Clinical Development Under Pressure

Regulatory scrutiny and new innovations impact the future of Clinical Development

External and Internal Factors Leading to Change

Regulatory and Payer Scrutiny

Crowded drug markets are leading to a raising of the bar for demonstrating health outcomes and meeting increasing quality and safety standards.

Changing Competitor Landscape

Increasing competition within Pharma, and the emergence of health-focused products from new industries, is driving the need for speed and innovation to reach the market faster.

Unfit Structures and Governance

Conventional approaches and governance structures are not built to handle the speed of Clinical Development today, leading to increased complexity and reduced employee engagement.  

Pharma 3.0: The New Operating Model

Following these new demands, the industry is shifting toward a Pharma 3.0 business model. The aim of the business model is to re-orient development toward patient centricity, create a clearer link for employees between what they do and the value they create, reduce internal complexity, and create organizational agility.

What is Changing?

Traditional decision making happens in governance and review committees.  In a Pharma 3.0 model, development teams are being increasingly empowered to drive the agenda and truly own the clinical trial design.  Rather than focusing on “My input allows the committee to decide,” leaders are challenged to think “I need this input from the committee in order for me to accomplish X.”

Traditional development happened in silos.  While multiple functions would collaborate on clinical development, the prevailing mindset was like an assembly line of efforts “I need to work on this and then connect with function X.” Leaders in the new model ask critical questions, such as “Are we aligned on what we need to accomplish?  Do we have the right people in the room to accomplish this?”  Leaders will increasingly act as a cross-functional architect, building teams that are fit for the purpose they serve. An advice-seeking process will ensure those outside of the team are informed and involved when fully necessary.

Traditional development saw everything as highly regulated and inflexible.  In reality, much of the complexity that exists in clinical development is a result of operating principles instead of regulatory requirements.  The Pharma 3.0 model recognizes, for instance, that a clinical trial protocol needs to meet a strict quality standard, but that the process of getting to that standard can be more iterative and inclusive.

By emphasizing progress over perfection, delivering ideas quicker, and making improvements over time, solutions to challenging problems can actually be made faster.

What does this mean for Senior Leaders in Clinical Development?

The key challenge for leaders is a shift in mindset. Senior leaders on governance bodies had to have the expertise and experience to take tough decisions, and those decisions had to be correct. The new way of thinking – empowering others to decide, not needing to have all of the answers today, and iterating toward a solution – can be seen as the opposite of leadership. Without a change in leadership mindset at the top, a shift toward Pharma 3.0 processes and governance will fall flat.​

In Governance Bodies

  • Setting the vision for others, empowering them to act
  • Changing from final decision maker to coach and mentor
  • Creating connections and removing roadblocks for empowered teams
  • Ensuring psychological safety for the organization to experiment and learn

Leading Clinical Development Teams

  • Keeping patient-centricity at the front and aligning action behind it
  • Facilitating cross functional work and systems thinking
  • Embracing ambiguity by taking smart risks and planning scenarios
  • Finding solutions through experiments and learning cycles