Patient need has always been the reason for drug development. But while industry has long spoken of “patient-centricity” as a key to continued progress, the concept has fallen short — largely due to well-meaning conversations about patients rather than with patients. Only recently has a true “patient voice” become recognized as an essential asset in the development of medicines that matter to patients, a result of sustained patient advocacy and regulatory efforts such as the US Food and Drug Administration (FDA)’s Patient-Focused Drug Development initiative. Patient perspectives can have an invaluable impact on clinical trials.
The need is even more acute for novel and emerging, and particularly oncology and “next-generation” cell therapies in difficult to treat settings, which pose unique challenges for patients and their families.
How can we continue to get closer to meeting and beating the real-world expectations of patients and caregivers, and ensure we stay one step ahead of the heightened expectations of regulators, payers and customers?
Join this webinar to learn more about why engaging patient perspectives is essential to clinical trials.
Speakers
(Moderator) Jane Bentley, Vice President, Oncology Business Strategy, Syneos Health
In her role as the Innovation and Business Strategy Lead for Oncology at Syneos Health, Jane leads the Syneos Health Oncology initiatives in advance cell therapy, including CAR T therapies in collaboration with Gryt Health and the development of a new patient ad board solution (CRAFTT Express) for Oncology Biotech customers. Jane is an active participant in Syneos Health’s cross functional consortia for the Patient Voice, Cell and Gene Therapy and Rare Disease. She has over 30 years of global oncology clinical research expertise in Pharma/CRO, including 20 years leadership experience in oncology global trial management across Phases I-IV. Before joining Syneos Health Jane held oncology leadership roles in several Global CROs and consultancy organizations. Her experience in global trial management includes key oncology/hemato-oncology indications (breast cancer melanoma, glioblastoma, prostate cancer, multiple myeloma, AML, supportive care neutropenia/anemia) including immunotherapies and biologicals and across Phases I-IV. Her experience also includes global leadership of registration programs and support of clients in the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspection readiness.
She is currently a member of the board at the Institute of Clinical Research and previously held the post of Hon. Lecturer in Clinical Research at Liverpool John Moores University. Jane holds a BSc in pharmacology and a PhD in toxicology from University of London. She is currently enrolled in a course of study towards an MBA in International Health
Message Presenter
Lynn Donald, Senior Project Director, Novel and Emerging Therapies, Syneos Health
Lynn Donald is an experienced and passionate leader with over 22 years in clinical research, including extensive oncology project management experience spanning all aspects of clinical trials from Phase I, including first-in-human studies to large global Phase III. Responsible for oversight and delivery of key portfolios of studies including supporting clients with strategy and risk mitigation with strong focus on cell/gene therapy, Lynn is a key member of Syneos Health’s Cell and Gene Therapy Consortium and leads the Cell Therapy Working Group, driving best practices in cell therapy studies. She is also a member of the Patient Voice Consortium.
Message Presenter
Dr. Rayna Patel, Co-Founder and CEO, Vinehealth
Dr. Rayna Patel is a Medical Doctor and Neuroscientist with an MPhil in translational medicine. She has extensive experience in academia (Cambridge, Harvard, MIT, Columbia) and was an Associate Fellow of Clare Hall College, Cambridge. Rayna has subsequently held strategic and commercial roles in government policy, tech startups and the Cabinet Office’s Nudge Unit, where she used behavioral science to rewire patient behaviors through digital products. She is currently CEO and Co-Founder of Vinehealth, a digital platform using a combination of behavioral science and AI to improve the quality of life and survival of cancer patients, whilst generating crucial real-world data to better inform healthcare delivery and drug development.
Message PresenterWho Should Attend?
This webinar will be of interest to CAR T based biopharmaceutical professionals engaged in clinical operations functions.
What You Will Learn
Attendees will gain insights on:
- Perspectives on patient-focused research, incorporating the patient as a key stakeholder in all aspects of clinical trials from design of protocol, to approaches to trial recruitment and managing patient burden
- Industry strategies to address the changing regulatory landscape and requirements for patient-focused drug development
- Insights on different strategies available and how sponsor, CRO, patient support/advocacy groups and other industry players can work together make it easier for patients to become involved and be heard
Xtalks Partner
Syneos Health
Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
To learn more about how we are shortening the distance from lab to life®, visit syneoshealth.com.
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