Life Sciences Lawyer - biotechnology law & business blog of attorney Anthony Cerminaro

FDA Issues New Early Stage Guidelines

2006-01-13T17:04:00.000-05:00

"The Food and Drug Administration (FDA) announced steps to advance the earliest phases of clinical research in the development of innovative medical treatments. This should make it easier for universities and small drug companies to test promising therapies in humans without having to pay the enormous amounts of expenditures normally required."

Read more in this Patent Baristas post.

Technorati Tags: biotech, biotechnology, fda, medical

Top Ten Life Sciences Decisions

2006-01-10T12:45:00.000-05:00

"The United States' most influential courts have made 2005 a vintage year for decisions affecting the life science and pharmaceutical sectors. As the year draws to a close, the time is ripe to review the most significant decisions and evaluate the current state and trends of the living, ever-changing patent jurisprudence." Read more in this article from McDermott Will & Emery via Mondaq (free registration required).

Today's Biometric Technology

2005-12-20T10:56:00.000-05:00

This post from Marcus P. Zillman points to the website, Biometric Technology Today stating:

"The rate of change within the biometric industry is staggering. What was once a futuristic concept is here and now. Whether you are an end-user, a developer, a vendor, an integrator or an investor in biometrics, Biometric Technology Today gives you immediate access to authoritative information on key industry developments and covers the industry on a worldwide scale."

Primer on Licensing and Technology Transfer

2005-10-04T10:48:00.000-04:00

"In a research-intensive sector such as the pharmaceutical industry, the creation, protection and transfer of technology are key elements of most companies´ business strategies. In this guide, Philip Mendes, Partner of Innovation Law in Brisbane (Australia) presents the main contractual agreements through which technology is transferred in the pharmaceutical industry. With a special focus on patent licensing, the guide also presents other technology transfer agreements such as confidentiality agreements, IP assignments, material transfer agreements and strategic alliances. The guide is published by kind permission of the International Trade Center, the joint technical cooperation agency of the UNCTAD and WTO for operational, enterprise-oriented aspects of trade development."

NIH Stem Cell Information

2005-08-15T13:27:00.000-04:00

The NIH Stem Cell Information web site contains information on stem cells broken into the following categories:

Stem Cell Basics
FAQs
Report on Stem Cells
Research Ethics and Stem Cells
Stem Cells and Diseases
Glossary
Media Center
Other Online Resources

Research Topics
Stem Cell Registry
Research Protocols
Stem Cell Research at NIHUniversities and Institutions
International Research
Research Funding
Training Programs
Scientific Literature
Mouse ESC Literature Database
NIH Stem Cell Libraries & Projects
Meet Our Scientists

Federal Policy
NIH's Role in Federal Policy
Policy & Guidelines
NIH Stem Cell Task Force
Statements & Testimony
Congressional Legislation

News & Announcements
News Headlines
Upcoming Events
NIH Funding Announcements

Primer On Stem Cells: Part 2

2005-08-05T11:46:00.000-04:00

"In order to understand the legal issues surrounding stem cells, it is important to understand the science. Therefore, today we continue our brief overview of stem cell terminology. As you may recall, we've already discusse the differences between pluripotent and multipotent stem cells. Today's blog [post from Farella Braun Martel] will focus on umbilical cord blood as a source for stem cell transplantation."

VCs Cautious On Stem Cell Investments

2005-07-10T14:08:00.000-04:00

� David Shabelman writes:

"Politics aside, stem-cell research in the United States appeared poised to take off, thanks to passage of Proposition 71 in California, which earmarks $3 billion for stem-cell research over 10 years. But as this article from Wired.com points out, it's been anything but smooth sailing for stem-cell research companies. The companies still must prove to a venture capital industry already bitten by one biotech bubble in the early '90s that the research will lead to promising therapies and that political factors surrounding the research won't impede things. "

Setting a Patent Stategy

2005-06-30T11:28:00.000-04:00

"To add the most value, [biotechnology] companies need to do more than file applications early and often...Patents provide potential leverage for obtaining cash, technology, and desired collaborations through licensing. They are also attractive assets to potential investors, collaborators, and acquiring companies. And they can help remove roadblocks set by third-party patents through cross-licensing...

Consider the case of a startup biotechnology company. Frequently, the company begins by obtaining a license for its initial core technology from a university and then develops and enhances that technology through its own research and development efforts. Eventually, the company seeks to partner with a large pharmaceutical company for further research, development, regulatory approvals, and marketing...

The first step in the patent strategy comes when the company begins negotiations to license its core technology from the university. It starts with a strategic analysis of the patent rights supporting that technology, typically through a due diligence process...The patent rights need to be examined to assess their realistic scope and significance... Patent counsel should conduct a "freedom to operate" assessment of the technology. Any third-party patent rights that might be infringed by the use of the technology must be identified and analyzed...

Beyond the initial results of the due diligence, a strategic plan represents an ongoing process that evolves as the company's business plan evolves.

One basic issue is what to patent... The plan should also set decision-making criteria for each point in the process of obtaining a patent... In addition, the plan should provide a long-term approach for identifying and neutralizing third-party patent rights that may block research, development, or marketing of the biotech's products...

If a biotech company has developed and implemented an intelligent patent strategy and has successfully done the many other tasks necessary to develop its products, then the company is ready for its collaboration with big pharma."

Read more in this Cooley Godward LLP article from Mondaq.

Tech Transfer Offices Can Facilitate Business Startups

2005-06-27T16:43:00.000-04:00

"There exists in some quarters a long-standing belief that, in terms of starting biotech companies, university technology transfer offices are staffed with highly educated order takers who do not understand business. If the lawyers and scientists in these offices are not actual impediments to getting business done, then at best they are bureaucrats frozen in idleness until an entrepreneur spies a technology worth millions and thaws them out long enough to strike a deal.

The truth is somewhat different. Tech transfer offices can indeed wait passively for entrepreneurs to walk in the door and license something. But sometimes startup formation begins at the universities, which in their excitement about their technologies do not wait for entrepreneurs. Instead, they spin off companies and seek CEOs to manage them. This happens not just at Stanford and MIT, which benefit mightily from flourishing venture capital activity nearby. Other universities also do startups very well -- or are getting better -- even where VC activity is less intense, or is mainly devoted to other industries, or where spinoffs lack a tradition of encouragement."

Read more in this article from Signals Magazine.

Stem Cell Breakthrough in Pittsburgh

2005-06-25T15:30:00.000-04:00

"Hailed as a ground-breaking study, scientists in Pittsburgh say they've discovered that adult stem cells have the same ability as embryonic stem cells to multiply.

The previously unknown characteristic indicates post-natal stem cells may play an important therapeutic role, according to the researchers at the city's Children's Hospital."

Read more in this WorldNetDaily article.

The National Agricultural Law Center

2005-06-19T19:51:00.000-04:00

In 1987, Congress recognized the University of Arkansas School of Law for its "unique expertise in the area of agricultural law" and called for the creation of the The National Agricultural Law Center at the Law Schooll. Since then, the National AgLaw Center has been funded with federal appropriations through the National Agricultural Library, an entity within the USDA Agricultural Research Service. The National AgLaw Center is the only agricultural and food law research and information facility that is independent, national in scope, and directly connected to the national agricultural information network.

The Center conducts objective legal research and provides timely, accurate, and non-partisan agricultural and food law information to those in the agricultural community.

Biotech grant to create jobs in Southwestern Pa.

2005-06-19T19:43:00.000-04:00

"Five Pennsylvania biotechnology companies will split $5 million in state funding, a move that will create about 100 jobs in Allegheny County.

The funding, announced Monday by the Pennsylvania Department of Community and Economic Development, comes from Gov. Ed. Rendell's Governor Action Team plan.

Read more in this article from the Pittsburgh Business Times.

Aborted babies used in Russian anti-ageing fad

2005-06-19T19:29:00.000-04:00

"WEALTHY Russians are switching from investing their roubles in luxury yachts and designer jewellery to stem cell therapies in an attempt to maintain the vitality of youth into their old age.

The treatments, in which stem cells extracted from aborted or miscarried foetuses are injected into the body, is the latest anti-ageing weapon, following Botox injections and facelifts, to keep Moscow's youth-obsessed high society looking young.

And those who have admitted visiting the clinics now springing up across the Russian capital claim it works and has wiped years off their age."

Read more in this Scotsman.com article.

State bid to end cloning ban

2005-06-19T19:28:00.000-04:00

"A PUSH to relax Australia's legal restrictions on stem cell research was launched yesterday by the Victorian Government, as fears grow that Australia could fall behind other countries if it maintains its ban on therapeutic cloning.

Victorian Treasurer John Brumby warned yesterday Australia could 'lose our competitive edge and ... our best people' if a legislative review announced by the federal Government on Friday did not allow the present laws to be relaxed. "

Read more in this article from The Australian.

Merck v. Integra LifeSciences Decision Boon to Big Pharma

2005-06-14T18:00:00.000-04:00

"While the U.S. Supreme Court's opinion did not extend the statutory research use exemption to patented research tools under 35 U.S.C. ss.271 (e)(1) in Merck KGaA v. Integra LifeSciences I, Ltd . (2005 WL 1386324 (U.S.)), the Court unanimously ruled for a broader interpretation of the exemption from patent infringement for use of a patented invention 'solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.' The Court specifically noted that patented 'research tools' were not part of that interpretation."

Read more in this Patent Baristas post.

Seed Shrinkwrap License Does Not Implicate Plant Variety Protection Act

2005-06-14T17:46:00.000-04:00

"Illinois farmer, Edward Showmaker, filed suit against Advanta USA, claiming that the language of the shrinkwrap license agreement on Advanta's soybean seed violated the misbranding provision of the Plant Variety Protection Act (PVPA). The Advanta's Garst Brand Seed D445N, Variety 57004 purchased by Mr.. Showmaker was neither patented or PVPA certified...

The United States District Court for the Southern District of Illinois dismissed the case for failure to state a claim upon which relief can be granted because the contractual language in the Agreement did not implicate the PVPA's misbranding provisions. "

Read more in this Patently-O post.

Business Week Biotech Issue

2005-06-10T14:44:00.000-04:00

"Make sure to read this week's BusinessWeek -- devoted to the biotech sector. You can access many of the articles here."

From this Biotech Stock Blog post.

A Prescription for Life Sciences - BetterManagement.com

2005-06-04T21:57:00.000-04:00

"We have all read the press articles on the future of the Life Sciences industry and the pressures to become more cost effective. AMR Research recently talked to business and technology leaders in pharmaceutical, biotech, and generic manufacturing companies to crystallize the big picture. The result is the following set of core components that must be addressed in varying degrees in every company's business and operations strategy (this is also forming our research agenda):

Research and development...
Commercializing the product innovation pipeline...
Improving sales and marketing performance...
Predictable product supply...
Demand-Driven Supply Network (DDSN) transformation...
Integrated business and operations performance management...
Capitalizing on IT...
Using assets and investments and minimizing risks..."

Read more in this BetterManagement.com article.

Biotechnology at the Tipping Point?

2005-06-03T12:21:00.000-04:00

"There has been a flurry of news reports this year showing the heightened awareness of the biotech industry and the concomitant growth.

Business Week recently published an article touting that Biotechnology has finally come of age after 30 years of biological research. Now, recent developments in gene and exotic chemical manipulation have brought a wave of biological drugs, many of them reengineered human proteins. These drugs represent real progress for a range of diseases all but untreatable just five years ago...

It's not all rosy, though.."

Read more in this Patent Baristas post.

Vivisimo Velocity for Life Sciences

2005-05-25T12:49:00.000-04:00

Vivisimo, the creator of innovative clustering software for better search and discovery, introduced the Velocity for Life Sciences 4.2 (VLS) search and discovery platform that includes meta-alerts, collaboration, document delivery and advanced reporting capabilities for improved knowledge sharing among functional groups across an enterprise. Velocity for Life Sciences 4.2 is the industry's first rapid-deployment, highly customizable enterprise-search platform that combines dynamic clustering, search and meta search into one solution providing a single point of access for all information sources - internal and external. The VLS platform is built on the widely deployed Vivisimo software and includes the company's award-winning Clustering Engine. Velocity for Life Sciences features also include:

-- Meta Alerts: Velocity allows users to create alerts from multiple information sources from a single point of access. Users no longer need to access each source individually; instead, they can initiate and receive alerts from several sources in one combined email. Alerts can be initiated simply by clicking on a result or by adding them through user profiles.

-- Collaboration and Exporting: With a simple click, Velocity users can export results into Endnote, Procite, Reference Manager, Documentum eRooms, or email reports in HTML or plain text format. It can also save reports as text, HTML or XML, making it easy to share, collaborate and preserve searches. Velocity allows users to save their searches and return to the results at a later time in order to better meet the work habits of individual users.

-- Customizable Reports: Velocity's comprehensive reporting feature is entirely customizable and enables administrators to ask and answer critical business questions. For example, administrators can learn what "resources" (journals, feeds, etc.) are actually used and which should continue to be licensed. Administrators can also learn what keywords or phrases are found through the search application, and how and with what frequency users reformulate their queries.

-- Full-Text Document Delivery: Velocity has interfaces with leading document delivery organizations such as Infotrieve. Now through a single solution, Velocity users can access full-text documents with the advantages of third-party providers that maintain document ordering quotas for document cost control.

-- LinkOut: Velocity incorporates the Entrez LinkOut feature providing full-text access to journals and databases that have been licensed by the organization.

-- Document-Level Security: Velocity document-level security provides administrators complete control over access to individual documents or groups of documents. It allows only authorized users access to search results involving sensitive information.

From this post from Marcus P. Zillman, M.S., A.M.H.A. Author/Speaker/Consultant

EU Invites Public Comment on Tissue Engineering Regulation

2005-05-22T14:56:00.000-04:00

"A new biotechnology area has emerged: human tissue engineering, which combines various aspects of medicine, cell and molecular biology, materials science and engineering, for the purpose of regenerating, repairing or replacing diseased tissues. Current applications of this nascent field of 'regenerative medicine' include treatment for skin, cartilage and bone diseases or injuries.

More complex products - such as heart valves or blood vessels - are already in the pipeline. Tissue engineered products currently lie outside any legislative framework.

This is why the European Commission is working on a clear regulatory framework. Before tabling a formal proposal later this year, the Commission has now invited the general public to comment on a draft regulatory framework for authorisation, supervision and post-authorisation vigilance of advanced therapies (tissue engineering, cell and gene therapy). This consultation is part of the impact assessment of the upcoming proposal. "

Read more in this Medical News Today article.

Turning Biotechnology into Companies

2005-05-22T13:46:00.000-04:00

This Infectious Greed post contains links to videos from the following panels held at the recent VentureForth @ UCSD - Biotechnology Entrepreneur Conference 2005 held in San Diego:

Keynote #1: Dr. Charles Cantor, Sequenom
Panel #1: Academia to Market
Keynote #2: Ivor Royston, Forward Ventures
Panel #2: Trends in Biotechnology
Panel #3: Legal & Tech Transfer Issues

Biotechnology Offers Hope, Fears to Developing Countries

2005-05-13T11:02:00.000-04:00

"Brazil and other developing countries pondering whether or how much to use genetically modified agricultural crops must balance many different concerns.

They range from battling domestic starvation and malnutrition and ensuring health and safety, to preserving the environment, fulfilling multilateral trade obligations and protecting and enhancing trade opportunities, a recent United Nations Conference on Trade and Development (UNCTAD) study says.

The study, entitled International Trade in GMOs and GM Products: National and Multilateral Legal Frameworks reports that genetically modified crops pose especially difficult choices for the world’s poorer nations."

Read more in brazzilmag.com article.

Lawsuit hampers Calif. stem cell funding

2005-05-12T10:31:00.000-04:00

"California officials conceded Monday that a legal challenge has severely hampered the ability of the state's stem cell agency to borrow even a penny of the $3 billion in research money it had hoped to raise over the next 10 years.

Attorney General Bill Lockyer and Treasurer Phil Angelides said their offices are aggressively fighting the lawsuit while pursuing alternative ways for the California Institute for Regenerative Medicine to borrow money to fund medical research."

Read more in thie The Beaufort Gazette article.

Making a Constitutional Issue of the Right to Conduct Research

2005-05-09T12:27:00.000-04:00

"A Nobel laureate who campaigned for California's $3 billion stem cell initiative is warning that ideologically driven laws to prohibit research could abridge the constitutional rights of researchers and would face legal challenges.

Paul Berg, a biotech pioneer and a professor emeritus at the Stanford University School of Medicine, made the comments during a luncheon speech April 28 at BayBio 2005, a conference of the Bay Area biotechnology association.

"Given the federal government's threat to prohibit certain lines of research, it seems relevant to ask if the freedom to conduct scientific investigation and to report its results is legitimately different from the rights afforded to the press for their freedom of inquiry and publication," Berg said. "In short, lacking clear evidence of certain danger or harm, I believe the case can be made that the freedom to conduct scientific inquiry is inherent in the right to free speech granted in the Constitution's Bill of Rights."

Read more here.

Guidelines Released for Embryonic Stem Cell Research

2005-05-04T10:26:00.000-04:00

The National Academies announced recommended guidelines for research involving human embryonic stem cells, “and urged all institutions conducting such research to establish oversight committees to ensure that the new guidelines will be followed. The guidelines are intended to enhance the integrity of privately funded human embryonic stem cell research by encouraging responsible practices, said the committee that wrote the report, a joint project between the National Academies' National Research Council and Institute of Medicine…

Embryonic Stem Cell Research Oversight, or ESCRO, committees should be established, but not as replacements for other research compliance bodies such as institutional review boards, the guidelines say. In addition to experts in biology and stem cell research, ESCRO committees should include legal and ethical experts as well as representatives of the public.

Stem cells usually are harvested after three to five days from a blastocyst -- an early stage of development before implantation in the uterus. The ESCRO committees should review proposals for research that takes stem cells from excess blastocysts at in vitro fertilization clinics or from blastocysts created expressly for stem cell research. They also should review any proposed use of blastocysts created by nuclear transfer, often referred to as therapeutic cloning. Nuclear transfer must not be used for reproductive cloning, the guidelines committee said, reiterating a recommendation from a previous National Academies report.

Proposals to generate additional human embryonic stem cell lines by any means should be reviewed and approved by an ESCRO committee, the guidelines say. They add that human embryos used for research should not be grown in culture for longer than 14 days, or until the point when the body axis and central nervous system -- called the primitive streak -- begin to form…

The ESCRO committee should maintain a registry of stem cell lines banked at an institution, the guidelines add. The registry should include a proof of informed consent, a medical history of the donors, and a characterization of any genetic markers on the cell lines. Repositories of stem cell lines also need a secure coding system to protect the identity of donors.

The Academies' guidelines also address how far scientists should go in mixing human and animal cells to create so-called chimeras, which researchers may need to do in order to test the therapeutic potential of human stem cells in animal models. The guidelines say no animal embryonic stem cells should be transplanted into a human blastocyst, and approval by an ESCRO committee should be secured before any human embryonic stem cells are put into an animal. Also, no animal into which human embryonic stem cells have been introduced should be allowed to breed. In addition, no human embryonic stem cells should be put into nonhuman primate blastocysts.

Human embryonic stem cells should be introduced into nonhuman mammals only under circumstances where no other experiment can provide the information needed, the guidelines say. Experiments in which there is a possibility that human cells could contribute in a "major organized way" to the brain of an animal require strong scientific justification, the committee added.

The committee urged the formation of a national independent body to periodically review whether the guidelines need to be updated in light of unforeseen advances in stem cell science and evolving public attitudes.

The National Academies developed the guidelines on behalf of the scientific community and without government involvement. Although compliance is voluntary, the committee called on private funders, professional societies, journals, research institutions, and others involved in embryonic stem cell studies, to require adherence to the guidelines."

From this press release.

GM rice 'good for Chinese farmers'

2005-05-03T12:55:00.000-04:00

"Genetically modified (GM) rice reduces health risks for farmers and increases their profits because it demands far fewer pesticide applications than conventional rice, according to research in China.

The joint Chinese-US study, published today (29 April) in Science, also shows that one of the two types of GM rice under investigation had slightly higher yields than non-GM rice."

Read more in this article from SciDev.Net.

Biotech's promise arriving with a price tag

2005-05-01T12:34:00.000-04:00

"For 30 years, prognosticators have proclaimed that the future of health care belongs to biotechnology -- to the promise that miraculous and less-expensive treatments will flow from a deeper understanding of disease at the genetic and molecular level of the human body....

Has the future arrived?

Yes and no.

Yes in the case of a few wonder drugs, and in the wealth of research that has inched us closer to teasing out the basic mechanisms of how ailments work...

But the bright future hasn't arrived in this sense: The price tag for creating a promised proliferation of new drugs continues to soar, with the secrets of how to design molecular-based drugs proving frustratingly complex, and far more expensive than anyone imagined."

Read more in this SFGate.com article.

Business Mocels for the Commercialization of Biotechnology Tools

2005-05-01T12:30:00.000-04:00

"Biotechnology research tools require different commercialization strategies than drugs. They typically feature lower barriers to entry, increased risk of replacement / commoditization, and lower development costs. This series of Articles [from About.com] details issues in developing business models for biotechnology research tools, intellectual property protection, and valuation."

Venture Investors Shifting Away From Biotech

2005-04-26T10:07:00.000-04:00

"Venture capitalists are investing less in biotechnology and more in Internet companies, according to initial data for the first quarter this year.

While there are no signs that venture capitalists have picked up or slowed down their overall investment pace, they appear to have pulled back from biotech, the hottest sector of the past two years, according to a survey to be released today by VentureOne and Ernst & Young. However, measuring quarterly trends is tricky because venture capitalists like to keep their bets secret. It takes weeks, sometimes months or years, for some investments to be reported."

Read more in this MercuryNews.com article.

EU Universities Weigh Spin-offs versus Licensing in Tech Transfer

2005-04-20T15:34:00.000-04:00

"With regional development and high-tech employment near the top of the agenda in many countries of the EU, a flurry of conferences will be discussing the best way to put the fruits of academic research, including biotechnology, to economical use.

Lessons learned in the UK, one of the European countries most advanced in exploiting its homegrown knowledge, could prevent other countries from making the same mistakes when developing their biotech sector. In particular, the high number of companies spun out of UK universities is spurring debate over whether the country should start shifting priorities from creating spin-offs to licensing inventions to outside companies.

Read more in this news @ nature.com article.

Open Source Biotechnology Project

2005-04-10T17:51:00.000-04:00

"'Open Source Biotechnology' refers to the possibility of extending the principles of commerce-friendly, commons-based peer production exemplified by Open Source software development to the development of research tools in biomedical and agricultural biotechnology.

The Open Source Biotechnology Project examines the feasibility of Open Source Biotechnology in the current industry environment. In particular, it explores:

1. Whether it would be possible to run a viable biotechnology business on Open Source principles, and

2. What such a business might look like, including the application of specific Open Source-style licences to particular classes of biotechnology research tools."

FDA Issues Final Guidance on Risk Management of Drugs and Biologics

2005-04-09T20:14:00.000-04:00

"The U.S. Food and Drug Administration (FDA) recently issued three final guidances based on draft guidances published in May 2004. The final guidances are directed at improving the assessment and monitoring of risks associated with drugs and biological products in clinical development and general use.

The first of the final guidances relates to premarket risk assessment and focuses on considerations for the stages of clinical development of products. It builds on a number of existing FDA and ICH guidances related to preapproval safety assessments.

The second guidance deals with the development and use of risk minimization action plans. It includes a call for broader input from patients, health care professionals and the public when recommendations are made on whether to initiate, revise or end risk minimization interventions.

The third final guidance, addressing heightened postmarketing vigilance, recommends reporting and analytical practices for monitoring the safety concerns and risk of medical products in general use."

For more information, please see this Pharmacapsules @ Gowlings report.

No Research, Development Only Business Model

2005-04-04T22:15:00.000-04:00

"New business models are emerging in the biotechnology industry that are geared to reducing investor risk in order to attract funding from investors who are not willing to expose themselves to the level of risk normally associated with biotechnology firms...

Hence the emergence of the NRDO model. NRDO stands for No Research, Development Only, and refers to companies that attempt to reduce the high risk of failure and long periods of unprofitability typically associated with biotechnology start-ups by eschewing drug discovery. Instead they concentrate on shepherding existing but as-yet-unapproved drugs through the clinical trial pipeline and hopefully toward FDA approval...

Theoretically, the NRDO model has the potential of being beneficial to all involved parties.

By increasing the efficiency of the market, it allows biotechnology firms that are adept at drug discovery to concentrate on what they do best, while at the same time allowing big pharmaceutical firms to profit from licensing out technology that would otherwise have sat on a shelf without producing returns, and it obviously benefits the drug development companies that are following the NRDO model.

Consumers benefit from the availability of treatments that wouldnt otherwise have reached the market, and investors benefit because they will have more varied and lower-risk investment options...

In practice, however, it is unclear whether, or to what extent, the NRDO model actually reduces risk. The drug development process still has a high failure rate, and it is not yet known whether firms following the NRDO model will be more successful at getting drugs to the market than traditional biotechnology firms..."

From this Genetic Engineering News article via this post from About.com.

Weapon Against Bioterrorism: Life Sciences Code of Ethics

2005-03-29T15:22:00.000-05:00

"Unprecedented advances in the life sciences and the potential for the misuse of the scientific enterprise for bioterrorism or biowarfare have created a pressing need for an international consensus on the steps that must be taken to reduce this grave threat to humanity.

Counterbioterrorism measures must include providing ethical guidance--especially for scientists, physicians, scientific institutions, and others engaged in research and development in the life sciences throughout the world. In this Policy Forum [from Science Magazine], an ethical code is proposed that captures the essential aspiration that research and development in the life sciences will seek to do no harm and, where possible, to benefit humankind; extends the prohibitions of the Biological Weapons Convention (BWC) to the broader scientific research community; specifies actions that scientists and others must take to protect against the misuse of biological agents and dual-use information; and addresses areas of contentious research by incorporating ethics and safety reviews."

The Proposed Code:

"CODE OF ETHICS FOR THE LIFE SCIENCES

All persons and institutions engaged in any aspect of the life sciences must

1. Work to ensure that their discoveries and knowledge do no harm (i) by refusing to engage in any research that is intended to facilitate or that has a high probability of being used to facilitate bioterrorism or biowarfare; and (ii) by never knowingly or recklessly contributing to development, production, or acquisition of microbial or other biological agents or toxins, whatever their origin or method of production, of types or in quantities that cannot be justified on the basis that they are necessary for prophylactic, protective, therapeutic, or other peaceful purposes.

2. Work for ethical and beneficent advancement, development, and use of scientific knowledge.

3. Call to the attention of the public, or appropriate authorities, activities (including unethical research) that there are reasonable grounds to believe are likely to contribute to bioterrorism or biowarfare.

4. Seek to allow access to biological agents that could be used as biological weapons only to individuals for whom there are reasonable grounds to believe that they will not misuse them.

5. Seek to restrict dissemination of dual-use information and knowledge to those who need to know in cases where there are reasonable grounds to believe that the information or knowledge could be readily misused through bioterrorism or biowarfare.

6. Subject research activities to ethics and safety reviews and monitoring to ensure that (i) legitimate benefits are being sought and that they outweigh the risks and harms; and (ii) involvement of human or animal subjects is ethical and essential for carrying out highly important research.

7. Abide by laws and regulations that apply to the conduct of science unless to do so would be unethical and recognize a responsibility to work through societal institutions to change laws and regulations that conflict with ethics.

8. Recognize, without penalty, all persons' rights of conscientious objection to participation in research that they consider ethically or morally objectionable.

9. Faithfully transmit this code and the ethical principles upon which it is based to all who are or may become engaged in the conduct of science."

Digital Signature Trials to Start

2005-03-29T14:56:00.000-05:00

"The first pilot projects testing a digital signature standard that's being developed for worldwide use by the pharmaceutical industry are due to be launched within the next three weeks, according to officials involved in the effort.

The standard, called Secure Access for Everyone (SAFE), is designed to enable the use of legally enforceable electronic signatures over public-key infrastructure (PKI) networks. Backers envision the digital signatures being used in business-to-business transactions and communication with government regulators.

Among other benefits, the SAFE credentials are expected to make it faster and more cost-efficient for pharmaceutical companies and researchers to submit applications and get approval for drug trials than with current paper-based processes, said Guy Tallent, SAFE's program director."

From this BioITWorld article.

Supreme Court Hearing Set on Experimental Use Safe Harbor Statute

2005-03-28T13:06:00.000-05:00

"Party and amicus briefs have been filed and the stage is now set for the April 20 hearing of Merck KGaA v. Integra LifeSciences at the Supreme Court.

Merck v. Integra is slated to determine the scope of 35 U.S.C. �271(e)(1), the safe harbor statute that permits a drug manufacturer to perform potentially infringing experiments needed to obtain FDA approval without incurring liability for patent infringement. A major question will be how attenuated an experiment may be and still fall within the protection from infringement liability offered by the statute."

For summaries and PDF copies of the various briefs filed in the case, please see this post from Patently-O from which the foregoing quote was taken.

Evolution Can Occur Quickly

2005-03-26T13:15:00.000-05:00

"In a stunning example of evolution at work, scientists have now found that changes in a single gene can produce major changes in the skeletal armor of fish living in the wild.

The surprising results, announced in the March 25, 2005, issue of journal Science, bring new data to long-standing debates about how evolution occurs in natural habitats.

'Our motivation is to try to understand how new animal types evolve in nature,' said molecular geneticist David M. Kingsley, a Howard Hughes Medical Institute investigator at the Stanford University School of Medicine. 'People have been interested in whether a few genes are involved, or whether changes in many different genes are required to produce major changes in wild populations.'

The answer, based on new research, is that evolution can occur quickly, with just a few genes changing slightly, allowing newcomers to adapt and populate new and different environments."

From this Biology News article.

The US Drug Pricing System is Broken

2005-03-23T16:10:00.000-05:00

"The pricing system for drugs in the United States is broken, said David Brennan, executive vice president of the North American division of AstraZeneca, the drug maker with headquarters in the U.K. and Sweden. Trouble is, no one, including the drug companies themselves, has any clear idea how to fix it.

Brennan, who was also appointed to AstraZeneca's board last week, made these remarks at a Wharton healthcare conference in February. Not surprisingly, he doesn't advocate a radical overhaul: Such a move could hurt the productivity of an industry that has contributed substantially to advances in human health and longevity during the last three decades, he said. What's needed is realistic cooperation among all the players -- drug makers, insurers, consumers, doctors, hospitals and employers."

Read more in this Kowledge@Wharton article.

How to Make Money in Bioinformatics

2005-03-22T10:18:00.000-05:00

"This report from a recent Harvard Business School panel discussion about business models for bioinformatics presents the complex answer to a vexing question for bioinformatics firms - How can you make money selling bioinformatics? The short answer: 'You have to pick a big enough niche, and you really have to understand the customer.'"

Via this about.com post.

Agrobacterium-mediated transformation of plants patent dispute settled

2005-03-17T13:32:00.000-05:00

From this post from Navigating the patent maze:

"In November 2004, I reported the conclusion of a long running dispute in the U.S. Patent Office on who first invented Agrobacterium-mediated transformation technology (previous post). A few weeks ago, a joint press release from Bayer CropScience, Max Planck Society, and Monsanto announced that the interference ended by settlement among these parties. Under the agreement, the organizations will cross-license their respective Agrobacterium-mediated transformation technologies; Bayer (the exclusive licensee of Max Planck's technology) and Monsanto will provide each other non-exclusive licenses related to R&D and sale of transgenic crops; Monsanto will give Max Planck a license in the U.S. for research purposes...

If the technology is not licensed to anyone else - neither of these companies is known to widely license technology - then they are able to effectively stifle other companies from entering the transgenic plant field. Agrobacterium is the most widely used method for transforming plants; there are very few other means of transformation, only bombardment (owned by Cornell and licensed to duPont) is frequently used. With luck new transformation technology developed at CAMBIA using non-Agrobacterium strains will break the stranglehold."

The Stem Cells Patent Landscape

2005-03-13T13:41:00.000-05:00

Stem cells have been in the news a great deal recently, both for their medical promise and the difficult ethical questions the use of embryonic stem cells present. This article from Goodwin Procter LLP via Mondaq discusses some of the science, medical treatments, ethics, politics and the IP status of the business of stem cells, stating:

"The patent landscape for both adult and embryonic stem cells is very crowded, with hundreds of issued patents having claims to methods of isolating stem cells, methods of propagating stem cell lines, methods of differentiating stem cell lines, and methods of using stem cells in treatment.

On the embryonic stem cell patent front, the University of Wisconsin holds the dominant patent position in primate embryonic stem cell line production. The Wisconsin Alumni Research Foundation ("WARF"), founded to handle the University’s patents and technology transfer, holds patents affecting 64 stem cell lines, including extensive rights to five lines.

Among companies, Geron Corporation is a significant player that to date has a portfolio of 240 stem cell patents. Geron obtained an exclusive license from WARF for its human embryonic stem cell technology, which ultimately ended up in litigation that was settled in 2002. Under its present license from WARF, Geron holds exclusive rights to develop certain therapeutic and diagnostic human embryonic stem cell products.

WARF and Geron have agreed to grant research rights to their existing human embryonic stem cell patents and applications to academic and governmental researchers without royalties or fees. Third-party for-profit companies may form collaborations with Geron or obtain licenses to Geron’s intellectual property on market terms. WiCell Research Institute, a WARF subsidiary, distributes the cell lines. WARF and WiCell Research Institute agreed to reasonable terms for such distribution in a Memorandum of Understanding with the NIH on September 5, 2001.

The adult stem cell patent landscape is also very crowded, with hundreds of patents directed to various aspects of the technology. For example, Osiris Therapeutics, a clinical stage biotechnology company founded to commercialize adult stem cells derived from bone marrow, has 42 issued patents directed to certain technologies, including methods of isolating and differentiating such cells, and methods of using the cells as immunosuppressants, for cartilage regeneration, and for repair of connective tissue."

UN votes to ban human cloning

2005-03-11T10:20:00.000-05:00

"By a vote of 84 in favor, 34 against and 37 abstaining, with 36 absent, the UN today approved a declaration calling on all UN Member States to ban all forms of human cloning, including cloning for medical treatment, as incompatible with human dignity and the protection of human life.

While in general agreement, some delegates said they opposed banning therapeutic cloning. The Declaration, negotiated by a Working Group last month, also banned 'genetic engineering techniques that may be contrary to human dignity' and called for a prevention of the exploitation of women and adequate protection for human life in the application of life sciences. The Declaration has been welcomed by many as a clear expression of the ethical norms that should guide scientific research."

From this Biology News post.

Getting Beyond Fear of GM Crops

2005-03-07T12:58:00.000-05:00

"GM crops are created in laboratories, using highly precise techniques. They have been tested repeatedly, and they are regulated by the EPA, FDA, USDA and other agencies. Americans have collectively eaten over a trillion servings of food containing one or more GM ingredients, without a single case of harm. Indeed, as Greenpeace co-founder Patrick Moore and others have demonstrated, every single claim of risk to people or the environment -- from monarch butterfly deaths to destabilized insect ecology and diminished biodiversity -- has been refuted by scientific studies.

And still Dr. John and his fellow radicals place ultra precaution against minor, distant, theoretical risks to healthy, well-fed Westerners above the very real, immediate, life-threatening risks faced by our Earth's poorest and most malnourished people.

Farmers the world over are increasingly turning to GM technology, planting 200 million acres last year. They don't for a minute believe ag biotech is a magic bullet that will make them rich and solve the world's hunger problems. But they know it dramatically increases crop yields, farm profits and family nutrition -- while reducing pesticide use, crop losses to drought, insects and disease, and the amount of land that will be needed to feed a world population that is expected to hit 9 billion by 2050, before leveling off.

Bt cotton has let Chinese farmers reduce their pesticide use by 50 to 70 percent -- while increasing their yields by 25 to 66 percent, and their incomes by US$300 per hectare (US$120 per acre). Since most of these chemicals were applied via hand spraying, they've also slashed accidental pesticide poisoning. Farmers in other Third World countries have had similar experiences."

From Ethis March 7, 2005 article

BioBlast Scheduled

2005-03-03T11:45:00.000-05:00

Join the Pittsburgh Biotech community for the first BioBlast of the year! -- The Common Ground for Science and Business

Come to BioBlast, and interact with fellow life scientists. Over drinks and food, share tidbits about research, start-ups, and discoveries. Meet venture capitalists, entrepreneurs, scientists, and business people from the life sciences industry.

Date: Wednesday, March 9, 2005
Time: 6:00 p.m. - 9:00 p.m.
Venue: WQED, Studio A - 4802 Fifth Ave, Pittsburgh

From more information click here.

The Patentability of Biotechnology

2005-03-01T12:29:00.000-05:00

"Since the 1970s particular attention has been paid to the patentability of biotechnology focused on genetically modified organisms and other products derived from living systems. Does patent law protect such subject matters? Can biotech patenting be harmonized? How can the traditional principles of patentability be applied to new forms of technology? Should biotechnology be regarded as subject matter for patent protection? [3] The Aim of this analysis (based mainly on US law) is to highlight biotechnology patent novelties and compare them to established principles of patent law."

Does FDA Safety Initiative Aid Investors more than Patients?

2005-02-24T21:17:00.000-05:00

"Looking at the events of the past five months, one has to now wonder if the creation and placement of the DSB [Drug Safety Oversight Board] and other changes at the FDA will protect investors more than the public. The original public outcry was about the safety of Vioxx and how the FDA (and Merck) could allow it on the market. With the independent panel of experts believing Vioxx should remain on the market but with stricter warnings, it begs the question, was all this necessary and whom do these changes really benefit?

Patient safety is probably not going to benefit much if at all from the changes at the FDA. Prior to the formation of the DSB, the burden of continued monitoring fell in large part to the pharmaceutical company due to legal worries. Patient safety and the fear of litigation is what drew Merck to pull Vioxx off the market. That drastic and major reaction by Merck caused its shares to fall over 30% from its pre-recall value.

For a company to take such a drastic step, highlights the fear pharmaceutical companies have over litigation. The DSB is now placing more of the burden of drug safety on them and this protects the financial interests of pharmaceutical companies because they may not have to act so proactively. If the DSB supports continued marketing of a particular drug, then this lowers the company’s legal risk. Now that the independent counsel has approved keeping Vioxx on the market, some of Merck’s litigation risk has diminished.

The new initiative from the FDA does not really protect consumers any more than in the past, the only thing that has changed is the shifting burden of drug monitoring. Responsible pharmaceutical companies have always monitored their drugs because of the enormous liability issues that surround a poor product. As evident with Vioxx, a company will pull a $2.5 billion product off the market to try and save itself from some litigation. Now that the burden is on a government oversight committee, we cannot expect unsafe drugs to be found any quicker or examined anymore thoroughly than the prior system.

If the DSB was in existence prior to the recall of Vioxx, we might have seen a greatly different story unfold. A story in which Vioxx was never removed from the market but just new warnings added. A story in which Merck’s shares do not fall 30%. This story shows the same amount of protection for patients as the real story but also protects the value of Merck. This new drug safety initiative might potentially protect companies but may do little to increase patient safety.

From this frost.com article.

Drug Patent Approval Watch Newsletters Available

2005-02-23T10:13:00.000-05:00

Enter your email address at Drug Patent Approval Watch to receive notification of new drug patent approvals.

Via this Biotech Blog post.

Birchmere to invest $44 million in biotech

2005-02-21T17:04:00.000-05:00

"Birchmere Ventures, a North Side-based venture capital firm, has secured more than $44 million to invest in fledgling biotechnology firms, the state said yesterday.

The total includes $10 million from the state Tobacco Settlement Investment Board, which tapped Birchmere to raise private dollars to match the tobacco settlement money it would provide to help finance promising biotech ventures in Western Pennsylvania."

From this Pittsburgh Post-Gazette article.

Security Resource Sheet For Biologics Manufacturers

2005-02-20T19:24:00.000-05:00

"The physical security of biological products and the facilities in which they are manufactured and otherwise held is an important public health issue. Effective security can help prevent terrorism, counterfeiting, or tampering activities that could harm United States citizens by, among other things, disrupting medical supplies. Therefore, the physical security of regulated products is an important focus for Center for Biologics Evaluation and Research of the US Food and Drug Administration"

This CBER - Security Resource Sheet For Manufacturers of Biological Products: may be helpful in protecting facilities and products.

Biotech Venture Investing in Denmark

2005-02-20T19:00:00.000-05:00

This article from VC Experts provides an overview of venture capital investing in Denmark from the investor point of view and contains valuable information for entrepreneurs generally. An excerpt:

"There are very few barriers of contact between venture capitalists and entrepreneurs in Denmark. Usually, the phone numbers and email addresses of the venture capitalists are public and freely available, and many companies approach the decision-makers directly.

As in all industries, anyone with a track record of exits will be preferred over less experienced people. If a person can show that he has built a biotech company and exited with a nice historical return for the co-investors, his value to future venture investors is immense, and he is likely to receive capital. However, since most entrepreneurs are first timers, this is usually not the case. In those situations, investors look for entrepreneurs who have clarity in presenting the investment case - meaning that the entrepreneur has put a lot of careful thought into every possible scenario over the next couple of years and has determined steps to prevent failure.

At BankInvest Biomedical Venture, we are looking for three things:

First is clarity of plans. What are their goals? What might prevent them from reaching their goals? What steps are taken to alleviate those risks?

Second is focused management. Can they attract co-investors? Are they cash-focused? Have they made a six-year cash liquidity plan including expected valuations of the company tied to significant (corporate, scientific) milestones?

Last is the technology platform, which generates numerous potential products. What, exactly, is the product to be sold, and why would anyone pay a premium to buy this product?"

Crisis management in Biotechnology

2005-02-10T22:39:00.000-05:00

Biotechnology product development faces significant internal and external challenges. While scientific setbacks may be difficult to predict, many external problems can be anticipated and prepared for. Read this article from About.com for strategic guidance to anticipating and managing biotechnology crises.

Promise of Agriculture Biotechnology Withering

2005-02-03T11:37:00.000-05:00

"The biotechnology industry and its supporters have long proclaimed all the great things that genetically engineered (GE) crops will do for agriculture, consumers, and the environment in America and around the world. The first generation of products developed and commercialized in the 1990s have, in fact, been commercially successful in the United States and several other countries. Those GE crops – primarily insect-resistant corn and cotton and herbicide-tolerant corn, cotton, soybeans, and canola – have been found safe to humans and the environment. Indeed, they have benefitted the environment and farmers and have been widely adopted by farmers. However, the promise of additional benefits has not been realized. The “second generation” of crops, such as ones engineered to be salt-tolerant or to have enhanced nutritional qualities have still not gotten beyond the laboratory. Is agricultural biotechnology a growth industry with a steady stream of new products or one limited to marketing a few hugevolume commodity crops with narrow agronomic benefits?"

So states the executive summary of this report from the Center for Science in the Public Interest that analyzed existing publicly available regulatory information to determine whether development of new biotech products has been increasing, decreasing or remaining constant. CSPI also assessed how long it takes two federal regulatory agencies to complete their review of biotech crops so those products can be commercialized. The report continues:

"The study found that the number of biotech crops going through the regulatory review process decreased sharply between the last five years of the 1990s and the first five years of the 21st century. Furthermore, the products that the government reviewed between 2000 and 2004 were not “novel” because they involved engineering crops with the same or similar genes that were commercialized in the 1990s. Also, while the number of products to be reviewed by federal regulators declined by two thirds between 2000 and 2004, the time it took to receive a regulatory clearance doubled. Those unexplained trends should worry those who believe that agricultural biotechnology can be used safely and can benefit farmers, consumers, and the environment in the United States, other developed countries, and in developing countries. Public discourse is needed to understand what factors account for the trends and whether and how they can be reversed."

For Baby Biotechs, "a Dangerous Time"

2005-01-26T17:11:00.000-05:00

From Businessweek.com post:

"Veteran VC Bob Higgins explains why he expects failures among the crop of startups 'caught at $200 million and $300 million valuations' "

Surge in biotech investments fuels overall VC gain

2005-01-21T14:04:00.000-05:00

"Well-heeled investors poured billions into young biotech companies last year, powering overall start-up investing to its first annual increase in four years. The venture-capital investments underscore the growing interest in the emerging biomedical industry, which is creating treatments for cancer and other diseases.

The rise in overall investing also shows that the VC industry may have finally emerged from a funk that began with the 2000 tech bust, according to research out today by VentureOne and Ernst & Young."

From USATODAY.com.

The Definitive Study of Entrepreneurship

2005-01-21T13:23:00.000-05:00

From About.com:

"London Business School and Babson College just released their Global Entrepreneurship Monitor report, which is 'the largest annual measure of entrepreneurial activity worldwide, spanning 34 countries and a total labour force of 784 million people.'

Many of the findings are what you might expect, but some of the findings regarding funding were especially interesting, and contain some lessons for entrepreneurs that may surprise you...

Self-funding by entrepreneurs and funding from informal investors (family, friends, colleagues, neighbours and strangers) are the lifeblood of an entrepreneurial society...

By far the rarest source of capital for nascent entrepreneurs is classic venture capital. So rare is it, that even in the US, which has more than two-thirds of the total venture capital in the entire world (74% VC among G7 nations in 2003), far fewer than one in ten thousand new ventures receive their initial financing from VC firms. US companies received $8.1 million VC funding compared to an average of $1.2 million per company in other G7 nations in 2003."

Patents: Planning, Protecting, and Saving Money

2005-01-21T13:00:00.000-05:00

Patents are a vital component of any biotechnology company. They serve to protect markets, indicate R&D strength, and require careful planning to balance their benefits and costs. Read this article from About.com for strategies to protect inventions, and save money.

Monsanto's "Seed Police" Sow Controversy

2005-01-20T13:59:00.000-05:00

"Monsanto's "seed police" snared soy farmer Homan McFarling in 1999, and the company is demanding he pay it hundreds of thousands of dollars for alleged technology piracy. McFarling's sin? He saved seed from one harvest and replanted it the following season, a revered and ancient agricultural practice.

"My daddy saved seed. I saved seed," said McFarling, 62, who still grows soy on the 5,000 acre family farm in Shannon, Mississippi, and is fighting the agribusiness giant in court.

Saving Monsanto's seeds, genetically engineered to kill bugs and resist weed sprays, violates provisions of the company's contracts with farmers.

Since 1997, Monsanto has filed similar lawsuits 90 times in 25 states against 147 farmers and 39 agriculture companies, according to a report issued Thursday by The Center for Food Safety, a biotechnology foe."

From Wired News.

Biotech Virtual Mini MBA

2005-01-20T13:43:00.000-05:00

Want to learn more about starting, building, growing and managing a biotechnology company? Get your virtual MBA in biotechnology through this e-seminar from About.com.

Pennsylvania Bio - Mission and Goals

2005-01-20T13:02:00.000-05:00

"Pennsylvania Bio will be a catalyst to ensure Pennsylvania is a global leader in the biosciences by developing a cohesive community that unites the region's biotechnology, pharmaceutical, research, and financial strengths.

Pennsylvania Bio will:

Be a catalyst for the development of a cohesive biotechnology community in Pennsylvania and the mid-Atlantic region;

Facilitate the development of strategic partnerships among state and regional pharmaceutical companies, biotechnology companies, medical device companies and research institutions;

Be the public policy leader and the principal public advocate for the bioscience community in Pennsylvania;

Advance public understanding of and appreciation for the role that the bioscience industry plays in shaping the future of healthcare; in developing drugs, vaccines, devices and diagnostics that save and improve the lives of patients; in promoting the quality of life worldwide; and in contributing to our local, national, and global communities and economies;

Develop opportunities to increase funding for our members;

Be a leader in statewide efforts to educate, retain, and attract a diverse, high quality biosciences workforce; and

Provide the highest quality programs and most cost effective services to our members."

From Pennsylvania Bio.

Facing Biotech Foods Without the Fear Factor

2005-01-12T16:47:00.000-05:00

"While certainly not the article to illustrate many of the misconceptions about genetically modified foods, this one does an effective job of presenting all the arguments in one coherent piece. An excellent explanation of how essentially all the foods we eat are genetically modified, and why molecular biology techniques are actually safer than the previously practiced alternatives."

From about.com.

More States to Push for Stem Cell Research Funds

2005-01-09T17:28:00.000-05:00

"It's already started - now that California has passed Prop. 71 to allow for $3B to go toward stem cell research over 10 years, other states are sprinting to offer funding for stem cell research within their borders. For the most part, these states fear a drain to California of companies and scientists. "

Read more atLaw under the Microscope.

New Life Sciences Angels Firm

2005-01-09T16:32:00.000-05:00

"A new private investment group, Life Science Angels (LSA; Palo Alto, California), has been formally launched, back- ed by what it termed 15 'exclusive sponsors.' LSA was founded by life science executives and angel investors Allan May, Casey McGlynn and Greg Scott.

The perfect target [for LSA]," he said, "is an early seed or early-stage company where less than a million dollars can achieve identifiable milestones that we think will guarantee an up-round behind us - the kind where, with that kind of money, our experience and contacts can, in 12 to 18 months, make a specific difference to achieve those milestones."

In medical devices, he listed cardiology, orthopedics and "neuro" as "classic areas" that LSA will be interested in backing.

Supporting companies in biotech, he said, will be "more complicated" with LSA being "much more careful" in its model. As a type of milestone, he described a company with a compound "in preclinicals, then in clinicals the next year."

FromBioWorld Today:

The Governance of Biotechnology

2005-01-02T19:12:00.000-05:00

dna
Originally uploaded by TigerTigerTiger.

"The revolution in information technology in Silicon Valley has flourished because of opportunities for public-private partnerships and for private investment. Its success has fueled, in turn, reconsideration of the right formula for technology governance globally.

If full recognition of the political consequences of the revolution in information technology has come only as the resolution succeeded, what of the coming changes in biotechnology? Will they, too, be implemented through a decentralized, privatized, globalized marketplace in which consumer demand is the largest factor determining development? Or is biotechnology fundamentally different?

The short answer is that biotechnology is different in at least one critical way: its full implications touch on our deepest hopes and fears. Biotechnology, after all, involves foods, drugs, and medicine. It offers the possibility of saving a dying child or contaminating the food supply. Most far reaching, however, it raises the spectre of transforming us. Until this time, human evolution has been beyond our control. As we unlock the secrets of the genome, we may become able to curtail aging, select the most perfect of our potential offspring, breed athletic superstars, or alter moods to create continual harmony.

How do we begin to make decisions about these possibilities? And perhaps more critically, who gets to decide?"

From STS Nexus.

Before You License Your Product or Technology Platform

2005-01-02T15:48:00.000-05:00

" Licensing products and technology platforms is an integral part of many biotechnology company business plans. There are many important legal, business, and scientific considerations in developing successful licensing agreements. Here's some guidance."

Before you start your biotechnology company

2005-01-02T15:47:00.000-05:00

"Taking the right steps to initiate a biotechnology venture can avoid future problems and save time and resources. These articlesprovide an overview of important topics in starting and growing your biotechnology company. "

Got Patential?

2004-12-23T19:54:00.000-05:00

"If, on the night before Christmas, you still don't know what to give that biotechnology giant or budding lawyer-scientist, San Diego inventor Richard Warburg has a suggestion.

The intellectual property attorney's latest creation, 'Patential' promises not to cure any diseases or facilitate medical procedures of any kind. It's a board game that attempts to unravel the mysteries of the drug patenting and licensing process...

Game players are entrepreneurs with cash flow and choices to make. Buy or license a drug patent. Apply for a patent. Enter clinical trials. Or sit tight and raise more money from investors.

The road ahead is printed with all the myriad contingencies and successes one might find in the real world of drug development. An eerie illustration of cold hard cash and pills on the box cover depicts what awaits game players inside. Sometimes the Food and Drug Administration (news - web sites) expedites its review and you find yourself ahead. Other times, it's hard to find enough volunteers to test your drug on, and you have to hold off. Sometimes patients die, or the government passes a new law and you've got to have your attorney look things over."

Biotech Crops Pose Legal Issues

2004-12-21T13:53:00.000-05:00

"A farmer whose pollen drifts on the wind from his cornfield to a neighbor's could face a lawsuit from a multinational corporation.

A farmer who saves his own seed and plants it the next year, as many have done for generations, could also be sued.

These are real risks for the thousands of North Carolina farmers growing genetically modified crops, such as soybeans, corn and cotton plants that have been bred to withstand weed killers, according to a new report from farm advocacy groups."

From newsobserver.com.

How to Shop Around Your Most Valuable Asset

2004-12-21T13:44:00.000-05:00

"With an almost non-existent IPO market and reduced venture capital investments, many Biopharma companies are looking for alternative sources for capital infusion to fund their R&D and clinical operations. Out-licensing is one of the available options that gains importance in recent years. Emerging Biotech companies that are able to sign an out-licensing agreement with a credible licensee are better positioned to survive the long proof-of-concept stage in the product lifecycle. In addition to the immediate capital infusion, the licensee benefits from increased technological credibility and investor confidence. This often translates into enhanced capability to raise further capital in the private or public market, usually at higher valuation. Although attuned to the importance of out-licensing, many companies are struggling to execute an effective out-licensing strategy and some fail to maximize the value of their most valuable assets. "

Read the rest of this article at about.com.

Biotech Research Tool Patents: The Good, The Bad, and Freely Available?

2004-12-20T13:22:00.000-05:00

"Recent patent appeals court cases have strengthened the protection afforded by research tool patents. This article from Testa, Hurwitz & Thibeault LLP's Michael H. Brodowski reviews recent case law in research tool patents and strategies to maintain the value of these assets."

From about.com.

Management Issues Challenge Biotech Startups

2004-12-18T15:47:00.000-05:00

"Emerging biotechs and pharmaceuticals companies... often struggle with the transition from being primarily research-oriented to focusing on product development and commercialization.

Many biotech companies fail to make the leap from the lab to clinical trials and beyond, winding up on the scrap heap or getting bought well before investors would have liked to see that happen. Why such companies fail has often been a real head-scratcher for those in the industry and its analysts.

A recent study of biotech management practices, however, suggests that a primary reason for such failures is an ongoing conflict, at many companies, between the collegial, informal, creativity-based management model common to scientific endeavors and one that has more discipline, structure and predictability. As part of that conflict, biotechs tend to hire managers whose expertise is in the science end without management experience, and that can be fatal..."

Management Issues Challenge Biotech Startups December 15, 2004 - News:

Democratic Transhumanists Unite

2004-12-18T14:50:00.000-05:00

"Biopolitics is emerging as an axis of modern politics alongside economic politics and cultural politics. Transhumanists, people who embrace technologies that extend and enhance regardless of their effect on “natural” life spans, limitations or social institutions, are the progressive end of the new biopolitical continuum. BioLuddites, who call for bans on technologies that threaten the “natural,” are conservative end of the new biopolitics.

But biopolitics only complicates the preexisting political landscape, they doesn’t supplant it. There are Christian fundamentalists, centrists and socialist-feminists forming alliances to to oppose human genetic engineering and nanotechnology. But the transhumanists are, so far, much less diverse, mostly adhering to one or another flavor of libertarianism. Democratic transhumanists, pro-scitech social democrats or Left technoutopians are conspicuously absent from their theoretical niche in this new political landscape. This essay is an attempt to identify democratic transhumanists and urge their coalescence."

From linkfilter.net

Biotech IPO's Analyzed

2004-12-15T11:00:00.000-05:00

"Since the fall of 2003, 33 young biotechnology and specialty pharma companies have entered the public domain. Together, they embody the new generation of drug discovery and development firms, whose fledgling product candidates could ultimately become breakthrough therapies for everything from ocular diseases to psychiatric disorders. But do these newer drug candidates - or the technologies used to create them -- differ from those already on the market or under development by more mature firms? And if so, how?"

From about.com

ASX enforces draft biotech code

2004-12-15T10:54:00.000-05:00

"The Australian Stock Exchange appears to have toughened its stance on announcements from the biotechnology sector, with at least one company being asked to water down comments about a new licensing deal.

Prima BioMed was yesterday delayed from releasing a statement to the market because it was told by an ASX officer that information provided about the value of the deal did not comply with an industry code of conduct for reporting.

The code, developed by the exchange in conjunction with industry peak body AusBiotech, is still in draft form and companies have no legal obligation to follow it."

From www.theage.com.au.

Angel investors shy away from biotech

2004-12-14T10:23:00.000-05:00

"Angel investors often avoid biotech startups because of long and costly development times of biotech products, as well as a tendency for venture capitalists (VCs) to set over-diluting terms when entering in follow-on financing rounds. These trends are exacerbating an early-stage funding gap in the biotech sector..."

From Bioentrepreneur:

In the Beginning, There is a License

2004-12-10T15:19:00.000-05:00

From Testa, Hurwitz & Thibeault via Mondaq (free registration required):

" While this article is not a primer in technology licensing, it does address some recurring issues in biotechnology licensing transactions, namely, reservation of rights, sublicensing, and royalty stacking. "

Plant Variety Registration is Not a Bar to Trade Secret Protection

2004-12-10T14:12:00.000-05:00

From Navigating the patent maze:

"One form of legal protection for biotechnology inventions, which is not often used, is trade secrecy. This right, in contrast to patents and copyrights, is not registered and is of unlimited duration, as long as the holder of the trade secret makes reasonable efforts to maintain secrecy. With regard to keeping parental lines of hybrid seed as a trade secret, for example, identification by private code of fields of inbred parent lines of corn has been deemed, in the 1994 Iowa case Pioneer Hi-Bred v. Holden Foundation Seeds, sufficient to constitute a reasonable effort to maintain secrecy, even though the corn was grown outdoors and subject to misappropriation by informed "flashlight breeders."

Furthermore, acquisition of the viable parent seeds that occasionally appear in bags of hybrid seeds is not antithetical to trade secrecy. But what if the parental lines are protected by Plant Variety Certificates (akin to plant breeder's rights)? One might think that the disclosure requirement to register a plant variety would destroy the secrecy necessary for maintaining the lines as trade secrets.

The short answer from the District Court of the Western District of Wisconsin is NO, registration does not extinguish trade secrecy."

Recent Cases Strengthen Research Tool Patents.

2004-12-09T10:06:00.000-05:00

"Biotech research tools come in many forms. Examples of such research tools include screening techniques, rational drug design schemes, and chemical or biological compounds having useful physiological properties such as specific receptor binding. These research tools can assist in the discovery, identification, characterization, and development of commercial products, e.g., pharmaceuticals and biologics, but are not themselves readily marketable.

Consequently, a company or university that creates research tools should be aware of the recent developments for protecting and exploiting them."

From about.com:

A Primer on Stem Cells

2004-12-09T10:05:00.000-05:00

stem-cell-5
Originally uploaded by TigerTigerTiger.

From Howstuffworks:

"Inside an embryo no bigger than the period at the end of this sentence are dozens of stem cells. Initially, these cells are blank slates, meaning that their fate is undecided. But they have great potential. Stem cells are pluripotent, which means that they can develop into every cell, every tissue and every organ in the human body.

Their almost limitless potential has made stem cells a significant focus of medical research. Imagine having the ability to return memory to an Alzheimer's patient, replace skin that was lost during a terrible accident or enable a wheelchair-bound person to walk again.

But before scientists can use stem cells for medical purposes, they must first learn how to harness their power. They can't treat disease until they learn how to manipulate stem cells to get them to develop into specific tissues or organs."

This article explains stem cell basics and is an excellent primer to allow you to better understand the fierce debate surrounding their research and use.

Carnegie Mellon scientist develops way to deliver promising genetic tool into living cells

2004-12-09T09:18:00.000-05:00

From EurekAlert:

"By exploiting an HIV protein that readily traverses cell membranes, Carnegie Mellon University scientists have developed a new way to introduce a gene-like molecule called a peptide nucleic acid (PNA) directly into live mammalian cells, including human embryonic stem (ES) cells. The work, published online December 2 in Chemical Communications, holds considerable promise in genetic engineering, diagnostics and therapeutics. "

Collaborations and Licensing - Key Legal Issues

2004-12-09T09:14:00.000-05:00

This article from Pharmalicensing.com "gives an overview of two of the principal types of relationship in which a company in the biotechnology sector is likely to be involved at some point in its lifecycle. It begins with a discussion of the reasons why a biotech company might benefit from entering into a licensing or collaborative arrangement, and then considers the principal legal terms which each type of agreement should contain."

The Ethics of Biotechnology: Bigger, Faster, Stronger

2004-12-08T23:30:00.000-05:00

Event Horizon: Bigger, Faster, Sronger:

"I came across this article (Baseball's Bioethical Dilemma) by accident, but it is probably one of the best pieces on bioethics that I've read in a long time. The article grounds the subject in the latest controversy over the use of steroids in baseball, and then goes on to assess the broader implications of biotechnology and encourages us to have a public debate about the potential uses and misuses of the technology. Brave new world indeed."

Life Science Insights Top Ten List for 2005

2004-12-08T17:00:00.000-05:00

From Bio-It World

"The outlook for 2005 is one of “cautious optimism,” with an increased emphasis on issues of compliance, pharmacovigilance, outsourcing, and the pharma CIO. Those were some of the key takeaways of the first annual Life Science Insights (LSI) Predictions for the life sciences industry, delivered today by Jim Golden, vice president for research....

And so with apologies to David Letterman, the LSI Top Ten list for 2005:

1. Technology growth later in the value chain...
2. Disaggregation happens...
3. Innovation will happen - somewhere else...
4. The line between IT and drug discovery . . . will continue to blur...
5. Thus, the rise of the Pharma CIO...
6. Data standards will drive a fragmented industry...
7. The curse of Eliot Spitzer...
8. Pharmacovigilance...
9. Lost on the NIH Roadmap...
10. Venture capital is back"

Are States Equipped to Oversee Biotech Trials?

2004-12-07T12:24:00.000-05:00

From UPI via MENAFN:

"The field testing of genetically modified crops is growing across the country, but questions are being raised about whether state regulators are equipped to oversee the trials.

The federal and state governments have an important role in supervising agricultural biotechnology, but a report released Thursday questions whether some states have the critical tools necessary to hold up their end of the role.

The survey conducted by the Pew Initiative on Food and Biotechnology found a common concern about whether state governments have the legal authority, financial resources and trained staff to properly regulate the testing."

link to Electronic Journal of Biotechnology

2004-12-06T17:32:00.000-05:00

Electronic Journal of Biotechnology

The Cuban Biotech Revolution

2004-12-06T17:24:00.000-05:00

From Wired 12.12:

"Embargo or no, Castro's socialist paradise has quietly become a pharmaceutical powerhouse. (They're still working on the capitalism thing.)"

Efforts to clone primates move forward

2004-12-06T16:46:00.000-05:00

From EurekAlert:

"Using newer cloning techniques, including the 'gentle squeeze' method described by South Korean researchers who earlier this year reported creating the first cloned human embryonic stem cell line, University of Pittsburgh scientists have taken a significant step toward successful therapeutic cloning of nonhuman primate embryos.

It is the first time researchers have applied methods developed in the Seoul laboratory to nonhuman primate eggs. Resulting cloned embryos progressed to the blastocyst stage, a developmental step in which the embryo resembles a hollow, fluid-filled cavity surrounded by a single layer of cells. Called the inner cell mass, this layer contains embryonic stem cells. Growth of a cloned nonhuman primate egg to the blastocyst stage is farther along the developmental spectrum than ever achieved before..."

Patenting Nature's Bounties

2004-12-06T16:44:00.000-05:00

From sciencebase.com:

"Attempts to patent and commercialise the fruits, figuratively speaking, of the developing world, those natural pesticides, revitalising potions and grubby microbes, have been causing a major headache for those who take their ethical dilemmas seriously.

Meanwhile, the potential for boosting the indigenous governments' coffers has not gone unnoticed and now upfront return on their countries' resources are being demanded. Cash would be nice but a return in kind might suffice, especially if the added value provided by Western science is enough to turn what might be a 'primitive' remedy into a fully functioning, safe and more effective antimalarial, for instance."

New Methods Could Bridge Stem Cell Ethical Divide

2004-12-04T22:38:00.000-05:00

From Beliefnet.com:

"A Stanford University biology professor and two Columbia University physicians told a presidential advisory council Friday (Dec. 3) that new approaches could resolve the thorny ethical problems swirling around embryonic stem cell research.

Several members of the President's Council on Bioethics reacted with enthusiasm, but some conservative religious groups remain skeptical. "

Crisis Management in Biotechnology

2004-12-04T13:21:00.000-05:00

From About.com Biotechnology:

"Biotechnology product development faces significant internal and external challenges. While scientific setbacks may be difficult to predict, many external problems can be anticipated and prepared for. Read on for strategic guidance to anticipating and managing biotechnology crises. "

Get in the First Punch, Recover with a Plan

2004-12-04T12:31:00.000-05:00

From Small Business Success, Marketing & Entrepreneurship:

"My favorite way to learn about effective small business growth and entrepreneurship is to look beyond small business and entrepreneurship. Experts are all too often incestuous regurgitators. New ways of processing things are found outside of the same-old, same-old. I'll throw out some of these lessons-from-beyond in this feature from time to time.

From Bare Knuckles And Back Rooms by Ed Rollins, a terrific and entertaining book if I ever read one:

Mike Denton [boxing coach for Rollins in his early years] taught me two invaluable lessons, in the ring and out. Number one: 'The guy who lands the first good punch usually wins.' To help me be that guy, he taught me th throw a left hook. Executed well, the left hook is the most deadly punch there is. It's especially valuable when some idiot tries to hit you with a lead overhand right. The counter left hook will always beat him to the punch.

Number two: 'Every fighter gets knocked down. A bad fighter doesn't get up. A good fighter jumps right back up and starts swinging. A great fighter gets up on one knee, takes an eight count, clears his head, things about what he's going to do next, then stands up and starts fighting again with a plan to survive.'"

WorldChanging: Another World Is Here: Generic Biomedicine

2004-12-04T12:19:00.000-05:00

From WorldChanging:

"The American patent on Human Growth Hormone -- useful for fighting wasting diseases associated with AIDS -- expired in 2003. So why isn't there a far-less-expensive 'generic' version available in the US? Because HGH is a protein 'biologic' drug, and protein drugs are far more difficult to produce than 'small molecule' drugs, and the FDA says it can't be certain that the generic versions are identical to the originals.

So goes the story in the December Technology Review. Biotech companies have made substantial sums on life-saving complex protein drugs, and now the patents are starting to expire. With 'small molecule' drugs (the kind regularly advertised on television and in the hundreds of pieces of spam you got today), the process of duplicating the molecule in order to create a generic version is straightforward, as are the tools for confirming that the drugs are identical. But proteins are big, complicated molecules, with varying properties depending on how they fold. Biomedical proteins aren't just conjured up in test tubes, but are often produced by reengineered bacteria. Duplication is difficult. But help is on the way..."

Biotechnology Information Directory

2004-12-01T17:52:00.000-05:00

The Biotechnology Information Directory - A Public Service of Cato Research contains over 3000 links to companies, research institutes, universities, sources of information and other directories specific to biotechnology, pharmaceutical development and related fields. It places emphasis on product development and the delivery of products and services.

Biotechnology Benefits Biodiversity

2004-12-01T11:28:00.000-05:00

From Globetechnology:

"There are three certainties: the population will continue to rise for decades to come, people will be fed, and all agriculture has some impact. If we want to save biodiversity, we must save the remaining wilderness.

Without a doubt the largest threat to biodiversity is converting wilderness to farmland. Agricultural biotechnology has shown that it can reduce the impact on the environment while maintaining or increasing yields. Therefore its incorporation into world agriculture will help protect biodiversity."

Biotechnology and the Pursuit of Happiness

2004-11-30T14:01:00.001-05:00

"Look younger, perform better, feel happier, and become more “perfect." Biotechnology promises to make all of these possible, but what kind of society do we find ourselves in when these modifications are an everyday reality?

This ground-breaking report [from Change This], the first of its kind in public bioethics, examines the ethical and humanitarian implications of genetic modification and the effect it is likely to have on humanity and our happiness."

Biotechnology and the Pursuit of Happiness

2004-11-30T14:01:00.000-05:00

California's New Stem-Cell Initiative Is Already Raising Concerns

2004-11-27T15:54:00.000-05:00

The New York Times reports:

"As California moves to begin a lushly financed program of embryonic stem cell research, medical ethicists and other skeptics are concerned that the $3 billion that state voters approved for the endeavor could become a bonanza for private profiteers.

Critics say the ballot measure that passed by a wide margin on Nov. 2 contains inadequate safeguards to ensure public oversight of the financial allocations and guarantee public benefit from any medical breakthroughs. They also worry that the promise of stem cell studies has been oversold to the public and say the money might better be directed to more mature medical technologies.

Even those who support human embryonic stem cell research voice concern that the program will be captured by advocates for research into certain diseases or narrow lines of inquiry, and that the public will have little say in how the money is spent."

Biological Informatics link added

2004-11-27T15:43:00.000-05:00

Biological Informatics "is a Subject Tracer™ Information Blog developed and created by the Virtual Private Library™. It is designed to bring together the latest resources and sources on an ongoing basis from the Internet for biological informatics (health informatics, neuroinformatics, biodiversity informatics and biomolecular informatics)

Study Shows Stem Cells Can Preserve Vision

2004-11-26T17:12:00.000-05:00

From sciencedaily:

"For the first time researchers have shown that transplanted stem cells can preserve and improve vision in eyes damaged by retinal disease. In the cover article in the November 2004 Investigative Ophthalmology and Visual Science, scientists from Harvard's Schepens Eye Research Institute describe results of a mouse study in which transplanted stem cells develop into retinal cells, prevent the death of 'at risk' retina cells in the recipient mice and improve the vision of treated mice."

U.S: Crop Testing Rules Menace Food Supply, Say Critics

2004-11-26T15:05:00.000-05:00

From ipsnews:

"Proposed rules for experimental genetically engineered (GE) crops will allow contamination of the U.S. food supply, critics said this week, as a new poll reported Americans want stricter regulation of GE foods.

The U.S. Food and Drug Administration (FDA) released a ”draft guidance document” Nov. 24 that acknowledges experimental GE crops (also known as genetically modified or GM crops) that have not been approved for human consumption could cross-pollinate or mingle with food crops.

Under the proposed guidelines companies are ”encouraged” to submit to the FDA their safety evaluation of a new protein ”prior to the time you have concerns that (it) could enter the food supply,” which critics interpret to mean that by advising beforehand, firms will escape legal liability for any contamination."