Creating a Comprehensive Drug Development Strategy | Page 9

Other

Figure 8.

The Final Catch-All

The final area of strategic drug development is a catch-all for a range
of other activities integral to the process. Issues to consider include:
• Intellectual property. Has your compound been patented? What
about any novel processes used to create it? Do you need to license
any technology (e.g., slow-release tablet coatings, needleless injection
systems) to create the final dosing form?
• Reimbursement. Does your product advance the standard of care?
What data will be needed to convince payers that the drug is worth

Intellectual property
Patents,
novel processes,
licenses?

Reimbursement 
Is the drug
worth covering?
A
 t what price?

Marketing
Target audience?
Differentiators?
How will you market?

covering, and at what price? Do your projected sales cover the cost of
manufacturing the drug? What about the total development program?
• Marketing. Who is the target audience for your product (e.g., general
practitioners, oncologists, cardiologists, etc.)? Will you use direct-toconsumer marketing (where allowed)? How is your product different

Risk Evaluation and Mitigation Strategy
(REMS). Ensure the benefits of a
compound outweigh the risks.

from the competitors?

Conclusion
A comprehensive strategic drug development plan is a guide to achieving your end goal, whether that is selling your asset to a larger company
or bringing your product to market around the world. This living document evolves over time as more information about the compound becomes
available as a result of preclinical, nonclinical, and clinical research. It should also updated based on changes in science, regulatory requirements,
and the marketplace during the estimated 10 to 15 years it takes to get a drug from preclinical testing to approval.1
Creating a comprehensive drug development strategy is hard work that is likely to require ͥ