Finish as ‘First-to-File’ in Pharma Generics’ Launch Race -Part 2

In the previous edition, we saw that new product development projects to launch generics drugs involve unique external and internal hurdles. Generics NPD projects are fraught with technical, supply chain, regulatory challenges. You need specialized human resources, equipment, and materials to finish such projects successfully.?

NPD projects meander over two to three years through various phases of idea-to-launch. Activities get missed, outcomes remain untested, delays happen and their ill-effects cascade during their execution.?

Let’s take a closer look at the hurdles.?

NPD projects need the waterfall project planning and execution methodology.?

Sequential phases like development, sample preparation, or clinical trials may need iterations. API procurement may take longer.??

Ensuring that a thousand page product dossier for regulatory approvals is complete and accurate is a big challenge. If any mistake or missout occurring early in a project gets detected after filing the dossier, it will need resubmission and extra time and cost.?

Generics NPD projects test everyone’s patience. It is easy to lose track of risk factors identified initially, as new risks emerge.?

Not finding the right people and equipment resources at the right time is a common problem. Also, the dependence on vendors and contractors can introduce uncertainties in timelines and regulatory compliance.

Experienced hands in pharma companies know all the above hurdles first-hand.? But they are constrained by their legacy methods.?

Legacy tools multiply the severity of challenges.

Missing accurate snapshots

The risks in generic drug NPD projects become unmanageable because of the traditional methods of emails and spreadsheets. The standalone systems for managing human resources, procurements, financials, and project planning make it impossible to get an instantaneous snapshot of a project showing its overdue activities, current, and projected costs.?

Potential bottlenecks

To anticipate structural delays, skills or equipment shortage, it is necessary to drill down to loading of resources and various dependencies. Risks multiply due to inability to discover potential bottlenecks.

Lost learnings

Another important but below-the-radar problem with the legacy tools is that organisations keep repeating their mistakes. Templates, checklists, and table of contents don’t get updated. Accumulated experience is lost when people leave. Even if experienced people are available, it is a well known fact that human minds are not good at keeping track of a large number of activities.

The invisible elephant in the room

The making of a thousand page dossier is an elephant in the room which remains invisible until it is late. Unlike sample preparation or API procurement, the work on the dossier has no immediate dependencies. Delays or errors don’t show up until the time of its submission. At times, the deficiencies in the documentation become apparent only after the regulator points them out.

Poor visibility

Legacy systems can’t give you real time visibility, therefore it is very difficult to bring everyone on the same page - a prerequisite for cross functional collaboration.

Inefficient interfaces and broken processes

NPD project cycles start with strategy formulation, they thread through many stages to end with assessment of market performance. Processes get disturbed at every interpersonal, interdepartmental interface because the interfacing needs spreadsheets and emails. Spreadsheets versions and email threads make everything intractable.

Pharma companies need a modern solution that powers their race to ‘ first-to-file’ finish, instead of hindering it. Technology makes it possible.

Professional Services Automation (PSA) software solutions for project organisations? came into existence to overcome shortcomings of standard solutions like the ERP which were created for pure products businesses. PSA provides a platform for integrating various standalone software like HRMS, ERP, etc. and creating seamless workflows across departments. PSA provides the means to capture and disseminate validated information across departments.?

Modern PSA’s open-to-configure architecture and no code \ low code technology lets industry-standard workflows and dashboards be created, yet let them be configured as needed.

Modern PSA’s features for the generics NPD projects

Templates and processes

PSA provides templates and processes for all stages of NPD projects -from strategy formulation to performance of news drugs in markets. Here are a few examples.

NPD idea list

A typical screen shows and lets you edit ideas for new drugs and their details like names, types, therapeutic category, dosage form, budgets, management approval status, etc. It has an idea approval workflow.

NPD budget

You can construct NPD’s budget. You can drill down the NPD idea list to detail a specific drug’s detailed budget showing costs of materials and people, equipment needs etc.?

Business case preparation and evaluation

PSA has workflows for preparing sales forecasts and estimating cost of goods and expected ROI. It compares all product ideas on the same screen for management decision making.

Project planning & execution

PSA lets you plan your NPD projects using the waterfall method and support visualization of progress and changes made using interactive Gantt charts. The project management screen shows you a project’s critical path. The plan is dynamically adjusted as per evolving situation. PSA lets you find current costs and estimate expected costs and timelines.?

A comprehensive email and notification system lets you work without interruptions - you don’t have to leave your current flow.?

Sample preparation and inventory management activities are inbuilt.

PSA’s mobile app lets you get updates and act on urgent tasks.

Rigorous risk appraisal and mitigation

PSA keeps updating a project’s risk profile depending on your actions. It flags overdue actions.?

Dossier management

PSA lets you manage dossier preparation, review, and updation work. It maintains a structured and live table of contents and an index of all documents. You can see the status of all documents - yet to be made, ready, and in progress. It provides workflows for document initiation, submission dates, and agent details. The workflows support? document writing work. Selectable templates and data pulled from PSA’s repositories speed up document writing.?

There is a dedicated screen for compiling the final dossier.

There is a subsystem for tracking and managing queries by authorities.

Launch and product performance

PSA has worksheets for planning product launch, capturing sales, and analyzing product’s performance in the market.

Modern PSA’s workflows take full advantage of AI technology.

Conclusion

An advanced PSA, like the above, is best placed to power your? 'First-to-File’ race because of its open low code \ no code modular platform. By digitalizing the idea-to-market NPD project cycles, the PSA brings transparency, visibility, collaborative and learning work culture, speed, and efficiency to Pharma NPD projects.

Kytes, powered by AI, is an advanced PSA that brings you all the above benefits and more.?

Please contact us at [email protected] for a demo and more information.