On this interview conducted on the Cell and Gene Therapy Summit Tour London, we speak to Ramin Baghirzade, Global Head of Business at Charles River for Gene Therapy, about the Gene Therapy CDMO solutions that Charles River Laboratories offers and more. 

Please could you introduce yourself, tell us about your skilled background, and what inspired your work in gene therapy?

I’m Ramin Baghirzade, Global Head of Business at Charles River for Gene Therapy. I have been with the corporate for a few yr and a half, and I actually have a medical background. I have been within the industry most of my life, initially at Roche, after which further worked in cell and gene therapy space in Lonza and AGC Biologics. What inspired me to work in gene therapy was the doubtless curative nature of cell and gene therapies.

As Global Head of Business Gene Therapy CDMO Services at Charles River Laboratories (CRL), could you tell us about a number of the Gene Therapy CDMO Solutions that CRL offers?

We have now three gene therapy CDMO sites and two centers of excellence. We have now one center of excellence for plasmid DNA with two sites within the UK, in Alderley Park and Keele, and one other center of excellence for viral vector manufacturing in Rockville, Maryland, USA. That is where we do the viral vector production, including AAV, lenti, retro, and adenoviruses.

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Along with that, our CDMO services are powered by biologic testing solutions. We depend on a worldwide network of testing facilities allowing us to expedite timelines and have control internally.

At today’s Cell & Gene Therapy Summit, you can be giving a chat covering CRL’s Gene Therapy Journey. Could you give a temporary overview of the contents of the talk? What’s next for the CRL Gene Therapy Journey?

At Charles River, we spent significant effort and resources attempting to connect the dots inside the organization and permit our customers and partners to depend on Charles River throughout their drug development journey, from discovery to commercialization.

Despite being a big company, we be sure that each time a customer involves us, their experience is as seamless as possible, which suggests they’ve a single point of contact that’s in a position to navigate them through your entire Charles River portfolio. We have been specializing in integrating the entire offering across those domains.

We launched two platforms, one for AAV and the opposite for plasmid manufacturing for AAV, called the nAAVigation platform, where we managed to cut back the event times from the classic 18 months to slightly below eight months.

On the plasmid side, we launched the eXpDNA platform earlier this yr, allowing expedited plasmid DNA manufacturing and release. It’s about five weeks for high-quality (HQ) plasmids and just ten weeks for GMP-grade plasmids.

As a part of our portfolio, now we have launched off-the-shelf plasmids, including pHelper for AAV manufacturing and three lenti plasmids unveiled on the summit.

Significant advances in technology have allowed gene therapy to be seen as a viable treatment option for a lot of diseases. For you, what’s essentially the most significant technological advance in gene therapy, and the way do you foresee technology shaping the longer term of gene therapy?

Challenges still remain inside the cell and gene therapy space; one is the business viability, and tied to which might be challenges from the manufacturing viewpoint and the price related to that. You possibly can almost hear the tabloid headlines saying, “3.5 million drug approved,” and now the query stays, “what happens when those sorts of products turn out to be available for more common diseases?”

Imagine in the event you could cure diabetes, which might cost three million, 4 million as a price tag; who can pay for it? Importantly, who’s going to fabricate it? Because also the manufacturing processes are still quite complex. I feel rather a lot is yet to be done to make therapies more mainstream and available for more common diseases.

With gene therapy potentially impacting patients, how essential are patient and public perspectives on cell and gene therapies?

At Charles River, patients are on the front and center of all the pieces we do. That is the explanation why even inside this series of thought leadership events, for us it is usually really essential to listen to direct feedback from patients, and the feedback that we hear is that rather a lot more is to be done to make therapies more widely available.

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Also, in terms of ultra-rare and rare diseases, rather a lot is to be done to encourage drug development for those ultra-rare diseases, for which perhaps, a business case shouldn’t be as straightforward.

The Gene and Cell Therapy Summit goals to attach fellow leaders shaping cell and gene therapy development. What importance do events like today’s summit hold in collaboration between academia and industry?

I feel it is important to bring all the important thing stakeholders together and permit them to mingle and listen to different perspectives. That has been one in all the principal objectives of such a event; we attempt to bring different perspectives and stakeholders together, talk, after which discuss topics of common interest. This also allows us to construct this ecosystem inside the cell and gene therapy community, where we exchange ideas and partner across those domains to see how we will take the industry to the subsequent level.

Certainly one of the principal objectives set out for today is to permit leading experts and executives within the cell and gene therapy space to navigate and discuss the most important critical challenges they face. What are the most important challenges in gene therapy today, and how will you foresee these challenges being overcome?

Manufacturing is one such challenge, and attempting to overcome this challenge has been very essential for Charles River. There’s been a number of internal workshops and discussions. Again a few of those offerings which we’re bringing online are really tied to those challenges within the industry where, for instance, on the plasmid side, we are going to make them available off the shelf in order that already on day zero, they’re available, so it becomes rather a lot more of a cheap and time-efficient solution.

One other challenge we see is reimbursement and market access because we’d like to make those therapies commercially viable. Latest business models are emerging, for instance, payment-by-installment, outcomes-based payments, etc.

What are you personally most enthusiastic about when considering the longer term of cell and gene therapies?

I’m very obsessed with the sector because we’re now at an inflection point where it’s now not science fiction. That is now becoming a mainstream reality, and it’s fascinating to see increasingly more products coming to market. I expect there to be a snowball effect as more treatments come to market further boosting investor confidence. The extra money that’s being poured into the sector, the more products can be coming to the market.

What excites me is seeing how these therapies turn out to be mainstream and possibly also move into the primary line of care because a number of these drugs have been positioned historically as a final resort.

What’s next for you and your work?

We have now great vision and ambitions at Charles River, so we plan to proceed bringing more offerings and capabilities. It has been a terrific journey in Charles River, and I plan to proceed to remain on the journey.

About Ramin Baghirzade

Dr Ramin Baghirzade is the Global Head Business – Gene Therapy CDMO Services at Charles River Laboratories. With 15+ years of experience in life science and healthcare, Dr. Baghirzade previously held roles of accelerating responsibility at Roche, Lonza, and AGC Biologics in global business development, strategic marketing and market intelligence functions. He holds a Ph.D. Degree in Medical Sciences, in addition to an MBA.