Thousands of chemical products are developed at lab benches annually. Many hold a glimmer of promise for both researcher and patient. The researcher hopes to see the product successfully through to manufacturing, and the patient hopes for a treatment that will enhance or extend their life. Of the products that move on to clinical trials, only 1 out of 8 will actually see manufacturing. Why is it so difficult for a pharmaceutical product to permeate the market, particularly in a field where people's’ lives depend on its success? Here we analyze common roadblocks along the route to manufacturing and ways to better approach them.
Research & Development
- Sky-high manufacturing costs of NMEs: New molecular entities (NMEs) require up to 75% more money input than generics or pre-existing drugs that require incremental modifications. NMEs also require clinical trials 100% of the time and have a high rate of failure, meaning that the financial payoff may never come. By choosing a lower-risk route, such as improving a non-NME or producing a generic drug, the odds of seeing financial return will be much higher. Additionally, you can develop industry partnerships to streamline the research process.
- High likelihood of failure: Tying in with the above point about manufacturing costs, NMEs comprise only ⅓ of the pharmaceutical drug market. This is largely because of their high rate of failure, whether in the R&D or clinical trial stage of drug development. There is unfortunately no cut-and-dry method to getting a NME to market; however, high quality equipment that is scalable to clinical trials and manufacturing will set you off on the right foot.
- Patient recruitment & retention: Also, the most costly aspect of clinical trials, patient recruitment and retention is a huge challenge that is difficult to overcome. Too many researchers operate under the assumption that patients will flock to their study, so choose not to market the study. Additionally, the budget allotted to patient recruitment is oftentimes far too low to see substantial results. To improve your recruitment efforts, use patient demographic information to assess the locations, age & socio-economic groups, and gender that you want to target. Additionally, the study site is the #1 determinant of patient participation. It is important to make a well-informed decision before plopping down somewhere.
- Scalability: Also known as the ability of a system or method to scale be translated to larger sample sizes, scalability is a significant challenge in the pharmaceutical industry. By failing to select scalable equipment in the R&D stage, by the time a drug reaches manufacturing, a technique that once worked will no longer achieve the same results. This costs researchers valuable time and money. The solution is simple, however. Many pharmaceutical equipment companies manufacture equipment that scales easily. For example, if you purchase a laboratory homogenizer from a company, if it is a scalable product, the same company’s pilot-plant and industrial homogenizers will also yield the same results.
Although the roadblocks associated with drug development are significant, so is the payoff if your drug makes it to the consumer medicine cabinet. Regardless of the product you are working on, it will need to prove its value in both safety and effectiveness to even get to the manufacturing stage of drug development. This can be accomplished by utilizing high quality equipment starting in the R&D phase.
Pion produces homogenizers that can yield a variety of relevant products, such as emulsions, suspensions, dispersions and lipids. Importantly, these products go on to make up the injectables, inhalants, anesthetics, and vaccinations that attain FDA approval for manufacturing.
Pion has extensive experience assisting its product users as they transition through the drug development process as our equipment scales with your application.