Jeff Summers

Background

About Jeff Summers

U.S FOOD AND DRUG ADMINSTRATION Deputy Division Director (Safety), Biologic Oncology Products 2007 – present Medical Team Leader, Biologic Oncology Products 2006 – 2007 Senior Medical Officer, Biologic Oncology Products 2003 – 2006 • Render regulatory judgments on investigational new drug applications (INDs) and biologic licensing applications (BLAs). • Manage regulatory issues for a large portfolio of licensed and development-stage products for the treatment of cancer. Provide advice to commercial and academic sponsors regarding proposed non-clinical and clinical drug development programs. Integrate consult advice from statisticians, product reviewers, pharmacologists and toxicologists. Draft Agency communications (e.g. regulatory actions, letters and responses to Sponsor submissions). • Responsible for coordinating and implementing measures to address emerging safety issues for biologic products used in cancer patients. EXTREME CAPITAL MANAGEMENT Managing Director 2007 – 2015 • Manage a portfolio of non-FDA regulated securities for short-term investment opportunities. • Drug Development Consulting CARROLL COUNTY HOSPITAL CENTER Pediatric Attending 2003 – 2006 • Provided pediatric hospitalist coverage for inpatient pediatrics, level 2 neonatal nursery, high risk deliveries, and ER consults. NATIONAL CANCER INSTITUTE & JOHNS HOPKINS UNIVERSITY Pediatric Oncology Fellow and Lymphoma Foundation Scholar 1998 – 2002 • Conducted basic science research studying 1) tumor induced T cell tolerance using a transgenic murine model and 2) the isolation, immortalization, and genetic manipulation of human colorectal tumor infiltrative lymphocytes. FRED HUTCHINSON CANCER RESEARCH CENTER Post-Doctoral Fellow 1990 – 1995 • Conducted basic science research studying DNA binding transcription factors. Specialties: Drug Development Regulatory Policy Oncology Molecular and Cellular Biology