Life-Science Panorama

A Journal for Industry Executives

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November 14th, 2006

Are We Witnessing the Beginning of the End for Big Pharma?

by Daniel R. Matlis 

Recently I attended a Pharmaceutical Industry panel and heard a high ranking industry executive illustrated the beginning of the end for the Pharmaceutical Industry.

He described the last 30 years as the golden era for research based Pharmaceutical companies. He lamented that most of the “easy drugs” have been invented and explained that the rate of invention for new pharmaceuticals is slowing.

In addition, 20 years from the invention date, the drug goes off patent (it typically takes 12 to 15 years for a drug to get approved after invention) and a robust generics industry is ready to take the drug off Big Pharma’s hands.

He went on to say that it’s only a matter of time before all pharmaceutical compounds are discovered and developed, at great expense to big pharmaceutical companies. These drugs will then be produced by the generics industry, and sold at a much lower price.  He questioned whether, at that point in time, there will be anybody around to develop new pharmaceuticals.

As I was listening, I thought about the saying “the only constant is change”. I assumed this was a relatively recent refrain, maybe dating back to the industrial revolution. After some research I found, to my surprise, that the phrase was coined nearly 2500 years ago by the Greek philosopher Heraclitus.

It makes sense; after all, human progress has demanded change throughout history. The stone-smith was put out of a job by the bronze-smith and he in turn by the iron-smith and so on. And one day, the Pharma-smith will be put out of a job by the personalized-medicine-smith. This cycle will go on until the end of time, or until we stop progress.

Is Big Pharma doomed?

This reminds me of the movie “Millennium”.  As the film is about to end, Kris Kristofferson and Cheryl Ladd step into a worm hole to the unknown. A voice says: “It is not the end.  It is not the beginning of the end.  It is the end of the beginning”.

So too, in our industry, we are not witnessing the beginning of the end of our fight against disease and human suffering, but the beginning of a new chapter.

As I discussed in “Chemicals to Cell Culture“, the Life-Sciences industry is undergoing a metamorphosis. Historically separate disciplines, like pharmaceuticals, devices, diagnostics, biotech, and nanotech, are converging.

This convergence is enabling the development of personalized treatments in our quest to eradicate disease and end human suffering.

In my opinion, those Life-Science companies that embrace change and seek new technologies will not only survive but thrive.

Those who hope that it will go away, will go the way of the stone-smith and the bronze-smith and the….

November 11th, 2006

The Election’s Impact on the Biotech Industry

Source: CNBC/The Wall Street Journal 

Jim Greenwood, president of the Biotechnology Industry Organization, discusses the impact of the election on the Biotechnology Industry in general and stem-cell research in particular.

See the Complete Interview

November 9th, 2006

Bio Strategy Partners Adds Axendia to Member Roster

Axendia.jpg BioStrategyPartners.jpg

BioSP supports the development of Life-Science Companies in the Tri State region (PA, NJ, DE)

FOR IMMEDIATE RELEASE
CONTACT: Monica Malave
Director, Marketing & Communications
mmalave@axendia.com
http://www.axendia.com/

Yardley, PA, November 9, 2006 -  Axendia, a trusted advisor to Life-Science Executives on Business, Regulatory and Technology strategies, today announced that it has joined Bio Strategy Partners (BioSP).

BioStrategy Partners’ mission is to provide discovery, pre-seed and seed Life-Sciences companies within the Tri State region (PA, NJ, DE) with the tools to help them grow their businesses to the next level. BioStrategy Partners utilizes its portfolio of extensive experience and strength in both scientific and business expertise, to enable small and emerging companies leverage their discoveries within their communities. Providing the tools to enable the earliest of Life-Sciences attain a dominant position within the industry.

“We are pleased to have Axendia, a leading advisory firm in the Life-Sciences Market, as a member of Bio Strategy Partners” said Joel Smith, Chairman of the Advisory Board, BioSP. “We are dedicated to merging solid science with good business practices allowing pre-seed companies to survive the critical phases of development. Axendia’s deep understanding of the Business, Regulatory and Technology issues in this industry will be of great value to our member companies”

“The Philadelphia region is the cradle of American healthcare and Life-Sciences”, said Daniel R. Matlis, founder and President of Axendia. “We share BioSP’s goal to nurture entrepreneurial and emerging Life-Science companies in our community to support their quest to improve patient’s lives, relieve human suffering and contribute to the economic development in the region. We are honored join Bio Strategy Partners in this noble cause”

About Axendia:
Axendia is the leading analysis firm focused strictly on the Life-Sciences and Healthcare markets. Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues. With over 16 years experience in the Life-Sciences and Healthcare industries, Axendia provides a unique combination of hands on experience coupled with strategic vision. This enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia’s can be found at http://www.axendia.com/.

About the Bio Strategy Partners:
Established in 2004, BioSP harnesses business expertise in the region to work one-on-one with early entrepreneurial efforts, representing the brightest hopes for tomorrow’s medicines coming out of the area’s research labs. A virtual incubator, BioSP offers due diligence for viable discoveries, and then matches the discoveries with the most promise with experienced entrepreneurs and experts in finance, marketing, licensing, and other disciplines. For further information visit the BioSP website, http://www.biosp.com/, or contact Dr. Carolyn d’Arville, 215/348-9300 (Carolyn@biosp.com).

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November 2nd, 2006

Understanding Your Patent Portfolio, Reducing Risk Through Due Diligence

by Leslie Gladstone Restaino

The explosion of Life sciences innovation and the globalization of the marketplace have heightened the importance of intel1ectual property (IP) in biotech business transactions. More than 70% of the total-market value of Standard and Poor’s 500 companies derive from intangible assets. The success of Life sciences companies depends not only on continuing innovation and business acumen, but also on the strength of their corporate portfolio of intellectual property rights. Any party acquiring an interest in intel1ectual property rights (whether by license, strategic alliance, or as an investor in or acquirer of life sciences entities), should conduct a due diligence analysis to ensure that the technology underlying the transaction in fact has its purported value and is properly protected. This is particularly critical because IP assets can have a significant affect on predicted cash flow, product development, and income. Any assessment of the transaction is insufficient without proper IP consideration. Often, IP is considered late in the game and in only a cursory manner, leading to significant negative results.

The purpose of a due diligence analysis involves assessment of potential risks and benefits related to the transaction, including identifying risks that may undermine the value of the technology and developing strategies for overcoming such risks. The analysis must confirm that a purported technology owner actually owns the intellectual property rights to the technology, has the right to transfer it, can use the technology without substantial risk of treading on third-party intellectual property rights, and that intellectual property rights are valid and enforceable.

Read The Complete Article

About the Author:

Leslie Gladstone Restaino is a Member of the Firm of Sills Cummis Epstein & Gross, P.C in the Intellectual Property and Corporate Practice Groups. She concentrates her practice on the special business and legal needs of public and private life sciences companies. Ms. Restaino represents established pharmaceutical companies and start-ups in the life sciences industry throughout all phases of their life cycle and understands the business concerns of growing and established companies.

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