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European Biopharmaceutical Review

Outsourcing for Biotechs: The Need for a New Model?

Dr John Hall and Duncan Birne at AAI Pharma raise concerns as to the current modus operandi for outsourcing in the biopharma sector

The CRO industry was formed in the 1980s to meet the resourcing needs of multinational pharmaceutical companies. This model, generally based on relatively rigid contracts focused on the provision of services to established, sophisticated purchasers has been very successful for both pharmaceutical sponsors and CROs, some of which have grown to rival their customers in geographical reach and revenue.

The past decade has seen the growth of a scientifically sophisticated biotech industry. The innovation productivity of these companies has rivalled, if not exceeded, that of more established companies, many of whom now see partnership with biotech as a more cost-effective source of new products.

In addition, the investment community has withdrawn from early biotech euphoria and now takes a harder look not only at the biotech IP in which it is investing, but also at the ability of the biotech to add value in a timely and cost-effective route towards IPO or, more often, partnership with pharma. With some notable exceptions, the CRO industry has been slow to respond to this new market reality and it is time to consider the need for a new partnership between CROs, investors and biotechs.

THE NEED FOR A NEW MODEL

Contract research organisations (CROs) emerged as a significant role player in the pharmaceutical sector in the early 1980s. They now comprise a heterogeneous group of companies ranging from small local providers to international corporations employing many thousands of people and with a global presence.

Publicly traded pharmaceutical and biotechnology companies reported R&D expenditures of over $80 billion in 2006, of which Frost & Sullivan estimates approximately $30 billion is spent conducting Phase I-IV clinical studies with $12 billion outsourced. By any standards, the emergence of this industry over the past 30 years has been spectacular, and the leading CROs have drug development experience, expertise and geographical reach which frequently matches or exceeds that of their sponsors.


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Dr John Hall has over 30 yearsí experience in the pharmaceutical, chemical and consulting industries. He has worked in a variety of R&D posts in the UK, France, Belgium and the US. John graduated in Pharmacy and has a PhD in Pharmacology from the University of Aston in Birmingham, UK. His career has taken him to Hoffman-La-Roche, Inveresk Research, Monsanto/Searle and Quintiles where he worked for 11 years in a variety of roles before joining AAIPharma as President, European Operations in May 2006. In recent years he has also served as a Non-Executive Director of Edinburgh Research and Innovation, a member of the Governing Council of the Roslin Institute and as Vice Chairman and Non-Executive Director of Scottish Enterprise Edinburgh and Lothian. John has published in the fields of pharmacology and the management of pharmaceutical R&D.

Duncan Birne has spent the last five years in corporate development functions within international CROs managing M&A transactions, strategic outsourcing relationships, as well as structured finance and direct equity investments in emerging biotech companies. Prior to entering the CRO sector, Duncan worked for Cazenove, the UK Investment Bank, as an equity analyst covering the US biotech sector and was part of PA Consulting Groupís UK-based life science practice. Duncan graduated from the University of Glasgow with a degree in Biotechnology.

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Dr John Hall
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Duncan Birne
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