Josephine M. Torrente Director 202-737-7554
Josephine M. Torrente
Practice Areas
Industries
FDA Regulatory Categories

Overview

Josephine Torrente’s practice is devoted to bringing promising new drug and biological products, including cell therapies, to market. Ms. Torrente advises clients throughout drug development, from preclinical and Phase 1 matters to complex Phase 3 study design issues, Special Protocol Assessment (SPA) negotiations, and advisory committee preparation. As part of this process, she assists clients in responding to FDA information requests during development and NDA or BLA review with a view toward fully understanding and addressing FDA concerns at the earliest possible time.

Ms. Torrente has provided counsel on issues specific to the drug development of therapies for serious and life threatening diseases (accelerated approval, surrogate endpoints, historical control groups, fast track, breakthrough therapy and orphan drug designation), 505(b)(2) applications (bridging studies and selection of an appropriate listed drug), safety issues (design and timing of large safety studies, including cardiovascular outcomes trials, REMS utility and elements, trade name matters, and abuse-deterrent formulations of prescription opioids), and FDA’s fixed dose combination drug rule. In this context, Ms. Torrente attends drug development meetings at both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), frequently communicating with various FDA division and office directors.

In light of her knowledge of FDA legal matters, and her scientific educational training and experience, Ms. Torrente is frequently asked to represent pharmaceutical and biotechnology companies in formal dispute resolutions (FDRRs) within CBER and CDER. She represents clients on matters such as clinical holds, disagreements over pivotal study design features and SPA issuance, and application deficiencies raised in FDA-issued complete response letters.

Ms. Torrente also performs transactional work related to financings, mergers and acquisitions, and licensing deals involving pharmaceutical and biotechnology companies. She routinely leads teams of specialized HPM attorneys in conducting FDA-related diligence. In this role, Ms. Torrente provides practical advice, helping clients make determinations on acquisitions and valuations.

Education & Admissions

Education

J.D., summa cum laude, Temple University Beasley School of Law
M.S., Biomedical Engineering, University of Alabama at Birmingham
B.S., Biomedical Engineering, Case Western Reserve University

Admissions

District of Columbia
Women in Bio
Food and Drug Law Institute

Experience

  • Successfully appealed a Complete Response Letter that would have required additional adequate and well-controlled trials; obtained FDA approval with no new studies.
  • Advocated for a biotechnology company before FDA to obtain 5-year Hatch-Waxman exclusivity for a complex mixture product whose components were already approved.
  • Provided regulatory counsel to a brand name company in the first negotiation over single shared REMS with generic companies.
  • Successfully argued to the FDA Chief Counsel’s Office that a class of combination products that were previouslyregulated as drugs should be considered biologics, following legislation on biologics exclusivity.
  • Authored white paper arguing for accelerated approval in the face of pre-NDA comments from FDA indicating that thedrug was unlikely to be approved on existing data.
  • Provided strategic advice to client teams preparing for successful Advisory Committee meetings for drugs in the oncology, metabolic diseases, and Central Nervous System (CNS) therapeutic areas.
  • Led formal appeals of matters related to pre-approval CVOTs, pivotal trial enrichment strategies, magnitude of clinical benefit, validity of interim data, and imputation of missing data.

Tissue Products or HTC/P

  • Counseled client regarding resolution of GMP/GTP issues in light of ongoing Phase 3 clinical trial.
  • Submitted requests for designation of combination cell therapy products as medical devices or drugs.
  • Assisted client in managing issues related to identity and potency assays for novel cellular therapy products.
  • Provided regulatory counsel to major contract manufacturer of HCT/P therapies.

Corporate Transactions

  • Led U.S. regulatory diligence for merger of companies with combined expected annual revenue of more than $475 million.
  • Acted as lead FDA counsel representing issuers or underwriters for various IPOs and follow-on offerings.
  • Routinely advises investor groups on risks and potential FDA actions based on publicly available information  for various drug and biological products.

Honors & Awards

  • Chambers and Partners
    2013-2019
  • LMG Life Sciences
    2019 Regulatory Attorney of the Year, FDA Pharmaceuticals
Education

J.D., summa cum laude, Temple University Beasley School of Law
M.S., Biomedical Engineering, University of Alabama at Birmingham
B.S., Biomedical Engineering, Case Western Reserve University

Admissions

District of Columbia
Women in Bio
Food and Drug Law Institute

Practice Areas
Industries
FDA Regulatory Categories