Small pharma companies, sometimes known as biotechs, are known for being nimble and fast. These qualities enable them to be the innovators of the industry and thus, acquisition targets for large pharma.
However, small pharmas also experience clinical operations pain points that are unique to their size and fast rate of growth.
Below, in no particular order, we’ve identified the top 6 small pharma pain points in clin ops (as well as potential solutions):
- Small number of employees
- Lack of processes
- Lack of standardization
- Strategic volatility
- Poor quality vendor services
- CRO/vendor micromanagement
Small number of employees
Small companies have smaller departments, and that includes that of clin ops. However, the trials these companies run are no smaller or less complex than those of large pharma. After all, a registrational phase 3 trial requires the same effort and resources regardless of trial sponsor.
For this reason, small companies need to do more with less (i.e. be efficient).
Here are some solutions:
- Hiring a CRO or FSP to supplement the small in-house clin ops team
- Hiring consultants to supplement the in-house team
- Rapidly creating a core set of SOP/processes/tools to standardize basic activities to avoid recreation from scratch with each study
- Deploying an in-house technology platform to automate and standardize much of the work and trial oversight that the sponsor is responsible for (whether using a CRO or not).
- This also allows smooth scaling of the overall trial portfolio without having to linearly hire more people and/or experience “growing pains”
Lack of processes
Small companies are building their clin ops departments from scratch. This means little to no department infrastructure exists to guide how the department functions and achieves its goals.
Here, solutions can be:
- As above, hiring a CRO and using their processes and applicable (where applicable)
- Hiring a consultant to quickly create a core set of SOPs and processes
- Deploying an in-house technology platform that has standard clinical operations processes and best practices “baked in”, thereby guiding the user to conduct and oversee their trial properly.
Lack of standardization
Because processes and SOPs standardize activities across study teams, the lack thereof has a negative effect.
This leads study teams to repeatedly create processes and tools from scratch (or eschew process altogether and do things randomly).
Not only this, but lack of standardized trial oversight and reporting requires either a) the study team to repeatedly manually standardize their study progress reporting or b) requires senior leadership to interpret trial progress across various formats. Both these ultimately lead to wasted effort and confusion. This is especially prevalent in companies using CROs, as different CROs are used across trials, so trial execution and reporting can vary widely.
Here are solutions:
- As above, hiring a consultant to quickly create a core set of SOPs and processes
- Convening various study teams to regularly share and align on best practices from their experience (e.g. in a monthly departmental meeting)
- Deploying an in-house technology platform to standardize the work and trial oversight that the sponsor is responsible for (whether using a CRO or not)
Strategic volatility
Small pharma’s size allows them to change trial strategy on a dime. This is valuable because unlike large pharma, their financial runway is limited. For this reason, a series of quick yet sound decisions in a constantly shifting pharma landscape gives them the best path to a commercialized product.
Some conditions that can change trial strategy:
- FDA or other health authority requests that a trial determine how a drug affects a second-line patient population. This requires the addition of a part 2 to the small pharma’s trial.
- A pharma company with a competing drug gets early approval by the health authority
- A partnership with a large pharma company falls through, shortening the small pharma’s financial runway and affecting several trials
- The small pharma company is acquired
- The small pharma announces missed trial milestones/targets at an earnings call and the company’s share price drops
- The small pharma’s key trials show lack of efficacy or superb efficacy
The solution:
- In order for a company to be ready to rapidly change an existing trial, start a new trial, or speed timelines in a neat and efficient way, they need to have already mitigated the foundational pain points above. This means, they need to have:
- Sufficient employee/technology to work ratio
- Strong processes
- Strong standardization
Poor quality CRO/vendor services
While this is not true for all vendors, it unfortunately happens that some large vendors will deprioritize small pharma clients by a) providing them with less time/effort or b) inferior project teams. Depending on the criticality of the services provided, this can adversely affect the trial and create more work for the study team. Solutions can be:
- From the onset, hiring boutique vendors that have a smaller client base, and therefore, value each client
- Requesting that the vendor assign a different project director and/or team
- Starting an escalation pathway:
- Raise the situation to the vendor’s leadership (preferably via the small pharma’s leadership)
- Define and set service quality benchmarks to be met by a deadline
- Then, if all else fails, change vendors
CRO/vendor micromanagement
Small pharma study teams tend to micromanage their CRO/vendors. Obviously, there should be vendor oversight, but micromanaging involves doing or redoing part or all of the vendor’s work for them and/or following up for updates more than 1x/day. This can be because:
- As stated above, the vendor is providing poor quality service
- The small pharma’s senior leadership is very hands-on, causing the study teams to follow suite
- The company’s tight financial runway and/or aggressive study timelines that leave no room for error in study conduct
- Leadership and/or the study team has worked at small biotechs before and experienced one of the above, but can’t shake the habit even if unnecessary in the current situation
The solution for each cause:
- First, confirm if the situation truly requires micromanagement (i.e. poor quality CRO/vendor services). If so, try to resolve it by trying solutions suggested in that section.
- A hands-on senior leadership doesn’t necessarily require the study team to micromanage their vendors.
- Instead, the team should provide leadership with frequent status reports and always a rationale behind key issues or decisions. This is usually what leadership really wants – assurance and transparency that the trial is being conducted competently.
- Even with aggressive timelines, micromanaging vendors increases the study team’s work and their odds of burnout, not to mention a poor relationship with the vendor (it’s not unheard of for a vendor to “quit” their sponsor). High level of stress cause everything to think less clearly and be inefficient.
- Instead of this, clearly communicate and obtain the vendor’s buy-in of the timelines. Like the step above, ask the vendor to provide frequent status reports and rationales.
- If it’s found that the timelines cannot be realistically be met with existing resources, commit to a resource increase on either the vendor or pharma ends.
- Become mindful of this, breathe, and let go. It can be challenging to change habits, but awareness is a key step. Or, if you’re not the team member setting this tone, send this article to the person who is.
