Doranne Frano, M.S., M.B.A.

Senior International FDA Regulatory Advisor

doranne@torreypineslaw.com
main: +1 (858) 869-1250

Doranne Frano is an accomplished global regulatory affairs and quality executive having more than four decades of experience guiding pharmaceuticals, medical devices, and combination products from pre-IND development through global clinical trials, marketing approval, and commercialization. As a Senior International FDA Regulatory Advisor with Torrey Pines Law Group, Doranne advises the firm&s clients on global regulatory strategy, submissions, and quality compliance for programs in oncology, hematology, cardiovascular disease, rare diseases, neurology, and women&s health.

Doranne brings to the firm the perspective of a regulatory executive who has served as a strategic partner to chief executive officers and senior leadership teams. She continues to serve at the executive level as the head of regulatory affairs and quality for a clinical-stage oncology company, where she reports to the chief executive officer and leads global regulatory strategy, CMC, and quality systems for multiple programs in the United States, Canada, and the European Union. In that role she has filed three U.S. Investigational New Drug applications (INDs), an EU clinical trial application through CTIS, a Canadian clinical trial application, and a Swiss clinical trial application, and has supported Orphan Drug and Fast Track designations in breast cancer and sarcoma. As Vice President, Regulatory Affairs of HUYA Bioscience International, she filed two oncology Japanese New Drug Applications (JNDAs) in 2020 that were approved following six-month reviews, filed four INDs that cleared FDA&s 30-day review, and coordinated clinical trial applications in 11 European countries, South Africa, Canada, and Japan. As Vice President, Regulatory Affairs and Regulatory Operations of La Jolla Pharmaceutical Company, she led a priority-review New Drug Application (NDA) that was approved in four months and directed a 12-person regulatory team through commercial launch and postmarketing compliance.

Earlier in her career, Doranne held senior regulatory and quality leadership positions at Ambit BioSciences, Acadia Pharmaceuticals, Somaxon Pharmaceuticals, WomanCare Global, BioVascular, Profounda, and Women First HealthCare, where she established regulatory and quality departments, led regulatory agency inspections, directed manufacturing and technology transfers, and conducted regulatory and quality due diligence for in-licensing transactions, investors, and partners. At G.D. Searle and its successor Pharmacia, she led worldwide regulatory activities for women&s healthcare products and a COX-2 oncology program, supported the transfer of more than 30 marketed products across more than 60 countries, and co-chaired the company&s regulatory approval committee for labeling and promotional materials. She also directed regulatory functions at KV Pharmaceutical, Smith & Nephew Solopak, Premier Health Alliance, and Morton Grove Pharmaceuticals.

Doranne&s practice encompasses global regulatory strategy and lifecycle management; IND, CTA, NDA, JNDA, MAA, 505(b)(2), and 510(k) submissions; interactions with the U.S. Food and Drug Administration, the European Medicines Agency, Japan&s Pharmaceuticals and Medical Devices Agency, and Health Canada; orphan and expedited program designations; chemistry, manufacturing, and controls (CMC); eCTD regulatory operations; GxP quality systems and inspection readiness; pharmacovigilance; and regulatory due diligence. Through Liberty Consultants, the regulatory consultancy she has led since 1995, she has advised drug, device, and combination-product sponsors throughout the United States, Europe, and the Asia-Pacific region, including Singapore, Australia, Korea, China, and Taiwan, and has served as U.S. agent for foreign sponsors.

Doranne&s published work includes “Optimizing Presurgical Conditions with a GnRH Agonist in Women with Leiomyoma,” which appeared in Alternatives to Hysterectomy in April 2000.

Doranne earned her Bachelor of Arts in Business from Northeastern Illinois University and her Master of Business Administration from Roosevelt University. She received her Master of Science from the Temple University School of Pharmacy.

At Torrey Pines Law Group, Doranne works alongside the firm&s patent attorneys and technology transactions lawyers to align regulatory pathways with intellectual property and commercialization strategy, helping clients bring lifesaving, enduring, and commercially valuable technologies to market.