Agency Interactions

As part of its regulatory service offering, PharmaLex has had extensive experience representing clients at FDA regulatory meetings and regulatory advice communications. We have worked with clients across all stages of development, from discussing IND readiness at pre-IND meetings, clarifying critical developmental questions at Type C meetings, and have assisted clients with halted development programs at Type A meetings as well as supporting later-stage development at End of Phase 2 and pre-NDA meetings. PharmaLex has also assisted clients at Biosimilar Biological Product Development (BPD) meetings from Biosimilar initial advisory meeting (BIA) to BDP Type 1-4) to support biosimilar product development in the US.

PharmaLex’s expertise is not limited to specific divisions or indications, as we have interacted with nearly every division at the FDA, including specialized units such as the Division of Clinical Outcome Assessment (DCOA, formerly SEALD) and office of orphan product development (OOPD).

PharmaLex offers support during all aspects of the meeting process, from assisting with meeting strategy, through authorship, review, and submission of meeting-related documents, Sponsor meeting preparation, FDA meeting attendance, and follow-up activities. PharmaLex prides itself in understanding the goals of the client and identifying appropriate strategies for both effectively communicating with the FDA and fostering a collaborative relationship with the Agency, thereby resulting in efficient product development often saving Sponsors time and money.

• Proven track record
  • Just in the last 5 years (2015-2020) supported 60+ FDA meetings, including pre-IND, End of Phase 1 and 2, Pre-NDA, Type C, Type A, and Biosimilar (BIA, BPD 1, 2 and 3) Meetings, ANDA controlled correspondence and Pre-ANDA meetings.
• Diverse experience portfolio
  • Experience spans small and large (polymers) molecules, biologics including CGT, regenerative medicine, recombinant proteins, biosimilars, and combination products
  • Expertise working with multiple FDA review divisions across both CDER and CBER, supporting numerous indications at various stages of development
  • Expertise in various therapeutic areas such as rare diseases, advanced therapies, acute and chronic pain, CNS disease, oncology, and gastrointestinal disorders providing a wide range of experience to support multiple different types of programs
• Ability to support all aspects of meeting preparation and related activities
  • Substantial experience in assisting clients with FDA meeting strategy, formulating thoughtful meeting discussion topics, designed to maximize meeting opportunity, leading to efficient development programs
  • Significant experience with authorship and submission of required meeting materials, including meeting requests and briefing documents, in compliance with FDA guidelines, to ensure FDA is well informed of the Sponsor’s program and developmental strategy to support meeting discussion
  • Able to prepare and lead meeting rehearsals to certify all attendees are well prepared prior to meeting with the Agency, including assisting with the overall messaging strategy to support the Sponsor’s goals of the meeting
  • Ability to attend and/or lead FDA meetings on behalf of the Sponsor, assisting with the facilitation of the meeting discussion and fostering collaboration with the FDA

Aiding and steering of follow-up activities and interactions occurring from the FDA meeting including authorship and submission of meeting minutes and developing appropriate program strategy based on FDA meeting discussion.