Building IND-Ready and Investor-Ready Development Programs

Fran has over 25 years of experience with strategic and operational global drug development from early discovery to filing and post-marketing.  She possesses a broad knowledge of strategic drug discovery and development, with a special focus on development strategy and the application of model-informed drug development (MIDD).

Colin has 33 years in the pharmaceutical industry primarily in multi-disciplinary drug development leadership roles, including 25 years with early development/early-stage programs.​

At Certara, Colin leads numerous programs in Oncology, CNS, Infectious Disease and Global Health therapeutic areas and supports biotech companies with their funding initiatives. Prior to Certara, Colin worked for very large (Pfizer, Wyeth-Ayerst), mid-size (Celldex), and start-up (Kolltan, Iterum, Maxwell BioSciences) pharmaceutical companies as well as consultant firms (Deloitte and Lachman Consultants) in drug development, business operations and process improvement roles.  ​He earned an undergraduate degree in Pharmacy from Rutgers University and an MBA degree from the University of North Carolina – Wilmington.

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.

Geoff brings 20+ years of expertise and a demonstrated record of regulatory and business accomplishments covering the United States, Europe, Asia Pacific (with in depth experience in Japan, China, and Korea), and Middle East having lived and worked in many countries championing regulatory affairs.

Carrie Zanon Malinczak, PhD, is Director of Toxicology at Certara, where she provides strategic and scientific leadership in nonclinical safety assessment and toxicology programs supporting drug development. With more than 25 years of experience across biotechnology, pharmaceutical, medical device, and life sciences organizations, she brings deep expertise in toxicology, immunology, virology, molecular and cellular pathology, and translational research.

Dr. Tong Zhu has over 25 years of experience specializing in translational medicine, early development, and clinical pharmacology. She has a wealth of knowledge in pharmaceutical research and development. She was responsible for leading Astellas’ Primary Focus strategy in Mitochondria Biology by working globally to help identify and develop innovative drugs targeting mitochondrial biology. In almost 14 years at the company, she held various leadership positions in its Clinical Pharmacology & Exploratory Development division. Before her time at Astellas, Dr. Zhu held positions with increasing responsibilities at Abbott Global Pharmaceutical Research and Development (now AbbVie) on Clinical Pharmacology and Pharmacometrics teams.