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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….


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)

CONTACT: Monica Malave
Director, Marketing & Communications

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

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,, or contact Dr. Carolyn d’Arville, 215/348-9300 (



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.


Can Microsoft Accelerate the Pace of Drug Discovery and Development?

Source: Microsoft Corp.

Yesterday, at Microsoft’s biotechnology Executive Forum, Microsoft announced the initiation of the BioIT Alliance’s second proof of concept, called the Biomarkers Project, along with an update on the Alliance’s first proof of concept, the Collaborative Molecular Environment.

The BioIT Alliance is a cross-industry group working to integrate science and technology to accelerate the pace of drug discovery and realize the potential of personalized medicine. The early focus of the Alliance has been to address the data-capture and data-integration challenges that face the industry.

“The life sciences offer one of the best opportunities for information technology to accelerate the pace of drug discovery and development,” said Craig Mundie, chief research and strategy officer at Microsoft. “Our collaboration in the Alliance will help the life science industry move discoveries from the lab to the clinic much faster.”

The Biomarkers Project: Initiation of Second Proof of Concept 

“One of the most important fields of research today is in gaining an understanding of the relationship between genetic traits and clinical outcomes,” said Dr. Michael Hanley, vice president of Discovery Research at Amylin Pharmaceuticals Inc. “The research and pharmaceutical community is hindered by the lack of integration among the software tools that are used to gain this insight.”

To address these challenges of software integration, the BioIT Alliance is collaborating on its second proof of concept, the Biomarkers Project. This undertaking will simplify the process for identifying and validating genomic biomarkers — the characteristics that indicate the presence of a disease or the likely efficacy of a drug.


It’s Time to Deepen the Gene Pool

By Daniel R. Matlis

In my “Final Word” column, published in Pharmaceutical Formulation and Quality, I discussed the need to deepen our industry’s gene pool. 

Johnson and Johnson has taken a huge leap to diversify the industries’ gene pool.  J&J recently announced the appointment of LaVerne H. Council to the position of vice president and chief information officer.

Council comes to J&J from Dell Inc.  She brings to the position a wealth of global experience in information technology, supply chain management and business operations. During her tenure at Dell, Council was responsible for infrastructure engineering, networking, security, and enterprise application interfaces and was the global supply chain technology leader for Dell’s core operations.

Skeptics might ask how her experience at a major computer maker qualifies her for the position at one of the most prestigious life-science companies? After all, what do PCs and healthcare have in common? Well, more than you think.

Read the complete column in Pharmaceutical Formulation and Quality.