Today, it’s more difficult to develop a new medication that meets an unmet need, as products are more effective and safer than in the past, explained Jack Modell, MD, vice president and senior medical officer, Rho.
“It gets difficult with drug development because there are still a lot of unmet needs, a lot of opportunities, but they are harder to find, and the hurdles are higher because we’ve got better medications,” said Modell. “Therefore, the trials tend to be longer, larger, more expensive, and the regulatory hurdles even higher as well.”
The industry also struggles with clinical trial recruitment and ‘not getting the right patients,’ he said, noting the presence of ‘professional patients,’ among other challenges.
As one way to address this, Modell suggested the use of computerized assessments, such as interactive voice response. “For some things, computers are better than people,” he said during a discussion with Outsourcing-Pharma and colleague, Matt Healy, Rho vice president of clinical operations, at the company’s headquarters in Durham, NC.
“We’re at a point in time now where things are progressing faster than they ever have before,” said Healy, who cited the advent of technology and changes in guidances as key to this acceleration.
“The hurdles are high when you have a drug that the world doesn’t need,” added Modell. “But when you have a drug that the world needs and is waiting for … FDA and everybody else will do what they can to help get that drug approved.”