What does it take to thrive in the ever-evolving world of pharmaceutical R&D? Gareth — a biotech leader, educator, and former translational researcher — has built a unique career across academia, big pharma, and early-stage biotech. In this exclusive interview, he shares how he made the leap into industry, the shifts he’s seen in drug development, and the skills he believes professionals need to succeed in today’s complex R&D landscape.

 

A Career That Began in Academia

Gareth’s journey began where many scientists start — in academia. After completing his PhD, he undertook postdoctoral research in both the UK and the US, before moving into a faculty position.

“I initially thought my career was set in academia,” he reflects. “I was at Harvard Medical School, leading translational research on novel cell-based therapies within regenerative medicine.”

It was during this time that Gareth got his first real taste of drug development. Through a collaboration with United Therapeutics, he helped develop a first-in-class exosome-based product, championing it from early-stage concept to the clinic.

“We managed to get a successful IND — and the real turning point was meeting the first patient enrolled in the trial. That was the catalyst. I knew I wanted to do it again.”

 

Transitioning to Industry: From Discovery to Delivery

Gareth’s transition into industry was anything but linear — but it was rich in experience. He has since held a wide range of roles including:

• Principal Scientist
• Global Project Lead
• Asset and Portfolio Lead
• Due Diligence Advisor
• C-level Executive in Start-ups

He has worked with major companies such as Boehringer Ingelheim, Vertex Pharmaceuticals, and InnoSkel, as well as founding his own biotech ventures.

“I’ve been lucky to work with brilliant people and truly innovative science. Some of the assets I’ve worked on are now helping patients, which is incredibly rewarding.”

This broad perspective — across discovery, development, and strategic leadership — gives Gareth a rare, 360° view of pharmaceutical R&D.

 

The Changing Face of Drug Development

The pharmaceutical industry has undergone major shifts in recent years, and Gareth has had a front-row seat.

“When I started out, we were working with complex biologics with no regulatory precedents. You had to invent the roadmap as you went.”

Today, the field is moving rapidly toward precision medicine and complex biologics. These include:

• Bispecific and trispecific antibodies
• Antibody-drug conjugates (ADCs)
• T-cell engagers and engineered proteins

“We’re now able to leverage an unprecedented amount of biology to create therapies that are more targeted and effective than ever before.”

He also points to a growing emphasis on biomarker strategies early in development:

“Biomarkers are now seen as essential from the start. If you get them right during preclinical work, you increase your chances of success in the clinic.”

 

The Rise of AI in Drug Discovery

Another major shift is the use of AI and machine learning in drug discovery and development.

“AI is already changing how we approach things — from target identification to predicting development outcomes. And it’s only going to get bigger.”

Gareth believes that staying informed about these technologies is essential for all professionals in drug development — not just data scientists.

“If you work in R&D, you need a holistic understanding of these changes. Whether you’re in biology, chemistry, regulatory, or portfolio, the field is becoming more interconnected.”

 

Why Pharmacology Matters for Everyone

Gareth frequently teaches Educo’s course Pharmacology for Non-Pharmacologists, and for good reason. He sees a clear knowledge gap between scientific principles and the roles many professionals perform every day.

“Pharmacology is often seen as something for bench scientists — but it’s deeply relevant to regulatory, clinical, and commercial teams.”

He gives clear examples of how pharmacology supports cross-functional success:

• Regulatory professionals must understand PK/PD to interpret labelling and justify safety margins
• Clinical teams need to link trial data to mechanisms of action
• Project managers benefit from understanding timelines grounded in scientific rationale
• BD/licensing teams gain stronger insights when assessing pharmacology packages

“Even if you’re not hands-on, having that pharmacology knowledge in your back pocket makes a huge difference. It improves decision-making across the board.”

 

The Challenge of Portfolio Strategy in Pharma

One of Gareth’s other core areas of expertise is portfolio management — a function that is increasingly critical, but often misunderstood.

“Managing a portfolio in pharma is uniquely challenging — but I’d argue it doesn’t have to be.”

He points to several persistent challenges:

• Risk and scientific uncertainty
• Shifting timelines
• Complex regulatory hurdles
• Stakeholder alignment
• Trade-offs in resource allocation

 

“Every drug has a ‘near-death experience’ before approval. That’s why agile thinking and dynamic portfolio planning are so important.”

He teaches that success lies in being able to balance project-level needs with big-picture strategy — and aligning science, operations, and business goals in a single framework.

 

Cell and Gene Therapies: Huge Potential, Real Hurdles

Gareth has also worked extensively with cell and gene therapies (ATMPs) — and he’s candid about the challenges these advanced modalities pose.

“Cell and gene therapy is an umbrella term for a wide range of modalities. They all differ — in risk, in mechanism, in manufacturing.”

He outlines several key issues:

• Uncertain mechanisms of action
• Long-term safety concerns
• Irreversibility in gene editing (e.g. CRISPR)
• High complexity and cost
• Regulatory novelty and CMC bottlenecks

 

“The regulatory agencies have made real progress, but we’re still pioneering in many areas. And the price tag and access concerns haven’t gone away.”

Despite this, he remains optimistic:

“There are now precedents — and we’re learning how to overcome these hurdles. These are life-changing therapies. It’s worth the effort.”

 

Mindset Matters: Succeeding in Advanced Modalities

What’s Gareth’s advice for professionals transitioning into ATMPs or other complex therapies?

“It’s about mindset. You need a dynamic, agile personality — someone who’s willing to ask questions, think differently, and lead through uncertainty.”

He encourages people to:

• Engage early with regulators (e.g. INTERACT meetings)
• Involve patient advocacy groups
• Embrace the need for new frameworks

“This is where the most exciting science is happening — we’re going after the root causes of disease. You just need the mindset to match.”

 

Where to Start: Courses That Bridge the Gap

For those looking to upskill, Gareth is happy to recommend a starting point.

“If you’re thinking about building your skills in any of these areas, get in touch. We run courses on pharmacology, portfolio management, and advanced due diligence — all designed for professionals working in real-world pharma.”

He adds that training is not just about knowledge — it’s about confidence:

“Being able to communicate complex ideas across teams is hugely valuable. That’s what we focus on in these courses.”

 

🚀 Ready to Advance Your Skills in Drug Development?

Whether you’re entering the field, managing a portfolio, or navigating complex biologics, Educo Life Sciences offers practical, expert-led training to support your growth.

👉 Explore Gareth’s Courses:

Pharmacology Essentials Training: Understanding Pharmacology in Drug Development

Mastering Development and Regulatory Strategies in Cell Therapy

Pharmaceutical Portfolio Strategies: Governance and Portfolio Management

 

 

Interview with Educo Life Sciences Expert, Gareth Willis

Gareth Willis is an experienced biopharmaceutical R&D professional, drug hunter and global project lead with 10+ years of leadership in project/program management, portfolio governance and scientific strategy. He has a successful record of progressing complex, multi-million-dollar drug development programs through internal and external initiatives. He has furthered his practical experience in both Europe and the US, in clinical, pharmaceutical, VC and academic environments facilitating the preclinical -> clinical transition of novel medicinal products. Relevant former roles and institutions include Principal Investigator/Lecturer (Harvard Medical School & Boston Children’s Hospital), Fellow and Project Lead (Vertex Pharmaceuticals), Global Project Lead (Boehringer-Ingelheim) and Asset and Scientific Evolution Lead (invoX Pharma).

In his current role(s), he leads a dynamic cross-functional global team that pushes scientific and drug development boundaries, developing novel medicinal products and drug-device combinations (modality and indication agnostic), to meet unmet patient needs worldwide. He has a wealth of experience in establishing agile governance frameworks to oversee a diverse clinical and preclinical portfolio. Notably, he has extensive experience in translational biomarker strategies, indication expansions (repurposing), and effective tech-transfer for up-scale bioprocessing of biologics.

Overseeing a global team, Gareth has a proven track record in increasing pipeline visibility and executing external collaborations. He has bridged the gap between preclinical -> clinical, implementing novel ‘first-4-patient’ initiatives, such as 5’R research frameworks, relevant clinical biomarker strategies and optimising human dose prediction models to enhance the probability of success of medicinal products.