Frontida BioPharm, a pharmaceutical contract development and manufacturing organization (CDMO) based in Philadelphia and Chicago areas, has launched its new Category 1 (CAT.ONE) in vitro testing and evaluation services to support development and regulatory approvals for abuse-deterrent formulations of pain management and Central Nervous System (CNS) targeted therapies.
 
To enable the launch of its CAT.ONE services, Frontida has hired a team of industry-recognized scientists with a proven track record of success in performing FDA-compliant Category 1 laboratory-based manipulation and extraction studies to support the evaluation and NDA and ANDA regulatory submission of products designed with abuse-deterrent properties.
 
The team joining Frontida—Dr. Eric Kinzler, Chris Altomare, Greg Gironda, and Amanda Camody—previously collaborated on the design and execution of over 60 such studies involving investigational and approved abuse-deterrent products currently prescribed in the U.S.
 
To support the team, Frontida has also acquired specialized product manipulation equipment uniquely designed to simulate various abuse techniques (such as chewing, smoking, and vaping) and essential to reproducibly perform Category 1 evaluations. Frontida will leverage its established expertise in analytical development and high-throughput sample processing to rapidly deliver results for these studies.
 
“Frontida’s team is excited to augment our product development expertise for clients seeking to develop and commercialize new abuse-deterrent products,” said Ron Connolly, executive vice president of business development, alliances and regulatory affairs, Frontida. “The scientific leadership team we have brought on board to launch our new CAT.ONE service offering has proven to be among the best in industry in designing and executing studies to demonstrate whether a product’s formulation attributes can reduce its potential for abuse.
 
“With the team’s proven track record and collective experience, we can quickly support the approval process, provide technical insight into how to incorporate abuse-deterrent properties into the formulation matrix, and help our clients navigate the regulatory and technical challenges of obtaining new approvals and product launches in important therapeutic categories. Coupled with our ability to commercially manufacture and package DEA-regulated products, Frontida can provide a high quality and reliable CDMO partnership to leading brand and generic pharmaceutical companies.”