“The idea behind our Center was to establish an academic focus for the gathering of relevant information and for scholarly analysis and interpretation, and through the publication of such research to raise the intellectual level of debate on questions of public policy.”
- Dr. Louis Lasagna
Founder of Tufts CSDD
Tufts CSDD founded at the University of Rochester by Dr. Louis Lasagna
in Rochester, New York, to provide objective and robust analyses and add a scholarly, evidence-based voice to policy debates on biopharmaceutical innovation. CSDD focused primarily on the intersection of innovation by the research-based pharmaceutical industry and regulation by the U.S. Food and Drug Administration (FDA).
Seminal research documents a ‘drug lag’ in new medical therapy launches in the United States compared to Europe
At this time, primary funding consisted of unrestricted grants & fees for professional development programs.
Tufts CSDD moves to the Tufts University School of Medicine in Boston, Massachusetts
and broadens its focus to include economic, political, scientific, and legal issues.
Seminal studies quantify the capitalized cost to develop a successful drug and the success/failure rates of drugs in development.
Kenneth I. Kaitin Becomes Executive Director of Tufts CSDD
Under Kaitin’s leadership, Tufts CSDD established a multidisciplinary approach to assessing critical drug development issues with a global perspective, and expanded its string of widely referenced studies including the cost to develop a new pharmaceutical product, benchmarks on clinical development times and success rates, R&D strategy and the impact of U.S. legislative and regulatory initiatives.
Tufts CSDD broadens focus to include global drug development trends and issues, & expands coverage to operations management, execution and collaborations
The Center also expands the focus of empirical research to include strategies, practices and solutions optimizing drug development efficiency, cost and performance.
Seminal studies characterize protocol design complexity, protocol amendment experience, data management practices, outsourcing and investigative site engagement.
At this time, primary funding transitions to include restricted grants & multi-company sponsorships
Tufts CSDD expands focus to include technology use & clinical team/patient diversity, equity & inclusion
Seminal studies demonstrate site and patient burden, racial and ethnic disparities in clinical trials and predictors of optimized performance
Primary funding expands to include recurrent and diagnostic studies
Kenneth Getz becomes Executive Director of Tufts CSDD
and expands research areas to include strategies and innovations reducing operational inefficiencies, improving patient enrollment effectiveness, lowering risk and costs, and boosting overall productivity.
Seminal studies include the adoption of risk-based quality management practices, measuring patient and investigative site participation burden, quantifying the impact and return on investment in virtual and remote solutions supporting clinical trials.
About Louis C. Lasagna, MD
1923-2003
Dr. Louis Lasagna, beloved educator and gifted scholar, was a pioneer, a visionary, an intellectual, and a renaissance man. His accomplishments extend over a vast array of subjects. Through his teaching, he personally influenced the lives of thousands of individuals. Indirectly, his legacy continues to affect millions.
In a remarkable career that spanned five decades, Dr. Lasagna worked and wrote extensively in the fields of clinical trial methodology, analgesics, hypnotics, and medical ethics. In 1954, he was the first to study and describe the now well-accepted placebo effect. Later he demonstrated the necessity of placebo-controlled clinical trials in studying analgesics, and he became a lifelong advocate of using rigorous scientific evaluation in the study of new drugs. His testimony in Congress at the 1962 Kefauver hearings was instrumental in establishing the efficacy requirement for new drugs in the Food, Drug, and Cosmetic Act.
In addition to his pioneering work in clinical pharmacology and trial design, Dr. Lasagna was a tireless advocate of what he often referred to as “common sense drug regulation.” He was the first to document the fact that overly cautious regulation serves as a disincentive for innovation in the research-based drug industry and delays access to new medicines. His strong belief that solid data and analyses should serve as the basis for political discussions regarding drug policy led to his founding in 1976 of the Center for the Study of Drug Development. The group, now in its fourth decade, moved from the University of Rochester to Tufts University in 1984, when Dr. Lasagna joined the faculty of the Tufts University School of Medicine and became the new Dean of the Sackler School of Graduate Biomedical Sciences.
Recognized as a leader in the science of drug regulation, Dr. Lasagna served on the Commission on the Federal Drug Approval Process, which reported its findings to Congress in April 1982. He was a member of the General Accounting Office’s Health Advisory Committee. He was chairman of the President’s "National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS" — also known as the "Lasagna Committee" — whose findings became the backbone of President George H.W. Bush’s Competitiveness Council FDA Reform Proposal in 1991. In 1990, he was appointed to Health Secretary Louis Sullivan’s "Blue Ribbon Panel" to examine FDA performance and recommend initiatives to improve efficiency at the agency. And in 1995 he served with three former FDA commissioners on the "Rogers Group" to prepare an agenda for FDA reform.
In 1964, Dr. Lasagna wrote in a Time Magazine article that the Hippocratic oath, spoken by medical school graduates for generations, was in need of updating to make it more relevant to today’s physicians. He called for a worldwide competition to update the oath. His own entry, which suggested that “warmth, sympathy, and understanding” are often a physician’s most powerful tools, is today recited by doctors at graduation ceremonies at many medical schools across the United States.
Dr. Lasagna worked tirelessly on behalf of intellectually disabled children. The father of a son with Down syndrome, Dr. Lasagna was a longtime advocate for better public understanding of the needs of intellectually disabled individuals. In 1988, the Kadima School for Special Children in Natanya, Israel, dedicated the Professor Louis Lasagna Building, which includes classrooms, consultation rooms, and an auditorium. Importantly, the addition raised the school’s enrollment capacity from 20 to approximately 150 students, essentially serving the entire country of Israel.
Dr. Lasagna served as Dean of the Sackler School of Graduate Biomedical Sciences at Tufts University from 1984 to 2002. He also served as Director of the Tufts Center for the Study of Drug Development until 1998. He had the unique honor of having two endowed chairs named for him, at the University of Rochester School of Medicine and Dentistry and at Tufts University School of Medicine. In 1997, his seminal 1954 article on the placebo effect was ranked by Lancet editor Richard Horton as among the world’s 27 most notable achievements in a medical canon going back to Hippocrates.
Personable, compassionate, modest, a lover of music and the arts, Dr. Lasagna was an educator and scholar in a class by himself. The author of over 500 books, articles, reports, and commentaries, Dr. Lasagna was the recipient of numerous honors and awards, including honorary Sc.D. degrees from Hahnemann Medical School (1980) and Rutgers University (1983), and an honorary doctoral degree from the University of Alcalá in Spain (1998).
Dr. Lasagna died on August 6, 2003 following a long battle with lymphoma. He was 80 years old.
