Lessons with a senior drug Substance consultant about drug development and CMC management

In this article, Senior Drug Substance Consultant James Mencel from DS InPharmatics offers information on his experience with CMC management and how the pharmaceutical industry has been impacted by expedited drug development programs.

The article will describe breakthrough designations, best practices and the regulations required regarding these programs.

Usually, a minimum of eight years is required for a novel drug to finish the journey to the marketplace from first discovery. It can take an average of five to seven years for Phase 3 trials alone. The expense of drug development is made greater as the process becomes longer.

There has recently been much-expedited activity, particularly in the smaller biopharma fields.

This delivers some novel difficulties for CMC that are on the border between phase two and phase three programs, despite the possibility of improving life-threatening conditions. By nature, fast-tracked CMC development programs vary from regular programs.

CMC and expedited development

The FDA’s primary aim is to offer lifesaving products to patients. The organization fully supports expedited drug development where there is a strong cause for it. The interest in this from the market is both business and scientific.

Aside from the breakthrough alone, accelerated strategies make getting to the initial in-human investigations and proof-of-concept to direct decisions on developability more efficient, and the development strategies later can attain faster commercialization and approval.

The advantages of accelerated CMC development should be balanced against the danger of insufficiently understanding the process and product. An aim of any CMC development program must be to guarantee the continual manufacture of an effective and safe commercial product.

The development speed does not change or minimize the content of the latest Drug Application (NDA/BLA) CMC Quality Modules. The extent and type of the CMC information anticipated at the time of NDA/BLA submission may be flexible in contrast to what can be submitted after approval or during BLA/NDA review.

The majority of this is dependent on process knowledge, the robustness of the control strategy, and product knowledge, along with the danger of negligible CMC data versus the advantages for the patient.

CMC development must be aligned with clinical development from the start. The existing process should be continually dependable and viable if the program is expedited and commercialized. A process must be able to provide all the required information for CMC submission.

Frequent meetings during the development can be used to schedule inspections, streamline paths for qualifying expression systems, and determine comparability across sites.

Better communication at the BLA review cycle can allow challenges to be solved faster and reach a consensus on what must be submitted after approval.

Expedition support

There are a number of techniques to accelerate drug development, but the majority of them result in restricted CMC timeframes. The FDA will not compromise in quality, although it understands that there is stress on CMC.

Instead, the FDA meets with sponsors more often than normal to assist them in moving through expedited development for the efficiency, suitability and quality of the drug product and substance.

Regulatory support is received by the expedition for development. The stress for CMC is continual, and eventually, the filing must be submitted, and the FDA has to approve.

Expedition procedures

Plenty of negotiation should be expected in the process. ICH determines processes for the testing, marketing and expedited development of novel treatments designed to help people with conditions that are life-threatening where there are no effective alternative treatments. There is no flexibility on accurate scientific techniques.

For example, a smaller degree of stability may be allowed by the FDA, but trustworthy data from earlier stages of development and the same chemical process on the equivalent site will be required.

For example, if the FDA was approached with a request to change locations, the agency will listen to the justification for the request to change from where the pivotal registration or clinical trial batches were made to the place where process validation will be performed.

A strategy must be in place that demonstrates consistency in the material produced in both locations. The FDA will predominantly only approve this in expedited development as they will appreciate a three or four-year window is not available.

In Phase Three, a one-year window is available to achieve everything that would be achieved in three years.

When to seek expedition

There is both scientific and business interest in expedition, as outlined before. One example is where an anti-cancer agent program is being developed, established on a model that has been proven to be essentially authenticated.

The majority of sponsors will contact the FDA for expedition prior to reaching phase one when a validated model, a molecule that targets it and a receptor site are in place. This usually occurs for discoveries that involve conditions that are challenging to treat.

A different acceleration journey can arise in the course of clinical development. If impressive data is received that demonstrates a therapeutic potential of substances for conditions that have no cure, the FDA would be keen to listen to the case.

Corporate organizations included in this must determine whether all the processes are ready because the data is made public at this phase. Success and traction will be expected. It will not be good for optics if the required infrastructure for the development is not in place.

In summary

The chemistry must be focused on in every stage of the journey. If expedition is being discussed, development personnel should be included, and all aspects must be perfected from the chemical process to data and testing because the existing process may be the commercial route.

Imperfections must be anticipated ahead of time as factors like particle size and polymorph cannot be altered after a certain stage. Prepare for all factors to perform as expected when the phase three trials occur.

Acknowledgments

Produced from materials originally authored by Meranda Parascandola from Design Space InPharmatics LLC.

About DS InPharmatics LLC

DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.

Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.


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Last updated: Mar 17, 2022 at 10:52 AM

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