Digital Technology in Clinical Trials Conference
Megan Doyle, JD, MPH
- Global Policy Lead, Digital Health, Diagnostics, Oncology
- Amgen, United States
Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health from Johns Hopkins University. After seven years in the medical device practice at Hogan Lovells, she joined Amgen as a Senior Counsel for Health Regulatory. For four years, she counseled Amgen on drug, device, combination product, digital health, and companion diagnostic matters. Currently, she is a Director in Amgen’s Global Regulatory and R&D Policy group, where she is the Global Policy Lead for Oncology and Medical Device-related matters.
Jonathan Andrus, MS
- President and Chief Operating Officer
- Clinical Research IO (CRIO), United States
Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical operations and data management teams. His early career includes experience in pharmaceutical consulting and contract research organizations. Andrus serves on the board and executive committee of the Society for Clinical Data Management (SCDM), is a co-lead with the Decentralized Trials and Research Alliance (DTRA) workstream initiative, serves as co-author on upcoming eCOA Consortium publications, and has been on the advisory boards of CDISC and DIA.
Rachel Chasse, MS
- Digital Operations Lead
- AbbVie, United States
Rachel Chasse is a Digital Operations Lead at AbbVie. operationalizing digital health technologies for success in clinical trials. Previously, she was the founding Director of Innovation at the Digital Medicine Society (DiMe), fostering collaboration and connection within the digital medicine field, leading DiMe's scientific programming and strategic vision. Before DiMe, Rachel worked in the Digital Medicine group at Pfizer, operationalizing digital innovation for inclusion within clinical trials. Before Pfizer, she worked in dementia research supporting patients and their families at Washington University in St. Louis where she earned her Master of Science in Clinical Research Management.
Elena Izmailova, PhD
- Chief Scientific Officer
- Koneksa, United States
Elena Izmailova, PhD (Chief Scientific Officer) leads scientific strategy and partnerships at Koneksa Health Inc with over 25 years of experience in academic and industry research. Her academic appointments include Harvard Medical School and MIT. She is a co-founder of the Digital Medicine Society (DiMe) and a member of the Editorial Boards for Clinical and Translational Science and Digital Biomarkers Journals. She has a PhD in Biology; her main scientific interest is clinical biomarker development and validation.
- Executive Director, eCOA Consortium
- Critical Path Institute, United Kingdom
A patient-based clinical technologies expert with over 25 years of clinical research experience, Scottie serves as the Executive Director of the eCOA Consortium at Critical Path Institute. Beginning his career in clinical data management, Scottie first encountered ePRO technology back in 2003, taking a role as ePRO lead at Wyeth’s Vaccine Research Unit. Establishing himself as an industry SME and thought leader on ePRO and eCOA, he served as the Head of Patient Technologies and Global Head of ePRO at Wyeth and then Pfizer until 2011. He launched his own consulting firm in 2013, supporting a range of industry entities with eCOA strategy and implementation, He joined C-Path in 2021.
Sarah Krug, MS
- Executive Director
- CANCER101, United States
Sarah Krüg is the Executive Director of CANCER101, a patient advocacy organization whose mission is to help patients and care partners navigate cancer care and partner with their healthcare team to make informed decisions. Sarah is also CEO of the Health Collaboratory, a global innovation hub focused on amplifying the voice of the patient in healthcare innovation and cultivating trust across healthcare. She previously held the position of Global Education Director at Pfizer, as well as Patient Advocacy Relations, where she also established the Global Investigator Initiated Research Program. Prior to joining Pfizer, Sarah spearheaded the development of Disease Management clinical pathways at MSKCC.
Jules Mitchel, PhD, MBA
- President and CEO
- THI Pharma Services, United States
Dr. Mitchel is a President and CEO of THI Pharma Services. He also created the team at Target Health developing software tools to enable the “Paperless Clinical Trial.” Dr. Mitchel recently served on the Executive Committee of CTTI where he represented the Steering Committee. Dr. Mitchel has held positions at Ayerst Laboratories, Pfizer Laboratories and Pfizer Consumer Health Care. Dr. Mitchel is currently Adjunct Professor of Pharmacology and Toxicology at the Ernest Mario School of Pharmacy (Rutgers), Adjunct Clinical Professor in the Department of Dermatology (SUNY Stony Brook School of Medicine) and Lecturer at New York Medical College.
Steven Murray, PhD
- Group Vice President and Principal Engineer, Electrical and Data Sciences
- Exponent, United States
Dr. Murray is a Group Vice President at Exponent, specializing in failure analysis of electrical and mechanical systems, and using advanced data tools to inform failrue analysis and understanding of risk. Engineering systems investigated include appliances, computers and consumer electronics, medical electronics, and large electrical generators and motors. These investigations have involved understanding and analysis of complex electrical and electronic systems, fracture and fractography, risk assessment, environmental effects, electrical and magnetic modeling, and materials defects. Dr. Murray was a Consulting Assistant Professor at Stanford University where he taught the course Techniques of Failure Analysis from 2006 - 2015
Lauren Oliva, PharmD, RPh
- Director, Global Regulatory Policy & Digital Health Policy Lead
- Biogen, United States
Lauren Oliva is the Global Regulatory Policy Lead for Digital Health at Biogen. She oversees the development and execution of R&D’s policy roadmap for digital health technologies to enable Biogen’s neuroscience portfolio. She is passionate about patient centric drug development and the impact of multi-stakeholder initiatives to advance the adoption of new technologies. Lauren is actively engaged with the Critical Path Institute, CTTI, and the National Academies’ Drug Forum. Lauren has over 10 years of experience in the pharmaceutical industry. She received her PharmD from Rutgers University, Ernest Mario School of Pharmacy and has previously served as adjunct faculty and lecturer at MCPHS University in Boston, MA.
Shelly Steele, MA
- Senior Scientific Advisor, eCOA
- WCG Clinical, United States
- Senior Director, Scientific Data Organization
- Parexel International, United States
Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate, and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working with and for contract research organizations, technology partners and clinical trial sponsors. His areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials. He has been on the program committee of several Drug Information Association meetings and is chairing and speaking at this year’s DIA Annual Meeting.
Shyreen Kamal, PharmD
- Manager, Scientific Programs
- DIA, United States
- Vice President, eCOA
- IQVIA, United States
Shrawan Patel, MD
- Managing Director
- Strategy Health, United States
Scott Askin, MSc
- Global Program Regulatory Director
- Novartis Pharma AG, Switzerland
Currently working in the area of Regulatory Affairs for Novartis, Scott has over 20 years of industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to his current role in Regulatory Affairs Policy, Scott led several of Novartis’s digital innovation projects. Since his transition into Regulatory, Scott continues to advise digital program teams internally in areas such as eConsent, eSource, Decentralized Clinical Trials, Blockchain & AI, and collaborates externally in several cross-industry initiatives.
Sanghita Bhattacharya, PhD
- Associate Director Data Science Portfolio Management
- The Janssen Pharmaceutical Companies of Johnson & Johnson, United States
Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as Pharma in R&D and commercial organization. She received her Ph.D. in Bioengineering from The University of Toledo, OH, and B.S in Mechanical Engineering from BPUT, Bhubaneswar, Odisha India. She is also a certified Project Manager (PMP) through PMI, FPX trained as well as Prosci certified change practitioner
Katie Chowdhury, MS
- Director, RA Digital & Medical Device Team, Emerging Technology & Combo Products
- Abbvie, United States
Katie joined AbbVie in May 2021 as a Director of Regulatory Affairs for the newly formed Digital & Medical Device Team in the Emerging Technology & Combination Product group. In this role, her team supports internally developed SaMD projects providing regulatory strategy during development and GRL support prior to global launch. Her team also supports the assessment and implementation of DHT in clinical trials from a regulatory perspective. In addition, she is the lead Device Regulatory for the ABBV-RGX-314 partnership between AbbVie and Regen X Bio supporting both key ancillary devices required for the Subretinal and Suprachoroidal delivery of the biologic.
Elena A Christofides, MD
- Chief Executive Officer
- Endocrinology Associates Inc., United States
Elena Christofides, MD, FACE, is a physician and the chief executive officer at Endocrinology Associates, Inc in Columbus, Ohio. She is also the founder and director of Endocrinology Research Associates, Inc, an independent research facility. Dr. Christofides earned her undergraduate degree from Ohio State University in Columbus, Ohio, and her medical degree from the Ohio State University College of Medicine. She next undertook a residency at Mount Carmel Medical Center in Columbus, followed by an endocrinology and metabolism fellowship at Louisiana State University Medical Center in New Orleans, Louisiana. Dr. Christofides is dual board certified in internal medicine and in endocrinology, diabetes, and metabolism.
Aman Thukral, MPharm, MS
- Head of Digital Operations & Clinical Systems Data and Statistical Science (DSS)
- AbbVie, Inc., United States
Aman Thukral is the Head of Clinical Systems and Digital Operations at AbbVie. In this position, Aman is responsible for leading Slinical Systems and Digital Operations. Also, he manages the implementation and roll-out of novel digital technologies at AbbVie, such as wearables, sensors, and apps. Aman has total 15 years of experience in the eClinical industry and this role for over five years.
Courtney Webster, MS
- Founder, Operator
- Nymbly, United States
Tai Xie, PhD
- Founder and CEO
- CIMS Global, United States
Tai Xie is the founder and CEO for Brighhtech International, a data focused CRO and CIMS Global, an innovative eClinical company. He served as CEO for Biopharm Solutions, a biotech company focused on innovative drug delivery technologies. He was an Adjunct Assistant Professor of Biostatistics Department, School of Public Health, Rutgers University. He has extensive experience in innovative trial design and statistical analysis and reporting, data management, eClinical and eHealth, applying ML and AI to clinical trials. He is an active researcher with several research papers published in distinguished journals on topics including cancer prevention, adaptive design, dynamic data monitoring, survival analysis, personalized medicines and more.
Robert Berlin, JD, MPH
- Head, US Regulatory Policy
- GlaxoSmithKline, United States
Rob Berlin is Head of U.S. Regulatory Policy at GlaxoSmithKline (GSK). Rob leads a team focused on driving U.S. regulatory policy, advocacy, and intelligence activities, to ensure optimal advancement and lifecycle management of GSK’s product portfolio. Rob came to GSK from the FDA where he most recently served as the Director of the Division of Clinical Policy within thae Office of New Drug (OND) Policy, an office he helped to establish as a founding member of the leadership team. Prior to joining OND Policy, Rob worked in CDRH, FDA’s Office of Policy, and in the Office of Chief Counsel. He began his career at Hogan & Hartson (now Hogan Lovells) after completing his law degree and M.P.H. in Epidemiology at the University of Minnesota.
M. Khair ElZarrad, PhD, MPH
- Director, Office of Medical Policy, CDER
- FDA, United States
Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama, as well as a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health.
Jennifer Goldsack, MA, MBA, MS
- Chief Executive Officer
- Digital Medicine Society (DiMe), United States
Jennifer Goldsack is the Chief Executive Officer of the Digital Medicine Society (DiMe). Founded in 2019, DiMe is the first professional organization for experts from all disciplines comprising the diverse field of digital medicine. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health. DiMe is a 501c3 non-profit organization dedicated to advancing digital medicine to optimize human health. We do this by serving professionals at the intersection of the global healthcare and technology communities, supporting them in developing digital medicine through interdisciplinary collaboration, research, teaching, and the promotion of best practices.
Seleen Ong, MRCP, MSc, FFPM
- Executive Director Clinical Group Lead
- Pfizer, Inc., United Kingdom
Seleen Ong, Clinical Group Lead at Pfizer, is responsible for a global clinical team working across the anti-infectives therapy area. Her work includes leadership in the clinical execution of late phase clinical trials and she serves as the Clinical Innovation expert within the group where her main interest is in the implementation of digital technology in clinical trials. She obtained her medical degree from Kings College London and her Master’s in International Health Policy from the London School of Economics. She is a Member of the Royal College of Physicians and Fellow of the Faculty of Pharmaceutical Medicine in the United Kingdom.
Samantha Roberts, PhD
- Group Director, US Regulatory Policy
- Genentech, A Member of the Roche Group, United States
Samantha Roberts is a Group Director in Roche/Genentech's US Regulatory Policy office where she focuses on the implementation of regulatory policy priorities to modernize drug development and review. Her portfolio includes patient-focused drug development, digital health, diversity and inclusion, and model-informed drug development. Prior to joining Roche/GNE, she worked at Friends of Cancer Research (FOCR) where she contributed to the genesis of the Breakthrough Therapy designation and initiatives to expand access to trials. Before FOCR, Dr. Roberts was a post-doctoral researcher at the FDA's Center for Biologics Evaluation and Research. She holds a Ph.D. in microbiology and molecular genetics from Emory University.
Sam Roosz, MBA
- Co-Founder and CEO
- Crescendo Health, United States
Abba Elizabeth Theogaraj, PhD
- Regulatory Senior Group Director
- Roche, Switzerland
Elizabeth Theogaraj is a Global Regulatory Leader at Roche. Elizabeth is a seasoned regulatory professional with extensive experience across the full project lifecycle including developing strategies and leading major Regulatory submissions. Elizabeth has a PhD in Neuroendocrinology from Imperial College, London. At Roche, Elizabeth is working in Oncology Precision Medicine. Elizabeth led the team developing the first fully decentralized clinical trial (DCT) in oncology (Alpha-T). Using this experience, she has been leading HA interactions to help shape HA thinking for DCTs. The has resulted in very positive discussions with various global HAs and helped shaped the regulatory guidances released on DCTs.
Steve Bourke, MS, MSc
- Personal Pulse Gmbh, Switzerland
Personal pulse working across the healthcare system to give and gain value. Are you inspired to create lasting change for people who are patients? Leave patient-centric in the past and create a sustainable future where citizens hold the empowering position of partner. Steven (Steve) Bourke is a dynamic advocate for Empowering People who are Patients. A passion for effective clear health communications combined with over ten years of expertise in biomedical research offers a distinctive advocate who excels in building bridges. Founder of PersonalPulse: Empowering People who are Patients, Co-founder RheumaCura Foundation, A EUPATI Fellow in training, BioMarin International Advocacy Lead
Tala Fakhouri, PhD, MPH
- Associate Director for Policy Analysis, Office of Medical Policy, CDER
- FDA, United States
Edgar Simard, PhD, MPH
- Head of Epidemiology, Biostatistics, and Data Management
- Verily Life Sciences, United States
Edgar Simard has over 20 years of experience as an epidemiologist and has led RWE teams across both the biopharma (GSK) and medical device (Medtronic) industries. He is currently the Head of Epidemiology, Biostatistics, and Data Management at Verily Life Sciences whose ambition is to bring precision health to everyone, every day. His group is responsible for evidence generation across all of Verily's offerings and platforms. He is also an adjunct professor of epidemiology at the Emory University Rollins School of Public Health and has over 50 peer-reviewed publications.
Alan Yeomans, MSc
- Regulatory Affairs Manager
- Viedoc, Sweden
Alan Yeomans has worked with the development of computerised systems for 40 years as hardware designer, programmer, system architect, project manager and in several management roles including CTO, Quality Manager and Regulatory Affairs Manager. Alan has been Quality Manager and Regulatory Affairs Manager for Viedoc Technologies since late 2008, where he is responsible for Quality Assurance of their EDC vendor business. Alan has earlier worked as CTO for a Swedish CRO (CDC) and as CTO and QM for an international ePRO provider (Clinitrac). Alan graduated with a Bachelor of Engineering (Electronics) from the University of Western Australia in 1980 and studied Control Systems at the Imperial College (London) in 1983.
Lesley Maloney, PharmD
- Director, Regulatory Policy - Digital Health and Integrated Solutions
- Genentech, A Member of the Roche Group, United States
Lesley R. Maloney, Pharm.D., is Global Regulatory Policy Lead for Digital Health at Genentech/Roche. She is responsible for shaping the external regulatory environment on integrated and digital solutions, including use of digital health technologies in drug development for digitally-derived endpoints, SaMD, and AI/ML. She was previously Head of US Regulatory Policy for Roche Diagnostics. Prior to joining Roche, Dr. Maloney worked for the U.S. Food and Drug Administration in the Office of the Commissioner, where she served in various roles, including Senior Policy Advisor and Deputy Chief of Staff. Dr. Maloney holds a doctor of pharmacy degree from the University of Oklahoma and did an Executive Residency at ASHP.
- Assistant Director, Digital Health Center of Excellence, CDRH
- FDA, United States
Anindita (Annie) Saha is the Assistant Director for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Ms. Saha is leading the development of partnerships, regulatory science, strategic planning, and operations for the DHCoE to empower digital health stakeholders in advancing healthcare. Additionally, Annie supports CDRH’s patient science and engagement efforts to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs) including patient-reported outcomes (PROs), and patient-generated health data (PGHD).
Reem Yunis, PhD
- Vice President, Digital Transformation Strategy
- Medable, United States
Dr. Yunis is a scientist with multidisciplinary training and experience in mechanism of diseases. Reem enjoys working in startups bringing forward long term vision and strategies. At Medable, she works cross-functionally with engineers, product development, regulatory, and data science to develop first-in-class DCT solutions. She is leading the scientific development of digital clinical measures. Reem holds a PhD in genetics from the Hebrew University of Jerusalem.
Imein Bousnina, PharmD, MSc
- Program Director, US Regulatory Policy, Product Development Regulatory
- Genentech, A Member of the Roche Group, United States
Imein Bousnina, Pharm.D, is a Program Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Imein trained as a pharmacist and holds an MSc in International Regulatory Affairs. Over her seven years at Roche-Genentech, she has specialized in FDA's regulation of New Alternative Methods, digital health (including Software as a Medical Device and Digital Health Technologies used in drug development), rare disease drug development, and companion diagnostics. She actively engages in several external groups including BIO, PhRMA, EveryLife Foundation for Rare Diseases, NORD, DiMe, and PMC among others, and serves in leadership roles on some of their taskforces.
Ritu Kapur, PhD
- Head of Clinical R&D | Head of Digital Biomarkers
- Verily Life Sciences, United States
Dr. Kapur is Head of Clinical R&D and Head of Digital Biomarkers at Verily Life Sciences, an Alphabet company focused on precision health. She leads the team of clinical research scientists who drive the evidence generation strategy across Verily and manages a portfolio of R&D and commercial programs that use wearable and passive sensing technologies to better diagnose, monitor, and treat disease. Dr. Kapur is a Neuroscientist with over 15 years of experience in evidence generation, medical device development, neuromodulation, and signal processing. Her work is focused on using traditional and machine learning methods to extract clinically relevant information from implanted and wearable sensors, building a base of evidence for their
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