Fred brings extensive experience and a deep knowledge of small molecule, targeted therapeutics and immuno-oncology (BiTE, antibody, ADC, cell and gene therapies) development. He has established and managed US, EU and JP clinical, regulatory and safety operations for clinical oncology drug development, as well as in China, Japan, S. Korea, Taiwan, and Australia.
Fred is a US-trained, board certified medical oncologist, with specific training and experience in oncology drug development and pharmacology, as well as in preclinical to clinical translational medicine. He has had extensive interactions with the FDA, EMA, and other regulatory authorities, as well as negotiating and managing contracts with CROs and vendors in support of clinical Phase I-III global development in accordance with ICH GCP. He has designed, written, implemented and managed multi-national Phase I-III clinical protocols and set up and managed all related operations and key recruitment/engagements (CRO selection, feasibility, drug supply, site/investigator selection, regulatory, drug safety, data management, biostatistics, DSMBs, and KOLs).
Fred has also successfully prepared and filed multiple commercial INDs/CTNs with the FDA, EMA, PMDA, Eastern Europe, and Australia; specifically, these involved preparing the protocol, IB, IC, Pharm/Tox, CMC, and other required sections as well as the regulatory interactions.
Fred has extensive expert due diligence experience in medical, clinical development and IP for asset for potential acquisitions and investments, and input/justification for NPV/DCF analyses for investment firms and companies. He serves as a key advisor for several of the leading pharma/biotech companies in the industry.BACK