All posts by Administrator

26Dec/06

Top 7 questions for Pharma and Biotech in 2007

It’s that time of the year.  Mike Huckman, CNBC Pharmaceutical Industry Reporter, shares his outlook on the industry as part of CNBC’s top 7 for 07 series.

Here are Mike’s top 7 Questions on Medicine and Money in 2007:

Could the next diet pill craze start in 2007?

Will big Pharma keep doing deals with BioTechs?

Will Pfizer have to think big and do another huge deal?

Could Bristol-Myers Squibb and Sanofi-Aventis loose the patent on Plavix?

Will Generic Drug competition continue to threaten big Pharma’s profits?

Will the new Congress legalize prescription drug importation?

Will the new Congress let the government negotiate lower drug prices?

Want to know his predictions?  See the complete CNBC story

13Dec/06

My Body, My Choice?

By Daniel R. Matlis

No, it’s not what you think; I’m not going “pro” this or “anti” that on you.

I am referring to the Food and Drug Administration’s (FDA) proposal to make experimental drugs widely and easily available to seriously ill patients.

According to Dr. Andrew C. von Eschenbach, Acting FDA Commissioner “This proposed reform is carefully designed to balance several objectives.” von Eschenbach added “One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market.”

The proposed rule is a direct response to a 2 to 1 decision by the U.S. Court of Appeals for the District of Columbia Circuit overturning a lower court’s ruling in a case brought by the Abigail Alliance for Better Access to Developmental Drugs.

The court ruled that “barring a terminally ill patient from the use of a potentially life saving treatment impinges on the right of self-preservation.” Further, the court held that once drugs have passed safety trials, they should be made available if they might save someone’s life.

Judge Judith W. Rogers wrote “If there is a protected liberty interest in self-determination that includes a right to refuse life-sustaining treatment, even though this will hasten death, then the same liberty interest must include the complementary right of access to potentially life-sustaining medication, in light of the explicit protection accorded ‘life’.”

Dr. Janet Woodcock, FDA’s Deputy Commissioner for Operations stated “FDA hopes this proposal will increase awareness in the healthcare community of the range of options available for obtaining experimental drugs for seriously ill patients,” she added that “By clarifying and streamlining the processes, FDA also hopes to encourage companies to make such drugs available, and reduce barriers for healthcare practitioners in obtaining them.”

The proposed rules, which are open for comment for 90 days, are described in detail at the following FDA web address: http://www.fda.gov/cder/regulatory/applications/IND_PR.htm

I hope and pray that none of us ever face such a choice, but if we do, it should be our choice to make.

06Dec/06

Pharma’s Business Model Doesn’t Seem to Be Working

That’s not just me saying it. Alan Murray, Managing Editor at the Wall Street Journal agrees.

In an Interview on CNBC, Mr. Murray said “The Fact of the matter is the way they (Big Pharma) develop drugs, the way they sell drugs and the way they interact with government regulators and the public all needs to change”. 

His comment on “The era of the blockbuster looks like is probably over” conveyed a similar message as of my last article on the “Beginning of the End for Big Pharma”. 

Click here to see the complete interview. By the way, you can fast forward the commercial to get to the interview.

14Nov/06

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….

09Nov/06

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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