IMPACT (now part of Syner-G BioPharma Group) has been providing Regulatory Affairs support to a mid-size pharmaceutical company since 2009. Even though this company has a Regulatory Affairs Department, their rapid growth over the years has made “in-sourcing” of help a necessity. One area of particular need for the company has been identifying experienced regulatory affairs professionals to serve on their core Product Development Teams (PDT).
IMPACT has provided a Regulatory Lead (RL) for four separate CNS development programs being pursued by the company. For each program, the RL represented the regulatory function on the PDT and coordinated the activities of a Regulatory Subteam, including members from CMC regulatory affairs, regulatory operations, labeling, and promotion and advertising. The RL was responsible for developing and driving the regulatory strategy for each project and interacting with the rest of the PDT to move the program forward as efficiently as possible, all under the watchful eye of the company’s Research and Development Committee. The RL was also the primary contact for all correspondence with the FDA related to the program.
For Program 1, the IMPACT RL took over responsibility during Phase 3 testing of the drug. During this time, routine IND maintenance was required, such as protocol and new investigator submissions, IND annual reports for the FDA and DSURs for Europe. Of more importance was defining the regulatory strategy for the NDA [(505)(b)(2)] submission and kicking off the NDA preparation process. An unanticipated development necessitated a Type A meeting with the FDA, which the RL managed to a successful outcome.
Following submission of the NDA for Program 1, the RL coordinated the activities of the NDA “Rapid Response Team” which responded to all FDA reviewer queries, culminating in label negotiations, agreement on post marketing study requirements, and exclusivity determination. Obtaining agreement with Division of Medical Error Prevention and Analysis (DMEPA) on an acceptable proprietary name for the product was another challenge faced by the RL! The drug was approved in 2014 and the RL is currently involved with NDA life-cycle activities.
For Program 2, the IMPACT RL was brought onboard at the end of Phase 2. One of the first tasks was to take the team to an End-of-Phase 2 meeting with the FDA, which yielded agreement from the Agency on the Sponsor’s plan for an efficient Phase 3 confirmatory trial. This product also has a device component which adds another aspect of regulatory complexity. Phase 3 is underway and NDA planning has begun!
Programs 3 and 4 are for the same drug (an NCE) being studied for two distinct indications with different routes of administration. For these programs, the RL is driving the regulatory strategies from IND enabling toxicology studies through submission of the INDs.
Client testimonial forthcoming