CMC - Key Persons

Job Titles:

• Principal
• Co - Founder of R LS

Lucy, a co-founder of R LS, is a highly skilled Regulatory CMC strategist, writer, reviewer and negotiator with more than 16 years of regulatory experience. Lucy joined R LS from Celgene (now BMS) where she was a Senior Director of Regulatory CMC. During her 12 years of tenure, Lucy was the team leader responsible for the original NDA/MAA approvals of OTEZLA® and INREBIC®, and for the global footprint expansions of REVLIMID®. She provided oversight to numerous development compounds and commercial products, chaired CMC meetings with FDA and EU national authorities, and led cross-functional teams to establish overall CMC development strategies

Job Titles:

• Principal

Rick has significant experience in Regulatory Affairs with over 30 years experience in the pharmaceutical industry and more than 25 years in regulatory, drug development, and commercialization. Prior to founding R LS, Rick worked at Celgene Corporation for 15 years where he started the CMC Writing Group and three years later assumed responsibility for the Global Regulatory CMC organization. During his tenure, he expanded the Global Regulatory CMC organization overseeing small molecule, biologics, and cellular therapy modalities. Rick was responsible for the US and global expansion of REVLIMID ® , the original NDA/BLA/MAA submissions for six small molecules, one recombinant fusion protein, and the original BLA submission for one cell therapy. During this time, Rick oversaw over 20 clinical compounds from first-in-human through commercialization. In addition, as head of Global Regulatory CMC, he started an Analytical & Technical Services and a Technical Operations Alliance Management group. Rick started his career at Merck & Co., Inc in the Analytical & Quality Services where he developed and validated GC, HPLC and physical property methods for commercial small molecules before transitioning to a regulatory CMC position.

Job Titles:

• Principal
• Co - Founder of R LS

Rob, a co-founder of R LS, has over twenty years of global regulatory CMC biopharmaceutical experience, spanning development to commercial products. His experience includes, pre- and post-approval regulatory CMC, pharmaceutical development and commercialization, health authority interactions, and supply chain continuity and sourcing strategies, with broad global responsibility for direct and indirect interactions and negotiations with health authorities on all matters related to CMC. Rob, a co-founder of R LS, has over fifteen years of global regulatory biopharmaceutical experience. He joins from Celgene/BMS where he was a Director of Global Regulatory CMC and a key member of the leadership team. Rob joined Celgene to establish the European branch of the expanding Global Regulatory CMC department. Working across the full portfolio of clinical and commercial products, Rob provided leadership on all aspects of the drug development process, with particular focus on EU and International regulatory strategy. Rob relocated to the US to become the Regulatory CMC lead for the REVLIMID® program and provide regulatory oversight for other commercial and clinical programs (early to late state). Most recently Rob was the Regulatory CMC strategic lead for the ZEPOSIA® program, successfully gaining initial approvals in the US and EU and establishing the global footprint.

Job Titles:

• Principal
• Co - Founder of R LS

Dr. Zibas, a co-founder of R LS, joined from Celgene Corporation (now Bristol Myers Squibb) after more than 19 years in various positions in Global Regulatory CMC, Quality Operations, Quality Assurance and Quality Control. Earlier in her career, she spent several years in the Analytical Development at Schering Plough Corporation (now Merck). At Celgene, Sigita spent the last 12 years in Global Regulatory CMC and was a member of that group's leadership team. In her role at Celgene, she provided regulatory CMC support and direction to clinical (early to late phase) and commercial programs for small molecules, biologics and most recently, a cell therapy. This included leading the Regulatory CMC team for POMALYST® during the original US NDA submission/ approval and through many worldwide health agency submissions/ approval. Most recently, Sigita was the Regulatory CMC lead for the submission of the US BLA for a cell therapy. She was also responsible for Structured Product Labeling and was a core member of the Celgene pilot group for FDA's Secure Supply Chain Act initiative.