Planning

Even in the preclinical stages it pays to think about process development. Can your molecule or biologic be scaled up? What changes might need to be contemplated to ensure the product is stable and scalable? What challenges are you likely to face?

And when you’re ready to take the next step into clinical studies, should you look to China, India or elsewhere for clinical supplies? What about quality? What cultural and communication issues are we likely to meet? Can we trust that our IP will be respected?  When should we lock in the process for commercial manufacture? 

Even in the preclinical stages it pays to develop a big picture plan for the program. This can be refined as time goes by. It's important to think through some fundamental issues. Can your molecule or biologic be scaled up in a cost effective manner? What changes might need to be contemplated to ensure the product is stable and scalable? What challenges are you likely to face? When do I need to undertake the various activities to drive my product to the clinical stage gate?

Planning out when and how to address the critical questions helps give your staff, management and board an aligned vision for the program, helps inform investors, and helps plan capital raisings.

Where am I getting my Investigational Product? How pure does it need to be? to what standard should it be made? How much analytical support do I need? What about stability? Where is all this going to be done - in house or outsourced or a mix of both. And importantly what is required of the data management?

How do I find a good CRO and how do I manage them?

What policies and procedures do I need in place to make this all happen?