CHALLENGING ROAD TRIPS FOR SMALL BIOTECHS
At small and emerging biotech companies, the challenges and risks involved in project management during early-phase development
can differ in both type and degree from those at major biotech companies. For example, smaller biotech companies often prefer
the selection of a CMO that they can work with through the entire process of a project, from Phase 1 through to commercial
production. Thus the selection of a CMO by the small biotech company is crucial to the success of the project. There are many
issues to consider and questions to ask before a final selection is made to be certain the CMO and the company are well suited.
These include how swiftly can the CMO move a project ahead? How effectively will the supplier handle the company's active
pharmaceutical ingredient? Is the CMO financially stable and flexible? Will the CMO understand the company's overall goals
beyond the project at hand? Is there a sense that the relationship will be trusting and collaborative? In many cases, the
smaller biotechnology companies are less experienced in many of the technical and regulatory issues that must be addressed
in bringing a new compound to the development phases and then to market. Because these problems tend to occur more often during
early-phase development, these companies may need to frequently update project specifications when unexpected roadblocks appear.
For many of the complex new compounds being developed today, there exists a significant risk that a project may be cancelled
at any point in the process. For these reasons, the depth of experience, capacity for innovation, and flexibility an experienced
CMO can bring to the smaller biotech company will lend vital support to the successful management of early-phase development.
For smaller biotech companies that typically lack the financial resources that larger companies bring to bear, the selection
of a CMO can make the difference between the success or failure of not just the project underway but, possibly, the very company
MANAGING THE TRAVEL BUDGET
The troubling financial situation over the last several years has resulted in tightened credit markets and the reduction in
the flow of necessary capital. Moreover, the enforcement of increasingly stricter licensing regulations that pose especially
high hurdles for small biotechnology firms, especially those lacking the internal expertise to address them, also has created
a more difficult environment. Today, small and emerging biotech companies feel particularly pressured to get a drug development
project underway and through the early phases as quickly as possible.
Often, because of their size and limited capabilities, the smaller company may only learn about the many problems surrounding
the early drug development process as they move forward. They also may be unaware of potential problems between the laboratory
and the market and their own limitations in addressing them. Small biotech companies with little experience in bringing a
product to market are less likely to have acquired the knowledge of how the development process works. In such cases, working
with a CMO that is willing and capable of adapting its support services to changing circumstances is essential.
A high-quality CMO can contribute critical consulting and production support to help manage the difficult procedures and decision-making
inherent in early-phase development. Together with a well-integrated project management team, a small company can maintain
its milestone schedule and keep a project on budget.
DECISIONS MADE ON THE ROAD
Another consideration is how important the size of a drug company is in determining decision-making processes. At smaller
biotech companies, the CEO may not have a scientific background. However, this function is central to the decision-making
process. Typically, large firms assign the decision-making process to contract management, purchasing, or outsourcing departments.
The small biotech CEO's central role and the personal nature of decision-making underline just how important it is for a CMO
and its customer to cultivate personal relationships and develop close partnerships among key staff members. Cultivating comprehensive
relationships that last beyond the fulfillment of the initial project is critical. A CMO that helps the customer's business
as a whole becomes more successful and will lead to huge payoffs in developing a productive partnership and an ongoing business
THE SUCCESSFUL TRIP REALIZED
Biotech project management is a complex issue, and many of the greatest challenges and risks come during the early phases
of drug development. However, moving from the early phases into Phase 3 and commercial production, companies will have a much
better shot at success with a well-integrated project management plan and team in place from the very outset. The key features
of the plan include:
- a deep appreciation of the small biotech's unique challenges, strengths and limitations, and decision-making processes
- a clear focus on sound project planning and management
- a consistent, hands-on approach in every phase of the project
- development of specific project tools for the planning and controlling phases
- thorough, accessible documentation at all points
- anticipation and quick response to emerging crises, problems and changing circumstances.
To summarize, CMOs that thoroughly understand and apply a carefully integrated project management plan can make a significant
difference in helping small biotech firms carry their compounds from early-phase development to Phase 3 and commercial production.
They can help you reach your destination safely and make the trip a successful one.
Peter Soelkner is managing director at Vetter Pharma International GmbH, Ravensburg, Germany, +49 (0)75137000, firstname.lastname@example.org