Collaboration Delivers Integrative Clinical Development Services for Pharmaceutical Industry
CLEVELAND- December 2, 2014-The Ohio Clinical Trials Collaborative (OCTC) and PacificGMP have entered into a co-marketing relationship to employ PacificGMP’s contracting and biopharmaceutical development services with the OCTC’s integrated research, clinical trial and core lab services.
The OCTC has partnered with an outstanding array of nationally renowned organizations focused on designing and performing clinical trials.
“By working closely with the OCTC network, we at PacificGMP believe that our clients will be able to complete their clinical trials faster and more quickly, thus bringing needed therapies, vaccines, and diagnostics to the public,” said Gary Pierce, the Chief Executive Officer and General Counsel of PacificGMP.
PacificGMP’s client pool is largely the biopharmaceutical companies located in the southwest United States, particularly San Diego, San Francisco, and Los Angeles. Likewise, the OCTC is well positioned in the eastern United States and Europe to approach clusters of biopharmaceutical industry companies located in North Carolina, Maryland, New Jersey, Massachusetts, United Kingdom, Germany, France, and Switzerland. The partnership will provide both parties with broader market exposure. With the global clinical pipeline of new products rapidly expanding in the biologics market, the partnership seeks to bring together client pools from both OCTC and PacificGMP to yield sales outreach on a more consistent basis. By way of a current good manufacturing practice (cGMP) manufacturing partner, the partnership supports production of biological active pharmaceutical ingredients (APIs) as well as clinical trial development.
“PacificGMP provides all the key elements of developing and manufacturing a biologic product successfully from cell line development to upstream and downstream process development, cGMP manufacturing for clinical trial purposes, analytical performance, and regulatory support,” Pierce said.
The OCTC will provide its clinical trial customer with access to PacificGMP’s biological manufacturing technology to optimize the customer’s drug manufacturing process and ensure an uninterrupted supply for clinical and drug launches. The relationship is intended to save the customer time and money and accelerate time to market. PacificGMP’s approach relies on single-use, flexible bioprocessing platforms and expertise in monoclonal antibodies, hard-to-express proteins, vaccines, and cell therapies.
“By integrating PacificGMP’s development and manufacturing activities with the clinical trial work provided by the OCTC,” Pierce said, “we can offer our industry and academic research community participants the full continuum of clinical support and the peace of mind knowing that they will successfully complete their clinical activities on the road to a commercial launch.”
Added OCTC Chief Executive and Director James Chmiel, MD, “Our collaboration with PacificGMP is part of the OCTC’s strategy to be able to serve the global pharmaceutical industry with integrated product development capabilities to speed time to market. Similar to our partnership with ClinicalRM, a full-service contract research organization, we each bring complementary services and expertise in a seamless integration that together mirror that found in big pharma and fill much needed gaps in a biopharmaceutical company’s repertoire.”
PacificGMP’s core services revolve around GMP manufacturing for human usage. We manufacture master cell banks and drug substances and drug products under cGMP standards for human clinical trials, development and qualification of release assays, fill/finish of drug product, oversight of necessary third party vendors and advising on regulatory matters. We also manufacture under cGMP, proteins for commercial, non-therapeutic purposes. As an integral part of manufacturing under GMP standards, PacificGMP creates document packages sufficient to meet the requirements facing organizations in obtaining regulatory approval of drug product used in human clinical trials. PacificGMP generates with its partners the Chemistry, Manufacturing and Controls (CMC) section of Investigational New Drug (“IND”) applications. For more information, please go to www.pacificgmp.com.
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.
Ohio Clinical Trials Collaborative
John Peterson, PhD, 216-368-0180
Global Business Development Director
Gary Pierce, 858-550-4094 Ext. 422
CEO and General Counsel
Case Western Reserve School of Medicine
Jeannette Spalding, 216-368-3004