Experts' Insights Archives

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.

With a rich and varied career, including running her own business, Sally Tucker is a prominent Life Sciences figure that we couldn’t wait to speak with. One of our Lift Up Allies, Robb Green, sat with Sally and learned about her thoughts and experiences. We were not surprised to find that Sally’s principles included striving for diversity in leadership, and championing other women. We were also keen to learn her insights about being a working mother, and how she used her experience to further her career.

Motherhood in the Workplace

As a mother of three, Sally is no stranger to motherhood in the workplace. As such, she’s learned some invaluable insights, and used her experiences as a mother to shape and advance her career.

Sally gladly shares her thoughts and experiences with the Lift Up community, so we can all benefit from her experience as a mother in the workplace.

Many women may question if motherhood is the right move, or if it will significantly impact our careers. In Sally’s experience, the impact of maternity leave is minimal and should be thoroughly enjoyed. In the grand scheme, it’s a short but fundamental part of your life.

But when it comes to actually taking time off work, Sally argues that the world becoming more connected has made it harder for women.

“With technological advances and the ability to always be connected, it has become harder for employees to switch off and to truly be ‘off duty’.”

Maternity Leave & Guilt

When women take maternity leave, it’s common to feel guilty. In the moment, it can feel like you’re taking a long time off; in the span of your entire career, it’s negligible. Taking and enjoying that time doesn’t make you any less of an employee, or mean you’re less valuable.

In fact, I would argue there are many transferable skills you develop as a mother that benefit organisations in the long term. These include:

prioritisation,
multi-tasking,
time management,
compassion, and
empathy (to name just a few).

Motherhood is a gift. Our children are the leaders of the future and we have the responsibility of guiding, coaching, and nurturing them through many different phases from infancy to independence.

That is a big responsibility but doesn’t mean that we cannot do it without also being successful ourselves. Sally wants those women who plan on returning to the workplace, to take that time and enjoy it (as much they can when there is so much to learn). Establish new routines and return with additional skills, feeling empowered and motivated, knowing their worth and value.

The amount of time any one woman takes off is individual to each person and can change between pregnancies, based upon personal circumstances. For instance, while Sally took around six months of maternity leave for her first two children, she only took two weeks for her third.

When asked about the difference, Sally revealed that her third child arrived while running her business. In her own words:

“It was my own business, at a critical time and with the ability to work from home. It seemed harder to let go but also easier to make it work, maybe because it was the third time round, I had help and my youngest was a very easy baby. It is true I was further along in my career, with more responsibilities but it really does come down to personal choice and what works for each mother.”

“Mother’s guilt is a real thing — returning to work too soon, wanting to work, not feeling you are always there, feeling like you are juggling… The list is endless. It actually took me a long time to come to terms that I am a better mother working. I love my children but I also love my work, and I believe them seeing their mother working and striving to make a difference is teaching them valuable lessons that will serve them well in the future.”

Sally took the amount of time off that she felt was right. Ultimately, doing what you think is right will always be the best decision for you.

Developing Interpersonal Skills

Sally revealed that becoming a mother helped her develop skills that easily transferred to her work life. One of these major ones was improving her empathy, and awareness of the bigger picture.

As a mother of 3, Sally is acutely aware that there is more than one side to every story. Considering and applying this to work is hugely important. We, as leaders, must always probe, ask questions, and consider each and every possible aspect. It allows for perspective and broader consideration which, in turn, fosters fairer and more sound decision-making.

Diversity in the Workplace

It goes without saying that the Life Sciences industry still has a long way to go to achieve equality.

“It’s great that we’re talking about diversity and inclusion, but the fact we talk about it shows we still have a long way to go.”

Men and women are of equal importance within the workplace. There is no ‘one way’ that fits everyone, and we need to be more appreciative of each other’s strengths to benefit all.

Despite this, however, women are still vastly underrepresented in Senior Leadership and Board-Level positions. That is, in Sally’s viewpoint, something that requires addressing. We need equality and equity in the representation of leadership positions to support the needs of the diverse workforce.

Diversity in Leadership

Perhaps one of the best ways of achieving workplace diversity, is by aiming for diversity in leadership. This can bring greater visibility for people from diverse backgrounds, inspiring them to set higher personal goals.

Additionally, the way men and women lead is very different. With the workforce comprised of both men and women, this must be reflected in leadership too.

We need greater respect and empathy for each other’s capabilities and strengths. As a whole, a diverse leadership team can bring a range of benefits to their organisation.

One benefit is that diverse teams can generate a range of solutions that may not have been realised if this diversity wasn’t in place. We have long realised the importance of brainstorming and how these activities can benefit idea generation.

In Sally’s opinion, this is also the case in leadership and strategic planning. Diversity at the top can lead to broader discussions and considerations that can ultimately benefit the organisational direction.

Championing Other Women

During her conversations with Robb, Sally mentioned that she had been lucky to have worked with numerous inspirational women throughout her career, many of whom have become good friends and valued mentors over the years. This began very early on in her career when she conducted her PhD.

Her PhD supervisor was a woman, Sarah Hosking, who provided inspiration at an early stage. Sarah is now the CEO of the Cancer Council and remains a friend and mentor to Sally to this day.

In fact, Sally’s perspective on championing other women aligns directly with one of Lift Up’s core principles. Supporting one another brings greater visibility to each other’s achievements. As the public eye sees more women in high-power positions, it becomes easier for other women to progress too.

If you, like Sally, want to help champion other successful women in our movement towards equity, join the Lift Up community. As a part of our community, please share anything from our library of easily accessible content.

Together, let’s #CloseTheGap.

With Iain McCulley

The increase of AI and robotics in the medical field is met with mixed feelings — but that doesn’t have to be the case. In fact, introducing AI and robotics into medical professions can revolutionise how we administer treatment, making lives better for both the patient and the professionals.

Some of the topics I’ll explore include:

Robotics in Surgery
Advancing Medical Diagnosis
Overcoming the Talent Crunch

Robotics in Surgery

Surgeons (just like many other medical professionals) are chronically overworked. If the stress of the job isn’t enough, there is a major backlog in the NHS. This can lead to fatigue, exhaustion, and burnout.

Pushing yourself to this extreme is guaranteed to have you running on fumes in no time, but that’s not the only option anymore.

Benefit for Patients

This is where I think AI, specifically Robotic Surgery, can create some drastic improvements. Current advancements mean that some AI robotics can complete minor surgeries, allowing surgeons to focus on more complex operations.

What’s better, because of AI surgery’s precision, patients experience less scarring and bleeding. In turn, they recover faster, and fewer are re-admitted following surgery.

Ultimately, this means that patients spend less time in the hospital, so more patients can be seen sooner. This limits the waiting time for patients, and means that those with painful conditions don’t need to suffer as long, while waiting for their surgery.

Benefit for Surgeons

There simply aren’t enough surgeons to handle the current demand, and reduce the backlog. “Rather than contributing to a loss of jobs, this can help fill gaps and help support the surgeons we do have with their workload”. In turn, they could have more time to focus on their personal well-being, and produce better results in more complex procedures, like keyhole surgery.

AI is already everywhere. From the navigation on your SatNav, to the Autocorrect on your mobiles and computers, to even which posts you see on Social Media. We rely on Artificial Intelligence in almost every area of our lives, so why not let it improve surgery too?

Advancing Medical Diagnosis

It’s not just surgeons who can benefit from AI, however. In fact, GE Healthcare recently acquired an AI Imaging Firm, Caption Health, to help detect disease earlier and provide more precise diagnoses. A single misdiagnosis can be a costly mistake; by bringing AI-enhanced devices into the mix, we can spot other potential causes more easily, and reduce the number of incorrect diagnoses.

Telemedicine

This is especially important as telemedicine and virtual diagnoses become more common. Post-pandemic, this area has sky-rocketed, with many GPs taking virtual appointments in an effort to see more patients.

Of course, one issue with an online consultation is a greater chance of misdiagnosis. AI-powered diagnosis tools should help reduce the chances of misdiagnosis, and ensure that patients get the correct treatment sooner.

Improved Patient Experience

Of course, this can result in a greatly improved patient experience. It means GPs can focus on the patient, while AI collects and sorts information. For instance, AI could map symptoms against family illnesses and highlight the likelihood of different causes.

Using AI in examinations could also suggest rarer illnesses and diseases, which may not be spotted in an initial consult. Altogether, this leads to a better standard of care, while simultaneously reducing the workload.

The Talent Crunch

The peak of the Talent Crunch is fast approaching. There’s a growing deficit of workers with a suitable skill set, and the MedTech industry will be one of the most significantly impacted industries — especially considering the general scarcity of skilled professionals in the market.

One of the biggest misconceptions is that AI, robots, and digital health will replace humans and there’ll be a loss of jobs. In reality, companies need to utilise technology and adapt if they want to overcome the worst of the talent crunch. This, in turn, will actually create more opportunities for highly-skilled professionals.

Professional Freedom

Medical Professionals across the world are stretched thin. Due to a shortage of skilled, qualified workers, many of these experts may have had to pivot their careers and become more generalist than specialist.

AI and robotics can ease the strain, making it possible for medical professionals to return to their passions.

Overcoming the Talent Crunch

By effectively combining Digital Health with Healthcare, I anticipate that rather than limiting the positions on the market, it’ll actually create more jobs. Of course, the skill requirements for these jobs will also evolve.

As these positions evolve, finding candidates with the correct blend of skills will become more challenging.

I always recommend looking to solve problems internally; however, this isn’t always possible. It’s more important than ever to find the right talent partner who can act as an extension of your business.

The Future of MedTech and AI

The idea of involving AI and Robotics, or Digital Health, in the MedTech space can be unsettling. It’s a new technology, so nobody can really predict how exactly life will be affected, but I’m optimistic.

There is very little chance that Digital Health will replace jobs, nor should they. I firmly believe that if we learn how to merge AI with Healthcare effectively, then this could completely revolutionise the space.

If you want to stay up to date on the latest MedTech news, then make sure to follow Iain McCulley on LinkedIn!

With Thomas Wirth

Starting your own business is a challenge, but creating a Biotech comes with its own challenges. Recently, we spoke with Thomas Wirth, the Founder/Co-Founder of two Biotechnology businesses, Aurealis Therapeutics and Celloryx AG.

Founders must keep four things in mind if they want to be successful:

Be tenacious, but not stubborn. Listen to others and accept that you will have to make sacrifices along the way.
Stay true to yourself, don’t compromise on your values.
Choose your team carefully; it’s all about trust.
Make decisions based on scientific and business rationale, never on emotions.

In CGT development you have to be willing to accept compromises, whilst keeping the risk/benefit ratio in mind. Accept that not everything that’s desirable is also feasible. You have to keep the balance.

First Factors to Successfully Establishing a Biotech

There are two main ways a founder comes to start up a new Biotech business.

The first is an Academic who has specific research and data, and uses that data to create a company.

Thomas is from the other path. While he had Academic background knowledge, his skills were developed in a hands-on working environment. While leading a pre-clinical team at a Gene Therapy company, Thomas witnessed both the benefits and the bottlenecks of gene therapy-based medicines, and contemplated how to solve them.

When creating his business, Thomas realised that trying to control everything isn’t cohesive to success. He stated, “owning 10% of something is better than 100% of nothing. It’s all about how much a Founder is willing to give up to achieve a goal.” That isn’t to say you should compromise your values. Staying true to your values is essential to good business.

The Biggest Issues that Biotech Founders Experience

The first main issue is not knowing where to start, and this is for three reasons:

You don’t have the right people at university telling you what you should be looking at.
You don’t have the network to know who you could ask.
You don’t have the funding to ask consultants.

When it comes to Cell and Gene Therapy, it’s an extremely fast-paced industry. Thomas’ expectation is that the life cycle of oncological gene therapy products is typically relatively short; meanwhile, development times are quite long.

While having experts is ideal, you also need to be realistic. For instance, doing everything per regulatory guidelines is the ideal. In reality, each CGT product is so unique that it has to be evaluated on a case-by-case basis.

Sometimes, it is not possible for you or your Biotech to accomplish a specific task. In this case, don’t be afraid to discuss with regulatory authorities. If you feel something is not viable, justify your view and propose solutions.

On the other hand, there is also a business aspect to be aware of. Doing anything and everything is probably every scientist’s dream; unfortunately, it’s unlikely to bring success since it dramatically increases your development timeline.

“No institutional VC will invest in your business if it takes five years to reach IND.”

Finding the right balance is crucial. Bringing the product to market as fast as possible is great for the business, but minimising risks and errors ensures it’s safe for the patient.

On the business side, VC firms typically want to understand the following:

What is the value of your product?
Is there a market for it?
What is the patient population?
Does the product have the proper protection?
Will the protection last long enough to ensure ROI?

As current gene therapy products typically fall under the Orphan Drug Act/Orphan Designation, they receive market exclusivity for either 7(+2) years in the US or 10(+2) years in the EU. With this in mind, you could disagree with the last bullet point. However, Thomas argues that one should not rely on these incentives.

For example, in the Orphan Drug Act, there are three exemptions under which the USFDA can approve a product for which indication market exclusivity already exists. These are:

If the holder of the orphan drug exclusivity consents,
If the availability of sufficient quantities of the drug cannot be ensured by the ODA holder,
or most importantly,
If the new drug is clinically superior to the already approved or licensed drug.

In the future, we’ll see more gene therapies developed for indications not falling under the ODA or Orphan Designation. With this in mind, one of the most common mistakes becomes more apparent.

When to file your IP

Filing it as soon as possible can be a good idea, since this protects your idea from the offset. This can be useful if there are several competitors with similar ideas.

On the other hand, it significantly reduces how long your product is protected on the market. The time to market for gene therapy products is much longer than for small molecules or antibodies.

The third problem people (particularly academics) face is publishing information far too soon. Their decision comes from a good place — wanting to raise awareness (and funding) for their business and product.

Unfortunately, doing this unnecessarily increases the risk to your business at such an early stage. A better option is to remain in stealth mode and postpone patenting for as long as possible.

Types of Experts You Need at the Beginning

Specialist knowledge is essential to running a successful business. Hiring and trusting people who fill the gaps in your knowledge is critical to developing long-term, consistent success.

“Have the right people before you establish anything”.

As a Biotech Founder, you should have the deepest understanding of the product. If you don’t want an Executive Role, make sure you’re in an Advisory Role.

You need three types of people to help you be successful. They are a:

CMO, who understands your product and how to make it.
Regulatory Expert, to ensure you have everything in place for filing an IND.
Business Specialist, to tell you what’s possible with your current resources.

Most importantly, you need someone capable of overseeing the entire project. They’ll be in charge of keeping the idea alive.

How to Find The Right Talent

When adding the ideal employee to your team, you don’t always want someone with the best knowledge and skills. Top leaders, like Thomas, believe that trust and culture fit is far more important.

“I always put trust in front of potential expertise, because you can train people.”

For instance, if a potential candidate lacks the skills, there’s always the option for them to learn and improve. If they don’t fit your company culture though, then they may end up damaging your business.

A poor culture fit could leave your company during a difficult time or reduce the morale of your existing team.

To avoid this, choosing your team based on who is the best overall fit is essential, rather than who has the best skills and experience.

Want to learn more about hiring in Biotech businesses? Read Biotech Vs Biopharma now!

Making a Move into Cell and Gene Therapy

Thomas’ greatest piece of advice for people looking to move into CGT is “stop being black and white”. It’s better to gain experience from a range of roles, and properly develop your understanding of how the business works.

It’s okay to challenge and re-interpret everything. For instance, when developing immune-oncology products, you may want to use mouse cytokines. Unsurprisingly, human cytokines may respond quite differently to mouse cytokines.

The question becomes ‘what is the value of information gained from mice’?

On the other hand, what would be the value of information gained from mice using human cytokines? And yet you must find a way to demonstrate that:

The drug is safe,
The drug is efficacious, and
The drug has an acceptable risk/benefit ratio.

The ability to challenge and re-interpret requirements needs excellent scientific and regulatory understanding to avoid roadblocks in your drug development path. If something isn’t feasible, bring it up, justify why not, and present potential solutions.

Be focused but open-minded. Work as a team. Have someone capable of overseeing the entire project, not only from a scientific aspect, but also from a business perspective.

Above everything, you must have fun. Don’t be compulsive; you won’t achieve your goal by force.

Thomas Wirth is a visionary and the Founder of two Biotechnology companies. With decades of experience in Cell and Gene Therapy businesses, Thomas has developed impeccable insights and understanding into this field. He is always willing to discuss his thoughts and findings; connect with Thomas to learn more.