Once you have integrated the business plan and the commercialization plan, you should then dissect each major milestone and
assign appropriate time frames for the components of each. For example, achieving good clinical practice (GCP) is a major
milestone that must be sustained over the duration of the trial. Often, and especially with innovative biologics, the FDA
will investigate all aspects of clinical trial activities to ensure that GCPs have been installed and complied with. Be realistic
when estimating the time frames for the many activities that constitute each milestone. In achieving GCP, the manufacture
of clinical trial material (CTM) can be multi-faceted, complex, and often plagued by high variability. Similarly, the selection
of the contract research organization (CRO) at this stage can be time-consuming. If a sponsor elects to transfer the responsibility
of designing, conducting, and statistically analyzing an investigational trial, it is on them to begin the selection process
before filing the Investigational New Drug Application (IND). This process can take as long as four to five months before
the appropriate CRO is identified and enlisted.
With a fully integrated business plan and commercialization scheme set in a reasonable time frame, you can determine when
you will need people, funding, and infrastructure resources. As your business unfolds, the actual time consumed for any given
step may differ from your initial projections, requiring that you continue to iterate the plan and adjust it accordingly.
PREPARE FOR PRESSURE FROM STAKEHOLDERS
With a commitment to methodical growth, a clear understanding of core capabilities, and a time-sensitive, integrated business
and development plan, all the elements would seem to be in place for a stable, steady progress toward your goals without flaming
out or becoming a zombie. However, the best-laid plans are still susceptible to one potential source of disruption: investor
pressure. The differing investment needs at various stages of funding bring different kinds of stakeholders, with different
agendas and different goals, which can put unexpected pressures on your company.
For the typical academic researcher or entrepreneur who founds a biotech, the first stakeholder is the university in whose
lab the core concept was born. The university's technical transfer office may help the researcher put a discovery into patentable
form. However, it's important to consider how your decisions at this point may affect the business you hope to build around
the idea. If you are claiming the idea has utility in treating cancer, you won't be able to get the patent approved until
proof-of-concept. For a technology platform, the patent hurdles are often different and sometimes much lower. In any case,
the financial pressures at this stage are usually benign—the university will want to firm up the ownership of the intellectual
Once you begin to develop the business, the parade of stakeholders begins. Initially, you are likely to depend upon a financial
angel, typically an individual or a small group of investors, for the funding to get the company off the ground. Angels typically
choose to exit after the next several rounds of financing. For Series A and B funding, the investors are likely to be private
equity or specialty investment firms who want to oversee the company's initial growth spurt and cash out after taking the
company to the initial public offering (IPO) stage. These investors want control of the company's direction through board
seats and the appointment of key managers.
As the situation changes and a drug candidate looks promising, they are likely to try to push you into Phase 1 trials as rapidly
as possible and then have the company go public to execute an exit strategy for their investment. As they sell their stakes,
you again find yourself cash-poor and working with an entirely new slate of directors, who now represent ordinary stockholders.
These new owners will manage the company through the rough stages when disappointments can lead to dramatic drops in stock
price, making further raising of capital dilutive.
In the face of these constantly evolving pressures to alter the pace of development, maintaining your chosen course and speed
can be difficult. You will need to be able to educate each new group of stakeholders about the most likely path to success.
You must also be adept in dealing with your pre- and post-IPO boards. Fortunately, with a well-integrated business and development
plan, you will have the comprehensive view required to counter purely financially motivated pressures.