Drug Safety in a Start Up Biotech

Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • September 15, 2016

When and how should a biopharma start-up consider establishing their own Medical Safety group? The opportunities and challenges differ greatly between an emerging biopharma company and a fully established entity. A start-up needs to assess the priorities of the company, the stage of development, the talents and resources available while building for success into submission, approval and through to commercialization.

Join Dr. Ed Tucker as he takes us along this journey with lessons learnt from both an organizational and personal perspective.

As a medical science leader with 26 years of experience, Ed will illustrate specific start-up needs, including how to mitigate inherent risks and lay out foundational principles to creating a medical safety group to meet the evolutionary steps of a startup biopharma company.

Speakers

Ed Tucker, Senior Vice President for Medical Safety, Quality and Compliance, Acerta (a majority owned company of AstraZeneca)

A medical science leader with 26 years of experience in healthcare and Pharmaceutical industries. Dr. Tucker graduated in Pharmacology and Medicine at Leeds University. He practiced in the specialties of Internal Medicine and Cardiology in the UK. He is a Member of the Royal College of Physicians (MRCP), UK. He attained his Diploma of Pharmaceutical Medicine (DPM) at the University of Wales, UK and his MBA at Stamford University, CT.
He has been appointed to positions of increasing responsibility in clinical development, medical affairs pharmacovigilance (PV) and quality. He has led teams that have supported biological, consumer and pharma enterprises in three large corporations (Bayer, J&J and Genentech-Roche).

In 2015 he moved to Acerta Pharma, a 2-year-old Dutch blood cancer firm which no one had heard of yet, and relocated a young family to San Francisco, CA.

Acerta was subsequently acquired by AstraZeneca in 2016 with a $7 billion valuation – the largest ever exit of a privately held European biotech.

Who Should Attend?

  • Drug Safety Leaders
  • Chief Medical Officers
  • Chief Executive Officers
  • Business Development Leaders

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