Overcoming Operational Challenges: How Intentional Planning Leads to Patient Diversity in Clinical Trials

(Moderator) Nicholas Kenny, Chief Scientific Officer, Syneos Health

With over 21 years of experience in clinical development and consulting, Nick Kenny is passionate about rapidly moving compelling new science for unmet medical needs through the development process to arrive at early and innovative decisions.  ​

Kenny has been with Syneos Health since 2006, where he grew and led the Oncology team until moving to the Chief Scientific Officer role in 2018, where he oversees the Medical Team for Syneos Health, the Consortia Models for e.g. Rare Diseases and Cell and Gene Therapies and is a leader on Governance for our Dynamic Assembly of cutting edge data assets.  He also serves as senior representative to the Clinical Trials Transformation Initiative (CTTI) Steering Committee and Forum for Collaborative Research.​

A cancer survivor (Hodgkin’s Lymphoma), Kenny spent his early career in biomedical research in the UK, US and Canada, and held a faculty appointment at the University of Vermont Medical School for several years. He is currently on the Board of Directors for Hospice of Wake County.

Julian Jenkins, PhD, Group Vice President and Head of Development Operations and Project Management, Incyte Corporation

Julian is the Group Vice President and head of Development Operations and Project Management at the Incyte Corporation in Wilmington, Delaware. His team is accountable for the strategy, planning and execution of Incyte’s oncology, inflammation and autoimmunity clinical development portfolio. He has almost 30 years’ experience in the life science and pharmaceutical industry, including a variety of scientific, business and operational leadership roles at Incyte and GlaxoSmithKline, and a number of years as a leader on the TransCelerate Biopharma oversight committee.

Julian is an adjunct professor in drug development and business administration at the University of the Sciences in Philadelphia, and has published and presented research in the areas of virology, hematology and clinical trial technologies. Julian grew up in the Welsh Valleys and received his PhD from the University of Nottingham Medical School in the UK.

Jim Kremidas, Executive Director, Association for Clinical Research Professionals (ACRP)

Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. Prior to ACRP, Jim consulted for a variety of clients, such as investigator sites, academic institutions, sponsors, and suppliers. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing patient enrollment strategies for global clinical trials.

Prior to that, Jim spent 24 years with Eli Lilly and Company. From 1999 to 2008, he led their clinical trial patient recruitment and retention efforts. In this role, he focused on predicting and accelerating the enrollment rates for all corporate studies. Jim is on the advisory board of CISCRP (a non-profit organization focused on enhancing patient participation in clinical trials) and is a volunteer for the Clinical Trial Transformation Initiative (CTTI) with Duke and the FDA. He is a frequent presenter at industry conferences and has written articles and papers that have been published in a wide variety of trade journals.

Cathy Trzaskawka (“Traz”), Executive Director and Head, Global Advocacy, Bristol-Myers Squibb

In her current role, Cathy heads global advocacy at BMS, developing and advocating company positions on priority issues to maximize patient access and promote a strong climate of biopharmaceutical innovation and the value of innovative medicines, working with advocacy organizations and other key stakeholders. Under her leadership, BMS Global Advocacy has developed and launched several global initiatives for, and with, advocates.

The Patient Expert Engagement Resource (PEER), is an enterprise wide, consistent and systematic advocate engagement and input process for the entire life cycle of medicines; the www.CovidAdvocacyExchange.com (CAE), is an innovative and bold online resource to elevate awareness, engagement and impact of advocacy efforts to support patients affected by COVID-19; and the Global Oncology Advocacy Leaders (GOAL) consortium develops impactful resources for the advocacy community through peer-reviewed publications, data generation and case study collection.

Ms. Trzaskawka started her career in the New Jersey State House as a communications specialist working with the Assembly Health & Human Services Committee, among others, before moving onto Governor Christie Todd Whitman’s team as Deputy Director of Intergovernmental Affairs. From the State House, Cathy continued on as a community affairs lobbyist, to corporate affairs, then took an incredible opportunity as Executive Director of the Leukemia & Lymphoma Society (LLS), SNJ. Her move into pharmaceuticals came from her advocacy and patient education work at LLS. She has held several senior positions at pharmaceutical companies, including GSK, Endo, and now BMS.

Cathy has an excellent track record of utilizing optimism and strong personal beliefs to overcome social and business challenges, and mobilizing people around a higher purpose, while being committed to corporate social responsibility.

Worta McCaskill-Stevens, MD, MS, Chief, Community Oncology and Prevention Trials Research Group, NCI Community Oncology Research Program (NCORP)

Dr. Worta McCaskill-Stevens is a medical oncologist and Chief of the Community Oncology and Prevention Trials Research Group, which houses the NCI Community Oncology Research Program (NCORP), a community-based clinical trials network launched in 2014. As NCORP Director, she oversees the program supporting community hospitals, physicians and others to participate in NCI-approved cancer treatment, prevention, screening and controlled clinical trials, as well as cancer care delivery studies. After arriving at the NCI in 1998, she became the program director for the Study of Tamoxifen and Raloxifene (STAR), and assumed responsibilities for breast cancer prevention with the CCOP. She chaired the 2009 NIH State-of-the Science Conference on ductal carcinoma in situ; is a member of the Early Breast Cancer Clinical Trialist Group (Oxford, UK); and is a member of NCI’s Breast Cancer Steering Committee.

After attending Washington University and the American College of Switzerland, she completed medical school and an internal medicine residency at Georgetown University followed by a medical oncology fellowship at the Mayo Clinic (Rochester, MN). Prior to her current position, she was the Co-Director of the Breast Care and Research Center at the Indiana University Cancer Center. In 2016, she was the recipient of the American Association for Cancer Research Jane Cooke Wright Memorial Lectureship, which recognizes an outstanding scientist who has made meritorious contributions to the field of cancer research and who has, through leadership or by example, furthered the advancement of minority investigators in cancer research.

Her other honors and awards include the Kaiser Family Fund Award for Excellence in Academic Achievement and Leadership in Medicine; Omega Alpha Medical Honor Society; the NIH Director’s Award for Clinical Trials; the NCI Merit Award for breast cancer prevention; and listed on Ebony magazine’s 2013 Power 100 – Most Influential African Americans in Science and Health. Prior to medical school, Dr. McCaskill-Stevens was a medical editor for Marcel Dekker and the Alan Guttmacher Institute.