Dr. Salomon Azoulay

Chief Medical Officer, Head of Research & Development, Sumitovant

Dr. Azoulay, you are the Chief Medical Officer and HEad of research & development at Sumitovant. Tell us about your role.

Being the CMO and Head of R&D at Sumitovant is very exciting. I joined Sumitovant last December as part of the Roivant-Sumitomo Pharma deal, after serving 18 months as CMO for Roivant. My role today has multiple facets. First, my team and I oversee the technical evaluation of potential assets we may want to in-license. We have a group of experts who manage that process for both Sumitovant and Sumitomo Pharma.

The second aspect of my role involves staying very close to the drug development progress in our five subsidiary, the “vants.” While the accountability for drug development remains with the vant, I have a responsibility to serve as a guarantor of the quality of all our assets. That common oversight and awareness is something we must deliver to Sumitomo Pharma. My role is not to supervise their development but to create consistency and innovation across our shared portfolio. By providing this central oversight, we are able to maximize efficiencies and best practices to benefit seamless registrations and regulatory approvals. With this in mind, we created an R&D portfolio governance team specific to Sumitovant, where a cross-functional group made up of senior leaders assesses portfolio decisions.

I also work very closely with our CEO, Myrtle Potter, and the entire leadership team to provide advice on anything related to R&D and the Sumitovant organization. I am looking at leveraging the size of our group to optimize the way we are working as well as leveraging the numerous talents we have in-house. 

Who are your closest internal partners?

I am going to start with my team, ACES, a group of functional experts for whom I have great respect. They are enjoying very much what they are doing and bring unique expertise to the table. It is a fun group.

Besides ACES, it is difficult to identify the closest internal partners as I believe we are interacting with every functional group at Sumitovant: from Commercial to Finance, Legal and BD. We work very closely with DrugOme and Digital Innovation. They are supporting us in making our deliverables better and faster.   

I am in regular contact with Myrtle and the entire executive leadership team. It’s a small group and we are in touch almost daily. We are also developing very solid connections with Sumitomo Pharma at every level.

What’s your favorite part of the job? What are the challenges?

I’m very excited about the extent of our portfolio and our pipeline – from small molecules to large molecules and gene therapy, administered through diverse routes. My role and ability to be involved in such a wide array of assets keep me constantly engaged and excited. There is such a diversity in terms of diseases and therapeutic areas that from a medical perspective is quite invigorating. 

I’m also excited to see that Myovant and Urovant are so close to marketing products. Moving from the development phase to launch and commercialization is what gets everyone excited. It’s an opportunity to see all the hard work pay off and get necessary drugs into the hands of patients.

As the organization is still somewhat young, there have been some growing pains as we defined roles and responsibilities in a way that creates equilibrium between vant-level ownership and matrixed governance. It can be a balancing act, but we want to make sure we are delivering according to Sumitomo Pharma’s expectations while being sensitive to vant leadership. 

In your opinion, what is the biggest impact Sumitovant will have on patients and the world? 

Our impact can be significant. Just look at the portfolio and pipeline we have today. We have Relugolix, a Myovant product, that has shown to be safe and effective (pending confirmation from the FDA) for three disease targets: prostate cancer, uterine fibroids, and endometriosis. This product has significant potential in areas of very strong unmet needs.

The second, a Urovant product, Vibegron for overactive bladder that is under review by the FDA. You can either be the first or the best in class with a new product. This product has great potential to be differentiated. 

Spirovant has two gene therapy products for cystic fibrosis. With that, we may not just improve the disease trajectory, we could potentially fully treat the disease. We are talking about curing patients here. Gene therapy is a very exciting area, difficult in many aspects but it can be so rewarding.

Another exciting product is a treatment for a childhood disease called congenital athymia at Enzyvant. These children would usually die without treatment since they have severe immunodeficiency. With this product, which could be on the market soon, we could give them a functioning immune system. Again, we truly have the potential to cure and positively transform lives.

Altavant is developing a product for pulmonary arterial hypertension with a new mode of action that has the potential to be a disease modifier, not just improving symptoms. It could be a game changer.

We also have an asset for bronchiolitis obliterans, a debilitating complication of lung transplants that can just be given through a spray.

This portfolio has the potential to dramatically impact the lives of patients for the better, fully aligned with our vision. In addition, we have additional assets already in the pipeline at the different vants and we are looking at other licensing opportunities to complement our portfolio.

Based on your past and current experience – and the trajectory you have observed – where will the bio-pharma industry be in the next 10 to 20 years?

I think the demand is more and more for innovative treatments and less for me-too, or second-line, products. The community is asking for treatments that transform the lives of patients. The payors are aligned with that, they simply won’t pay for me-too anymore. So there is a general trend toward products that have a big impact on patients and society. It can be survival, quality of life, something that is measurable.

Financially, I am concerned about drug pricing, especially in Europe. If you want to discover and develop innovative medicines, you have to invest a lot of money. And if you do not invest, innovation will not happen. The vast majority of medical innovations come from the U.S. due to significant R&D investments. Countries with lower drug prices generally don’t invest as much in pharmaceutical and medical R&D but benefit from discovery and development in the U.S. 

What also worries me is the misalignment between high expectations for novel treatments and innovative drugs and the simultaneous criticism of high drug prices. You simply need to invest to get to these transformative drugs. R&D investment will be critical to meeting the expectations people have of our industry. As an industry we have to strike the right balance that allows for continued innovation at a price that payors and patients can afford. That’s a difficult balance. 

What do you think are the most significant challenges currently for the biopharma industry? What are the opportunities?

The most significant challenge pharma is facing is the lack of confidence and trust from the public. It is linked to the perceived high drug prices and the impression that everything revolves around maximizing profit. It is wrong, but the industry has not done a good job at articulating how drugs are priced and, unfortunately, there are recent examples of unnecessary price hikes.

Overall, healthcare has made exceptional progress in managing, and even curing, diseases. But drug development is costly. We need to do a better job of educating the public and collectively condemn companies that don’t do the right thing. 

COVID is an exceptional opportunity. The reaction from pharma has been great: rapidly mobilizing and collaborating in ways like never before to urgently develop a safe, effective vaccine. But getting a vaccine is not enough; pharma has to continue to be guided by science, not influenced or driven by politics. We will have to demonstrate that the vaccine is truly safe and effective and that companies and regulatory agencies are driven by data only. In addition, we will have to make these vaccines available at a reasonable price universally. We cannot miss this opportunity to do the right thing. We have to build confidence and get people vaccinated across the board. It will create trust that all of us, pharma and the public, will benefit from.

How will your role – and roles similar to yours – change along the way?

All roles, including the CMO position, should continue to evolve. One thing that should not change is the responsibility we have with regard to the safety of the drugs that the company will develop and market. That is a key responsibility: to continuously assess the risk-benefit of our assets, independently from any other consideration, especially commercial.

I see the ongoing development of the CMO role at different levels. The first is related to increasing responsibilities, beyond medical, in strategic decisions like company direction and vision, investments, licensing opportunities, etc., while leveraging and promoting the use of new technologies for decision making. On the other hand, at a time when clinical trials have never been so expensive, there is also a need for innovative plans that will reduce time and costs and offer the chance to bring more drugs to market for the benefit of patients. COVID will give us an opportunity to force us to think differently and develop new tools to manage the operational aspect of our programs. We are in a different time that needs a different response.

In summary, I see the role evolving into a more strategic position while being more innovative and creative to optimize our resources. 

What is your vision for Sumitovant and patient care?

Our Corporate vision is that “Sumitovant will change lives for the better.” For a recently created company, Sumitovant has exceptional potential. Through our five vants, our portfolio is not only diverse but innovative. We are targeting oncology, women’s health, urology, and a spectrum of rare diseases including gene therapy.

It is a differentiated portfolio that has the potential to significantly impact the lives of many and in some cases save lives of children and young adults who would have otherwise died. There are many reasons to be proud of what Sumitovant has accomplished in a short period with so many pending regulatory approvals, but it is certainly not enough. We have to continue to bring in new products with the same potential of making a difference. In my view, there is no longer a place for me-too products. 

Our immediate future certainly depends on the success of Relugolix and Vibegron, but looking at a longer term it will depend on the extent of the second generation of products that will be approved. 

In your opinion, what’s the most pressing societal issue healthcare is facing these days?

The public is asking more and more for breakthrough therapies. In some respect, pharma is a victim of its own success. The expectations are high. Even the COVID vaccine may create unrealistic expectations: If we are able to develop a vaccine so quickly now, why can’t the same be done for all other diseases? The pressure will be immense, but I welcome it. It will force us to think differently, to be even more creative. The cause is great and unique as our daily goal is to improve the lives of people.

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