Helen-Marie Dunmore

ESTP Congress
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Helen-Marie Dunmore is a principal scientific advisor with significant experience with regulatory requirements in the nonclinical development of small molecules, biologics and advanced therapy medicinal products (i.e. cell and gene therapies).

Prior to joining Charles River, Helen-Marie served as a senior nonclinical assessor at the MHRA (and an EMA nonclinical expert), reviewing the entire nonclinical data package (pharmacology, toxicology, ADME and/or ERA) submitted in support of clinical trial authorisation applications (from first in human to postmarketing) or marketing authorisation applications across therapeutic areas (e.g. CNS, (immune)oncology, cardiovascular, respiratory, gastrointestinal), across novel drug modalities, often for first in class compounds.

Helen-Marie has extensive experience with presenting nonclinical findings and making recommendations to UK/EU Advisory Committees (e.g. the CHM, CHMP, CAT, SWP) and providing scientific/regulatory advice (on behalf of the MHRA and/or CHMP/CAT/SAWP at the EMA) to varied stakeholders. She was also involved in reviewing regulatory guidance and representing the MHRA on UK/European working groups.

Helen-Marie has a master’s degree in applied toxicology from the University of Surrey (United Kingdom) and is a registered toxicologist in the UK and Europe.

• Over 20 years of experience in the industry (nine years at MHRA/EMA nonclinical expert)
• UK and European regulatory authority interactions (e.g. MHRA, EMA SWP, CHMP, CAT and national EU member states)
• Specialist in authoring and reviewing nonclinical regulatory documentation (e.g. IB, IMPD, briefing materials, clinical protocols, expert reports and labelling SmPCs and PILs)
• Experience with early access/regulatory schemes (e.g., EAMS, ILAP, PRIME, PIPs, Orphan designation, ATMP classification)
• As an exregulator, providing scientific advice on nonclinical and regulatory strategy and study design
• Has experience presenting (e.g. SOT), lecturing at UK universities (e.g. UCL), training (e.g. EU GLP inspectorate) and mentoring
• Passionate advocate of the 3Rs.