27/05/2022 | Press release | Archived content
Jenna Brager, PhD, RN, MS
Senior Executive Director of Regulatory Affairs for MyMD Pharmaceuticals, Inc.
As a biotech company progresses through the various stages of drug development and commercialization, understanding how its potential study drug brings value to the industry, stakeholders, and the overall strategic development plan needs to remain in the forefront.1 Considering a new indication for a drug program is not only exciting but also a significant undertaking. During the preliminary stages of consideration, a broad, high-level screening of opportunities should be performed to determine what has already been done in the specific therapeutic area as well as how the drug will be differentiated from treatments currently available.2 Here, the goal is to quickly eliminate or move away from opportunities that are not truly aligned with the drug development plan.
The following steps provide a guide to preparing for a new drug indication:
Before designing a new protocol in support of human clinical trials, one must understand the landscape in which the drug was previously tested clinically and pre-clinically (if possible).
For example:
Before moving forward with a new indication, the company must have a clear path in mind for the drug. It is important to understand the strengths and limitations of previously conducted trials and how current trial design has accounted for these lessons as necessary.
In addition to the information obtained above, it is important to focus on the published literature surrounding the therapeutic indication.
For example:
Exploring the literature will help the company understand how other drugs geared towards the indicated have performed in clinical settings and if various outcomes were achieved.
Communicating with experts in the field not only increases overall buy-in and confidence in the drug development plan, but also leads to potential partnerships (site identification, principal investigator identification, etc.) that is necessary to implement the clinical trial.
For example:
If the experts are excited about the potential of the new drug indication, the company is certainly on the right track. Partnering with experts in the field is essential to pushing the drug program forward. This strengthens the application to the Agency as it reiterates that the experts believe that the drug shows promise and is worth testing in a clinical trial setting.
Understanding the path previous drugs followed to come to market while also staying up to date with recent press releases surrounding other drugs in the area of interest will help guide one's drug program.
For example:
Recognizing where the FDA currently stands should be a primary factor in the company's plan to push a drug forward. This will help ensure that the company is most appropriately aligned with the Agency.
Summary
Gaining a thorough understanding of the landscape prior to initiating a new drug development program is essential to a company's success. Growing a strong knowledge base of the therapeutic indication requires evaluation of the cost of manufacturing (e.g. tablet, capsule, infusion), previous clinical trials (efficacy) and preclinical trials (toxicities), and understanding the most recent published literature. The company should communicate with current experts in the field, and review the regulatory pathways and the FDA's perspectives such as pediatric indications, Orphan Drug Designation, right to try legislation, and compassionate use criteria. Long-term considerations will include the need for Phase 4 post marketing clinical trials and specific FDA regulated safety monitoring programs. These are the key steps to performing due diligence for a new drug indication.
References
Dr. Jenna Brager, PhD, RN, MS, is the senior executive director of regulatory affairs at MyMD Pharmaceuticals. Prior to joining MyMD, Dr. Brager served as the Director of Clinical Research for LifeBridge Health and was a clinical investigator at Johns Hopkins Hospital. Dr. Brager received her B.S. in Nursing from the University of North Florida, graduating cum laude and received her Ph.D. from the Johns Hopkins University School of Nursing.
Dr. Brager welcomes comments, questions, and requests for future blog topics. Please email [email protected].