• July 27, 2023

Many smaller and start-up pharma companies may have a concept of a molecule they want to develop, and they may understand the clinical side, or the tox side, but there is a chance they may not understand the CMC side (Chemistry, Manufacturing, and Controls) involved. This is one area where Olon USAs specializes in helping our clients determine their path forward. We call it their Development Road Map. We take the whole project and run with it to help them make the best decisions on their projects. Just like taking a road trip with the family, we need to set the destination and timing of where we are going together, and then develop strategies and tactics for a successful trip.

Where to Begin – and How to Establish What’s Needed

When starting out, our customers are just trying to develop a proof of concept and identify their lead molecule. In our synthetic chemistry group, we can make several analogs for them. They can dose them into their test subjects and pick the one they want as their lead candidate for development. We then take that lead candidate, make a few more grams of it, scale it up, check for impurities, and see how the synthetic process works. They can do a little bit more in vivo work. Then, if that’s a program they want to move forward with, we can move it right along the process from making their GLP tox/pharmacokinetic lots and scale up into our kilo labs. From there, if they need larger scale, we can scale it up into the pilot plant for GLP or GMP API.

We can help smaller startup companies develop their timelines and give them the information needed to plan the trajectory of their projects. One of the other advantages we have as an international organization – with sites around the world – is that we have a lot of other services we can provide, other than the ones found at our site here in the U.S.. If the client needs salt screening or a polymorph study done, for instance, we can do those things, too.

Estimating Costs and Developing Budgets

Olon can help develop budgets for our newer/smaller clients so they will know how much money they need to discuss with their board and investors. We talk with them about the pitfalls and the additional work that might need to be done along the way in discovering more information about their molecule.  Unexpected things sometimes happen in development, it is how quickly we react and take course corrections that keep timelines on track.

Ultimately, our goal is to really be a partner with our clients throughout the process – from the very beginning – and learn everything we can about their molecule., When they get to the point at which they are ready to run clinical trials and have their pre-IND meeting with the FDA, they have all the information they need to be able to answer questions with confidence.

Getting the Answers You Need for Your Global Concerns

With nearly a dozen sites worldwide – and over half of those in Europe – Olon has the answers our customers need to do work successfully in the U.S., Europe, and APAC regions. In Italy alone, we have a regulatory group of 50 people. So, in addition to providing valuable input on how to begin and maintain your program(s) here in the U.S., Olon can also offer insight on the best way to continue your business overseas as well. We can advise our clients on the things our customers can do to optimize their development plan. With so many unanswered questions about regulations and multi-site logistics facing many of our customers, our expertise and guidance gives them the security they need to move ahead confidently with their project.

Olon has the experience, the network, the talent and the wisdom to help anyone in this space ensure that their development pathway is set up for success. What might this mean for your projects? Call us today and find out!