Pinney and Lifetree collaborate to offer 'one-stop' solution for CNS drugs

The deal, described by the companies as “unmatched,” ​aims to provide clients with “one-stop comprehensive clinical, regulatory, and post-marketing services for central nervous system (CNS) drugs” ​- an area of particular expertise for Pinney.​

The two companies say news of their collaboration comes at a critical time for the pharmaceutical industry as the FDA increases its activities on issues relating to risk management and mitigation, such as interactions between drug ingredients, and human behaviour.

Jack Henningfield, vice president of research and health policy at Pinney, said: “Human abuse liability testing addresses the FDA requirement to include studies relevant to abuse for CNS-acting drugs. It is a vital component in the development of any CNS drug.”​

Study design​

The collaboration, says Pinney, will provide pharma sponsors with a broad range of services, including the offer to conduct and design studies, as well as analyse and interpret data and handle the subsequent regulatory filings required under the FDA's Controlled Substances Act, and its Risk Evaluation and Mitigation Strategy (REMS).

“Our clinical research staff delivers quality GCP-standard clinical trials necessary for regulatory submissions of CNS drugs,” ​said Lynn Webster, chief medical director at Lifetree, “We understand the problems in evaluating abuse liability and provide solutions. Timely assessments conducted as early as phase one may yield important information useful for clinical trial designs.”​

High standards​

Alice Jackson, president and co-founder of Lifetree, said:”Through this partnership our high standards for the design, conduct and interpretation of clinical studies will be further strengthened,” ​a sentiment echoed by Jeffrey Kinell, CEO of CRI Worldwide, whose company acquired Lifetree in January this year.

“The collaboration with Pinney builds upon a legacy of scientific advancement as pharmaceutical sponsors seek highly specialised services for their emerging human abuse liability needs,” ​Kinell said.

John Pinney, president of Pinney Associates said he believed news of the collaboration would interest potential clients seeking expertise in human abuse liability and risk management.

“For sponsors, integration of these services enables them to secure product approvals, obtain the appropriate labelling and scheduling, and develop comprehensive risk management that will be reassuring to regulators,”​ he said.