Sanofi Genzyme UK medical boss Marc Moodley discusses oncology plans, NICE and Brexit

Marc Moodley has worked at Sanofi since 2018 and is the new medical head, UK and Ireland for the company’s Genzyme unit.

A pharmaceutical physician with experience in R&D, global medical affairs, and business development, Moodley spoke to pharmaphorum’s Richard Staines about his plans and the expansion of the company’s offering in oncology.

Please could you summarise your career to date, and what interested you in your new role?

I'm an MD by training, with over 15 years pharmaceutical experience. This is my third large multinational company. I've been responsible in the past for UK medical operations teams and medical affairs teams. I've worked at a global level, regional level, international in R&D, and had a short stint in strategic marketing as well.

I think it's a very attractive position, and we have a very exciting portfolio. The company will be going through a growth curve over the next few years with multiple new products, and new launches in an interesting number of therapeutic areas where we can make the biggest difference to patients’ lives.

We have products that are clearly differentiated which are making a difference to patients’ lives now. We also have a number of unique molecules coming through in the next few years in phase two and phase three.

What's your new role at Sanofi going to entail?

I'm responsible for Genzyme’s medical departments, and the job has several different facets. I'm responsible for the medical affairs team across all the therapeutic areas where we operate today and making sure the teams work well with the other parts of the business and externally.

Part of my role is also to ensure that the UK has a space at the global table within Sanofi that is front and centre.

How are you going to apply your expertise to your new role at Sanofi?

I’ve been very fortunate that besides my MD, I'm a consultant pharmaceutical physician and I hold an MBA in finance, which allows me to speak several languages within the pharmaceutical company. It allows me to understand both the R&D process and the R&D commercial interface really well.

Having worked across the pharmaceutical interface in the past, I'm able to bring skills to R&D, global medical affairs, regional medical affairs and the commercialisation team.

Please could you tell us about Sanofi’s plans for oncology in the UK?

Oncology is a key area for focus for Sanofi. Within our R&D investment cycle, a large percentage of that investment and development is going into oncology. We will see the fruit of that over the next five years. In the UK business, we are interested in making sure that the company invests globally in oncology and that we partner with the right universities and academic institutions in the UK. We must also attract global clinical studies that are running from a variety of these molecules in all phases within the UK institutions, so that UK patients can benefit and be part of that scientific journey.

The issue of NICE always comes up when it comes to oncology. Are there plans to take any further interactions with NICE over (cancer drug) Caprelsa?

It’s been very disappointing that even after two years working very closely with NICE, that its final guidance has recommended against funding for Caprelsa.

Caprelsa gives patients with advanced thyroid cancer the opportunity to extend life on average by about two and a half years, which for these patients is a very precious time. We're obviously committed to continuing to talk to NICE to engage with them to explore all options of how and where this could be appropriate for patients to receive in the NHS.

We do not believe that the MTA, the multiple technology assessment, is always the best tool to reassess these sorts of molecules with much more rare diseases. The way I think of it is when I went to my first golf lessons, I wouldn't use a driver on the putting range. For these sorts of rarer diseases, the MTA is not always the right tool.

Still on the subject of Caprelsa, have you tried to bring in the patient input with NICE, or is that something Sanofi plans to explore further?

I think it's really nice that you're bringing the patients into this, and the way the patient feels, as this is often neglected. These things are often very much about hard science and clinical endpoints. We have had multiple discussions with NICE on this, I believe we have engaged appropriately with the patients and patient organisations that brought that perspective to the table. As of today, we still do not have the proper reimbursement in the UK, which is very disappointing for patients. We will continue to try and engage NICE regarding this medicine.

How do you think NICE should change its reviews of oncology products?

The NHS and the government have taken a positive step in particular with the Cancer Drugs Fund which is now becoming part of the NICE process.

What this now means is that while NICE does the review and then looks for further evidence, it will be reimbursed.

Earlier this year we obtained the license for Libtayo which is one of our newer oncology medicines for advanced cutaneous squamous cell carcinoma. It's indicated in patients who are ineligible for curative surgery or in whom curative radiation is not appropriate. It's for very ill patients. To its credit, the Cancer Drugs Fund has allowed this drug to be reimbursed at the point of marketing authorisation. That is positive. I think the NHS and NICE are making lots of positive steps in particular with the Cancer Drugs Fund.

That said, there still remains a disparity in terms of access to cancer treatment across the four Home Nations, England, Scotland, Wales and Northern Ireland. Obviously, we would like to have innovative medicines which will have benefits for patients to be made more available, and for there to be less of a variation in terms of who receives these medicines. We will continue to work closely with them on this.

In terms of going back to the question on how NICE could modify or change the methodology, I think that is something for them to think about further. We hope to see a better degree of sophistication in the methodology, especially for things like rare diseases or diseases that are less common.

Other therapeutic areas do now have more tailored medicines, which are much more sophisticated. Therefore, some of the criteria they need to look at in their assessment need to become a bit more sophisticated. That's what we would like to see.

Are there any other major challenges facing oncology drug manufacturers in the UK or even just drug manufacturers?

There always have been and I believe there always will be challenges facing the pharmaceutical industry. We are a vital cog in the UK economy. The cost of managing oncology patients in the system has increased - there's no doubt about it.

That is in part due to the cost of the oncology medicine but it's also in part due to the fact that the NHS is getting better at diagnosing patients earlier and treating patients well. Patients are also living longer. We will have much more personalised and individualised medicine and the cost of that innovation remains high.

Getting that medicine to those patients in an appropriately timed manner is valuable to the health system, to all patients, and to the manufacturers. It's challenging and we all need to work together to ensure the patients will benefit from it.

Has the Life Sciences Industrial Strategy done enough to encourage big pharma to work with the NHS and indeed invest in the country?

I think the Life Science Industrial Strategy as championed in the framework by Professor Sir John Bell is a great idea. I think it really does encourage investment in the UK. It does set up very clearly that the government views this as a valuable sector.

It has encouraged a good degree of investment from Sanofi, and I think it's a great starting point, but we need to do more. The government and the framework need to do more. I think there's still some way to go.

What issues are you expecting to arise because of Brexit?

Ultimately, the patient is what's important here, and it doesn't matter whether you're a British company, French company or an American company. We have an obligation, a goal and an ethos to supply patients who need our medicines.

We have obviously prepared for the uncertainty that Brexit brings, in terms of our supply. We don't know what's going to happen, but we feel comfortable in the preparations we have made, such that we have a very high degree of confidence in the security of our supply in terms of our stock levels. I don't think it matters where your company is based. The entire industry is thinking, "How can we support patients in the UK through the uncertainty around Brexit?"

What about the MHRA and the regulatory issue? Pharma will always file with the FDA first, then the EMA. Some people are saying that the UK will become a “third country” when it comes to filing medicines. How do you see it panning out?

The MHRA has been a leading regulator in the world in the past and I'm sure it will remain so in the future.

I think you could look at this with either a glass half-empty or a glass half-full approach, in respect to the matters we don't know. Both the FDA and EMA use a common technical document for all the regulatory submissions that go in. I would imagine there wouldn't be much deviation from that in the future.

It is my hope that the MHRA will continue to be a world class regulator and I believe it will remain so.

Conclusion

This is an interesting time for Sanofi, which will see the company branching out from its roots in diabetes and in addition, focusing on new areas, including oncology. The competition is going to be tough, and like many other firms it has encountered issues in the UK with NICE. But Moodley’s optimistic leadership style will set it off on the right track during this period of change and uncertainty.

About the interviewee

Dr Marc Moodley has worked at Sanofi since 2018 and is currently the medical director for Sanofi Genzyme UK & IE.

He is an experienced pharmaceutical physician whose clinical career has helped patients in both developed and developing markets, gaining true insight into patient needs and the shortfalls in many healthcare systems. His 15-year pharmaceutical career has spanned across R&D, global medical affairs and business development across several specialist therapeutic areas.

In addition to his primary medical degree and CCT in pharmaceutical medicine, Marc holds an MBA from Imperial College.