By John Russell
February 10, 2010 | Given the massive effort required to win regulatory approval for a new drug it is easy to understand the euphoria surrounding agency approval following an NDA submission and perhaps to forgive the sense that the hard work is over. But for internal ‘regulatory affairs’ teams the work not only continues but intensifies. Ensuring compliance with post-marketing requirements is a daunting task for even one approved drug, let alone a portfolio of many.
Whippany, NJ–based ISI, long a leader in submission software and consultancy services, has for the past few years also pushed into post-marketing services and tools. “The problem is there is all this information about what products are registered, for which markets, what the details for manufacturing are, etc.,” says Kate Wilber, director of regulatory services at ISI, “and pharma companies are really having trouble pulling it all together. It’s all a question of having theses little bits and pieces of information that are all part of the license approval.”
For the regulatory affairs function inside biopharma the failure to have needed information can delay critical decisions, draw regulator agency ire, and harm the company and patients. J&J’s recent massive recall of several products late in 2009 is a case in point. The problem turned out to be a chemical in pallets on which products were stored at a particular manufacturing facility that was contaminating products.
FDA sharply criticized J&J for its relative slowness to act but J&J is just the most recent and visible pharma having trouble dealing with a post-marketing problem. The practical truth, says Wilber, is few drug companies – big or small – have adequate post-marketing tracking systems. “Very few companies have an overview of that essential information in one place for all of their products,” she says.
There are lots of homegrown solutions of varying degrees of sophistication; often solutions tracking one product don’t link to systems tracking other products to provide decision makers with a comprehensive overview. “You might have a different spreadsheet for each of your sites,” says Wilber. Often in homegrown systems, “we’re seeing that they do not necessarily have accurate data.”
Commercials tools have been around for some time, and deployed properly, they can help drug companies not only respond to problems but also evaluate portfolios to drive business goals. ISI offers RegTracker, an Oracle-based software package whose newest release, version 4.2, is scheduled for April. Like similar products, it is highly configurable. Wilber says RegTracker’s reporting features are especially strong, and that a user interface can readily be put on the web allowing easy access company wide.
However, these sophisticated tools are not trivial to deploy. It can take two months for a small company with one or two approved compounds, six months for moderate size company, and 12-18 months for a big pharma. Moreover, while the FDA and other agencies have issued a myriad of post-marketing requirements to follow, they haven’t mandated how needed information needed should be tracked.
There is typically a substantial services component required when deploying a commercial regulatory tracking product. Indeed, Wilber says ISI’s business is roughly a 50/50 split between software and services. The payoff in using systems like RegTracker, she says, is companies get a single comprehensive view of their post-marketing activities in terms of regulatory requirements.
“Depending on what you choose to track, it could be possible to discover an issue at a particular site and then see every single product manufactured at this site [and identify other products impacted,” she says. “If they go to an even deeper level they could see not just which products are manufactured at the site but also which products are stored there and potentially even specific storage conditions, perhaps even to the pallet supplier.”
Wilbur emphasizes that manufacturing is just one of the many processes regulatory affairs teams track. She notes in Europe, for example, if you have a product approved and you don’t market it within a set period of time, you can actually lose the license to market that products: “What’s happened is all the different strengths of drugs, say 10mg, 20mg, 30mg, and 40mg, are approved, and the company only ever markets the 30 and 40 strength, it could lose the approval for the other two strengths.”
Senior management might be provided with even higher-level views of the data to help inform market-choice, supplier choice decisions, and the like.
A major challenge, of course, is choosing the right data to track as well as to ensure the data you have tracked us clean. The old adage "garbage in/garbage out" applies strongly in these deployments. Wilber says ISI has “best practice” methodology it follows in helping clients deploy RegTracker and that the process has solid milestones.
In theory the same drivers that are prompting the biopharmaceutical industry to embrace outsourcing generally – e.g., cost pressure, focus on core competencies, reduced IT resources – should also be driving the industry to use more commercial software for tracking critical regulatory required information and executive decision support.
Wilber says those forces are nudging the industry forward, but that the pace is measured and varies. Smaller companies often tend to see the longer-term payoff potential and can get started more quickly. Larger companies are often wary of lengthy, difficult deployments and painful data migration efforts. However recent mergers and acquisitions -- and the necessary systems integration projects they create -- are inclining large companies to look more favorably at commercial solutions to consolidate their view of regulatory-governed activities.
Deployment isn’t easy, Wilber agrees. ISI conducted a fair amount of research including focus groups to gauge customer needs and worries. “The feedback has been that data entry is incredibly underestimated. And that while it’s nice to have automated data mapping, nine times out of ten it is going to cost more than actually doing manual data entry and manual data cleanup. We understand this and we also understand that making sure we get the data from existing systems into the new system is going to be one of the key priorities of the implementation.”