Dr. Annalisa Jenkins, M.B.B.S., F.R.C.P. is a life sciences thought leader with over 25 years of experience building and financing companies pursuing cures for the most challenging diseases globally. She has consistently mentored leadership teams advancing programs from basic research through clinical development, regulatory approval, and into healthcare systems globally.
Annalisa graduated in Medicine at the University of London and received her Fellowship of the Royal College of Physicians London. She trained in Cardiovascular medicine and was a research fellow at Imperial College. Earlier in her career, Annalisa was a medical officer in the British Royal Navy during the Gulf Conflict, achieving the rank of Surgeon Lieutenant Commander. She also held senior leadership roles at Merck Serono, and Bristol Myers-Squibb over 15 years.
Annalisa served as President and CEO of Dimension Therapeutics, a leading gene therapy company she took public on the NASDAQ and subsequently sold to Ultragenyx. Following her relocation back to the UK, she developed a portfolio of roles spanning the public, private and charitable sectors including Genomics England, The King's Fund, British Heart Foundation and Chair of YouBelong, a leading mental health care charity. She is also a Board member of several growing public and private companies including Compass Pathways, Affimed, Mereo Biopharma and Skye Bioscience. Annalisa serves on a number of advisory boards and contributes publicly on leadership with purpose, social entrepreneurship, diversity and innovation.
For CEOs it is vital to build a globally aligned regulatory strategy, optimize clinical and CMC planning, and navigate the evolving FDA & EMA landscape efficiently.
The question is no longer just how to get a drug approved, but where to begin, how to align strategies across regulatory agencies, and how to avoid common pitfalls that lead to costly delays. With the FDA emphasizing faster approvals and real-world evidence while the EMA maintains its rigorous scientific review process, biotech leaders must carefully consider how to sequence regulatory filings and optimize their engagement with both agencies.
Annalisa Jenkins, M.B.B.S., F.R.C.P. has served as a committee member of the Science Board to the U.S. Food & Drug Administration, which advises FDA leadership on complex scientific and technical issues. Some things to think about prior to this CEO Clinic:
Should I prioritize FDA or EMA approval first?
What are common regulatory pitfalls that delay approvals?
How can I optimize regulatory interactions (e.g., FDA Type B meetings, EMA Scientific Advice)?
What changes in FDA and EMA policies should I prepare for?