Dr Evan Papanastasiou | MD MSc PhD MBA
The Clinical Scientist fulfils multiple roles requiring expert knowledge in a therapeutic area; initiates and supervises scientific publications; offers crucial input in due diligence discussions and contributes to the setting and delivery of successful advisory boards and scientific meetings.
“Writing the perfect paper is a lot like a military operation. It take discipline, foresight research, strategy and if done right, ends in total victory.”
Ryan Holiday, American Author
It is important for the clinical scientist to be competent in reviewing the medical literature and generating concise summaries, given various time constraints.
The clinical scientist will often act as an initiator of scientific publications and presentations required to disseminate information internally and externally; thus will steer and supervise medical writing agencies in generating high-quality material, such as study reports, systematic reviews, meta-analyses and corporate presentations.
“True genius resides in the capacity for evaluation of uncertain, hazardous and conflicting information.”
Sir Winston Churchill, British Politician
Pharmaceutical companies have to follow elaborate due diligence processes during acquisition of novel IMPs from smaller biotechs, or development of their own compounds; these agents have usually undergone pre-clinical testing (PoM studies) or might have entered early stages of clinical development (PoP or PoC studies, usually up to Phase I or II). Careful examination of the existing data will inform a decision to proceed to more resource-intensive investigations (Phase II or III studies) or to abandon this clinical development pathway. Equally rigorous efforts are required at later stages of LCM, when multiple clinical applications of one particular IMP are considered. The role of the clinical scientist is pivotal in providing a comprehensive evaluation of all available data and explore the possible clinical applications of the medicinal product in question.
CNS trials can prove particularly challenging, as manifested by the relatively high failure rates, compared to other medical fields. The clinical scientist focusing in the CNS will benefit from a robust knowledge and experience in a relevant medical specialty (usually gained through formal medical training and ascertained by board certification in the case of an MD); besides knowledge in neuroscience (usually gained through doctoral studies and/or relevant research work) will also be necessary, to comprehend brain biomarkers which are increasingly emerging as surrogate endpoints along with traditionally used clinical ones.
“Meetings should have as few people as possible, but all the right people.”
Charles W. Sharf, American Businessman
Medical Advisory Boards are organised by pharmaceutical companies to obtain expert opinion from HCPs and KOLs on their products or a disease area. They can be jointly administered by Clinical Development and Medical Affairs functions, depending on the status of the medicinal product in question. The clinical scientist / lead physician has a principal role in various aspects of these meetings: conception and initiation, identification and invitation of delegates, drawing topics and content, guiding medical writing agencies in producing relevant material, chairing the meeting to allow fruitful discussions, and finally overseeing the creation of informative summaries and reports which capture lessons learnt during these exchanges. Prior knowledge of the clinical area and the underlying science is required from the clinical scientist to afford constructive interactions with invited experts.
SCPs are cross-functional meetings that aim to bring different professionals of the same pharmaceutical company together, in order to align communication strategies and update clinical development plans (e.g. TPPs); the clinical scientist / lead physician can notably contribute in the design, materialisation and running of these events, providing expert opinion and deep knowledge of the disease area and the medicinal product under consideration.
