Clinical Trials of the Future

Clinical Trials of the Future (CTF)

The Clinical Trials of the Future initiative brings together experts in clinical trials, technology and other relevant disciplines to shape the future of how clinical trials are conducted. The aim is to leverage upcoming trends to enable more efficient and successful drug development resulting in the acceleration of new treatments reaching patients.

Currently the CTF initiative has five Domains:
    (1) Connected Clinical Trials
    (2) Ethics of Innovations
    (3) Clinical Development of the Future
    (4) Clinical Trial Site of the Future
    (5) Clinical Assessments of the Future

An update of the activities of these domains will be presented at CNS Summit 2018.

The current Leadership Council for the CTF initiative includes:

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    Sohini Chowdhury, Michael J. Fox Foundation

    Sohini Chowdhury
    Deputy Chief Executive Officer
    Research Partnerships
    Michael J. Fox Foundation

    Sohini joined The Michael J. Fox Foundation in 2005. As Deputy CEO, Sohini oversees the Research Partnerships team and works closely with the Foundation's executive leadership and Board of Directors in building the organization’s capacity as an unprecedented stakeholder in drug development — a nimble, resourceful, patient-focused problem-solver whose efforts are demonstrably accelerating progress toward treatment breakthroughs and a cure. Sohini was elevated to the role of Deputy CEO in 2017.

    In her previous capacity as SVP, Research Partnerships at the Foundation, Sohini established and led the formal industry strategy, building ongoing relationships with pharmaceutical firms and biotechs as research partners and as sponsors of the Foundation’s scientific and educational programs. She has led development of programs critical to increasing patient engagement in Parkinson’s research including the Fox Trial Finder smart-match tool and Fox Insight. Sohini also is responsible for administrative and operational oversight of the MJFF-sponsored landmark clinical study PPMI, or the Parkinson’s Progression Markers Initiative, launched by MJFF in 2010 to identify and validate Parkinson’s biomarkers.

    Prior to joining MJFF, Sohini worked at the World Economic Forum for five years. As the Senior Community Manager of the Forum's Technology Pioneers program, she was responsible for annually selecting and integrating innovative biotech, energy and IT technology companies into Forum activities. Sohini also worked directly for the Forum's CEO, acting as his liaison with key Forum stakeholders and overseeing several in-house projects.

    Sohini graduated with an MA from Georgetown University, and holds a BA in International Studies from Vassar College.

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    Judith Dunn, Roche

    Judith Dunn
    Vice President
    Global Head Clinical Development
    Head of Roche Innovation Center NY

    Judy joined Roche in 2010 as part of PD Neuroscience. She founded the Development Integration Team which facilitates early scientific collaboration between the REDs and PD. Judy has also held positions in the research and commercial divisions of Pfizer, led Psychiatry Clinical Development at Sepracor, and served as Vice President of Clinical Research at Flexion, a biotech company.

    Judy has a keen interest in methodology and holds leadership positions in several external societies focused on improving the drug development paradigm. Judy attended Wesleyan University and the University of Rochester, obtaining undergraduate and graduate degrees in Neurobiology. She was recipient of a Research Fellowship in Neuropharmacology from the Center for Brain Research at Strong Memorial Hospital as well as a Postdoctoral Fellowship in Clinical Research from Pfizer.

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    Adam Hanina, AiCure

    Adam Hanina

    Adam Hanina is co-founder and CEO of AiCure, a leader in advanced medication adherence solutions powered by artificial intelligence. He is a passionate advocate for the use of healthcare software as a clinical research and population health tool.

    Prior to AiCure, Mr. Hanina was responsible for further developing Cerner Corporation’s European strategy and was a Visiting Fellow of eHealth at Imperial College in London, UK. Mr. Hanina has spoken extensively on the topic of healthcare innovation and has held numerous advisory board positions including for the Indian High Commission’s Healthcare, Pharmaceutical, & Biotech Committee, and for Deloitte Consulting’s Health Informatics Network for Europe (HINE).

    Mr. Hanina has been responsible for much of the vision and strategy at AiCure and is the primary inventor of the patented technology. He has acted as a subject-matter expert on medication adherence technologies for the National Institutes of Health (NIH) and is currently a principal investigator for multiple NIH innovation grants. He holds an MBA from the Wharton School of Business.

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    Magali Haas, Orion Bionetworks

    Magali Haas
    Founder and CEO
    Orion Bionetworks

    Dr. Haas founded Orion Bionetworks in July 2012 and serves as its CEO and President. Magali has over 15 years of pharmaceutical executive and clinical research experience, predominantly at Johnson & Johnson, where she assumed broad end-to-end development leadership roles in medical marketing, full clinical development, early development, and translational and biomarker sciences in psychiatry and neurology. She successfully filed NDAs in the US and Europe for risperidone indications in Autism, Adolescent Schizophrenia, Juvenile Bipolar Disorder and Conduct Disorders. She also led Development Teams evaluating compounds for Depression, Neuropathic Pain, Epilepsy, and Migraine Disorder.

    She served 3 years as Chief Science and Technology Officer for One Mind for Research, a nonprofit organization launched in May 2012 by Patrick J Kennedy. She orchestrated the launch of One Mind’s seminal programs, Apollo, an informatics research portal and, Gemini, an international TBI/PTSD research program.

    As an “intrapreneur” at J&J she established the first Neuroscience Translational Medicine & Integrative Solutions department, and co-founded the first Companion Diagnostics Center of Excellence as well as J&J’s Healthcare Innovation team. She serves on several advisory boards including the International Neuroinformatics Coordinating Facility, Brain Canada, Prophase, Pear Therapeutics and IMEC for nanoelectronics.

    Magali earned her BS in bioengineering from the University of Pennsylvania, an MS in biomedical engineering from Rutgers University, New Jersey, and her MD PhD with distinction in neuroscience from Albert Einstein College of Medicine, New York.
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    Don Jones, Scripps Translational Science Institute

    Don Jones
    Co-Founder & Chairman, WLSA
    Chief Digital Officer, Scripps Translational Science Institute

    Donald Jones is the Chief Digital Officer of the Scripps Translational Science Institute in La Jolla, California, where he works with the Director, Eric Topol, MD and Steve Steinhubl, MD, Director Scripps Digital Medicine, one of the first clinical trial centers focused exclusively on digital health and medicine products.

    Through February 2014, Mr. Jones served as Qualcomm Vice President of Wireless Health Global Strategy and Market Development. Mr. Jones is globally recognized as a leader in the field. In 2011, working with XPrize Foundation CEO, Peter Diamandis, and Qualcomm’s CEO, Dr. Paul Jacobs, he conceived the $10M Qualcomm Tricorder Xprize for a consumer device capable of making multiple diagnosis. In 2005, he founded and is Chairman of the Wireless Life Sciences Alliance ( Mr. Jones is widely asked to speak and recent engagements have included the Milken Institute, Sanofi Executive Committee, J&J Innovations Master Class, MIT Emtech, the MEMS Industry Group, the NIH Directors Leadership Meeting, and the world’s largest trade show, CES. He is a member of the Milken Institute Advisory Committee on Biomedical Innovation.

    Jones holds a bachelors’ degree in biology and bioengineering from the University of California, San Diego, a Juris Doctor from the University of San Diego and an MBA from the University of California, Irvine.
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    Amir Kalali, Quintiles

    Amir Kalali
    Vice President,
    Head, Neuroscience Center of Excellence

    Dr. Kalali is recognized globally as a leading innovator at the intersection of life sciences and technology, advising companies on building the future of their business. These include Bracket, AiCure, and the Platypus Institute.

    He is an advisor to the Center for Digital Transformation at the Paul Merage School of Business at the University of California, Irvine, the premier research center helping leaders across industries take advantage of the new digital economy.

    He is Professor of Psychiatry at University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development, published by Cambridge University Press. He has authored over 150 peer-reviewed publications.

    Dr. Kalali was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development (ISCDD), a founding member of the International Society for CNS Clinical Trials and Methodology (ISCTM), where he serves on Executive Committee, the Scientific Committee, and previously chaired the Membership and Publication Committees. He is also a founder and Co-Chair of the Scientific Program Committee of the CNS Summit, and serves on the Scientific Program Committee of the American College of Neuropsychopharmacology.

    Previously he was the Global Head of the Neuroscience Center of Excellence at QuintilesIMS.
    In this role, he led for the enterprise-wide strategy for neuroscience, encompassing drug development and health care services. He was responsible for numerous successful drug development programs that have led to new treatments for patients.

    Dr. Kalali regularly presents at national and international scientific meetings, and lectures frequently on drug development, innovation, technology, digital medicine and health.

    He has been involved in initiatives by the Institute of Medicine Forum on Drug Discovery, Development, and Translation, as well as the NIH FAST and the NIH NCATS New Therapeutic Uses program.

    He is particularly interested in educating clinicians worldwide, and has trained clinical investigators from over sixty countries, and impacted the education of scientists globally including when he held the role of the Chairman of the Educational Committee of the Collegium Internationale Neuro-Psychopharmacologicum (CINP).

    His awards include the ISCDD Leadership in CNS Drug Development Award in 2012.

    In 2005, 2006 and 2008 and 2011 and 2012 PharmaVOICE magazine named Dr. Kalali as one its 100 most inspiring leaders in the life sciences as voted by his peers. In 2014 he was honored with the PharmaVOICE Inaugural Red Jacket award, recognizing those who have been most lauded by their peers since the awards began.

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    Andreas Koester, J&J

    Andreas Koester
    Vice President, Clinical Trial Innovation & External Alliances

    Andreas Koester is the Vice President, Clinical Trial Innovation and External Alliances at Janssen Research & Development, part of the Janssen Pharmaceutical Companies of Johnson & Johnson. In this role, Andreas is leading the company’s efforts to enhance and optimize pharmaceutical clinical trials. He is also leading industry-wide efforts to define opportunities for collaboration in the pre-competitive space.

    Andreas Koester has more than 20 years of R&D experience working for pharmaceutical companies and Contract Research Organizations.

    His background is in drug development, spanning first in human, proof of concept and large registration trials. He worked in leadership roles for trials that led to approvals of Prezista®, Intelence® and Reminyl®. Andreas is a graduate of Leipzig Medical School and earned his Ph.D. in Clinical Pharmacology from Humboldt University in Berlin.

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    Greg Koski, ACRES

    Greg Koski
    President and CEO

    Greg Koski PhD, MD, is President and CEO of ACRES. He is also Senior Scientist at the Institute for Health Policy and Associate Professor of Anesthesia, Massachusetts General Hospital, Harvard Medical School. He is internationally recognized in the realm of clinical research, research ethics and integrity, and human subject protection.

    As the first Director of the Office for Human Research Protections at the U.S. Department of Health and Human Services (OHRP), Dr. Koski championed a "culture of conscience" in human research, focusing on prevention of harm and quality improvement beyond mere regulatory compliance. He created a new Program for International Activities within OHRP, and collaborated with the World Health Organization to coordinate and strengthen global mechanisms for ethical conduct of human research.

    He has been influential in many efforts to enhance protection of human subjects including processes for accreditation of human research protections programs, certification of physician investigators and the formation of the an industry organization for contract research organizations, and the decision of the World Medical Association to clarify the intent and applicability of the Declaration of Helsinki regarding the use of placebos in clinical trials.

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    Nick Kozauer, FDA

    Nick Kozauer
    Clinical Team Leader, Division of Neurology Products
    Food and Drug Administration (FDA)

    Dr. Nick Kozauer is currently a Clinical Team Lead in the Division of Neurology Products at the US Food and Drug Administration (FDA) where he is involved with the regulation of drugs being developed for the treatment of Alzheimer’s disease and other dementias, seizure disorders, peripheral neuropathies, and rare disease such as Amyotrophic Lateral Sclerosis (ALS) and Muscular Dystrophies. Prior to joining the FDA in 2010, Dr. Kozauer was the Director of Neuropsychiatry at the Johns Hopkins Memory Clinic at the Copper Ridge Institute. Dr. Kozauer also spent time as the Senior Therapeutic Regulatory Lead for CNS Drugs at Quintiles. He completed a residency in adult psychiatry at Georgetown University Hospital followed by a Neuropsychiatric/Geriatric Psychiatry fellowship at the Johns Hopkins Medical Center.

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    Olivier Leclerc, McKinsey & Company

    Olivier Leclerc
    Senior Partner
    McKinsey & Company

    As a Senior Partner of McKinsey's Healthcare and Pharmaceutical Practice, Olivier serves biotechnology, pharmaceutical and medical device clients across a range of strategic, operational, and organizational topics. Olivier is passionate about biotechnology/leading-edge science, and serves a broad range of clients - from very large companies to pre-IPO, venture-backed biotechs on a worldwide basis. He also serves investment firms focused on healthcare.

    Over his 15-year tenure, Olivier has developed expertise in sales/marketing, pricing/contracting, market access/reimbursement, post-merger management, product launch strategy, along with leading McKinsey's Oncology practice in the US.

    Olivier works extensively on technology topics and leads the McKinsey Digital Initiative in Pharma and Medical Devices. The healthcare industry is facing unprecedented technology-driven changes creating discontinuities, as well as significant opportunities for impact. The solutions and tailored applications we are developing enable our clients to implement our strategic recommendations faster and better.

    Olivier has published several articles over the years in the McKinsey Quarterly, as well as in healthcare publications. Beyond healthcare, Olivier enjoy exploring new problem solving approaches and has recently published in the McKinsey Quarterly on innovative problem solving (5 Routes To Innovative Problem Solving). He has recently published a book, The Design of Insight, on the same topic with Mihnea Moldoveanu from the Rotman School of Business.

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    Craig Lipset, Pfizer

    Craig Lipset
    Head of Clinical Innovation

    Craig Lipset is Head of Clinical Innovation within Worldwide Research & Development at Pfizer. Craig’s team is impacting clinical research through digital tools, innovative research approaches and unprecedented collaborations. Craig previously served as Venture Partner in Pfizer Venture Investments (Pfizer’s VC arm), where he focused on diversifying the company’s $50M annual budget for private investments in the areas of diagnostics and health technology. Craig was also Senior Director in Molecular Medicine, where he spearheaded initiatives driving innovation in clinical research and personalized medicine by drawing upon tools from health information technology, telemedicine, and eHealth.

    Craig brings over 15 years of leadership and innovation in the field of drug development. He previously served as Associate Vice President of Program Management at Adnexus Therapeutics (acquired by Bristol-Myers Squibb), and on the founding management team for Perceptive Informatics (now part of PAREXEL International). Listed among the 2010 PharmaVOICE most inspiring people in the life sciences and among Pharmaceutical Executive’s 2011 Emerging Leaders, Craig recently served as program chair for the 2012 Annual Meeting of the Drug Information Association. His work was recently acknowledged with the 2012 BioIT Best Practices award for Clinical & Health IT. Outside of Pfizer, Craig serves on the Board of Directors for the Foundation for Sarcoidosis Research and for the MedStar Health Research Institute, and is a Mentor at health tech accelerator Blueprint Health.

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    David Ormesher, closerlook inc.

    David Ormesher
    closerlook inc.

    David Ormesher provides leadership and direction for closerlook, inc., a digital marketing agency serving the pharmaceutical industry. As founder and CEO, Ormesher has taken closerlook from a small, creative media boutique and grown it into a recognized leader in creating innovative relationship-marketing solutions that help pharmaceutical brands build and maintain meaningful relationships with their most valuable healthcare professionals.

    Since founding the company in 1987, David has created a rich, cohesive culture at closerlook by maintaining a hands-on approach to building client success and sustaining lasting account relationships. He has guided the growth and evolution of the firm, attracting a world-class team of account, strategy, user experience, design, technology, data analytics and relationship-marketing services experts.

    David is a frequent speaker at marketing conferences and a recognized thought leader in the areas of interactive and relationship marketing for the pharmaceutical industry. He was recently named one of PharmaVOICE magazine’s inaugural Red Jacket winners for his legacy of leadership, innovation and philanthropy in healthcare.

    David is an early-stage investor and board member of physIQ, a personalized physiology analytics company. In addition to his entrepreneurial leadership, David is also active on several non-profit boards including MATTER Chicago, Lurie Children’s Hospital Foundation, The Poetry Foundation, i.c.stars, an innovative business and leadership training program for inner city youth, and he is founder of Bigger Future, a social-enterprise building the capacity of high-potential entrepreneurs in Rwanda. David is a trustee of Lyric Opera of Chicago where he serves as president and CEO.

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    Reed Tuckson, Tuckson Health Connections

    Reed Tuckson
    Managing Director, Tuckson Health Connections
    President, American Telemedicine Association
    Formerly Executive Vice President & Chief of Medical Affairs, UnitedHealth Group
    Formerly Senior Vice President, American Medical Association

    Reed Tuckson, MD, is the current President of the American Telemedicine Association and managing director of Tuckson Health Connections, LLC, a health and medical care consulting business that brings people and ideas together to promote optimal health outcomes. A graduate of Howard University, Georgetown University School of Medicine, and the Hospital of the University of Pennsylvania’s General Internal Medicine Residency and Fellowship Programs, Dr. Tuckson is the former Executive Vice President and Chief of Medical Affairs at UnitedHealth Group where he was responsible for working with all of the Company’s business units to improve the quality and efficiency of health services.

    Previously, Dr. Tuckson served as Senior Vice President, Professional Standards, for the American Medical Association (AMA). He is former President of the Charles R. Drew University of Medicine and Science in Los Angeles; has served as Senior Vice President for Programs of the March of Dimes Birth Defects Foundation; and is a former Commissioner of Public Health for the District of Columbia. Dr. Tuckson is an active member of the Institute of Medicine of the National Academy of Sciences and served as the Chairperson of its Quality Chasm Summit Committee and a member on their Committee on the Consequences of the Uninsured. Currently, he serves as Chair of the Secretary of Health and Human Services’ Advisory Committee on Genetics, Health and Society.

    Additionally, Dr. Tuckson recently served as a Commissioner, Certification Commission on Health Information Technology (CCHIT); and is currently a member of the Performance Measurement Workgroup, Ambulatory Care Quality Alliance (AQA); and the Quality Workgroup, American Health Information Community (AHIC). Dr. Tuckson has also held other federal appointments, including cabinet level advisory committees on health reform, infant mortality, children’s health, violence, and radiation testing. Recently, Dr. Tuckson participated in United Health’s establishment of a national telehealth network aimed at serving rural, difficult to access and underserved patient populations.

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    Ajay Verma, United Neuroscience

    Ajay Verma
    Chief Medical Officer
    United Neuroscience

    Ajay Verma is a neurologist who is devoted to the advancement of neurotherapeutics and neurodiagnostics. He studied zoology at the University of Maryland and received his MD and his PhD in neurotoxicology from The Johns Hopkins University, training with Dr. Solomon Snyder. His neurology residency training was in the US Army at Walter Reed Army Medical Center, where he remained on clinical staff for another 11 years. Ajay spent 12 years on the faculty of the Uniformed Services University of the Health Sciences, the US Military’s Medical School. Since leaving the Army as a Lt. Colonel in 2006, Ajay has served in leadership roles at Merck & Co., Inc., Novartis Pharmaceuticals, and Biogen where he directed drug development, biomarkers, and experimental medicine efforts in Alzheimer’s and Parkinson’s disease, ALS, neuropathic pain, multiple sclerosis and other brain and neuromuscular disorders.

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