About Us: Expert CMC Consulting Services

Robert Hargreaves, Principal

Rob, a co-founder of R³LS, has over 18 years of global regulatory biopharmaceutical experience. He joined R³LS from Celgene (now Bristol Myers Squibb) where he was a Director of Global Regulatory CMC and a key leadership team member.

At Celgene, Rob established the EU branch of the expanding Global Regulatory CMC department. Working across the full portfolio of products, Rob provided leadership on all aspects of the drug development process, with a particular focus on EU and International regulatory strategy. Rob relocated to the U.S. to become the Reg CMC lead for the Revlimid® program and provide regulatory oversight for other commercial and clinical programs (early to late stage). Most recently, Rob was the Reg CMC strategic lead for the Zeposia® program, successfully gaining initial approvals in the U.S. and E.U. and establishing the global footprint.

Rob began his career in regulatory affairs as the Regulatory Affairs Manager for a generic active substance manufacturer. He authored multiple DMF, ASMF and RTQs as part of multiple generic submissions worldwide.

Prior to his regulatory affairs career, Rob worked as a post-doctoral research associate at Arizona State University, Tempe, AZ, and the Paterson Institute for Cancer Research, Manchester, UK. Rob’s research focused on the design, discovery and synthesis of potential anti-cancer agents.

Education

Rob earned his BSc (Hons) in Chemistry and his PhD in Medicinal Chemistry (oncology) from the University of Manchester (UK).

Sigita Zibas, Principal

Sigita, a co-founder of R³LS, joined from Celgene Corporation (now Bristol Myers Squibb) after over 19 years in various positions in Global Regulatory CMC, Quality Operations, Quality Assurance and Quality Control. Since working with R³LS, she has authored INDs for small molecules and cell/ gene therapies, supports CMC activities for several early-stage therapies, and has provided Regulatory CMC support for late phase commercial assets. Earlier in her career, she spent several years in Analytical Development at Schering Plough Corporation (now Merck).

During the last 12 years of her tenure at Celgene, Sigita worked in Global Regulatory CMC and was a member of that group’s leadership team. At Celgene, she provided regulatory CMC support and direction to clinical (early to late phase) and commercial programs for small molecules, biologics, and 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 and leading the Regulatory CMC team for the submission of the US BLA for BREYANZI®. She was also responsible for Structured Product Labeling, was a core member of the Celgene pilot group for the FDA’s Secure Supply Chain Act initiative, and was involved in IDMP activities.

Earlier at Celgene, Sigita was a leader in Quality Operations, where she built teams within Quality Control and Quality Assurance. This also included establishing and managing robust quality systems for the rapidly growing pharmaceutical company. As part of Quality Assurance, she actively participated in GMP inspections.

Before joining Celgene in 2001, Sigita was at Schering Plough, where she provided analytical development support for clinical products in all phases of development up to commercialization. This included HPLC and dissolution analytical methods and validation for small molecules in solid and semi-solid formulations used to support regulatory submissions.

Education

Dr. Zibas holds a BA in chemistry from Miami University and an MS and PhD in chemistry from Seton Hall University.

Robert Wildman, Principal

Rob, a co-founder of R³LS, has over 20 years of global regulatory CMC biopharmaceutical experience, spanning development to commercialization of 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.

Most recently, Rob was Executive Director, Technical Commercialization at Bristol Myers Squibb (BMS), where he led the worldwide manufacturing and technical transfer divestiture activities for OTEZLA® to Amgen. Prior to its acquisition by BMS, Rob spent six years in leadership roles in global regulatory CMC at Celgene, where he was responsible for marketed sterile injectable products and development assets in phases 1-3 through NDA. Rob then built the Technical Commercialization function at Celgene, which was responsible for developing commercialization and launch strategies for the mid to late-stage small and large molecule pipeline, launch execution, and life-cycle management approaches for in-line marketed products.

At Merck & Co., Inc., Rob was Senior Regulatory Scientist CMC, where he directed a group of CMC scientists to execute global post-approval site consolidation and outsourcing activities for small molecules, including solid oral, sterile injectable, and ophthalmic products.

Education

Rob earned his BS degree (with honors) in Environmental Sciences from Rutgers University.

Richard Couch, Principal

Rick has significant experience in Regulatory Affairs, with over 30 years of experience in the pharmaceutical industry and more than 25 years in regulatory, drug development and commercialization.

Before founding R³LS, Rick worked at Celgene Corporation (now Bristol Myers Squibb) for 15 years, where he started the CMC Writing Group and assumed responsibility for the Global Regulatory CMC organization three years later. Rick expanded the Global Regulatory CMC organization during his tenure, overseeing small molecule, biologics and cellular therapy modalities. Rick was responsible for the U..S and global expansion of REVLIMID®, the original NDA/BLA/MAA submissions for five small molecules, one recombinant fusion protein, and the original BLA submissions for two cell therapies. Rick oversaw more than 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 into a regulatory CMC position.

Education

Rick earned his MS in Chemistry from Lehigh University and his BS from Ohio University.