The FDA Group’s CEO, Nick Capman, sits down with William V. Williams, MD, FACP, President and CEO of BriaCell Therapeutics Corporation, a company at the forefront of developing personalized cell therapies and immunotherapies for cancer. Dr. Williams reveals the current landscape and future potential of cancer treatments, focusing on the role of immunotherapies and cell therapies in revolutionizing patient care.

Discussion points include:

» Dr. Williams's extensive background in drug development and his transition to leading BriaCell Therapeutics Corporation.

» The significant unmet needs in cancer immunotherapies, particularly for 'cold' cancers that lack a preexisting immune response necessary for current treatments like checkpoint inhibitors.

» The advantages of cell therapies, such as their non-toxic nature and low side effect profile, and the advantages of personalizing these therapies using the human leukocyte antigen (HLA) system.

» Emerging developments in cancer immunotherapy, including bispecific T cell engagers (BiTEs), which show promise in targeting and destroying cancer cells by engaging T cells.

» Innovative approaches on the horizon for cellular therapies, such as transforming cancer cells into antigen-presenting cells to activate the immune system against 'cold' tumors.

» The regulatory landscape for cell therapies, with insights into navigating the FDA's review process and the importance of adhering to their feedback.

» The transformative potential of cell therapies for cancer treatment and the financial challenges faced by small biotech companies in a high-interest economic environment.

Dr. Williams is a seasoned biopharmaceutical executive with over 35 years of industry and academic expertise, including significant clinical management in multinational pharmaceutical companies. Dr. Williams has served as BriaCell’s President & CEO since Oct 2016.

Previously, Dr. Williams was appointed VP of Exploratory Development at Incyte Corporation from 2005 to 2016.

He facilitated the entry of over 20 compounds into the clinic, including approvals for ruxolitinib (Jakafi) and baricitinib (Olumiant). As VP of Clinical Pharmacology and Experimental Medicine at GlaxoSmithKline, Dr. Williams evaluated numerous molecules in clinical studies in various therapeutic areas. He was involved in new or supplemental drug authorizations for a number of oncology drugs, including Bexxar (lymphoma), Hycamtin (ovarian cancer), and Navelbine (non-small cell lung cancer) as well as ibandronate (Boniva) for osteoporosis.

As Head of Rheumatology Research at the University of Pennsylvania, he ran a major research program in receptor biology, collaborated with David B. Weiner, PhD to develop DNA vaccines, and was able to bring novel DNA vaccines into the clinic for the treatment of cutaneous T cell lymphoma.

Dr. Williams earned his BSc. in Chemistry and Biotechnology from MIT and his Medical Doctorate from Tufts University School of Medicine. He has worked in the molecular immunology laboratory of Mark I. Greene, MD, PhD, FRCP, at the University of Pennsylvania, developed novel methods of bioactive peptide design, and collaborated in the study of the activation of the p185/Human epidermal growth factor receptor 2 (HER2) receptor. HER-2 is a protein that is known to promote the growth of cancer cells. Dr. Williams is the named author of over 130 peer-reviewed publications, over 15 patents, and numerous INDs and NDAs.

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