Add to Calendar 5/2/2019 8:00:00 AM 5/2/2019 10:00:00 AM Power of the Patient: How Patient Foundations Connect Academia, Industry & Regulators to Accelerate Clinical Development
Never before has the power of the patients been more evident in clinical research and development as evidenced by successful collaborations and regulatory trends. The process of therapeutic development has historically prioritized scientific concerns critical to the pathophysiology of disease indications (including pathways and mechanisms) in an effort to advance programs as efficiently as possible. Moreover, the organizations most involved in drug discovery and development in the past have largely been academia, biopharma and regulators. In the past decade, there is greater understanding that accelerating these efforts into the clinic can hit roadblocks due to reasons beyond scientific rationale – including an under appreciation for the key role that patient engagement can play towards successfully bringing safe and effective therapies reflective of the needs of patients who would most benefit. Incorporating the patient voice along with academia, industry and regulatory bodies can only strengthen this foundation of organizations already determined to address clinical unmet needs. Join our speakers and MassBio NonProfit Committee for an interactive and informative discussion on this important topic.
MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139
Patient Affairs Staff (PAS) Office of the Commissioner, FDA
Susan Chittooran is a Patient Engagement Project Manager on the Patient Affairs Staff (PAS) within the Office of the Commissioner at the FDA. Susan serves as the central point of contact in Patient Affairs for patients, caregivers, and patient advocates who wish to engage with the Agency, resolves patient-related concerns and inquiries, and serves as the liaison between patients and subject matter experts within FDA’s medical product centers. In her role, Susan also assists offices in FDA’s three medical product centers and the Oncology Center of Excellence in identifying and coordinating patient stakeholder participation in FDA meetings and workshops. Susan also manages the communications and social media for Patient Affairs. Prior to joining Patient Affairs, Susan spent three years at FDA’s Office of Health & Constituent Affairs where she was responsible for engaging with stakeholders including healthcare professionals, patients and patient advocacy groups, and consumers to incorporate their perspectives in regulatory processes and policies, coordinated FDA’s stakeholder communication calls, and managed portfolios on biosimilars and opioids. She was also responsible for managing and planning the Center for Devices & Radiological Health (CDRH)’s inaugural Patient Engagement Advisory Committee (PEAC) meeting - the only FDA advisory committee that is comprised solely of patients and caregivers. Prior to joining FDA, Susan worked in the New York office of the Women’s Bureau, U.S. Department of Labor for six years where she planned meetings, listening sessions, and events related to agency priority areas with diverse stakeholder groups including other federal agencies, non-profit organizations, foundations, and businesses. She also served as a Special Assistant to former Women’s Bureau (WB) Director in Washington, DC, where she was responsible for supporting the Director and WB leadership in the planning and implementation of the White House Summit on Working Families.