Medidata NEXT Korea 2020

COVID19가 환자 중심 임상 시험에 미치는 영향과 가상 임상 접근 방식 논의 Scott Gottlieb, M.D. Physician, Former Commissioner FDA: Scott Gottlieb is a physician and served as the 23rd Commissioner of the U.S. Food and Drug Administration. Dr. Gottlieb’s work focuses on advancing public health through developing and implementing innovative approaches to improving medical outcomes, reshaping healthcare delivery, and expanding consumer choice and safety. He serves on the boards of Pfizer Inc. and Illumina, Inc., is a resident fellow at the American Enterprise Institute and a partner at the venture capital firm New Enterprise Associates.; Dr. Gottlieb is an aggressive advocate for advancing the health of patients, promoting healthcare access, and driving innovation. The agency’s historic and prolific advances in new policy distinguished his tenure as the FDA’s commissioner, in addition to a record-setting number of approvals of novel drugs, medical devices, and generic medicines. Under his leadership, the FDA advanced new frameworks for the modern and safe and effective oversight of gene therapies, cell based regenerative medicines, targeted drugs, and digital health devices. The FDA implemented new reforms to standardize drug reviews and make historic improvements of post market data collection and the use of real-world evidence. They promoted policies to reduce death and disease from tobacco, improve food safety, and aggressively confront addiction crises.; Previously, Dr. Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and before that, as a Senior Adviser to the Administrator of the Centers for Medicare and Medicaid Services, where he helped advance policies to improve healthcare quality and promote the effective use of new medical technologies. Dr. Gottlieb is widely published in leading medical journals and periodicals, including The Wall Street Journal, The New York Times, and The Washington Post. He has held editorial positions on the British Medical Journal and the Journal of the American Medical Association and is a regular contributor to CNBC. Fortune Magazine recognized him as one of the “World’s 50 Greatest Leaders” in 2018 and again in 2019. In 2018 and then again in 2019 Modern Healthcare named Dr. Gottlieb the “Most Influential Physician Executive and Leaders” in its annual survey of 50 physician executives, and Time magazine named him one of its “50 People Transforming Healthcare in 2018.”

case Study 글로벌 제약사 Merck의 통합플랫폼 기반의 eCOA 활용사례를 통한 임상시험의 미래 (Operationalizing eCOA Platforms - Benefits and Lessons Learned) Robert Schneck, Senior Specialist, Clinical Data Management, Merck: Robert Schneck has worked for over a decade in the eCOA space, first as a programmer and then as a project manager on the vendor side. He now works as one of the Program leads on the eCOA services team at Merck.

코로나 시대의 RBQM의 진화 (The Evolution of Risk-Based Quality Management: Accelerating Adoption and Maturity) Anina Adelfio, Vice President, Industry Relations, Association of Clinical Research Organizations: Anina Adelfio is Vice President of Industry Relations for the Association of Clinical Research Organizations (ACRO). ACRO represents the world’s leading clinical research and technology organizations. Anina supports the CRO Forum, a branch of ACRO that is set up to interact with industry groups, mainly TransCelerate Biopharma. Since 2015, she has supported ACRO’s Risk Based Quality Management committee, bringing together thought leaders from across the industry to advance the adoption of RBM – and RBQM. Anina lives in downtown Washington, DC with her husband and standard poodle, Kiki.

인공지능을 활용한 신약개발전략 : NEXT AI (Unleashing the NEXT Generation of AI in Life Sciences) Amy Abernethy, Principal Deputy Commissioner, FDA: As the Principal Deputy Commissioner of Food and Drugs, Dr. Amy P. Abernethy, M.D., Ph.D., helps oversee the agency’s day-to-day functioning and directs special and high-priority initiatives that cut across offices overseeing FDA’s regulation of drugs, medical devices, tobacco and food. Dr. Abernethy, a hematologist/oncologist and palliative medicine physician, is an internationally recognized clinical data expert and clinical researcher. Her areas of expertise include cancer data, real world evidence, clinical trials, health services research, patient reported outcomes (PROs), clinical informatics, and patient-centered care. Before coming to FDA, Dr. Abernethy served as chief medical officer, chief scientific officer, and senior vice president for oncology at Flatiron Health (a member of the Roche Group), where she led the research oncology, clinical operations and data science teams, and contributed to the overall strategic vision of the company, including directing their research vision on real world evidence. Prior to that, Dr. Abernethy was professor of medicine at Duke University School of Medicine, where she ran the Center for Learning Health Care in the Duke Clinical Research Institute and the Duke Cancer Care Research Program in the Duke Cancer Institute. At Duke, she pioneered the development of technology platforms to spur novel advancements in the care of people with cancer and other serious life-limiting illnesses. Dr. Abernethy was formerly an appointed member of the National Academy of Medicine’s National Cancer Policy Forum, an elected member of the American Society for Clinical Investigation, and Past President of the American Academy of Hospice & Palliative Medicine. Dr. Abernethy received her M.D. at Duke University, where she also did her internal medicine residency, served as chief resident, and completed her hematology/oncology fellowship. She received her Ph.D. from Flinders University in Australia, with a focus on evidence-based medicine and clinical informatics, and her bachelor’s degree from the University of Pennsylvania.

인공지능을 활용한 신약개발전략 : NEXT AI (Unleashing the NEXT Generation of AI in Life Sciences) Bhooshi de Silva, Senior Vice President, Global Head, Corporate Development, Strategy and Ventures, PPD: Senior Vice President, Global Head, Corporate Development, Strategy and Ventures Bhooshi de Silva serves as global head of corporate development, strategy and ventures for PPD. In addition, de Silva leads the company’s enterprise data functions and manages venture partnerships. He collaborates with the senior leadership team on key strategic initiatives, leads PPD’s data and disruptive innovation priorities, and plays a key role in driving the company’s evolution and growth. Since joining PPD, de Silva has led the organization in completing several strategic partnerships and acquisitions, and in strengthening and expanding the company’s capabilities in priority focus areas. In joining PPD, de Silva brought 15 years of biopharmaceutical industry experience. He started his career at Pfizer, where his roles included R&D portfolio management, U.S. commercial development, and U.S. customer strategy and negotiations. In 2009, de Silva was named vice president of business development evaluation and strategy, leading a team in the evaluation of licensing, acquisitions and corporate strategic initiatives. Later, he served as head of corporate development, corporate strategy and head of international at Optimer Pharmaceuticals. De Silva played an integral role in the commercialization strategy and Optimer’s sale to Cubist Pharmaceuticals. He has an impressive track record of achievement in corporate strategic initiatives and M&A transactions

인공지능을 활용한 신약개발전략 : NEXT AI (Unleashing the NEXT Generation of AI in Life Sciences) Anshul Thakral, Executive Vice President, Chief Commercial Officer, PPD: Anshul Thakral serves as chief commercial officer of PPD. He joined PPD’s executive team in 2016 to lead the company’s biotech customer segment, with nearly 20 years of experience in the pharmaceutical and biotechnology industries, as a general manager, management consultant and entrepreneur. In 2019, his responsibilities were expanded to include full commercial responsibilities across both of PPD’s major customer segments: biopharma and biotech. Before PPD, Thakral ran the global life sciences business unit at Gerson Lehrman Group (GLG), where he created a customer business model to serve the pharmaceutical and biotechnology industries. Prior to GLG, he worked at McKinsey & Company, where he was an associate principal in the health care practice, counseling senior management and CEOs of global pharmaceutical and biotechnology companies on critical topics including growth, strategy, research and development, business development, go-to-market approaches and commercial models. Thakral earned his undergraduate and master’s degrees in biomedical engineering from Johns Hopkins University and an MBA from the Wharton School at the University of Pennsylvania.

단일 환자 포털을 통한 가상화 기술 활용 전략 Enabling (Virtualization Technologies Through a Single Destination Patient Portal) Rosamund Round, VP, Patient Innovation Center, Parexel: Rosamund Round is Vice President of Parexel’s Patient Innovation Center. She is dedicated to improving clinical research access and experiences, which led her to create the decentralized clinical trials service. By partnering closely with patients she continues to drive Parexel’s mission, to put patients at the heart of trials. Her role brings together experience in health psychology, innovation and patient engagement, and she has been delighted to help drive the industry’s continuous improvement of patient centric practices.

Case Study 빅데이터를 활용한 기관 선정 최적화 사례 (The Case for Data Collaboration to Drive Clinical Trial Performance) Chris Komelasky, Executive Director - Strategic Feasibility, Site and Patient Access, PPD: Chris Komelasky is an executive director of strategic feasibility. He leads PPD’s Global Investigator Services team responsible for the data quality and stewardship of PPD’s global investigator database and the site identification process. He also leads PPD’s Strategic Site Collaborations team responsible for developing innovative ways to partner with KOLs, sites and site networks. Chris has led a portfolio of strategic initiatives spanning data analytics, technology and process improvement, helping to enable the move towards better data-driven decision making. Previously, he helped lead the design and build out of the Rare Disease and Pediatric Center of Excellence and its supporting strategy, capabilities and service offerings and the commercial integration of a real-world evidence service provider. Chris has extensive experience as a management consultant and healthcare executive in the areas of strategy, operations, data analytics, commercialization and business transformation. Prior to joining PPD, Chris had been at GlaxoSmithKline for 5 years, leading a Sales Operations team in GSK’s Primary Care unit, helping the sales and marketing teams improve the strategy and execution of their product launches for their respiratory and diabetes portfolio. Chris worked in the area of global strategy and business transformation for GSK’s dermatology business unit, leading the change management and strategic initiatives that spanned the R&D, regulatory, supply chain, and commercial areas. Chris spent more than 9 years in management and strategy consulting at Accenture and ZS Associates. Chris holds a B.S. in Systems Engineering from the University of Virginia and an MBA from Duke University’s the Fuqua School of Business.

Case Study 빅데이터를 활용한 기관 선정 최적화 사례 (The Case for Data Collaboration to Drive Clinical Trial Performance) John Van Hoy, Executive Director, Data Science & Advanced Analytics, PPD: John has been in the life sciences industry for the last 15 years. With roles that span clinical trial operations, management consulting, and functional leadership, he has developed a focus on the use of data and analytics to help life sciences companies like Genentech and PPD get a competitive advantage. He has held two leadership roles in the area of data science for clinical research and has been at the forefront of industry efforts to bring innovation and predictive modeling to clinical trial operations and patient data analytics. He aims to help organizations by identifying novel use cases in data science, and building and managing data science teams to deliver those use cases.

코로나 시대의 환자 경험 향상을 위한 언텍트 임상시험 전략 : myMedidata (Improving Access to Clinical Trials for Rare Disease Patients through Registries) David Fajgenbaum, Co-founder and Executive Director, Castleman Disease Collaborative Network (CDCN): David Fajgenbaum, MD, MBA, MSc, FCPP, is an Assistant Professor of Medicine in Translational Medicine & Human Genetics at the University of Pennsylvania, Director of the Penn Center for Cytokine Storm Treatment & Laboratory (CSTL), Executive Director of the Castleman Disease Collaborative Network (CDCN), and Associate Director, Patient Impact for the Penn Orphan Disease Center. David Fajgenbaum is a groundbreaking physician-scientist, disease hunter, speaker, and bestselling author of the acclaimed memoir, Chasing My Cure: A Doctor's Race to Turn Hope Into Action. He went from being a beast-like college Quarterback to receiving his last rites while in medical school and nearly dying four more times battling Castleman disease. To try to save his own life, David spearheaded an innovative approach to research through the Castleman Disease Collaborative Network (CDCN) and discovered a treatment that is saving his life and others. Now, he is spreading this approach to other diseases such as COVID19. One of the youngest individuals ever appointed to the faculty at Penn Medicine and the top 1 percent youngest grant awardees of a leading NIH grant (R01), David Fajgenbaum has been recognized on the Forbes 30 Under 30 list, as a top healthcare leader by Becker's Hospital Review, the Global Genes RARE Champion of Hope: Science awardee, and one of three recipients--including Vice President Joe Biden--of a 2016 Atlas Award from the World Affairs Council of Philadelphia. He has published scientific papers in high-impact journals such as Blood, Lancet Hematology, and the Journal of Clinical Investigation, including a paper selected as one of the top innovations in science and medicine by STAT News in 2020. Before co-founding the CDCN, David co-founded and led the Actively Moving Forward Support Network, a non-profit organization dedicated to supporting grieving college students. David Fajgenbaum has been profiled in a cover story by The New York Times as well as by Good Morning America, CNN, and the Today Show, among others. David earned a BS from Georgetown University magna cum laude with honors and distinction, MSc from the University of Ox-ford, MD from the University of Pennsylvania Medical School, and MBA from The Wharton School.

AI와 머신러닝을 활용한 임상시험 이미징의 혁신 (Innovations in Clinical Trial Imaging) Kevin Thomas, CEO, Saliency: Kevin Thomas is CEO of Saliency, a software company that automates medical imaging assessments and quality control tasks for clinical trials. It halves the turnaround time for quality control, preparation of images for physician review, and image annotations. Kevin has 10 years of experience in the application of artificial intelligence to address challenges in biomedical research. Prior to co-founding Saliency, he attended medical school and performed graduate research in biomedical informatics, both at Stanford University. He has conducted research in Canada as a Fulbright Scholar and has served as an R&D consultant for Global 500 companies and professional sports teams. His work has been published in top journals in medical imaging.

Case Study 보스톤 사이언티픽의 전자동의를 활용한 환자중심 임상 (The Drive to Be Patient-Centric with eConsent: A Medical Device Case Study) Shari Swanson, Principal Business Analyst, Boston Scientific Corporation: Shari is a Principal Business Analyst in Rhythm Management’s Clinical Project Management Organization at Boston Scientific. She has been working in the Medical Device Industry for 27 years and has over 20 years of clinical experience at both Boston Scientific and Medtronic, working in the Rhythm Management and Structural Heart divisions. She works collaboratively across divisions and has expertise in several areas of the clinical process, specifically Data Management, Central Monitoring and Technology Solutions. Shari also has experience managing projects and has a passion for innovation and has been the driving force in implementing eConsent.

Case Study 코로나 19 팬데믹에서의 임상시험의 변화 (Adapting Your Trial in a Pandemic) Tommy Lee, VP of Clinical Operations, TissueTech Inc.: Tommy’s research experience spans 20 years across multiple therapeutic areas in all phases of clinical development and product types. These include pharmaceuticals, biologics, medical devices and human cell and tissue products (HCT/Ps). He has managed and overseen global clinical teams and trials, held multiple roles in Clinical Operations within large CRO's, functional service providers, large and small biotech and medical device and organizations. He has completed post graduate training focused in Clinical Research through The George Washington University School of Medicine and Tufts University in Clinical Research Administration, Pharmacology, Drug Development and Regulations, Leadership for Drug Development Teams and maintains certification as a clinical research professional through the Association of Clinical Research Professionals. As Vice President of Clinical Operations at TissueTech, Tommy has helped to build a full clinical operations department and infrastructure providing strategic leadership and input into the development of the clinical trial protocols, timelines, and budgets for the company’s assets so that the clinical designs are implemented in the most optimal manner to achieve their objectives. In November 2017, the FDA issued new guidance to the human cell and tissue-based product (HCT/P) industry in efforts to ensure safer and more efficacious delivery of HCT/Ps to patients. As a result, TissueTech is undergoing a rigorous biologics license application process that includes a series of investigational new drug clinical trials focused on unmet medical needs to treat chronic wounds, musculoskeletal disorders, rare diseases and restore ocular surface function. These multi phase clinical trials are being conducted at multiple locations throughout the United States under the supervision of Tommy Lee, MSHS, Vice President of Clinical Operations.

Case Study 통합플랫폼이 가능케한 우수한 환자 및 기관 경험 (Delivering a Superior Patient and Site Experience with a Unified Platform) Erin O’Boyle, Head of Clinical Operations, Rezolute: I joined Rezolute Bio in 2019 and I have nearly 20 years of clinical experience across all phases of development covering several therapeutic areas from large global programs to small pediatric rare disease studies. Prior to Rezolute, I worked at Fibrogen and led all clinical outsourcing and governance activities for their clinical programs, which ranged from the largest Phase 3 global anemia program ever conducted resulting in NDA filings to a small Phase 2 rare orphan pediatric program that was later expanded into an extension study. Prior to that, I was the Head of Clinical Operations at Heron Therapeutics and successfully led a CINV clinical program from Phase 1 up through NDA approval. What I have learned most in my various clinical roles is that in order to be successful, clear and consistent communication across all active study contributors sets the foundation for any clinical study and needs to remain in full force for the duration of the study.

Case Study 성공적인 임상을 위한 Syneos Health의 메디데이터 통합 플랫폼 표준화 (Partnering for Success on a Unified Platform) Joshua Wilson, Executive Director, Biometrics, Strategic Technologies, Syneos Health: Joshua leads the Strategic Technology Advancement Team within the Biometrics business unit at Syneos Health. He drives the use of innovative and advanced technologies, collaborating with sponsors, operations teams, and technology providers to deliver fit-for-purpose and targeted solutions to advance clinical development. During his 20 years of clinical research experience, he has led data operations and technical implementation teams, working closely with a wide range of sponsors and industry-leading technology providers. He is passionate about the need to implement technologies that reduce burden on patients and providers to advance research and world health. He is an active participant and contributor to the SCDM’s Innovation Committee and Medidata NEXT.

차세대 임상 운영: 디지털 변화의 성공을 위해 필요 조건 The Next Generation of Clinical Operations - What it Will Take to Successfully Drive Digital Change Gaurav Agrawal, Partner and Leader in R&D Practice, McKinsey & Company: Gaurav is a leader in McKinsey’s Pharmaceuticals & Medical Products Practice with over 15 years in-depth experience in R&D and innovation across therapeutics and vaccines. He serves biotechnology, pharmaceutical, and vaccine companies on growing through innovation, enhancing clinical trial strategy, and dramatically improving R&D productivity and performance Gaurav co-leads McKinsey’s work in product development excellence globally, with a focus on advancing biopharma asset development and bringing transformative therapies and vaccines to patients faster and better. His work has included accelerating the pipeline through patient-centric trial approaches, exploring advanced analytics approaches to make trial decisions and accelerating trial enrollment as well as incorporating digital strategies in trials – and more broadly thinking about the next paradigm of clinical trials and evidence generation Gaurav also led McKinsey’s R&D work during the Ebola epidemic and currently chairs McKinsey’s global COVID-19 taskforce for pharmaceutical and medical technology clients. Prior to joining McKinsey, Gaurav was general manager for a small generics company leading their expansion into regulated markets such as United States, Europe and Japan. He holds an MBA from Harvard Business School and a BTech in mechanical engineering from Indian Institute of Technology.