What went wrong? Lack of planning, limited funds, poor communication, and unrealistic expectations are only some of the mistakes that were made before they even turned the key in the ignition. We think they are foolish and immature young people, and rightfully so. But how often do we hear of small biotech companies committing many of the same mistakes in their early-phase drug development business with stakes much higher than a failed road trip?
Planning for success in early-phase drug development is in many ways similar to the planning of a successful road trip. Positive outcomes depend on preplanning and critical decision-making as quickly and as accurately as possible. The high costs associated with the lack of planning can include the loss of valuable time and money, outright failure of the project, potentially serious damage to the reputation of the company, and in the worst-case scenario, business failure.In today's high-cost, highly competitive drug development environment, no biotech firm can afford to enter Phase 3 and commercial production without solid data gathered from early-phase development. Given today's complex regulatory environment and the limited financial resources at so many biotech companies, the pressure to develop new and profitable molecules is tremendous. Although many compounds are screened for their therapeutic potential, few prove suitable to move forward for clinical evaluation, while even fewer ever reach Phase 3 and commercialization.
Having in place a well-integrated project management strategy developed in concert with a contract manufacturing organization (CMO) is the key to allocating resources, creating a top-notch project management team, satisfying regulatory authorities, and advancing the compound to Phase 3, and then getting the drug to commercial production and finally to the patients who need it. For injectable products, often considered the most technically challenging and expensive drugs to develop, the project management process is especially vital to success. Today, the small biotech company that understands the value of an integrated project management strategy has taken the first big step in reducing a drug's time-to-market, optimizing costs, and increasing their return on investment.
Is your company ready for its road trip? Here's what you need to know.
DEVELOP A ROAD MAP
Like any well-planned trip, no compound should enter into early-stage development without a good road map. Plan your trip before you get behind the wheel.
What does the road map for an integrated project management strategy look like? Generally, it includes four phases:
In the present biotech business, each phase of the project is becoming more and more challenging, and risks, particularly financial risks, are increasing exponentially. Engaging a highly experienced CMO to help develop a project management strategy for drug development can be very helpful.