I hope certification on or before September 14. (90 working days+ weekends+ 2 holidays (IMO) since the application was filed May 7, 2021) Without a doubt, this will be an important milestone in the pathway to approval of DCVax-L.
Navigating regulations: novel cell therapy platforms and their path to clinical manufacturing
Nina Bauer Moderator Head of Commercial, Gene Editing and Novel Modalities, Merck KGaA
Natika Calhoun Senior Regulatory Consultant, Merck KGaA She previously served as the site Head of Quality for MilliporeSigma’s viral vector manufacturing site in Carlsbad, California, USA, where she was responsible for leadership of the Quality unit, and for preparing the facility for commercial and inspection readiness to support its first FDA and EU licensed products, which resulted in successful FDA and EMA inspections.
Anthony Davies Founder and CEO, Dark Horse Consulting
Matt Muldoon Senior Director Supplier Management, Allogene Therapeutics
(NB): A very broad question that essentially goes back to the overall regulatory environment – do you think that international harmonization of requirements between various regulatory agencies is a strong trend, and would such harmonization be more viable in specific disease areas? Anthony, any thoughts on international harmonization?
AD: We recently hired Don Fink from the FDA, and in the last 5 or 10 years he has been involved in a lot of harmonization discussions between the FDA and other regulators. We also have a lot of clients for whom we often take the US material to the MHRA, and we take the EMA trials to the PMDA in Japan.
It is a strong trend, and it is increasing. There are great things around the world, like the EudraLex and the International Organization for Standardization. It is increasingly international, and I think this is the way it is going to go.
Especially with the COVID vaccine situation. It is kind of nuts to have the MHRA approve a vaccine first, out there in London, then the FDA with a very fast second, and the EMA just struggling, frankly. There is no need for that, and I think things like the pandemic will just reinforce that trend. These products are either gene therapies like the AstraZeneca and J&J vaccines, or basically a gene therapy, like Pfizer and Moderna. I think that will reinforce the trend. I would say it is a strong yes to the question.
NC: I echo the strong yes.
The good news is that as our clients are submitting their BLAs, or getting new products that they want to get approved; the agencies are asking us first for our inspection reports. They want to see which agencies have inspected the site, referring to our viral vector manufacturing facility. The first question, for example if we have had the FDA come, is can we see your inspection report? Other agencies are definitely looking at those and making acceptances without necessarily coming to do an on-site inspection themselves.
I will also bring up COVID. In 2020 we had several inspections from different agencies planned. Of course, restrictions for travel, for coming on-site, for the safety of our operations, and having a 2-week quarantine for regulators to come from another country and sit in a hotel for weeks before coming on-site, just made everything entirely unfeasible.
They looked at what the other agencies had reported on before, and we were able to move forward, or have extensions, and so on. That was inter-agency, and is a direct benefit of the harmonization that is happening.
MM: Maybe it goes without saying, but obviously manufacturers clearly benefit from that harmonization. As much as possible, trying to follow a single set of clear guidance is an extreme advantage, especially as some of the players coming up in this space are smaller companies, and quite frankly don’t have the resources to look at regulatory guidance from many different places.
As much as that industry trend continues, it significantly helps the industry as a whole to push these therapies from the clinic to a commercial setting.
