Rima Bawarshi Nassar, Ph.D.

Rima Nassar, Ph.D. has managed and led global regulatory affairs groups (strategy, CMC, labeling, operations, ad/promo) for over 2 decades. She has grown and expanded groups according to business and pipeline demands. Rima has developed global regulatory strategies aligned with company goals/objectives and supported successful and seamless drug development and health authority submissions and interactions. She has overseen critical submissions to regulatory agencies including FDA, EMA, and PMDA. Rima has led and currently leads high level regulatory activities for all phases of drug development, including IND initiation to registration and post-approval. She represents companies at Health Authority meetings and prepares teams for such interactions. Interprets health authority advice/response, regulatory precedents, guidelines, and policy to drive the regulatory strategy; assess regulatory risk and develop mitigation strategies. Rima provided proactive regulatory advice to internal teams (clinical development, CMC, preclinical, quality, medical affairs, commercial, etc) to ensure optimal product support. Managed and supervise preparations for advisory committee meetings with FDA. With expertise in multiple therapy areas – most notably oncology, hematology, and diabetes/metabolism and extensive experience with expedited approval pathways and oncology projects/initiatives (Project Optimus, Project Front Runner, Real World Evidence, etc). She has led regulatory business development and due diligence activities; provided regulatory input into new business ventures/collaboration activities; collaborated with partners to bring new assets / products through the regulatory process and served as member of company Global leadership and Research and Development leadership teams. Chair of the Labeling Review Committee to ensure alignment in important labeling issues between sponsor and global health authorities. Rima has the ability to work in biotech and pharma companies of varying size and employee number: BMS, Bracco Diagnostics, Novo Nordisk, Sanofi, and Genmab. Strong scientific and pharmaceutical background as well as strong interpersonal, negotiation, and team skills. Her Notable Achievements are:Approved products: Epkinly (epcoritamab-bysp) 4 mg/48 mg at Genmab; Adlyxin/Lyxumia (lixisenatide) Injection at Sanofi; Activella (estradiol/norethindrone acetate) Tablets (0.5 mg/0.1 mg) at Novo Nordisk. Approved efficacy supplements: Apidra (insulin glulisine) SoloStar at Sanofi; Lantus Origin Study at Sanofi (with an optimal label). Elected to the Board of Directors at Genmab representing the US employees. Established Regulatory Business Development at Sanofi to lead and manage regulatory activities for potential in-licensing/out-licensing opportunities. Led and directed regulatory due diligence activities for Afrezza^® (inhaled insulin product from Mannkind) at Sanofi prior to the alliance agreement. Led two parallel advisory committee meeting preparations for lixisenatide: open session (efficacy and safety data without the interim cardio-vascular study data) and closed session (fire-walled group for interim cardio-vascular study data).