In 2016, the FDA approved less than 50% of drugs submitted for approval the previous year, highlighting significant hurdles in pharmaceutical development. This white paper delves into the reasons behind this low approval rate, offering insights into the latest cost models involved in taking a drug from discovery to patient.
Challenges Facing the Pharmaceutical Industry
The pharmaceutical industry is navigating complex obstacles, including escalating costs, stringent regulations, and extended timelines. With rising competition and ever-evolving market demands, pharmaceutical companies must optimize their processes to stay competitive.
Project Management in Pharma: A Closer Look
The pharmaceutical sector faces unique project management challenges that require specialized solutions. The development lifecycle—from discovery to R&D, clinical trials, and marketing—is fraught with risk and requires meticulous planning and execution. We explore how Project Portfolio Management (PPM) software plays a pivotal role in mitigating these challenges.
The Role of an EPMO (Enterprise Project Management Office)
A robust Enterprise Project Management Office (EPMO) can transform how pharmaceutical companies manage their portfolios. By establishing clear processes, standardizing operations, and improving visibility, the EPMO enables organizations to respond swiftly to changes, ensuring they stay on track toward delivering new products to market.
The Impact of PPM Software in Pharma
PPM software provides pharmaceutical project managers and senior leadership with real-time visibility, control, and insights into their drug development pipeline. By streamlining project tracking, communication, and risk management, PPM tools enhance decision-making, helping companies accelerate the time-to-market for life-saving drugs.
Conclusion
By adopting modern project management techniques and tools like PPM software and the strategic integration of an EPMO, pharmaceutical companies can overcome industry challenges and bring new products to market more efficiently, ensuring a competitive edge in the fast-paced healthcare sector.
Extract:
“Even though technology has changed the Pharmaceutical landscape forever, the scientific processes and methodologies are still understandably thoughtful, deliberate, and oftentimes slow. Speeding up research projects has dangerous consequences. Making scientists accountable for success-driven projects is also fraught with danger.
On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average. How do we, or should we increase scientific productivity? Pharma’s output level has remained more or less at a stable level for the past decade. And there is little reason to believe that this productivity will suddenly increase any time soon. Precision or personalized medicine, to get the right patient the right treatment at the right dose, the first time can potentially be addressed by technological advancements.
The harsh reality is that through increased consumer demand, shorter research and development lifecycles, and cut-throat competition, the pharmaceutical industry is moving faster than ever. Some would argue that pharmaceutical companies suffer from a legacy of “the old guard” style of management where the cultural environment can feel similar to the public sector. Massive organizations need to change and change fast if they are to survive. “
