Meet the Maker: EPM talks to Billy Amzal

Here, we have a chat with Billy Amzal, PhD, X-Eng, MSc, MPA, who has been appointed as Certara’s senior vice president, decision and real-world data analytics.

1. Could you briefly describe yourself?

I have two children and live in Paris. I am a mathematical engineer with master’s degrees in public health, statistics, and public administration, and a PhD in Bayesian modelling and biostatistics.

I began my career in the pharmaceutical industry by holding several positions to lead model-based drug development at Novartis. Then I moved into the regulatory side of the business, developing and leading the methodology group, establishing new evaluations processes and regulations at the European Food Safety Authority. After that, I conducted epidemiological and pharmaco-economic research on HIV in Thailand to improve public health policies in developing countries.

I've been in the consulting business for seven years in charge of conceptualising, developing, and implementing analytical tools to support drug value evaluation and strategic decision making for drug positioning, regulatory decisions, or pricing and reimbursement.

2. Please describe your average day in five words.

Analytics, brainstorming, strategy, interdisciplinary, multicultural.

3. At what point did you decide to be involved in the pharma market?

During my PhD, I developed an algorithm, which I applied to three problems, one in finance, one in the food industry, and one in pharma. I used it to test how I could turn quantitative concepts that I developed into impact. I was then in a good position to choose an industry in which to work.

Unlike my classmates with a similar analytical background who were all choosing a financial path into banking and trading jobs, I realized that life science offered more exciting opportunities, more appealing to me, ones where I could make a bigger difference than by joining an army of people with the same profile as me.

4. What has been your biggest achievement?

I gain great satisfaction from starting a job with a vision of how to address a specific mission, and then succeeding in implementing that vision, harvesting the results, and impacting public health.

I am probably most proud of the food safety regulations that I managed to develop from scratch, implement and promote in Europe despite a lot of political hurdles. Food safety is really a serious concern for the general public, internationally and especially in Europe, regarding topics like genetically modified organisms, pesticides and chemical contaminants. I could see my work make a large impact on general population health and a sustainable change in EU policy.

5. What would you say is your worst trait?

I tend to be a bit too rational. Sometimes you need to incorporate some irrational thinking in your decisions.

6. What do you love about your job?

The opportunity to turn insights, ideas – and in my case, also data analytics – into impactful decisions for patient care and public health.

7. If anything, what would you change about your job?

I like my work to have an impact on an even greater scale. That is always what drives me.

8. If you weren’t in the pharma industry what job would you like to do?

In my early years, I considered becoming an astrophysicist. I did a master’s degree in theoretical physics, focusing on defining and evaluating the temperature of a black hole using the superstring theory.

I would also have considered working in the musical industry, organising events or helping artists to develop their talents. That is something that I really enjoy doing as a volunteer.

9. What challenges do you foresee being important over the next 10 years?

The pharmaceutical industry’s business model is changing rapidly. Now instead of just selling pills or drugs, manufacturers are willing to offer integrated solutions involving, for example, devices to monitor patients, connected devices to optimize prescriptions, and full care pathways to treat patients.

There is therefore a transition underway from selling drugs to selling real-life outcomes. Meaning that if you sell a pill and it does not impact individual or population outcomes then you don't get paid. In fact, you may have to pay a penalty if the drug is ineffective.

Regulators and payers do not evaluate new drugs based only on randomized clinical trials anymore but also on real-world evidence. If a drug works pharmacologically that does not necessarily mean that it will make a difference in a real-life setting. That's changing the whole business paradigm.

We are working withbig pharmas, regulators and non-governmental agencies, developing the concepts and analytical methods and tools to make those changes possible. For example, predictive models can be used to anticipate the real-world value of a drug before it reaches the market and inform the decision on what level of effectiveness to commit to. We have been doing this type of work at Analytica Laser [now a Certara company] for almost a decade already.

10. In your opinion, what will offer the biggest opportunities in the future?

It relates to those important challenges I just mentioned.

With the traditional clinical development process, you conducted clinical trials, stages one, two, three, obtained marketing authorisation, and then waited to see what happened in real life.

But say, for example, you develop a new statin for cardiovascular disease that is shown to be superior in clinical trials. When it reaches the market, physicians will not prescribe that statin just because it's new or shows better efficacy.

It can takethree to five years after a new drug is introduced for healthcare providers to consider switching patients that are stable on their current medication to a new, apparently superior version.

The only patients that will be prescribed that new drug in the short term are the most severe cases, patients that could not be controlled with other medications. So the real-life effect that you will see in terms of clinical outcomes for those patients will be much worse than what was observed in the clinical trials.

On top of that, you may have a drug with which patients are very poorly adherent in real life. Again, that may impact the real-world effect that you see a lot compared with the clinical trials, which are by definition very controlled with highly selected patients.

Public health impact and real-world value based only on clinical trials are too theoretical because they don’t account for factors such as patient behaviors or real-life prescription patterns.

As a payer or regulator, you don't want to base your decisions only on theoretical effects, you want to be more pragmatic, especially nowadays with more constrained budgets. You want to make sure that you get real-world benefit for all the money you spend.

As a pharmaceutical industry decision maker, you need to be able to anticipate those factors to drive real-world value and public health impact. You also need to start measuring them early enough.

Hence, the change in paradigm applies to both the pharma business model and public health evaluations. This represents an opportunity for all of us to be better treated with better informed, more personalised care.