Notes from IIR's Clinical Trials Congress 2009 held this past February in Philadelphia.
Roy Vagelos, retired chief executive officer and chairman of Merck, took audience members through his illustrious and exciting career at the pharma giant. His objective was to shed light on lessons industry can learn from the golden age of pharma-and in doing so, made one lament the fact they hadn’t the chance to be a research scientist in the early 1980s.
What an interesting time. Hope for the next cure seemed as high as motivation. So, what can we learn from those glory days of R&D? A few things.
Veteran's insight
For starters, breakthroughs mustn't be considered the only path to success. Plus, "no breakthrough is ever perfect," says Vagelos. Which leaves room for other success routes. In Merck's case, it was a second-generation antihypertensive drug that had real advantages over the first generation-the biggest advantage being no loss of taste, thus no black box.
Vagelos also touched upon the impact of company culture. He learned of its power firsthand after a drug the company had developed to kill deadly worms in horses and dogs had been successfully tested in treating river blindness in sub Sahara Africa. After a few major setbacks, including no financial backers, the "magical drug" (as the New York Times dubbed it), received approval and Merck decided that it would provide the drug itself.
"[That] had a terrific effect on people at Merck. We lived what we said; we were there to make important drugs," said Vagelos. "That set a culture for the company, which is one of the reasons the company had such success."
Another reason is expertise. For Merck, in-house expertise led to the first recombinant vaccine in the world. And outside expertise led to the company's first bisphosphonate. But if not for the expert eye of one Merck employee, who noted the work being done by a small company in Italy, that compound never would have been brought in, said Vagelos.
"No matter how much you outsource," he warned, "you better have somebody with great expertise."
The future is now
As for what we can expect moving forward, it was no big surprise to hear Vagelos predict big pharma will take a back seat to small pharma when it comes to discovery. They're the ones working hard to attract bright, young professionals, as the bigger folks slim down their R&D workforce.
The result, according to Vagelos: "Many companies will outsource more and more of their discovery because there's more going on outside."
Inside industry, meanwhile, he described a great revolution taking place, where the science is making strides with the help of genomics and proteomics. In the eyes of Vagelos, the post golden age of pharma isn't tarnished, it's alive and well, and will continue to thrive. "People will live better because of what is accomplished in this great industry," he said.-
Kerri Nelen
Final ENLIVEN Trial Results Confirm Long-Term Benefit of Turalio in Tenosynovial Giant Cell Tumor
July 9th 2025In final data from the Phase III ENLIVEN study, Turalio (pexidartinib) demonstrated durable tumor responses and a consistent safety profile in patients with symptomatic TGCT not amenable to surgery.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success
July 7th 2025How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.