Drug developers are all too familiar with the numerous challenges faced at each phase of the clinical trial process. Solid chemical process research and development (PR&D) plays a crucial role in ensuring that the required amount of drug can be manufactured to the required quality in an economically and environmentally sustainable manner. Knowing just how important it is to get PR&D right across all phases, time and resource-squeezed organizations will often outsource projects to contract research organizations (CROs) – tapping into their additional expertise and facilities.
Though the relative importance of speed, quality and cost will vary across the drug development timeline for a new chemical entity (NCE), one important factor remains constant: risk management. When working with a CRO, potential challenges can be governed using effective communication. It is critical that both parties remain on the same page. The CRO should take the time to fully explore the broader contexts and objectives of a project, be able to grasp the chemical and technical challenges in detail, and be asking any questions that will allow it to create a customized solution.
Lines of communication should be kept open throughout the various stages and phases of a PR&D project; no doubt a customer’s concerns will be dynamic and alter according to the uncertainties and risk associated with getting a molecule to market. Organizations looking to outsource PR&D need to know that their CROs are there to listen and support them through every challenge that may crop up across all drug development phases. Likewise, one must give CROs the opportunity to ask questions; they can’t manage expectations effectively if they are kept in the dark about certain aspects of a project.
During drug development, it is common to be constrained by both the clock and the budget, resulting in limited PR&D considerations. Balancing these pressures with successful risk reduction is the key to success. If the right process research is undertaken at the right time, across multiple phases, there can be a significant return on investment. Technical support is continually available when a drug developer partners with a CRO across a project, and an outsourcing organization’s trusted expertise and experience can be exploited to operate with overall greater efficiency.
Increasingly, many organizations that develop novel therapeutics are considering next generation routes for NCE manufacture. An improved manufacturing route can be developed post-product launch or in parallel to initial drug development. The preferred time point for starting the manufacture of a next generation route will depend on the resource and time constraints that the drug developer has. If a manufacturing route has scope for improvement, you can start seeking such development support as early as phase II clinical trials. That said, it is natural for drug developers, who are financially or otherwise constrained, to be unwilling to spend time refining a manufacturing route. The logic behind this is that if a route is already safe and will provide a sufficiently early return on investment, then a next generation route is initially unnecessary. Consequently, the early focus is often on ensuring that an NCE can get to market as quickly as possible, but after this has been confirmed there is then scope for exploring how to improve the sustainability and profit margins of a route. Nonetheless, delaying the manufacturing route optimization may increase the risks of project difficulties in terms of material supply to feed clinical and other studies.
Any CRO that a drug developer chooses to partner with for PR&D must know how to time the range of activities that will ultimately secure the manufacture of the drug to meet research and commercial demands. This includes the development of any next generation routes that are required. Being able to effectively develop PR&D solutions for each phase of an NCE project requires a multitude of skills and experience. After all, PR&D is a balancing act of three key demands: speed, quality and cost, but also requires proficiency in risk management and communication. Good manufacturing is always founded on exemplary reaction understanding and process development. However, cost-effective risk management ultimately underpins the creation of phase-dependent solutions. Given that you will be investing a significant sum of money, it is imperative to know that your CRO will support you on your journey.
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