Science Events in Boston
Stay up-to-date with all of the life science events taking place in the Greater Boston area with the Science in Boston events calendar! From academia to industry and biotech to pharma, our events calendar is your complete source for life science conferences, symposiums, networking, and workshops in Boston. We even cover science pub nights and science fundraisers!
If you’re interested in promoting your life science event on the Science in Boston events calendar, please use our event submission form.
- This event has passed.
Cambridge Biomedical December 2nd – Lunch Event, Enrollment and Retention in IO studies: Patient and Site Centricity
December 2, 2019 - 8:00 am - 5:00 pm
Overview
Enrollment and Retention in IO studies: Patient and Site Centricity
Abstract
Enrollment and patient retention remain the most significant barriers to executing successful randomized clinical trials for sponsor companies today, impacting timeline, quality, and budget. More than 80% of clinical studies fail to complete enrollment on time, and approximately half of the sites selected for clinical trials enroll between zero and one patient.
Overcoming the recruitment challenge requires a sponsor’s delicate coordination of multiple stakeholders, all of whom have different goals and motivations: CROs, vendors, regulators, and the two most important partners, investigators and the patients they are treating.
Rapid developments in the immuno-oncology (IO) field in recent years offer both a challenge and an opportunity for drug developers to design and execute trials with patients and sites in mind (“patient and site centricity”). The FDA has also evolved in its own patient engagement approach with programs like the Patient-Focused Drug Development (PFDD) initiative.
Kelly Brady, Vice President, Clinical Operations Seres Therapeutics
Kelly holds a BS degree in Neuroscience from Lafayette College, and an MS in Biotechnology from Johns Hopkins where she began her career as a research associate in the Orthopaedic Oncology department. Kelly has held positions of increasing responsibility in Clinical Operations and Clinical Program management over the past 12 years.
As a clinical associate at Osiris Therapeutics, Kelly managed global pediatric and hematology projects (GVHD, COPD), and was a member of the operational and submission team who worked on Prochymal, an allogeneic stem cell therapy which received approval for treatment of GVHD in children in Canada in 2012. Following Osiris, Kelly moved to Millenium/Takeda where she was global phase 3 clinical leader for the Adcetris trials in Hodgkins Lymphoma, in conjunction with Seattle Genetics, run in 29 countries. Kelly then held positions in Operations and Program management at Acetylon, and was a member of the team involved in the acquisition of the company by Celgene. Prior to joining Seres, Kelly was Senior Director, Global Clinical Program Lead at Akebia, overseeing the pivotal program including 4 Phase 3 cardiovascular outcomes studies in 27 countries, and initiated a Clinical Trial Educator program in North America.
Kelly continues to be active with the Leukemia and Lymphoma Society, and lives in Cambridge with her husband.
