BIO 2014 presented another mix of the topical, the practical and the surreal, including memorable tango dancing near Argentina’s booth. Keynote speakers Richard Branson and Hilary Clinton drew rock concert-like lines of attendees, who waited for well over an hour just to get to hear them.

Branson, who speaks rather modestly and without the glibness one would expect of the self-made billionaire, made his talk memorable by cutting off the necktie of a pharma CEO, and later threw water on the moderator, Jim Greenwood.

Clinton, who was introduced by Virginia governor Terry McAuliffe, and preceded on the program by a funny and self-deprecating California governor Jerry Brown (who introduced her husband when he spoke at the conference quite a few years ago) revealed just how articulate she is, with anecdotes from her days as secretary of state and her husband’s presidency.  She also shared experiences backpacking and working her way through Alaska as a college student one summer. For a brief period, she said, she became a “slimer,” charged with scooping out the guts of salmon at a fish packing plant. She questioned the unusual and suspect color of some of the fish, and, in response, was fired but told to come back the next day to get her pay.  When she returned, she said, the entire fish packing operation had vanished. “What better training for life in Washington?” she quipped.

How well do you understand FDA?
Themes for the conference portion of the show were extremely relevant this year—including one presentation on understanding FDA (what regulators mean versus what you might think they mean). There were sessions on cell therapy, upstream and downstream bioprocessing, clinical trial optimization, results-based payment, translational medicine, manufacturing and operations and R&D.  And most sessions featured interactive polls, in which audience members were asked to respond to questions and text their answers. Most did not participate but roughly 25% did.

Two sessions were particularly interesting: “Targeting the End Game” on advancing cell therapy clinical trials, in which speakers noted the need for solving CMC issues, improving analytics and assays, and getting beyond the limits of the cliché “the process is the product.” For one thing, said one, Phase I processes will change by the end of the year. Risk analysis will be critical, speakers agreed.
Of particular interest was a presentation by Chris Murphy, SVP at Genzyme/Sanofi, who discussed problems at the Allston plant and how the facility went from Consent Decree to Operational Excellence.  

The facility had been pushed very hard, and was producing three products in 2009, when it received its first Warning Letter from FDA, he recalled, which snowballed into a full Consent Decree. By 2011, just around the time the company was acquired by Sanofi, it was submitting its first work plan for the consent decree to FDA.

When faced with a consent decree, companies can either shut the plant down for six months, or run it while revising quality systems, a challenging course that Genzyme chose to follow. Murphy likened it to “changing the tires on a car that is moving at 60 miles per hour.” Operators and staff were subject, not only to company QC, but to that of the company’s interim third-party contractor, Quantic, which was re-reviewing records, so they were dealing with two layers of quality control while trying to adjust manufacturing, eliminate quality problems and improve supply efficiency.

Assessing and addressing gaps
Quantic came up with a list of 500 gaps between existing and ideal standards, to set the baseline for improvements. Basically every major procedure, and all training had to change. “This is not for the faint of heart,”  Murphy said.

New full time employees were hired, with the following being the most sought after skills: technical skills, knowledge of process capability, Quality and analytics, and Lean Sigma. Management had to work hard to keep employees motivated so they could effectively deal with all the changes taking place around them.  

The solution was getting operators and supervisors to take more control and manage the process and their priorities, rather than having to ask permission from people at multiple organizational levels. Improving communication and “having difficult conversations” were key, Murphy said, and morale visibly improved as the facility moved from a focus on siloed expertise to multifunctional, integrated operations.

In short, the presentation could inspire any company, sponsor or CMO, whose management and staffers have struggled to balance the drive for efficiency, and that for patient safety and quality. Parent Sanofi has supported efforts, Murphy said, and part of the program has intensified the operator-patient connection by increasing communication with patients, who often come to visit and speak with employees.