Oncology Clinical Trials: Solving Complex Challenges with Data-Driven and Innovative Approaches

Dr. Jai Balkissoon, MD, FACS, Vice President, Medical and Scientific Strategy Lead, Immuno-Oncology, Cell and Gene Therapy, Head of Immuno-Oncology, Cell and Gene Therapy Center of Excellence, Clinical Research Group, part of Thermo Fisher Scientific

Jai Balkissoon, MD, is a surgical oncologist and the Medical and Scientific Strategy Lead for Immuno-Oncology, Cell and Gene Therapy at PPD and 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 lymphoma with adoptive cell therapies and vaccines either with or without gene modification.

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 a medical degree from Howard University College of Medicine in Washington, DC.  He completed a general surgery residency at Howard university and a surgical oncology and immunotherapy fellowship at the National Cancer Institute (NCI) in Bethesda, Maryland.

Vito Romita, PhD, MSc, Senior Director, Global Project Management, Project Delivery - Hematology Oncology Therapeutic, PPD, part of Thermo Fisher Scientific

Dr. Vito Romita is a clinical research professional with 26+ years of experience in the drug development industry primarily in the CRO environment and has worked with small, mid-sized biotech and large pharma.

Vito obtained his PhD from McGill University (Montreal, Quebec, Canada) and graduated with honors.

Vito has and continues to dedicate his career to advancing therapies across several indications applying his deep expertise in operationalizing complex clinical trials across all phases; the last 15 + years focused on hematology-oncology with a more recent emphasis in areas of immuno-oncology and adoptive cell and gene therapies, an area rapidly evolving over the last decade.

Jürgen Hummel, Executive Director Statistical Science, Biostatistics, PPD, part of Thermo Fisher Scientific

Jürgen Hummel is based in Edinburgh (Scotland, United Kingdom) and joined PPD in 2006. He is pillar head for statistical science, a pillar within the Biostatistics department which specializes in implementing innovative study designs. Specifically, Jürgen has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up in 2011. He also provides statistical consultancy both internally and externally.

Jürgen’s career spans over 25 years, in which he held a variety of technical and managerial positions in different organizations, predominantly within the CRO industry. He earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and is a chartered statistician with the Royal Statistical Society. He has also been active in cross-industry bodies such as Statisticians in the Pharmaceutical Industry (PSI), where he served on the board of directors.

Meriam Djemai Zoghlache, Senior Director, Early Development, Hematology and Oncology, PPD, part of Thermo Fisher Scientific

Meriam Djemai Zoghlache has more than 20 years of experience in the CRO environment. Since 2001 she has focused on Early Development Studies, first in CNS then in HemOnc and joined PPD in 2015. While delivery EDOS studies for clients she has been a driving force in creating the EMEA PPD Select Early Phase Oncology Site Network. As our Hem Onc EDOS Pillar Lead Meriam is driving PPD’s strategic EDOS initiatives to ensure our company is considered THE key player in Early Phase Oncology, not only by our customers but also by our sites and patients through adoption of the best practices and innovations to ensure safe and on-time delivery of critical milestones. Meriam is homebased in Brittany, West of France

(Moderator) Dr. Margaret (Meg) Twomey, MD, Director, Clinical Science, Strategic Development Consulting, PPD, part of Thermo Fisher Scientific

Dr. Margaret (Meg) Twomey joined PPD/Evidera in 2020 as a Director of Clinical Science on the Strategic Development Consulting team, based in North Carolina. Dr. Twomey is an expert in protocol design and the development of Phase I-III clinical trials in neurology, psychiatry, ophthalmology, and genetics/rare diseases, including advanced therapies, biosimilars, and medical devices. She led the design of a complex and innovative Phase III adaptive platform trial in PTSD, from idea conception and synopsis development through full protocol writing, agency interactions, and IND submission. She is a creative problem solver, leveraging exceptional data analysis and visualization skills to provide scientific insight and considerations for clinical development planning and regulatory strategy from pre-IND through NDA/BLA/MAA. In addition to supporting clients, Dr. Twomey sits on the Patient Reported Outcomes and Externally Controlled Trials Working Groups, which aim to integrate the latest scientific and regulatory best practices across PPD.

Prior to joining PPD/Evidera, Dr. Twomey gained medical monitoring, pharmacovigilance/signal detection, and project management experience across all phases of drug development through various roles at Syneos Health and INC Research. She received a medical degree from the University of North Carolina School of Medicine and Bachelor of Arts degree in Biology and Anthropology from Haverford College