The recent rise of biotech promises more personalized, more precise, and more effective treatments for everything from rheumatoid arthritis to cancer. This $63 billion sector of the U.S. health care industry is one of the fastest growing segments, jumping nearly 37 percent from 2008 to 2012. And while the space offers new hope in the field of medicine, it also presents new challenges for manufacturers.
Competition among manufacturers is reaching a boiling point and the resulting race to market places a premium on effective and efficient regulatory compliance and validation.Validation in particular is crucial to ensuring patient safety and providing an invaluable check on manufacturers’ facilities in this increasingly regulated market. Validation is the process of examining the equipment and facilities used to produce medicines and medical devices -- in short, ensuring the 1 millionth pill off the line is just as effective and safe as the first. The validation staffing industry has changed considerably in the three decades since the Food and Drug Administration (FDA) mandated the practice. More recently a new generation of drugs and a health care market made more competitive by the Affordable Care Act have made top validation engineers and consultants more essential than ever to protecting patients, preserving reputations, and controlling costs. Here are four reasons why:
1. Ever-more sophisticated and valuable medicines.
Some biotech drugs, such as new cancer medications, are incredibly complex and expensive, especially new personalized medicines customized to specific patient needs. In this new environment, validation engineers are being called upon to deliver greater diligence and care in assuring equipment works repeatedly. “The growing specialization of medications means greater risks in validating the manufacturing process -- any errors could equal millions of dollars in unnecessary costs,” says Rick Kohlhepp, Executive Vice President and General Manager, Validation Services at Yoh. “When there’s more cost and complexity in the manufacturing, you need professionals with more nuanced understandings of efficient and effective validation approaches.”
2. Reputations can be ruined by a single dose.
The greater expense and intricacy involved in validating biotech drugs raise the stakes for manufacturers, which face an increasingly restrictive regulatory environment. “Your reputation walks out the door with your validation professionals,” says Kohlhepp. “You have to make sure you’re getting the highest quality talent that understands the complexity, cost, and consequences of effective validation.” Unfortunately the best professionals are often difficult to come by. “Even when they’re available,” adds Kohlhepp, “they’re often only available for a week or a week and a half at a time.” Partnering with an experienced validation talent provider can help deliver the right professionals exactly when they’re needed.
3. A surge in high-profile mergers and acquisitions.
The tight window for many validation engagements is more readily capitalized on by larger manufacturers, which employ vendor-neutral programs to augment their staff. They call upon dozens of companies to source specific expertise for a particular project. But with accelerating mergers and acquisitions among large pharma companies, few are opening new manufacturing plants that require a large-scale validation. Instead, more and more are looking for revalidation in smaller doses to ensure recently acquired, costly equipment will achieve the best patient outcomes. The revalidation process is critical to this transition phase, and one that should be handled by only the most experienced validation professionals.
4. Emerging manufacturers can’t miss a step.
Emerging pharma, biotech, and medical device manufacturers must compete with the larger, established players using far fewer resources, emphasizing the need to avoid costly errors and delays in bringing new products to market. Adding to the challenge, these emerging players are more often opening new facilities and installing new equipment that requires validation, but because of their size and infancy, don’t have the capacity to do so in-house. The fate of these emerging companies is even more closely tied to effective validation because they don’t have other products to fall back on and a single error could trigger their downfall. In these instances, a team of outside validation experts can efficiently vet the equipment and processes through project-based validation while avoiding unnecessary spend now, and later down the road.As medicines and medical devices grow more personalized and complex, validation professionals will grow increasingly vital to proving these treatments are produced safely and effectively for every patient. Mergers continue to drive more intense competition, in which the push to ready drugs for market mandates shorter timelines and tighter budgets. All of which underscores the importance of working with a partner that maintains a pool of top validation talent to ensure compliance, control costs, and promote more positive patient outcomes.