Welcome to Partnology’s Biotech Leader Spotlight Series, where we highlight the remarkable accomplishments and visionary leadership of biotech industry pioneers. This series is about showcasing the groundbreaking strides made by exceptional leaders who have transformed scientific possibilities into tangible realities. Through insightful interviews, we invite you to join us in following the inspiring journeys of these executives who continue to shape the landscape of the biotech industry. This week we are recognizing:
Camilla Simpson, Chief Executive Officer
Camilla Simpson is CEO and Board Member at Zehna Therapeutics. Camilla has over 25 years of US and International business and Research and Development strategy experience across a diverse group of organizations: from seed investments to public multi-national companies. Camilla has a proven track record in delivering novel products for multiple disease indications to global markets in areas of high unmet medical need. Her key accomplishments include the registration of Brineura® for CLN2 Batten’s Disease, Xagrid® for Essential Thrombocythemia, Fosrenol® for Hyperphosphatemia in CKD and Solaraze® for Actinic Keratosis. Prior to Zehna, Camilla founded Rare Strategic LLC where she provided strategic advice to early-stage venture-backed companies. Camilla has held numerous executive leadership positions, including SVP, Head of Product Portfolio Development at BioMarin Pharmaceutical Inc., Global Head of Regulatory Affairs at BioMarin Pharmaceutical Inc., and VP Global Regulatory Strategy- Early Development and Business Development at Shire Pharmaceuticals. At Shire she was part of the acquisition team for Movetis, Sarcode BioSciences, Ferrokin BioSciences and Advanced BioHealing. Camilla serves on the boards of Dyve Biosciences, GRI Biosciences and Spruce Biosciences. Camilla received a BSc from National University of Ireland, Galway, a BSc Hons, from Kingston University, UK, and an MSc with distinction from Birkbeck College, University of London.
Walk me through your career, highlighting key moments or decisions that shaped your path toward becoming a biotech CEO:
Initially, I entered the industry without a full understanding of how I would add the most value or knowing how to navigate a pharma/biotech career path. My first role was at a large multi-national company, which gave me a chance to see how the industry operates and how larger companies are structured and why. I always advise people to consider starting their career at a large pharma/biotech company as it exposes you to how a grown up company functions and these large companies often have excellent career development and training programs. At this stage of your career it’s wise to be laying the foundational knowledge that you will rely on for your whole career, to ensure career longevity. Pharma/biotech is a long journey for the dedicated and resilient.
Early on, I contributed to writing sections of regulatory dossiers as part of my work, which introduced me to the importance of translating scientific data into submissions that regulatory authorities review to approve drugs for patients. This exposure helped me to see the potential for alternative career paths. Soon, I noticed a regulatory role open up internally, and as I had built good relationships and demonstrated strong work, I was able to transition into the regulatory affairs function smoothly. That was a pivotal decision, being open to change and new opportunities rather than sticking rigidly to an initial plan.
In regulatory, I focused on European drug development and approvals and attended conferences where I learned about startup culture and earlier-stage companies. Eventually, I made a big leap by joining a young company, Shire, in 2002. At the time, Shire was relatively unknown, so leaving a large established company to join a smaller, riskier venture was a major decision. That risk paid off, Shire became a massively successful company, and I rapidly progressed within the regulatory function as the company grew through acquisitions.
At Shire, I conducted regulatory diligence on companies we were considering acquiring, which gave me broad exposure to various company types, multiple modalities, and therapeutic areas. We evaluated 20 to 40 companies a year, which provided a great breadth of experience. Later, my role expanded globally, including responsibility for the US market. That shift to a global regulatory role was a significant step in understanding the broader regulatory and healthcare landscape.
Eventually, I moved to BioMarin, a rare disease company, driven by a strong interest in the development of medicines for rare diseases patients. A major personal decision was relocating to the US to lead BioMarin’s global regulatory affairs, as being present at headquarters was essential in a US headquartered global company.
After leading regulatory affairs at BioMarin, I transitioned into a broader, cross-functional role as Head of Product Portfolio Development. This role was critical as it involved leading multifunctional teams, value creation and prioritizing programs for investment. These are key skills for a biotech CEO, knowing where to focus resources and how to identify and drive strategic value.
Looking back, I think the key lessons are: develop deep expertise in your initial function, demonstrate success, then broaden your scope cross-functionally. Being able to lead multi-functional teams and manage cash allocation and understanding and identifying program inflection points is crucial preparation for the CEO role.
Tell me more about Zehna Therapeutics, what are you currently working on?
Zehna Therapeutics, is a spin-out from the Cleveland Clinic, so it’s been a completely new experience for me to work closely with a research institution that has launched its own science. I’m collaborating directly with our founder, Dr. Stanley L. Hazen, who discovered the TMAO pathway, which is the focus of our company. TMAO is a microbial metabolite implicated in cardiovascular (for example: Abdominal Aortic Aneurysm) and chronic kidney diseases.
Our approach is to inhibit the production of this metabolite with small molecule inhibitors, and translate that approach into meaningful benefits for patients. Working with such an esteemed founder has been incredibly rewarding. We’ll be raising again toward the end of the year to support Phase 1 data generation, and we’re excited to engage with investors at that stage. Zehna represents an unique opportunity to invest in the next frontier in cardiometabolic disease treatment.
Given your background in regulatory leadership, how do you integrate regulatory strategy into corporate strategy from day one?
Our products truly live and die by regulatory decisions. If we’re motivated to get products to patients, we need to be equally motivated to understand the regulatory pathway and how to successfully apply it throughout development and registration.
Even at the earliest stages, seed companies or those still in research, there’s a tremendous amount of regulatory information that is crucial for informed decision-making. For example, your ability to secure funding can depend on whether the indication you’re pursuing is supported by positive regulatory precedent. If it’s an area with many past failures or no clear regulatory pathway, that resistance to a flexible path forward is critical to understand, as it will be a tough road ahead.
So, it’s very important to study existing regulatory precedents, both policy-wise and product-wise, when making decisions about building a company or developing a portfolio. I also think it’s essential to stay current on guidance documents and draft guidance to be knowledgeable about the path ahead and to maximise opportunities and incentives provided by regulatory authorities.
For early-stage companies like ours, which is pursuing a completely novel approach, there’s never been a drug approved for inhibiting a specific microbial pathway, so we prioritized early engagement with the FDA. We had a Type C meeting to lay out our IND-enabling strategy and ensure there would be support and no surprises.
So, yes, it’s absolutely critical to keep regulatory precedents and guidance top of mind and to engage early with regulatory authorities for the success of your corporate strategy.
What’s your framework for prioritizing programs in a portfolio when resources are limited?
I think the reason resources can be limited is primarily because funding is often limited. In that context, it becomes crucial to understand what investors or shareholders prioritize, what they see as value creation for the company and what they expect the company to demonstrate.
From there, you evaluate your programs against those criteria. This might mean narrowing your focus to a particular indication or modality that aligns with your company’s core scientific fundamentals and investment proposition. It could also involve closely re-examining the inflection points in your development timeline and identifying which programs are likely to deliver value in the near to medium term.
Ultimately, it’s about understanding your funding position and runway, and clearly defining your company’s value proposition from an investor or valuation perspective and aligning your resources with that.
How do you effectively communicate scientific complexity to investors while keeping the focus on business value?
I think it depends on who you’re speaking with. When talking to investors, particularly venture partners, you can dive into the science—explaining the science behind your proposition in detail. For other investors, it’s important to keep your scientific messaging focused on what makes your opportunity unique, how it compares to what others have done, and why it matters. Ultimately, all of this should translate into clear business value and benefit for patients.
How do you define the “must-have” leadership qualities for a biotech CEO leading a company from seed stage through clinical development?
Speaking about my day-to-day role, what I really rely on is my clinical development, early development, and regulatory experience. I’m faced with pivotal decisions weekly, deciding which experiments to run, how to interpret the data, and what the next steps should be in the context of value creation and de-risking. Therefore, strong proven leadership in drug development is important, and I think the team gains confidence knowing you have that background and can guide them through these tough decisions while managing the runway.
You also need to be astute about people. In early-stage companies, you’re building the team from scratch, so you have to assess whether candidates have the right skills and if they’ll stay resilient through the inevitable challenges. Understanding talent, having a deep network, and knowing who can thrive in that environment is critical.
Another key aspect is navigating board dynamics. The board is a very important part of an early-stage company because they are deeply involved in program decision-making and of course business and financial strategy. As a CEO, you suddenly have many “bosses,” not just one, and that dynamic requires strong interpersonal skills. Being able to influence, get buy-in, and incorporate feedback from board members is essential.
Finally, working closely with founders or co-founders is a vital relationship. It’s important to respect their vision and discovery while helping move the science forward to the next stage. Being able to collaborate effectively with highly scientific individuals and helping them transition their science to the clinic is a key part of leading early-stage biotech companies.
