This is Part I of a 3-Part series detailing a product’s pathway from research & development (R&D) to clinical trials to manufacturing.
Over the past 60 years, vaccines helped eliminate smallpox and reduced the polio infection rate by 99%. (1) However, the cost of getting such a drug through the R&D phase alone is $1-2 billion, a 25% increase over just 5 years ago. Combined with decreasing return rates and a 10-15 year lapse between R&D and market, thousands of potentially great products have been led to the gallows. Following are some powerful ways to minimize R&D costs, which may increase your drug’s likelihood of making it to the consumer doorstep. (2)
Decrease Your Likelihood of Failure
Drug manufacturers can largely eliminate a product’s likelihood of failure by producing a generic, as opposed to brand name, product. 8 in 10 drugs currently on the market are generics, which have the same quality and performance as brand names. Although they contain the same active ingredients, generic drugs may contain different excipients and can be sold at such comparably low costs because they are produced at comparably lower costs. (3)
Incrementally Modify your Product
Manufacturing costs for new molecular entities (NMEs) are substantially higher than those of regular drugs that only require incremental modifications; estimates indicate that NMEs are nearly 75% more costly than non-NMEs. Additionally, NMEs always require clinical trials but non-NMEs, which comprise ⅔ of the pharmaceutical drug market, sometimes do not. These criteria combined point towards choosing incremental modifications of already existing drugs over an NME as a cost-efficient direction. (4)
Develop Industry Partnerships
Pharmaceutical corporations interested in conducting all of their R&D independently must swallow high costs to maintain operations. Possibly one of the easiest way to reduce R&D expenses is to partner with external industries that can streamline the research process with their own equipment and expertise. 10 powerhouse pharmaceutical companies- Pfizer, Johnson & Johnson, and AstraZeneca to name a few- recently signed an initiative intended to do just that. (5)
Use High Quality Equipment
The costs associated with laboratory equipment can be astronomical, especially if its regular use confers frequent replacement. Instead of purchasing a low-cost, low-quality product many times over, invest in a high-quality product that will last for years. The long-term monetary expenses associated with the latter are significantly lower.
For example, BEE International produces homogenizers and is trusted by pharmaceutical researchers and lab managers around the world. They deliver an array of key benefits, such as production of nano/micro emulsions and dispersions and lipids and suspensions, which must be synthesized during the R&D phase. These products can later be used for applications such as injectables, targeted drug delivery, inhalants, time release, anesthetics, and importantly, vaccinations.
In addition, BEEI has extensive experience in the challenges that our pharmaceutical customers face as they transition from concept, through to R&D, clinical trials, all-important FDA approval and finally, to manufacturing.
Learn more about BEEI’s high quality homogenizers by visiting http://www.beei.com/industry/pharmaceutical-process-equipment, and stay tuned for Parts 2 & 3 of this product manufacturing series!