David Lederer Email & Phone Number

Tarrytown, New York, Us

Currently, I'm the Senior Physician, Global Program Head and Clinical Development Lead for Regeneron’s siRNA NASH portfolio. Global strategist for 3 early clinical development programs in the NASH portfolio. Manage Medical Directors/Senior Medical Directors and guide cross-functional teams in clinical programs. Prior to corporate restructuring in 2023, served as Senior Physician in Early Clinical Development, overseeing 6 global early development programs across diverse therapeutic areas, including respiratory, cardiovascular, obesity, and allergy.Selected Achievements Include♦ Successfully led re-design of Phase 1 and Phase 2 NASH studies to improve recruitment and speed time to proof-of-concept.♦ Led the design of early development clinical strategy from pre-IND through Phase 2 proof-of-concept for a respiratory asset.♦ Drove attainment of successful IND equivalent for a respiratory asset with the launch of its first in-human study in 2023.

Tarrytown, New York, Us

I advanced to global clinical lead for the Phase 3 itepekimab development program in COPD. Served as respiratory clinical expert for the dupilumab clinical development program (COPD, asthma, allergic bronchopulmonary aspergillosis). Partnered with Alliance Partner for sBLA dossier preparation/submissions (dupilumab pediatric asthma & eosinophilic esophagitis) and acted as lead clinical contributor to breakthrough therapy designation request, fast track, orphan drug designation, and Pediatric Investigation Plans/PSPs in the respiratory dupilumab program. Expanded role to early clinical development for a pulmonary hypertension asset.Selected Achievements Include♦ Attained global approvals for dupilumab through successful submission of BLAs/MAAs.♦ Designed and managed the ongoing Phase 3 program of itepekimab for COPD with an Alliance Partner.

Tarrytown, New York, Us

In 2019, I transitioned to the biotechnology industry to lead clinical development with an emphasis on respiratory therapeutics. Directed clinical strategy, study design and medical monitoring of respiratory and COVID clinical studies (Phase 2 dupilumab for allergic bronchopulmonary aspergillosis & Phase 2/3 sarilumab for COVID-19).Selected Achievements Include♦ Designed and oversaw 1 of the 1st studies on COVID in 2020. Enrolled ~2000 patients in 2 months for the Phase 2/3 study of sarilumab for COVID-19. Results led to the inclusion of sarilumab in guidelines for the management of COVID-19.

Chicago, Il, Us

During my time as a practicing Physician, I was enlisted to serve on the 4-member executive medical team for this non-profit organization focused on raising awareness, providing disease education, and driving pulmonary research. Oversaw Interstitial Lung Disease (ILD) programs across 60 US medical centers. Articulated foundation mission and goals with donors. Selected Achievements Include♦ Established the PFF Scholars Program providing funding to early-career investigators in emerging research in the field of pulmonary fibrosis.

New York, Ny, Us

Contributed to this society medical journal as editorial lead of a 50-member team that edits and publishes clinical trials, original research, ATS documents, systematic reviews, and case conferences in clinical, epidemiological, and health services research related to adult and pediatric pulmonary, respiratory, critical care medicine, sleep, and population health.

New York, New York, Us

Throughout my prestigious career as a Pulmonologist, I honed my expertise in Interstitial Lung Disease (ILD) and lung transplantation. PI of multiple NIH R01 grants, funded clinical and epidemiological studies in idiopathic pulmonary fibrosis, interstitial lung disease and lung transplantation. Served as Founder & Director of the Pulmonary & Intensive Care Translational Outcomes Research (PICTOR) Group, which focused on discovery, clinical research, and training for researchers working in pulmonary care and lung transplantation. Directed ~5 clinical operations professionals and oversaw numerous junior faculty and Fellows in pulmonary and critical care research. Selected Achievements Include♦ Established and oversaw patient care as Co-Director of the Interstitial Lung Disease Program.♦ Mentored and guided junior faculty members in designing clinical and translational research and navigating policies and complexities of adhering to Columbia University and NIH guidelines and standards as Associate Division Chief for Clinical & Translational Research.♦ Directed clinical care as Associate Director of the Lung Transplant Program.

New York, New York, Us

New York, New York, Us

Master Of Science - Ms, Biostatistics

Doctor Of Medicine - Md

Bachelor Of Science - Bs, Biology