Steve’s career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud-based solutions with a focus on driving more integrated approaches to patient-centric trial management. Steve was most recently Senior Vice President and General Manager of Oracle Health Sciences. Prior to that, he was the visionary behind the integrated clinical technology suite introduced by Phase Forward which was acquired by Oracle in 2010.

Steve also sits on the board of two residential homes for abused children, and started a non-profit company, The One By One Project, with his wife, to help people in need in the Boston area.

Dr Marsha Samson joined the FDA from CDC where she served as a Career Epidemiology Field Officer (CEFO) assigned to the DC Health Department to strengthen state, tribal, local, and territorial epidemiology capacity for public health preparedness and response. D. Samson earned her BS in biomathematics from Florida State University, her MPH/MSHSA from Barry University, her PhD in Epidemiology from the University of South Carolina, and completed her postdoctoral training at Georgetown University in cancer biology. Now, Dr Samson manages key CDER initiatives related to the use of AI/ML in the development of drugs and obtained her Regulatory Affairs Certification (RAC) in drugs and devices. Dr Samson is committed to fostering equal opportunities for accessing secure and efficient medications, as well as enhancing public health in general.

Doug Schantz is Senior Vice President at Asklepios BioPharm, a gene therapy company. In his current role, Mr Schantz has responsibility for Program Leadership, Study Management, Data Management, and Medical Writing.

Prior to joining Asklepios BioPharm, Mr Schantz was Vice President, Clinical Operations at Alexion Pharmaceuticals and was accountable for project delivery of Alexion’s portfolio and led a group responsible for program leadership and study management across all phases of drug development and in all of Alexion’s therapy areas, which include hematology, metabolic diseases, neuroscience and nephrology.

Prior to joining Alexion, Mr Schantz was an Executive Director in Development Operations at AstraZeneca, heading up US Site Management and Monitoring. In this role, Mr Schantz led the transformation to an in-house monitoring group in 2017 and is the proud recipient of the Society for Clinical Research Sites Eagle Award for best sponsor in 2018. Additional contributions and roles included leading late-phase, full-service outsourcing (SCOUT), development and implementation of the late-phase sourcing strategy and implementation of risk-based quality management for the AstraZeneca enterprise.

Additional experience included working at Pfizer for 17 years and Eli Lilly and Company for 8 years, having held a wide variety of positions in clinical research, including clinical development, project management, portfolio management and data management.

Mr Schantz was trained as a paramedic at the University of Medicine and Dentistry of NJ and holds a BA in Public Administration from Kean University. Mr Schantz volunteers as a guest lecturer in the graduate program in Clinical Research Administration at Eastern Michigan University, serves on the Leadership Council for the Society for Clinical Research Sites, facilitates the Linking Leaders Clinical Operations Roundtable and participates on the Disruptive Pharma (DPharm) program committee and DPharm Idol competition. Mr Schantz is the president and volunteer coach for the Saline Area Soccer Association and earned the distinction of Michigan State Youth Soccer’s Volunteer of the Year in 2022.

Patrick Schorderet has over two decades of experience in consulting, global companies, startups and academia. Dr Schorderet has a proven track record of delivering innovation across the entire pharma value chain. He brings a unique profile at the interface of science, technology, and business, to support holistic and people-centric transformation towards a more connected world.

Meri Kay Scott is responsible for leading the Digital Health Research and Development – Clinical Operations team at Eli Lilly and Company.

Digital Health R&D allows Dr Scott to connect her more than 25 years of global clinical development experience with technology and passion for patients and sites by leading execution of Digital Health Technologies in clinical studies and engaging in Lilly’s Digital Health focus on science-driven patient engagement. This includes the development of digital biomarkers/digital measures for innovative and optimized clinical trials, and provides timely diagnoses, smarter interventions, better adherence and improved health outcomes for patients who require our medications.

Within her 20+ years at Lilly, Dr Scott has had a breadth of technical, managerial and leadership roles in clinical drug/trial development, clinical project management and global clinical operations across therapeutic areas, much with a focus on diabetes, from early drug development to the market. Most recently, her experience is being leveraged in Lilly’s technical space.

Additional career highlights include academia at Purdue University and similar clinical work at Amgen. She earned her bachelor’s degree in Pharmacy at South Dakota State University with her Masters and PhD in Clinical Pharmacy from Purdue University, specializing in nephrology and diabetes.

Craig Serra is the Head of Commercial Solutions and Partnerships for Flatiron’s Clinical Research business unit, where he is accountable for sales, business development, partnerships, and related activities for the clinical research team. Mr Serra was previously the Global Head, Strategy and Innovation for Data Operations at Novartis and has held senior leadership roles at IQVIA and Pfizer, as well as served in a multi-faceted executive role at a niche CRO (DSP Clinical). He is a recognized industry leader and was named Pharmaceutical Executive’s “2020 Emerging Pharma Leaders” and PharmaVOICE “100 Most Inspiring People” for both 2017 and 2020. Mr Serra earned a BA in Psychology from Rutgers University, an MBA in Management and an MS in Information Systems from Fordham University, and an MS in Pharmacology and Toxicology from Michigan State University.

Judy Sewards currently serves as the Vice President, Head of Clinical Trial Experience and Participant Recruitment at Pfizer.  In this role, Ms Sewards leads a team responsible for designing and delivering new communications and services that provide ease and convenience for more than 6,000 clinical trial sites around the globe and over 100,000 participants who graciously join Pfizer’s trials every year to help advance potential medical breakthroughs. She also stewards the company’s equity commitment to diversity in clinical trials and is launching novel enrolment strategies to help address access barriers and accelerate clinical development, focusing on new ways that engage participants within each investigator’s practice, institution, and community.

Ms Sewards was formerly Vice President, Digital Innovation in Pfizer’s Strategy & Commercial Operations organization, where she set and activated new digital and big data strategies to help the enterprise meet business and customer needs in the future health landscape. Prior to that, she held a number of leadership positions within Pfizer’s commercial organization, including Team Leader for the U.S. Celebrex and Flector Patch businesses, Head of the Primary Care Marketing Innovation Incubator, and Consumer Lead for the iconic Viagra brand.

Before joining Pfizer, Ms Sewards led insights, brand strategy and advertising at Merrill Lynch Global Wealth Management. Her other diverse experience ranges from tech start-up to brand advertising and management consulting.  Ms Sewards received her bachelor’s degree from Smith College, where she also served as a member of the Board of Trustees.

Elmutaz Shaikho is a registered pharmacist, 9x certified AWS technologist, and bioinformatics scientist, holding an MBA. With a deep interest in the intersection of data, technology, and pharmaceuticals, Dr Shaikho began his career as a pharmacist in 2002. Over the last 5 years, he has leveraged computational science, cloud technology, and ML/AI to not only enhance patient care but also drive innovation in the pharmaceutical industry. These efforts have aimed at reducing the gap in patient unmet needs and accelerating time to value through cutting-edge technologies. Recognizing that advances in science are crucial for understanding diseases and developing drugs, Dr Shaikho also champions data, technology, and ML/AI as the transformational forces of successful organization.

Dr Michael Sherman serves as venture partner at RA Capital Management, a $9 billion multi-stage investment manager, dedicated to evidence-based investing in public and private healthcare and life science companies developing drugs, medical devices, diagnostics, services, and research tools.

Prior to joining RA, Dr Sherman served as executive vice president and chief medical officer at Point32Health, formed by the merger of Harvard Pilgrim Health Care and Tufts Health Plan, two leading not-for-profit health plans insuring over 2 million members. Prior to the merger, he served as chief medical officer of Harvard Pilgrim Health Care, nationally recognized for both innovation and quality.  He has been widely recognized as a pioneer in bringing advances in transformational therapeutics, precision medicine, and digital therapeutics to Point32Health’s members by launching structured pilots that balance access and affordability and also generate real world evidence.

Dr Sherman holds board appointments with several well-respected nonprofit organizations, including the Personalized Medicine Coalition, the Harvard Business School Healthcare Initiative, and NEHI (Network for Excellence in Health Innovation). For a decade, he served as chair of the Board of Managers of the Harvard Pilgrim Health Care Institute, which encompasses the Department of Population Medicine at Harvard Medical School—the nation’s only appointing medical school department based in a health plan.

Before pursuing an MBA at Harvard Business School, Dr Sherman received his MD from Yale and practiced as a cardiac anesthesiologist. He also holds a BA in Anthropology and Natural Sciences and an MS in Biomedical Anthropology from the University of Pennsylvania.

As a Senior Consultant at ZS, Tricia Siddharth is a dynamic contributor to the Research and Development Excellence team. Ms Siddharth’s expertise spans real-world data generation, clinical trial operations, and a comprehensive understanding of the spectrum from early clinical development to early commercialization. With a strategic focus on leveraging real-world data, Ms Siddharth employs AI/ML to develop predictive and modeling tools that enhance the efficiency of clinical development processes. This approach not only drives optimal clinical trial outcomes but also enriches the understanding of the value that commercialized drugs offer patients in both oncology and non-oncology indications.

Maureen Silverman is the Director of Monitoring Strategy and Oversight at Regeneron. Maureen and her team are responsible for providing monitoring strategy support for Regeneron-led studies that includes implementation of Risk Based Monitoring and oversee execution of Regeneron’s Oversight Monitoring program.

Maureen has been in the industry for 20+ years and worked for various pharmaceutical companies in Clinical Operations roles, overseeing study management and operational execution of early to late phase programs in CNS, Cardiovascular, Infectious disease and Immuno-oncology therapeutic indications.