Learn how the likes of Bayer, Novartis and Jounce Therapeutics are reducing patient burden and how patient advocacy groups such as NPAF, Patient Advocates in Research and RDCRN-CPAG are approaching new clinical trial initiatives, to ensure you’re continuing to put the patient at the heart of your trials, however they’re run
Join a series of challenging conversations, tackling cultural drivers, prejudice and mistrust in clinical trials, including commentary from the likes of Seqiris, Bristol Myers Squibb, X4 Pharma and Genentech and ensure your trials are reflective of the patient population they aim to serve
Develop a greater understanding of how to adapt to the growing use of digital and decentralized trials through exclusive discussions with the likes of the FDA, GSK, UCB, and Mass General Brigham, and ensure you remain at the forefront of innovation and patient-centricity, all whilst remaining compliant
The Future of Clinical Trials Summit adopts a practical approach to trial design and execution through unfiltered conversation, use cases and debate. Separating theory from reality, this program brings together thought-leaders from big pharma, biotech, patient advocacy groups and industry to look at current and future capabilities, through a series of real-world examples. For anyone focused on developing a more patient-centric approach to clinical trials, adopting a decentralized model or looking to be more reflective of the population they aim to serve, this is an event not-to-be-missed.
Dr Rob Scott is a Zimbabwean born physician and a graduate of University of Cape Town. Rob has held leadership positions in global Pharma for over thirty years. At Pfizer he developed Lipitor and Norvasc, including personal involvement in many large scale CV trials. He also invented and developed the first commercially available Polypill, Caduet. At AtheroGenics, he designed and implemented the first large cardiovascular outcomes study to be wholly performed by a small biotech. At Amgen, Rob conducted the first outcome study for a PCSK9i, FOURIER. Rob was able to accelerate the program by 18 months and achieve the first regulatory approval in a highly competitive race with Sanofi/Regeneron. Rob was also successful in getting FDA approval for the heart failure drug, Corlanor despite not having a single US subject in testing. Rob was a member of the FDA Cardiac and Renal Drug Advisory Committee from 2012 to 2016 and participated as a committee member fourteen times as well as leading the successful sponsor team for Repatha. Rob recently retired as the Chief Medical Officer at Abbvie where he had responsibility for around 40 new molecular entities, four thousand people and a budget of close to two billion dollars. During his tenure, Abbvie achieved over 14 major regulatory approvals including Venclexta, Orilissa, Skyrizi and Rinvoq. He also created the Development Design Center, a Center of Excellence focused on using predictive analytics and big data to design and implement better clinical trials. He has been a board member of Transcelerate and the PhRMA R&D Leadership Forum. Rob is a leader in digital transformation of clinical research including a broad range of aspects from predictive analytics, innovative program and study design, synthetic and historical controls, pragmatic and real world studies, use of passive data collection using IoT and wearables and risk based monitoring to name a few. Rob is currently on the board of ArisGlobal, Confo Therapeutics, Draupnir Bio, Oncospherix and WindTree Therapeutics and the scientific and strategic advisory boards of Variant Bio, Morningside Biopharma, Cytel, Inflexion and BioEthics International.
Kristen serves as Executive Director of the American Porphyria Foundation, a 501(c)3 rare disease patient advocacy group including eight distinct rare diseases.
When her background in business and a focus in public health intersected with a child diagnosed with an ultra-rare disease, all roads led to porphyria advocacy. Kristen’s primary goals are advancing research, patient and physician education, disease awareness, legislative advocacy, and developing patient support programs. Above all, Kristen strives to put patients first, because they too often come last.
Kristen is as a member of the Porphyrias Consortium, co-chair of the NIH Rare Disease Clinical Research Coalition of Patient Advocacy Groups, member of the Board of Directors of the American Porphyrias Expert Collaborative, Board Member-Elect of the NIH NCATS Advisory Council and Cures Acceleration Network Review Board, and serves as an Elder at Bradley Hills Presbyterian Church in Bethesda, MD. Her most important role is mom to three sons, the youngest who lives with erythropoietic protoporphyria (EPP).
Kristen holds a Master of Business Administration from The George Washington University and a Masters Certification in Public Health from the University of Maryland.
Dr. Balch has more than 15 years of executive leadership in the non-profit sector with an emphasis on consensus-building and collaboration. He became the CEO of both PAF and NPAF in 2013. From 2006-2013, he served as Vice President of the Preventive Health Partnership — a national health promotion collaboration between the American Cancer Society, American Diabetes Association, and American Heart Association. Prior to his work with the Preventive Health Partnership, Dr. Balch was the Executive Director of Friends of Cancer Research.
Dr. Balch volunteers as a board member for the Council for Affordable Health Coverage (CAHC), Innovation and Value Initiative (IVI), Pharmacy Quality Alliance (PQA), Specialty Pharmacy Certification Board (SPCB)) and the Foundation for the Accreditation of Cellular Therapy (FACT). Dr. Balch has served on the Executive Board of Patient Advocate Foundation and National Patient Advocate Foundation since 2007. From 2006 to 2016, Dr. Balch served on the board of Fight Colorectal Cancer including several years as Vice Chair.
Dr. Balch also serves on numerous advisory boards and committees including:
• National Committee for Quality Assurance (NCQA) Consumer Advisory Council
• Duke-Margolis Value-Based Payment Advisory Board
• National Comprehensive Cancer Network (NCCN)’s Quality and Outcomes Committee • Hutchinson Institute for Cancer Outcomes Research (HICOR) Advisory Board
• Core Quality Measure Collaborative (CQMC) Steering Committee
• Journal of Clinical Pathways Editorial Advisory Board and contributing editor
• Payment and Policy subcommittee for the National Quality Forum (NQF) Task Force: Driving Value through the Next Generation of Quality
• Finance Committee and the Membership Committee for the National Health Council (NHC) • Core member of the International Headache Society (IHS) Global Patient Advocacy Coalition • Working group member for the National Academies of Medicine’s Action Collaborative on Clinician Well Being and Resilience
He earned his PhD in 2003 from the University of California, his master’s degree in 1997 from the University of Texas; and his bachelor’s degree (cum laude) in 1994 from Trinity University in San Antonio.
Katie Baca-Motes leads strategic initiatives for Scripps Research Translational Institute (SRTI), including launching SRTI’s new Digital Trials Center, focusing on expanding SRTI’s portfolio of decentralized clinical trial initiatives including DETECT, a COVID-19 research initiative, PowerMom, a maternal health research program and PROGRESS, an upcoming T2 Diabetes/Precision Nutrition program. She also serves as Co-Investigator of The Participant Center for the All of Us Research Program.
She has over 12 years of experience managing research projects with SRTI, Walt Disney Company, Aetna, Janssen, and others. The research projects have leveraged insights from behavioral economics and other social sciences to improve clinical trial enrollment, increase the return on incentive schemes, understand the psychology behind consumer decisions, identify effective donor communication, increase the effectiveness of corporate wellness programs and improve patient outcomes. Katie has an MBA from The Rady School of Management, UCSD and serves on the Alumni Board.
Johan is a physician with more than twenty-five years of experience in the pharmaceutical industry as well as over fifteen years in Oncology clinical development and medical affairs. Focus has been on both targeted agents, small molecules as well as antibody therapies; in this in both solid and liquid tumors, as well as immune-oncology. Johan worked for several years at Novartis in Oncology Translational Medicine with particular focus on biomarker driven clinical studies in order to identify the optimal patient population as well as optimize clinical benefit. In addition, Johan has worked closely with other functions while in medical affairs to optimize pre as well as post-launch programs to further optimize business opportunities.
Michele Rhee is Head of Patient Affairs and Advocacy of X4 Pharmaceuticals. She has more than a decade of experience leading patient affairs and advocacy across pharmaceutical and nonprofit industries. Michele is embedded within the rare disease and oncology patient communities through both her extensive professional work and her personal experience with a cancer diagnosis at age 20 and rare disease diagnosis at age 21. Partnering with these communities, she has led patient interviews/advisory boards and represented the patient perspective, which has directly informed trial design, patient support services, and disease education programs, among other efforts. Michele previously served as Head of Patient Affairs at Enzyvant where she helped build the Patient Affairs function, developing and maintaining both global patient advisor and advocacy partnerships across disease areas. During her time there, the company was nominated for a Global Genes 2019 RARE Champions of Hope award, in part, due to its expanding efforts in Patient Advocacy. Prior to her work at Enzyvant, Michele served as Global and R&D Patient Advocacy Lead at Takeda Oncology, Head of Global Patient Affairs at Bluebird Bio, and Director of both Strategic Initiatives and Program Initiatives at the National Brain Tumor Society. In addition, Michele has served as Chair of the MassBio Patient Advocacy Roundtable since 2017, is a founding board member for Costs of Care, an organization dedicated to helping clinicians and health systems deliver better care at lower cost, and was named a 2019 PharmaVOICE 100 honoree. Michele received her MPH from Yale School of Public Health and her MBA from Yale School of Management.
Stephen D. Wiviott, MD, FACC is a graduate of University of Pennsylvania and Harvard Medical School (HMS, Honors). He served as a Medicine resident and Chief Medical Resident at Brigham and Women’s Hospital (BWH). Following his medical residency training, he served as a Cardiology fellow at Johns Hopkins Hospital. He is Associate Professor of Medicine at Harvard Medical School, and a Senior Investigator with the TIMI study group. He attends in the Levine Cardiovascular Intensive Care Unit and general Cardiology service at BWH.
As an investigator, Dr. Wiviott has played important roles in the planning, implementation, leadership, and interpretation of multicenter, national, and international clinical trials in acute coronary syndromes including the TRITON-TIMI 38 trial, PRINCIPLE-TIMI 44 and of the TIMI 38 Coronary Stent Registry. He has also served in leadership of trials of secondary prevention of cardiovascular disease as global PI of DECLARE – TIMI 58, CAMELLIA – TIMI 61, and DAPA ACT HF – TIMI 68 assessing CV safety and efficacy of metabolic therapies. He is the Chairman of the TIMI Clinical Events Committee and recognized as an expert in event definitions and adjudications. Dr. Wiviott is an author of over 200 peer-reviewed publications in major medical and cardiovascular journals including 15 original articles in the New England Journal of Medicine. He was named in 2014 and 2017 by Thomson Reuters and Clarivate Analytics as one of “The World’s Most Influential Scientific Minds” and in 2016-2020 as a “Highly Cited Researcher,” recognitions inclusive of the top 1% of researchers in Clinical Medicine by citation.
Building on his trials experience, Dr. Wiviott serves as Vice President for Clinical Trials Research and Administration for Mass General Brigham and leads the MGB Clinical Trials Office. The CTO provides contracting, budgeting, and clinical trial management services for Partners hospital investigators and industry sponsors and is tasked with supporting and growing clinical trials research at Partners.
Michelle is the Sr. Director of Innovation in Pharma R&D Clinical Operations at Bayer.
She has over 20 years of experience in Clinical Research across many different roles. She began her journey as a research nurse and site director. From there she became a Clinical Research Associate at a CRO, and finally joined Bayer in 2008 where she has held multiple roles in: Clinical Operations; Training and Quality; and now in Business Excellence and Innovation.
Michelle has also participated as a patient in 2 clinical trials and also has experienced them through the role of a caregiver for both parents while they were in clinical trials. This experience allows her to consider the firsthand viewpoint of a patient, caregiver, site, CRO and sponsor when looking at innovative opportunities.
Michelle’s greatest passion is customer focused innovation and responding to the voice of the patients and sites.
Mike received his B.A. in Biochemistry from the University of Wisconsin-Milwaukee and PhD in Biophysical Chemistry from Princeton University. Previously, Mike Benecky worked at GSK for 9 years as Senior Director, Global Regulatory Affairs in Precision and Digital Medicine in Research Triangle Park, North Carolina. At GSK, Mike developed regulatory strategy to implement Digital Sensor/App Technology for both commercial-facing and clinical trial applications. Successful projects included launch of the MyAsthma mobile app as a CE-marked medical device, execution of the PARADE Virtual Real World Clinical Study in Rheumatoid Arthritis Patients and implementation of digital sensor technology to monitor medicine adherence within respiratory medicine clinical trials.
In April 2020, Mike joined UCB as a Senior Director, Global Regulatory Lead-Devices developing regulatory strategy for UCB Teams seeking to implement within sensor technology within neurology clinical trials and for UCB AI/ML Software as a Medical Device products.
Since 2010, Laurie has led the company’s global health literacy efforts in support of improved patient communications, including medication labeling, packaging, clinical trial materials, and patient education. She has recently expanded her role to include health equity and social determinants of health, with a focus on oncology. Laurie has worked to include respondents with low health literacy into patient labeling research, earning a national health literacy award. She works and speaks internationally. She has co-chaired two US working groups on lay summaries and health literacy in clinical trials, at the MRCT (Multi-Regional Clinical Trials Center of Brigham and Women’s and Harvard). She served as an invited member of the EMA lay summaries working group, where she helped to influence guidance to reflect principles of health literacy, numeracy and readability. She was an invited speaker by the FDA at a 2017 labeling conference, with an international audience of over 2000 people in 42 countries. She has delivered many keynote talks, including at SCOPE (Summit for Clinical Ops Executives) with 2300 people, ISMPP (Medical Publications), Women’s Leadership Conference, and the Asia Health Literacy Conference. She has co-authored multiple publications and serves on the US National Academies Health Literacy Roundtable. She won an MM&M Top 40 Healthcare Transformers Award. She serves on the company’s Diversity Business Consortium, with health literacy as a key priority. She is a passionate ally of the company’s Employee Resource Groups, co-chairing a working group on mentorship for the League of Employees of African Descent. She has a bachelor’s degree from Yale and an MBA from Wharton. She lives in Pennsylvania with her husband, two daughters and three dogs!
Pete Schaeffer has worked across both the pre-clinical and clinical areas in roles to improve performance and decision making, led continuous improvement programs, and collaborated with teams to drive new ways of working. In his current role at GlaxoSmithKline of Digital Process Optimization he focuses on improving ways of working on clinical trials. Pete has also taken a leading role in implementing patient technology at TransCelerate by leading the Patient Technology and Patient Experience workstreams which aligns with his passion of improving patient experience and accelerating clinical trials. He earned a BS and an MBA from Penn State University and is certified in Project Management.
Meghan McKenzie is Principal Inclusion, Internal Partnering in the Chief Diversity Office at Genentech. Meg has over 25 years of experience in clinical research. Her vision includes developing strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical development and she is passionate about gaining patient insights early in program development to support equitable healthcare for all patients, regardless of race/ancestry, sexual orientation, gender identity, age, ability or socioeconomic status. Meghan has a daughter at UCSC (online), and enjoys her husband’s “covid-time’ cooking as well as her new ‘office’ dog-mate, Brodie.
Angel Soubhie, Medical Director and Head of the Clinical Trial Scientist team, has more than 10 years of experience in the Pharmaceutical Industry. She’s been working with clinical trials in diverse therapeutic areas (Cardiovascular, Coagulation, Hematology, Oncology, and Pulmonology) in Bayer since 2010.
Sarah Bilali is currently Director of Global Regulatory Affairs for Medical Devices at UCB Biosciences Inc, located in Raleigh, NC. Since 2015, Sarah has been spearheading efforts for UCB on the integration of medical devices into the clinical trial pharma environment.
In 2018 Sarah joined the newly formed Medical Device Quality Assurance organization to lead quality support for medical device clinical trial activities with a specific focus on digital devices. In 2020, Sarah took on a new role in Global Regulatory Affairs as Director, Global Regulatory Lead-Devices to develop regulatory strategy for UCB in the sensor, mobile app and algorithm based software as a medical device products.
Sarah holds a Bachelor of Science in Psychology from Muskingum University and Master of Arts in Psychology Experimental Research from Cleveland State University.
David Morin, MD, FACP, CPI, FACRP has participated as a Principal Investigator in hundreds of studies (Phase I-IV) since 1989. He became an ACRP Credentialed Clinical Research Trainer (CCRT) in 2010, and ACRP Fellow in 2017. Dr. Morin received the “Outstanding Physician Leadership in the Profession” award by ACRP/APCR in 2012. He obtained his pharmacy degree and pre-med with High Distinction at the University of Rhode Island, his MD with Honors at the University of Vermont, and completed medical residency training at the University of Virginia in Charlottesville. Dr. Morin is Board certified in Internal Medicine and a Fellow of the American College of Physicians (FACP). In addition to serving as the Director of Research at Holston Medical Group, a large multispecialty practice in TN, VA, & NC, he continues to provide patient care and serves as the Director of the High-Risk Disease Prevention program for a fortune 500 company. An author, speaker, an entrepreneur as Founder/CEO of Trike, LLC which developed the SiteOptex® Software System designed to optimize research efficiency. He has served on the Board of Trustees for ACRP since 2016 and on many related committees and is currently Vice-Chair. He co-developed the ‘CRC Bootcamp’ and is also an instructor for the ‘Competency Based’ Investigator training program with ACRP. Past activities include serving as a teaching attending for East Tennessee State College of Medicine, employee health director for Bristol Regional Medical Center, medical director of a CRO and an Accountable Care Organization, and a pharma consultant.
Dr. Michelle Tarver is the Deputy Director of the Office of Strategic Partnerships and Technology Innovation where she helps provide leadership for all scientific collaborative and emerging technology-related activities at the Center for Devices and Radiological Health (CDRH). She provides leadership and oversight for CDRH in matters relating to public health emergency preparedness and response activities, digital health, cybersecurity, conformity standards development and implementation, partnerships, and patient science and engagement involving medical devices. Under her leadership, CDRH is advancing efforts to include diverse and underrepresented populations in the evaluation of medical devices. She also continues to advance inclusion of the patient perspective as the Program Director for Patient Science in the Digital Health Center of Excellence.
As the Head of Diversity Strategy at Bristol Myers Squibb, Lorena has been leading the diversity in clinical trials efforts for the past two years, with the objective of recruiting a patient population that reflect both the demographics of the real world and represent the epidemiology of the disease being studied.
Prior to working at BMS, she spent several years in the Latin America and Canada Region in Novartis, where she started her career in Pharma back in Mexico over 15 years ago.
As a strong inclusion advocate, she leverages her experience, intersectionality and personal purpose, as well as the roles she holds the WOCIP Board of Directors, the RedShoeMovement and her hometown Diversity Committee to build an inclusive culture that values differences and serves ALL populations.
Lorena was awarded the 2020 PEOPLE EN ESPANOL MAGAZINE Recognition: “Las 25 mujeres mas poderosas” celebrating women who have made a difference empowering others.
Edward Ramos, Ph.D., is director of digital clinical trials for the Digital Trials Center (DTC) at Scripps Research. In partnership with CareEvolution, Inc., where he also sits as the Principal Science Officer, the DTC team seeks to decentralize research through use of digital health technologies, employing novel strategies for remote, “site-less” participation, and applying state-of-the-art methodologies for data analysis. Dr. Ramos has led independent research projects and has been coordinating and administering large-scale national research efforts for over 12 years. His expertise spans population genomics, bioinformatics, mobile health, and digital clinical trials. In his previous positions serving in various capacities at the National Institutes of Health (NIH), Dr. Ramos oversaw and managed portfolios that focused on innovative and groundbreaking initiatives aimed at improving public health, including the Participant Center of the All of Us Research Program, an ambitious program launched by NIH inviting one million people across the U.S. to help build one of the most diverse health databases in history, which could help in the development of better treatments and ways to prevent different diseases. Dr. Ramos began his federal service as a legislative fellow and legislative assistant, advising then-U.S. Senator Barack Obama on health and science policy. He received his Ph.D. in molecular biotechnology from the University of Washington with his thesis work carried out at the Fred Hutchinson Cancer Research Center.
Bray Patrick-Lake, MFS, is Senior Director of Strategic Partnerships at Evidation Health. She develops collaborations to support the design and implementation of patient-centered studies, digital measures, and health programs. She serves on the Digital Medicine Society Scientific Leadership Board, Duke Margolis RWE Collaborative Steering Committee, Reagan Udall Foundation IMEDS Steering Committee, and Medtech Color Steering Committee. Previously, Bray served on the All of Us National Advisory Panel, National Academies of Sciences, Engineering, and Medicine (NASEM) Health Science Policy Board, and as co-chair of the Advisory Committee to the NIH Director that authored vision for the Precision Medicine Initiative’s Cohort Program.
Shalome Sine is a Project Manager at CISCRP responsible for planning, moderating, and executing Patient Advisory Boards, patient interviews, and various other patient engagement activities. She is also an MPH candidate at Tufts University. Prior to CISCRP, Shalome held several positions as a research assistant focusing on areas such as RNA studies, neuroscience and memory investigations, and drug development processes.
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