Working Together to Deliver Integrative Chemistry, Manufacturing and Control Development and Operational Direction Services for the Pharmaceutical Industry
CLEVELAND- May 19, 2015 - The Ohio Clinical Trials Collaborative (OCTC) and Bryla CMC-Reg Consulting, LLC, of Snohomish, Wash., have entered into a co-marketing agreement to leverage the synergies of the two organizations in delivering services to industry. The OCTC will provide integrated research, clinical trial and core lab services, while Bryla CMC-Reg Consulting will offer commercialization services in chemistry, manufacturing and control, known as “CMC”.
“Our co-marketing relationship with the OCTC creates a unique opportunity for Bryla CMC-Reg Consulting to advance science and clinical research for new investigational drugs in various therapeutics areas through the OCTC and its academic and industry networks,” said Piotr Bryla, PhD, President of Bryla CMC-Reg Consulting, LLC.
The OCTC provides its industry partners with translational science research support in areas such as genetics, protein, RNA and DNA sciences, proteomics, metabolomics, regenerative medicine, stem cells, and basic medical sciences for all diseases. The OCTC provides the partners of Bryla CMC-Reg Consulting access to OCTC’s research and clinical networks.
Bryla CMC-Reg Consulting provides an extraordinary range of services to meet the requirements of CMC: all aspects of formulation, aseptic and non-aseptic manufacturing processes and analytical development, technology transfer, process scale up, phase-appropriate validation, supply chain management, regulatory development of specifications, dating period, impurity limits and starting materials, stability trending, quality system, preparation of CMC module 2/3 electronic regulatory submissions following recent ICH/FDA guidelines, QbD and QbR platforms, and liaison services with regulatory authorities.
Bryla has a quarter century of industry experience and expertise in directing clinical CMC development and operations. His company provides expertise in global CMC regulatory affairs for active pharmaceutical ingredients and drug products from discovery through all clinical phases and to commercial launch. Product experience spans small molecular weight therapeutics, semisynthetic drugs, and monoclonal antibody therapeutics.
Bryla CMC-Reg Consulting has an existing partnership with TeraCrystal, a state-of-the-art, solid-state chemistry lab, to provide services in pre-formulation, solid state chemistry and crystal engineering experimental support. OCTC clients will be able to access this expertise through Bryla CMC-Reg Consulting.
“I have strong aspirations for this partnership in providing synergy in support of our research and clinical networks coupled with Bryla’s commercialization process,” said John Peterson, PhD, Executive Director, Global Business Development of the OCTC.
About Bryla CMC-Reg Consulting
Piotr Bryla, Ph.D., President of Bryla CMC-Reg Consulting, LLC and Worldwide Who’s Who member, is a seasoned professional expert in directing clinical and commercial CMC Development and Operations for global pharmaceutical companies, as well as worldwide external manufacturing and research organizations. He has a proven track record of delivering results which ensures rapid, risk-reduced and cost efficient progression of clinical candidates (small, semisynthetic and monoclonal antibody therapeutics) through development and commercialization processes; solid CMC technical and regulatory knowledge of small molecular weight and biological (protein) products; record of launching drug products in the US market; worked for major corporations, small start-up biotech companies, and directed CMOs/CROs worldwide. Recognized as strategic leader with demonstrated expertise in situational leadership. Partner with TeraCrystal for cost effective solid characterization laboratory support.
About the Ohio Clinical Trials Collaborative
The OCTC is an initiative under Governor John Kasich’s vision of a premier research medical corridor in Ohio that is co-founded by the Clinical and Translational Science Collaborative at Case Western Reserve University, the Center for Clinical and Translational Science at The Ohio State University, and the Center for Clinical and Translational Science and Training at the University of Cincinnati. With offices at Case Western Reserve University’s School of Medicine, the OCTC seeks to establish Ohio as one of the most efficient and effective states in which to test new medications and treatment strategies. The OCTC offers economies of scale and unique capacity, leveraging expertise from across the state of Ohio to conduct clinical trials on behalf of industry sponsors. For more information, please go to www.ohioclintrials.org.
Case Western Reserve School of Medicine
Jeannette Spalding, 216-368-3004
Ohio Clinical Trials Collaborative
John Peterson, PhD, 216-368-0180
Global Business Development Director
Bryla CMC-Reg Consulting, LLC
Piotr Bryla, PhD