Early Considerations for Commercial Success

Becky Johnson-Kent
4 January 2023
Automation & Digitisation
Cell Therapy
Clinical Trials
Gene Editing
Gene Therapy
For this interview, Phacilitate’s Becky Johnson-Kent speaks with Serene Forte, Senior Vice President, Head of Genetic Medicine at Relief Theraputics, as she prepares to Chair the session Commercializing Gene Therapies : Building Your Strategy From Translation Through to Commercial’ at Advanced Therapies Week 2023.
To start with, please could you introduce yourself and what you’ll be speaking about at ATW 2023?  

Hello, my name is Serene Forte, and I am a PhD virologist by training. I spent several years involved in translational research at the academic setting after earning my PhD, followed by more that twenty years of experience in the biotech industry with the last eight years focused on rare disease and the last six specifically focused on gene therapy. I have worked on three near-to-market or already approved gene therapies, two of them based on AAV and one based on HSV-1.

My focus has been on understanding the entire process to get a gene therapy treatment from concept to approval. I have spent considerable time learning and understanding the details of the product and patient journeys as they relate to a gene therapy. I would say that my mantra is ‘always keep commercialization in mind along the entire journey’. I started this work prior to any gene therapy being approved in the US when all we had as an analog were the new CAR-T therapies. I look back now and see how far the field has come and marvel in what it will look like in the future.

I will be chairing a session on the commercialization of gene therapy.

Find out more. Join us at Advanced Therapies Week 2023 >>


What are the challenges associated with the commercialization of Gene Therapy? 
  • Asset selection & development costs: Certainly, making sure you are selecting the right asset for your company to develop is key. From the beginning you should be trying to understand how commercially viable it will be. There are many questions that you should ask during this stage, including does it have a known mechanism of action, is there a clear endpoint, is it aligned with your current therapeutic areas, do you have the right team to develop, market, support, and successfully launch it? Are you clear on the costs associated with developing a gene therapy?
  • Market access & reimbursement: This is the holy grail; can you get your product reimbursed? What is the value story? Do you have the right team in place to gain access and reimbursement? What is the reimbursement landscape going to look like when we have several high value, high cost gene therapies approved at the same time?
  • Durability: For gene replacement therapies, durability is paramount. How long will the effect last? Are you targeting slowly dividing or non-dividing cells? How much durability will you need to demonstrate to gain approval by a health agency? How do you plan your clinical studies to address this?
  • Finding patients: Finding addressable patients in rare disease is critical to a successful commercialization of your gene therapy treatment. Many times, patients have diseases for which there are no treatments available, and this tends to be a deterrent for treating physicians from diagnosing their patients. In addition, if there isn’t a genetic test available, you may need to develop one and try to get it on various panels. You will also need to prepare the market, if this is a rare disease that isn’t well known or understood, the market may not be very developed.
What’s needed in order for to improve the advanced therapies landscape?  

We need to be able to bring these therapies to all patients who need them not just to treat the diseases that have many patients (the rare) but to also be able to treat those patients who numbers are low (the ultra-rare) and may not seem to represent a commercially viable target population. I think we are moving in the right direction with the creation of such groups like the Bespoke Gene Therapy Consortium.

What are you looking forward to discussing during your session? 

This is a potentially lengthily topic that can go in any number of directions, but I would like to discuss the challenges of commercialization of gene therapies and what the learnings to date have been. How do we get better as an industry so we can bring these life-alternating medicines to patients who desperately need them?

Where do you see the field of Gene Therapy in 5-10 years’ time? 

One thing we need to be aware of and be thinking about now is how are these advanced therapies going to be paid for once we see the numbers of approvals increase dramatically. In 5-10 years, we will see gene therapies used for non-rare diseases and the first gene editing products on the market. It will be interesting to see how our healthcare evolves with this changing landscape.

What are you most looking forward to about ATW 2023? 

I am looking forward to seeing old friends/colleagues and meeting new ones. I am also looking forward to listening to many leaders in the field of Advanced Therapies share with us their updates on the projects and therapies they are working on. And, of course, this should go without saying as I live in Boston, I am looking forward to the sunshine and warm temperatures.


Don’t miss Serene’s session, Commercializing Gene Therapies : Building Your Strategy From Translation Through to Commercial’ at Advanced Therapies Week 2023, Thursday January, 19th 2023.

Join us at Advanced Therapies Week >>