Dr Eric Helmer, director of clinical pharmacology, UCB, Slough
What do you do? and what is a typical week for you?
A typical week is composed of cross function project meetings (internal or external) and well as writing and/or reviewing documents supporting projects in various phases from FIH to registration.
I focus on clinical pharmacology activities on projects in our early phase drug discovery pipeline which drives clinical development. I provide valuable input to project teams to ensure the global clinical development is completed to a high quality, that they meet regulatory standards and are delivered according to agreed timings.
I provide clinical pharmacology strategies for the projects I am involved which include the execution and reporting of assigned clinical pharmacology studies. I write the clinical pharmacology sections in the Common Technical Document (CTD submissions) which includes regulatory defense/interactions in addition my input into scientific advice meetings.
In addition to these core activities as a clinical pharmacology director I also:
- Provide due diligence support for clinical pharmacology related aspects of licensing and acquisition.
- Manage clinical pharmacology-related aspects of clinical trial/program budgets.
- Establish, expand and maintain key networks of external academic leaders, as well as alliances with partners from the pharmaceutical industry.
- Publish key clinical pharmacology studies in international, peer reviewed journals and present at international scientific meetings.
What qualifications and experience do you have?
- Doctor in Pharmacy Pharm D (industry option), specialized in Biopharmacy, Biodynamics and Pharmacokinetics (University René Descartes (Pr SCHERRMANN, PARIS V, FRANCE)).
- Certificate in Human Pharmacology (CHP), Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom.
What’s the most interesting aspect of your job?
The variety of projects (New Chemical Entity/New Biological Entity), different therapeutic areas, different stages of drug development from translational medicine to First in Human/Proof of Concept.
Cross functional scientific meetings whereby a mix of strategy and operational insights are discussed and implemented.
What are your research interests?
Early in human studies (microdose and/or microtracer).
What one piece of advice would you give to someone seeking a career in clinical pharmacology?
Undertake a first curriculum that gives you a broad understanding of drug development and try to experience all the different aspects of drug development from preclinical to clinical, regulatory, biopharmacy, commercial/marketing.
Then specialise in the clinical pharmacology related area/discipline which you prefer the most (pharmacology, pharmacokinetics/pharmacodynamics, biopharmacy…).
Be tenacious and patient as drug development is a long process with a very high attrition rate.