ACRES in association with iiBIG present:

SYNERGY: Where Clinical Research, Innovation, Collaboration <br>
                  and Systems Thinking Come Together!

OCTOBER 1-2, 2015

OMNI BOSTON

BOSTON, MA

Facilitators and Panelists

SYNERGY is an innovative new type of clinical research event. ACRES allies and other stakeholders will be invited to come together in a person-to-person format to directly participate in designing the future of clinical research. Using the stories of key leaders and facilitated cross-sector discussions, participants will examine mistakes being made throughout the clinical research ecosystem and share lessons learned, as they identify opportunities and systems solutions. SYNERGY will abandon a simple “talking-heads” content-flow model in favor of an interactive, personally engaging, solution-generating model—every attendee will be a participating thought-leader!

FOR INQUIRIES ABOUT PROGRAM CONTENT:
Please contact the director of program development:

Mary Tobin
Mary Tobin, Ph.D., Special Advisor to the President and CEO, ACRES
Email: mtobin@acresglobal.net


FOR ALL OTHER INQUIRIES
Please contact:

Don Buford
Don Buford, CEO, iiBIG LLC
Phone: 212-300-2521 | Email: donb@iibig.com

REGISTER NOW
Event Details
What: SYNERGY
Why: Where Clinical Research, Innovation, Collaboration and Systems Thinking Come Together!
When:
Where: OMNI Boston
Boston, Massachusetts

About The Speaking Faculty

Peter AltermanPeter Alterman, PhD, Chief Operating Officer, SAFE-BioPharma Association
Dr. Peter Alterman is Chief Operating Officer of SAFE-BioPharma Association. Until his retirement from federal service, he was Senior Advisor to the National Program Office of the National Strategy for Trusted Identities in Cyberspace, NIST. Before that he served as the Senior Advisor to the NIH CIO for Strategic Initiatives, Assistant CIO for e-authentication at the National Institutes of Health and Chair of the U.S. Federal PKI Policy Authority. Dr. Alterman serves on several industry identity and access management committees and workgroups. He has received numerous government and private sector awards for pioneering work in federated identity management. He received his M.A. from Adelphi University and his Ph.D. from the University of Denver.

Cerdi BeltriCerdi Beltre, Director of Data Strategy and Business Development, Merge eClinical
Cerdi Beltre has over 18 years of clinical research experience - which began in the Dept. of Preventive Medicine at Stony Brook University, NY. She spent 17 of these years at North Shore-LIJ Health System in NY. As the Director of Clinical Research Operations, she oversaw clinical research operations for this 7 billion dollar healthcare system, which conducted over 2100 studies annually. As the Administrative Director, she also ran the Clinical Research Service Department, and drove the creation of the Finance, Investigational Pharmacy, and Recruitment Cores. She directed initiatives to increase enrollment into research, revenue, and an organized structure that supported investigators. She also conducted many courses, including ones to help prepare coordinators for certification. Prior to this role, she managed phase 1 - phase IV clinical trials as a Research Coordinator. As an IRB Manager, she led a Capstone project to reduce IRB review time; and co-led the development of a Regulatory Binder, which was adopted by other organizations. She was also a Research Compliance Manager for a number of years; conducting for-cause and quality improvement audits, and monitoring. She is certified as an IRB professional, and coordinator. Has a bachelor’s degree in psychology from Stony Brook University. Was the Society for Clinical Research Sites (SCRS) Summit Community Vice-Chair, and was on the board of the Association for Clinical Research Professionals (ACRP) New York Metropolitan Chapter. Currently she is on the Board of Women in BIO in the Research Triangle Park Chapter area in North Carolina, the Women in BIO Sponsorship Committee, and the ACRES Global Technology Consortium Planning Group. Currently she is the Director of Data Strategy and Business Development at Merge eClinical where she is responsible for the execution of the strategic initiatives for Investigator Information Services. She is leading the initiative to create a Global Investigator Performance Score.


Bonnie BresciaBonnie A. Brescia, Founding Principal, BBK Worldwide
Bonnie A. Brescia is co-founder of BBK Worldwide, the world leader in patient recruitment for clinical research and development. A pioneer of patient recruitment over the last 30 years, Bonnie helped to shape the discipline and continues to be a well-recognized and highly sought after thought leader in the field. Her insights into the workings of the clinical research community inform BBK’s product development, campaign execution, and global expansion.


Brendan BuckleyBrendan Buckley, MD Dphil FRCOI, Chief Medical Officer, ICON
Dr. Brendan Buckley MD, DPhil, FRCPI is Chief Medical Officer and Executive Vice President of ICON plc, one of the world’s largest clinical research organizations. A medical graduate of the National University of Ireland and a doctoral graduate in Biochemistry of Oxford University, he has over 30 years’ experience in clinical research while in academic clinical practice. He is Honorary Clinical Professor at University College Cork (UCC). Prior to joining ICON, he was Director of the European collaborative Centre for Clinical Trials in Rare Diseases at UCC. He was a member of the Board of Directors of Ireland’s national health products regulator the Irish Medicines Board (now the HPRA) in 2004-2011 and chaired its statutory Advisory Committee for Human Medicines. He was a member of the EMA Committee for Orphan Medicinal Products (COMP) from 2000-2003 and a member of the EMA Scientific Advisory Committee on Diabetes and Metabolism until 2011. He was a co-founder of Firecrest Clinical, a company in Limerick focused on improving the performance of clinical trial sites. He has directed a number of very large outcomes trials in metabolic /cardiovascular disease and chairs the independent data and safety monitoring boards for a number of large clinical development programmes. He is a member of the scientific advisory boards of a number of research charities. Prof Buckley also chairs the statutory Anti-Doping Committee of the Irish Sports Council.


Rob CurryRob Curry, Vice President, Operational Excellence Services, Covance
Robert Curry is the Vice President of Operational Excellence in Covance’s Clinical Development Services organization, one of the world’s leading suppliers of clinical development solutions. Mr. Curry leads the Clinical Development Transformation Office that is focused on dramatically reducing the cycle time and cost required to execute clinical trials. Mr. Curry joined Covance in 2004 and has 20+ years of experience in the Biopharmaceutical industry. Since joining Covance, Mr. Curry has been responsible for significant operational and productivity improvements, achieved through leadership of the organization’s Operational Excellence, Change Management, and Employee Education groups. Earlier in his career at Covance, Mr. Curry served as the Executive Director of Business Solution Delivery and as the Director of IT Portfolio Management for the Covance Corporate IT organization. Prior to joining Covance, Mr. Curry held roles of increasing responsibility for Accenture Ltd. During his 12 year career with Accenture, Mr. Curry provided process, technology and human capital consulting services to top tier biopharmaceutical companies, primarily in the areas of Research and Development, Supply Chain Management and Finance Operations.

Susan S. EllenbergSusan S. Ellenberg, Ph.D., Professor of Biostatistics, Perelman School of Medicine, University of Pennsylvania
Dr. Susan Ellenberg is Professor of Biostatistics, Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania. Dr. Ellenberg’s research has focused on practical problems and ethical issues in clinical trials, including surrogate endpoints, data monitoring committees, efficient clinical trial designs, and special issues in cancer and AIDS trials. At Penn, she is senior statistician for three multicenter clinical trials and directs the Biostatistics Core of the Penn Center for AIDS Research. She also served for many years as Associate Dean for Clinical Research, overseeing the human subjects protections programs, training and centralized research support of the medical school. Prior to her appointment at Penn, Dr. Ellenberg held positions of increasing responsibility in the federal government. From 1993 to 2004 she served as Director, Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration; prior to that she served as Chief of the Biostatistics Research Branch in the Division of AIDS, National Institute of Allergy and Infectious Diseases. Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member of the International Statistical Institute.


Greg KoskiGreg Koski, PhD, MD, CEO & President, ACRES (Alliance for Clinical Research Excellence and Safety)
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.


Rebecca Daniels KushRebecca Daniels Kush, President and CEO, Clinical Data Interchange Standards Consortium (CDISC)
Rebecca Daniels Kush, Ph.D. is Founder, President and CEO of the Clinical Data Interchange Standards Consortium (CDISC), a non-profit (501c3) standards developing organization (SDO) with a focus on global clinical research standards and their link with healthcare; the CDISC vision is “Informing patient care and safety through higher quality medical research”. She is also a Director on the Board of the CDISC Europe Foundation, which is a research partner in three consortia of the Innovative Medicines Initiative (IMI). Dr. Kush has over 30 years of experience in the area of clinical research, including positions with academia, the U.S. National Institutes of Health, a global Clinical Research Organization and biopharmaceutical companies in the U.S. and Japan. She earned her doctorate in Physiology and Pharmacology from the University of California San Diego (UCSD) School of Medicine. She leads the Scientific Advisory Committee for the Coalition For Accelerating Standards and Therapies (CFAST), a partnership with the Critical Path Institute in collaboration with the FDA. Dr. Kush currently serves as a member of the IT Workgroup of the U.S. NIH/NCI National Cancer Advisory Board and was appointed in 2011 to represent research on the U.S. Health Information Technology Standards Committee. In 2013, she launched the Essential Standards to Enable Learning (ESTEL) Initiative for the Learning Health Community.

J. Scott LowryJ. Scott Lowry, Founder, HealthIDx
Mr. Lowry (or Scott) has over 35 years senior management experience in financial services, real estate, and technology industries. In these capacities his positions included, Chairman & CEO of Great Western Bank, Phoenix, AZ., Executive Director, Canary Wharf Development Company, London, England, President & CEO, Digital Signature Trust Co., Salt Lake City, UT., and as CEO of his latest venture HealthIDx, Washington DC. Mr. Lowry is considered an industry leader in authentication and Public Key Infrastructure (PKI). He served on the Federal PKI Technical Working Group, the Direct Trust Certificate Policy Working Group, and HIMSS Patient/Provider Authentication Working Group. He was also a reviewer of NIST Special Publication 800-63 and senior advisor to the GSA eAuthentication Program. In healthcare, Mr. Lowry is a Institute for Healthcare Improvement Certified Improvement Advisor. Hold also MBA in Finance and Marketing from the University of Utah and a BA in Commerce from the University of Maryland

Briggs MorrisonBriggs Morrison, Managing Director, MPM Capital, and Chief Executive Officer, Syndax Pharmaceuticals
Briggs Morrison, M.D. joined Syndax as Chief Executive Officer in 2015. Prior to joining Syndax, he served as Executive Vice President, Global Medicines Development & Chief Medical Officer at AstraZeneca from 2012 to 2015, leading the company’s global, late-stage development organization and serving as a member of the AstraZeneca Senior Executive Team. He previously held a number of positions at Pfizer Inc. from 2007 to 2012 that culminated in his appointment as Head, Medical Affairs, Safety and Regulatory Affairs for Pfizer’s human health business, and also served in roles of increasing responsibility at Merck Research Laboratories from 1995 to 2007, ascending to the role of Vice President, Clinical Sciences, Oncology, responsible for clinical development of all novel anti-cancer drugs. Dr. Morrison is Chairman of the Board of Transcelerate, an industry-funded company charged with improving aspects of clinical trials, a member of the Executive Committee of CTTI (the Clinical Trials Transformation Initiative sponsored by FDA) and is on the Board of ACRES (Alliance for Clinical Research Excellence and Safety). Dr. Morrison received a B.S. in biology from Georgetown University, Phi Beta Kappa, and an M.D. from the University of Connecticut, followed by an internship and residency in Internal Medicine at the Massachusetts General Hospital, a fellowship in Medical Oncology at the Dana-Farber Cancer Institute and a post-doctoral research fellowship in Genetics at Harvard Medical School.

Leslie PlattLeslie Platt, JD, Senior Advisor, Health & Human Services, MITRE Corporation
Leslie Platt, JD, is a Senior Advisor on Health and Human Services at the MITRE Corporation, a non-profit organization that operates federally-funded research and development centers for the US government. Mr. Platt is a nationally recognized life sciences attorney and executive with experience in national health policy, biomedical research and development, strategic and impact investment, diversity, disparities reduction, and public-private partnerships. In the Federal government, Leslie served as Executive Assistant to the Director and Chief of Operations, Office of the Director, at the National Institutes of Health; as Deputy General Counsel-Legal Counsel at the Department of Health and Human Services, and as Counsel and Staff Director of the White House Agent Orange Working Group. Mr. Platt was a Charter Member of the Federal Senior Executive Service and has received many awards for distinguished public service. In the private sector, Mr. Platt was Counsel at Pillsbury Winthrop Shaw Pittman LLP; Principal at Ernst &Young LLP; Chief Operating Office & General Counsel at The Institute for Genomic Research (TIGR); and Senior Vice President & General Counsel at the ATCC. He has authored a number of articles and frequently lectures at industry conferences in the U.S. and around the world.

Kristina SheridanKristina Sheridan, MS, Associate Dept. Head, Emerging Technologies, Systems Engineering Technical Center, MITRE Corporation
Kristina Sheridan is a long-term caregiver and patient advocate with 25 years of experience in systems engi­neering. She is the associate department head for The MITRE Corporation’s Emerging Technologies Department and the principal investigator for a research project focused on patient empowerment. Ms. Sheridan combines her experi­ence as a caregiver of chronic pediat­ric patients and as a systems engineer to help the healthcare and health information technology (IT) com­munities understand the complexities of managing chronic illness and to develop IT capabilities that ease the day-to-day burden of managing care. Ms. Sheridan advocates for the design and development of patient-facing health IT to support self-management at home, and to facilitate an authentic patient-provider partnership within the clinical setting. Ms. Sheridan has been a trusted advisor to senior government officials at the U.S. Food and Drug Administration, the Centers for Medicare & Med­icaid Services, and the Veterans Health Administration. Prior to working for MITRE, Ms. Sheridan spent 18 years working in the space industry launching and operating a fleet of over 60 communication satellites.  Ms. Sheridan received her B.S. in mathematics from Lancaster Univer­sity, UK, and her M.S. in astronautics and space engineering from Cranfield University, UK.

Mary TobinMary Tobin, Ph.D., Special Advisor to the President and CEO, ACRES (Alliance for Clinical Research Excellence and Safety)
Mary F. Tobin, Ph. D, is Special Advisor to the President and CEO of ACRES, providing strategy, planning and business development expertise. Other efforts include developing and overseeing ACRES Patient Engagement Initiative, designing innovative formats for multi-stakeholder events and conducting research and analysis to support ACRES mission. Works on communications, cultural competency and outreach activities. As Managing Director of IMPACT LLC, a biomedical consulting practice, she oversees company operations, contracting with private sector, non-profit and federal agency biomedical research organizations. Work has included developing strategies for increasing recruitment of under-represented populations and assessing the healthcare and cultural landscape for conducting clinical trials internationally. Additional activities included organizational effectiveness and executive development consulting and Russian expertise in promoting clinical trial industry in former Soviet Union states, including HHS-DOD project on converting former USSR bio-weapons facilities into clinical trial sites. For Akkord International, Tobin provided cultural expertise to Russian and American organizations. She brought Russian politicians, academics and business people to US and strategized American-Russian new business development. She oversaw and designed on-going senior executive development and political competence programs for US federal government, including federal relationships with Congress and conducted variety of interventions and change initiatives for diverse federal agencies. Mary served for many years as Adjunct Professor at the University of Maryland, College Park.


Kimberly WarrenKimberly Warren, MS, Director, HHS Portfolio, CAMH FFRDC, Systems Engineering and AI, MITRE Corporation
In her role as portfolio director, Kimberly Warren leads MITRE’s strategy to identify, shape, accelerate, and implement research, development, and critical program work for the Department of Health and Human Services. As a senior leader, Ms. Warren provides strategic leadership and direction for the complex analysis and critical thinking required by business, policy, technology, and operational interests across the health domain. Ms. Warren advises leaders across government, academia, and private industry to bring strategic and practical solutions to meet our nation’s goals to transform health and healthcare. She works to align interests, leverage best practices, and has extensive contacts with a wide variety of technical and critical-thinking talent. Together, they bring solutions, value, and impact to novel innovations that work. Having worked across multiple federally funded research centers (FFRDCs) at MITRE over the last 25 years, Ms. Warren brings that expertise to bear for the health domain. Earlier, Ms. Warren was the director of MITRE’s health- related research and technical capability development. She was responsible for broad academic, industry, and sponsor stakeholder partnerships to accelerate innovation in health and healthcare.

Jeffrey WendelJeffrey Wendel, MBA, President and Chief Executive Officer, Chesapeake IRB
Jeffrey Wendel is the President and CEO of Chesapeake IRB which provides independent IRB oversight domestically and internationally. He has over 20 years of executive leadership experience providing consulting and systems integration services to Global 500 companies in the pharmaceutical, financial services and high technology industries. Prior to joining Chesapeake IRB, Mr. Wendel served as president and board member of a systems integration group that completed a successful IPO; led an international business unit focused on simulation software modeling; and established a government services division supporting US and international agencies. He led the successful integration of an acquired firm, and actively participated in an international expansion effort that leveraged existing clients and partners. Mr. Wendel earned a BS in Systems Engineering from the US Naval Academy and an MBA from Loyola College. He is a retired US Navy nuclear submarine officer. Mr. Wendel is the Chairman of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Board of Directors. He is also a member of the Board of Directors of Community Support Services (CSS) which provides work place and living assistance to individuals with developmental disabilities.


Matthew WhalenMatthew Whalen, PhD, COO, ACRES (Alliance for Clinical Research Excellence and Safety)
In the course of his career, Whalen has worked in or with all five sectors of the workplace (Government, Industry, Academia, Non-Profit, and Multi-Lateral) related to biomedical clinical research, strategic and organizational change in different enterprises, or both. Whalen is a social entrepreneur investing his time and expertise in organizations and programs that are socially-responsible. They range from economic development public-private partnerships to both for-profit and non-profit organizations. As the founding COO of the neutral non-profit Alliance for Clinical Research Excellence and Safety (ACRES), he is responsible for operational strategy and business planning and development on a day-to-day as well as long-term basis. He also continues to coach executives and senior managers in a range of sectors which he has done for 30 years. Additional leadership experience includes co-founding/-leading Chesapeake Research Review, Inc. (an independent ethics committee and professional services firm); and VP roles with the Pharmaceutical Safety Institute (a non-profit dedicated to developing Safety Culture in the biomedical R&D enterprise) and the Washington, DC office of Right Management Consultants. Whalen’s faculty experience includes the University of Maryland, College Park (Business, Honors Program, and Arts and Humanities), Temple University, Philadelphia, and Trinity College, now University (Washington, DC).


Jack WhelanJack Whelan, Author, Lecturer, Research Advocate, Cancer Warrior and Survivor
Jack was diagnosed with a rare, incurable blood cancer with a five-year outlook for patients requiring treatment. Travel on an intensely personal and oft-humorous bumpy ride on the road to Personalized Medicine. Encounter some relapsed/refractory detours, conflicting signals and biomarkers and inhibiting roadblocks in the health care system. Learn why Jack, not much of beer drinker himself hangs a bottle of Guinness on his chemo infusion rack and speaker’s podium. Using communications and research skills from his career as a Wall Street Research Analyst in Information Technology (IT) and career Sales VP, he now helps bridge the communications gap between life sciences professionals and patients as an effective Patient Advocate, Research Advocate and Legislative Advocate. Jack hopes all can appreciate the noble work of life sciences employees in cancer research. A decided friend to biopharma as an engaged, informed e-Patient Opinion Leader and advocate, he regularly speaks to and for these companies to open much-needed lines of communications with patients, providers and policymakers. He encourages all patients to explore novel targeting agents many of which are now in Clinical Trials. Jack understands the realities of his blood cancer. His goal is repeated periods of progression free survival during which the promise of science and delivery of successful therapeutics will be achieved.

Gunther WinklerGunther Winkler, PhD, Founder & CEO, Biomethius
Dr. Winkler is a seasoned biotech executive and entrepreneur. He started his industry career at Biogen where he held senior positions in R&D and in Corporate Administration including Senior VP, Asia Pacific, VP of Strategic Initiatives and Head of Global Clinical Operations. Dr. Winkler left Biogen Idec in 2011 and pursued his own entrepreneurial ventures. His current position is CEO of Biometheus, which specializes in precision medicine. Biometheus’ lead technology is a genetic test to predict placebo responders in clinical trials.