By Richard Steiner, Pharmatech Associates – 02/27/2023

At the National Institute for Pharmaceutical Technology & Education (NIPTE) pathfinder workshop at The Bush School of Government & Public Service in Washington D.C., a high-ranking group of leaders from academic, industry, and regulatory agencies came together to discuss ways to accelerate drug product development and approval in light of critical patient needs and the national emergency of drug shortage and supply chain risks.

Welcome keynotes were given by Dr. Gintaras Reklaitis from Purdue University, Dr. Ronald Piervincenzi, CEO of USP, and Dr. James Coburn from the FDA. Their discussions gave clear emphasis on the importance of working together to focus on patient safety and to shorten time to market for life-saving medicines.

The group of 66 participants concentrated on the entire life cycle of a pharmaceutical product from early development, clinical development, to product formulation and process development. The industry perspective, spearheaded by Pharmatech Associates CEO, Bikash Chatterjee, was clearly expressed in contributions by major innovators, CDMOs and excipients suppliers. The FDA presented a collaboration session discussing regulator expectations when time to market is shortened.

It is clear that there are many opportunities to further accelerate drug development and market launch as witnessed by the fast development of COVID-19 vaccines and treatments. Success was achieved by working hand-in-hand and to benefit the process for both sides, particularly for critically ill patients needing faster access to lifesaving treatments and commodity products without supply chain shortfalls, all under the guidance that patient safety, treatment efficacy, and affordability are the guardrails for any future initiative.

In summary, in addition to optimizing regulatory frameworks, developing platform formulations on platform technologies such as continuous processing, digital twins, advanced modeling capabilities, PAT and real-time release capabilities were the main buzzwords in the breakout sessions. Above all, it was identified that the main hurdle to overcome was to increase collaboration for all stakeholders involved in the lifecycle management of a drug product, whether it is a small molecule, large molecule, a biological, or chemical entity.

This three-day workshop was a great starting point for more teamwork among the parties involved. A comprehensive proposal of all findings will be put together for national health authorities with follow-up action items summarized from the breakout sessions.

Bringing brilliant minds together inspired all the participants who left Washington D.C. with momentum and greater understanding on how to get things done in a collaborative spirit. Regulatory, industry, and science can only achieve improvements quickly if everyone walks together in the same direction.

More details on this initiative will be published and this will certainly be of public interest in North America and the whole globe.

For information on NIFTE and for continuous manufacturing support and expertise contact Richard Steiner.