Jennifer L. DiGiacinto, Pharm.D.

Expertise

Medical writing in all aspects of the drug development process in accordance with U.S. and European regulations and ICH guidelines, including INDs, clinical study reports, NDAs, and sNDAs (in standard and electronic format), and CTDs.
Experienced in IND and postmarketing safety surveillance, including adverse event data gathering, coding, and reporting.
Extensive experience in a wide variety of therapeutic areas and with clinical drug information evaluation.

Professional Experience

June 2007- Present

Clinical Pharmacologist
Salamandra, LLC, Bethesda, MD

Reviewing, evaluating and writing clinical safety and efficacy reports and clinical pharmacology reports for New Drug Applications (NDAs) and Investigational New Drug Applications (INDs) and other regulatory submissions with a special focus in antiviral drug development.
Preparing comprehensive summary reports of data for INDs and NDAs along with drafting labeling for drug products.
In-depth understanding of current drug development regulations, policy, and procedures.
Providing pharmacological assistance for in vitro metabolism studies.

May 2006 -
Present

Volunteer Clinician/Pharmacist
HIV/HCV Clinic, Washington DC Veterans Administration Hospital

Reviewing patient medical charts to maximize drug therapy outcomes.
Providing patient education and co-morbidity drug therapy resources for practicing ID clinicians.
Mentoring Residents and Fellows.
Responsible for the care of difficult patient populations.

July 2000 -
June 2007

Senior Clinical Pharmacology Reviewer
U.S. Food and Drug Administration, Rockville, MD

Reviewed and evaluated clinical pharmacology data contained in NDAs and INDs.
Reviewed and evaluated results of clinical pharmacology studies submitted in support of NDAs, INDs, and providing drug development recommendations to the Sponsor during the various IND and NDA stages.
Prepared comprehensive summaries of data reviewed in INDs and NDAs along with drafting labeling language for the drug product being reviewed.
Submit recommendations and conclusions for NDA approval along with developing post-marketing commitments needed to answer further questions pertaining to the drug product.
Participated in several working groups responsible for drafting new Clinical Pharmacology Guidance�s and HIV Guidances.
Participated in several working groups responsible for developing new approaches to clinical development for novel small molecules to treat HCV.
Lectured as an FDA representative at professional meetings and other academic arenas.
Reviewed clinical protocols (all Phases) submitted to the FDA.
Evaluated the safety and efficacy data from Phase 2 and Phase 3 study reports and compared safety and efficacy analyses on submitted data sets.
Prepared comprehensive study report reviews and provided regulatory and drug development advice to the Sponsor including study design and targeted population being studied.
Provided input on the primary and secondary endpoints selected for Phase 2 and Phase 3 studies, and provided advice as to what regimens to evaluate in the pertinent populations.

July1998 -
June 2000

Clinical Pharmacology Fellow
University of Illinois- College of Medicine, Peoria, IL

Jan. 1999 -
Jan. 2000

Staff Pharmacist
Order of Saint Francis Hospital, Peoria, IL

Sep. 1997-
Present

Athletic Drug Control Crew Member
Big 12 Conference- North Division, Aegis Laboratories

July 1997 -
June 1998

General Practice Pharmacist Resident
University of Nebraska Medical Center, Omaha, NE

Professional Activities

Education

Fellow Clinical Pharmacology, University of Illinois- College of Medicine, Peoria, IL (1998-2000)
Resident General Practice Pharmacist, University of Nebraska Medical Center, Omaha, NE (1997-1998)
Pharm.D. Doctor of Pharmacy, University of Nebraska Medical Center, Omaha, NE (1997)
B.S. Pre-Pharmacy, University of Nebraska at Omaha, Omaha, NE (1993)
B.S. Communications, University of Nebraska, Omaha, NE (1985)

Honors, Awards, and Certifications

FDA Commissioner�s Special Citation Award - ATRIPLA Review Team (2007)
FDA CDER Special Recognition Award (2003)
University of Nebraska Medial Center, College of Pharmacy Roche Pharmacy Communications Award (1997)

Publications