Designing a High-Value Drug Development Program: From Concept to First-in-Human (FIH)

VP, Global Head, Clinical Pharmacology & Translational Medicine
Certara Drug Development Solutions

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.

Vice President. Clinical Pharmacology & Translational Medicine
Certara Drug Development Solutions

Dr. Offman has over 20 years of drug development experience and joined Certara in 2017 where he leads translational pharmacokinetic and pharmacodynamic efforts in Certara’s Clinical Pharmacology & Translational Medicine group. Dr. Offman has supported the development of several oncology products including Asparlas (calaspargase pegol), Oncaspar (pegasparaginase) and brigatinib (Alunbrig), and was instrumental in the approval of RedHill Biopharma’s Talicia for H. pylori infection. Prior to joining Certara, Dr. Offman was responsible for clinical pharmacology and pharmacometrics at Celerion, leading study design, data analysis and interpretation for clinical pharmacology studies including first-in-human, drug-drug interactions, mass balance and special population trials. Prior to joining Certara, Dr. Offman oversaw biopharmaceutics and scientific affairs for Genpharm, a subsidiary of Merck KGaA as well as Mylan. Additionally, as a clinical pharmacologist, Dr. Offman has supported development and approval of Epanova (Omthera), XHANCE (Optinose) and Austedo (Auspex).

Vice President, Clinical Pharmacology and Translational Medicine, Certara

A pharmacist by training, William has a MSc in Toxicology and a PhD in Pharmacokinetics and Metabolism. He has 25 years of experience in Pharmaceutical companies and PK/Tox laboratories. Before joining Certara, William worked for pharmaceutical companies, headed up the Clinical PK/PD and Pharmacometrics department of a global CRO and was Senior PK assessor at the MHRA where he provided PK and PD assessments, interacting with non-clinical, pharmaceutical, medical assessors and with Company staff using appropriate CHMP and ICH guidelines. As a Member of the Modelling and Simulation Working Group to provide support to the European Medicines Agency’s scientific committees and working parties on modelling and simulation and more general methodological discussions and qualification procedures regarding modelling and simulation, he advised pharmaceutical companies on good clinical pharmacology trial design, adequacy of data, appropriate analyses and other pharmacokinetic issues relating to license applications, at company meetings.