The Hidden Common Project Risks in the Life Sciences

While the pharmaceutical industry works toward recovery from the effects of the COVID-19 pandemic, companies in this sector continue to face project risk in many work areas. Even though the global pharmaceutical market is estimated to reach over $1.17 trillion by the end of 2021, heightened exposure to losses in clinical trial design and execution, drug approval, product quality, and global commercial practices can threaten that recovery and make it difficult for manufacturers to return to normal production levels under recent market conditions.

Here are five common project risks for life science companies to focus on when developing actionable, data-driven risk analysis and management over the next few years.

1. Disruptions in the Supply Chain

In the global economy, as a medication takes the journey from a manufacturing facility through wholesale to the patient, many risks are faced. Recent global crisis’s have further amplified these effects. The Suez Canal blockage in March of 2021 caused delays to commodities in Europe and Asia. The ripple effect of this caused a delay in raw materials and consumable components utilized in the manufacture of pharmaceutical materials. As consumable manufacturers faced this struggle, a backlog of much needed manufacturing resources became a larger risk. This impact was amplified with the prioritization of COVID-19 relief efforts. This has created a higher risk profile that would impact downstream activities such as release, delivery to hospitals, pharmacies, and ultimately patients. To add to this risk, there is an additional vulnerability with tampering, counterfeiting, and backwards engineering that a pharmaceutical company may face. These risks are faced by Commercial and Clinical products alike.

In recent years, pharmaceutical manufacturers and wholesale distributors have been tracking products more closely with:

• Additional component quantities maintained on hand
• Acceptance of additional costs for expedited orders and excess material orders
• Utilization of specialty shipping companies to better track, and insure against temperature excursions, delays, or other anomalies
• Serial numbers on all packages are required by the S. Drug Supply Chain Security Act
• Radio frequency identification (RFID) tags on individual bottles of medication

2. Moving Fast

In an industry marked by moving faster, delivering projects on time is more important than ever. Early phase clients face challenges associated with introducing a product to manufacturing, while commercialized products face the challenge of maintaining suppliers and reducing costs to increase revenue generation. Although moving fast is the industry standard, this becomes a risk because an unplanned event can cause detrimental impacts to organizations, such as a missed funding milestone, an agency hold placed on the study, or a backlog of supply. How can an organization adapt to these challenges? FlexPro Project Managers know the best way to navigate these challenges, by identifying contingency plans, assessing potential impacts via what-if scenarios and identifying consequential risks.

• Recognize that moving fast in and of itself is a risk
• Identify when and where recoveries and efficiencies can be gained through concurrent work streams

3. Drug Development is Hard

Clinical and pre-clinical phase activities are difficult. Phase I to new drug applications (NDAs) have an 86% attrition rate, with late-stage trial failures. Small pharmaceutical organizations may have stage-gate related funding, in which achieving the next milestone is critical to continuing business. Analytical development, stability program management, and clinical supply are crucial in continuing forward with any development program. A failure in any of these stages can have dire consequences. Understanding how each of these complex project stages interlinks to support the overarching goals is critical to success.

• Stability programs need to be planned early to support any filing
  • A contingency plan for a stability program can alleviate the heartache of an early ending program, keeping the clinic supplied
• Analytical method transfers can have risk mitigated by person-in-plant, Subject-Matter-Expert discussions, and video walkthroughs
• Thinking long-term about clinical design and supply requirements reduces the risk of material shortages and allows a better understanding of costs associated for Fiscal Years.

4. Pharmaceutical Fraud

Pharmaceutical fraud is an ever-present risk that can impact all aspects of the business. A fraud case in any segment of the production workstream can lead to a costly recall. Pharmaceutical fraud can involve: Off-label claims, current Good Manufacturing Practice violations, or unethical sales practices — all leading to delays, cost overruns, or government agency warnings. Understanding these risks, and looking to mitigate them early, can ultimately save time and money.

Mitigation techniques can include:

• Due diligence of any partner Contract Manufacturing Organizations or Contract Test Labs
• Professional third party assistance for reviews
• Training for all members of staff on cGMP, ethical sales, and why it matters.

5. Poor Pharmaceutical Project Management

Good pharma project management involves finding a qualified project manager who’s highly experienced in the pharmaceutical industry with the technical qualifications to understand the real-time complexity of pharmaceutical projects. Because pharma projects have unique needs with unique project risks, candidates with general project management experience will likely perform poorly. In addition to good communication skills and project management certification, pharma project managers should focus on areas that are critical to pharmaceutical projects, including risk management and mitigation.

Industry-Certified Project Management With FlexPro

FlexPro offers a wide range of world-class project management services that incorporate industry-certified best practices into comprehensive and carefully developed leadership processes, including expert knowledge of GMPs and mitigation of common project risks in the pharma industry. Precise execution of your strategy is our top priority to help you reach your goal.

Contact us today to discuss your project and how we can help.

Written Kevin Campomizzi, Senior Project Manager at The FlexPro Group.