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European Biopharmaceutical Review

Why is Scientific Due Diligence Essential in Drug Development?

Due diligence is the process of acquiring objective and reliable information, prior to a specific event or decision. By common agreement, due diligence means 'making sure you get what you think you are paying for'. It is not measured by any absolute standard but depends on the relative facts of the special case. In order to effectively perform due diligence, it is essential to have an understanding of what really matters with respect to the decision at hand. This requires expertise in various areas such as competitive pharma/biotech landscapes, the customer marketplace, operations, business development, strategy, business analysis and technical or scientific expertise. Without this kind of experience, it is difficult to truly know what may be significant risks, specific to any given situation. Only this expertise guarantees that the significant risks are identified and quantified, and that the right questions are addressed to the right people. Working according to a standard list will not suffice.

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By Dr Konrad Burk, Founder of ClinDescience GmbH, Dr William McCulloch, CMO of Gloucester Pharmaceuticals, Dr Alexander von Nieciecki, CEO of BioProof, and Dr Wolfgang Meyer, Senior Director of European Drug Regulatory Affairs and Dr Benno Rattel, Senior Director of Drug Development at GPC Biotech AG

Dr Konrad Burk is Professor of Urology and a member of the faculty at Frankfurt University, Medical School in Germany. He has been active in the field of oncology for more than 25 years. After 15 years of clinical work in urology and oncology, he entered industry in 1987. As Head of R&D, he has been responsible for clinical development in three companies and has been involved in the evaluation of numerous compounds for in-licensing. In 2001, Dr Burk founded ClinDescience GmbH, where he offers his expertise in drug and clinical development of oncological therapeutics to pharmaceutical and biotech companies, as well as due diligence services to venture capital firms.


Dr William McCulloch earned his MB ChB from the University of Glasgow in Scotland. He is a Member of the Royal College of Physicians (UK) and a Fellow of the Royal College of Physicians (Glasgow). He practised Medicine for seven years in the UK. His areas of responsibility have included non clinical and clinical development, regulatory and medical affairs, licensing and sales force training, with a focus on oncology and serious infectious diseases. For the past seven years, he has worked as a Pharmaceutical Advisor. Dr McCulloch is Chief Medical Officer of Gloucester Pharmaceuticals, Cambridge, US.


Dr Alexander von Nieciecki earned a PhD in pharmacology and is a registered Pharmacist for analytics and pharmaceutical technology. Since joining the pharmaceutical industry, he has been responsible for GMP production documentation and has spent over 10 years in charge of biopharmaceutics, pharmacokinetics and bioanalytics. Presently, he is CEO of BioProof, a contract service organisation which performs bioanalytics under GLP (LC-MS/MS, ELISA, bioassays), pharmacokinetic/ toxicokinetic evaluation and scientific writing.


Dr Wolfgang Meyer is a registered Pharmacist who joined the industry in 1987. Since then, he has worked in drug regulatory affairs within four companies (from small to big pharma, as well as biotech). Since 2001, he has been a Senior Director of European Drug Regulatory Affairs and Drug Safety at GPC Biotech AG in Munich.


Dr Benno Rattel is a Veterinarian who earned a PhD in pharmacology and board certifications in pharmacology, toxicology and animal welfare. For over 15 years, he has been responsible for the non clinical safety assessment of small molecules and biopharmaceutics. Presently, he is Senior Director of Drug Development at GPC Biotech AG.

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Dr Konrad Burk
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Dr William McCulloch
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Dr Alexander von Nieciecki
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Dr Wolfgang Meyer
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Dr Benno Rattel
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