How do you manage product development? What are the decisions and risks associated with it? How can you reduce these risks and get investor support? Design Space InPharmatics Senior Program Management Coordinator Judy Magruder shares critical insights on these and other early-stage questions on drug development.
Below, learn how to create and manage real-time drug development plans, manage resources, minify risks while meeting regulatory requirements.
You might be a startup company that has recently acquired a patent or a scientist who has made progress in his lab. Before you roll out a development strategy, think of the entire process and what it would take to get the product to market.
Map out everything from the science to the financing to market and regulatory matters before zeroing into the smaller aspects of your strategy –the micro-plans.
Once you have spent time thinking about the big picture, you have to think about what critical milestones they need, usually in the next financial cycle because, at the end of the day, the business has greater control over the science. And once you set your milestones, shift focus to IND.
How do you ensure that IND is filed quickly? Fragment the strategy into three buckets; CMC, clinical, and non-clinical. Each has critical elements that you must focus on; at the beginning, development is mostly non-clinical and extensive studies on the safety and efficacy of the product. You need an API to do that. CMC comes in next and material development and other preclinical aspects then lastly clinical trials.
Use Gantt charts as a planning and visualizing tool. Create multiple scenarios and identify risks. Then figure out what risks you can sustain and which ones you can't. Once you get the bigger picture, keep your eyes on the micro plans. Constantly update them because there is always new information. In drug development, the only constant thing is change, micro plans are dynamic, but your objective is to stay on track with the larger objectives.
Establishing evidence of effectiveness and safety is a priority as formulation development is left to the later stages. Ask yourself: What do I know about the molecule? What do I know about synthetic routes and impurities? How do I design the right safety studies that address those risks?
Plan and support collaboration between toxicologists, safety specialists, and the drug developers who understand how the molecule works in non-clinical models and then make materials and test in safety assays.
While these are typical early-stage activities, look back at the primary objectives and incorporate into your tests the possible safety elements and concerns when the product reaches the market.
In all drug development stages, close multidisciplinary collaboration is required, and so clear communication is critical for attainment. You can start your group meeting and say, we've got a safety alarm. We need to look at the CMC and remove a few impurities or find out what caused the problem, so let's change gears.
When you do that, be sure to show people the critical path and help them understand exactly why you need to make the change, what the new objectives are, and the timelines. Hopefully, the changes needed do not affect your timelines but make sure people understand the connections of your drug development program's aspects.
The FDA has a reputation for not looking at the blood and the sweat you have poured into the new drug; their only concern is the documents you submit. Sometimes, you encounter pleasant surprises with the agency—I worked with a first-tier company that acquired an asset that had previously been available at the clinic. Still, they didn't have much of the original details.
When you take over a project, sometimes there is a lot of detail, sometimes a lot of it is lost. So, in this case, a lot was lost. And in their first interview with the FDA, they said, let's have a pre-IND meeting, you saw a molecule before the IND was withdrawn, but now, it's new. And the company made what I thought was a very skimpy IND package, yet the FDA was willing to work with the company.
Molecules were safer, based on the data they had. And so the FDA considered the evidence sufficient. You can submit your kind; it turns out you don't need to have to make your own clinical batch when you enter IND. In that case, the certificate of analysis is the prioritized document before the clinical trial.
The FDA has clearly stipulated IND requirements, but when faced with unique circumstances, it doesn't hurt to ask.
In conclusion, drug development is like many other things in life. Unless you have a plan, there is no guarantee that you will get there. If you want to increase your chances of success, you need a plan that shows you how to get there.