then available. Despite the dotcom fever of the day, they had little interest in building a company of their own around the technology they had developed.
 
Among those they called on was friend and Yahoo! founder David Filo. Filo agreed that their technology was solid, but encouraged Larry and Sergey to grow the service themselves by starting a search engine company. "When it's fully developed and scalable," he told them, "let's talk again." Others were less interested in Google, as it was now known.
 
Unable to interest the major portal players of the day, Larry and Sergey decided to make a go of it on their own. All they needed was a little cash to move out of the dorm — and to pay off the credit cards they had maxed out buying a terabyte of disks. So they went looking for an angel investor. Their first visit was with a friend of a faculty member.
 
Andy Bechtolsheim, one of the founders of Sun Microsystems, was used to taking the long view. One look at their demo and he knew Google had potential — a lot of potential. As Sergey recalls, "We met him very early one morning on the porch of a Stanford faculty member's home in Palo Alto. We gave him a quick demo. He had to run off somewhere, so he said, 'Instead of us discussing all the details, why don't I just write you a check?' It was made out to Google Inc. and was for $100,000."
 
The investment created a small dilemma. Since there was no legal entity known as "Google, Inc.", there was no way to deposit the check. It sat in Larry's desk drawer for a couple of weeks while he and Sergey scrambled to set up a corporation and locate other founders among family, friends, and acquaintances. Ultimately they brought in a total initial investment of almost $1 million.
 
On September 7, 1998, Google Inc. opened its door in Menlo Park, California. The door came with a remote control, as it was attached to the garage of a friend who sublet space to the new corporation's staff of three. Google.com, still in beta, was then answering 10,000 search queries each day. That December, PC Magazine named Google one of its Top 100 Web Sites and Search Engines for 1998.
 
Google quickly outgrew the confines of its Menlo Park home, and by February 1999 had moved to an office on University Avenue in Palo Alto. At eight employees, Google's service was answering more than 500,000 queries per day. Interest in the company had grown as well.
 
On June 7, the company announced that it had secured a round of funding that included $25 million from the two leading venture capital firms in Silicon Valley, Sequoia Capital and Kleiner Perkins Caufield & Buyers. In short order, key hires began to fill the company's modest offices. At one point the office became so cramped that employees couldn't stand up from their desks without others tucking their chairs in first.
 
The gridlock was alleviated with the move to the current headquarters in Mountain View, California. What had been a college research project was now a real company offering a service that was in great demand. On September 21, 1999, the beta label came off the website. The rest is now history…

Paul Candelaria: paul@cahb.org
 
What is BioSpace?
Part 2 – Biotech Bay –
In the previous issue, we overviewed BioSpace and Hotbed campaign in several geographical regions in the US and the world. The Hotbed campaign is still actively expanding and three new communities (BioSoutheast™, BioPenn™, and BioSoutheast™) joined since last month.
 
Table. List of BioSpace Hotbed communities as of 5/15/2004
  • Biotech Bay™
  • Biotech Beach™
  • Bio NC™
  • BioCapital™
  • BioCorridor™ (MI)
  • BioGarden™ (NJ)
  • BioMidwest™
  • BioPenn™
  • BioSoutheast™
  • Genetown™
  • Pharm Country™
  • BioForest
  • BioTechxus
  • BioMidwest
  • BioUK
  • BioCanada
  • BioIsrael
We will introduce each Hotbed community every month and the first is Biotech Bay where BioSpace was born http://www.biospace.com/hotbed.cfm?RegionID=11.
 
Biotech Bay covers San Francisco Bay Area and its surroundings in Northern California, almost overlapping with Silicon Valley. Its web site provides information about, Breaking News, New Jobs, Events, Features, as well as a list of Biotech Bay Campaign Participants. It also provides a search engine on comprehensive Biospace database relating to bio and medical science and technology, although it is not so sophisticated as Yahoo or Google (see other article in this issue). You can immediately find many useful resources by simply supplying key words that you want to look up.
 
At the time of this publication (5/15/2004), 262 companies, organizations, and universities are participating in the Biotech Bay hotbed community. Selected are:
  • Agilent Technologies Inc. (Life Science, Palo Alto, CA)
    . A global technology leader in communications, electronics, life sciences, and chemical analysis, including DNA microarrays, microarray scanners, software, and reagents. It covers more than 110 countries worldwide. The total numbers of employees are 40,000. Net revenue was $6.1 billion in 2003.

  • Bio-Rad Laboratories, Inc. (Human Diagnostics, Hercules, CA)
    . A manufacturer and distributor providing thousands of products that incorporate a wide range of technologies including proteomics, bioinformatics, electrophoresis, imaging, immunoassay, chromatography, microbiology and gene transfer. The total numbers of employees are 4,300.

  • Celera Genomics (Genomics, Human Therapeutics, South San Francisco, CA)
    . A world leader in genomics providing a comprehensive program to develop pharmaceutical products by improving diagnosis and treatment of many complex chronic diseases based on its unique genomics, bioinformatics, and proteomics technology.

  • Cell Genesys, Inc. (Biotherapeutics, South San Francisco, CA)
    . Developing and commercializing novel biological therapies for patients with cancer. It has several human clinical trials under way in multiple types of cancer using its cancer vaccines and oncolytic virus therapies.

  • Chiron Corporation (Human Diagnostics, Human Therapeutics, Emeryville, CA)
    . A global pharmaceutical company developing and commercializing high-value products for infectious disease and cancer based on its platforms in proteins, small molecules and vaccines. The total numbers of employees are more than 3,700 worldwide. In 2001, its net revenue exceeded $1 billion with over $200 million of net income.

  • Genentech, Inc. (Biotherapeutics, South San Francisco, CA)
    . Genentech is the founder of the biotechnology industry. It is among the world's leading biotech companies, with 13 protein-based products on the market for treating life-threatening medical conditions and 20 projects in the pipeline. The total numbers of employees are more than 6,000. Net revenue was $3.3 billion in 2003.

  • Geron Corporation (Human Therapeutics, Menlo Park, CA)
    . A biopharmaceutical company developing and commercializing therapeutic and diagnostic products for applications in oncology and regenerative medicine, based upon three core technologies: telomerase, human embryonic stem cells, and nuclear transfer.

  • Gilead Sciences (Human Therapeutics, Foster City, CA)
    . A biopharmaceutical company that develops and commercializes therapeutics by focusing its research and clinical programs on anti-infectives, including antivirals and antifungals. Net revenue was $467 million in 2002.

  • Protein Design Labs, Inc. (Human Therapeutics, Fremont, CA)
    . A leader in the development of humanized monoclonal antibodies for autoimmune, inflammatory conditions, asthma and cancer.

  • Varian Medical Systems (Medical Device, Palo Alto, CA)
    . A leader in the design and manufacture of integrated systems for treating cancer with radiation therapy.


Hiroaki Masuda: hmasuda@cahb.org
 
Bio-Novelty
A single bone marrow-derived stem cell unlikely differentiates into the organs
Krause DS and Theise ND who are professors in Yale University, demonstrated that a single bone marrow-derived stem cell (BM-SC) differentiated into several organs, such as lung, liver, gut, skin, etc in May, 2001. Their method was very unique, which was that they collected a single BM-SC from male donor mouse, and then transplanted the only single cell into lethal irradiated female mouse. The first question was whether the only single bone marrow cell could rescue the lethal dose irradiated mouse, or not. Second question was the single BM-SC could be differentiated into the different organs. In order to confirm these questions, they stained Y-chromosome in all organs of recipient female mice. If the single BM-SC could rescue the lethal irradiated mouse, they could see Y-chromosome in the hematopoietic cells and might be able to see Y-chromosome in the different organs. The result was striking to the medical field. They could save the lethal dose irradiated mouse and find the Ychromosome in lung, liver, gut and skin. This sensational paper was published in May three years ago. (Cell.2001 May 4;105(3):369-77).
 
On the other hand, Amy J Wagers and Irving L. Weissman, Stanford University group, demonstrated completely opposite result by using different approaches. Dr. Weissman who is a prominent professor said to be very close to Nobel Medicine Prize, used green fluorescent protein (GFP) marked BM-SC and parabiotic pair mice method. He used the single BM-SC from GFP mice and transplanted it into wild type mice. The parabiotic mice were controversial to medicine and animal right groups, but were approved for the experiment by the panel at Stanford medical center. A mouse
 
was surgically anastomosed to the other mouse and let them live together. One mouse was GFP mouse and the other was wild type. After they examined more than 10 million cells in brain, half million cells in liver, 1 million cells in kidney, and other organs in the wild type mouse, they found one positive cell in the brain and seven positive cells in the liver and no positive cell in the other organs. By using parabiotic mice models, they obtained similar number of cells for different organs. Weissman concluded that BM-SC does not differentiate into the organs.
 
These two studies are controversial. Since then many studies followed these two studies one by one. As of today, the positive cells of BM-SC in the different organs are 1) differentiated from BM-SC, 2) just the fusion cells of BMSC to the different organs. Weissman demonstrated and concluded again that BM-SC do not differentiate into the different organs and that the other data from other group which insisted BM-SC can differentiate into the different organs are wrong and those data can be fully explained by the fusion theory.

Toshihiko Nishimura: toshi@cahb.org
 
Acknowledgment
Publication of CAHB Newsletter is made possible by CLEA International, Inc., a subsidiary of CLEA Japan, Inc. This photo shows an aerial view of its Fuji breeding facility for experimental mice and rats, surrounded by deep greens in the foot of Mt. Fuji, Japan. Central Institute for Experimental Animals (CIEA), a non-profit organization in Japan, also greatly supports CAHB activity.

CLEA Japan, Inc. http://www.clea-japan.com/

CIEA http://www.rash2.com/CIEA.htm
 
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April 2004 - Volume 1 - Number 1
 
A message from our chairman
We are pleased to announce the first issue of our CAHB Newsletter. It covers breaking news and information about health and biosciences, as well as the Center’s activities. Although the Newsletter covers all of the US, special emphasis is given to the news in the Bay Area, including Stanford University, Silicon Valley, and the cities of Palo Alto, and Menlo Park.
 
We welcome your contributions, which will help make the Newsletter a success. Happy reading and best wishes!
 
Henry Vogel
Chairman of the Board of Directors
Center for the Advancement of Health and Biosciences (CAHB)
 
About us
Center for the Advancement of Health and Biosciences (CAHB) was founded and registered in California on December 3, 2001 as a not-for-profit organization. In its vision, CAHB supports and contributes to human health and biosciences.
 
Mission and Commitment:
CAHB fills the emerging necessity for R&D and commits to support US developmental initiative and scientific capacity building in various biotechnology fields especially health care, pharmaceutical, foods, agriculture, and environment.
 
Background:
The US biotechnology research & development field is facing an emergence in global competition. The final stage of R & D is validation stage for the product. The validation for biomedical products must have vivo test as well as vitro test. Although technologies for vitro study have been developed at high quality and with accuracy, the technologies for vivo study including gene-manipulated animals must be improved in terms of specification, reproduction, and accuracy. Therefore, the field is seriously in need of services in terms of intellectual property & information for further advancement of technologies, application & experimental capabilities aimed at capacity development and building market leadership at internationally.
 
Key Lines of Services:
  • To provide the opportunity to participate in world class top-level joint Research & Development.
  • To provide such leading technologies, information, and materials in acquiring opportunities.
  • To liaison for institutional development with leading international Research & Development institutions and centers.
  • To discover and evaluate the most appropriate technologies, information, and materials.
  • To coordinate and support licensing procedures.
  • To provide training and educational opportunity for instruction of advanced technologies and experiments.
 
Proposed Activities:
CAHB is dedicated to provide comprehensive services to strengthen US leadership and competitiveness in both research and development and in the international market. The same will be strong capacity development in the fields of health, medicine, pharmacology, and other biotechnology related fields.
  • Establish Resource Center as a world center of excellence for biomedical/biotechnology developmental research and development resources concerning the best practices and techniques of quality standardization and specification required for improving health, effectiveness of health care, safety and security of human health in complex environment utilizing laboratory resources.
  • As a center of biomedical/biomaterial model resource for the maintenance and preservation of international reference strains of laboratory based experimental biological materials, used for health and disease models.
  • Establish a human and relevant animal embryo bank and frozen cell repository.
  • Prepare authoritative statistics, reports/reference materials including information on subjects of importance to health development, Healthy People in particular, health care, process of health, disease control on both curative and preventive measures to support national and international emerging actions.
  • The Center provides service to evaluate and assess scientific value and reliability on proposed trials and experimentation.
  • The Center provides design service for best experimental biomaterials, form, and structure.
  • The Center provides postgraduate education & training opportunity to improve efficacy and applicability to justify clinical effectiveness.
 
Institutional Collaboration Work - National, International, Government, Non-Government, Universities, Industries -
  • Constant collaboration with NIH, Center for Disease Control, FDA, Health and Human Services, leading international research Institutions, Medical Schools, World Health Organization and International Council for Laboratory Animal Science (ICLAS).
  • Microbiological and genetic, clinical and health process monitoring for laboratory biological/animals in cooperation with ICLAS.
  • Development of experimental human health related biological models for human health/diseases especially in the fields of emerging health priority such as oncology, immunology, infectious diseases and ancillary areas of technology and colony management, and health process/development to satisfy US committed health target of " Healthy People 2010".
  • Development of transgenic biological material/animals for laboratory experimental tools and their application in various bioassays, including carcinogenicity and toxicology testing.
  • Development of biomaterials/animals quality maintenance technology and colony management to secure clinical and health assurance.
 
Promotion and Consulting Services:
  • Coordinate with scientific organizations in the exchange of intellectual assets, information and expertise in the development of reliable use of laboratory biomaterials to improve applicability to evidence-based human health development and clinical effectiveness.
  • Promote advances in testing and improving technical and regulatory requirements for registration of pharmaceuticals for human use.
  • Collaborate with WHO and other international agencies in various biomedical research projects for the benefit of US health and competitiveness improvement.
  • Hold annual scientific interdisciplinary meetings for medical and health scientists to ensure the dynamic exchange of new ideas and new research findings, and for improvement of their applicability.
  • Provide consulting and training services to assist individuals and private sector companies in the development of their drugs, biological materials and medical devices to bring them to market efficiently and cost effectively.

Toshihiko Nishimura: toshi@cahb.org
 
Announcement
 
Health & Bioscience Forum
Third Monthly Lecture Series
 
“Sleep and Cardiovascular Disease”
 
Speaker:
John L. Faul, M.D.
Assistant Professor of Medicine
Division of Pulmonary and Critical Care Medicine
Stanford University School of Medicine
 
Date: April 30, 2004 (Friday)
Time: 6:30 p.m. - 8:00 p.m.
Place: 525 Middlefield Road, Suite 100
Menlo Park, CA 94025
 
Networking Time: 6:00-6:30, 8:00-8:30 p.m.
Light refreshment will be served
 
 
City of Menlo Park - Our Hometown -
CAHB office is situated in the city of Menlo Park, California, USA. You might ask, “What is Menlo Park?” and “Where is it?” Our hometown, Menlo Park, is located between San Francisco and San Jose as a part of Silicon Valley in Northern California and has been well developed since its incorporation in November 23, 1927, being close to Stanford University. Menlo Park is a small beautiful city called “Tree City” and has about 10,400 trees on its streets. According to the US Census 2000, the population is 30,785 in 19 square miles area and the median income for a household is $84,609 (about 9,000,000 Japanese yen) that is more than double the US average ($42,151).
 
Menlo Park is primarily a residential community with very kind and warm people but there are several innovative institutes and firms. The most famous one is SRI International, founded as the Stanford Research Institute in 1946 by a group of industry inventors in conjunction with Stanford University. SRI International is now one of the world’s largest contract research firms and owns more than 10,000 patents in a broad area of science, engineering and technology. Another is Western Geographic Science Center of the US Geological Survey. It covers nine western US states, including California, Hawaii, and Alaska. Actually our office is located just between SRI International and Western Geographic Science Center. The other notable firm is a Silicon Valley venture capital (VC) community residing on a hillside of Sand Hill Road near I-280 freeway. It was originated back in 1972 when Kleiner Perkins first opened its office and many other VC’s have joined in the community since then.
 
Menlo Park is a city of innovation, yet it is friendly and pleasant. We are proud to have our office here in Menlo Park.
 
Last Month’s Top 10 Bio News
  • Antigenics Inc. announced the sale of its manufacturing rights for feline leukemia virus (FeLV) vaccine to French veterinary pharmaceutical manufacturer Virbac S.A. for $14.25 million in cash.
  • Pfizer, Inc.´s breast cancer drug increased survival rates by 63 percent compared with the standard therapy tamoxifen.
  • Molecular Staging Inc. (MSI) announced that Dr. Brian Henderson from the University of Southern California (USC) has chosen MSI's REPLI-g(TM) whole genome amplification technology in order to expand the amount of DNA available from over 4,000 precious cancer patient samples.
  • Geron Corporation announced that the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office has issued a decision on motions filed in the patent interference proceeding between Geron and Advanced CellTechnology Corporation of Worcester, Massachusetts.
  • InnoMed Technologies announced that the United States District Court in Orlando, Florida has determined that it has jurisdiction over Innomed's claims for patent infringement against the manufacturer of the Spiritus nasal interface, Worldwide Medical Technologies.
  • SynCardia Systems, a privately held developer of biomechanical cardiac replacement and assist devices, announced today that the U.S. FDA Circulatory Systems Devices Panel met yesterday and recommended that the CardioWest Total Artificial Heart be approved, with conditions.
  • Children's Hospital & Research Center at Oakland had found that Vitamin C plays an important role in normal airway function, may prevent symptoms associated with airway diseases such as cystic fibrosis and asthma, and may even help alleviate the dry cough suffered by smokers.
  • The U.S. Pentagon has granted $240,000 to a Swedish team for embryonic stem-cell research linked to Parkinson's disease, despite U.S. government limits on stem-cell research.
  • National Institute of Allergy and Infectious Diseases reported that the mouse immune system develops antibodies capable of single-handedly neutralizing the SARS virus, in the April 1 issue of the Journal of Virology.
  • U.S. Agriculture Secretary Ann M. Veneman announced details for an expanded surveillance effort for Bovine Spongiform Encephalopathy (BSE) in the United States.


Paul Candelaria: paul@cahb.org
 
USA Topics
Biotech companies and the patent office: a relationship-in-progress
Last month, the lower house of the U.S. Congress passed H.R. 1561, the United States Patent and Trademark Fee Modernization Act of 2003. This legislation would assist in enhancing patent quality and services by preventing diversion of these fees to other government programs and providing the funds necessary for Patent and Trademark Office (PTO) operations.
 
Patents spur the discovery and development of new medicines and diagnostics, agricultural products, and other breakthrough technologies that are the hallmark of biotechnology. The biotechnology industry has produced more than 160 biotech drugs and vaccines that have helped more than 325 million people worldwide. None of these successes would have been possible without strong, predictable intellectual property protection. For start-up companies, patents are their sole assets, making the role of the PTO as the agency responsible for granting patents, critical to the biotechnology industry.
 
Biotech companies own and market ideas: for example, the discovery of a potential point of intervention in a disease process or the identification of a gene that might affect how that disease progresses. Biotechnology product development can take decades and hundreds of millions of dollars to achieve. The ability of biotechnology companies to raise funding from the capital markets is linked directly to the availability, strength and security of their intellectual property rights. Without quality patents, companies simply cannot raise funds to conduct their research and get their products on the market.
 
The PTO's 21st Century Strategic Plan recognizes the importance of patents and is aggressive in its efforts to improve PTO quality and services. However, this effort cannot be undertaken without adequate funding. H.R. 1561 would provide the PTO with the resources to implement many elements of the strategic plan. It would provide funds through user fees and ensure that these fees stay with the PTO. As few people know, the PTO is a fully user-fee-funded agency whose income in the past has been siphoned off for non-PTO programs.

Paul Candelaria: paul@cahb.org
 
What is BioSpace?
BioSpace is a comprehensive information resource provider on the internet for the life sciences community. Its web site (http://biospace.com) has more than 1 million unique visitors every month.
 
Services they offer - Internet Services -
  • Clinical Competitive Intelligence System
  • BioSpace Career Expos
  • BioSpace Job Posting
  • Online Regional Campaigns
  • Advertising/Sponsorship
 
Hotbed Communities
  • Biotech Bay (Northern California)
  • Biotech Beach (Southern California)
  • Genetown (Maine, Massachusetts, New Hampshire, Rhode Island, Vermont) 4. Bio NC (North Carolina)
  • BioGarden (New Jersey)
  • BioCapital (Delaware, Maryland, Virginia, Washington D.C.)
  • Pharm Country (Connecticut, New Jersey, New York, Pennsylvania)
  • BioCorridor (Michigan)
 
Other Communities
  • BioCanada (Canada)
  • BioForest (British Columbia, Idaho, Montana, Oregon, Washington)
  • BioIsrael (Israel)
  • BioMidwest (U.S. Midwest)
  • BioTechxus (Texas)
  • BioUK (England, Ireland, Scotland, Wales)


BioSpace - Hotbed Campaign Map

Toshihiko Nishimura/Hiroaki Masuda
 
Bio-Novelty
Key facts on cloning
The FDA scientific risk assessment had concluded that eating foods from animals which have been cloned for better health are safe for human consumption. This is consistent with 2002's National Academy of Sciences report on animal-based biotechnology.
 
Using the tools of biotechnology to produce more desirable and healthier farm animals is not a new practice. For decades livestock producers have used genetic twins to improve the health and efficiency of animals to provide beneficially healthy and nutritious meat and milk.
 
Cloning can help livestock producers deliver what consumers want: nutritious, wholesome food products provided to them in a repeatable and reliable manner, and at an affordable price.
 
Animals which have been successfully cloned: Sheep, cattle, goats, pigs, mice, rabbits, horses, rats.
 
Clone. A term that is applied to genes, cells or entire organisms that are derived from ɾand are genetically identical to ɾa single common ancestor gene, cell or organism respectively. Cloning of genes and cells to create many copies in the laboratory is a common procedure essential for biomedical research. Note that several processes commonly described as cell "cloning" give rise to cells that are almost but not completely genetically identical to the ancestor cell. Cloning of organisms of embryonic cells occurs naturally in nature (e.g., identical twins).
 
Somatic cell nuclear transfer (SCNT). The transfer of a nucleus from a fully differentiated cell into an egg that has had its nucleus removed. This technique was used to clone Dolly the sheep in 1996.
 
Difference between cloned and transgenic animals.
Cloning is asexual production, producing offspring that are genetically identical to the single parent organism, whereas transgenic technology introduces genetic material from one organism into another.
 
Timeline
Earliest form of animal cloning began in 1978 with the splitting of an already formed embryo. SCNT overcomes limits of earlier techniques and allows breeders to copy an adult animal whose traits are well known. It is conceivable to produce thousands of clones from a single animal.
 
1996
First successful adult or SCNT clone was Dolly, the sheep. Although researchers had been working on cloning for more than 20 years this brought it to the forefront of public attention.

Paul Candelaria: paul@cahb.org
 
Acknowledgment
Publication of CAHB Newsletter is made possible by CLEA International, Inc., subsidiary of CLEA Japan, Inc. This photo shows cherry blossoms in full bloom, as seen from the president’s office of CLEA Japan. Central Institute for Experimental Animals (CIEA) also greatly supports CAHB activity.
 
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Center for the Advancement of Health and Biosciences
1230 Bordeaux Dr., Suunyvale, CA 94089
Tel. (480) 400-0107
Fax. (408) 400-0977

info@cahb.org
© 2004-2011 Center for the Advancement of Health and Biosciences

 

 

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