Charting the Course: Strategies for Therapeutic Vaccine Study Success

Dr. Judith Neville, PhD, PMP, Director Project Management, Therapeutic Vaccines, PPD Clinical Research Business of Thermo Fisher Scientific

Dr. Neville is an accomplished and highly experienced Oversight Director for Therapeutic Vaccines. With a Ph.D. in Virology from the University of Edinburgh and 25 years of industry, government and academic experience, Dr. Neville possesses a deep understanding of the intricate mechanisms of viruses and their interaction with the human immune system.

Throughout her career, Dr. Neville has consistently demonstrated exceptional expertise in managing and overseeing clinical trials. Her extensive knowledge of virology, immunology, and vaccine development enables her to provide invaluable guidance in the design, implementation, and evaluation of these crucial studies.

As an Oversight Director, Judith is responsible for ensuring project delivery, from protocol design and participant recruitment to data analysis and reporting. She works closely with cross-functional teams, to ensure that all trials are conducted in accordance with industry guidelines and regulatory requirements.

With her vast experience and comprehensive understanding of clinical trial management, Dr. Neville is committed to driving innovation, fostering collaboration, and ultimately contributing to the development of safe and effective therapeutic vaccines that can revolutionize patient care and public health.

Dr. Jaikrishna Balkissoon, MD, FACS Global VP, Head Cell and Gene Therapy, PPD Clinical Research Business of Thermo Fisher Scientific

Dr. Balkissoon, MD, FACS, is a Surgical Oncologist and the medical and scientific lead for immuno-oncology, cell and gene therapy at PPD. He is the visionary behind the creation of the PPD Immuno-oncology/Cell Therapy Center of Excellence. With more than 25 years’ experience in both clinical practice and clinical research, Dr. Balkissoon is committed to capitalizing on advances in the rapidly changing therapeutic landscape to establish PPD as a world-class partner in advancing immunology-oncology/cell therapy studies.

His personal immuno-oncology and cell therapy experience includes treating patients with advanced melanoma, kidney cancer and non-Hodgkin’s lymphoma with adoptive cell therapies and vaccines either with or without gene modification. He developed an immunotherapy program in Northern California for treating advanced melanoma and kidney cancer patients with high-dose interleukin-2.

At PPD, he has been the therapeutic advisor for cell therapy studies in oncology and provides drug development strategy, medical, scientific and product development guidance to both external clients and PPD’s internal clinical operations and business development teams. He also consults on investigational new drug submission and clinical input toward protocol development, including adaptive designs when feasible.

With extensive clinical oncology experience and as a Senior Executive in the pharmaceutical and biotech industries, Dr. Balkissoon joined PPD in 2013 after previously working at Genentech and Oxigene in South San Francisco where he was Vice President of Clinical Research.

Dr Balkissoon holds a Bachelor of Science in Biology from Beloit College in Wisconsin and an MD from Howard University College of Medicine in Washington, DC. He has also completed a general surgery residency at Howard University.

Mario Davinelli, Executive Director, Project Management, Vaccines, PPD Clinical Research Business of Thermo Fisher Scientific

Mario Davinelli, PhD, serves as Executive Director in the Vaccines, Government and Public Health Services Therapeutic Unit at PPD Clinical Research business of Thermo Fisher Scientific. Mario leads the therapeutic vaccines business segment and the strategic proposal development services for government and public health.

Dr. Davinelli joined PPD in November 2010 and has over 20 years of global experience in clinical research, in the medical device industry and the CRO environment. He has served as Project Manager and Oversight Director in numerous clinical development multinational programs, leading large global study teams.

He has also served as a Subject Matter Expert for rare diseases and vaccines. He has therapeutic area operational experience in vaccines, infectious diseases, cardiovascular diseases, rare and genetic diseases, neuroscience, metabolic, oncology, along with extensive research operations experience in phase I-IV trials, natural history and observational studies, health authority safety surveillance studies, investigator-sponsored research (ISR), health economics and outcomes research.

Prior to joining PPD, Dr Davinelli worked for six years as a Study Manager for Medtronic. Before that he worked as a post-doc fellow at the University of Bologna, pursuing pre-clinical research in the field of biomechanics. Dr Davinelli earned his PhD in Bioengineering and Master’s degree in Electronic/Biomedical Engineering at the University of Bologna, Italy.