The start of the 2015 Annual Meeting was magic…literally. Chad Juros, founder of the Spread the Magic Foundation, a nonprofit corporation that performs magic to raise money for pediatric cancer patients, started the three-day conference with a message of positivity and gratitude. A childhood cancer survivor and medical miracle, Chad’s father taught him magic as a survival tactic, a way of diverting attention from the negative to the positive in his life. But as accomplished as he is, Chad closed his speech by admitting he, in fact, does not know “real” magic. “The true magicians in this world are those who are bringing these miracle treatments and services that saved my life,” Chad said. “I’m living proof that the hard work that each and every one of you in this room does – no matter how big or small – does make a difference.”
The accountability that comes with producing the drugs that can facilitate miracles was not lost on any of the speakers throughout the conference. As Martin VanTrieste, Senior VP, Quality, at Amgen, pointed out, “the privilege of serving patients comes with significant responsibilities.” Unfortunately, as many speakers pointed out, the industry has failed patients when it comes to quality. Fran Zipp, previously Head of Quality for Teva and now President at Lachman Consulting, spoke openly and honestly about the cost of poor quality. Zipp pointed out that 2014 was the biggest year for serious drug recalls in the last 10 years and when we consider all the innovation, technology and advanced processes we have available, this should not be the case. “As a professional in the pharmaceutical industry, each one of us should be mortified by this,” stated Zipp.
The need to invest in quality, and more importantly, how to achieve this quality, was emphasized throughout all the educational sessions. Key points included:
• The need to invest in innovative equipment and automation: Jeff Boyd, Head of Technical Operations and Gene Therapies, Novartis, pointed out, “we need equipment to innovate with us…or even, ahead of us.”
• Continued emphasis on QbD: Quality by design is understood throughout the industry, but still not widely adopted.
• The need to adapt to an expanding supply chain: Using track and trace, serialization and automated systems to create an extensive system.
• Continuing the fight against counterfeit drugs: It is estimated that 10% of the world’s drug supply is counterfeit, with disturbing new trends emerging in counterfeit oncology and diabetes drugs. According to Michael Dalton, Advisor, Global Product Protection, Eli Lilly, “Sophistication of counterfeits continues to improve, making it harder and harder to tell the difference between authentic and counterfeit drugs.” Fortunately there is new technology pharma can use for authentication.
• Continued emphasis on Lean and Six Sigma principles: Creating a business case for operational excellence in order to improve manufacturing performance and quality.
Overall, the message of the conference was surprisingly humble: the industry has a responsibility to provide quality treatments to patients and isn’t meeting this responsibility to the best of its ability. This acknowledgment is refreshingly human, and perhaps that in and of itself, is part of the problem – human beings make mistakes. As Fran Zipp pointed out, “more dependable often means less human involvement.” There are amazing advances in technology, equipment and processes out there in the pharmaceutical industry, many of which were discussed and highlighted at the PDA Meeting. Meetings like these give the industry a great opportunity to come together and collectively discuss challenges, successes and failures, in an overall effort to not only keep pace with -- but transform -- the rapidly changing drug industry.
