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
Chief Operating Officer at National Organization for Rare Disorders
Pamela Gavin sets the strategic direction for National Organization for Rare Disorders (NORD) and implements programs and services that provide innovative solutions to address the needs of the rare disease community. She is responsible for bringing together all stakeholders within the rare disease space and works closely with NORD’s board of directors, donors, corporate council and member organizations, other partners, and staff. Prior to joining NORD in 2010, Pam spent 13 yrs executing complex, multi-stakeholder programs aimed at improving healthcare safety. As a consultant to the federal government, she implemented a new web-based portal for reporting pre-market and post-market safety data to Food and Drug Administration (FDA) and National Institutes of Health (NIH), for which she received Special Citations from the FDA Commissioner and Director of the Center for Food Safety and Applied Nutrition (CFSAN) for outstanding leadership and teamwork. As Senior Director in the Office of the President at the University of Pittsburgh Medical Center, Pam worked in an equity partner business unit, bringing new concepts and emerging technologies to market to improve healthcare delivery. She oversaw several strategic business initiatives, including a clinical trial enrollment and adverse event reporting system; a multi-biomarker assay for the early detection of ovarian cancer; a medical simulation training system; and a clinical decision support system for infection control and antibiotic management. Pam is the co-founder of SafeCare™ Systems, LLC, which developed one of the country’s first patient safety management systems and provides data driven solutions to healthcare providers, clinicians, administrators, and support staff. She served as director for RMF Strategies, a division of the Risk Management Foundation of the Harvard Medical Institutions, responsible for the commercialization of data driven risk management solutions. Pam earned an undergraduate degree in biology.