Increasing Small Molecule Biotech API Outsourcing Presents Challenges For CMC Management to Find Solutions

Long Branch, NJ--(Marketwire) - Gone are the days when the pharmaceutical scene was dominated only by "Big Pharma" and the blockbuster drugs it discovered. Today, like the mammals that arose after the demise of the dinosaurs, legions of biotech, biopharmaceutical, and "virtual" pharmaceutical companies are advancing their compounds through pre-clinical development and into human trials with a new, cost effective business model. It relies on sub-contracting, or outsourcing, circumventing the costly overhead typical of traditional pharmaceutical companies, like manufacturing facilities, according to Mark Alexay of Pharma ChemOutsourcing.

The "virtual" model is a response to several factors that have converged over the past 10 years. One is the genuine viability of smaller companies now leading the discovery of new drugs. Before 2000, they were mostly a gathering force. Today, hundreds have compounds in trials. Another is the declining productivity of Big Pharma. To its credit, the explosion of new drugs they brought about in the 80's and 90's brought new therapies to key areas like hypertension and cholesterol-lowering. However, it has been difficult to replicate that successful discovery engine with new ones to replace them. In a sense, Big Pharma is a victim of its own success.

Thirdly, globalization of the pharmaceutical services industry has exploded. Both in the US and abroad, R & D service companies are constantly evolving in response to the new demands of growing biotech. It may take the combined effort of the rest of the world to facilitate the discovery of the next wave of sorely needed blockbuster drugs.

Quietly over the past three years, the Pharma ChemOutsourcing Conference & Exhibition has emerged to fill the information and networking niche for emerging pharmaceutical companies and the CRO and CMO communities working with them. The need for information is vast — small companies, often with fewer than 10 scientists nurturing their firm's IP, are often overextended in the role of managing projects and scouting suppliers. The twin pressures of time and money draw precious resources away from the science. Biotechs need better information to make the important supply chain decisions. And CROs need to know what the small biotech segment wants.

That information void is filled at Pharma ChemOutsourcing. On September 16, 2009 in Long Branch, NJ, CMC managers and other chemists from over 30 biotech companies will share their experiences and opinions on API sourcing at the conference. Participants include speakers from King Pharmaceuticals, Medivation, GPC Biotech, Theravance, Bionumerik Pharmaceuticals, Anthera Pharmaceuticals, Palatin Technologies, Magen Biosciences, Inspire Pharmaceuticals, Geron Pharmaceuticals, Phenomix Corporation and CoNCERT Pharmaceuticals.

Additional speakers include BioMarin Pharmaceuticals, Array BioPharma, Reata Pharmaceuticals, Proteolix, Novalar Pharmaceuticals, Lexicon Pharmaceuticals, Orexigen Therapeutics, Targacept, Helsinn Therapeutics, OSI Prosidion, NovaDel Pharma, Anacor Pharmaceuticals, Ceragenix, Millennium Pharmaceuticals (Takeda), Pharmasset, Oscient Pharmaceuticals, Cenomed Biosciences, Alkermes, Epix Pharmaceuticals, and Ardea Biosciences.

This is the first time such a large and diverse gathering of small company CMC managers have gathered to expound their views about chemistry outsourcing. The September 14-16 conference and exhibition in NJ will be host to a remarkable gathering of talented scientists, project, and executive managers.

For more information about Pharma ChemOutsourcing and to view the 120-speaker conference agenda please visit www.chemoutsourcing.com or contact Mark Alexay at malexay@chemoutsourcing.com or 201.452.4023.

SOURCE: Apaporis