In an effort to further bolster Akron’s competitive advantage in attracting, conducting and succeeding in clinical trials, leaders of the Austen BioInnovation Institute in Akron (ABIA) announced today the creation of the Center for Clinical Trials and Product Development (CCTPD). The new center, which had previously been part of one of ABIA’s original Centers of Innovation, will capitalize on opportunities in clinical trials and biomedical product development through its clinical research, product development and regulatory expertise.
In all, the ABIA – a unique collaboration of Akron Children’s Hospital, Akron General Health System, Northeast Ohio Medical University, Summa Health System and The University of Akron – now has five Centers of Innovation which work in concert to span the lifecycle of product development ranging from creating innovation to assessment of commercial potential to early-stage product development and prototyping to clinical trials, marketing approval and simulation training.
The CCTPD, which will be led by Dr. Stan McDermott, a 30-year pharmaceutical development and clinical research industry veteran with U.S. and global experience, is poised to offer ABIA partners and other clients new medical device and drug consulting, regulatory strategy assistance and FDA connection, product assessment and recommendation, clinical protocol development, biostatistical capabilities and project management. These capabilities will help to secure partnerships in clinical research for the partner institutions, and help to guide the development of new products and drugs stemming from Akron.
“With the creation of the new center, we are able to provide the ABIA partnership and biomedical companies with a wider breadth of expertise in medical device and biopharmaceutical development that will allow us to optimize Akron’s value and increase speed to market by providing a single stop, full-service support system for product development and regulatory approval” said Dr. McDermott.
The move to create the new center was made, according to ABIA President and CEO Dr. Frank L. Douglas, because ABIA leaders saw that Akron could take a larger role in securing clinical trials and biomedical development for both patients and companies in Northeast Ohio.
“The decision to create the Center for Clinical Trials and Product Development came as we realized the opportunity to further capitalize on the medical strengths of Akron by focusing efforts on the important steps of clinical research and testing,” said Dr. Frank Douglas, President and CEO of ABIA. “The creation of the CCTPD helps us to provide even more power to our partners and to companies in Northeast Ohio by focusing on the research, testing and regulatory approval pathways that healthcare innovators must learn to navigate.”
Joining McDermott in providing expertise for the new center will be Rob Ngungu, RAC, who brings the ABIA partnership extensive experience in regulatory affairs and product development gained during years of working in U.S. and international biopharmaceutical and medical device industries. Mr. Ngungu brings over 30 years of drug and device development, regulatory affairs and clinical strategy experience.