Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Dr. Fran Brown is a highly respected professional with proven leadership skills and 28 years of broad experience within pharmaceutical development and due diligence. She has extensive experience with strategic and operational global drug development from early discovery to filing and post-marketing. This experience spans multiple therapeutic areas, small molecules and biologics, global regulatory requirements and registration pathways. She possesses a broad knowledge of product development and portfolio management, with a special focus on development strategy, regulatory interactions and product filings.

Her past appointments include leadership roles within large Pharma as well as in small biotech organizations including head of clinical pharmacology, clinical leader, project development leader, head of clinical operations and due diligence asset assessment. She has over 10 years of experience in providing consulting advice to the pharmaceutical industry and non-profit Global Health Organizations ranging from individual project support, to strategic TA strategy and development planning, portfolio management and corporate transformation. She joined Certara in 2017 and is currently the SVP of Drug Development Science within Integrated Drug Development.

Max brings both scientific training and experience in healthcare product development that are important for evidence-based value and access strategies for pipeline and marketed products. Leading a team of analysts and focusing on projects involving late stage, launch, and due diligence efforts, Max’ experience cuts across all major therapeutic areas and care settings with special emphasis on CV / metabolic, oncology, gene therapies, ophthalmology, GI, and dermatology. Max and team have designed successful pricing and contracting strategies for products at launch and throughout the life cycle. He also leads projects focusing on managed markets communications strategies.

Mikael Dolsten, M.D., Ph.D recently retired from Pfizer Inc after a 16-year tenure as Chief Scientific Officer and President of Pfizer Research & Development.

Dr. Dolsten oversaw at Pfizer the regulatory approval of over 36 medicines and vaccines, while advancing more than 150 drug candidates into clinical studies. He championed breakthrough innovations across small-molecule medicines, biotherapeutics, gene therapies, and vaccines and played a leading  role in the global  response to the COVID pandemic .

His leadership experience includes serving as President of Wyeth Research, Executive Vice President and Head of Worldwide Research at Boehringer Ingelheim, and Global VP at AstraZeneca managing cardiovascular, metabolic, and gastrointestinal R&D. Earlier, he led R&D at Astra Draco (pulmonary & inflammation) and headed Immunology-Oncology research at Pharmacia, Sweden. During his 30+ years as a R&D leader he has been connected to some 50 drug & vaccine approvals and several 100s of novel candidate drugs  transiting to clinical studies. Dr Dolsten has VC experience from work with Orbimed , ATP and Pfizer venture groups and has  been involved in numerous small and large corporate business transactions exceeding 100B$ size.

Dr. Dolsten currently sits on the public boards of Agilent Technologies, Novo Nordisk (Observer) and Rocket Pharmaceuticals. He serves as chairman , board member or advisor of several  private Biotechs  including Orbis Medicine, ImmuneAi, Enveda Bio, Fair Journey Biologics, Orogen Therapeutics, Marengo Therapeutics, Mast Cell Sciences, Quarry Thera  and ChAI discovery . Dolsten serves as investment advisor to Blackstone Life Sciences, GV (legacy Google Ventures) , Bains & Co, Canaan Partners, AN Ventures  and Formation Bio. His supervisory affiliations include the Scripps Research Institute, the Foundation for the NIH, Research America and membership in The Royal Swedish Academy of Engineering Sciences. Dr Dolsten has advised Obama, Biden,  Trump administrations in public health initiatives  and the UK Government’s G7 leadership for pandemic responses .

With over 160 scientific publications and numerous patents, Dr. Dolsten holds both a Ph.D. in Tumor Immunology and an M.D. from the University of Lund, Sweden, where he serves as a Visiting Professor.

Paula Kaplan-Lefko, PhD is a regulatory affairs leader with more than a decade of experience guiding the clinical development of autologous and allogeneic cell and gene therapies for oncology and autoimmune diseases at Atara Biotherapeutics and UCLA.  She has served as a global regulatory lead, driving the development and execution of regulatory strategies, including global clinical trial application submissions, regulatory authority interactions on a range of clinical topics, and the pursuit of expedited pathway designations. Prior to her regulatory career, she spent 9 years at Amgen as a nonclinical pharmacology lead, overseeing multiple small molecule and protein therapeutic programs in oncology and supporting their advancement through early development.  Her PhD and postdoctoral training in cancer biology provide a strong scientific foundation for strategic regulatory planning and risk assessment across therapeutic modalities.