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4 Key Questions Most Small Biopharma Companies Fail to Ask Before Entering a Clinical Trial


August 2018


Forgotten when a drug receives FDA approval is the arduous road a biopharma company took to complete its clinical trial pathway. Many products fail during clinical trials, not because the product failed, but because the clinical trial wasn’t designed properly or in a fashion that would point it toward regulatory approval. This process is not only expensive but has a profound effect on an organization and its future.

Most small biopharma companies lack the resources and experienced personnel needed to successfully conduct the appropriate clinical trials. Not being fully prepared with the proper clinical trial strategy could doom a drug before it’s even put into a human. To make up for these needs, these biopharma companies must involve CROs thoroughly, beyond just conducting the clinical trials but being a key component of the planning process. So, before entering a clinical trial or picking a CRO, consider these five questions.

1. What is your approach to a labeling strategy?

One of the most important considerations for an FDA or global regulatory approval strategy is what the ideal product label is. The label is the roadmap for a successful clinical trial strategy. It details how you’re going to compete, your patient population, your indications, and how your product will be used in the marketplace. The label is the primary tool the FDA utilizes in its guidelines as it examines your clinical data. So, it’s critical to your product that you work towards an ideal product label from the onset. The label is where a biopharma company sets the stage for how it will compare to the competition, justify its pricing and set the standards for its efficacy.

2. How do I determine which indication to pursue?

Many small biopharma companies commonly bring everyone together for brainstorm sessions when choosing an indication. However, these companies tend to exclude a CRO in these discussions. A good CRO should have a very defined process that combines market research with scientific expertise, to properly weigh not just the economic potential of the indication but the timing and risk associated with each indication’s regulatory pathway. This expertise should be valued, and why companies should involve CROs at this stage to do more than just conduct the clinical trials.

3. How do I develop a realistic market assessment and market strategy?

Assuming that a biopharma company truly understands its product’s scientific advantage and pricing strategy, the company then needs to develop a global and regional approach where it can determine which parts of the world to emphasize and bring its product to market. The primary economic exercise involved here needs to be realistic assessment of a product’s lifecycle from time of introduction to what happens with competition, and finally, expiration. This requires a market-by-market assessment, taking the time to understand patient numbers and competitive products and prices associated with those products.

4. How and when do I pick a CRO?

CROs should be viewed as a development partner, not a commodity that simply conducts clinical trials. This thinking can help be the cornerstone of a good search process. Biopharma companies should pick a CRO early, ideally when they are in the position to review their preclinical trial package. Here, they can assess if they are indeed ready to go into clinical trials. When researching their future partner, companies need to look for a well-rounded CRO – an organization that can help determine the primary indication and develop a strategy accordingly, assist with regulatory submissions, help design labeling and a total clinical program.

Along with these four questions you should ask, there are also two questions that you should never ask. Never ask a CRO about how many trials it has done in a specific disease or how many people it currently has doing a specific type of trial. Since staff in this industry comes and goes, it’s the leadership you want to focus on. The ability of a CRO’s leadership team to assemble the right people at the right time for your trial is key. What biopharma companies should be looking for is what general experience the CRO has – they not only know how to run a trial but can work hand-in-hand with you to help you succeed.

Pick a CRO you envision being with you throughout the entire process. Make sure you know the individuals who will be running your trial from a management perspective. Determine if the personality and elegance and experience in these individuals is what you will be comfortable with and, most importantly, can trust.