Getting Off The Blocks In ‘First-to-File Race: The Business Case

We studied molecules and other particles in college. We know that these tiny entities are important in many ways. But our knowledge is vague and abstract. For? pharma generics companies, however, selecting the right molecule is a matter of success or failure.

In pharma parlance, ‘ a molecule’ refers to the substance that has the healing properties. Many brands can have the same molecule that has therapeutic properties. For example, Crocin, Tylenol, and Calpol contain the same molecule : Paracetamol. The development of the above medicines started with selecting the ‘ molecule ‘Paracetamol.

The ‘ First-to-File ‘ race among pharma companies starts with selecting a molecule that fits in their respective business strategies. Molecule selection greatly influences a company’s growth and sustained profitability. Therefore let’s understand molecule selection in a bit more detail.?

The molecule selection phase makes unique demands on the project management of NPD - the demands that legacy enterprise software can’t meet. A modern PSA illustrates how end-to-end digitalization technology helps in meeting the demands. Let’s take the case of Pharma Generics Ltd. (PGL), a fictitious company.

Candidate molecules and business case preparation

PGL’s business development team has on its radar molecules that will go off-patent in future. From 100s of such molecules the BD team narrows down to 4 or 5 candidates. Each of the short-listed candidates must be studied from techno-legal-commercial angles before selecting one of them for product development.

The business case of each candidate captures details of the original innovator product like its dosage form and strength, recommended dose, appearance, storage requirements, therapy area, and packaging. Its proposed manufacturing location and market geographies have regulatory implications. A product to be manufactured in India and marketed in the US must meet standards laid down by the US and Indian FDA.?

The BD team then proposes details of the proposed product - dosage form, strength, packaging etc.

Cross-functional evaluation

Teams from various departments assess the product.

- Market/Business Development provides market size data

- Legal assesses patent risks

- R&D evaluates technical feasibility

- Manufacturing assesses production capabilities, costs, investments etc.

- Supply Chain team analyzes ingredient sourcing

- Quality Control identifies any testing challenges

- Regulatory Affairs considers dossier filing challenges

The BD team obtains all the above inputs and prepares revenue forecasts based on market size, projections, and competitor data. It calculates costs, transfer prices to distributors and arrive at profitability metrics like ROI and NPV. The BD team thus prepares a comprehensive business case for each of the candidate molecules.

Management decision

PGL’s management evaluates all the business cases and chooses the one that is the best strategic fit and approves budgets kicking off the product development phase.

The process of molecule selection

The workflows for the above vary from company to company, but basics remain the same. The process seems logical and well structured on paper. But the reality is quite different - especially in Indian companies of visionary founders.?

Founder-Entrepreneurs skillfully work out many aspects in their minds using their insights and intuition. However, having a formal process improves chances of selecting the right molecule.

You don’t have to be an expert or a pharma insider to know that all the above involves capturing multi-faceted information from different teams and sources. It is easy to see that legacy enterprise software and project management systems can’t cope with capturing, processing, and discussing the rich information sets.?

Companies therefore use a plethora of spreadsheets to bridge the above chasms left open by legacy software. It is very difficult to get everyone on the same page. Cross-functional collaboration is next to impossible.

Remember our fictional multi-year ultra relay race in Finish as First-to-File in Pharma Generics Launch ? that needs multiple internal teams to be present for valid baton passing? Doesn’t the molecule selection resemble the fictional race?

Digitize the molecule selection.

A modern PSA with its open-to-interface and modular architecture and no code \ low code implementation is best suited to digitize the above molecule selection process.

Digitizing the above process removes multiple data versions and eliminates re-entering of information, errors, and its obsolescence. Digitizing brings transparency and instant visibility. It enables cross-functional collaboration.

Since PSA maintains data connections with HRMS, inventory, costing, and accounting it is speedier to make reliable forecasts of resources.

In essence, digitizing improves the chances of selecting the right molecule.

Phases coming next and things to watching out for

Business case preparation isn’t a one-off exercise. During the course of product development a company PGL needs to periodically reassess the business logic of molecule selection and product development. Changed circumstances or internal failures may render a new product unviable. It is better to watch out for such developments.

Modern PSA, a valuable ally

Whether it is periodic evaluation of product portfolio or product development phase, modern PSA is a valuable ally. I shall examine the challenges in the product development phase that lasts for 2 or 3 years and their solution in forthcoming editions of PSA insights.

Kytes, an advanced PSA, brings all the necessary technologies together. Kytes handles all the above demands with aplomb.?

Kytes helps you confidently get off-the-blocks in your ‘ First-to-File’ race.?

For more information and a demo, please contact us at [email protected]