Plain language summaries (PLSs) aim to meet a need in the industry for clinical trial transparency in a way that is meaningful and understandable for patients and the general public. As the pharmaceutical industry steps up to meet this requirement, patient panels play a crucial role in ensuring that information shared by sponsors is readily understood and accessible to the public. In this webinar, featured speakers will discuss learnings from facilitating a number of PLS patient panels and the benefit of engaging patients in the process of PLS writing.
Vidhi Vashisht, Associate Director, Development Operations, Kinapse, a Syneos Health Company
Vidhi Vashisht leads plain language summary services at Kinapse and is the subject matter expert for plain language summaries and clinical trial disclosure (CTD). She has nine years of experience in clinical research and clinical trial disclosure. She is passionate about bringing clinical research information to the patients, their families and the public. She has experience across varied therapy areas and all phases of clinical research.Message Presenter
Madiha Khalid, Senior Medical Writer, Development Operations, Kinapse, a Syneos Health Company
Madiha Khalid is a lead writer for the plain language summary program at Kinapse with 5 years of experience in regulatory and clinical writing. She holds a PhD in Chemistry and has worked in the academic research and pharmaceutical industry for 14 years. In the PLS program at Kinapse, she leads process document development, writing, subject matter expert review, and patient panel facilitation.Message Presenter
T.J. Sharpe, Patient Advisor, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shared his journey through cancer in the Patient #1 Blog. In addition to writing, he is a keynote speaker and consultant to the biopharma and clinical research industries. He brings an educated patient voice as a true stakeholder in challenging healthcare’s status quo and making a difference in patients’ lives via his company, Starfish Harbor LLC. A prior career as an IT consultant in the healthcare field combined with his writing background helps give a translational understanding across the many nuanced layers and drivers in drug development.Message Presenter
Who Should Attend?
This webinar will be of interest to professionals who:
- Work in the clinical trial transparency or medical writing domain
- Are responsible for producing, reviewing and/or approving plain language summaries
- Are establishing processes for plain language summaries
What You Will Learn
- The importance of PLSs in providing clinical trial transparency
- The benefit of engaging patients in the process of PLS writing
- Key learnings from a number of PLS patient panels
Kinapse, a Syneos Health Company
Kinapse is the market leader in clinical trial disclosure and transparency and offers end-to-end services in this area including protocol registration, protocol maintenance, results postings on international and national registries, redaction and anonymization, plain language summaries, and XML support.