Recently, a friend of mine shared with me a story about his daughter and how she and her three college friends managed to
turn what should have been a wonderful spring break vacation into a miserable two-week trip that all of them would rather
forget. It seems they had decided to take a "leisurely drive" from their college in Washington State to visit another friend
in California, stopping along the way to visit mutual friends and enjoy the scenery. Their excitement and enthusiasm was short-lived,
however, and the trip resulted in them getting lost numerous times, mechanical failures and breakdowns, sleeping in the car
most nights, bad food, missed meetings with friends, and strained relationships among the passengers. In fact, two of the
girls do not speak to each other to this day.
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:
- initiation: objectives, project scope, and deliverables are defined, and the project team is put together
- planning and coordination: a plan is designed that outlines tasks and individual responsibilities; potential risks and means
to address them
- controlling: the project itself is executed, and any potential problems are quickly addressed and eliminated
- closing: at the end of the project, lessons learned are documented, reported, and applied to current and future projects.
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.