You get what you manage. That’s become my way of thinking when it comes to outsourcing work in the pharmaceutical industry. For ten years I developed chemistry at the bench and then sourced that work to external CRO’s. I’ve been asked to make milligrams to 100’s of kilograms of material for non-clinical and clinical use. Then I spent almost 2 years starting and growing a process chemistry contract lab before becoming a consultant. From all of those experiences I established a set of guardrails I use in approaching every new outsourcing opportunity.
- You get what you manage: There are many ways to say the same thing but at the end of the day any project will only be as successful as the time and effort you put into making it a success. You can’t expect to put little effort in and have things delivered on time and on budget.
- We’re all on the same team: For most of us, we are willing to put in long hours and work weekends because we know we are helping patients. We know how important the work we are doing is. This is because it has been discussed at meetings and we make the patient need part of our daily life. For many at a contract lab, they don’t get the opportunity for this. It’s up to us as the person sourcing the work to make them feel part of the extended team so they know how important their role is. I speak from experience when I say the more you take the time to do this, the higher the likelihood a team will be willing to work weekends or holidays to hit your delivery date and enable the clinical study you have been taking about.
- Listen to experience: If you are at a pharmaceutical company, you may be fortunate to see 1-2 projects per year. For me I know I touched 12-15 programs in my 10 years working at pharmaceutical companies. In 18 months working at a CRO, I had evaluated 30-40 programs and actively worked on over 10 programs. Why do I tell you this? Most times I have witnessed people within pharma not necessarily asking or listening to ideas generated by their CRO’s. There’s the perception you know more or have greater experience because you’re at a pharmaceutical company rather than a working at a contract lab. If you take the time to listen you will see this is completely reversed. Working for a pharmaceutical company gives you great knowledge of that molecule or program but very little broader experience.
Those are my guardrails based on my experiences. If you agree or disagree or want to hear more please come to see a panel of experts speak about this topic and their own strategies and experiences at Mass Bio’s Going Virtual with CROs: Accelerating Product Development While Minimizing Organizational Scale forum on October 31st.
Register for the event here: https://www.massbio.org/events/going-virtual-with-cros-accelerating-product-development-while-minimizing-organizational-scale-2258
Ray is a member of the Senior Leadership team at Syner-G having responsibility for leading the CMC Development and Project Management business units. His team is responsible for providing scientific solutions for drug development programs including identifying and managing CRO/CMO/CDMOs for Syner-G’s clients to support drug substance, drug product and analytical development activities.