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Renaissance Baltimore Harborplace Hotel

Oct 16, 2023 7:30 AM - Oct 17, 2023 6:30 PM

202 E Pratt Street, Baltimore, MD 21202, USA

Real-World Evidence Conference

Translating Insights into Real-World Value

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.

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.

Simon  Dagenais, PhD, MSc

Simon Dagenais, PhD, MSc

Real-World Evidence Lead, Internal Medicine, Pfizer Inc, United States

Simon is an epidemiologist and health economist with expertise in designing, conducting, and communicating scientific studies related to the clinical and economic value of therapies for neurologic conditions. He is currently the global RWE lead for Internal Medicine at Pfizer. Prior to Pfizer, Simon was the global lead for Neurology in the RWE COE at Vertex Pharmaceuticals and supported programs for acute pain, Duchenne muscular dystrophy, and other neurologic conditions. Prior to Vertex, Simon worked in RWE, health economics and outcomes research, and pharmacovigilance at Pacira Pharmaceuticals.

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.

Brad  Jordan, PhD

Brad Jordan, PhD

Associate Vice President, Regulatory Policy and Strategy, Eli Lilly and Company, United States

Dr. Brad Jordan is a Head of Regulatory Affairs Policy at Flatiron Health, where his team works to advance the use of Real-World Evidence for regulatory decision-making. Brad was at Amgen for 15 years prior to joining Flatiron, where he led Global Regulatory and R&D Policy for Oncology and for Biosimilars and Biologics.

Nirosha M. Lederer, PhD, MS

Nirosha M. Lederer, PhD, MS

Head, US Government Partnerships; Senior Director, RWE Strategy, Aetion, United States

Nirosha Mahendraratnam Lederer, PhD is Head of US Government Partnerships at Aetion. In this role, she leads partnership opportunities with the US federal government and advises clients on RWE trends. Before joining Aetion, she led the RWE portfolio at the Duke Margolis Center for Health Policy including developing policies and strategies for increasing the usability and acceptance of RWD and RWE for regulatory and payment decision-making. She previously served as SME in Patient-Focused Drug Development at the US FDA Oncology Center of Excellence and worked at Avalere Health. Dr. Lederer served on Capitol Hill with the House Committee on Ways and Means Subcommittee on Health during the passage of the Affordable Care Act.

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

Yun  Lu, PhD, MS

Yun Lu, PhD, MS

Mathematical Statistician, Office of Biostatistics and Pharmacovigilance, CBER, FDA, United States

Dr. Yun Lu is a Mathematical Statistician and real-world evidence (RWE) reviewer working for the Food and Drug Administration (FDA)/Center for Biologics Evaluation and Research (CBER)/Office of Biostatistics and Pharmacovigilance (OBPV). Dr. Lu received her Ph.D. in Biostatistics from Johns Hopkins Bloomberg School of Public Health. Dr. Lu joined FDA/CBER in 2010 and she has extensive experiences with reviewing RWE related submissions and conducting vaccine safety and effectiveness studies using real-world data (RWD) including Medicare claims data from the Centers for Medicare and Medicaid Services (CMS).

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.

  Sponsored Sessions

Sponsored Sessions

, United States

Daina  Esposito, PhD, MPH

Daina Esposito, PhD, MPH

Executive Director, Global Safety Epidemiology, Moderna, United States

I shape and execute quantitative strategies for safety signal identification and evaluation, assessment of risk-benefit balance, and conduct of real-world evidence studies as lead for the Global Safety Epidemiology team at Moderna. In this capacity, I work closely with a cross-functional team of physicians, pharmacovigilance scientists, biostatisticians, and experts in regulatory science to ensure comprehensive assessment of the safety profile of Moderna’s products.

Rohini  Hernandez, PhD, MPH

Rohini Hernandez, PhD, MPH

Director, Center for Observational Research, Amgen, United States

Rohini Hernandez, PhD, MPH, is a Director of Observational Research in the Center for Observational Research at Amgen. She leads a Pharmacovigilance Epidemiology team focused on leveraging real world data to support benefit/risk assessments globally and across therapeutic areas. Prior to her current role, Rohini worked in the oncology therapeutic area at Amgen, where she designed and led observational studies in support of bone health among patients with solid tumors. Her research interests include exploring methods for controlling biases in pharmacoepidemiology studies, with a specific focus on identifying opportunities for improved assessment of product safety during pregnancy. She received her PhD in Epidemiology from Boston University.

Michelle  Iannacone

Michelle Iannacone

Epidemiologist, Methods Lead, Pfizer, United States

Sunday  Clark, DrSc, MPH

Sunday Clark, DrSc, MPH

Director Oncology Global Evidence & Outcomes, Takeda Pharmaceuticals, United States

Meredith Nahm Zozus, PhD

Meredith Nahm Zozus, PhD

Professor; Division Chief and Director, Clinical Research Informatics, University of Texas Health Science Center, United States

Meredith is a Professor, Division Chief and Scientific Director of Clinical Research Informatics for the University of Texas Health Science Center at San Antonio. She is the lead PI of the ACE-RWD program.

Stefanie  Prilla, DrSc

Stefanie Prilla, DrSc

RWE Coordinator, European Medicines Agency, Netherlands

Dr. Stefanie Prilla is a pharmacist and doctor of natural sciences. Stefanie has more than 15 years of experience in the field of regulatory science with a focus on EU marketing authorisations. Since 2007, she has been working for the European Medicines Agency (EMA). Before joining the EMA data analytics task force, Stefanie held the post of PRIority MEdicines (PRIME) Scientific Coordinator. Previously, Stefanie supported the set up of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) as well the IMI PROTECT project which was led by EMA. In her current role, Stefanie coordinates EMA studies using real-world data to support EU regulatory decision making.

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.

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.

Dallas  Hodgson

Dallas Hodgson

Vice President, Innovation Partnerships, Purpose Life Sciences, Canada

Dallas Hodgson is VP, Innovative Partnerships at Purpose Life Sciences. At PLS he is focused on providing life sciences partners and sponsors with clinical trial research services specializing in novel trial designs and augmented epidemiology. Dallas has over 30 years of experience working with real-world data (RWD) to generate evidence for Clinical, Regulatory, HEOR, Market Access, and Commercial functional groups.

Rob  Kalesnik-Orszulak, PharmD

Rob Kalesnik-Orszulak, PharmD

Senior Director, Global Regulatory Strategy, Bristol Myers Squibb, United States

Rob Kalesnik-Orszulak is a Senior Director of Global Regulatory Strategy at Bristol Myers Squibb. As Team Lead for genitourinary (GU) tumors, Rob has built a high performing team of global regulatory leads each working on a number of global filings in renal, bladder, and prostate cancer. As the Regulatory Innovation Lead for Real World Evidence (RWE) and Data Science, Rob is also responsible for establishing the regulatory department's expertise, capabilities, and strategy around RWE across all therapeutic areas at BMS. Rob has over 8 years of experience leading regulatory strategy across the drug development lifecycle, from first-in-human trials to mature products, with a focus in oncology.

Tom  Kaminski

Tom Kaminski

CEO, Clinetic, United States

Tom is the co-founder and CEO of Clientic, a health technology company harnessing the potential of electronic health record (EHR) data to accelerate clinical research and evidence generation. Previously, he worked at LabCorp for ten years where he led Corporate Strategy and the launch of several new products and business units. Tom also previously worked at Duke University where he led business strategy for the Duke Clinical Research Institute (DCRI) and led the launch of the Duke Institute for Health Innovation (DIHI).

Andrew  Kress

Andrew Kress

Chief Executive Officer, HealthVerity, Inc., United States

Andrew is the CEO of HealthVerity, a company that operates a healthcare data marketplace using novel technologies to connect data at the patient level from a broad set of external data partners. Previously, he was SVP, Healthcare Value Solutions for IMS Health, responsible for real world evidence solutions, payer and provider services, and clinical trial optimization solutions. Prior, he was the CEO of SDI Health, a leader in healthcare data & analytics prior to its acquisition by IMS Health.

Sally  Omidvar

Sally Omidvar

VP, Life Science Research Success, Truveta, United States

Sally Omidvar is the VP of Life Science Research Success at Truveta where she is responsible for enabling and supporting the research of Truveta’s life science and medical device customers. Prior to Truveta, Sally was CTO for Healthcare at DataRobot where she worked to develop and expand machine learning use cases among payers, providers, and life science customers, as well as managing large scale COVID-19 engagements with HHS, CDC, and FDA. Prior to DataRobot her work included collaborations with Google and Gavi utilizing artificial intelligence to inform last-mile vaccine logistics and as a researcher at the CDC engaged in international emergency response.

Motiur  Rahman, PhD, MPharm, MS

Motiur Rahman, PhD, MPharm, MS

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States

Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes, stakeholder engagement, collaborating on Agency-funded demonstration projects, and providing consultancy on RWE study submissions. He joined FDA in 2022 after a 10+ years of working experience in academia and industry in conducting observational studies across a wide range of therapeutic areas. Dr. Rahman is a Pharmacist by training and holds a PhD in Pharmacoepidemiology and Master’s in Statistics.

Adam  Shiell, PharmD

Adam Shiell, PharmD

Global Regulatory Strategist , Flatiron Health, United States

Adam has 10 years of regulatory affairs experience, focusing on oncology drug development. At Flatiron Health, Adam is the regulatory lead for prospective clinical research, working with sponsors on novel ways of using real-world evidence (RWE) to advance their portfolios. Prior to joining Flatiron, Adam worked in regulatory affairs at Eli Lilly & Company as a regulatory lead for oncology compounds in both early and late phase development.

Kimberly  Smith, MD, MS

Kimberly Smith, MD, MS

Real-World Evidence Analytics Team, Office of Medical Policy, CDER, FDA, United States

Kimberly Smith is a nephrologist with the Real-World Evidence Analytics team in the Office of Medical Policy (OMP), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. In her current role, she develops and implements programs and policies related to the use of real-world evidence in drug development. Prior to her current role, Dr. Smith served at FDA as team leader for the Division of Clinical Trial Quality in OMP and as the nephrology team leader in the Division of Cardiology and Nephrology in CDER’s Office of New Drugs. Before joining the FDA, she was with the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services.

Sonja  Wustrack

Sonja Wustrack

Managing Director of Integrated Evidence Generation, OM1, United States

Emily  Castellanos, MD, MPH

Emily Castellanos, MD, MPH

Senior Medical Director, Research Oncology, Flatiron Health, United States

Emily Castellanos is a medical oncologist and hematologist who serves as medical director at Flatiron Health, where she leverages her clinical and research expertise to develop innovative approaches to real-world evidence generation and inform product strategy. She has a special interest in integrated approaches to real-world data, such as clinico-genomics, clinico-claims, or imaging data, as well as novel approaches to real-world study design.

Thomas David Brown, MD, MBA

Thomas David Brown, MD, MBA

Chief Medical Officer, Syapse, United States

Shahid  Hanif, PhD, MSc

Shahid Hanif, PhD, MSc

Managing Director, GetReal Institute, Netherlands

Shahid Hanif is the Managing Director of the GetReal Institute, a not-for-profit multi-stakeholder association based in the Netherlands, which aims to facilitate the adoption and implementation of real-world evidence in regulatory, HTA and clinical decision-making in Europe. He leads the GetReal Institute, which follows two Innovative Medicines Initiative (IMI) funded programmes, to establish it as a leading independent and sustainable European forum for stakeholder dialogue, consensus development and co-creation of solutions to advance the use of real-world evidence.

Dena  Jaffe, PhD

Dena Jaffe, PhD

Lead Data Strategist, Oracle, Israel

Dr. Jaffe is a Real-World Data Strategist at Oracle. Her work involves the curation of the Oracle EHR RWD for real-world evidence. Dr. Jaffe has over 20 years of experience in epidemiology, quality of care, and RWE studies. Prior to joining Oracle, Dr. Jaffe was the deputy director of the Israel National Program for Quality Indicators in Community Healthcare and faculty at the Braun School of Public Health and Community Medicine, Hebrew University, Jerusalem. She has published across numerous therapeutic areas including cancer, migraine, depression, and Gaucher disease, with a focus on health inequalities. Dr. Jaffe received her PhD in epidemiology from Case Western Reserve University and a MS in pharmacology from Hebrew University.

Bess  LeRoy, MPH

Bess LeRoy, MPH

Head of Standards Development, CDISC, United States

Bess LeRoy has over 15 years of experience working in public health research. She is currently the Head of Standards Development at CDISC. She has been a CDISC team member since 2011 and has been involved in the development of over 16 CDISC Therapeutic Area User Guides. Bess has a BS from the University of Michigan, an MPH from Boston University, and is currently pursuing a DrPH from Johns Hopkins University.

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.

David  Moeny, MPH, RPh

David Moeny, MPH, RPh

Acting Deputy Director, Office of Pharmacovigilance and Epidemiology, OSE/CDER, FDA, United States

David Moeny is a pharmacist and pharmacoepidemiologist with experience in clinical pharmacy practice, public health, drug utilization, regulatory pharmacoepidemiology, and international collaborations. At FDA, he has worked in both drug utilization and epidemiology teams and as the director for the Division of Epidemiology-II, participating in numerous evaluations of drug safety issues in Sentinel and other systems. He is currently serving as the Acting Deputy Director for the Office of Pharmacovigilance and Epidemiology in the Office of Surveillance and Epidemiology at the Food and Drug Administration, and is serving as the Rapporteur for the International Council of Harmonization M14 Guideline.

David  Paulucci, MSc

David Paulucci, MSc

Director, Data Science, BMS, United States

David Paulucci is Director of Data Science in the Department of Global Biometrics and Data Sciences at Bristol Myers Squibb. In his role, David is responsible for conducting exploratory analyses, and developing statistical learning models to support global drug development in oncology. Prior to working at BMS, he spent 3 years at Mount Sinai Hospital, carrying out analyses leading to more than 20 publications on surgical outcomes for localized kidney and prostate cancer. David received his MS in Biostatistics from the Icahn School of Medicine at Mount Sinai. His key areas of interest include supervised machine learning, and predictive modeling of heterogenous treatment effects.

Donna  Rivera, PharmD, MSc

Donna Rivera, PharmD, MSc

Associate Director for Pharmacoepidemiology, OCE, FDA, United States

Donna R. Rivera, PharmD., MSc., is the Associate Director of Pharmacoepidemiology in the Oncology Center of Excellence at the US Food and Drug Administration. She leads the Oncology Real World Evidence (RWE) Program, focused on the use of Real World Data (RWD) and RWE for regulatory purposes as well as management of the RWD research portfolio strategy and development of related regulatory policy to support the OCE mission. Dr. Rivera has interests in the use of RWD to increase knowledge of unrepresented populations and advance health equity, observational study designs and RWD methodological approaches, and appropriate uses of RWD for drug development to increase access of effective therapies to patients.

Jonathan  Assayag, PhD, MSc

Jonathan Assayag, PhD, MSc

Director, RWE Scientist Oncology, RWE Center of Excellence, Pfizer, Canada

Jonathan is a Director and RWE Scientist in the RWE Center of Excellence at Pfizer, where he designs and executes on RWE strategy and works with teams across the drug development lifecycle. Jonathan has more than 10 years’ experience utilizing real-world and clinical data to conduct and communicate healthcare research. His prior work includes working in medical affairs where he also led RWE education initiatives for Pfizer colleagues. Jonathan holds a PhD from McGill University in Pharmacoepidemiology where he is also currently an instructor in the department of Medicine.

Adrian  Cassidy, PhD, MSc

Adrian Cassidy, PhD, MSc

Head Global Evidence Generation, Novartis, Switzerland

Adrian Cassidy is the Vice President and Head of Global Evidence Generation at Novartis with responsibility to develop novel data and evidence applications across the development lifecycle of innovative medicines. As an epidemiologist, Adrian has over 20 years of industry and public sector experience in real world evidence generation, as well as an established track record of building and leading highly successful evidence generation groups and data/digital/analytics platforms. Adrian is passionate about solving healthcare challenges and transforming clinical practice to deliver outcomes that matter for patients.

Lucy  Mosquera, MSc

Lucy Mosquera, MSc

Senior Director, Data Science, Replica Analytics, Canada

Lucy Mosquera has a background in biology and mathematics, having done her studies at Queen's University in Kingston and the University of British Columbia. In the past she has provided data management support to clinical trials and observational studies at Kingston General Hospital. She also worked on clinical trial data sharing methods based on homomorphic encryption and secret sharing protocols with various companies. At Replica Analytics, Lucy is responsible for integrating her subject area expertise in health data into innovative methods for synthetic data generation and the assessment of that data, as well as overseeing our analytics program.

Elizabeth  Packnett, MPH

Elizabeth Packnett, MPH

Lead Researcher, Real World Data Research & Analytics, Merative, United States

Elizabeth R. Packnett, MPH, is a lead researcher in the Real World Data Research and Analytics group at Merative supporting pharmaceutical and life sciences clients in the design and implementation of research studies. She has led several studies leveraging real world data for regulatory reporting including post-authorization safety studies to evaluate risk of prenatal exposures and evaluations of compliance with risk evaluation and mitigation strategies. The results of her research have appeared in numerous peer-reviewed publications related to maternal and child health, behavioral health, vaccination, and chronic respiratory disease. She holds an MPH in epidemiology from the University of Michigan School of Public Health.

Mayur  Saxena, PhD

Mayur Saxena, PhD

Chief Executive Officer, Droice Labs, United States

As an entrepreneur and scientist, Mayur has concentrated on advancing medicine with high-noise, big data analysis. Before founding Droice, he played key roles in several startups, including co-founding a biotechnology firm in the diabetes space. He earned his BTech at IIT Kanpur and his MS and PhD at Columbia University, focusing on the computational physics of disease.

Abi  Seifert, MBA

Abi Seifert, MBA

Global Head Country Development Quality, Novartis , United States

Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and compliance in clinical development programs and in the use of RWE/RWD. She currently leads a team of QA associates in the oversight of GCP and PV quality in 60+ countries at Novartis. Abi holds a Masters in Management and is a Lean Six Sigma Blackbelt. She is currently a collaborator on the TransCelerate Audit Readiness Considerations team creating a set of recommendations for documentation of processes for programs using RWE/RWD in regulatory decision-making.

Mingyang  Shan, PhD

Mingyang Shan, PhD

Senior Advisor, Eli Lilly and Company, United States

Mingyang Shan is a senior research advisor in the Real-World & Access Analytics Capabilities team at Eli Lilly and Company, where he applies a spectrum of advanced analytic methods to deliver RWE and enable innovative evidence generation. His current focus is on developing methodology and best analytical practices to leverage evidence from real world data in drug development. Prior to joining Eli Lilly, Mingyang completed his Ph.D in biostatistics at Brown University where his research interests converged at the intersection of missing data, causal inference, and Bayesian inference.

Hasham  Ul Haq

Hasham Ul Haq

Machine Learning Engineer, John Snow Labs, United States

A Machine Learning Engineer with experience across various sectors, including healthcare. At John Snow Labs, my primary focus is to build scalable and pragmatic systems for NLP, that are both, production-ready, and give SOTA performance, which includes building bespoke models for different use-cases. Recently, a new direction of R&D is to adapt Large Language Models to different tasks with minimal error.

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 14 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.

Joseph B. Franklin, JD, PhD

Joseph B. Franklin, JD, PhD

Head of Strategic Affairs, Verily, United States

Joe Franklin leads the Strategic Affairs team at Verily and focuses on evidence generation strategy, including regulatory and privacy strategy at the intersection of clinical research and care. Before joining Verily in 2021, Joe held a variety of positions at FDA, including as senior advisor on data and evidence initiatives. Joe led the biosimilars policy staff in the Office of New Drugs and served as an attorney in the chief counsel’s office for multiple periods during his career at FDA, including during COVID-19, when he advised FDA on emergency use authorizations and supported the U.S. government’s global vaccine deployment. Joe has a PhD in cell biology from his early career as a bench scientist.

Darren  Toh, DrSc, FISPE

Darren Toh, DrSc, FISPE

Professor, Harvard Medical School and Harvard Pilgrim Health Care Institute, United States

Darren Toh, ScD is DPM Endowed Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute. He is a pharmacoepidemiologist with an interest in the comparative safety and effectiveness research of medical products. His research has been focused on 1) assessing the risks and benefits of medical products using electronic data collected as part of routine healthcare delivery, and 2) developing and applying privacy-protecting analytic methods to conduct multi-center studies in distributed data networks. Darren is Principal Investigator of the FDA-funded Sentinel Operations Center.

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