Expertise in all things FDA
Menu
Expertise in all things FDA
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.