Co-organized by: The US Food and Drug Administration (FDA), the Yale Center for Clinical Investigation (YCCI), Hispanics Increasing Diversity to Enhance Advocacy in Science (HIDEAS)-Puerto Rico, Universidad de Puerto Rico- Medical Sciences Campus, Universidad Central del Caribe, Ponce Health Sciences University, the Puerto Rico Science, Technology and Research Trust (PRST), and the Puerto Rico Consortium for Clinical Investigation (PRCCI).

• The 2018 Clinical Research Summit is a one of a kind and exciting full day event that will bring together Puerto Rico leaders from all the groups involved in clinical research: patients, FDA, investigators, sponsors, clinical units/sites and Clinical Research Organizations. An opportunity to connect and network with all the key players and special guests.
• Explore the new advances in clinical research locally and internationally, learn from opinion leaders about diversity in clinical trials, why it is important and how to achieve it, dive into emergency preparedness and response under the light of Hurricane Maria, and discuss best practices on quality and compliance with the FDA.
• Visit the Exhibitors Hall to find out about sponsors, research sites, patient/community groups and others.

See our Preliminary Program for details.

Program:

7:00AM – 5:00PM

Registration Open & Exhibit Hours

7:00AM Registration Opens 

9:00AM Welcome Remarks & Introduction 

9:15AM Keynote Speakers 

10:30-10:45AM Coffee Break /Exhibitors Hall

10:45AM Patient-centric Panel Discussion

12:00PM-1:00PM Lunch 

1:00- 5:00PM  Afternoon breakout sessions

3:00-3:15PM Coffee Break

Session 1 | Quality and Compliance

Session 2 | Diversity in clinical trials

Session 3 | Emergency preparedness/lessons learned from Maria

Confirmed Speakers include:

FDA:

• Annette Melendez, Consumer Safety Officer, US Food and Drug Administration, Puerto Rico Office: “Inspectional Process”
• Dr. Cynthia Kleppinger – Medical Officer, Division of Clinical Compliance Evaluation, Center for Drug Evaluation and Research, US Food and Drug Administration: “Understanding Principal Investigator’s Responsibilities and Oversight of Clinical Investigations” and “Compliance in Clinical Research ‘Doing it Right the First Time”
• Jovonni Spinner, MPH, CHES, Senior Public Health Advisor, US Food and Drug Administration, Office of Minority Health: “Recruitment Challenges – Precision, Personalized and Diverse: New Tools and Strategies”

Guest Speakers:

• Dr. Lester Martinez-Lopez, Major General, U.S. Army (retired), Chairman of PRCCI Board and Board Member of National Alliance for Hispanic Health
• Dr. Gabriela Dávila Loaiza, Director of Clinical Site Management, North Cluster of LATAM, Global Product Development, Pfizer
• Dr. Oscar Soto-Raíces, Medical Director Mindful Clinical Research, former President, Puerto Rico Rheumatology Association, founder and first President of Puerto Rico Foundation for Rheumatic Diseases - Fundación FER
• Tesheia Johnson, MBA, MHS, Associate Director for Clinical Research Yale School of Medicine and Chief Operations Officer for Yale Center for Clinical Investigation
• Amarilys Silva, Pharm.D., Director Medical Affairs, Eli Lilly
• Helen Kellar-Wood, Ph.D. –  Lead Immunoscience Diversity & Patient Engagement, Global Clinical Operations, Bristol-Myers Squibb
• James A. Borowiec, Ph.D., New York University, School of Medicine
• Stephanie Berger, MS, Puerto Rico Consortium for Clinical Investigation (PRCCI) Director of Quality and Training

*Full agenda/ program will be issued upon confirmation of all speakers