Drugs and Biologics@NDA Partners

Contact us at DrugsAndBiologics@NDAPartners.com

Since 2003, NDA Partners has provided strategic regulatory guidance to established and emerging pharmaceutical companies based on our five general Development Principles for Optimal Product Development. These principles focus on FDA and EMEA regulations and opportunities, and address product differentiation, program/project management, clinical efficacy and safety, clinical pharmacology, animal pharmacology/toxicology and chemistry, manufacturing and controls (CMC) strategy and requirements.  Our clientele comprise national and international biotech and pharmaceutical firms and government organizations. Our combined experience includes senior leadership totaling several decades at the FDA Centers for Drug Evaluation and Research (CDER), Biologics Evaluation and Research (CBER), and Devices and Radiological Health (CDRH) as well as in the biotech and pharmaceutical industry. Our experience includes commercial drug development and regulatory leadership responsibilities for both drugs and biologics. Product area expertise in a wide variety of clinical therapeutic areas enables advisory services for development of companion diagnostics, use of the Animal Rule pathway, specification of decision-making criteria, and assistance with FDA-Sponsor interactions, such as rehearsal for Pre-IND, EOP2A, EOP2, Pre-NDA/BLA and Advisory Committee meetings.

The Drug & Biologics Team at NDA Partners can provide drug development and regulatory support for small companies to enable establishment of development and regulatory capacity. For companies of any size, the Drug & Biologics Team partners with internal development and management teams to design programs for effective decision-making, based on objective, cumulative knowledge that is integrated from all relevant sources within and outside the development program. We assist organizations to make effective decisions based on milestone-specific data and analyses.

NDA Partners drug & biologics expert services include:

• Assessment of product readiness for advancement to the next stage of development, including gap analyses.
• Creation of product development plans that include early Proof-of-Principle (PoP) and Phase 2A clinical Proof-of-concept (PoC) studies (i.e., studies meant primarily to provide rapid and convincing evidence for favorable benefit-risk profiles and premium reimbursement).
• Development of Target Product Profiles to focus development programs and design of pre-clinical and clinical development programs with product specific Go/NoGo decision criteria.
• Clinical pharmacology gap analyses based on FDA and EMEA criteria.
• Pharmacostatistical services, including data mining, pharmacometric modeling and simulations, and statistical analyses.
• Pre-submission meeting preparation, including development of briefing documents, meeting materials, rehearsals, and post-meeting follow up (Pre-IND, EOP2A, EOP2, Pre-NDA and Advisory Committees).
• Retrospective analyses of unexpected clinical study results.
• Program Management.
• Business development and due diligence, with a focus on competitive advantage.
• Litigation support and expert testimony.