In both the generic and innovator pharmaceutical API production sectors, time-to-market is a critical factor.
How critical? A one-day delay in reaching the market could mean the loss of $1 million.
Because of this, from a risk-analysis standpoint time- or speed-to-market may be the decisive factor when it comes to pursuing a product or candidate. And it continues to become even more important as the costs for drug development have soared.
Beyond just cost, time to market is also an issue of global dimension. Earlier this year, China began considering measures to shorten time to market for approved imported drugs in an effort to ease a shortage of such medicines.
As noted at American Pharmaceutical Review:
“Speed — specifically, speed-to-market — has been and remains the key to success. In order to achieve fastest time-to-market, one must have reliable access to cGMP process capacity, when and where it is needed. A product’s success depends on a rapid transition to market, which is why achieving full-scale production in less time has many benefits, such as extended patent protection for approved drugs. Likewise, penetrating new markets before the competition can produce a profound and lasting advantage. Manufacturing capability, once perceived as a time-consuming obstacle to initial market penetration, now determines success more than ever before.”
Controlling the Risk of Market Entry Delays
Fortunately, there are steps drug manufacturers typically take to help reduce the risk of market entry delays. While the risk cannot be completely eliminated, the use of certain Best Practices can decrease their likelihood.
- The ‘File First’ Principle & Paragraph IV
First-to-file is (and has been, for quite a while) the key lynchpin strategy for maintaining higher profit margins among drug innovator companies. But generic pharmaceutical companies are also benefiting from being first to file. Using paragraph IV certification, being first to market when a patent expires can be a key competitive advantage.Paragraph IV certification is the newest tool for ensuring a first-to-file status (and some hefty marketing exclusivity benefits) for generic drug makers. Eric Guttag, in his Primer on paragraph IV Certifications at IPWatchDog, writes:
“Briefly, in making a Paragraph IV Certification, the generic drug maker says the patent is at least one of the following: (1) invalid; (2) not infringed; or (3) unenforceable. That’s the Reader’s Digest version on the requirements for a Paragraph IV Certification; after that, the story gets much more complicated and adversarial.”
It’s fair to say that Paragraph IV certifications offer opportunity, but also some risks. As Guttag mentions, it is – in fact – a complex issue, and pharma companies risk losing the first-to-file advantages of Paragraph IV if clinical and manufacturing timelines are not met.
- Clinical & Manufacturing: Downstream Consequences
Today, drug development takes an average of about 5 years – and the clinical and CMC areas are the major contributors towards the time and cost of development. Given that CMC is well-upstream of a marketed product, it can have a substantial impact on getting to market in a timely manner.In the API manufacturing realm, any delays in producing the API can have downstream consequences – potentially delaying follow-on clinical or production steps. According to the FDA’s Office of New Drugs 2016 Annual Report: “Failures in the manufacturing supply chain played a major role in the drop in new drug approvals…Pharmaceutical manufacturers are in urgent need of better project management practices that will improve agility.”
- Breaking Silos and Focusing on Flexibility & Responsiveness
Breaking silos and sharing knowledge demands streamlined data management and well-defined workflows – coupled with a constant focus on regulatory compliance. And while both regulatory and CMC are critical to project management, it’s the overall coordination of all departments that is the ultimate objective. Bringing together functions such R&D, marketing, manufacturing, regulatory, legal, and others in a system of open, transparent communication makes a company more agile, and maximizes its ability to avoid unseen challenges.
- Flexibility & Leveraging Data in Real-Time
Being responsive demands accurate planning, driven by data sharing in real-time so teams can make more-informed decisions, faster. It also allows for a greater degree of flexibility and adaptability. And flexibility matters: “In a survey conducted at a recent ISPE meeting, pharmaceutical executives indicated that flexibility was the most important characteristic of future manufacturing operations.”
With rising drug development and commercialization costs, the smallest delays in getting to market can have large financial repercussions. Companies need to adopt strategies that minimize and control the risks to enhance speed-to-market.