Global Advisory Board

Tim Storey is an acclaimed speaker, author, and life coach, well known for inspiring and motivating people of all walks of life, from entertainment executives, celebrities and athletes to adults and children in the most deprived neighborhoods in the country. Tim has traveled to seventy-five countries and spoken to millions of people. He often meets privately to counsel high-profile leaders in various industries.

Tim Storey helps people create the future they desire. He has inspired people from all walks of life, from entertainment legends to professional athletes… from executives to deprived children in third world countries. Using seasoned foundational principles and humor to get honest with people so they can overcome the obstacles that are holding them back.

Along with a rigorous speaking calendar and private life coaching sessions, since the early 90s, he has held regular spiritually motivating intimate sessions in Hollywood and across the world called the The Study, bringing together industry leaders. In 2015, Tim was interviewed for a full hour segment of Oprah’s OWN Super Soul Sunday, which was one of the highest rated shows in it’s history. Tim has been honored to be a guest keynote speaker at many conferences throughout his life.

He leads The Congregation Church in Yorba Linda, CA, which meets weekly and provides spiritual insight and direction for people of diverse ages, backgrounds, and needs. He hosted an exclusive Saturday morning series on SiriusXM Radio. Tim is featured on nationally syndicated Keep the Faith Radio each weekend, providing short inspirational moments and will be featured on Steve Harvey Radio throughout the year. Tim has authored multiple books, with the most recent, Comeback & Beyond, being a top seller on Amazon.

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)”

Dr. Kasher is passionate about improving outcomes, bringing patient and research sites into the development process and dramatically decreasing the time to market for promising drug candidates. He is known as a pharmaceutical development change catalyst with 28 years of leadership experience at Eli Lilly, where most recently he managed a portfolio of innovative clinical development approaches to achieve 50% cost and time reductions over a five-year period beginning in 2017.

Dr. Kasher continues to advocate for innovation within clinical trials, as president of Patients Can’t Wait. Dr. Kasher was a founding member of TransCelerate Biopharma Operations Committee and the Avoca Quality Consortium. He sits on the DPharm Europe steering committee and faculty, is a member of Linking Leaders and is chairman of the DrugDev Advisory Board. In 2013, CenterWatch named Dr. Kasher one of “20 Innovators Changing the Face of the Clinical Trials Industry.” Dr. Kasher received a bachelor’s. in chemistry from Franklin & Marshall College, a doctorate in pharmacology from the State University of New York, and a post-doctoral fellowship in physiology at Yale University School of Medicine.

He is a heart and cardiovascular patient survivor.

“BlueClouds are easy to use/readily configurable systems which empower an individual, group, or organization to collect, clean and share verified data/information through verified connections with an individual, group or organization around the world in real time.”

Dr. Kalali is the Founder of CNS Summit. He previously served as vice president of Medical and Scientific Services and as Global Therapeutic Team Leader CNS of Quintiles Inc. Dr. Kalali is globally responsible for the medical and scientific aspects of development programs in psychiatry and neurology. He is also a professor of psychiatry at the University of California, San Diego. He also served as a clinical research faculty of the University of California, Irvine, where he held several positions. His focus is in accelerating development of new treatments through the principles of collaboration, innovation and emerging technologies.

Mr. Moreira has more 25 years of experience in clinical research and industry consulting. He has a long tenure of 15 years at EMD Serono over Clinical Operations, as Global Head of Clinical Strategic Partnering, as VP of Clinical External Innovation and is currently with Agenus Biotechnology. Mr. Moreira is also a Visiting Scholar at Boston College where he teaches at the Pathways in Clinical Research Program. He is very active in several industry-wide organizations and also serves on the Steering Committee of the Clinical Trial Transformation Initiative.

Mr. Moreira is a Timpanio-auditorial and hearing patient.

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/

For the past 30 years, Mimi is helping Patients and Caregivers Access Medicines through Policy-Shaping & Research By Partnering with Patients, WHO, WEF, HTAs, Pharma, Civil Society, Families and Survivors.

Mimi is the Chairman, Board of Trustees at Partners for Patients NGO (Serving 193 United Nation Countries For Non-Profit). She founded the organization in 1990.  Her first partnership over 30 years ago was with The International Lions Club and New York City Schools serving Glaucoma  Patients. Over the years, she also worked very closely with The African Enterprise to help educate HIV orphans including supporting a food, medical and orphanage program.  Recently, her research included partnering with Sub-Sahara Africa medicinal military leaders to spur policy-shaping to support healthcare infrastructure improvements in Uganda, specifically to find the cure for Burkitts Lymphoma and Blood Cancer.

In addition to her volunteer work, she is also employed at the International Myeloma Foundation.

Her role is Sr. Vice President, Global Policy, Access, Research and Advocacy in 140 countries and through relationships and partnerships, she has successfully created multilateral and bilateral agreements and collaborations.  Mimi has worked in Pharma for +25 years working at Merck, Novartis and Roche.

She is passionate about advocating for patients and caregivers by improving healthcare policies, advancing medical knowledge, driving innovative digital solutions in the quest to increase medical access to treatments for patients, especially in the most marginalized regions of the world.

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. Bilkic has more than 25 years of experience in the pharmaceutical industry where he has held various positions from working in research on the lab bench to managing clinical trials. His work history includes major pharma companies, CROs, as well as sites which has provided him a broad view and understanding of challenges and successes in clinical research. Dex holds an Honors BSc and an MBA degree. He is an accomplished leader in the pharmaceutical industry with a progressive and extensive experience including trial feasibility, start-up and recruitment, as well as contractual negotiations and vendor selection/management. Dex has also served under TransCelerate Biopharma Inc., working to enhance clinical research efficiency.

Mr. Jones advises companies, healthcare providers, governments and foundations on digital heath, the Internet of Medical Things and technology-enabled services. He is globally recognized for his expertise in wireless technologies, mobility and network effect for fitness, health and healthcare products, apps, services and therapies. He sits on multiple boards and has spent more than 30 years developing, founding and growing mobile healthcare enterprises. In the early 1980s, he developed the $3B critical care transportation sector. During the mid-80s and into the 90s, he won billions of dollars of multi-year EMS contracts throughout the US. In the mid 1990s, he developed AMR’s healthcare call center strategy, American Medical Pathways.

Jones is a founding advisor of Golden Hour Data Systems, an information technology and revenue cycle management company, managing more than $2B in aero-medical revenue. In 1998, the Director of the US National Highway and Transportation Safety Administration asked Jones to co-author the Federal Government’s EMS Implementation Guide for the Future. In 2000, the Journal of Emergency Medical Services named Jones ‘One of the 20 Most Influential People in EMS’.

“BlueCloud provides the industry with private, secure communication networks and is key to driving network effect in health care and life science by reducing friction and producing economic efficiencies by using data rich directories and facilitating information sharing and coordination of workflows.”

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.