A BioPhorum Fill Finish team has given its rationale for vial-size choices in the pharmaceutical development process to a National Academies of Sciences, Engineering, and Medicine (NASEM) consensus study committee.

The NASEM committee is commissioned by the US Congress to examine federal healthcare costs, safety and quality concerns associated with discarded drugs resulting from weight-based dosing of medicines contained in single-dose vials. Once the study is complete, the committee will write policy recommendations for US Congress.

Historically, the industry has not been fully engaged in the debate, so the BioPhorum presentation was welcomed by the NASEM Committee

The BioPhorum team provided an overview of the rationale for vial size choices and the technical challenges for using multiple stock-keeping units. Some of the suggestions from the BioPhorum team to help minimize waste were:

• Broad, efficient and consistent access to a forum for proactive regulator engagement and dialogue on a science-based strategy
• Allowing more flexible bracketing approaches during development that can translate into a final dosage form
• Global harmonization
• Regulators can help simplify validation, manufacturing and clinical pathways from weight-based to fixed-dose
• Minimize end-user variability of administering drugs (e.g. with clearly defined guidance on closed system transfer devices) to make global practice consistent
• Accepting the scientific rationale for establishing product specifications and shelf lives
• Where applicable (i.e. subcutaneous, fixed-dose), prefilled syringes can minimize overfill and regulators can help support the transition to prefilled syringes by:
• Enabling an efficient conversion for changing from vial to syringe
• Supporting risk-based combination product regulations for simple changes.

“As a subject matter expert, I cannot over-emphasize the importance of vial fill volume in product development and presentation,” said Yusuf O. Oni, Principal Engineer – Drug Product Development at Bristol-Myers Squibb. “Working on this team has shown me that we can, and need to, provide more education to all the stakeholders involved in patient and drug journeys beyond the pharmaceutical industry.”

As well as giving the biopharmaceutical perspective on drug wastage – and hopefully influence the final policy – the webinar was an opportunity to hear the other stakeholder perspectives and allowed the project team to benchmark their practices against each other.

Based on the committee’s review, it will identify relevant drugs and examine:

• Current delivery practices, including manufacturing, storage and transportation guidelines
• Guidance from relevant federal agencies to biopharmaceutical manufacturers and distributors
• Federal drug reimbursement and cost-sharing policies
• Implications of current dosing practices on patients’ safety and quality of care
• Financial consequences of discarded drugs.

 Representing BioPhorum Fill Finish was Dr Kedar Gokhale, Associate Director in Drug Product Development at Janssen Research and Development Biotherapeutics.

To learn more about the NASEM Consensus Study on the Implication of Discarded Weight-Based Drugs, and to view a video of the webinar including Dr Gokhale’s presentation, visit the NASEM website here.