2016 ISPE Annual Meeting & Expo

The second day of 2016 ISPE Annual Meeting & Expo began with two powerful keynote presentations. Both spoke to the importance of pharmaceutical engineering to patients.

ISPE CEO and President John Bournas opened the session by introducing Flemming Dahl, Head of Quality, Senior Vice President at Novo Nordisk, who spoke about “Developing the Workforce of the Future, Today.”

Novo Nordisk is focused on three main treatment areas: diabetes, hemophilia, and growth disorders. The company employs 41,000 people and spends $2 billion on R&D annually. The company produces about half of the world’s insulin, which treats close to 27 million patients. “Our key contribution,” Dahl said, “is to discover and develop innovative biological medicines and make them accessible to patients throughout the world.”

But developing a drug takes time and money. Only one in ten thousand ideas makes it to market. The average development timeline for a commercialized drug is around 10 to 15 years; the cost is approximately $1.3 billion.

Innovation can help reduce those costs, however. By implementing continuous improvements for its drug Victoza—minimizing wasted time, optimizing steps and procedures—the company was able to optimize capacity 250%, with yield maximized more than 50%.

Another innovation is the company’s oral semaglutide—the first protein-based medicine in a tablet. “Biologics in a tablet—that’s the dream for a company like ours,” Dahl said.

Despite these successes, however, the company is facing a lack of talent. Novo Nordisk needs engineers of all kinds: IT/automation, mechanical, chemical, and quality engineers.

This is a problem across other industrial sectors as well. The two biggest reasons for the shortfall are a lack of available applicants and a lack of technical competence.

As a result, said Dahl, Novo Nordisk is looking for people who can share knowledge and work across disciplines. The industry needs a way to develop and share experience, as well.

This is where ISPE can be influential, Dahl said.

The organization can bring political attention to the need for engineers, and stimulate positive public discussion around the field of engineering. Dahl urged attendees to “Lead by example; it’s not enough to be an expert in your area. You have to be able to share your knowledge and work in other disciplines, as well.”

Finally, he said, ISPE should work to build pride within our profession. “Stand up and be proud of what you do. It’s a fantastic time to be an engineer.”

Gavin’s Story

Mike Arnold, Business Process Owner for Investigational Products and Senior Director of Strategic Partnerships for Pfizer’s Global Clinical Supply Chain and incoming International Board of Directors Chair, introduced the next speaker, Nicole Pierson, mother of a 10-year-old brain tumor survivor.

“I know you in industry don’t always get to see patients,” she told the crowd, “but we’re thankful for the work you do.”

At age 5, her son Gavin developed a rapidly growing brain tumor. The diagnosis, she said, “changed our lives forever.”

The original treatment plan of chemotherapy followed by surgery and radiation was halted after two months when it failed to slow the tumor’s growth. During the next year, Gavin’s parents and doctors fought to keep him alive. They applied for a clinical trial, but the prognosis seemed hopeless.

Gavin’s tumor, which he nicknamed “Joe Bully,” began to flatten his brainstem “like a pancake,” his mother said. Despite the grim prognosis, Nicole said, “I just couldn’t stop fighting for him” Gavin endured his fifth craniotomy in a desperate bid to keep him alive.

Finally, Nicole applied to Pfizer’s compassionate use program for the company’s anti-tumor drug palbociclib (ibrance). A blood test confirmed that his tumor had the protein required to be admitted to the program and get the drug. They also found a minimally invasive laser ablation treatment that could treat his tumor. “We went from nothing to TWO options,” Nicole recalled. “We began to hope that Gavin would get to celebrate his seventh birthday.”

Gavin was the first pediatric patient to take palbociclib. “He called the medication ‘Joe Bully medicine,” his mother said. “He’d take the pill and say ‘Joe Bully, you’re going down!’”

And he did. The drug stopped the tumor from growing and gave Gavin time to recover from his multiple surgeries. He celebrated his seventh birthday without a wheelchair.

He also had laser ablation therapy to decrease, and eventually eliminate the tumor. He is in now in remission. “He had to fight neuro deficits from chemo,” Nicole explained, “but despite that, he’s now a purple belt in karate.

“There are days when were still scared,” she admitted. “We don’t know if it will come back. But we have a different perspective on life now. We treat every day as a blessing.”

Hop Image from 2016 ISPE Annual Meeting Keynote Speaker Nicole PiersonNicole showed the audience a photo of the bottles that the drug came in, arranged into the word “hope.” She had saved them all. “I can’t throw them away,” she said. “Every time I picked them up, it was like a bottle of hope.”

As she concluded, she told the audience, “I hope something I said will inspire you to continue the work you do. Thank you Pfizer for giving us hope when we had none. Thank you ISPE for inviting me and letting me share our story.”

Nicole and Gavin Pierson - Keynote Speaker 2016 ISPE Annual Meeting & ExpoAs the audience stood to applaud, Michael Arnold welcomed Gavin onstage to give him a gift: a jacket bearing his name, the ISPE logo, and the title of “ISPE Young Professional.”

RELATED POSTS