Safety Scientific Working Group

Speakers

Bio

Paul “Skip” H. Hayashi, MD, MPH, FAASLD

Dr. Hayashi is the Associate Director of DILI within the Division of Hepatology and Nutrition, FDA. He got his BA in microbiology at UCLA and MD at UC San Diego. After residency and gastroenterology training at UC Davis, he completed a research fellowship at the NIH and a transplant fellowship at the University of Colorado. He received an MPH at Saint Louis University, Missouri. In 2006, he became Medical Director of Liver Transplantation at the University of North Carolina serving in that capacity as associate and then full professor before joining the FDA in 2020. His research and publications have focused on drug-induced liver injury for the last 20 years. He was a Co-Investigator for the NIH Drug-Induced Liver Injury Network and remains Co-Chair of the Causality Committee.

Barbara Hendrickson, MD

Dr. Barbara Hendrickson is on faculty at the University of Chicago and a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is a physician with subspecialty training in pediatrics and infectious diseases. Dr. Hendrickson has 20 years of pharmaceutical experience and has been involved in multiple product submissions to global health authorities. She has extensive experience with clinical trial safety planning, monitoring and data assessment. She co-leads the Interdisciplinary Safety Evaluation workstream and the Aggregate Safety Assessment Planning task force of the American Statistical Association Biopharm Safety Monitoring Working Group. She also has authored multiple publications related to clinical trial safety.

Cindy McShea, MPH

Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she leads the Safety Statistics Team within the Biometrics and Quantitative Sciences group. She has over 25 years of experience in the pharmaceutical industry, 20 of which have been spent in statistical and leadership roles within late phase clinical development in neurology and immunology therapeutic areas. She is a contributing member of the Drug Information Association-American Statistical Association Aggregate Safety Assessment Planning Task Force.

Speakers

Bio

Margaret (Peg) Fletcher, MD, PhD

Margaret (Peg) Fletcher, MD, PhD is an oncologist and clinical pharmacologist with over 25 years’ experience in drug development and safety of oncology, neurology, and metabolic disease products, Dr. Fletcher is an expert in evaluating drug safety data and balancing corporate obligations with patient safety. She has led or supported safety portions of 12+ new or supplemental drug or biologics applications, with FDA approval for 4 new chemical entities and 5 sNDAs.  Peg received her MD & PhD (biochemistry) from the University of Chicago and held executive roles in Oncology, Safety & Pharmacovigilance, and Licensing before founding MedAssessment.

Mac Gordon, MS

Mac Gordon, MS, received a Masters in Statistics and graduate certificates in Public Health, Pharmacovigilance and Pharmacoepidemiology. He has been involved in pharmacovigilance, signal detection and safety data visualization for most of his career, including membership and leadership in several multi-disciplinary industry working groups. Currently he is a compound statistical lead at Janssen coordinating across 11 indications and several therapeutic areas. His focus has been late development immunology and clinical trial safety for the past 17 years.  Mac is involved on many internal teams focused on safety statistics and leads process development initiatives, currently the implementation of the ASAP process.

Barbara Hendrickson, MD

Barbara Hendrickson, MD is on faculty at the University of Chicago and a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is a physician with subspecialty training in pediatrics and infectious diseases. Dr. Hendrickson has 20 years of pharmaceutical experience and has been involved in multiple product submissions to global health authorities.  She has extensive experience with clinical trial safety planning, monitoring and data assessment. She co-leads the Interdisciplinary Safety Evaluation workstream of the American Statistical Association Biopharm Safety Monitoring Working Group.  She also has authored multiple publications related to clinical trial safety.

Scott Proestel, MD

Scott Proestel, MD, is Vice President of Medical Informatics at Medpace, Inc. He is board certified in Internal Medicine and Clinical Informatics and was an Assistant Professor of Medicine at Georgetown University for three years.  Prior to joining Medpace, he worked at the US FDA for 19 years as a medical officer, team leader, and division director in pre-market and post-market safety, where he also conducted research on the use of artificial intelligence to evaluate spontaneous safety reports and queries using large language models.  He served at the NIH as a Deputy Director and then Director of the Office for Policy in Clinical Research Operations where he oversaw operations for six global clinical trial networks.

Radhika Rao, MD MPH

Radhika Rao, MD, is a Medical Director at AbbVie.  With clinical practice experience over 15 years as an Internist and Spinal cord Injury Medicine specialist, Dr. Rao served veterans at Edward Hines, Jr. Veterans Affairs hospital in Chicago. She also was on faculty as an assistant professor of medicine at Loyola Medical Center and participated in medical education at Loyola. Dr. Rao joined Pharmacovigilance at AbbVie Inc. in 2013 contributing to the safety monitoring of products and MedDRA Management Committee training (maintenance of CMQs with MedDRA versioning etc). Dr. Rao delivers lectures in Pharmacovigilance and actively participates in the CIOMS MedDRA Labeling Expert working Group.

Speakers

Bio

Veronica Pei, MD

Dr. Y. Veronica Pei is a commissioned officer in the U.S. Public Health Service currently serving as Lead Physician for the Biomedical Informatics and Regulatory Review Science (BIRRS) team in the Office of New Drugs (OND), FDA.  She is board-certified in emergency medicine and clinical informatics. In her current role, Dr. Pei is serves as subject-matter expert on numerous committees and working groups related to data standards, business informatics, and governance and is involved in development, implementation, and support of bioinformatics initiatives within OND, including the Standard Safety Tables and Figures. She is also FDA’s topic lead for ICH M11 expert working group on the Structure and Content of Clinical Protocols.

Michael Fries, PhD

Mike is currently the head of Biostatistics at CSL Behring, where he has worked for over 9 and half years.  He has nearly 25 years in the industry, having previously worked at GSK and TAP pharmaceuticals. He also spent several years as a visiting Assistant Professor in the School of Computer Science at DePaul University.  He is a member of ASA Safety Scientific Working Group, and has a specific Interest in Quantitative Decision Making in drug development and applications of Bayesian Statistics.

Jürgen Kübler, PhD

Co-Chair of Safety Working Group

Executive consultant at QSciCon

30+ years of experience in drug development with a focus on drug safety

Statistician by training

Xiao Ni, PhD

Xiao Ni is Head of DMD Biostatistics at Sarepta Therapeutics, a biotechnology company based in Cambridge, Massachusetts.  In this capacity, he leads 3 biostatistics teams to support 4 Duchenne developmental programs. He also leads a group of 9 Data Scientists at Sarepta to increase efficiency and enable rapid data insights through modern data science tools & mindset.  He has been a member of the ISG since 2018 and contributed to ISG tool library such as safetyGraphics, qtexplorer, etc. Xiao is passionate about open-source collaboration.

Speakers

Biography

Natalia Andriychuk

Natalia Andriychuk is a Statistical Data Scientist in the R Center of Excellence SWAT (Scientific Workflows and Analytic Tools) team at Pfizer. In her current role, Natalia provides robust technical solutions to business lines across Pfizer utilizing strong technical knowledge of R, R packages, Shiny, and other associated data science and data analytics tools. She develops training on R and associated tools for Pfizer colleagues and helps to build an R community at Pfizer. Natalia is an advocate for the open-source development as she passionately believes in the transformative power of collaborative innovation and knowledge sharing.

Dr. James Buchanan

Dr. James Buchanan is presently an independent drug safety consultant. He graduated from the University of California, San Francisco with a PharmD degree in clinical pharmacy. He worked in the area of clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General Hospital before entering the pharmaceutical industry.  Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety in the clinical development department. He subsequently moved to Gilead Sciences to establish a drug safety department. After leaving Gilead Sciences, Dr. Buchanan started the drug safety department at Tularik Inc where he acted as Chief Safety Officer until the company was acquired 5 years later by Amgen. Following the merger with Amgen, he moved to Nuvelo to establish a drug safety department and act as Chief Safety Officer where he also had responsibility for clinical operations, biostatistics and data management.  Dr. Buchanan next served with BioSoteria for 5 years as the head of the medical and safety consulting group, which was subsequently acquired by Dohmen Life Science Services. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group and is a co-lead on the Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development.

Preston Burns

Preston Burns is a Principal Data Scientist at Sarepta Therapeutics where he enables interactive safety and efficacy exploration for Pharmacovigilance, Medical Monitoring, and Data Management groups at Sarepta by heading development of R Shiny applications. He is a seasoned visual analytics R and JavaScript developer and has provided statistical and data science consultation to the NIH, USDA, and commercial clients. Currently located in Kentucky, he remains loyal to Carolina basketball but has adopted local customs regarding Bourbon and the use of “bub”.

Spencer Childress

Spencer Childress, a South Carolina native and North Carolina resident, started as a statistical programmer before moving into other areas of data science, like interactive data viz, analysis pipelines, and exploratory data analysis.  His professional principles include data-driven everything, well-organized codebases, and efficient visual design.  Outside of office life Spencer enjoys gardening, gaming, and volleyball.

Cindy McShea

Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she leads the Safety Statistics Team within the Biometrics and Quantitative Sciences group. She has over 25 years of experience in the pharmaceutical industry, 20 of which have been spent in statistical and leadership roles within late phase clinical development in neurology and immunology therapeutic areas. She is a contributing member of the Drug Information Association-American Statistical Association Aggregate Safety Assessment Planning Task Force.

Speakers

Biography

Dr. Hong Yang

Dr. Hong Yang is a senior advisor on Benefit-Risk in the Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research, US Food and Drug Administration. Since joined FDA in 2004, she has led many benefit-risk assessments to inform CBER regulatory decisions.  She has been active in research and collaboration to develop novel benefit-risk approaches, as well as training and outreaching for implementation of FDA benefit-risk framework.  She was a member of FDA Benefit-Risk Guidance Working Group and FDA Benefit-Risk Framework Implementation team. She contributes to CIOMS (COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES) Working Group XII report (CIOMS Working Group XII Benefit-Risk Balance for Medicinal Products). She also actively participates in two American Statistical Association Safety Working Group teams, Benefit-Risk Assessment Planning and Benefit-Risk Assessment Tool Suites. Dr. Yang is also a member of International Society for Pharmacoepidemiology Benefit Risk Assessment, Communication and Evaluation special interest group.

Dr. Leo Plouffe

Dr. Leo Plouffe brings more than 25 years of industry experience. He was most recently at Bayer for more than 12 years, where he held leadership roles within U.S. Medical Affairs before taking on the role of Global Head of Benefit-Risk Management, Pharmacovigilance. In that role, he worked in collaboration with functions across Bayer to implement a new benefit-risk management process across the portfolio and R&D pipeline. Prior to Bayer, Leo was at Eli Lilly for more than 12 years, holding roles of increasing responsibility in both Clinical Development and Medical Affairs across a broad range of therapeutic areas. He started his medical career as a faculty member at the Medical College of Georgia, where he achieved the position of Professor, Section Chief of Reproductive Endocrinology and Genetics.

Leo earned his medical degree and completed residency training in obstetrics and gynecology at McGill University Medical School. He is dual boarded by the American Board of Obstetrics and Gynecology in Obstetrics and Gynecology and Reproductive Endocrinology. He is also a member of the Royal College of Physicians and Surgeons of Canada, Obstetrics and Gynecology. He has authored more than 70 publications in peer-reviewed journals, served as editor of two medical textbooks and contributed to numerous medical chapters and reviews. Leo has been active throughout his career in driving industry standards and currently serves on the Council for International Organizations of Medical Sciences (CIOMS) and is co-chair for the CIOMS XII – Benefit-Risk writing group.

Leo, along with his wife Eve, who is also an ob-gyn surgeon, and their Beauceron Gaston enjoy spending time outdoors and entertaining their friends visiting from across the United States. 

Dr. Lisa Rodriguez

Dr. Lisa R. Rodriguez is the Deputy Division Director of the Division of Biometrics IX, Office of Biostatistics, Center for Drug Evaluation and Research at FDA, supporting hematology products.  She received her Ph.D. degree in Statistics from Cornell University.

Prior to joining FDA in 2012, Dr. Rodriguez worked for several years in industry supporting a variety of therapeutic areas, in addition to a research/teaching position at the North Carolina State University Statistics Department and Bioinformatics Research Center.  Her work at FDA has covered issues in oncology, hematology, meta-analyses, benefit-risk evaluations for regulatory decision making, stem cell products, evaluation of biomarker and PRO/COA endpoints, survival analyses, biosimilars and adaptive designs.  She has also participated in several advisory committee preparations, from both industry and FDA perspectives.

While at FDA, Dr. Rodriguez also completed the Excellence in Government (EIG) Fellows Leadership Program and Strategic Decision and Risk Management Certification from Stanford University.  She is currently co-leading the Benefit-Risk Assessment Planning (BRAP) Taskforce within the ASA Biopharmaceutical Section Safety Working Group and is part of several internal FDA scientific working groups.

Dr. Mike W. Colopy

Mike W. Colopy, MPH, PhD has supported clinical trials and epidemiological studies since 1982. Viewing life as a series of decisions and positive tradeoffs, Mike’s vision of benefit-risk assessment is to see it extend beyond treatment-level and patient-level assessments for regulatory decisions to the individual patient level for shared doctor-patient decisions in the clinic. This progression is demonstrated in his UCB team’s recent online publication, Planning Benefit‑Risk Assessments Using Visualizations, Therapeutic Innovation & Regulatory Science | Home (springer.com).