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Virtual

Dec 06, 2023 12:00 PM - Dec 06, 2023 1:15 PM

(US Eastern Standard Time)

Pregnancy and Lactation: How Are we Going to Get Useful Data?

Presenters

Susan  Kindig, JD, MD

Susan Kindig, JD, MD

Prior Executive Director, Medical and Drug Safety, United States

Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience as an OB/GYN while in pharma to aid in the initial stages of the ConcePTION project, as a working group member for PRGLAC, and most recently on a pregnancy-related TransCelerate project. Susan earned her MD from Indiana University and her JD from Indiana University School of Law – Indianapolis. She is currently starting a foundation to support camps for teens across the country who are interested in medicine.

Amalia  Alexe

Amalia Alexe

Policy and Liaison Lead, QPPV Office, Advanced Accelerator Applications, A Novartis Company, Switzerland

Amalia is a Clinical Pharmacist, with ten years`experience in PV, with a passion for safety in pregnancy. She has completed her second MSc under EU2P program, with the Thesis: ‘Is my treatment harming my baby?`- a critical appraisal of a patient`s journey through pregnancy safety data available publicly. Amalia is currently enrolled in a PhD in PV, focusing her research on safety in pregnancy. Amalia is a member of IMI ConcePTION and is co-leading the development of the ConcePTION pregnancy & breastfeeding information exchange app. She is also the TransCelerate Topic Lead for the IGR PV Topic: Regulations Governing the Use of Medicines in Pregnancy & Breastfeeding. Amalia is currently a Policy & Liaison Lead in the QPPV Office of Novartis

Aaron  Pawlyk, PhD

Aaron Pawlyk, PhD

Chief, Obstetric and Pediatric Pharmacology and Therapeutics Branch, NIH/NICHD, United States

Dr. Aaron Pawlyk is the Chief of the Obstetric and Pediatric Pharmacology and Therapeutics Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Dr. Pawlyk is a pharmacologist with decades of leadership experience in drug discovery and pre-clinical development, pharmacogenomics, and mathematical modeling across multiple therapeutic areas. Under his leadership, the OPPT Branch aims to assure that there are safe and effective therapeutics for children and pregnant and lactating women and that these medications are used optimally according to individual needs. Before joining the NIH, he held multiple positions in the pharmaceutical sector.

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