Josephine M. Torrente
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.
In the year prior to joining HPM, Ms. Torrente focused on corporate transactions and securities matters at a large Philadelphia-based law firm. While at a major pharmaceutical company from 1991 to 1997, Ms. Torrente worked as a regulatory professional and a research scientist conducting nonclinical studies.
Prescription Drugs and Biologics
• 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 previously regulated 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 the drug 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.
• 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.
Awards & Recognition
• Chambers and Partners, Nationwide: Life Sciences, Band 3, 2014
• Chambers and Partners, "Leaders in their Fields, Life Sciences: Regulatory/Compliance," 2013
Women in Bio
Food and Drug Law Institute
Articles / Publications
• FDA Appeals - Improving Your Odds of Success: Trends, Expectations, Strategies,
March 21, 2012
• FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients,
December 12, 2006
• Pharmaceutical Law R&D 101: Legal Issues During Research and Development,
October 4, 2006
see more speaking engagements
• CBI's Expanded Access Program: "Legal Considerations Associated with Expanded Access", February 3-4, 2015
• DIA Annual Meeting, Formal Dispute Resolution at CDER: When, Why and How - Strategy for Discussing Formal Dispute Resolution, June 15 - 19 2014
• FDA Appeals - Improving Your Odds of Success; Trends, Expectations, Strategies, March 21, 2012
• Regulatory Issues For IP Professionals, Orphan Exclusivity
Regulatory Strategy and Appropriate Interaction with Authorities
The Regulatory Frameworks for Advanced Therapy Medicinal Products, November 22 - 23, 2011
• Fourth Annual Risk Management and Drug Safety Summit, Reading the Drug Safety Tea Leaves - Top Legal and Compliance Challenges that Lie Ahead at the Fourth Annual Risk Management and Drug Safety Summit, November 1 - 2, 2011
see more blog entries
• HP&M Seeks Alternative Statutory Reading of BPCI Act “Deemed to be a License” Provision,
May 9, 2016
• HP&M Asks FDA Not to Narrowly Constrict the Formal Dispute Resolution Process,
December 8, 2015
• Chipping Away at FOIA Exemptions: The Next Step in FDA’s Campaign to Release Complete Response Letters for Unapproved Drugs,
June 22, 2015
• CDER Announces Public Compendium of Clinical Outcome Assessments with Hopes of Facilitating Greater Use in Drug Development,
April 20, 2015
• Critical Path Innovation Meetings: A New Opportunity to Discuss Drug Development Issues with FDA,
April 2, 2015