Barriers and Solutions in Clinical Operations for Accelerating Precision Medicine in Rare Diseases
Moderator: Harsha K. Rajasimha, MS, PhD, Founder and Chief Executive Officer, Jeeva Informatics Solutions
Panelists: PJ Brooks, MA, PhD, Program Director, Office of Rare Diseases Research, NCATS, NIH; CJ Malanga, MD, PhD, Global Clinical Lead, Rare Diseases, Takeda; Sridhar Sivasubbu, PhD, Scientist and Head Of Business Development, CSIR Institute of Genomics & Integrative Biology; Chirag Trivedi, PhD, Clinical Study Unit Cluster Head – India-South East Asia, Sanofi
Precision medicines target patients with specific molecular markers and add additional complexities to clinical operations. Clinical Operations is complex and involves multiple stakeholders at a critical juncture during clinical development of investigational new therapies. Patient identification, eligibility screening, patient enrollment, lab tests, and ongoing evidence generation. Cell/gene therapies are novel modalities for delivering precision medicine to the right patients at the right dose at the right time. Clinical Operations for these novel modalities challenge every step of the traditional brick and mortar clinical trial operations. The panel will explore these challenges and current solutions to address them.