Internal Talent Drives PoC Success
Biotech Triallist Newsletter No. 1
Hello, Trailblazers!
Welcome to the first issue of Biotech Triallist, your go-to source for insights into the high-stakes world of biotech clinical trials.
We’re diving into proof-of-concept (PoC) trials—those make-or-break moments that can launch a therapy to stardom or send it to the morgue.
This issue tackles a critical question: Do you have the right talent and scholarship to make your PoC trial a success?
From the CEO’s vision to the CMO’s expertise and the unsung contributions of nonclinical colleagues, we’ll explore why internal talent is the key to winning in biotech.
Let’s get started!
The CEO: The Strategy Architect 🧭
In a small biotech, everything flows from the business strategy. The CEO is the architect, setting the course for success.
📈 Vision setter: The CEO defines the company’s direction, aligning science with market needs.
🪨 Stability provider: They must offer resolve to see the strategy through, even when challenges arise.
🚫 No vacillation: Wavering on strategy creates chaos, derailing clinical and operational plans.
A CEO’s steady hand is critical in PoC trials. Without a clear company strategy, other efforts—trial design, resource allocation—fall apart.
For example, a biotech company pursuing a novel immunology drug needs a CEO who is committed to a focused indication. Flip-flopping between indications wastes time and money.
A strong CEO ensures the team rows in the same direction. Their resolve empowers the CMO and team to execute with confidence.
The CMO: Your Biotech’s Yoda 🧬
The Chief Medical Officer (CMO) translates the CEO’s vision into clinical reality. They’re the Yoda guiding drug development.
🧠 Scientific mastery: A CMO must grasp the drug’s mechanisms and therapeutic area deeply.
🩺 Clinical expertise: They understand disease progression and patient needs.
🚀 Strategic alignment: They align trials with regulatory and investor goals.
Their expertise is make-or-break.
A weak CMO risks flawed endpoints or missed signals. They must be a therapeutic area expert to steer the trial right. Typically, such therapeutic area experts are board-certified physicians. However, Board certification is necessary but not sufficient.
The Risk of a Mismatched CMO 🔍
You may have seen situations where the CMO is a specialist in A, the SVP in B, the VP in C, and then they try to hire a physician of the right specialty, D, as a medical monitor/ medical director. The problem: The physician in the medical monitor role can assist with some clinical details of day-to-day operations, but is not necessarily qualified or scholarly to guide the clinical program.As a result, the whole clinical trial program is free from people who are appropriately qualified to have a vision and execute it accordingly.
Not good.
A CMO from the wrong specialty—like an oncology CMO in an immunology company or a surgeon CMO in diabetes—risks derailing your trial. Their lack of field knowledge creates gaps.
🎯 Therapeutic misalignment: An oncology CMO may miss immune disease nuances.
🩺 Clinical blind spots: A surgeon CMO might overlook diabetes endpoints, such as A1C.
📜 No historical context: They don’t know past failures or precedents, risking errors.
A mismatched CMO also struggles with the field’s ecosystem, limiting their impact.
🌟 Wrong KOLs: They contact irrelevant experts, missing key insights.
🤖 Blindly parrots KOL views: They don’t have the domain expertise to assess advice critically.
📊 Unreliable data: They may trust flawed primary sources, skewing the strategy.
📍 Poor site selection: They don’t know which clinical sites perform or which to avoid.
The Value of Nonclinical Colleagues 🌱
Nonclinical colleagues are unsung heroes in PoC trials. Their expertise shapes smarter decisions.
🧩 Prior experience: They bring lessons from past projects, dodging old pitfalls.
📚 Deep knowledge: Their scientific or operational insights inform strategy.
💡 Critical thinking: They challenge assumptions, refining approaches.
Their historical knowledge and anecdotes are gold. These insights guide trial success.
📜 Precedents: They know what’s failed before, saving resources.
🗣️ Anecdotes: Their stories reveal practical challenges, like site quirks.
A nonclinical scientist might recall a failed trial due to a poor biomarker. This could steer your PoC trial to victory.
The Pitfalls of Consultants 📉
Consultants seem budget-friendly, but they fall short in PoC trials.
🔄 No skin in the game: They advise and leave, lacking commitment.
📚 Limited context: They’re rarely privy to proprietary data.
⏰ Short-term focus: They can’t tackle iterative challenges.
External advisors risk fragmented strategies. You need leaders who live your mission.
You cannot outsource strategy or tactics (to KOLS, CROs, and such). The company owns it. If the company cannot do it, maybe it is not in the right business.
Why KOLs Aren’t Enough 🌟
KOLs bring prestige, but they can’t lead PoC trials.
🩺 Narrow focus: They excel in their niche but lack development expertise.
🧑🏼🎓 No Industry experience: Professors live in a different milieu and often have no clue how drug development works
🔒 Limited data access: They’re not privy to confidential results.
📊 Strategic disconnect: They might prioritize publications over regulatory needs.
A KOL might push for a splashy data release. A competent CMO knows its implications.
KOLs validate, but they don’t replace internal leadership.
The Power of Full-Time Talent 💼
Small biotechs run lean, but skimping on talent is a mistake. Full-time experts deliver.
🤝 Continuity: A CMO builds trust with investors and regulators.
🔥 Commitment: They’re invested in long-term success.
🧩 Holistic insight: They see the full picture, from lab to trial.
Studies like Noticewala et al. (JNCI, 2025) show industry trials succeed due to focus. Internal teams drive that.
Full-time talent isn’t just roles. It’s a team that’s all in.
How to Build the Right Team 🛠️
Assembling a PoC dream team takes deliberate choices. Here’s how.
🔍 Hire domain experts: Your CEO, CMO, and team need therapeutic expertise.
🌱 Foster scholarship: Encourage journal clubs or such for innovation.
🤝 Align incentives: Offer equity and mission-driven goals.
A CMO who asks, “Does this endpoint reflect our drug’s mechanism?” elevates trials. Curiosity fuels breakthroughs.
Don’t settle for mismatched talent. Seek thinkers who thrive in chaos.
Looking Ahead: The Stakes Are High 🚀
PoC trials are where dreams meet reality. The right internal talent is everything.
💡 Avoid shortcuts: Consultants and KOLs can’t replace a committed team.
🏆 Invest in leadership: A strategic CEO and expert CMO align science and strategy.
🌍 Impact lives: A strong team brings therapies to patients.
The biotech world is watching. Investors, regulators, and patients count on your trial.
Build a team to transform lives. Who’s ready to make history? Let’s do this! 🧬