Compliance Management / Regulatory Guidance / Facilty Design & Management

Learning from pharma's failures

PDA’s Annual Meeting found lessons in the industry’s continued ups and downs

By Meagan Parrish, Senior Editor

“I like stories of failure. Success stories can get really boring,” said Hal Baseman, chief operating officer of ValSource, to an audience that responded with knowing laughter.

We were planted in a speaker session on “Renovating Aging Facilities” at PDA’s Annual Meeting in San Diego. Throughout the conference, the focus had mainly been on the latest innovations, inspiring and motivating stories from patients, and how companies are using cutting-edge technologies to advance manufacturing. But for a moment, in the Q&A portion of this session, the tone shifted to failure, and why it’s useful to talk about what happens when a company messes up.

As they say, you learn more when you fail. And there aren’t just individual companies stumbling in pharma. Collectively, the industry needs improvement in a number of ways. Here are some of the biggest challenges that Baseman and others at the conference identified that pharma needs to address.

The scarcity of tech talent: A few decades ago, pharma was the place to go if you wanted a tech job. Now, of course, the competition in the tech world is fierce. If pharma wants to have the type of talent it’s going to need in the future, it will have to generate excitement about working in the industry once again.

Don’t neglect your fill/finish operations: According to Baseman, people often think of drug development as the “real sexy” part of the industry. But many crucial decisions that are being made about new products, regulatory issues, and post-approval changes are happening in fill/finish — so companies should focus on enhancing that part of operations.

Don’t shrug off the affordability issue: The availability of new drugs is just as important as product quality and safety. If patients can’t afford these technologies, they’re not going to help anyone.

Use multiple departments to solve emerging data problems: When using new tech, don’t just leave the data scientists to tackle challenges alone. Bring talent from other departments, including engineers and process professionals, to work with the data team and make the most out of recent innovations.

Accelerate drug development in the approvals stage: In one packed session, a representative from CDER broke down the numerous pathways the FDA has created to more quickly bring new drugs to market. Work with the agency to understand the various designations — from “breakthrough therapy” to “fast track” — to find out which might be right for your company’s newest treatment.

Embrace change: It’s been said numerous times — pharma is slow at adopting new technologies. “It’s time for us to get excited, and rise up, and do things we need to do to move the industry forward,” Baseman said. In fact, pharma has fallen so far behind other industries that Baseman believes there’s no longer time for evolution. “We need a revolution,” he said.

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