Pharma companies need to pivot faster due to increased pressures from new entries into the drug discovery space, new supply chain models, while maintaining compliant to regulatory requirements. Digital is the backbone of modernizing the pharmaceutical regulation.
Current trends & challenges
- Convergence of medicine and diagnostic
Biotech and infotech has broadened the detection and treatment of diseases. Personalized medicine is a reality. Targeted drug delivery mechanisms for specific diagnostics are now possible as the cost of profiling genome is becoming a commodity. The trajectory is faster discovery, faster detection, and improved efficacy.
- Entries to drug discovery
The days of only big companies are involved in drug discovery is a thing of the past. Supported by venture capitalist money, Biotech has exploded into the drug discovery game. As these companies pass clinical trials the need for an ERP eco-system that is ready for market and commercialization is a necessity.
- Mergers and Acquisitions
The M&A Model is a strong business strategy for large companies. As more start-ups and innovation enter the marketplace, companies continue to look for targets to add to their portfolio.
- Pressure from generics companies
The Life Sciences industry is exposed to major patent expiries of traditional blockbusters, with insufficient replacements in the pipeline. New Rx products must be measurably better than branded and generic products
- Supply Chain Model
Companies are no longer investing in their own manufacturing facilities. Contract manufacturing are purchasing sites and capabilities and leveraging their scalability to bring down cost. The planning and communication of supply and demand becomes more important than ever!
How we address them
- PMO & Implementation
Due to the changing business models, the need to pivot faster and with quality becomes more important than ever. Programs that drag on means more sunk cost and less investment into the heart of the business, drug discovery. We bring to the table the right level of agile for the transformation with an oversight of end-to-end program management. Throughout the implementation, we are by your side and bring in the right level of resources for your success.
Regulatory requirements do not disappear with the new business model. In fact, without the right validation strategy, programs get delayed, mostly due to rework. We have bailed out complex validation challenges with tight deadlines so that it can advance to the next stage of build or testing.
- Application Rationalization
Digital transformation requires expertise in application rationalization. Either getting from the “as-is” to the “to-be” or as in the case of start-up building the new ERP eco-system. We are here to help you strategize and make it into something tangible and not just an idea on a piece of napkin.
- Data Management
The heart of digital transformation is “data.” It is also the least sexy and often overlooked. We have been asked to lead or supplement when a crisis hits. We have also led the data clean-up and migration for Mergers and Acquisitions. We are no strangers in this space.