In his three-blog series based on interviews with industry experts, Scott Hluhanich explores the state of pharmaceutical drug development.
In this first blog, Scott examines the market challenges and obstacles businesses face when trying to get to market faster.
A recent report from PwC, “From Vision to Decision Pharma 2020” summed up the current state of pharmaceutical market:
“The commercial environment is getting harsher. Healthcare payers are imposing new cost constraints on providers and are scrutinizing the value of medicines more carefully. They want new therapies that are clinically and economically better than the existing alternatives, together with hard, real-world outcomes data to back any claims about a medicine’s superiority.”
The additional time and expense required to support evidence-based therapies requires companies to shorten the R&D cycle. “People want to get to market faster,” says Scott Weiss, vice president of product strategy for IDBS.
The faster a drug can be created, the faster human trials can begin, the faster the product can be marketed, and the faster the investment can pay-off, both in lives saved and money made. For example, approvals of blockbuster drugs to treat hepatitis C show that sales of the first-to-market drug were $4B greater than sales of the second-to-market drug[i]; a 12-fold difference!
It is easy to say that “faster is better” but the process for developing new drugs takes years. The challenges are looming and large. As previously untreated diseases are investigated, more and more data is generated, and it is generated by a wider team of academics, start-ups, and CROs. At the same time, the complexity of the large molecule development process is increasing while regulatory agencies issue tighter guidance. Keeping track of data from research and development that could be useful at later stages is tricky, time consuming, and, in the distributed model of drug discovery, sometimes entirely impossible.
To address these challenges, pharmaceutical companies historically spend millions of dollars each year to build, buy, or maintain multiple systems, each with a different dedicated function including:
- Capturing the scientific narrative and IP (e.g. lab notebooks)
- Data analysis, curve fitting, statistics (e.g. Excel, GraphPad Prism, Sigmaplot, R)
- Sample, results, instrument management (e.g. LIMS)
- Collaboration (e.g. SharePoint, shared folders, “C Drives”)
The separate systems, however, don’t interact. They tend to proliferate as groups buy new systems without deprecating olds ones. And as the systems proliferate, so do the data silos that they were supposed to prevent.
Scott Weiss sums up the today’s industry well: “you have a lot more biotechs emerging on the market space and they need something that integrates all the different aspects of development as quickly as possible so they can focus on their core business.”
But as emerging companies, they may not always have the money to invest on database administrators or IT architects, he adds, and are in need of solutions off the shelf. “Those are the expectations that companies have,” Weiss says. “It’s less about lots and lots of different point solutions and more about bringing together platforms and systems that solve many of the problems off the shelf.”
Click here to read part two and part three of Scott Hluhanich’s blog series.
[i] “Gilead’s Hepatitis C Dominance Unchecked By AbbVie”, http://www.fool.com/investing/general/2015/07/30/gileads-hepatitis-c-dominance-unchecked-by-abbvie.aspx