Global Advisory Board

Philippe Guglielmetti

Global Entrepreneur Stroke Survivor

Mr. Guglielmetti founded first company at 19 and one of the pioneers of the Internet in Europe.  In 1999, at the age of 34,  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. Co-founded I-base, one of the first companies in Europe specialized in marketing databases and sold to Publicis in 2006.  Incorporated Zeepro – a company designing and making 3D printers – in San Francisco in fall 2013.

Hemorrhagic cerebellum stroke survivor.

On May 9, 2015 -at the age of 50- 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). 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.

Always enjoyed communicating and exchanging and has participated in numerous conferences (TedX …) as an entrepreneur before the stroke.

He is living his rehabilitation as a new adventure.

Sean Stanton

President and CEO - LifeCore Solutions

Mr. Stanton has dedicated over 25 years of his career to creating successful, high-performing research sites. To date, Sean has led the start-up of 25 clinical trial sites, six inpatient hospitals, and 19 outpatient clinics. More than 5,000 clinical trials have been conducted at these sites, leading to more than 50 drug approvals. Prozac was the first approved drug Sean worked on, followed by many other well-known drugs used in a variety of therapeutic areas (e.g., General Medicine, Vaccine, Women’s Health, Diabetes; Pain; Mental Health; Heart Disease; Oncology; Neurodegenerative Diseases; Sleep Disorders; etc.). In these trials, he directed recruitment for the screening of 2,000 to 6,000 patients annually. A pioneer in patient recruitment, he was the first to pre-screen for screens and was on the forefront of direct-to consumer advertising, circa 1997.

He has brought innovative thinking to clinical research in all aspects of site practices, from purchasing and resourcing, to the use of benchmarking and metrics in business planning to guide strategic clinical trial practice growth. he is frequently sought as an industry expert to speak on topics including building successful clinical research sites; patient recruiting, particularly difficult to recruit populations and decreasing screen fail rates; protocol design; site selection; patient reported outcomes and other areas. He has advised hospitals and institutions on research site growth strategy and mergers and acquisitions at the site level.

Greg Ambra

CEO - DZS Clinical Services

Mr. Ambra has over 20 years of experience in the clinical research industry, having held strategic leadership positions in various drug/device development companies including Baxter Healthcare, Campbell Alliance, and ConvaTec (formerly part of BMS).

Along with multiple successful drug and device market experience in developing and leading high-quality, technology-focused, clinical service organizations.

In 2018, after 5 years of significant growth, expanding services, and developing a reputation of providing quality services with an emphasis on long-term partnerships, DZS Clinical Services was acquired by WDB-MD, a global contract research organization based in Japan with subsidiaries worldwide.

Providing high-quality research services and bringing new therapies to market remains the focus of DZS, WDB, and our global subsidiaries and partners. The large amount of innovative research ideas that remain untapped requires creative organizations and flexible business models.

Linda Coleman, JD

Director of the Human Research Protection Program - Yale University

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 – 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.”

Don Jones

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.”

Paulo Moreira

Global Head Clinical Operations - Agenus Biotechnology

Mr. Moreira has over 25 years of experience in clinical research and industry consulting.  He has a long tenure of 15 years at EMD Serono over Clinical Operations, Global Head of Clinical Strategic Partnering, VP Clinical External Innovation and 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.

Timpanio-auditorial and hearing patient.

Jeff Kasher, PhD

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.

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 thru verified connections with an individual, group or organization around the world in real time.”

Amir Kalali, MD

Founder, Chief Curator & Chairman - CNS Summit

Dr. Kalali is the Founder of CNS Summit.  Previously served 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.

Heike Schoen

Managing Director and Co-Founder - Lumis International GmbH

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. Profound knowledge of the clinical drug development processes and regulatory requirements from first in human to market access. Developing strategies and concepts for biopharmaceutical and medical device companies covering clinical operations,clinical research, outsourcing, vendor management and oversight management. Experienced to work in small, midsized and global companies within the CRO, Consulting and Biotech-Industry.
Broad spectrum of indications with a focus on Oncology, CNS, HIV and Medical Devices.  Regular invited speaker for topics in outsourcing, oversight management.  Leading a Global Board as President of the Global Board of Trustees of ACRP (2009-2011).

Specialties: Optimizing and/or creating efficient processes and structures, Solution oriented problem solving, extensive Clinical Trial experience in different indications, Project Management, Cross cultural training, Coaching and Mentoring

John Farinacci

CEO ResearchPoint Global - WuXi App Tec

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 various 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 in the health and science industry in July 2009.

Jamie Skipper, RN, PhD,

Healthcare Policy Advisor and Strategist CEO - Elevation Health Consulting

Dr. Skipper is a nationally respected expert on setting policies and standards for health data infrastructures.  She is currently the CEO of Elevation Health Consulting.  Here, Dr. Skipper advises public and private stakeholders across the healthcare arena on how to strategically improve health outcomes with a person-centric motto through leveraging, improving or building health technology.  Dr. Skipper is also the Chief Scientist at EMI Advisors, providing expertise to federal agencies and partners on building data infrastructure to support research.

“Site recruitment and patient recruitment for testing is one of the biggest cost and timing drivers for new drug and device development.  With the Bluecloud platform now enabling efficient and economical sponsor-to-site and sponsor-to-patient connections, patients can finally look forward to quicker and more affordable treatment options in the near future.” 

 

TJ Sharpe

Cancer Blogger, Survivor & Advocate

Mr. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog on http://www.philly.com/patient1/, on www.SkinCancer.net, www.oncology-central.com, and on www.NovartisOncology.com.  He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born.  Since then, he has undergone six surgeries and four immunotherapy treatments over two different clinical trials.  In addition to writing, he is a keynote speaker and consultant to the biopharma and clinical research industries, bringing an educated patient voice as a true stakeholder in challenging healthcare’s status and making a difference in patients’ lives via his company, Starfish Harbor LLC.

Greg Koski, MD, PhD

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.”

Dex Bilkic

Manager, Study Start Up & Patient Recruitment - Bayer 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.”