Strategic Planning in Clinical Trials and Drug Supply

By Jason Nolte

Jason Nolte, Clinical subject matter expert, discusses the importance of strategic planning teams and what they must utilize to stay relevant in the Clinical Trial & Drug Supply industry.

Jason Nolte, Clinical subject matter expert, discusses the importance of strategic planning teams and what they must utilize to stay relevant in the Clinical Trial & Drug Supply industry. Jason has over 19 years of clinical supply chain experience. Having worked at small biotech, large pharma, big biopharma, and on the supplier side, he has a broad understanding of the supply chain’s moving parts and how these parts work with or against one another. For the clients he supports, he brings a very diverse perspective to clinical supplies, solutions, and process improvements.

What do you feel are some of the biggest challenges facing strategic clinical drug supply planning today?

The biggest challenges are aligning all parties internally and externally, managing expectations, and getting time back to do necessary strategic improvements.

As the clinical supply chain grows in complexity, size, and scope, and as we bring novel approaches to running the studies with regards to just-in-time technologies, adaptive protocols, virtual organizations, outsourcing strategies, etc., we must find time to build the best teams, understand each organizational dependency, timelines, and roles, as well as make time to create good change for the future.

We get so caught up in being reactionary to the daily grind that we often lose sight of the fact that we have predecessor and successor stakeholders. When one thing happens, there can sometimes be a “butterfly effect” or global shift in multiple other things. We must become more strategic in the way we think, we must think big-picture, and we absolutely need to make time to understand our stakeholders’ roles better so that we can manage our own and their expectations.

Lastly, I have seen many organizations grow in size, scope, complexity, and volume, but unfortunately, processes do not evolve to marry the new needs of the organization. We must find time to improve individual and cross-functional processes to meet business needs. With bad process comes inefficiency, risks, gaps, and possible audit findings. Strategic planning needs to be a business imperative that is addressed each day, even if it is just a small action towards the larger plan

What are the key actions you feel are most frequently overlooked when companies begin developing their strategic plan for clinical drug supply?

There are three key actions which I feel are most overlooked as part of strategic planning: Engaging all key stakeholders (including the vendors), understanding the global implications of the clinical drug supply needs, and defining a timeline with key milestones to achieve the strategic plan.

Communication across all stakeholders, including study managers, clinical operations, clinical drug supply teams, regulatory, and vendors, is essential to understand the timelines to initiate new work. These timelines are impacted by country selection, sourcing of ancillary product or commercial drug, and how regulatory documents are created. Engaging the teams to build relationships to navigate the complexities and set expectations increases the probability of success. Also, leveraging best practices through checklists, questionnaires, and regular meetings will help teams to anticipate potential issues for remediation rather than react to a crisis.

An organization’s overall Clinical Development Plan can help the clinical drug supply team proactively prepare to support planned trials. Country selection can play a huge role in the overall strategy. By understanding enrollment trending data from prior studies, a sponsor can better plan for and predict the supply chain supply requirements. This can lead to better utilization of a drug across depots, regions, and countries and reduce a lot of risk, waste, and rework if the drug is not in the right place at the right time.

A well-defined and documented strategic plan which incorporates feedback from all key stakeholders is an invaluable tool in building alignment and driving accountability. Leveraging best practices to account for potential pitfalls and define key milestones provides the clinical supply team with the needed information and support to proactively manage the many moving components.

How do you recommend making the shift from “reactive planner” to true “strategic planner?” What are some key points to consider?

As busy as we all are in our respective functions, we must make time to build relationships internally, visit vendors, and educate/train interdependent organizations. Supply chain is a sequential process tethered by handoffs, collaboration, and concurrent processes, so we must learn about our entire supply chain in order to maximize resources, reduce costs, and be successful as a team.

It is very difficult to allocate time to process change when we are so busy ensuring supply continuity. As hard as it is to find time to eat lunch in clinical supply, we need to find time to develop new standards and processes that ensure Right First Time results and repeatable success. If we do not evolve and adapt our systems, tools, and processes to the needs of changing regulations and study designs, we will become extinct. Document your strategic plan with manageable and realistic milestones to meet your organizations long-term needs for success. Keep in mind: you don’t need to go it alone. There are industry experts who can help guide the creation of a repetitive framework for success, and you can avoid time and money waste by learning from others who have faced your challenges.

Finally, remember that a little every day equals a lot. Allocate time each day to be strategic, and hold you and your organization accountable to your strategic plan.

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