Randall E. Morris, United States

Professor of Cardiothoracic Surgery and, by courtesy, Medicine and Surgery
Department of Cardiopthoracic Surgery
Stanford University School of Medicine

Biosketch for Randall E. Morris

(February 11, 2018)

 

Randall E.  Morris   MD, FRCP, is a Research Professor of Cardiothoracic Surgery and, by courtesy, Medicine and Surgery (Emeritus) in the Stanford University School of Medicine. Dr. Morris, with his teams and collaborators, have discovered, patented, and/or were the first to identify and to publish on 4 first-in-class drugs (natural product, synthetic organic or monoclonal antibody) for: 1) the prevention and treatment of acute and chronic transplant (Tx) rejection or 2) the prevention of arterial restenosis after balloon injury and/or 3) the molecular mechanisms of action of these 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 $70 billion for on- and off-label uses.  

 

 

Sirolimus (rapamycin; first-in-class mammalian target of rapamycin [mTOR] inhibitor; Rapamune®, Wyeth-Pfizer).  At Stanford, Dr. Morris was the first to publish that sirolimus prevents acute Tx rejection (independently discovered to prevent Tx rejection at the University of Cambridge, UK) and to define its unique mechanisms of immunosuppressive action and first to discover its efficacy for preventing and treating Tx vascular disease and first to define its unique mechanism of action for these applications, preventing and first to discover its use for prevention of acute graft-vs. -Host disease (GvHD) after bone marrow Tx. Sirolimus has been approved and is marketed for prevention of renal Tx rejection. Dr. Morris and Dr. Clare Gregory at Stanford discovered and patented the use of mTOR inhibitors for the prevention of vessel narrowing post-coronary arterial angioplasty, the foundation for the first coronary artery drug-eluting stent (Cypher®; Cordis-Johnson & Johnson).

 

Mycophenolate mofetil (RS-61443, MMF; first-in-class inosine monophosphate dehydrogenase inhibitor; CellCept®, Roche; pro-drug for mycophenolic acid [MPA]). At Stanford, Dr. Morris was the first to discover and publish that MMF prevents acute Tx rejection and reverses ongoing acute Tx rejection. Dr. Morris also co-invented the use of MPA to prevent arterial narrowing after balloon angioplasty (patent issued).  MMF and MPA (Myfortic®, Novartis) became and remain the most prescribed immunosuppressive drugs (ISD) for recipients of all types of transplanted organs, cells and bone marrow Tx.

 

Tofacitinib (CP-690, 550; first-in-class Janus 3 (1/2) kinase [JAK] inhibitor; Xeljanz®, Pfizer).  At Stanford, Dr. Morris’s laboratory research, in collaboration with scientists at Pfizer, was the first to identify and to be published that tofacitinib prevents acute renal Tx rejection.  Tofacitinib advanced to Ph 2 trials in renal Tx recipients and was first approved and marketed for treatment of rheumatoid arthritis.

 

Efalizumab (first-in-class CD11a/LFA-1 monoclonal antibody [mAb] blocker; Raptiva®, Genentech).  At Stanford, Dr. Morris’s laboratory research, in collaboration with scientists at Genentech, was the first to show and to be published that monotherapy with a mouse anti-CD11a mAb and later a humanized mAb, efalizumab, prevents acute Tx rejection. Efalizumab underwent a brief Ph 2a trial in renal Tx recipients and was approved and marketed for treatment of psoriasis.

 

 

 

These classes of drugs were subsequently further developed in clinical trials by several pharmaceutical companies, with Dr. Morris often as an advisor, and received world-wide regulatory marketing approvals for 6 indications:

 

Prevention of renal Tx rejection and/or,

 

Prevention of liver Tx rejection and/or,

 

Prevention of heart Tx rejection and/or

 

Prevention of coronary artery restenosis after angioplasty  (Dr. Morris is the co-inventor on the foundational patent for mTOR inhibitor drug-eluting stents) or

 

Treatment of rheumatoid arthritis or,

 

Treatment of psoriasis.  

 

These four classes of immunosuppressants are used for many off-label indications in recipients of a variety of Tx organs and cell Tx and in recipients of bone morrow Tx to prevent and treat GvHD and to treat many autoimmune diseases.

 

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 Tx patients.

 

Earlier, Dr. Morris's team at Stanford was the first to publish on the prevention of acute Tx rejection by the novel dihydro-orotate dehydrogenase inhibitor, FK778 (Fujisawa/Astellas), licensed from Hoechst-Marion-Roussel/Aventis as MNA-715, an analog of leflunomide’s active metabolite (A77 1726) and to elucidate the primary biochemical immunosuppressive mechanism of action A77 1726. FK778 completed Ph 2 trials in renal transplantation. Leflunomide (Arava®, Aventis, now Sanofi) was approved for treatment of rheumatoid arthritis, and A77 1726 (teriflumomide, Aubagio®, Sanofi) was approved for treatment of multiple sclerosis.

 

Dr. Morris is now an emeritus professor and was the founder and Head of the Laboratory of Transplantation Immunology in the Department of Cardiothoracic Surgery at the Stanford University School of Medicine.  Dr. Morris’s laboratory was devoted to research in Tx immunology, ISD discovery and development, immunopharmacology including pharmacokinetics and pharmacodynamics, molecular mechanisms of drug action, biological mechanisms of and creation of novel animal models for acute and chronic rodent and non-human primate heart, lung and/or renal allo- and xeno-Tx rejection, acute GvHD after bone marrow Tx, and research in vascular biology.

 

Dr. Morris has consulted on pre-clinical and clinical development of immunosuppressants for dozens of pharmaceutical and biotechnology companies before being recruited to be Global Head of Transplantation Therapeutic Area Discovery Research and Head of Transplantation Translational Medicine at the Novartis Institutes of Biomedical Research (Early Discovery, Proof of Concept Trials and Ph 1 Trials, Strategic Alliances [In-Licensing]) and Head of Therapeutic Sciences in the Immunology and Transplantation Business Unit/Franchise (Ph 2, 3 and Ph 4 Trials, Medical Affairs, Business Development & Licensing, Sales & Marketing, Pricing & Reimbursement) at Novartis, AG in Basel, Switzerland and continued as an exclusive consultant for Novartis after returning to the US. Dr. Morris is now a non-exclusive consultant primarily in the field of immunosuppression for Tx and autoimmune diseases as well has having been a fact witness and contributor to appellate court briefs for three patent litigation cases.

 

Dr. Morris has published over 400 papers, abstracts and chapters and given over 550 lectures.  Awards and honors include N.I.H. Medical Scientist Training Program Fellowship, Stanford Medical Alumni Award, American College of Surgeons Schering Research Award, Karolinska Institute Transplantation Medal (Stockholm), Royal Society of Medicine Visiting Fellowship (United Kingdom), elected as an honorary member of the German Transplantation Society, elected as a Fellow of the Royal College of Physicians (Glasgow) as well as named Lectureships.  Dr. Morris was the President of the International Congress on New Trends in Experimental and Clinical Immunosuppression.  Dr. Morris served two terms as an elected Councilor of The Transplantation Society, and is currently serving as Historian on the Council. 

 

Education:

 

Westminster Public School, London, UK.

 

Stanford University AB (Honors in Molecular Biology project on treatment of sickle cell anemia project where Linus Pauling was an advisor)

 

Stanford University School of Medicine: MD with an additional >3 yrs. of transplantation immunology and immunosuppression research as part of the NIH Medical Scientist Training Program (in the Dept. of Cardiothoracic Surgery, Norman E. Shumway Dept. Chair) plus surgical internship.

 

University of Wisconsin at Madison surgical residency (Folkert O.Belzer, Chair of Surgery) including clinical renal transplantation surgery and a postdoctoral fellowship in immunology. 

 

Dr. Morris's current interests include R&D (pre-clinical discovery and development and novel clinical trial designs and clinical development) for:

Novel therapeutics for prevention and treatments for immune, inflammatory, ischemic, fibrotic and other causes of injuries to many Tx organs and cell allo- and xenografts and novel therapeutics for prevention and treatments for similar causes of diseases for non-Tx indications.
Prevention and treatment of acute organ injury/dysfunction/failure.
Defining the relationships between drug pharmacokinetics and pharmacodynamics.
Novel therapeutics for prevention and treatments for acute and chronic GvHD after hematopoietic stem cell [bone marrow] Tx.
Prevention and treatment of autoimmune diseases.
Novel therapeutic technologies designed to selectively target small molecules to specific cell subsets and tissues.
The use of new technologies for measuring biomarkers and biomarker measures for surrogate endpoints for accelerated regulatory drug marketing approvals.

 

Website: www.randallemorris.com

 

LinkedIn Profile: https://www.linkedin.com/in/randall-morris-md-frcp-8606a112/

 

Public LinkedIn Profile: https://www.linkedin.com/public-profile/settings?trk=d_flagship3_profile_self_view_public_profile

 

-- 

Randall E. Morris, MD, FRCP

Research Professor of Cardiothoracic Surgery and, by courtesy, Medicine and Surgery (Emeritus)

Stanford University School of Medicine

Stanford, California, USA

 

Carmel-by-the-Sea

P.O. Box 6535 for Mail Sent by US Post Office or Not by Express Mail

California, 93921-6535

USA; Phone: (001) 831-250-7670;

 

Pacific Standard Time Zone = GMT - 8 Hours

 

Email: randallemorris@gmail.com; rem@stanford.edu

 

Address Only for Express Mail Delivery, not for mail from US Post Office:

Dolores St. 2 NE of 3rd Ave.

Carmel-by-the-Sea

California, 93921

USA

 

 

Biosketch for Randall E. Morris

(February 11, 2018)

 

Randall E.  Morris   MD, FRCP, is a Research Professor of Cardiothoracic Surgery and, by courtesy, Medicine and Surgery (Emeritus) in the Stanford University School of Medicine. Dr. Morris, with his teams and collaborators, have discovered, patented, and/or were the first to identify and to publish on 4 first-in-class drugs (natural product, synthetic organic or monoclonal antibody) for: 1) the prevention and treatment of acute and chronic transplant (Tx) rejection or 2) the prevention of arterial restenosis after balloon injury and/or 3) the molecular mechanisms of action of these 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 $70 billion for on- and off-label uses.  

 

 

Sirolimus (rapamycin; first-in-class mammalian target of rapamycin [mTOR] inhibitor; Rapamune®, Wyeth-Pfizer).  At Stanford, Dr. Morris was the first to publish that sirolimus prevents acute Tx rejection (independently discovered to prevent Tx rejection at the University of Cambridge, UK) and to define its unique mechanisms of immunosuppressive action and first to discover its efficacy for preventing and treating Tx vascular disease and first to define its unique mechanism of action for these applications, preventing and first to discover its use for prevention of acute graft-vs. -Host disease (GvHD) after bone marrow Tx. Sirolimus has been approved and is marketed for prevention of renal Tx rejection. Dr. Morris and Dr. Clare Gregory at Stanford discovered and patented the use of mTOR inhibitors for the prevention of vessel narrowing post-coronary arterial angioplasty, the foundation for the first coronary artery drug-eluting stent (Cypher®; Cordis-Johnson & Johnson).

 

Mycophenolate mofetil (RS-61443, MMF; first-in-class inosine monophosphate dehydrogenase inhibitor; CellCept®, Roche; pro-drug for mycophenolic acid [MPA]). At Stanford, Dr. Morris was the first to discover and publish that MMF prevents acute Tx rejection and reverses ongoing acute Tx rejection. Dr. Morris also co-invented the use of MPA to prevent arterial narrowing after balloon angioplasty (patent issued).  MMF and MPA (Myfortic®, Novartis) became and remain the most prescribed immunosuppressive drugs (ISD) for recipients of all types of transplanted organs, cells and bone marrow Tx.

 

Tofacitinib (CP-690, 550; first-in-class Janus 3 (1/2) kinase [JAK] inhibitor; Xeljanz®, Pfizer).  At Stanford, Dr. Morris’s laboratory research, in collaboration with scientists at Pfizer, was the first to identify and to be published that tofacitinib prevents acute renal Tx rejection.  Tofacitinib advanced to Ph 2 trials in renal Tx recipients and was first approved and marketed for treatment of rheumatoid arthritis.

 

Efalizumab (first-in-class CD11a/LFA-1 monoclonal antibody [mAb] blocker; Raptiva®, Genentech).  At Stanford, Dr. Morris’s laboratory research, in collaboration with scientists at Genentech, was the first to show and to be published that monotherapy with a mouse anti-CD11a mAb and later a humanized mAb, efalizumab, prevents acute Tx rejection. Efalizumab underwent a brief Ph 2a trial in renal Tx recipients and was approved and marketed for treatment of psoriasis.

 

 

 

These classes of drugs were subsequently further developed in clinical trials by several pharmaceutical companies, with Dr. Morris often as an advisor, and received world-wide regulatory marketing approvals for 6 indications:

 

Prevention of renal Tx rejection and/or,

 

Prevention of liver Tx rejection and/or,

 

Prevention of heart Tx rejection and/or

 

Prevention of coronary artery restenosis after angioplasty  (Dr. Morris is the co-inventor on the foundational patent for mTOR inhibitor drug-eluting stents) or

 

Treatment of rheumatoid arthritis or,

 

Treatment of psoriasis.  

 

These four classes of immunosuppressants are used for many off-label indications in recipients of a variety of Tx organs and cell Tx and in recipients of bone morrow Tx to prevent and treat GvHD and to treat many autoimmune diseases.

 

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 Tx patients.

 

Earlier, Dr. Morris's team at Stanford was the first to publish on the prevention of acute Tx rejection by the novel dihydro-orotate dehydrogenase inhibitor, FK778 (Fujisawa/Astellas), licensed from Hoechst-Marion-Roussel/Aventis as MNA-715, an analog of leflunomide’s active metabolite (A77 1726) and to elucidate the primary biochemical immunosuppressive mechanism of action A77 1726. FK778 completed Ph 2 trials in renal transplantation. Leflunomide (Arava®, Aventis, now Sanofi) was approved for treatment of rheumatoid arthritis, and A77 1726 (teriflumomide, Aubagio®, Sanofi) was approved for treatment of multiple sclerosis.

 

Dr. Morris is now an emeritus professor and was the founder and Head of the Laboratory of Transplantation Immunology in the Department of Cardiothoracic Surgery at the Stanford University School of Medicine.  Dr. Morris’s laboratory was devoted to research in Tx immunology, ISD discovery and development, immunopharmacology including pharmacokinetics and pharmacodynamics, molecular mechanisms of drug action, biological mechanisms of and creation of novel animal models for acute and chronic rodent and non-human primate heart, lung and/or renal allo- and xeno-Tx rejection, acute GvHD after bone marrow Tx, and research in vascular biology.

 

Dr. Morris has consulted on pre-clinical and clinical development of immunosuppressants for dozens of pharmaceutical and biotechnology companies before being recruited to be Global Head of Transplantation Therapeutic Area Discovery Research and Head of Transplantation Translational Medicine at the Novartis Institutes of Biomedical Research (Early Discovery, Proof of Concept Trials and Ph 1 Trials, Strategic Alliances [In-Licensing]) and Head of Therapeutic Sciences in the Immunology and Transplantation Business Unit/Franchise (Ph 2, 3 and Ph 4 Trials, Medical Affairs, Business Development & Licensing, Sales & Marketing, Pricing & Reimbursement) at Novartis, AG in Basel, Switzerland and continued as an exclusive consultant for Novartis after returning to the US. Dr. Morris is now a non-exclusive consultant primarily in the field of immunosuppression for Tx and autoimmune diseases as well has having been a fact witness and contributor to appellate court briefs for three patent litigation cases.

 

Dr. Morris has published over 400 papers, abstracts and chapters and given over 550 lectures.  Awards and honors include N.I.H. Medical Scientist Training Program Fellowship, Stanford Medical Alumni Award, American College of Surgeons Schering Research Award, Karolinska Institute Transplantation Medal (Stockholm), Royal Society of Medicine Visiting Fellowship (United Kingdom), elected as an honorary member of the German Transplantation Society, elected as a Fellow of the Royal College of Physicians (Glasgow) as well as named Lectureships.  Dr. Morris was the President of the International Congress on New Trends in Experimental and Clinical Immunosuppression.  Dr. Morris served two terms as an elected Councilor of The Transplantation Society, and is currently serving as Historian on the Council. 

 

Education:

 

Westminster Public School, London, UK.

 

Stanford University AB (Honors in Molecular Biology project on treatment of sickle cell anemia project where Linus Pauling was an advisor)

 

Stanford University School of Medicine: MD with an additional >3 yrs. of transplantation immunology and immunosuppression research as part of the NIH Medical Scientist Training Program (in the Dept. of Cardiothoracic Surgery, Norman E. Shumway Dept. Chair) plus surgical internship.

 

University of Wisconsin at Madison surgical residency (Folkert O.Belzer, Chair of Surgery) including clinical renal transplantation surgery and a postdoctoral fellowship in immunology. 

 

Dr. Morris's current interests include R&D (pre-clinical discovery and development and novel clinical trial designs and clinical development) for:

Novel therapeutics for prevention and treatments for immune, inflammatory, ischemic, fibrotic and other causes of injuries to many Tx organs and cell allo- and xenografts and novel therapeutics for prevention and treatments for similar causes of diseases for non-Tx indications.
Prevention and treatment of acute organ injury/dysfunction/failure.
Defining the relationships between drug pharmacokinetics and pharmacodynamics.
Novel therapeutics for prevention and treatments for acute and chronic GvHD after hematopoietic stem cell [bone marrow] Tx.
Prevention and treatment of autoimmune diseases.
Novel therapeutic technologies designed to selectively target small molecules to specific cell subsets and tissues.
The use of new technologies for measuring biomarkers and biomarker measures for surrogate endpoints for accelerated regulatory drug marketing approvals.

 

Website: www.randallemorris.com

 

LinkedIn Profile: https://www.linkedin.com/in/randall-morris-md-frcp-8606a112/

 

Public LinkedIn Profile: https://www.linkedin.com/public-profile/settings?trk=d_flagship3_profile_self_view_public_profile

 

-- 

Randall E. Morris, MD, FRCP

Research Professor of Cardiothoracic Surgery and, by courtesy, Medicine and Surgery (Emeritus)

Stanford University School of Medicine

Stanford, California, USA

 

Carmel-by-the-Sea

P.O. Box 6535 for Mail Sent by US Post Office or Not by Express Mail

California, 93921-6535

USA; Phone: (001) 831-250-7670;

 

Pacific Standard Time Zone = GMT - 8 Hours

 

Email: randallemorris@gmail.com; rem@stanford.edu

 

Address Only for Express Mail Delivery, not for mail from US Post Office:

Dolores St. 2 NE of 3rd Ave.

Carmel-by-the-Sea

California, 93921

USA

Sessions chaired by Randall E. Morris



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