15 Key Insights on #HealthTech and Big #Pharma Partnerships - Part VII - Structures & Incentives (cont'd)
8. Navigating Risk-Averse Functions in #HealthTech and #Pharma Collaborations
Let’s again assume you’ve found your internal champion at the pharma company, and even a project sponsor with a budget (see key insight no. 5). You’ve done your best navigating the lack of a formal process and structure to partner (see key insight no. 7). Now, you will face the next hurdle: the multitude of functions pharma has set up to minimize risk. The ones you’ll encounter most often are #compliance, #privacy, safety, IT security, and regulatory affairs. This list is far from exhaustive.
Let me start by saying that all of these functions are there for very good reasons (all activities are illustrative examples):
- #Compliance ensures that physicians are compensated at fair market value if a pharma company engages with them
- #Privacy ensures that sensitive personal data is treated in a way that respects all applicable laws and regulations, like the EU GDPR
- #Safety plays a particularly important role in pharma, ensuring that any adverse events around drug use are reported to the relevant authorities as quickly as possible
- #ITSecurity ensures that pharma’s sensitive data isn’t attacked by external agents
- #Regulatory Affairs gets involved, for example, when software has to be regulated as Software As A Medical Device (SaMD), or checks compliance with the new EU AI act
Now, where is the issue you are likely to face with all these functions when you are trying to partner with big pharma for an innovative solution? It boils down to incentives. In the current setup of nearly all pharma companies, these functions are incentivized to keep risks to zero, so “this is not possible” is the most likely default answer you will get.
To make matters worse, each of these functions usually has a separate assessment process for new opportunities that isn’t synchronized with any of the other functions, even though many of them have interconnected steps.
What can you do as a startup to help navigate these functions? I can recommend three tangible actions:
1. Work with your internal champion to get all of these functions involved as soon as possible. They need to feel like it is “their” project as well, so you can move individuals from “this is not possible” to “maybe if we do it this way, it could work.”
2. Be aware upfront of what concerns your solution may trigger with each of these functions, and ideally have a very strong answer ready in your Q&A. Make sure your internal champion is aware of these answers, as he or she will be the one constantly navigating this internally.
3. Ask your internal champion about the review process from each function from the very beginning. This has two advantages: it highlights potential bottlenecks beforehand, and it will help you be better prepared for step 2.
Please do share your thoughts and lessons learned in the comments!
