FierceBiotech has previously explored the top 10 mistakes biotechs make, covering a broad range of issues from securing IP to plotting an exit strategy. Now we're taking a closer look at R&D pitfalls that many small companies encounter, and what your company can do to avoid these common mistakes.
Laurie Halloran (pictured) is the founder of Halloran Consulting, a Massachusetts-based firm that helps biotechs, pharmas and medical device companies use smarter approaches to clinical trial management. The group provides expertise for start-up companies that need help efficiently developing products, saving time and money throughout the clinical trial process. The work has made Halloran an expert on recognizing R&D hazards and helping her clients avoid common development errors. Here are her thoughts.
1. Poor planning
Halloran says the primary mistakes companies make revolve around their failure to think ahead and plan their development strategies for maximum efficiency. Many CEOs assume that if they've raised money, their company is in good shape. "What I see more is a lot of investors saying, 'you've raised the money, how are you going to spend it wisely without slowing development down?'"
The problem is many drug developers don't know what it means to spend money wisely. This is often the case when it comes to managing relationships with vendors. While it may be necessary to outsource some of your development, it doesn't guarantee you're getting the best value for your money. Employing a CRO doesn't ensure smooth sailing. Yet many execs simply follow the vendor's advice without asking questions. "CROs make money by adding more services rather than thinking the process through, then doing it the best way," she explains. Project managers, who usually manage multiple jobs, may not always be around to answer questions or deal with problems. If you're working with a CRO, be sure to ask why they recommend you do certain things.
Additionally, bringing in experts--be it CROs, labs, technology providers, statisticians, local regulatory experts for filing, etc.--can cause more problems than it solves if their efforts aren't properly managed. "The best intentions of getting the 'experts' in each of the disciplines without any type of coordination and direction from the sponsor side ends up leaving your trial in the hands of multiple vendors who play 'ping pong' with roles and responsibilities," says Halloran. "The sponsor is stuck in the middle not knowing which end is up.
2. Emotional attachment to a program
It's not unusual for employees at small companies to become emotionally attached to their product. "I see it with founders and inexperienced managers who have put their whole lives into a particular molecule," notes Halloran. To them the drug candidate represents the life and death of a company, and they expect contractors to treat their program with the same reverence they do.
Don't assume everyone will put your program first. Your company will always be more dedicated to its own development program than an outside contractor. On the other hand, it's vital to get much-needed objective advice from an outside expert. Stay dedicated to your program, but don't become blind when everyone is telling you it's time to let go.