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

Overview

Josephine Torrente’s practice focuses on bringing promising new drug and biological therapies through the FDA approval process. With more than 30 years of experience in the industry, Josephine provides essential regulatory insight and strategic perspective into the pursuit of aggressive objectives.

Josephine advises biotech and pharmaceutical senior executives and development teams on strategic direction at critical moments in drug development, from preclinical and Phase 1 matters to complex Phase 3 study design issues, and advisory committee preparation. Key to her success is the ability to fully understand and address or challenge FDA concerns at the earliest possible time.

Josephine also routinely leads teams of specialized HPM attorneys in conducting FDA-related diligence, providing practical and actionable advice that help 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

  • Best Lawyers, 2024
  • Chambers and Partners, 2013-2019
  • LMG Life Sciences
    2019 Regulatory Attorney of the Year, FDA Pharmaceuticals
    2023 Life Sciences Star
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