Expert’s Insights: Bringing Drug Discovery to Commercialisation

With Carlos Sanmarco

One of our brightest new minds, Mitchell Pease, recently sat down with Carlos Sanmarco. Carlos is an expert in Drug Development and Clinical Research, with over 22 years’ experience. Currently SVP, Head of Program Management & Operations of Sonata Therapeutics, Carlos is one of the most prominent minds on Drug Discovery, Development, and Commercialisation.

So whether you’re looking to improve your processes or simply trying to decide if you want to get into this space, read this article.

We’ll explore:

• About Carlos
• Drug Discovery Success and Failure
• Key Steps to Success
• Importance of Proper Program Management

About Carlos

Originally from Brazil, that’s where Carlos spent a significant portion of his early career. He thought he would be a pharmacist in the lab, but realised it wasn’t his passion. Instead, he switched over to coordinating the development of new drugs and hasn’t looked back.

Since moving to drug development, Carlos has worked in different therapeutic areas, like intensive care, oncology, pain, and diabetes. This gave him a range of experience which he took to medical quality, before becoming Head of Clinical Operations for one of Eli Lilly’s major affiliates.

During his time at Eli Lilly, Carlos was part of a process that optimised drug development from 10 years, down to 5. This was Carlos’ first experience seeing a product go from discovery to launch, and he began to consider why drug development is long-winded and expensive. Ultimately, his focus fell to the Biotech world, due to his curiosity and exposure at Eli Lilly.

With 17 years’ experience at Eli Lilly, Carlos moved to Boston and became the Pulmonary Global Program Lead for Acceleron Pharma. It was here that he brought an asset from strategy to Phase III, before Merck acquired the company in an unexpected takeover.

Shortly after, Carlos found his way to Sonata Therapeutics, a Flagship Pioneering company.

Drug Discovery Success & Failure

Not all drugs will succeed; larger companies try to figure out which will and won’t as early as possible. Terminating a project early can save a lot of funds, which can then be redistributed to other projects and improve their chances of success. While Carlos was a Global Program Lead at Eli Lilly, he worked on nine programs, but only one made it through to the late stages of development.

Smaller biotechs don’t have this luxury. Sometimes, killing a project at a biotech can kill the company. With this in mind, it’s not surprising that biotechs are more willing to take risks and move faster than large companies. Most of the time, a program is the main reason smaller companies survive.

Carlos’ greatest piece of advice to improve a drug’s success is this: don’t take shortcuts in drug development. It’s where mistakes happen; you can easily spend a lot of money and be left with nothing at the end.

Key Steps to Success

Success is the ideal end result of any project, but what does that mean?

For one, you need to have a firm understanding of what you want to achieve. Remember your end goal throughout the process and refer back to it. Here are Carlos’ top four key steps for success.

Stick to Strict Deadlines

One of the key contributors to repeated success is having discipline through the discovery phase. Hiring a good program leader at the beginning of the process can ensure this is taken care of.

It’s easy to get caught up in the academic ideology that science takes time, but you must keep pushing forwards. After all, drug development is a funnel.

By having that end goal in mind as you progress through the funnel, you constantly have something to work towards. Without it, the time to complete an objective can keep increasing. While this delay may not affect an individual stage too significantly, it can damage the overall timeline of the product.

Don’t Take Shortcuts

On the other hand, if there are delays, it can be tempting to skip critical stages during drug development and try to ‘catch up’ later. This could prove to be an even more costly mistake.

Trying to take shortcuts by skipping stages from discovery to clinical phases of development can be a severe error — and it’s one that Carlos has seen a few times throughout his career.

Decision-makers can feel compelled to rush through Phase III (or pivotal studies, for example). Their reasoning for this is very simple; jumping to Phase III gains investors’ approval and can lead to much greater funding — but it comes with a major drawback.

Lack of viability.

By jumping straight to Phase III, you may lack the critical data to make informed and accurate decisions. A product you may have thought was viable may have a crucial flaw. Unfortunately, this is something you won’t discover until after the investment has been made.

While it can take longer, making sure you hit every core element in the stages of drug development can help you identify critical weaknesses sooner, saving costs and resources.

Collect Accurate Data, Fast

You can’t make accurate, informed decisions without first having the right data. Carlos advises getting to Proof of Concept as fast as possible. The data gained from this will tell you how viable an opportunity is.

Robust data inherently brings greater value. A product which may have initially seemed like a guaranteed success might be proven to be a failure, or vice versa.

If You’re Global, Be Global

While the US market is large, it isn’t the only one. If you are (or want to be) a global company, you must also get feedback, research, and data from other regions. This goes from health care providers to, more importantly, the patients you aim to treat.

If you have the funds available, it’s worth opening centres in other countries. Not only to promote patient access, but to learn how you can develop a better product.

Importance of Proper Program Management

In Carlos’ view, one of the biggest factors causing companies to fail is the lack of discipline in executing the plan.

He explains, “we have good science, good planners, good ideas. We come up with what we believe is a robust plan, but we fail to execute it — most of the time by not following it.” Having strong program leads who can help keep that end goal in mind, and their team towards that finish line is essential.

A good program lead is a challenging find, but they can make or break a project. For instance, if new people join the project, they can be accurately informed why certain decisions were made. This can lead to a more cohesive understanding of the project, and ensure everyone is operating to the best of their ability.

Having that executional excellence is crucial in drug development. There can easily be many people involved, and keeping everyone on track will drastically improve the project’s success.

End Notes

In the end, it’s vital that you adapt as necessary. Knowing when to execute a program is an essential skill. Sometimes, despite best efforts, drugs fail, and that’s okay. This is part of science and innovation. If you’ve implemented a plan well, but it still fails, then the next best option is to limit further costs and focus on the next project.

If you want to learn more about drug discovery and development, we highly recommend following Carlos on LinkedIn. His insights are truly invaluable and can help make your project more successful.