FDA Issues New Early Stage Guidelines

"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

"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

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

"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

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

"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

� 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

"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

"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

"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

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.

"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

"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

"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

"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

"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

"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

"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?

"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

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