Writing Plain Language Summaries for Clinical Trials: What We Have Learned So Far

Debra Guerreiro, Associate Director, Plain Language Summary Program Lead, Janssen Data Transparency

Debra Guerreiro is the lead for the plain language summary initiative at Janssen R&D. She is responsible for the initiation, production, approval, translation and dissemination of aggregate clinical study results to Janssen study participants in compliance with regulatory authorities and other stakeholders. Debra has 15 years of diverse pharmaceutical experience in clinical research and project and resource management, holding positions at Merck & Co, Johnson & Johnson and Bristol Myers Squibb.  She enjoyed 10 years of cross-industry experience in business consulting and clinical trial transparency at Kinapse, Inc. She founded WynBridge, LLC focused exclusively on providing clinical trial disclosure operational and advisory services to align sponsors with their legal and ethical responsibilities. She also served as project manager for TransCelerate Biopharma, Inc, responsible for delivering positions papers on the anonymization of clinical documents and de-identification of trial datasets and the return of results to study participants.

Dianne Beland, Senior Manager, Clinical Trial Data Sharing/Disclosure, Celgene Corporation

Dianne Beland has been in the pharmaceutical industry for over 20 years. She is a strong research professional skilled in writing plain language summaries of results for Phase I-IV clinical trials. She has extensive experience in clinical research, vendor management, oncology, hematology and investigator-initiated trials. 

Jessica Valencia, PhD, Operational Excellence Expert, Novartis Pharmaceuticals, Patient Engagement & Advocacy

Jessica Valencia is an Operational Excellence Expert with over 15 years of pharmaceutical industry experience at Novartis.  In her current role, she has developed the process for the creation of plain language trial summaries and other patient communications for clinical trials. She is also closely involved in writing these communications for early phase clinical trials.  Jessica’s past experience includes preclinical drug discovery, clinical trial management, monitoring, medical writing, and process improvement.  She has supported numerous clinical pharmacology and translational medicine studies and submissions across various therapeutic areas.  In addition, Jessica has been responsible for process improvement, training, template creation and management related to protocol and clinical study report writing.  She also gained extensive vendor management experience when she built and managed the external medical writing network for Translational Medicine at Novartis.

Vidhi Vashisht, Associate Director, Clinical Trial Disclosure, 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 over eight 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.

 She holds a Master of Science (Pharmacy) degree with a specialty in medicinal chemistry.