A generous gift from longtime benefactors of Washington University establishes the Needleman Program for Innovation and Commercialization. For a small number of annually selected projects, the new program will provide funding to help move promising therapeutics to the stage where the Food and Drug Administration grants investigational new drug (IND) status. In some cases, the new center will support initial clinical trials as well.
A generous $15 million commitment from Philip and Sima Needleman, longtime benefactors of Washington University in St. Louis, will enable WashU to leverage its expertise in biomedical discovery to boost drug development. The Needleman Program for Innovation and Commercialization (NPIC) will bridge the gap between the identification of promising therapeutic targets in the laboratory and the initiation of clinical trials to evaluate the safety and effectiveness of investigational drugs.
Traditionally, it has been immensely challenging to advance potential drug candidates identified in the laboratory into early-stage clinical trials, because this work requires substantial funding not available to academic researchers through traditional sources. The program will provide new support during this critical window in the drug development process.
“We extend our deepest thanks to Philip and Sima Needleman for their tremendous generosity in supporting drug discovery efforts at the School of Medicine and across the university,” said Chancellor Andrew D. Martin. “This new program in drug development will provide the support and resources necessary to bring the most promising discoveries from the laboratory to the clinic, where they can help patients. Dr. Philip Needleman’s own career at the intersection of basic academic research and commercial drug development is a great example of the type of innovation and entrepreneurship this new program aims to cultivate.”
For a small number of annually selected projects, the Needleman Program for Innovation and Commercialization (NPIC) will provide funding to validate drug targets, perform pharmacokinetics and conduct extensive testing in model systems, with the goal of moving promising therapeutics to the stage where the Food and Drug Administration grants investigational new drug (IND) status. In some cases, the new center will support initial clinical trials as well. The new program complements and extends the university’s existing efforts in drug development and commercialization — drawing on a culture of innovative discoveries aimed at improving human health.
The Needleman program also will provide much of the same infrastructure as a typical startup venture, including financial support, project management, external drug development funding, as well as mentoring in business and intellectual property management.
“Philip and Sima Needleman have provided profound support for research and innovation at Washington University and have advanced our capabilities in drug discovery and commercialization,” said David H. Perlmutter, MD, executive vice chancellor for medical affairs, the George and Carol Bauer Dean of the School of Medicine, and the Spencer T. and Ann W. Olin Distinguished Professor. “This new program will strengthen our ecosystem of drug development with knowledge and resources necessary to nurture novel drug development, licensing and commercialization efforts. We look forward to harnessing these new resources, together with Phil’s personal guidance and boundless enthusiasm, to transform Washington University and St. Louis into a national hub for drug discovery and innovation.”
Philip Needleman, PhD, a former executive at the pharmaceutical companies Monsanto, Searle and Pharmacia, also has a long, storied history with Washington University, arriving at the School of Medicine in 1964 as a postdoctoral fellow. He later joined the faculty of the former Department of Pharmacology and then led that department from 1976-89. During his time at Washington University, he discovered an enzyme, COX-2, that plays a key role in pain and inflammation due to arthritis. He also identified an inhibitor of COX-2 that showed therapeutic potential, but traditional sources of funding available to academic researchers would not support the hunt for and optimization of a selective COX-2 inhibitor nor fund the additional studies needed to validate the effectiveness and safety of a therapeutic candidate ready for clinical trial.
To further this research, Needleman moved into industry, joining Monsanto as chief scientist in 1989 and leading the development of the compound, which was approved in 1998 as the drug Celebrex. The blockbuster nonsteroidal anti-inflammatory drug has been prescribed to millions of people as a treatment for osteoarthritis; rheumatoid arthritis in adults and children; ankylosing spondylitis, a type of arthritis that causes inflammation in the ligaments and joints of the spine; and to manage acute pain.
Washington University is conducting a national search for the inaugural director of the Needleman Program for Innovation and Commercialization. The university is seeking an experienced leader with a history of success in drug development.
“There is a lot of excitement about our search for an innovative director to launch and lead this new program,” said Dedric A. Carter, PhD, vice chancellor for innovation and chief commercialization officer. “There are myriad benefits to incubating new drug candidates internally. It allows us to get the structure in place for effective clinical trials that really honor the specific drug technology that we’re developing. If we can gather great people and get these systems in place, we can unlock tremendous capacity for developing new commercial therapeutics.”
The new program will work in close collaboration with the School of Medicine’s Center for Drug Discovery and the university’s Office of Technology Management. The Center for Drug Discovery is focused on the early stages of the drug development process, providing support for proof-of-concept research often also funded by the National Institutes of Health (NIH) to pinpoint disease targets and identify drug candidates that could lead to new therapies. The Office of Technology Management provides resources for filing patents and managing intellectual property and licensing agreements of new drug candidates.
Some drug candidates become attractive to venture capital investors and pharmaceutical companies at this early stage. But for those that require more preclinical development — such as extensive testing in model systems — and more support in the early clinical trial stages, researchers now will have the option to apply for support of their drug candidates through the Needleman Program for Innovation and Commercialization. An advisory council composed of members outside of Washington University who have expertise in the biopharmaceutical industry and drug development will select the projects that will be funded.
“Washington University researchers are always on the edge of discovery, working out the mechanisms of disease — that’s the great strength of the faculty,” Needleman said. “There isn’t a better time to be involved in drug development. With the latest tools of scientific discovery, researchers can define a lot of disease targets that used to be out of reach. This gift is an effort to help Washington University scientists take a valid therapeutic target from the stage where it’s just a twinkle in the eye and advance it all the way to consideration as an investigational new drug.”
The Needleman program will begin accepting proposals later in the spring.
“We look forward to engaging our investigators who are interested in pursuing this new development pathway for their most promising drug candidates,” Carter said.
The Needlemans’ gift continues a long history of generous financial support to Washington University, including an endowed professorship, a pharmacology prize, and fellowships in regenerative medicine at the School of Medicine and three endowed scholarships at the Brown School.
In 2019, the Needlemans committed $15 million to fund two cutting-edge research centers at the School of Medicine aimed at developing new treatments for neurodegeneration and chronic diseases associated with aging, diseases that collectively affect millions. That gift established the Philip and Sima Needleman Center for Autophagy Therapeutics and Research, and the Philip and Sima Needleman Center for Neurometabolism and Axonal Therapeutics.
The first center focuses on understanding autophagy, a vital cellular waste recycling system that has been implicated in many processes that affect health, including aging, infections, inflammatory diseases, obesity, diabetes, atherosclerosis and cancer. The second center focuses on the metabolism of neurons — how they burn energy — and how that impacts the health of the nervous system.
The couple are members of the William H. Danforth Leadership Society, the highest level of recognition for university donors. They received the William Greenleaf Eliot Society’s Search Award in 2011 and the Robert S. Brookings Award in 2019 for their extraordinary dedication to the university.
Philip Needleman is a member of the National Academy of Sciences and the National Academy of Medicine. At Washington University, he is an emeritus trustee and chair of the School of Medicine National Council. He is a five-time recipient of Washington University’s Distinguished Faculty Award and also has been recognized with the School of Medicine’s 2nd Century Award. He received an honorary doctorate of science from the university in 1999.
Sima Needleman earned a master’s degree in social work from the Brown School and worked as a medical social worker at what was then Jewish Hospital of St. Louis, now Barnes-Jewish Hospital. She began in the obstetrics department and later joined the staff of the in vitro fertilization (IVF) program. Led by Washington University faculty members, the program was the first to successfully perform IVF in Missouri, and Sima Needleman and her colleagues were among the vanguard in their work with IVF patients.
After 16 years at the hospital, she opened a private practice. She went on to serve in several volunteer leadership roles at the Brown School, including as a member of its alumni board and as president from 1993-95. She began serving as a member of the Brown School National Council in 1998 and became an emerita member in 2013. She was honored with the Dean’s Medal from the Brown School in 2006. Beyond her roles at Washington University, she is known for her dedicated volunteer work in the St. Louis community.