Drug developers routinely seek strategies and partnerships that can help bring drugs to market with shorter timelines. While most discussion of time reduction focuses on cost savings and competitiveness, the most important benefit of accelerating the commercialization of new drugs is the ability to bring life-changing and life-saving therapies into the hands of patients as soon as possible for maximum impact on their lives. Too much delay in bringing a drug to market not only extends timelines, it can reduce attention within the organization to the project, leading to a loss of funding and, ultimately, a failure to deliver the drug to patients.
Effective Partnerships Can Reduce Time to Market
In an increasingly fragmented pharmaceutical industry, in which many companies lack various in-house capabilities, one way to accelerate timelines is to strategically outsource certain steps in commercialization to a trusted expert. It is critical to select an outsourcing partner with specific strengths in needed areas that can be leveraged for efficient project management.
There are a number of considerations that companies must evaluate in choosing a strategic partner. Beyond possessing the required capabilities and capacity, a paramount consideration for anyone looking to outsource should be the qualities of the team itself. This includes its competency and the coordination among departments, including quality, legal and management, which reflects its ability to properly manage projects — a key to speed to market for any new product. Other often-overlooked factors include transparency, regulatory guidance and even something as simple as the chosen dosage form.
Choosing the Right Dosage Form
The choice of dosage form can significantly affect the speed at which life-saving therapies reach the market. For instance, two-piece hard-shell capsules present a number of advantages and considerable flexibility in terms of dosage control and the types of APIs that can be encapsulated. Hard capsules offer lower costs than other dosage forms, from both R&D and production perspectives, since the only required ingredients are the fill materials and the capsule shell. With none of the extra binders, coatings or other factors associated with solid dose tablets, two-piece hard capsules offer comparatively straightforward options to maximize revenue. Simultaneously determining your go-to-market dosage form and your marketed dosage look — including colors, logos and colored banding — can reduce the time it takes to get the drugs into the hands of patients.
The CapsCanada Difference
At CapsCanada, we can assure the quality of our products, which consistently run efficiently on capsule filling machines, reducing loss and maximizing margins. This is an especially critical benefit in early development stages, when access to a certain API may be limited. We provide critical services that can assist pharmaceutical companies with formulation: the ability to plan out a trial, perform a formulation test on the trial and determine whether it is viable with one of our dosage forms and, lastly, assessing its integrity within the capsule as well as its dissolution profile.
CapsCanada further supports our partners through our robust supply chain anchored by our dual manufacturing sites. These site options provide our customers with a secondary source from the same supplier, protecting them from any potential delays stemming from manufacturing issues. Finally, when a customer is ready to move their production back in-house, our technical services team works closely with their operators to optimize their in-house production.
We also offer a specific product — FM-CAPS® — designed to reduce time to market by addressing regulatory and design concerns simultaneously. Innovator pharmaceutical companies typically perform clinical trials and receive FDA approvals using clear capsules; after this, adding any colored dyes to the capsule to create a distinctive visual aesthetic will require FDA re-approval as an amended formulation — a process that can waste several months. Our FM-CAPS® contain all available dyes in a single capsule. When a drug is formulated and approved by the FDA using these capsules, a later decision on branding color can be made through dye subtraction rather than the addition of dyes, which eliminates the delay in resubmitting regulatory paperwork.
At CapsCanada, we understand the struggles that pharmaceutical and biotech companies face when trying to bring increasingly complex drugs to market as quickly as possible in a rigorous regulatory environment. Our experience working with pharmaceutical innovators for over 30 years, combined with our robust product offering, as well as our vertically integrated raw material supply chain and value-added services, provide the quality, reliability and expertise that our clients need to get critical therapies into the hands of the patients who need them the most.