Global Advisory Board
Linda Coleman, JD
Director of the Human Research Protection Program Yale University
Prior to joining Yale in April 2016, she held several positions at Quorum Review, an independent IRB and consulting company that serves institutional, independent, and international sites. From January 2016 – March 2016, Ms. Coleman served as Quorum’s Vice President of Regulatory & Legal Affairs of Kinetiq, a division of Quorum. Prior to 2016, she served as Quorum’s Director of Regulatory Affairs & General Counsel from 2011 – 2015, and its Director of Regulatory Affairs from 2007 – 2010. From 2011 to the present, Ms. Coleman has been a Task Force 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, health care 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.”
Merge / IBM Watson Health
Clinical research professional with 20+ years of experience who believes in changing human behavior by using multiple sources of influence. I bring 6 different research personas and perspectives to product innovation – Certified IRB Professional, Monitor, Auditor, Certified Research Coordinator, Operations Director and Sponsor-investigator. Strengths include: Leadership, building productive teams, knowing “the business of clinical research”, change management, and seeing through noise and complexity in clinical research.
Chairman, Cardiff Ocean Group Chief Digital Officer Scripps Translational Science Institute
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. He has spent over 30 years developing, founding and growing mobile healthcare enterprises. In the early 1980’s, he developed the $3B critical care transportation sector. During the mid-80′s and into the 90′s he won billions of dollars of multi-year EMS contracts throughout the US. In the mid 1990’s 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 over $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’.
“BlueClouds provide the industry with private, secure communication networks and are 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.”
Vice President, Global Clinical Operations External Innovation EMD Serono, Inc
Mr. Paulo Moreira is a Clinical Development executive with 24 years of experience in clinical research. He has been with EMD Serono for the last 15 year in positions of increasing responsibility within Clinical Operations, most recently, as the Global Head of Clinical Strategic Partnering and presently as the Vice President of Clinical External Innovation. 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.
Jeff Kasher, PH.D.
President, Founder Patients Can't Wait
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 to be realized 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 O4r3eperations Committee and the Avoca Quality Consortium, sits on the DPharm Europe steering committee and faculty, is a member of Linking Leaders, and Chairman of the DrugDev Advisory Board. In 2013 CenterWatch named Dr. Kasher one of the “20 Innovators Changing the Face of the Clinical Trials Industry.” Dr. Kasher received a B.S. in Chemistry from Franklin & Marshall College, a Ph.D. in Pharmacology from the State University of New York, and a Post-Doctoral Fellowship in Physiology at Yale University School of Medicine.
“BlueClouds are easy to use/readily configurable systems which empower an individual, group, or organization to collect, clean and share verified data/information thru verified connections with an individual, group or organization around the world in real time.”
Greg Koski, MD., Ph.D.
Co-Founder, President, CEO Alliance for Clinical Research Excellence & Safety (ACRES)
Dr. Koski is an internationally-recognized leader in clinical research championing a systemic approach to transforming the infrastructure and ecosystem for conducting clinical research globally; and a “culture of conscience” in human research, focusing on prevention of harm and quality improvement beyond regulatory compliance. Dr. Koski has been influential in enhancing research processes internationally, including processes for accreditation of research sites and human research protections programs, certification of physician investigators, and the formation of an industry organization for contract research organizations.
“The BlueCloud network provides a shared universal interface to connect and support collaboration and inter-operability at a critical moment in the system transformation underway in healthcare and research — it is a catalyst for change, both in technology and culture — its potential impact cannot be overstated.”
Amir Kalali, MD
Vice President of Medical and Scientific Services and Global Therapeutic Team Leader CNS of Quintiles Inc. Founder CNS Summit
Dr. Amir Kalali serves as Vice President of Medical and Scientific Services and 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 Professor of Psychiatry at the University of California, San Diego. He served as a clinical research faculty of the University of California Irvine, where he also held several positions. His focus is in Accelerating development of new treatments through the principles of collaboration, innovation, and emerging technologies.
Robert E. Stewart Sr.
Retired Former Chief Technology Officer Co-Founder CyberMedica
Mr. Stewart is the former Chief Operating Officer & Board Member of ultrasound biometry innovator Sonavation Inc. where he led Research & Development, Hardware Engineering, Software Development, Quality Assurance, Global Program Management, IT and Manufacturing. Bob joined Sonavation in 2012 as their Chief Product Officer from his role as the Chief Technologist of the Global Security Solutions Group at EMC where he specialized in the design of fault-tolerant hardware and software solutions addressing the most challenging data intensive problems for military and intelligence customers. Prior to EMC Stewart was Chief Technology Officer for John Sculley’s Verified Person a deep background screening concern located in New York City where Mr. Stewart led the design, development and operational deployment of several identity, search, data mining and entity linking products. Mr. Stewart was the Chief Technology Officer and Co-Founder of CyberMedica where he was the original Chief Technology Officer and Vice President before he purchased the company’s entire intellectual property portfolio and remaining assets in 2002. Bob subsequently worked with the WHO to leverage the IP of CyberMedica to improve responsible research around the world and participated as standards provider of peer-reviewed infrastructure platforms for technology to deliver secure open-systems for collaborative scientific research for biotechnology and pharmaceutical discoveries. Mr. Stewart has served as an investment adviser with a number of venture capital firms in North America and Europe. He has also been involved, both as an investment adviser and a transition manager, in substantial M&A activity including a $220M acquisition from BellSouth and a $290M acquisition from Compaq (now HP). He earned global recognition as the Chief Technology Officer for CMGI’s portfolio companies including Elon Musk’s first company Zip2.com, PlanetDirect.com and MyWay.com which was ranked a “Top-25 Portal” during his tenure.
“The intrinsic value to professionals and businesses alike is what makes the BlueCloud an easy choice for the industry to adopt immediately. BlueClouds are the penultimate nexus of both intelligent market foresight and modern data network effects. BlueCloud presents as a foundational fabric which is continuously strengthened by the power of its core as a system designed to enforce emerging and recognized as necessary standards and continuously self-reinforce its quality, time, and money saving value with each and every trusted interaction and connection.”
Manager, study start up & patient recruitment Beyer Pharmaceuticals
Mr. Bilkic has worked as an Associate Project Manager at AstraZeneca and a Scientist at GlaxoSmithKline Inc. Dex has more than 20 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. He is an accomplished leader in the pharmaceutical industry with a progressive and extensive experience in contractual negotiations, vendor selection/management and budget planning. His capabilities in providing strategic direction, managing diverse functional groups and eliciting peak team performance and leadership. Dex currently serves under TransCelerate Biopharma Inc., working to enhance clinical research efficiency.
“In clinical research it is paramount that we stay connected and organized. BlueCloud enhances our ability to share information and communicate as professionals as we strive to develop new medicines. Our industry is in great need of improvement to efficiencies and the BlueCloud Networking system is an effective way of getting us there. This greatly benefits all the stakeholders and is of special importance for the health and welfare of our patients.”