This week FierceBiotech is at the annual DIA meeting in San Diego. Attendees have been flocking to the myriad of sessions offered at the at the event, and there's plenty going on in the exhibition hall. Here's a look at several topics that have emerged as popular trends at this year's show.
- There are multiple sessions covering adaptive clinical trials. Within the last several years, technology has improved to the point that companies are now capable of the complex statistical calculations necessary to run a successful adaptive trial. By adjusting drug doses while the trial is in progress, companies can save a considerable amount of time and money. But there are pitfalls: adaptive trials are very difficult to plan, and poor planning can lead to major failures. While companies like Wyeth have embraced adaptive trials, much of the industry is still waiting on FDA guidance before tackling this tricky trial design.
- Though the field of project management has been around for a long time, it's enjoying the spotlight at this year's show. A project management team helps keep trials on time and on budget. While it may seem like a trial is going well, they can look beyond the basics to find problems before they spiral out of control. "Project managers can look under the hood and say, wait, we're really not on track," explained Molly Blake-Michaels of ClearTrial. Now more than ever, biotech and pharma companies need that kind of oversite to get the most out of their development programs.
- Faced with pricing pressures and the ever-increasing R&D costs for drugs, pharma companies are particularly focused on streamlining operations. Gone are the days when companies could afford to ignore redundancy and inefficiency; now it's all about finding ways to cut time and cost from each stage of development. It's this trend that has led to the increased focus on project management, adaptive clinical trials and better overall trial planning.
- Standards support has become a key focus in streamlining the clinical trial process, according to service provider BioClinica. "Unfortunately, this is often a difficult undertaking, especially when plates are full and budgets are challenged," says Mark Weinstein, president and CEO, in an announcement. He challenges life science companies to prioritize the implementation of standards for data acquisition, exchange and submission. Doing so will yield a competitive advantage, he says. It will also simplify processes and decrease costs during trials. Report
- "If you think transparency is a bad idea for your company, get over it," urged John F. Kamp, executive director of the Coalition for Healthcare Communication, who chaired the panel "Pharma in a New Age of Transparency." And rightfully so. As this issue continues to be framed as a public health issue, stronger disclosure policies will likely become the standard. Companies both big and small can no longer afford to remain indifferent to calls for transparency, especially when it comes to conflicts of interest among their relationships with researchers and physicians.
If you're in San Diego this year, be sure to stop by Fierce's networking party tonight from 5:30 to 7:30 at the San Diego Wine & Culinary Center across from the convention center. Click here for details. We look forward to seeing you there! - Maureen
George Miller and Calisha Myers also contributed to this article.