Taking the Long View
Long before he became a research executive, Andy Lee took a personal interest in HIV/AIDS. The South Africa native spent the first 30 years of his life in the epicenter of the HIV/AIDS epidemic. He’d seen both the devastation that HIV/AIDS can bring and, more recently, the promise of effective prevention and treatment.
“The past 30 years have seen considerable, steady progress in HIV, and we were on the cusp of making significant breakthroughs in HIV in Africa,” Andy said. “My belief was that in my lifetime we could eradicate HIV.”
Then, just months before his retirement as Senior Vice President and Head of Global Clinical Trial Operations at Merck & Co., came the potentially game-changing withdrawal of critical U.S. funds for HIV/AIDS research, particularly in sub-Saharan Africa where Andy grew up.
“Maybe my belief was too optimistic,” Andy said. Still, he remains confident that research can continue to advance in “this highly pressurized environment.”
Like other speakers at the 2025 AAHRPP Annual Conference, Andy acknowledged both the anxiety of the moment and the strengths that will continue to stand the research enterprise in good stead. He encouraged conference attendees to focus on “the long game,” offered assurances that the fundamental commitment to research will endure, and underscored the need to adapt and improve efficiency.
Above all, Andy urged attendees to maintain their AAHRPP accreditation and the standards that underpin high-quality, ethical research. That’s “what worries me most,” he said. “We have to ensure scientific integrity.”
“You are the gold standard,” he added, “the envy of those who aspire to conduct clinical research.”
Andy spoke of the “great value” of accreditation, its protections for research participants in thousands of clinical trials around the globe, and its role in advancing discovery and product development. “When we (pharmaceutical companies) see an organization that’s AAHRPP accredited, we breathe a sigh of relief,” he said. “It gives us immense confidence that you are doing the right thing … that human subjects are protected.”
From an operational standpoint, accreditation indicates “there’s a robustness to the work being done.” That assurance “saves a whole lot of wasted energy.”
Andy spoke of the vital connection between academic research and drug development. He pointed out the “tremendous amount of ongoing research that’s not affected” by current funding cuts and urged attendees not to become “distracted by the noise.” Instead, Andy called on them to focus on what they already do well and find ways to improve efficiency without reducing standards.
He cited the potential of e-consent, artificial intelligence (AI) and other technologies. He also suggested taking a hard look at accepted processes and practices. Can organizations reduce costs by sharing equipment across departments? Are there opportunities to streamline trial design by taking a more targeted approach to data collection, “asking the right questions and getting the right answers in as short a time as possible?”
“We all owe it to society to bring innovations to people with unmet medical needs faster, more efficiently, and with greater purpose,” he said. The way to accomplish that is for individuals involved in this enterprise to remain focused on their passion and its potential.
“Even with the changes, the U.S. is still a research powerhouse and a world leader in this space,” Andy said. “I still think it’s the most creative and innovative country that we work in. That’s why I immigrated here.”
“The pendulum will swing back, and you’ve got to wait for that,” he added. ”If you stay in it for the long term, you will come out on top.”