Interview Session with Aziza Ahmed, Regulatory Affairs CMC APAC, MSD International GMBH, Singapore
What do you think are the current FDA priorities to accelerate COVID-19 vaccines availability?
FDA is involved in many US government initiatives related to accelerating COVID therapies and vaccines. However, FDA needs to retain its independence related to review and determination of safe and efficacious therapies and vaccines. In general, what they can do is work with sponsors to provide advice on development and clinical trials and try to coordinate between the multitude of trials ongoing.
Some of the special government programs include:
- The Coronavirus Treatment Acceleration Program (CTAP) is an emergency program for possible coronavirus therapies (i.e., not vaccines). There are various guidance documents related to development, quality expectations and clinical trials available at https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
- The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership is a private-public partnership, including FDA, to develop an international strategy for a coordinated research response to the COVID-19 pandemic by prioritizing vaccine and therapeutic candidates, streamlining clinical trials, and rapidly expanding the clinical research resources focused on developing therapies for the COVID-19 pandemic.
- Project Warp Speed is a collaboration between various arms of the US government, including FDA, to accelerate the development of a COVID vaccine. It invests in manufacturing capacity and provides funding to companies to start manufacturing at an industrial scale earlier than usual (prior to the demonstration of efficacy and safety).
These programs are on top of regular accelerated review programs, such as Breakthrough Therapies: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
Your regulatory views on expediting drug approval during COVID-19 outbreak and working with associated challenges
I think it is important to point out that we cannot use the standard approach to approve a COVID related therapy worldwide and will need reliance and recognition approaches. As you know, typically, we get a drug or vaccine approved in US and/or Europe first and then expand to file in the second wave, then the third wave etc. with the whole process taking several years to get the product approved worldwide. That approach won’t be desirable or acceptable for a COVID product. But what’s the alternative? We don’t have the capacity to manage filings in 40 or more markets simultaneously and manage RTQs from all of those at the same time. Similarly, we do not have the capacity to host a dozen or more different pre-approval inspections for a new COVID therapy or a vaccine – we would need to focus on making product and not redundant inspections.
Options to move forward from an application review perspective could be:
- Collaborative review where multiple Agencies review together and provide a common set of RTQs
- Reliance where regulators start with an approved dossier and the assessment reports and see if any additional details are needed
- Recognition where regulators simply accept the review of another agency
Our Ebola vaccine used the first pathway, where WHO joined EMA as part of the assessment, and they provided a single set of questions to the sponsor. Then other agencies were able to accept the WHO pre-qualification. The ACSS review program is consistent with the second approach, where reviewer assessments are shared between Agencies.
Another watch out related to review is common dossier contents. For the options above to work, we would likely need to share the full dossier with all countries (this was done for the Ebola vaccine). It will be important that countries accept a common dossier, without the country-specific auxiliary information, like GMP records. Additionally, it will be essential that an aligned set of specifications be achieved, including the use of a single pharmacopeial standard.
Some of the review aspects could be challenging for developing regulatory agencies, as the first submissions will likely have incomplete CMC information, such as limited stability and/or validation data. Regulators in US & EU are used to this for accelerated product reviews, but that could be new and different for others. Worldwide acceptance of PACMPs could be very useful to provide quick implementation of aspects such as shelf life dating extension.
What do you hope to takeaway from Pharmacon Asia 2020?
I look forward to getting evolved insight/perspectives on meeting regulatory requirements in the current COVID-19 times & the possibility to share some of the outcomes with regulators.
Executive Director, Regulatory Affairs CMC APAC
MSD International GMBH, Singapore
Aziza Ahmed will be presenting “Comparisons of CMC Variations in the Region & Managing Complications” at the 7th Pharmacon Asia event happening from 23 – 25 September 2020.
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