Pitfalls in Early Drug Development: Nonclinical, Manufacturing, and Clinical Issues Webinar

October 26, 2011

A Complimentary Intertek Cantox Webinar

 

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Drug discovery and development is an intricate process which operates in a highly regulated environment. All drug development programs involve combining together many different disciplines including pharmacology, drug metabolism & pharmacokinetics, toxicology, chemistry & manufacturing (CMC), and clinical research and operations. The success of a drug development program is only as good as the weakest link in this complex and interrelated development chain. The submission of incomplete, inaccurate, or scientifically deficient data to a regulatory authority will result in rejection/clinical hold and cost a company and its investors significant time and money.

As drug development consultants, Intertek Cantox see's the same types of missteps in early drug development being perpetrated by a multitude of early stage companies developing biologic and small molecule therapeutics across a wide variety of therapeutic areas. This webinar addresses ways to avoid pharmaceutical product development common mistakes and is of relevance to scientists, entrepreneurs, investors, and drug development executives. 

Download copy of presentation and audio recording

Questions?
Please send your inquiries to pharma@intertek.com  


 

Presenter:
Lindsay N. Donald, DABT
Vice President of Pharmaceutical & Healthcare Group
Intertek Cantox

Lindsay N. Donald has over 25 years of drug development experience in industry within pharmaceutical, biotechnology companies and contract research organizations. He has been an American Board Certified Toxicologist for over 15 years and has worked in a variety of therapeutic areas including anti-inflammatory, anti-infective, oncology, gastro-intestinal disorders and numerous biological products such as thrombolytics, cytokines, monoclonal antibodies and growth factors.

As Vice President of the Pharmaceutical & Healthcare Group, he is intimately involved with the strategic planning, design and implementation of drug development programs for clients. Nonclinical and clinical safety data in support of regulatory filings are critically evaluated and he represents clients with various international regulatory agencies including the Food & Drug Administration and Health Canada.