Cardio-oncology is most frequently associated with a clinical focus on cardiovascular issues associated with the treatment and management of cancer patients, as many oncology therapeutic agents are also cardiotoxic. The collaboration and integrated treatment approach between the fields of cardiology and oncology has led to a proactive treatment approach which, along with improved cancer treatments, has also improved survival rates and quality life for cancer patients. This clinical collaboration is paralleled in the approach to the development of new oncologic therapeutic agents. Cardiac safety endpoints are important considerations in the development plan for an oncology treatment. With a focus on establishing a benefit-risk profile of new compound and/or the use of an existing treatment for a different indication, there is a need to develop a strategy to define the developing treatment’s cardiac safety profile. Cardiac safety endpoints/modalities in oncology drug development include electrocardiography (ECG), hemodynamics, cardiac imaging (i.e. echo, muga) and laboratory cardiac biomarkers. This webinar will focus on the integration and approaches to implementing ECG and cardiac imaging endpoints into an oncology study and development plan.
Jeff Heilbraun, VP, Medical and Scientific Affairs Cardiac Safety Service, Bioclinica
Jeffrey Heilbraun completed a Master of Science in Health Promotion and Disease Management. He was employed at The American University as an adjunct professor in the Health Promotion program. Throughout his career, Heilbraun has maintained his focus on the science, technology, trial design and regulatory considerations surrounding cardiac safety (ECG and blood pressure endpoints) within pharmaceutical development, with a special interest in hemodynamics. Heilbraun has supported publications in cardiac safety considerations in oncology drug development and the regulatory considerations for “off-target” blood pressure response in compound development.
M. Barbara Srichai-Parsia, Associate Professor of Medicine & Radiology, Georgetown University School of Medicine
Dr. Srichai is an Associate Professor of Medicine & Radiology at Georgetown University School of Medicine. She is Vice Chief of Cardiology, Director of Noninvasive Cardiac Imaging and Director of Medstar Women’s Heart Health Program. She has over 25 years of experience in CMR and has worked professionally within Radiology and Cardiology. She received her MD from The Johns Hopkins University School of Medicine and MS in Comparative Effectiveness Research at NYU. She completed internal medicine residency at Columbia University Medical Center in New York and cardiology fellowship at Cleveland Clinic. She did additional fellowships in advanced cardiac imaging and cardiac tomography at Cleveland Clinic.
As a female multimodality cardiovascular imaging specialist, Dr. Srichai has interests in several cardiovascular imaging areas, specifically cardiac MR, cardiac CT and advanced echocardiography. Her specific interests are in appropriate applications of multimodality imaging in cardiovascular disease, particularly subclinical coronary artery disease and cardiomyopathy including chemotherapy and radiation effects on heart disease. She also has subspecialty interests in women’s heart disease including dysautonomia and syncope. She has over 80 original peer reviewed papers as well as several book chapters and review articles.
Steven Soignet, Director, Medical Oncology, Bioclinica
Dr. Soignet joined Bioclinica as Director, Medical Oncology in April 2020. Prior to his position at Bioclinica, he was the co-founder and General Partner of Arcus Ventures, an oncology focused fund investing in companies developing cancer therapeutics and diagnostics. Prior to starting Arcus Ventures in 2007, he was the Managing Director of The Arcus Group, a consulting company that provided due diligence and strategic guidance for financial service and pharma/biotech clients. Dr. Soignet was venture partner of Cross Atlantic Partners, a healthcare and biotechnology venture capital fund based in New York City, in 2003- 2007.
Dr. Soignet held a faculty appointment in the Developmental Chemotherapy Service at Memorial Sloan-Kettering Cancer Center, and in the Department of Medicine at Cornell University Medical Center. His primary research focus was in early phase clinical drug development in both hematological and solid tumors, which involved novel differentiation agents, transcription modulators, cell cycle inhibitors, monoclonal antibodies, vaccines, and cytotoxic chemotherapies. He was a lead investigator of a Pilot and a large US Multicenter Trial that led to the US FDA and European approval of arsenic trioxide for the treatment of relapsed acute promyelocytic leukemia. Dr. Soignet’s research has been published in the New England Journal of Medicine, Leukemia, Blood, Journal of Clinical Oncology and Clinical Cancer Research.
Dr. Soignet received his B.S. from the University of New Orleans, and his M.D. (AOA, honors) from Louisiana State University School of Medicine. His internship and residency were completed in medicine at Vanderbilt University Medical Center and he then completed his fellowship training in medical oncology/hematology at Memorial Sloan-Kettering Cancer Center. He held several leadership positions at Memorial Sloan-Kettering Cancer Center, including Chief Fellow, Chairman of Chemotherapy Practice, Vice-Chairman of the Pharmacy and Therapeutics Committee and a member of the Investigational New Drug committee.
Dr. Soignet also served on the Board of Advisors of the American Red Cross, Greater New York Chapter, a board observer on T2 Biosystems, Tracon Pharmaceuticals, Vascular Pathways, XTuit Pharmaceuticals, and he was a member of the Board of Directors of Exosome Diagnostics.
Who Should Attend?
This webinar will provide valuable insight for team members associated with clinical trials, including:
- Medical/Scientific Affairs
- Project Management
- Clinical Monitoring
- Study Coordinator
What You Will Learn
The following topics will be covered in this webinar:
- Introduction to cardio-oncology in oncology drug development
- Regulatory consideration and trial design approaches related to ECG endpoints such as ECG-PKconcentration
- Cardiac imaging endpoints and considerations around the specific cardiac imaging modality to implement in a clinical trial
Bioclinica is a global, life-science provider that utilizes science and technology to reduce risk of clinical trials – helping companies to develop new, life-improving therapies more efficiently and safely. The company’s offerings include medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments and budget forecasting; pharmacovigilance, and trial management.