As a Medical Director at VCLS, Nicole is responsible for providing input to, and critical review of, the clinical sections of a variety of documents, including client clinical development plans, ODD, PIP and PRIME briefing documents. She also plays a key role in identifying questions to be raised with Regulators as part of the requests to EMA, National Agencies and Joint EMA-HTA bodies for scientific advice, and in critically reviewing the advice received. Nicole also contributes to responses to issues raised (by CHMP/National regulators) and when required actively participates in the rehearsal of client presentations for oral explanations, from a clinical regulatory perspective.
Nicole brings to this role extensive expertise across various therapeutic areas including antibacterial, antivirals, antifungal and anti-hepatitis medicines, women’s health, genito-urinary medicine, gastroenterology, pain as well as various drug-device combinations products.
Prior to joining VCLS, Nicole spent 14 years at the MHRA as a Senior Medical Assessor, where she gained significant expertise in the assessment of medical aspects of EU and UK medicinal product marketing authorization applications. During her time at the MHRA she led interactions with companies and provided scientific and regulatory advice to companies before and after submission of their applications. She was also part of the agency’s scientific review group which reviews MHRA’s written advice. She was involved in the MHRA inspectorate’s GCP and GMP regulatory activities.
Nicole was a member of the Infectious Disease Working Party (IDWP) at the EMA and served as the principal assessor to the Infectious Diseases Expert Advisory group at the MHRA, and acted as principal assessor for the COVID therapeutics Expert Working Group. She has a special interest in PK/PD, particularly of antibacterial agents, as well as pharmacokinetics and pharmacokinetic modelling.
While working at the MHRA, she made numerous presentations to the UK Committee for Human Medicines (CHM), the EU Committee for Medicinal Products for Human Use (CHMP), Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) and the EU Scientific Advice Working party (SAWP).
Her clinical experience is broad. It includes 5 years in Medicine in Germany and the UK (as Senior House Officer in General Medicine & Gastroenterology / Hepatology, Research Fellow in Hygiene & Infection Control, Senior House Officer in General Medicine). She also acquired 8 years experience in Anesthesia and Intensive Care (in UK and Canada) and after completion of her training worked as a Consultant in Anesthesia in a London teaching hospital.