Moving Through Clinical Development and Operations Obstacles on the Path to Commercialization

As a leader, many are faced with how you balance between strategic and tactical discussions and decisions, moving from discovery to commercial in clinical operations and preparing for challenges and opportunities.

Recently, more than 100 participants spent three days discussing clinical development approaches and best practices at Halloran’s CORE program. Through the active exchange of ideas attendees shared valuable insights, applying them to their respective organizations. Offering unparalleled access to industry leaders, decision-makers, and engaged participants who are passionate about life sciences and drug & device development leaders Bobby Reddy, Co-Founder and COO, Pi Health, Carrie Melvin, SVP, Clinical Operations and Medical Writing, MENARINI Group (Stemline), and Rich Daniels, Managing Director, Halloran Consulting Group, sat down for a fireside chat.

Question: What do you think has hindered the adoption of a ‘big picture’ approach, and what are the key consequences of sticking to the old methods?

Answer: Integrated product teams aren’t just for big pharma; small and mid-sized biotech companies need to adopt this mindset too. Failing to do so can have significant financial implications. One major risk is underestimating funding needs because critical requirements aren’t considered early on. While it may seem daunting to plan this way, these discussions are essential to ensure proper preparation and success.

Question: How do you create and integrate these plans? Where should we start?

Answer: Start by bringing together your cross-functional team to collaboratively build the plan. Taking an early, integrated approach is crucial to avoiding major obstacles later. It’s essential to move beyond a study-by-study mindset and adopt a long-term perspective. You need a clear overarching strategy, but the development plan must also be well-defined and realistic, even for smaller companies.

Question: When building a company and developing a product, what qualities should you prioritize in a clinical operations or development leader to ensure success?

Answer: In smaller companies, it’s essential to find versatile, highly experienced individuals. Ideally, clinical operations or development leaders should have both early- and late-stage expertise. While some companies aim to keep everything in-house, that approach is often no longer feasible, as outsourcing has become common. The cycle of hiring and layoffs is too challenging, so many turn to CROs for support.

For instance, Pi Health is a tech-driven oncology CRO with its own systems and a cancer hospital in India, helping biotech’s consider innovative options for global drug development. Thinking globally, increasing speed, and reducing costs are increasingly crucial in this industry. An international perspective and a focus on community settings enable companies to navigate the progressively complex landscape while optimizing enrollment and costs.

The U.S. market is also highly competitive, so it’s beneficial to find someone with global capabilities and long-term planning expertise. For companies focused on early-stage development with a growth mindset, leaders with a global perspective are essential—especially if the goal isn’t to sell the company but to continue expanding.

Question: Any final advice (or stories!) on overcoming obstacles on the path to commercialization?

Answer: Increasing diversity in clinical trials is essential, and expanding beyond urban centers will be critical for future success. Accessibility is key—almost everyone knows someone affected by cancer. Years ago, a cancer diagnosis felt like a death sentence, but today, advances and early detection bring hope. However, the pace of progress still needs to improve.

The industry must approach things differently. Physicians don’t need to be top-tier key opinion leaders to be capable of running clinical trials effectively. Patient-friendly protocols and streamlined data collection are also vital to making trials accessible.

Finally, it’s crucial to focus on what truly matters; if everything is a priority, then nothing really is. Prioritizing effectively can help drive meaningful progress forward.

We thank our expert panel for their contributions. To learn more about our CORE program being planned for the fall 2025, be sure to contact us to be placed on the mailing list for invitation notification.