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December 11, 2020

Responsibly moving a cell or gene therapy forward as quickly as possible is a challenge associated with navigating a project’s development pipeline. As budgetary benefits can come from a tightened timeline, developers should expedite projects whenever possible.

To help you plan your research initiatives, we asked CCRM’s experts for guidance. They were happy to share some general tips that will assist you as your project moves from development to trial.

1. Maintain Your Focus

Once you are actively on the path to commercialization, you need to invest in enabling a robust and reproducible process for Good Manufacturing Practices (GMP) production. When considering which developmental experiments to run, ask yourself whether the resulting data will inform decisions and next steps with the potential to move your project forward. If it is unlikely to produce an actionable result, you must critically examine the plan, and course correct.

“You have to be willing to try your best to do everything right the first time. Experimentation is really an R&D attitude. In this case, it’s better to think with a manufacturer’s mindset.”

- Steven Keizer, Director of Quality, CCRM

2. Fail Early

Ideally, during the development stages, each step you take will either reveal a clear path forward or help you arrive at a dead-end early. Uncovering one of those dead-ends late in your developmental journey could pose a costly challenge. By prioritizing experiments that test the potential of the path on which you’re travelling, you can minimize the impact a dead-end has on your project.

“If you need to pivot in a new direction, you want to know that as early as possible. Otherwise, you’ve wasted time and money on something that you can’t progress further.”

- Siofradh McMahon, MSc, Director of Clinical Translation and Regulatory Affairs, CCRM

3. Leverage CDMO Expertise

Your project’s development and manufacturing needs will likely present new challenges. The right contract development and manufacturing organization (CDMO) partner will have those skill sets and experience readily available. Having specialists on-hand who can provide you with fully-integrated, specialized services and developmental support tailored to your project’s needs will allow you to do what you do best – innovate and discover the next generation of therapies.  

“Think about what you actually need in order to get to a trial, and then put in place the resources, the people and the teams – like a CDMO – to help you get there.”

- Steven Keizer, Director of Quality, CCRM

4. Work with a Regulator

Working your way through the layered complexity of industry regulations can be difficult. Cell and gene therapy is an ambiguous space full of novel technologies and new ideas that even regulators are seeing for the first time. Regulators know how to navigate the area efficiently, and frequent interaction with them can help avoid potential regulatory or quality roadblocks. By knowing when and how to engage with your regulator, you can maximize the likelihood of meeting regulatory standards.

“If you can, go and have a meeting with the appropriate regulatory authorities and ask for their advice on your plans. Talk through your proposals with them. It will reduce the amount of ambiguity, the amount of risk and, ultimately, the amount of time you spend spinning on decisions internally.”

- Siofradh McMahon, MSc, Director of Clinical Translation and Regulatory Affairs, CCRM

The complexities of commercialization can make the journey from benchtop to bedside a challenge to navigate expeditiously. By adopting a collaborative mindset that capitalizes on your partner’s strengths, you will develop synergistic relationships that keep you on the right path. Look to subject matter experts for guidance and trust in their abilities to lead you where you – and your project – need to be to succeed.

If you want to connect with CCRM’s experts, or if you’d like to learn more about our CDMO services, please contact us.

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