Global Advisory Board

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development.  He is the founder of Clinical Innovation Partners, working with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement.  Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures.

Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science.

Craig has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who’s Who in eHealth.

“Craig is a patient with pulmonary sarcoidosis, which has catalyzed his commitment to empowering patients with their data to advance research (the basis of his TED talk)”

Mr. Farinacci is the founder of ResearchPoint Global. He served as executive vice president of Quintiles Transnational Corporation, where he provided key leadership in acquisitions and integrations, helping Quintiles to become the CRO industry’s market leader. He also served as president and chief operating officer and held other senior executive positions at Pharmaco (currently PPD). During his tenure there, he played a pivotal role in moving Pharmaco to the second largest CRO in the industry. He also worked with Sterling Drug earlier on in his career. He received the PharmaVoice 100 most inspirational leaders award in the health and science industry in July 2009.

Prior to joining Yale in April 2016, Ms. Coleman held several positions at Quorum Review, an independent IRB and consulting company that serves institutional, independent, and international sites. From January 2016 until March 2016, Ms. Coleman served as Quorum’s vice president of regulatory and legal affairs of Kinetiq, a division of Quorum. Prior to 2016, she served as Quorum’s director of regulatory affairs and general counsel from 2011 until 2015, and its director of regulatory affairs from 2007 until 2010.

From 2011 to the present, Ms. Coleman has been a member of the Industry Pharmacogenomics Education Task Force, a subcommittee of the Industry Pharmacogenomics Working Group (I-PWG). Ms. Coleman is also the team lead for the Mobile Clinical Trials working group of the Clinical Trials Transformation Initiative, and actively participates on other committees related to research, health law, and education.

Ms. Coleman was an attorney at Bennett, Bigelow & Leedom where her practice focused on regulatory compliance, Medicare and Medicaid reimbursement, healthcare litigation, business/transactional, behavioral health, employment law and general patient care delivery matters. In addition to her law degree, Ms. Coleman holds the following certifications: CHC (Certified in Healthcare Compliance), CHRC (Certified in Healthcare Research Compliance), CCEP-I (Certified Compliance & Ethics Professional – International), and CIP (Certified IRB Professional).

“Collaboration is essential in order to solve the complex problems that face our healthcare and research industry. BlueCloud has created the perfect collaborative mechanism to help modernize the healthcare and research industry because it provides solutions regarding issues and shared interests that cannot be addressed by any single individual or organization. Stakeholders with a shared interest and vision must therefore work together to develop solutions to the problems that plague our industry.”

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/

Ms. Schoen is Senior Manager for Lumis International GmbH with more than 25 years of experience in leadership positions in international clinical research and drug development. She has profound knowledge of the clinical drug development processes and regulatory requirements from first-in-human to market access. Ms. Schoen develops strategies and concepts for biopharmaceutical and medical device companies covering clinical operations, clinical research, outsourcing, vendor management and oversight management. She as experience working in small, midsized and global companies within the CRO, consulting and biotech industry. Her expertise covers a broad spectrum of indications with a focus on oncology, CNS, HIV and medical devices and is regularly invited as a speaker regarding outsourcing, oversight management. Ms. Schoen was president of the Global Board of Trustees of ACRP from 2009 until 2011.

Ms. Schoen’s specialties include optimizing and/or creating efficient processes and structures, solution-oriented problem solving, clinical trials in numerous indications, project management, cross-cultural training, coaching and mentoring.

Mr. Guglielmetti founded his first company at 19 and is one of the pioneers of the Internet in Europe. In 1999, at the age of 34, he IPO’d the unicorn Integra, an internet company founded three years earlier, and sold it two years later (with more than 1,100 employees) to Genuity, a subsidiary of Verizon.  Integra was the leading company in Europe for managed and e-commerce web site hosting, with operations in the United Kingdom, Germany, France, Italy, Spain, The Netherlands, Norway, Sweden, Denmark and Iceland. Mr. Guglielmetti  co-founded I-base, one of the first companies in Europe specialized in marketing databases and sold to Publicis in 2006 and incorporated Zeepro – a company designing and making 3D printers – in San Francisco in fall 2013.

On May 9, 2015 – at the age of 50 – Mr. Guglielmetti suffered a hemorrhagic pontine stroke. He survived and is since affected on both sides of the body because of the central location of the stroke (extremely rare). He recovered his independence for basic routines and considers himself very fortunate because the death rate for the type of stroke he had is close to 70% and most survivors remain in a severely disabled state.

Mr. Guglielmetti always enjoyed communicating and exchanging ideas and participated in numerous conferences, such as TedX as an entrepreneur before the stroke.

He is living his rehabilitation as a new adventure.