All drug development programs hit snags! No amount of planning or money will make everything flow perfectly. It helps to understand some of the big hurdles so you can avoid them and be ready to navigate.

GreenField works to help our clients understand these factors. We bring the discussion to the table so our clients can better plan and shorten the development timeline.

(These are in order of our own personal bias)          

1. ASSUMING (we all know what happens when we assume)

Assuming that suppliers have the item(s) you desperately need sitting on a shelf waiting for you to buy it

In the highly regulated world of pharmaceutical development, a random supplier will rarely have your drug substance, excipient, or component sitting on a shelf waiting for you to buy it. This point was driven home over the last two years when COVID-19 trashed the concept of JIT delivery.

Even for companies developing a generic or 505b2 product, it’s essential to understand that many suppliers manufacture their goods based on a forecast. Standing commercial customers get priority, and offering money rarely moves you up the list. 

If you have to manufacture a novel drug substance, excipient, or component, leave sufficient time in your clinical timeline for suppliers to develop and manufacture what you need. If you’re bringing synthetic technology to the table, that can shorten the development timeline, but your CROs need time to run through that synthesis before taking it into a kilo-lab or plant.

A good rule of thumb is to allow two weeks of development time per step and an additional 1- 2 weeks to manufacture in the plant, longer if the technology is unique or requires extreme conditions.

Include analytical methodology development timing. It can run parallel to chemical development but inevitably lags behind the wet-chemistry synthetic work. Labs need samples to develop their efforts. Once those methods are in place, in-process and release testing takes more time. We recommend that our clients allow for a minimum of 6 – 8 weeks for release testing on their drug substance or drug product.

Most importantly, we get people to understand that there are very few idle labs and plants. New customers need to queue with a CDMO’s existing customers and workload. Trust the CDMO when they tell you what their schedule will allow.

2. CONCEALMENT (know when to show your cards)

Too much secrecy

We understand the need to protect intellectual property. We urge our clients to ensure non-disclosure agreements (NDAs) are in place, regardless of the discussion stage or what information will be disclosed. However, when a CDMO asks questions about the project, the answers are critical to properly planning your program. Many clients want to keep information private such as regulatory status, delivery forecasts, realistic commercial forecasts, and clinical indications.

Trust the agreements you have in place. It is rare for a service provider to risk their reputation by misusing or abusing confidential information from a client. The more you help the service providers plan for you, the more dependable your development timelines are.

AND, remember, those NDAs work both ways. Ask your CDMO questions. They’ll answer them to the best of their ability without infringing on their other client’s confidentiality.

3. PROCRASTINATION (don’t be like the grasshopper)

Putting off critical supportive work until the last minute

To get drug product delivered to the clinic and conserve spending, many clients tend to put off supportive development work until the last minute. It’s essential to keep those submission-supportive studies in mind early in development. A simple, turnkey-type study may end up being more difficult than expected or yield an unexpected result. Getting these studies done earlier rather than later leaves time to understand the results and make any adjustments to your development plan design.

4. MISSED MESSAGES (who’s on first?)

Poor communication

Communication is a crucial element for smooth project flow. Efficient top-to-bottom and lateral communications help the team function in stride. The same applies to external communication. Ensure all of your supporting partners know the company’s goals. Let them know what part they play in achieving those goals. Be honest about timing and whether you include room for errors. Make sure information is updated promptly.

Lastly, document your meetings and conversations. Publish minutes that detail assigned tasks and due dates. The most common cause for delays in a project are situations where everyone on the team thinks someone else is performing a specific task when no one is.

Your experiences may highlight others. When we work with our clients, we build this into our project plans and advise our clients accordingly. Connect with us to consult about your project. We would love to hear from you. CONNECT WITH US HERE