Like An Intricate, Inscrutable Machine: Generics NPD

Imagine an intricate machine that needs several years to deliver. It has many parts. They are linked by gears and belts. Each moving part has its own motor. Such a machine needs to be well-designed, lubricated, and run to avoid screeching sounds, jamming, or breakdowns.?

Controlling the motors are people with their own priorities and constraints. They have their own dials and knobs. Of course, there is a Chief Engineer to oversee the machine’s run and guide the people. He will need really good synchronisation and meshing of all the moving parts to prevent accidents and logjams.

The entire idea-to-launch process of a generic drug is akin to our intricate machine, apparently as inscrutable.??

Within it, the product development phase that starts with a selected molecule and ends with a production-ready drug is also like the above intricate machine. It runs for several years and is expected to end with a production-ready drug well in time to achieve a ‘First-to-File’ pole position. The product development phase can get abandoned if recovery from breakdowns or logjams appears to be unlikely.

Therefore let’s dive into intricacies of product development and understand what we need to achieve synchronisation and meshing of multiple teams.

There are multiple goals.

The first goal is to develop the product exactly as per the specifications. The second is to finish the development in time. The timeline is crucial because any delay in readying a drug will adversely affect the ROI and the company’s market position. The third goal is to submit the dossier and obtain regulatory approval in time.?

Let’s assume that the R&D team is experienced and competent to handle all the technical work. But developing a drug needs much more than technical competence.:

Procurement of API and other raw materials

Active Pharmaceutical Ingredients (API) and other raw materials are long lead items. Also, their supply chains must be capable of scaling up from samples to pilots, to production quantities. Tasks like getting quotations, vendor approval, order placement, and quality compliance need to be coordinated with the sample preparation phase.

This phase is in the project’s critical path because without the APIs everything gets held up.

Sample preparation and testing

R & D’s formulations team prepares samples as per specifications. At the same time, its analytics team prepares test protocols for assay development, impurity analysis, and stability. It tests the samples to ascertain their conformance with the specifications.??

Several iterations may be required here.?

Every iteration has a time overhead therefore, tight project management that meshes the above activities together is crucial.

The above phases are followed by scientific review, pilot production, and scaling to up to say 100 , 100, and more pieces. The scaling up can only happen on the production floor and needs synchronising with production for availability of equipment and people. The supply chain also needs to perform and deliver higher numbers.

All the above need collaboration by various teams. Their collaboration needs transparency and real time visibility of all information. As I have explained several times in this PSA Insights newsletter, Modern PSA is best placed to enable collaboration.

Building the dossier? - don’t let it be below the radar.

The outcome of all the above phases is documentation. All test results must be accurately documented because these documents will be a part of the final dossier that will be submitted to the FDA.

It is a good practice to prepare and sign-off individual documents as and when the corresponding activities or tests are done. This ensures their correctness. The quality of documents needs to meet FDA requirements for accuracy and conformance to applicable standards.?

The R&D must deliver all required documents to the Regulatory Approvals team (RA) so that it can compile the dossier for regulatory approval in the shortest possible time.?

The goal is to get minimal queries and deficiency reports from regulatory authorities, because every query and deficiency will set the project back. Even minor defects cause delays.?

Like API procurement, dossier approval is on the project’s critical path. But unlike the API procurement, dossier preparation stays below the radar leading to delays which appear to be unexpected but they could have been prevented through strong project management.

Templatized document preparation, populating with data from various sources,? collaborative editing, version control, and active indexing are modern PSA’s unique capabilities.?

The above capabilities are absent in legacy project management or standalone document management systems.

To summarise, the drug development project’s deliverables are:

-Production-ready drug and GMP compliance

-Scaleable supply chain of API and other raw materials

-Comprehensive and high-quality dossier that gets regulatory nods from the FDA, EMA, WHO, etc.

Conclusion

The drug development phase is crucial for product’s performance in the market in line with the business case approved by company’s management. Modern PSA provides information and tools to achieve ‘ perfect meshing of all the moving parts ‘.

PSA’s real time snapshots and scenario building capabilities enable periodic review of drug development to assess if it is on track and what further actions are needed.

Kytes, a fully capable PSA, is your perfect ally in the ‘ First-to-File’ race. Please contact us at [email protected] for a demo and more information.