Speaker Biographies

Monique Adams is Executive Director, Global Head Diversity & Inclusion in Clinical Trials She is a thought expert on identifying innovative ways to improve the clinical trial experience for patients, clinical sites and the clinical teams who design and run the studies. She also manages the innovation project leads. Monique has a broad understanding of clinical development, gained through years of experience across Medical Affairs and Global Clinical Operations in different market environments. Monique is also the Vice-President of Women of Color in Pharma (WOIP) a nonprofit professional society founded in March 2015. WOCIP is committed to providing an environment that nurtures and empowers Black and Latina women employed in the pharmaceutical industry to take charge of their professional and personal development.

With specialization in Endocrinology and Metabolic Diseases, Dr. Barone has nearly 20 years of experience in management positions in Clinical Development, Clinical Operations and Medical Affairs. Prior to joining Alfasigma, he held roles of increasing responsibilities in both Biotech and big multinational pharma companies such as MSD, Novartis. Pfizer and Novo Nordisk. Extensive experience on both FDA and EMEA submissions contributing actively to the approvals of more than 10 new compounds in different therapeutic areas (Diabetes, CardioMetabolic, Endocrinology, Infectious Disease/Vaccinology) as well as in designing, implementing and managing structural changes/reorganizations/integrations within Development functions aimed to improve functional productivity, capability and effectiveness overall.

Alexa Berk, M.A. is Head of Real World Evidence at Ciitizen. Alexa has a BA in Psychology from Barnard College, Columbia University, and an MA as well as completed PhD coursework in Cognitive, Social, and Developmental Psychology from The New School for Social Research. Alexa has worked in health research for nearly 20 years, including health outcomes research design and management positions at Memorial Sloan-Kettering Cancer Center and at top pharmaceutical and medical device companies, managing large-scale global clinical trials. Most recently, Alexa was a Senior Director at Kantar Health, leading the design and execution of multiple HEOR and RWE studies with a variety of sponsors across disease areas including oncology and rare disease. Alexa has co-authored several journal articles in the oncology research literature including publications in the Journal of Clinical Oncology, Radiology, and the Journal of Cancer Education. In addition, Alexa has presented research at annual conferences for the American Psychological Association, the Society of Behavioral Medicine, the International Society for Pharmacoeconomics and Outcomes Research, the Miami Breast Cancer Conference, and the American Psychosocial Oncology Society. Alexa has also taught and guest-taught undergraduate and Master’s level classes at the New School for Social Research and the Columbia University School of Social Work, with a focus on health disparities, patient-reported outcomes, and research ethics in vulnerable populations.

Paul is Chief Medical Officer and serves on the Board of Directors for Phesi, and is a member of the Advisory Board for the George Washington University Milken School of Public Health and CStone Pharmaceuticals. Paul is also on the Advisory Board for ArisGlobal. Prior to his current positions Paul was Chief Medical Officer of Omada Health, where he oversaw the start of the largest clinical trial in digital therapeutics for diabetes prevention. Paul has served as Senior Vice-President, Global Chief Medical Officer in Paris for Sanofi Pharmaceuticals and concurrently as US R&D Head. At Sanofi, he represented the company at several FDA Advisory Committees and EMA Scientific Advisory Groups. He was responsible for important global functions: medical affairs, regulatory affairs, and pharmacovigilance with combined staff of about 2000 people in more than 100 countries.

Anthony Costello is President, Patient Cloud at Medidata, a Dassault Systèmes company. Costello leads the development of Medidata’s patient-facing activities and solutions including Virtual trials technology and strategy, Patient Cloud product apps, myMedidata patient portal, Disease Registries and Recruitment, Telehealth and Virtual Visits, and Sensor Cloud and Biomarker Discovery. Costello started his career in clinical research in the oncology research program at Genentech where he focused primarily on Herceptin and Avastin global research studies. After leaving Genentech, he went on to co-found several clinical trials technology start-up companies including EDC start-up, Nextrials (acquired by PRA Health Sciences) where he was co-founder and VP of Product Development and Virtual Trials and eConsent pioneering start-up, Mytrus (acquired by Medidata) where he was co-founder and CEO. Over his career, he has focused on disruptive and innovative technology that can simplify clinical trials for patients, sites, and sponsors. Costello was selected as one of the PharmaVoice Top 100 Most Inspiring People in Clinical Research, has served as Chairman of the Board for the Society for Clinical Data Management, and is currently a member of the editorial advisory board for Applied Clinical Trials magazine. He is a frequent author and presenter on topics related to the efficient use of technology in clinical research, and graduated with a BA from UC Berkeley.

Michelle Crouthamel is an “intrapreneur” and a pioneer of mobile technologies in pharmaceutical development. As the Head of Digital Science at AbbVie, Michelle leads a team of digital health strategists and signal processing scientists to modernize outcome assessments and advance drug development programs. Prior to joining AbbVie, Michelle led many successful innovation programs in R&D at Merck and GSK and received numerous awards. She is a scientific advisor to many tech companies, an inventor who holds multiple patents, and an author who published extensively in Neuroscience, Oncology, and Digital Health. Michelle also collaborates broadly with academics, tech, consortia, and health authorities to drive progress and realize the value of digital health.

Melinda Decker is Chief Commercial Officer of Mymee, the leading provider of 100% remote, digital care programs designed to help people with autoimmune disease reclaim their health. Mymee’s commercially validated trigger identification platform combines mobile technology, data analytics and personalized coaching to find the unique diet and environmental triggers behind each person’s disease symptoms and guide meaningful improvements in quality of life. Mymee currently offers it’s program directly to individuals, as well as through large self-insured employers and health plans. Melinda also serves as an advisor to MIT’s Health Science & Technology program and to several companies focused on digital health. She previously held leadership roles at AstraZeneca and Pfizer, spanning commercial and R&D. Melinda holds an MS in Biochemical Engineering and an MBA in Finance and Marketing.

Melissa Easy, Vice President of Clinical Technology Offerings for IQVIA, is responsible for the strategy, delivery, and development of technology portfolio and technology-enabled services that improve the delivery of clinical trials. She believes orchestrated technology can bring patients, sites, and sponsors together in a concerted effort to save time, money, and improve outcomes. Melissa founded DrugDev in 2009 and built collaborative relationships to become a trusted partner for many leading pharmaceutical companies. Prior to DrugDev, Melissa held many roles as a consultant to CROs and sponsors, where she accumulated insight into industry inefficiencies and formulated the concept for DrugDev. Melissa earned a bachelor’s degree in biotechnology and microbiology from the University of Technology, Sydney, and has received many awards, including being named as a PharmaVOICE 100 most influential people in life sciences, winning the ‘Partnerships in Clinical Trials Woman of the Year Award’ and being named by the Philadelphia Business Journal as a ‘Healthcare Innovator’, one of the ‘Top 40 Under 40’ and a ‘Woman of Distinction’. Most recently in 2020, she was named as an HBA Luminary.

Daniel Fürstenau is an Assistant Professor at the Copenhagen Business School Department of Digitalization. His research areas are IT management and digital health. He is also an Affiliated Professor at the Einstein Center Digital Future Berlin. He is the joint speaker of the Digital Health Group at the German Informatics Society and a member of the AIS and the Academy of Management.

Gregory A. Folz, CCRP, recently retired as the Administrative Director for the Research Institute of Deaconess Clinic. Folz has overseen more than 800 clinical trials in his research career, and successfully secured nearly $190 million in clinical trial grants for physician group practices and hospitals across the US. Recognized as a 2018 Top 20 Innovators in the research industry, Folz is also a recipient of the Site Innovation Award for the Society for Clinical Research Sites. In 2016, Folz founded Kits4Life, an international nonprofit organization to enable the life sciences industry to repurpose surplus clinical trials supplies for humanitarian aid. In collaboration with top pharmaceutical companies and the Task Force for Global Health, the organization has now supplied much needed medical supplies and equipment to humanitarian aid organizations in ten countries. In addition to serving as a national consultant and speaker on the advancement of clinical research operations, he currently provides strategic guidance to the Cardiovascular Research Consortium, and the Heart Failure Society of America, supporting national networks of research-savvy cardiology practices throughout the US. Folz also oversees the development of one of the nation’s largest repositories of cardiovascular data for academic research in heart disease. He has earned a designation of Certified Clinical Research Professional and is active in several industry organizations. Folz and his wife Ann live in Warrick County and enjoy spending time with their four children and 11 grandchildren.

Mohanad Fors is the Head of commercial digital innovation and the Digital Garden, Almirall's new startup accelerator. He led externally focused digital innovation hubs in different locations in the world, including Silicon Valley. He has more than twelve years of experience in sales, marketing and digital marketing with global, emerging markets, Europe, and the Middle East. Mohanad is the founder of successfully exited start-ups with strong knowledge in the start-up community. He won different global awards, including the European Excellence, Clio, and Cannes Lions awards for different innovative projects like the first navigation application for visually impaired patients available on smart watches.

Jennifer C. Goldsack co-founded and serves as the CEO of the Digital Medicine Society (DiMe), a global non-profit organization dedicated to advancing digital medicine to optimize human health. Jen’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine and Technology Leader at the World Economic Forum. Previously, Jen spent several years at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led development and implementation of several projects within CTTI’s Digital Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System. Jen spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware. Jen earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Ms Goldsack is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.

An experienced Vice President with over 25 years of experience in clinical operations strategy and leadership, Jason has an applied knowledge of leveraging data and analytics, digital technology, and collaborative partnerships. Jason provides consulting services for biotechs, pharma, vendors, and CROs to develop innovative approaches to optimise protocol designs, modernise clinical trial conduct, and accelerate delivery strategies. Jason is the Co-Founder of ClinOpsClarity, which provides a bespoke service for scoping, selecting, and onboarding outsourcing partners, and the Co-Founder of Emergent Teams, which equips teams and outsourcing partnerships to navigate constant change and accelerate performance in today’s fast-moving world. Jason is also a member of the ClinEco Advisory Board.

Shwen is a recognized pioneer in digital health and corporate innovation, as well as a respected biopharma industry thought leader who was named a Top 40 “Healthcare Transformer” by MM&M, a PR Week "Health Influencer 50", listed on the Constellation Research "Business Transformation 150" and has been recognized in Medika's list of "Fifty of the Most Influential Voices in Healthcare". Over the last 20 years, he has held leading roles in digital strategy and innovation within the biopharma industry. Most recently, he was the VP/Head of Global Digital Strategy at BMS, where he led innovation across the enterprise. Prior to that, he was the Co-Founder and Global Head of Open Innovation for the Novartis BIOME—a global network of innovation hubs. Currently, he is an independent consultant, investor, advisor, and mentor to various digital health start-ups.

Dr. Anya Harry is the Global Head for Global Demographics and Diversity at GlaxoSmithKline. Her passion for this area evolved from her experiences in the practice of medicine, public health and drug development and research. Previously, she was a Director in Clinical Development providing leadership and medical support for early as well as late stage programs and device initiatives in the Respiratory Medicine. After several years as a pulmonary-critical care physician in private practice, Dr. Harry became a medical officer and subsequently a branch chief at the US Food and Drug Administration. Prior to joining GlaxoSmithKline, she directed a multidisciplinary team for a global consulting firm with a large focus on rare diseases. Dr. Harry received her MD, PhD from Mount Sinai School of Medicine and completed residency at Yale New Haven Hospital. She completed a combined pulmonary and critical care medicine training at the University of Pennsylvania and the National Institutes of Health. Dr. Harry has authored many peer reviewed articles and book chapters.

A leader in the field of advanced analytics and data, Kyle helped create and now heads, AbbVie’s Development Design Center where he works with teams all over the world to ensure innovation, health technologies, and data tools are incorporated into AbbVie’s clinical trials. Whether it’s using real-world evidence and machine learning or incorporating wearables, sensors, and other devices into clinical trials, Kyle’s goal is to bring new and better treatments to more patients, faster. Before coming to AbbVie, Kyle was a physician who treated cancer patients and saw first-hand patients battle some of the most devastating diseases.

James Horne is Project Manager of the WEEE Forum and has 17 years’ experience in environmental consultancy and environmental project management focussed on waste. He previously worked as Project Manager for Urban Mines (now part of Anthesis), an environmental consultancy specialising in waste and recycling. Following this he established his own company, Horne Consulting, which offers waste consultancy services to the public and private sector. James has worked for the WEEE Forum since 2015 and was Project Manager for the successful ProSUM project, which set up the Urban Mine Platform. He currently works on the ORAMA, COLLECTORS, C-SERVEES, and CEWASTE projects focussing on communication and dissemination work packages as well as more technical elements. He has an excellent knowledge of the mechanics of H2020 funding and reporting and takes responsibility for this element of projects on behalf of the WEEE Forum. James also works centrally for the WEEE Forum on communications activities and project planning.

As VP, Global Clinical Development, Nephrology, Dr. Charlotte Jones-Burton is dedicated to creating healthier communities globally through drug development, patient advocacy and people engagement. Her three-pronged approach reflects her personal values of community, service, and health and wellness. Dr. Jones-Burton is a seasoned pharmaceutical executive, with significant experience leading clinical trial development for multiple medicines. She combines her leadership in research and people development with her clinical acumen in order to positively impact the lives of patients and communities who suffer with chronic diseases. Charlotte earned a medical degree and Master of Science degree in Epidemiology and Preventive Medicine, with a concentration in Clinical Research, from the University of Maryland School of Medicine. She is active in numerous professional associations and organizations and co-founded Women of Color in Pharma, a non-profit professional society focused on transforming the pharmaceutical landscape with women of color.

Hassan Kadhim is the Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at BMS. In his current role, Hassan's team owns the technology stack and capabilities within Global Development Operations, and drives change and innovation towards better outcomes for clinical trial stakeholders. Hassan is very passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Hassan regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Beyond BMS, Hassan actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges. He has a degree in bioinformatics and a graduate degree in pharmaceutical sciences, both from the University of Montreal in Canada.

Dr. Aaron Kamauu (MD, MS Biomedical Informatics, MPH, University of Utah School of Medicine) is an industry-leading advisor in the Real-World Data (RWD) space, specifically focusing on leveraging real-world healthcare data to support a variety of clinical research, informatics, clinical trials, and drug development activities, including pharmacoepidemiology, outcomes research, protocol design, site identification, data-driven patient recruitment, and the use of RWD to support evidence generation & submission to regulatory agencies (e.g., FDA). He has this experience across the spectrum of pharmaceutical/biotech, entrepreneurship, and large CRO businesses.

Joseph Kim serves as a Senior Advisor in Translational Technology and Innovation at Lilly, focusing on developing digital health solutions for patients. He also serves as the host of Lilly’s Podcast, Elixir Factor, which explores the factors that inspire bold advances in science, innovation and the resilience required to change history. He has spent over 20 years in the Pharma research industry utilizing a unique approach that integrates his experiences working for Sponsors such as Shire and Merck, CROs, and technology vendors. He has a robust combination of experience that includes early and late phase clinical research, and a well known history of innovation in the clinical research industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing the Face of the Clinical Trials Industry” by CenterWatch in 2013. He holds a BS in Molecular Biology from Lehigh University and an MBA from Villanova. He can be reached on Twitter: @JoPeKim

Dirk Langeneckhardt is Head of Data Integration and Submission Readiness at Merck Healthcare KGaA. In this role Dirk is responsible for external data integration, oversight and processes, data submission readiness consulting, DM process optimization and improvement as well as DM governance with CROs. Dirk has more than 30 years of experience in the field of clinical and medical research & development and is with the organization for 21 years, having held positions with increasing responsibility. He earned a Diploma in Geography, Geology and Botany from Cologne University and a Master of Business Administration from the Mitchell College of Business, Mobile, USA.

Jake LaPorte has many roles and is currently the co-founder of Prisma Therapeutics. He also founded and was the Global Head of The Biome—the digital innovation lab of Novartis. Prior to that, he was Global Head of Digital Development at Novartis and responsible for leading the company’s digital efforts to advance future, patient-centric paradigms of clinical trials. Jake began his career at McKinsey & Company, where he was a leader in their Pharmaceutical R&D practice, during his six-year tenure, developing an expertise in large, complex transformations and innovation. It was on a fateful, extended journey, however, where Jake read Ray Kurzweil’s The Singularity is Near and became captivated by the possibility of digitalizing the Pharmaceutical R&D engine; he has focused his career to the realization of this concept ever since. He co-founded Snapdragon Chemistry with the Head of the Chemistry Department at MIT, which seeks to enable companies to implement continuous flow chemistry in discovery, development, and manufacturing, with the ultimate goal of fully digitizing chemical synthesis. Jake has also held various leadership positions at PPD, Inc., where he collaborated with executives to develop and implement C-level, strategic initiatives, including a long-term transformation to create industry-leading approaches to clinical development in key therapeutic areas. Jake completed his PhD in Organic Chemistry from Harvard University, where he was an HHMI doctoral fellow, and received his BSc in Biochemistry and Mathematics, summa cum laude, from the University of Delaware.

Jason has over 19 years of experience working in Pharma, 14 years of which have been with Janssen. For the last 5 years, he has been a member of Janssen Clinical Innovation where he applies his strong technical and collaboration skills and global project leadership in delivering transformational innovation projects that have the goal to shape the future of clinical trial operations at Janssen. Jason is the Focus Area Leader for Environmental Sustainability in Clinical Research and is leading the transformation of Janssen’s global clinical operations towards sustainability.

Donna’s career spans across the pharmaceutical industry, professional conference development and legal field as a former practicing attorney. These combined experiences pivoted Donna into her most experienced role in Clinical Operations, with a focus on clinical site contracting, budgeting and payments. Donna leads a global Contracting and Budgeting team for Bayer, building Fair Market Value site budgets and providing training to the country organizations around the world. She also provides guidance and support on contracting and budgeting best practices for the local country organizations. Additionally, Donna is project lead and/or provides support and consultation for several major initiatives at Bayer, including implementation of automated payments and decentralized clinical trials. Donna is also on the Advisory Council on behalf of Bayer for Kits4Life, a non-profit platform to repurpose lab kits and bulk medical supplies from clinical trials for humanitarian aid and research in developing countries. Donna is the Chair of the Site/Pharma on-boarding workstream for Kits4Life. Prior to converting to Bayer, Donna was an Associate Director for PRA Health Sciences and embedded at Bayer as the U.S. Contracts Manager. Donna grew and managed a U.S. team of over 20 clinical contract specialists and associates. She managed the contracts team and operational aspects of clinical contracts, budget negotiations, to those thorny site payment issues. Donna is also a Patient Educator with Pathways Women’s Cancer Teaching Project and a member of their Advisory Council. Her Patient Educator role entails speaking on panels or 1:1 interviews with medical students and residents about her experience as a triple-negative breast cancer survivor. They are unique opportunities for healthcare professionals to learn about patients’ personal experiences through educational dialogue in a less formal setting. Donna earned her JD degree at The Washington College of Law, The American University, and BS in Political Science at Douglass College, Rutgers University. Donna’s five-year residency in Rome, Italy spurred her love for travel and historical adventures. She is married with two daughters, residing in New Jersey. But her heart remains in bella Roma!

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working as an advisor and board member with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig is also the Co-Chair for the Decentralized Trials & Research Alliance, the leading non-profit collaboration focused exclusively on improving access for research participation. Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University, and Adjunct Instructor in the Center for Health + Technology at University of Rochester. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. Previously Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures. He has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth.

Lisa leads the Strategic Customer Engagement organization at Medidata, ensuring our customers’ voices drives the value we bring to market. Lisa is a seasoned leader in the intersection of technology and clinical research, with nearly 25 years of experience across pharma, biotech, and medical devices. Her roles include leadership of product, engineering, AI research, and customer engagement organizations within both sponsor and product technology companies – supporting the industry’s ever evolving need for innovative technology to improve clinical development and patient outcomes. Lisa serves on the board of ACRO, and is on the advisory board for the Sexual and Gender Minority Alliance. Lisa holds a BS in Biomedical/Biochemical engineering from the University of Southern California.

Dave joined EMD Serono (Merck KGaA, Darmstadt, Germany) in 2016 as the Head of Clinical Quality Management. In this role he has global responsibility for the strategy, implementation, oversight, and improvement of risk-based approaches to quality management for the clinical development portfolio and associated business processes. Prior to joining EMD Serono he spent 23 years with Pfizer, most recently as Senior Director of Clinical Development Quality where he was responsible for the development and implementation of a comprehensive approach for quality by design and quality risk management in clinical trials and for leadership of the Clinical Development Quality team in China. Dave was also a member of the Expert Working Group that lead the development of ICH E6 R2.

Wim Nijhoff is a leader in Merck KGaA Global Development Operations/Clinical Quality Management department. In this role, Wim acts as the global Business Process Owner for Clinical Monitoring, including Risk-Based Monitoring for the company. In this role, Wim oversees and contributed to the creation and management of the processes, technology, and resources to support a data-driven analytical and risk-based oversight model across the pipeline portfolio. Wim has over 25 years of experience in clinical research and drug development in different roles in global pharma and CROs.

"Work Hard, Stay Calm, and Cure Cancer." This guiding principle defines Peter O'Neill, a leader in oncology clinical trials with over 25 years of experience at Sponsors, CROs, and Hospitals. Recognized as one of PharmExec’s Emerging Pharma Leaders in 2020, Peter specializes in transforming complex clinical operations into patient-focused processes. His passion for fostering high-performing teams and a culture of collaboration drives breakthroughs in cancer treatment. Outside of work, Peter finds balance and inspiration through cooking, photography, and music

Melissa Price, Sr. VP Emerging Oncology Products, leads the emerging medicines pipeline at bluebird bio, responsible for the strategy and execution of the cell therapy-focused early-stage oncology portfolio. She has held numerous leadership roles in other biotech companies, including VP Program and Alliance Management at microbiome-focused Kaleido Biosciences, VP Clinical Development at TARIS Biomedical focused on urologic oncology, VP Product Development at immuno-oncology company Heat Biologics, and Business Unit Head for a global external large pharma partnership at INC Research (now Syneos Health). She holds a Ph.D. in Organic Chemistry from Yale University.

Dr. Thomas Rooney is Global Project Leader of R&D Corporate Social Responsibility (CSR) at Sanofi. Prior to taking this new role in 2017 he was head of Neurodegeneration Research at Sanofi where he led research groups and headed drug development programmes focused on developing treatments for Neurodegenerative Diseases, including Alzheimer’s and Parkinson’s Disease. He received his BSc in Pharmacology from the University of Glasgow, UK (1984) and his PhD in Neuropharmacology from the University of Leicester, UK (1987). He then moved to Thomas Jefferson University in Philadelphia, USA (1988-1998) where he was a postdoctoral fellow and then Assistant and Associate Professor in the Dept. of Pathology and Cell Biology. Since 1998, he has worked at Sanofi R&D based in France. He has also represented Sanofi R&D on several public-private consortiums and for interactions with CSR external stakeholders and is a member of the Kits4Life Advisory Council.

Mark has worked in the pharma industry for over 25 years. While most of his time has been spent in clinical operations, he also spent some time working on process re-engineering. Mark is currently VP, Head of Site Management Americas Region at Bayer Pharmaceuticals. His oversight includes Canada, US and LATAM. His group is responsible for all Phase I-III clinical trials across various therapeutic areas including Cardiovascular, Women’s Healthcare & Oncology. Besides his focus on clinical trials, he sponsored the Kits 4 Life initiative at Bayer. Prior to his time at Bayer, Mark was a study coordinator at a clinical research site. Mark holds a BA in Psychology from Penn State University and an MBA from the University of New Haven.

Dr. Jessica Scott is the Head of R&D Patient Engagement at Takeda. Prior to Takeda, she was with Global Medical Organization, leading efforts related to clinical trial transparency, patient centricity initiatives, bioethical issues and the development of GSK’s approach to sharing aggregate results of clinical trial in plain language. Jessica received her MD from Tufts University School of Medicine, completing her residency in Family Medicine with the University of Virginia. She practiced Family Medicine in NC for more than a decade, leaving her medical practice to join GlaxoSmithKline. Jessica also attended Campbell University School of Law, graduating with honors with admittance to the NC Bar in 2010, where she is currently licensed.

Craig Serra is currently Executive Data Management and Clinical Systems Transformation Consultant currently supporting Amgen, where he is focused on leadership within the largest strategic initiatives spanning clinical development. With 23+ years in the clinical research industry, Craig has held senior leadership roles at Pfizer, Novartis, Flatiron Health, IQVIA, and DSP Clinical. He has been recognized for driving enterprise-wide transformations, pioneering AI- and technology-enabled approaches to data flow, and accelerating trial execution through innovation in data management and clinical operations. Prior to his current consulting work, Craig built the commercial function of the Clinical Research business at Flatiron Health, introducing new solutions in protocol optimization, site intelligence, patient matching, and EHR-to-EDC integration, scaling the portfolio 8x in under three years. At Novartis, he led strategy and innovation for a 1,500-person Data Operations organization and sponsored AI-powered initiatives in clinical technology and regulatory writing. Earlier, he helped redefine process ownership and RBQM adoption at Pfizer, modernized global eTMF at IQVIA, and served in a variety of executive leadership roles at DSP Clinical. Craig holds an MBA and dual MS degrees in Pharmacology & Toxicology and Information Systems. He has served on multiple industry boards, is a two-time PharmaVOICE 100 honoree, and is an active angel investor.

Four decades of drug development experience in government & pharma, in Europe and the US. Last decade in RBQM implementation, setting up Centralized Monitoring processes & tools, developing coherent indicator dashboards for different functions, moving from corrective action to preventive action. Currently focusing on continued implementation of ICH E6, based on R3.

Paulina Szczepaniak, MPharm and Associate Director & Clinical Data Management Operations Lead at MSD, started her career in 2015 and progressed through multiple roles with increasing levels of responsibility and technical expertise in various Therapeutic Areas (TAs). Paulina is ensuring quality in DM processes as sub-process owner and Subject Matter Expert (SME) in clinical trial data validation as well as acting as a change agent for the adoption and implementation of new technologies, following Industry standards and ensuring the best possible results for the end users.

Jean-Marc is Clinical Research Global Innovation Lead within Clinical Sciences & Operations at Sanofi. With more than 25 years of experience in the management of clinical trials, phase I to IV, in various therapeutic areas and in the different environments of the industry: biotech, pharmaceutical and CRO, Jean-Marc joined Sanofi 14 years ago. First as Medical Advisor in Multiple Sclerosis in the Canadian Clinical Study Unit, then developing a strategic partnership with investigator sites across the globe, towards site optimization and performance. Jean-Marc has participated in various initiatives such as Your voice Survey stream, also leading the Site Engagement workstream under SMILE (Sanofi Making Investigators Life Easier) and having various implications in initiatives to bring the voice of the sites all along the innovation journey. As a Global Innovation Lead, Jean-Marc is managing, facilitation the Clinical study unit innovation strategy and roadmap. Jean-Marc holds a master’s degree in Biochemistry at University Paris XI and MBA at ESSEC- IGIA in France.

As lead of the Philips Circular Economy program, Harald aims to drive innovation and business value creation via the transition to a circular economy. As such, he focuses on closing loops, product and business model design, further embedding sustainability and circular thinking into the core processes and culture of the company – with active engagement of employees. Harald is member of the ‘Regieteam’ of UPCM (het Uitvoeringsprogramma Circulaire Maakindustrie onder Nederland Circulair 2050). Harald is also linking pin with the Platform for Accelerating the Circular Economy (PACE), which is co-chaired by Philips’ CEO Frans van Houten. Prior to Philips, Harald worked as Director of the DNA Investigation Department at the Dutch Forensic Institute, and as transformation management consultant at McKinsey & Company. Harald holds a PhD in Molecular Physics, and a teaching degree in music.

I'm a systems neurophysiologist by training that applies my training as a scientist to pilot and deliver patient centric innovation in clinical trials. In my current role I am the procurement business partner for Takeda's Data Science Institute and our Patient Engagement Office. This puts me in the strategic position to facilitate the delivery of technological innovation that is best positioned to improve the clinical trial experience for patients. My focus is on developing and implementing a supplier strategy that not only creates operational efficiencies for the sponsor but also reduces the burden for patients enrolled in clinical trials.

Tracy is the Vice-President of Pharma Clinical Delivery & Operations at GlaxoSmithKline and is accountable for end-to-end delivery of clinical trials across all therapy areas and phases of development, including medical writing. Tracy has 20+ years experience working in drug development and has held numerous leadership positions and is a member of several external steering committees. Prior to her current position, Tracy served as the Vice President of Clinical Pharmacology Sciences & Study Operations and as the Oncology Clinical Operations Therapy Area Head. She has also served as a Therapy Area Head for Infectious Diseases and Dermatology. Previously, Tracy worked at Bristol-Myers Squibb and SmithKline Beecham in several project facing roles supporting both early and late stage development. Tracy is the company representative for the Clinical Trials Transformation Initiative (CTTI) and has served as the Rapporteur for the ICH M11 working group. She is also a Board Member for Biopharmaceutical Innovation at the University of Delaware Tracy studied Biochemistry and Pharmacology respectively, at Wake Forest University and Thomas Jefferson University.

Consulting and advising clients to expand the access and use of real world data (RWD) for evidence generation in life science R&D. Additional focus areas include data-driven “decentralized” trials and research, while seeking to advance & accelerate drug and medical device development as well as post-launch commercial planning. Building upon 25+ years of Life Science R&D experience to shape new research models and paradigms. Driving strategic engagements that span C-leader and Board-level planning, health system engagement and partner & collaborator outreach—all under the banner of robust research integrity—respecting all global patient privacy and data security regulations.

Experienced (20+ years) Clinical Development Leader specialised in Data Management with broad international Drug Development expertise and wide industry knowledge (small Biotech to large Pharma) with a passion for leading cross-functional teams to successful delivery.

Sven Vogelgesang is Head of Global Clinical Data Sciences at EMD Serono. Since over 25 years he is working in the pharmaceutical/chemical industry and held various positions, amongst others Sven was heading Clinical Information and Learning Management, Clinical Applications Services and Knowledge Management. Sven has a Master in Medical Informatics and an MBA from Ashridge Business School, UK.

Feng Wang serves as a Program Officer in UN Environment in its Paris office. He manages projects in the areas of Life Cycle Thinking and Sustainable Consumption and Production, to promote the application of life cycle knowledge in both public and private sectors. Feng holds a Doctorate Degree from Delft University of Technology in the Netherlands, on topics of eco-design and waste management of obsolete products. Before joining UN Environment, he worked as a researcher in the United Nations University in Germany and a visiting researcher in Statistics Netherlands, to carry out projects on quantifying global flows and environmental impact of electronic waste, and to provide policy recommendations and technical solutions for developing countries.

Brian Winger is currently a Sr. Advisor of Translational Technology & Innovation (TT&I) in Eli Lilly & Company’s Digital Health Office. He has a Ph.D. in Analytical Chemistry with more than 7 years of experience developing high resolution mass spectrometric instrumentation for life science applications as well as 20+ years of experience supporting the discovery and development of novel pharmaceutics while at Lilly. In the TT&I group, Brian has responsibility for identifying, developing and validating digital biomarkers to enable the establishment of relevant digital-based novel endpoints in support of Lilly’s medicine development portfolio.

Demetris is currently VP and Global Head of Data Monitoring and Management at Pfizer. Demetris started his career as a Laboratory Scientist in 1991 and transitioned into the Clinical Development space where he held roles of increasing responsibilities in Trial Management and Monitoring and led the implementation of the company’s first Clinical Trial Management system. In 2000, Demetris was a member and eventually the leader of the team which executed the industry’s first Tech-Transfer of a web based EDC system. He eventually led the Data Management and Standards organization and continued on to Merck & Co. following the merger in 2009. Subsequently Demetris was Vice President of Data Management at Novartis AG from 2014 to 2017. Since 2017 Demetris leads Pfizer’s Data Management and Risk Based Monitoring line functions in a new transformation; developing and transitioning into an internal operating model across multiple geographic sites in support of Pfizer’s portfolio. He also leads the Data and Automation work stream as part of Pfizer’s Development-wide transformation effort. He currently serves on multiple Boards, including SCDM’s Advisory Board, has served on the Board of Trustees and was the 2016 Chair.