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Dr. Morris, with his teams and collaborators, discovered, patented, &/or first published on the anti-rejection or anti-restenosis activities of 4 first-in-class natural product, synthetic organic or monoclonal antibody drugs.All branded and generic drugs within these 4 classes of therapeutics have generated aggregated annual peak sales of over approximately $10 billion and cumulative sales to date of approximately $80 billion for on- and off-label uses. 1.Sirolimus:. Dr. Morris first published that sirolimus prevents acute transplant (Tx) rejection (independently discovered at the University of Cambridge, UK) & discovered its suppression of chronic Tx rejection; Dr. Morris's lab discovered and patented the use of sirolimus/ mTOR inhibitors for the prevention of restenosis post-arterial angioplasty. 2.Mycophenolate mofetil (MMF, the pro-drug for mycophenolic acid [MPA]): Dr. Morris discovered that MMF prevents and treats acute Tx rejection; MMF and MPA became & remain the most prescribed immunosuppressants for recipients of all types of transplanted organ, cell and bone marrow transplants.3.Tofacitinib: Dr. Morris's lab, in collaboration with scientists from Pfizer, first published that tofacitinib prevents acute Tx rejection.4.Efalizumab: Dr. Morris, in collaboration with scientists from Genentech, first published efalizumab prevents acute Tx rejection.These classes of drugs were subsequently further developed in the clinic by several pharmaceutical companies, with Dr. Morris often as an advisor, and received world-wide regulatory marketing approvals for a total of 7 indications: 1.Suppression of acute renal transplant rejection and/or,2.Prevention of acute liver transplant rejection and/or.3.Prevention of acute heart transplant rejection and/or, 4.Prevention of chronic (coronary artery vasculopathy) heart transplant rejection and/or,5.Prevention of coronary artery restenosis after angioplasty (Dr. Morris is the co-inventor on the foundational patent for mTOR inhibitor drug - eluting stents), or6.Treatment of rheumatoid arthritis or,7.Treatment of psoriasis. At Novartis, Dr. Morris oversaw the preclinical discovery and early clinical development of the first-in-class selective protein kinase C inhibitor immunosuppressant, sotrastaurin (AEB071), which advanced through four Ph 2 trials in renal transplant patients.
R&D (pre-clinical discovery and clinical trial development) for novel therapeutics for prevention and treatment of immune, inflammatory, ischemic and other causes for injuries to all types of organ and cell allo- and xenografts and for prevention and treatment of acute organ injury/dysfunction/failure, acute graft-vs. -host disease after hematopoietic stem cell transplantation, and prevention and treatment of autoimmune diseases, the relationships between drug pharmacokinetics and pharmacodynamics, the discovery and clinical development of novel therapeutic technologies designed to selectively target small molecule immunosuppressants to specific immune cell subsets and tissues, the use of new technologies for measuring biomarkers and biomarker measures for surrogate endpoints for accelerated regulatory drug marketing approvals and novel clinical trial designs.