Regulatory, Equity, Diversity & Inclusion Leaders

Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology (Infectious Diseases), and Vaccinology. Currently, he is an independent consultant for Scientific, Clinical and Regulatory affairs. Past positions in the last 30+ years include: Senior Vice President for Scientific, Clinical Affairs, leading the Strategy of the Global Center of Excellence for Decentralized Clinical Trials at PRA Health Sciences and ICON plc; FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Real World Evidence and Decentralized Clinical Trials enabled by Digital Health Technologies and electronic Clinical Outcome Assessments (eCOAs); CEO and Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs at National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH); Senior Clinical Scientist, Schering Plough Corp. – Merck & Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research and Health Sciences; and a B.S. in Biology. He also has 5 years of postdoctoral specialty experience in Clinical Research (phases 1 & 2 trials) linked to in AIDS Malignancies, Immuno-Oncology and Viral Immunology (Infectious Diseases) done at the U.S. NIA and NCI, NIH.

Dr. Rodriguez-Chavez is a Founding Board Member of the Digital Medical Society (DiME). He is also a co-chair of the DiME’s Research Committee, driving digital medicine globally. He is a regulatory Advisor and Vice-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering industry standards on DCTs and DHTs. He is a former Leadership Council Board Member of the Decentralized Trials & Research Alliance (DTRA). He is a Board Member of the Hypertrophic Cardiomyopathy Association (HCMA) and a Health Equity Board Council Member for equity, diversity and inclusion in rare diseases at the Global Genes. He is a global content editor for regulatory science and an Editorial Board Member of the DIA Global Forum Magazine. He is also an active member of sixteen professional associations, including the Infectious Disease Society of America, American Federation for Medical Research, American Association of Immunologists, American Society for Virology, American Society of Microbiology, Society of Quality Assurance, Association of Clinical Research Professionals, New York Academy of Sciences, International AIDS Society, International Association for Dental Research, American Association for Dental Research, and Regulatory Affairs Professional Society.

LinkedIn: https://www.linkedin.com/in/isaacrc/

Mr. Toro is an accomplished consultant and entrepreneur with 28 years of experience. As president and CEO of his own Software Engineering firm, Toro Technologies, Inc., he developed a successful business which delivered critical path systems for MasterCard, AT&T Universal Card, Global Payment Systems and others in the payment industry. Mr. Toro successfully sold his company to PaylinX Corporation (later acquired by publicly traded Cybersource). After his exit, Mr. Toro has worked for over 10 years in structuring capital for growth for his own ventures and others across the Americas. Mr. Toro has an extensive background in Information Technology with emphasis in electronic transaction processing and healthcare information systems.

LinkedIn: https://www.linkedin.com/in/jorgetoroayala/

Expertise in the following areas:

A. Provide General Counsel/ Chief Compliance Officer services to life sciences companies, CROs, SMOs, and advertising companies with risk oversight by complying with a variety of legal, regulatory, and compliance issues including the Code of Federal Regulations, the False Claims Act, Anti-Kickback Law, HIPAA, Stark Laws, Foreign Corrupt Practices Act, etc. by adhering to the requirements suggested by the OIG, DOJ, US Attorney’s Offices, the FDA, and other governmental and non-governmental organizations.

B. Clinical trial negotiation services for, and against, investigators, CROs, and sponsors.
a. Formulation of letters of indemnification,
b. Negotiation of payment schedules,
c. Budget determination,
d. formulation and negotiation of master services agreements.

C. Assuring Quality, Regulatory and Legal Services
a. Review, presentation, and response to 483s, Warning Letters, and other titled and untitled FDA letters,
b. Systematic implementation and training of a comprehensive SOP program,
c. Review of promotional materials and actions of sales and scientific staff to ensure legal, regulatory, and medical compliance,
d. Conducting product recalls.

D. Apply for state and federal licensure with boards of pharmacy, attorney general’s offices, etc. for manufacturing and distribution facilities.

E. Building compliance systems within companies.

LinkedIn: https://www.linkedin.com/in/darshankulkarni/

Known as “Doc” Griggs, he is responsible for developing, implementing, and monitoring programs and initiatives that improve the overall health and well-being of the communities we serve. With over 13 years of experience in health education, promotion, and equity – nationally and internationally, he is passionate about creating and executing strategies that address the social determinants of health, increase access to care, and promote health equity for underserved populations.

He also serves as an Adjunct Assistant Professor, a National Advisory Board Member, a Medical Contributor, and a Health Equity Ambassador, among other positions, that allow him to share his knowledge, skills, and expertise in various domains of public health, wellness, and medicine.  He is a certified trainer, facilitator, and instructor in several areas, such as workplace wellness, nature prescription, cycling, and life reimagining. The founder and executive director of Doc Griggs Foundation, a non-profit organization that aims to empower communities to “Get Checked, Get Fit, Get Moving!” through education, advocacy, and outreach.

LinkedIn:  https://www.linkedin.com/in/eric-griggs-md-147a7557/

Tina has had leadership roles with F500 companies as well as key roles within startups. Role expertise spans executive leadership, strategy, product development, operationalization, program management with P&L experience up to 10M USD. She has managed teams up to 50, both in the US and internationally, and understands operational scaling.

Her goal is to drive HealthcarePoint business units to optimal profitability via the intersection of doing well by doing good. Innovation, optimization, digital, health and wellness are her watch words.

A registered pharmacist with a doctorate in pharmacy, Ryan is always searching for better ways to improve healthcare. He has experience in both clinical research and clinical trial review and is responsible for scientific review and counsel on BlueCloud initiatives. He currently works as a pharmacist in a large national pharmacy chain and is always looking to bring new and innovative processes to standardize and streamline the healthcare process.  Ryan lost family to stroke and cancer.