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Sheraton Philadelphia Downtown Hotel

Oct 24, 2024 7:30 AM - Oct 25, 2024 4:10 PM

201 North 17th Street, Philadelphia, PA 19103

Real-World Evidence Conference

Translating Insights into Real-World Value

Early Bird Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Speakers

David  Martin, MD, MPH

David Martin, MD, MPH

Vice President, Global Head RWE, Moderna, United States

David Martin leads Global RWE for Moderna. Previously he completed 20 years of active duty service split between the United States Air Force and Public Health Service. At the FDA he led the Division of Epidemiology in the Center for Biologics. Subsequently, he established the Real World Evidence group in the Office of Medical Policy to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act. He initiated key RWE pathfinding efforts with external stakeholders including RCT Duplicate and the open-source FDA MyStudies mobile application. He holds an MD and MPH from Johns Hopkins and is board certified in occupational & environmental medicine as well as clinical informatics.

Jaclyn  Bosco, PhD, MPH, FISPE

Jaclyn Bosco, PhD, MPH, FISPE

Vice President and Global Head of Epidemiology, IQVIA, United States

Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.

John  Concato, MD, MPH, MS

John Concato, MD, MPH, MS

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States

Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency processes, interacting with external stakeholders, and coordinating demonstration projects as well as guidance development. Dr. Concato joined FDA from Yale School of Medicine and the U.S. Department of Veterans Affairs, where he was a clinician, educator, independent investigator, research center director, and Professor of Medicine. He has a BE degree from The Cooper Union, MD & MS degrees from New York University, and an MPH degree from Yale University.

Diane  Gubernot, DrPH, MPH

Diane Gubernot, DrPH, MPH

Epidemiologist, US FDA, United States

Dr. Diane Gubernot is a Health Scientist in the Office of Biostatistics and Pharmacovigilance at the Center for Biologics Evaluation and Research (CBER) of the USFDA. She conducts regulatory reviews of RWE/RWD submitted in biologic product applications and performs research to help support RWE policy development as well as other public health initiatives. Dr. Gubernot has been with the FDA for more than 30 years and has worked as an Investigator in the Office of Regulatory Affairs, a Team Lead Epidemiologist in the Office of the Commissioner, and a regulatory product reviewer at CBER.

Rachele  Hendricks-Sturrup, DrSc, MA, MSc

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States

Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within the fields of health policy, business, and health innovation.

Camille  Jackson

Camille Jackson

Director, Regulatory Policy; Legal and Regulatory, Flatiron Health , United States

Camille Jackson is the Director and Head of Regulatory Policy at Flatiron Health, bringing nearly 20 years of experience within policy and program management across various corners of the life sciences sector. Earlier in her career, Camille held roles at Clarivate, Sanofi, PhRMA, The World Bank, NIH, The George Washington University, and the American Academy of Child and Adolescent Psychiatry.

Charles  Lee, MBA, MS

Charles Lee, MBA, MS

Executive Regulatory Science Director, AstraZeneca, United States

Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader over a 10 year period at Astrazeneca and Roche where he led cross-functional project teams for programs in the early development phase (Ph0 to Ph2b). Previous to that, Charles spent 10 years in Global Regulatory affairs where he held leadership roles on programs across several therapeutic areas in different stages of development. Charles holds BS in Biology from The Johns Hopkins University, MS from University of Virginia, MBA from Columbia Business School

Alexander  Liede, PhD, MSc

Alexander Liede, PhD, MSc

Senior Director, Global Epidemiology, Abbvie, Ireland

Alex is a Senior Director and Head of Evidence & Partnerships in Global Epidemiology at AbbVie based in Dublin, Ireland. Alex has 20 years of experience in the biopharma industry and leads a team of epidemiologists focused on real-world evidence solutions and innovative approaches using real-world data in support of safety strategy and cross-functional initiatives in drug development. Before joining AbbVie in 2019, Alex worked at Amgen in the Center for Observational Research, as a research scientist at Cedars-Sinai Medical Center in Los Angeles, and as a genetic counsellor with Cancer Care Ontario and Women's College Hospital in Toronto, Canada.

Sarah  Martin, PhD, MS

Sarah Martin, PhD, MS

Senior Director - Global Regulatory Policy (Oncology), Eli Lilly & Co., United States

Sarah currently serves as senior director of global regulatory policy for oncology at Eli Lilly. She previously served as senior director of science and regulatory advocacy for the Pharmaceutical Research and Manufacturers of America (PhRMA) where she led their regulatory advocacy efforts on key issues including real-world evidence. Sarah worked for the American Association for Cancer Research (AACR) where she led their efforts to modernize the regulatory process and engage in the development and implementation of programmatic and policy initiatives with the US FDA Oncology Center of Excellence.

Brittany  McKelvey, PhD

Brittany McKelvey, PhD

Director, Regualtory Affairs, Friends of Cancer Research, United States

Keri  Monda, PhD, MS

Keri Monda, PhD, MS

Executive Director, Center for Observational Research, Amgen, United States

Keri Monda, PhD, is an Executive Director of Observational Research and Head of the Data & Analytics Center within the Center for Observational Research (CfOR) at Amgen. In her role, she leads a team of epidemiologists and data scientists responsible for generating real-world evidence in support of programs from research and early development through launch and end of patent expiry, and oversees a large, integrated real-world data and analytics ecosystem. Prior to her time at Amgen, Keri was a genetic epidemiologists on faculty in the Department of Epidemiology at the University of North Carolina, Chapel Hill.

Tamei  Elliott, MS

Tamei Elliott, MS

Associate Director, Scientific Programs, DIA, United States

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Melinda  Baker, PhD

Melinda Baker, PhD

Director of Dataset Strategy & Commercialization, Mission Health Labs, Inc. (dba PicnicHealth), United States

Melinda Baker, PhD is the Director of Dataset Strategy and Commercialization at PicnicHealth. Melinda is passionate about empowering patients to take ownership of their medical records and helping life science partners infuse patient-centric methods into their research practices. She has dedicated her career to building new technologies and products that help researchers accelerate medical discoveries. Before moving to industry, Melinda obtained a doctorate from Princeton University and completed post-doctoral research at the University of Medicine and Dentistry of New Jersey. Her academic interests focused on using systems and structural biology techniques to understand signaling pathways of cellular motility and gene transfer.

Elise  Berliner, PhD

Elise Berliner, PhD

Global Senior Principal for Real World Evidence Strategy, Oracle Life Sciences, United States

James  Browning, MPH

James Browning, MPH

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States

James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled in statistical analysis, data visualization and data management with a focus on RWE used for regulatory decision-making. Currently, he leads multiple programming teams focused on generating RWE to support the development and continuous benefit:risk assessment of Amgen’s medicines. He also has an interest in the new regulatory guidelines for generating RWE and is exploring processes and standards to align with the evolving framework.

Ulka B Campbell, PhD

Ulka B Campbell, PhD

Head of Scientific Strategy, Aetion Inc, United States

Ulka Campbell is an epidemiologist and the Head of Scientific Strategy at Aetion, a healthcare technology and research services company, providing methods and regulatory support across therapeutic areas and leading research to inform regulatory RWE best practices. Previously, she was at Pfizer for 14 years leading regulatory studies and serving as the Head of Safety Surveillance Research, overseeing a team responsible for post-approval safety studies obligated to FDA and EMA. She has co-authored several publications and taught courses on pharmacoepidemiology, standards for decision-grade real world studies, causal inference, and epidemiologic methods, and is an Adjunct Assistant Professor of Epidemiology at Columbia University.

Jingyu (Julia)  Luan, PhD

Jingyu (Julia) Luan, PhD

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States

Dr. Jingyu (Julia) Luan is an Executive Regulatory Science Director in AstraZeneca, overseeing the global regulatory strategy and supporting the research, development and commercialization of CVRM products. She is a core member of CVRM Regulatory Leadership Team. Prior to AZ, she worked at FDA for 13 years and held positions with increasing responsibilities, including Statistical Reviewer, Team Leader, and Acting Deputy Division Director. She had extensive experience in multiple therapeutic areas for both new and generic drugs. In addition, she was a research faculty member at Johns Hopkins University and a statistical consultant at the University of Kentucky. Dr. Luan is President of Chinese Biopharmaceutical Association 2023-2024.

P. Karina  D'Angelo, PhD

P. Karina D'Angelo, PhD

Director, Scientific Data Strategy, Parexel, United States

Lisa  Ensign, PhD, MSc

Lisa Ensign, PhD, MSc

VP, Data Science, Medidata, a Dassault Systemes Company, United States

Lisa Ensign is a VP of Data Science at Medidata AI. Her current work in the Integrated Evidence team is focused on creating analytical approaches to improve and transform the efficiency and rigor of clinical trials, centered on the use of external controls. Dr. Ensign began her career at MD Anderson Cancer Center and has over 30 years experience in the life sciences sector. She received her MS in biostatistics from Harvard University and her PhD in clinical science from the University of Colorado, where she is also an instructor on ethics and the responsible conduct of research.

Mehdi  Najafzadeh, PhD, MA, MS

Mehdi Najafzadeh, PhD, MA, MS

Senior Director, Medidata AI, United States

Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the PI of large NIH and FDA funded projects that aimed at linking RCTs to RWD.

Nuvan  Rathnayaka

Nuvan Rathnayaka

Manager of Biostatistics, Target RWE, United States

Elsie  Grace, PhD, MS

Elsie Grace, PhD, MS

Senior Director, Global Patient Safety, Pharmacoepidemiology, Eli Lilly and Company, United States

Elsie Grace is a Senior Director at Eli Lilly and Company. Her work as a pharmacoepidemiologist within the Global Patient Safety organization focuses on providing epidemiologic expertise to the development, submission, and launch of products within the autoimmune therapeutic area.

Susant  Mallick, MBA

Susant Mallick, MBA

Founder and CEO, Life Sciences Practice Leader, Cloudhub BV, Netherlands

Susant Mallick comes up with 23+yrs of Pharma and IT background on building disruptive solutions/products in Clinical and Regulatory space. He is technology evangelist on cutting edge technology like (Artificial Intelligence, Machine Learning, IoT, Cloud etc) and an industry leading speakers across geographies. He has been working with various customers and partners in pharma and healthcare to drive digital transformation in clinical and regulatory landscape. He was instrumental in implementing/building many Regulatory solutions using advanced technology. Innovation and Digital Transformation in Healthcare and Life Sciences are two key focus areas.

Claudia A Salinas, PhD

Claudia A Salinas, PhD

Senior Director, GPS Pharmacoepidemiology, Eli Lilly and Company, United States

Dr. Salinas is a pharmacoepidemiologist, with a doctorate in Epidemiology from the University of Washington, currently working in late stage and postmarketing clinical development at Eli Lilly and Company. She has expertise in real-world data analysis and causal inference focusing on drug development and the comparative safety of medications, particularly for auto-immune disorders. In previous work she was engaged in prostate cancer research, including evaluation of genetic risk factors from inflammatory pathways. Her current interests include linkage of RWD and clinical trial data to enhance the evaluation of drug safety. She is an advocate for communication about pharmacoepidemiology careers in industry and welcomes trainee questions.

Andrew  Wilson, PhD, MS

Andrew Wilson, PhD, MS

Head of Innovative RWD Analytics, Parexel, United States

As the Head of Innovative RWD Analytics at Parexel, I have the privilege of collaborating broadly on the frontiers of using real-world data, emphasizing the importance of context within the 'data generation process.' My recent collaborations intersect machine learning, causal inference, and reproducibility in research. Working within the evolving regulatory landscape, which is increasingly open to modern, established methods, I aim to help advance the field of real-world data analytics. I hold an adjunct appointment at the University of Utah and maintain affiliations with various institutions to maximize collaborative opportunities.

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