90% of clinical trials fail. That statistic has been passed around so often that it no longer raises eyebrows in our industry, but we believe it should. Frankly, we find this statistic both unacceptable and unnecessary.
To be clear, the path to druggability will never be entirely without risk. But as an elite CDMO that focuses entirely on formulation development and clinical trial supply manufacturing of oral solid dosage (OSD) products, we know that many of these failures are entirely preventable with the help of solid science. In this blog, we’ll briefly explore a few common misconceptions and habits that contribute to failures and how a savvy drug developer can avoid them.
Focusing Only on Active Pharmaceutical Ingredients
We frequently engage with large pharmaceutical companies when they are considering acquisitions or collaborations with biotech companies for drugs approaching commercialization. What they tell us — over and over again — is shocking:
98% of biotechs don’t have a solid understanding of proper formulation development.
Too many exceptionally bright and well-educated biotech executives will assume that a dosage unit (e.g. a pill, capsule, or tablet) is little more than its active pharmaceutical ingredient (API) and that the excipients, packaging, and manufacturing processes are relatively unimportant. To be fair, these assumptions can also be found among seasoned professionals such as pharmacists, medicinal chemists, and MDs.
Unfortunately, focusing exclusively on APIs can present challenges for biotech companies as they transition from the formulation phase to the manufacturing of clinical trial materials for Phase II studies. This phase is critical, as it may be the point when large pharmaceutical companies begin to take an interest in a drug product and significant financial stakes will come into play.
A Lack of Clarity Around Forced Degradation Studies and Drug Stability Testing
The specific design and extent of stability and forced degradation studies will vary depending on the chemical structure of the drug substance, the type of drug product, and any product-specific storage requirements. Therefore, it’s very difficult for regulatory agencies to provide specific guidance for each drug.
Neither of these processes should be performed perfunctorily, as they play a critical role in providing formulators and manufacturers with necessary insights into the processes and additional ingredients required to increase the likelihood of a project’s success. This is exactly where a specialist’s expertise — or lack thereof — can make or break a novel therapy.
Not Understanding the Role of Formulation Development Services
Most blogs of this type often emphasize the challenges certain API properties can pose to formulation. However, with advancements in pharmaceutical science, many of these characteristics are no longer “roadblocks”. Only 10-15% of drug development failures can be attributed to an API’s suboptimal drug-like properties. Now, these characteristics are merely additional factors for scientists to consider when recommending a development plan. That’s why conducting a druggability study of your API is now an essential step in this process.
Failure To Match Clinical Trial Supplies With Your Protocol
For example, if you are conducting a double-blind study, your placebo must not only match the investigational drug visually but also in terms of taste, mouthfeel, and any detectable effects experienced by the patient. The goal is for both the healthcare staff and the patients to be unable to distinguish the placebo from the study drug during treatment.
Unfortunately, some drug developers invest substantial time and resources into clinical trials that may ultimately fail due to the oversight of a small but very important detail.
If there is one aspect of our industry we could improve, it would be fostering a broader understanding of the significant value a CDMO can contribute to the drug development process. However, the value you receive depends a great deal on the CDMO you choose to partner with.
How an Elite CDMO Can Increase Success Rates
No CDMO will advertise that it is unreliable, frequently late, and incapable of delivering on its promises. However, such companies exist, and if you consistently choose the lowest-cost option, chances are you have worked with a few of them.
We’re proud to say that over our 20-year history, we have earned an excellent reputation with pharmaceutical auditors. With over 800 successfully completed studies, we are recognized for standing by our commitments and providing high-quality documentation and products. When executives from large pharmaceutical companies review our work, they know it is reliable and trustworthy. This reputation is certainly good for us, but it is even more advantageous for our clients who ultimately seek to realize a strong return on their drug product.
As a specialized CDMO focused on OSD products from pre-formulation through clinical trial supply manufacturing, we recognize that we are a niche player in a vast industry. However, this is by design. Our lean structure allows us to pivot quickly and ensures that every client receives the full attention of our A-team because we simply don’t have a B-team. Leveraging our highly specialized expertise, we enhance the odds of successful OSD drug development, beginning with pre-formulation.
Getting a Complimentary Druggability Assessment
Poor formulation and clinical supply manufacturing choices often jeopardize projects before they even begin. We are working to change that.
If you have an API that you feel has potential as an OSD project, we are happy to provide a thorough Druggability Assessment — including a full API characterization to understand your API’s chemical and physical properties. To get started, we require an NDA, a small amount of your API, and a clear understanding of your therapeutic application, the targeted patient profile, and the dosage regimen.
Your Druggability Assessment report will include detailed data, a comprehensive formulation development plan, budget estimation, and timelines based on your risk tolerance. Whether you choose to execute your formulation development plan with us or not, you will have the information you need to move forward with confidence.
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