Execution: How Biotechs Can Plan and Run Successful Clinical Trials

Articles in this series:

• The Biotech Industry Today: What Leaders Need to Know
• Planning: Why It’s Worth the Time for Biotech Companies
• Fundraising: Best Practices in a Challenging Environment

How does clinical trial execution relate to strategic planning and fundraising, two important milestones for a biotech?

Joris: Execution of a clinical trial is closely connected to the development of the strategic plan and fundraising activities. Your plan is the backbone of your execution. And execution will help you raise funds because it’s a great way to measure whether you are delivering on what you promised. Many investors will hear your pitch but hold off on investing until you’ve run a successful clinical trial.

Chris: Right. A clinical trial may be the first time you’re able to provide investors with actual data, not just theories and assumptions. From an operational and technical standpoint, you need to think about when you can share data, even if it’s preliminary. That will move you towards your next inflection point and allow you to make a stronger case for additional funding. If you’re working with a Contract Research Organization (CRO) or other partner, focus on when you can access data. Of course, you also want to remain ethical; present potential investors with accurate results and disclose the status of the data.

How should biotech companies approach the execution of a clinical trial?

Joris: Drug development is complex by definition, with many moving pieces. The management team of a biotech deals with multiple issues simultaneously as they move into the execution phase, including not only clinical activities, but also non-clinical activities such as interaction with regulatory agencies, fundraising and partnering, company structuring and talent recruitment, anticipation of market access in various geographies, and much more.

I see two aspects to execution. One is all the functions run by independent internal teams – for example, a clinical trial run by your clinical team. And the other is what we might call the crossroads – where the separate teams come together and interact to share data, answer questions, and set common goals. The management team needs to coordinate these cross-functional interactions, and frequently check with the plan to confirm that your teams, both separately and together, are making progress. You must continuously validate the assumptions you made when developing your plan. Perhaps most importantly, identify red flags that appear during execution as soon as possible.

Chris: I agree, especially about the red flags. When it comes to clinical trials, you face high risk and high expense. You must prepare to pivot from your original plan and anticipated timelines as things change or if you find that certain tasks are not going according to plan.

What are the three main challenges biotechs encounter during the execution of clinical trials?

Joris: One challenge is that companies don’t invest enough time to understand the environment before beginning clinical trials. Especially if they’ve received funding, they often feel pressure to execute right away without answering basic questions. One example is patient recruitment into trials. Where are your patients, do you have the right inclusion criteria, do you understand the dynamics of successful recruitment? Sometimes biotechs settle for simple answers to these questions. We encourage biotechs to dig into the details and understand what difficulties lie ahead, so that you can plan and prepare.

Another challenge I often see with many of our clients is that they have a strong plan, which is great, but when things change during the clinical trial, they are reluctant to respond to those changes. No matter how good your plan is, you must constantly look for red flags and pivot as needed. For example, delays in your timeline are normal, and many are acceptable, but you should investigate to find out if there’s a flaw in your plan. You may have incorrect fundamental assumptions.

Chris: A red flag during a clinical trial can also show up in your finances. You may receive an unexpectedly high invoice from a vendor, which is a sign that something in your plan is off track. You may have to conduct additional trials for regulatory purposes that you didn’t anticipate, or you may have formulation issues that result in higher costs. Any number of things can happen that are just part of the clinical research process. Build that risk into your budget at the beginning so that you are able to respond and cope when you’re surprised by something you didn’t anticipate. If you think you’re going to spend two million dollars on a trial, and you have exactly two million dollars set aside for it, you have no room for error. Give yourself a cushion by expecting that something will change, and you will need to spend more.

An additional challenge is that you will need many different partners, especially as an early-stage biotech. Be selective: choose partners you can trust who will respond quickly to your needs. Also, you should plan to have a highly effective internal project management resource that can manage your partners and vendors. Sometimes we see executives trying to take on day-to-day project management tasks, and as we’ve discussed, you and your management team have enough on your plate.

What advice would you give to a biotech on managing its clinical activities?

Joris: Clinical activities are incredibly vital to your company’s success, and they are also your greatest expense. To reduce stress and risk, I suggest looking at clinical in two ways:

• Strategic: invest time and effort into understanding the ecosystem as well as how your clinical strategy and commercial strategy fit together. This will help you to anticipate issues.
• Operational: surround yourself with the right people – internal and external – who understand the environment in detail and know how to operationalize the trial, how to recruit and retain patients, how a clinical site works, and how to measure success.

Chris: As you plan your clinical program, you should also build a Patient Advisory Board, which will provide invaluable input to your study design. A poorly designed trial may not reveal itself until you are well into the trial, resulting in millions of dollars wasted. So, before you initiate your clinical activities, it’s important to engage with the right key opinion leaders and advisors, and find the right sites and the right partners to conduct the trial. You need both a great trial design and a great partner to be successful.

Keep Reading: Biotech Challenges & Ways to Overcome Them

• The Biotech Industry Today: What Leaders Need to Know
• Planning: Why It’s Worth the Time for Biotech Companies
• Fundraising: Best Practices in a Challenging Environment