Andy Lee | Senior Vice President and Head of Global Clinical Trial Operations

Andy Lee, Senior Vice President and Head of Global Clinical Trial Operations, Merck

Andy Lee is Senior Vice President and Head, Global Clinical Trial Operations (GCTO). In this role, Andy leads and manages GCTO, with particular focus on global, in-patient clinical trials, designed and executed to meet cost, speed and quality standards. Andy is also responsible for the design and study/data management of clinical protocols in all regions and countries, as well as the tools, systems and processes to conduct Merck clinical trials.
Andy joined Merck in September 2014 from Sanofi, where he served as Senior Vice President and Deputy Head of Clinical Sciences and Operations (CSO) and Head of the CSO Clinical Operations. In addition to directing CSO, Andy led the integration of Sanofi with Genzyme, where he was Senior Vice President, Global Clinical Operations responsible for Clinical Trials and Clinical Supplies. Earlier in his career, he spent more than 17 years in a range of positions of increasing responsibility at Pfizer.
Andy holds leadership positions in a number of professional societies, including the role of Treasurer of TransCelerate Biopharma, Inc., a non-profit organization that comprises the world’s leading pharmaceutical and biotech companies. He also serves as a member of the TransCelerate Operating Committee. Andy received his Masters in Bioenergetics and Physiology from Ball State University in Indiana and two undergraduate degrees from Rhodes University in South Africa.


Clinical Trials Day 1- Monday 29th October @ 08:55

Chair's opening remarks

Clinical Trials Day 1- Monday 29th October @ 09:00

What’s the most effective model for an organisation; internal, external, or hybrid?

  • A case study of Merck’s shift from outsourcing to an internal focused model
  • Highlighting the pros and cons of different approaches

Clinical Trials Day 1- Monday 29th October @ 09:40

Keynote Panel Discussion- Disruptive procurement methods: choosing your CRO

  • Multiple vs singular CRO input
  • Finding the balance between expertise and ethos
  • Pros and cons of different approaches

Clinical Trials Day 1- Monday 29th October @ 18:00

Chair's end of Day 1 remarks

Clinical Trials Day 2- Tuesday 30th October @ 10:00

Panel Discussion: The realities of virtual trials: how companies are migrating from site based to de-centralized research and what you can be doing to start

  • Discuss the driving force behind pharma’s interest in virtual clinical trials
  • What are the steps necessary to set started in conducting virtual trials
last published: 29/Oct/18 16:25 GMT
last published: 29/Oct/18 16:25 GMT

back to speakers

There are two parts to the Festival of Biologics: the five world-class international conferences covering Antibodies, Immunotherapy, BioSimilars, Clinical Trials, and High Potency APIs; and an exhibition featuring the most exciting technology and solutions for pharma and biotech. There is a registration fee to attend the conferences. To visit the exhibition is free.


Conference 29 - 31 October • Exhibition & Seminars 29 - 31 October

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