The impact of accelerated clearance pathways on the deployment of the analytical method toolbox for biotech products is among the issues drawing attention at industry/regulator conferences where the CMC challenges and the experience to date in accelerated review are being discussed.
The compression of CMC timelines is putting additional stress on both companies and agency reviewers to understand the relative strengths and limitations of the array of complex methodologies and how they need to be adjusted to particular biotech products and processes earlier in the development process.
Under discussion are: ● how prior knowledge about the methods can be more effectively leveraged ● how to handle the uncertainties prior to full method validation ● how these uncertainties tie into the risk/benefit equation for the breakthrough/priority candidates, and ● what the implications are for analytical method evolution across their lifecycles.
The analytical method component of the CMC challenge in the accelerated program context emerged into relief during the regulatory panel discussions at the 2016 European CASSS CMC Strategy Forum, held in Paris in May. Also drawing attention were the possibilities for further leveraging of regulator knowledge and for more inter-agency coordination in the biotech review arena.
The Paris forum followed the traditional model of bringing together a panel of regulators from different agencies around the world to highlight and compare ideas with the forum participants on the emerging issues they are facing in biotech product CMC regulation and the recent initiatives to address them.
The presenters at the opening regulatory session were Ireland Health Products Regulatory Authority (HPRA) Pharmaceutical Assessor Sean Barry, FDA Center for Drug Evaluation and Research (CDER) Office of Biotechnology Products (OBP) Review Chief Sarah Kennett, and Japan Pharmaceuticals and Medical Devices Ageny (PMDA) Office of Cellular and Tissue-based Products Principal Reviewer Yasuhiro Kishioka.
The three presenters addressed a similar range of front-burner CMC issues for biotech products, including problems in recent applications, their respective agency’s accelerated development programs, and the shifting approaches and expectations for lifecycle management. [Reviews of the presentations on Europe and the U.S. by Barry and Kennett, respectively, are provided in IPQ’s Aug./Sept. 2016 Monthly Update.]
Joining Barry, Kennett and Kishioka on the panel during the probing discussions that followed their presentations were CBER Division of Viral Products Deputy Director Robin Levis, Health Canada Center for Evaluation and Radiopharmaceuticals and Biotherapeutics Regulatory Scientist Anthony Ridgway, and EMA Quality of Medicines Principal Scientist Pascal Venneugues.