Below post by Justfactsmam gives about as comprehensive an oversight on how Brilacidin was developed, what it can do, what it has done in trials, and the backgrounds of the men who developed it (also gives the relationship between U of Penn and PolyMedix of which I was not aware) as one could hope to find:
Nothing wrong with repeating old news here...many here have never read about the $30M/60,000 super computing time used in formulation Brilacidin, no less the $10's of millions in testing Brilacidin in lab and human trials.
A complete SUMMARY of THE BRILACIDIN BACK STORY...was composed by Slcimmuno and posted on 02/23/15 under post #92313 (this is on IHUB)
But in the meantime lets play a little game "Did you know?" to see Board knowledge (or how very little they know) of the science of Brilacidin:
"Did you know?"
1. Brilacidin was formulated and co-developed by University of Pennsylvania and its Researchers. (not in Leo's garage)
2. The University of Pennsylvania and its Researchers (Founders) formed an entity Polymedix, the original patent filer, which patent was bought by and now owned by IPIX.
3. Among Founders and Originally Advisory Members were, William F. DeGrado PhD., Dr. and Richard Scott, Henry Heine, Phd., Gregory Tew PhD., Henry S. Heine, Ph.D. and others..(see below...and see where they are now!)
4. Founders spent $30M and in 2005 used 60,000 hours of the then NEW Pittsburgh Supercomputer Center's (PSC) "Big Ben",
5. "Big Ben" was built, in part, "to design of new materials, protein dynamics studies that lead to new therapeutic drugs" through which Brilacidin was formulated.
6. Brilacidin is a synthetic molecule targeting bacteria which mimics the activity of antimicrobial proteins that have a natural ability to prevent bacteria from developing resistance.
7. Brilacidin..uses synthetic molecules to mimic the mechanism of these "host defense proteins," which work by rupturing the skin of bacterial cells.
8. Brilacidin, is an ANTIBIOTIC... thatdirectly breaks the bacteria cell membrane very much like a needle going into a balloon...and because of that there's a very low chance the bacteria can develop resistance to it
9. PolyMedix has "... shown that Brilacidin kills more than 80 different strains of bacteria. Actually, we haven't found any strain of bacteria that we haven't been able to kill with these compounds," ... The compounds have been effective on the biowarfare pathogens black plague, tularemia and 12 strains of anthrax. (FUNNY THING...Brilacidin HAS NEVER FAILED A CLINICAL TRIAL UNDER IPIX/CTIX!)
KEY NOW...will Covid-19 "treatment" test show that Brilacidin "breaks the Covid-19 (and maybe many virus's) cell membrane very much like a needle going into a balloon????
Key players in the development of Brilacidin:
William F. "Bill" DeGrado, Ph.D., is the Professor of Pharmaceutical Chemistry at the University of California, San Francisco (UCSF) where he is the Director of DeGrado Lab research Laboratory and a member of the National Academy of Sciences.
He received a B.S. (chemistry) from Kalamazoo College and a Ph.D. (Chemistry) from the University of Chicago in 1977 working with Emil T. Kaiser and F. Kezdy. His graduate work focused on the design of the oxime resin for solid-phase synthesis, which was used for synthesis of protected peptides and is still in use for various types of combinatorial chemistry today. He also used peptide design to demonstrate that melittin adopts an amphiphilic helical structure, which is responsible for its membrane-disrupting activity.
He first held an industrial position at DuPont Central Research & Development (later DuPont Merck Pharmaceutical Company). He transitioned to academia in 1996, joining the University of Pennsylvania as the George W. Raiziss professor of biochemistry and biophysics and then moved to UCSF in 2011.
Dr. DeGrado was one of the original scientists involved, while at the University of Pennsylvania, in the discovery and subsequent development (see recent mechanistic studies) of Brilacidin and the larger Innovation Pharmaceuticals’ (patent successor to PolyMedix) Host Defense Protein (HDP)-mimetic platform.
Dr. DeGrado’s work laid the foundations for PolyMedix’s core lead drug development programs and product candidates. Both PMX-30063 antibiotic, the world’s first small molecule mimetic of host defense proteins intended for systemic use, and PMX-60056 heptagonist, a new reversing agent for heparin and Low Molecular Weight Heparins, are based on pioneering discoveries originally made by Dr. DeGrado.
He was the scientific founder of and Chief Scientific Advisor for PolyMedix, an emerging biotechnology company at the time developing new therapeutic drugs for serious, life-threatening acute cardiovascular and infectious disease. He was a Professor of Biochemistry and Biophysics at the University of Pennsylvania School of Medicine in Philadelphia, PA, and a member of the National Acad
Based on his work at PolyMedix, he was named the 2008 recipient of the prestigious Ralph F. Hirschmann Award in Peptide Chemistry. The award recognizes a person who has made outstanding contributions in the chemistry, biochemistry, or biophysics of peptides.
His published research includes contributions to the fields of protein design, synthesis of peptidomimetics, and characterization of membrane-active peptides and proteins, most notably the M2 protein.
The M2 proton channel from Influenza A virus. DeGrado’s early work with the groups of Robert Lamb and Larry Pinto established the overall structure and mechanism of the M2 proton channel, which is the target of the anti-influenza drugs, amantadine and rimantadine. A decade later their crystallographic, and NMR structures defined the fine details of the binding site for these drugs and explained the mechanism of the growing problem of amantadine-resistance. With Michael Klein, Robert Lamb and Larry Pinto, DeGrado extensively characterized the physiological properties of many drug-resistant mutants of the channel, identified those most likely to lead to resistance, and designed new drugs to address the problem of drug-resistant forms of influenza A virus.
Dr. DeGrado was one of the original scientists involved, while at the University of Pennsylvania, in the discovery and subsequent development (see recent mechanistic studies) of Brilacidin and the larger Innovation Pharmaceuticals’ (patent successor to PolyMedix) Host Defense Protein (HDP)-mimetic platform.
In 2017, at a lecture, Dr DeGrado has referred to Brilacidin, a promising immunomodulatory drug candidate currently being evaluated in mid-stage clinical trials. Brilacidin, based on insights gleaned from frog peptides, is a successful example of de novo protein design, described as: "the process of using peptide sequences that are not existent in, but inspired by nature" to build molecules as potential innovative therapeutics with novel attributes and applications. As to drug development, such novel synthetic design strategies of proteins ("the workhorses of all living creatures"
allow for improved pharmacokinetic properties and enhanced target specificity.
Dr. DeGrado has co-authored over 370 articles (list of publications), holds more than 25 patents, and is a member of the National Academy of Sciences, elected in 1999. In 2003, he was presented (pdf) with the Merrifield Award by the American Peptide Society. He received The Protein Society's Stein and Moore Award in 2015 and, most recently, was presented with the 2017 Biopolymers Murray Goodman Memorial Prize.
Michael L. Klein, is Laura H. Carnell Professor of Science, Director of the Institute for Computational Molecular Science, and Dean of the College of Science and Technology at Temple University in Philadelphia, USA.
He was previously the Hepburn Professor of Physical Science in the Center for Molecular Modeling at the University of Pennsylvania and worked with PolyMedix and instrumental in PolyMedix obtaining the patent titled, "Facially Amphiphilic Polymers as Anti-infective Agents" (developed into Brilacidin) allows compositions of matter and uses for a number of series of antimicrobial compounds for antibiotic and other anti-infective applications. to develop acute care products for drug resistant bacteria and acute cardiovascular disorders based on biomimetics - novel non-peptide small molecule drugs that mimic the activity of proteins. PolyMedix’s compounds are designed with a proprietary computational drug design technology licensed from the University of Pennsylvania, and are based on the work of Drs. William DeGrado, Michael Klein, and Gregory Tew.
PolyMedix has developed novel small molecule antibiotic drug candidates by mimicking the activity of the host defense proteins, one of the oldest and most effective antimicrobial defense systems present in virtually all living creatures. Unlike many antibiotic drugs which act on biochemical targets and to which bacterial resistance readily develops, PolyMedix’s antimicrobial compounds have the potential to be rapid acting broad-spectrum antibiotic drugs because they appear to work biophysically by a novel mechanism that targets and disrupts bacterial cell membranes. These new antibiotics compounds are active against Gram-positive, Gram-negative and drug-resistant bacteria, as well as have antifungal and antiviral properties. Laboratory testing has shown their mechanism of action is associated with a low incidence for the development of resistance.
Klein obtained a B.Sc. from the University of Bristol in 1961, followed by a Ph.D. in 1964. He was a researcher at the National Research Council 1968-1987, and joined the faculty of the University of Pennsylvania in 1987.
Klein's research in computational chemistry, particularly statistical mechanics, intermolecular interactions, and modelling of condensed phases and biophysical systems, is among the most highly cited in the field. He received the Aneesur Rahman prize in 1999, which is the highest honor given by the American Physical Society for work in computational physics, and was elected to the United States National Academy of Sciences in 2009.
Richard W. Scott, Ph.D., Vice President, Research at Fox Chase Chemical Diversity Center (FCCDC),a company focused on providing medicinal chemistry/chemical biology support to basic research programs. Our goal is to assist researchers to develop their fundamental research into bona fide drug discovery programs.
Dr. Scott has spent over 28 years in the pharmaceutical industry and has extensive experience in multiple disciplines including microbiology, anti-infectives, acute coronary care, neurobiology and animal model development. He began his career as a Principal Investigator in Central Research Development at E.I. Dupont deNemours and then moved to Cephalon, Inc. in 1991 where he held positions of increasing responsibility prior to becoming Vice President of Neurobiology. He led groups involved in recombinant expression of target gene products, establishment of transgenic and gene-targeted animal models of neurodegenerative disease processes, and drug discovery in signal transduction pathways. In 2002, he co-founded PolyMedix, a company focused on the development non-peptidic mimics of the host defense proteins for infectious disease and cardiovascular disorders. He led the research team responsible for the identification and selection of the clinical lead compound, brilacidin, that successfully completed a Phase 2 clinical study for treatment of acute bacterial skin and skin structure infections (ABSSSI) and identified a potent antagonist of heparin and low molecular weight heparins (delparantag) that also reached Phase 2 clinical study. Additional programs in the research group that were supported by grants from the NIH, NSF and Departments of Defense included the development of antimicrobial mimetics for treatment of Gram-negative infections, oral and disseminated Candidiasis, malaria and food-borne infections. Dr. Scott is an author on over 67 peer-reviewed journal articles and book chapters, and is an inventor on 8 US patents.
Gregory N. Tew, Ph.D.: Professor, Polymer Sciences and Engineering, at the University of Massachusetts. Dr. Tew is one of the original scientific founders of PolyMedix's technology. His research focuses on a number of topics including the design of simple, small synthetic oligomers that capture the biological activity of proteins, such as host defense peptides. He has successfully designed a number of molecular scaffolds that show potent broad spectrum antimicrobial activity and at the same time have minimal toxicity against mammalian cells. Dr. Tew is a founding member of the American Chemical Society Polymer Division, and a Fellow and member of the Defense Science Study Group. He has over 100 peer-reviewed publications and has received several prestigious scientific awards including the PECASE, which is one of the highest honors given by the U.S. federal government for young scientists. Dr. Tew received his Ph.D. in materials science from the University of Illinois.
Henry S. Heine, Ph.D.: Research Microbiologist at University of Florida's Institute of THerapeutic Innovation and Biodefense/Bioterrorism Therapeutic Countermeasures Laboratory
Senior Scientist at Ordway Research Institute in New York. Dr. Heine is currently a member of the American Society of Microbiology and voting member of the CLSI Subcommittee on Veterinary Antimicrobial Susceptibility Testing. He is a former member of the White House Task force for WMD Medical Countermeasures (BARDA-Bio WG) and FDA-CDER Anti-Infective Drugs Advisory Committee. His research focuses on the development and testing of both in vitro and in vivo animal model systems for evaluation of therapeutics against many of the CDC select agent class A and B bacterial pathogens. In addition, Dr. Heine has designed and evaluated non-human primate trials and provided advice and support for meeting the FDA's "animal rule" as the regulatory path to indication approval. Dr. Heine received his Ph.D. in microbiology from the Uniform Services University Health Sciences in Maryland.
Dr. Heine has been a Research Microbiologist at USAMRIID for 11 years and continued at Ordway. Research has involved developing standardized methodology for establishment of susceptibility ranges of licensed and investigational antibiotics and efficacy aerosol-challenge animal models of infection for key strains of Biowarfare/Bioterrorism bacterial agents. At the request of the FDA the Clinical Laboratories Standards Institute (CLSI, formally, National Committee for Clinical Laboratory Standards, NCCLS) helped to establish and standardize this testing criteria for Biowarfare/Bioterrorism bacterial agents.
An important aspect and interest is the development and use of relevant animal models of infection for the BW/BT agents. Understanding the pathogenesis and disease history as it relates to human disease and using these models for advancement of therapies. The design of effective treatment regimens for antibiotic and other therapeutic interventions against any of the potential bacterial BW/BT agents present unique challenges. Most importantly, the traditional drug development paradigm is not applicable in this instance, given the (fortunate) paucity of naturally occurring human cases. Application of pharmacokinetic/pharmacodynamic (PK/PD) principles can assure that animal studies are designed in a manner that preserves their predictive value. Dr Heine has overseen numerous murine model efficacy trials and several non-human primate testing trials and regularly interacts with the FDA in the labeling of indications for antibiotics against the various BW/BT bacterial pathogens. Many of these studies have required application of GLP practices.
Additional interests include: bacterial physiology, applied immunology (immunomodulation therapies), pathogenesis, and Mycobacteriology.
Dr. Heine serves on the editorial board for the peer-reviewed journals Antimicrobial Agents and Chemotherapy and Applied and Environmental Microbiology. He is currently an active member of the American Society for Microbiology He served as a voting member and now as an advisor to the CLSI veterinary antimicrobial susceptibility testing committee (CLSI-VAST). While at USAMRIID he served on the “Public Health Emergency Medical Countermeasures Enterprise) (PHEMCE) which oversees advanced research, development, procurement, and stockpiling of medical countermeasures (e.g. vaccines, medicines, diagnostics, and other necessary medical supplies).
Nothing wrong with repeating old news here...many here have never read about the $30M/60,000 super computing time used in formulation Brilacidin, no less the $10's of millions in testing Brilacidin in lab and human trials.
A complete SUMMARY of THE BRILACIDIN BACK STORY...was composed by Slcimmuno and posted on 02/23/15 under post #92313 (this is on IHUB)
But in the meantime lets play a little game "Did you know?" to see Board knowledge (or how very little they know) of the science of Brilacidin:
"Did you know?"
1. Brilacidin was formulated and co-developed by University of Pennsylvania and its Researchers. (not in Leo's garage)
2. The University of Pennsylvania and its Researchers (Founders) formed an entity Polymedix, the original patent filer, which patent was bought by and now owned by IPIX.
3. Among Founders and Originally Advisory Members were, William F. DeGrado PhD., Dr. and Richard Scott, Henry Heine, Phd., Gregory Tew PhD., Henry S. Heine, Ph.D. and others..(see below...and see where they are now!)
4. Founders spent $30M and in 2005 used 60,000 hours of the then NEW Pittsburgh Supercomputer Center's (PSC) "Big Ben",
5. "Big Ben" was built, in part, "to design of new materials, protein dynamics studies that lead to new therapeutic drugs" through which Brilacidin was formulated.
6. Brilacidin is a synthetic molecule targeting bacteria which mimics the activity of antimicrobial proteins that have a natural ability to prevent bacteria from developing resistance.
7. Brilacidin..uses synthetic molecules to mimic the mechanism of these "host defense proteins," which work by rupturing the skin of bacterial cells.
8. Brilacidin, is an ANTIBIOTIC... thatdirectly breaks the bacteria cell membrane very much like a needle going into a balloon...and because of that there's a very low chance the bacteria can develop resistance to it
9. PolyMedix has "... shown that Brilacidin kills more than 80 different strains of bacteria. Actually, we haven't found any strain of bacteria that we haven't been able to kill with these compounds," ... The compounds have been effective on the biowarfare pathogens black plague, tularemia and 12 strains of anthrax. (FUNNY THING...Brilacidin HAS NEVER FAILED A CLINICAL TRIAL UNDER IPIX/CTIX!)
KEY NOW...will Covid-19 "treatment" test show that Brilacidin "breaks the Covid-19 (and maybe many virus's) cell membrane very much like a needle going into a balloon????
Key players in the development of Brilacidin:
William F. "Bill" DeGrado, Ph.D., is the Professor of Pharmaceutical Chemistry at the University of California, San Francisco (UCSF) where he is the Director of DeGrado Lab research Laboratory and a member of the National Academy of Sciences.
He received a B.S. (chemistry) from Kalamazoo College and a Ph.D. (Chemistry) from the University of Chicago in 1977 working with Emil T. Kaiser and F. Kezdy. His graduate work focused on the design of the oxime resin for solid-phase synthesis, which was used for synthesis of protected peptides and is still in use for various types of combinatorial chemistry today. He also used peptide design to demonstrate that melittin adopts an amphiphilic helical structure, which is responsible for its membrane-disrupting activity.
He first held an industrial position at DuPont Central Research & Development (later DuPont Merck Pharmaceutical Company). He transitioned to academia in 1996, joining the University of Pennsylvania as the George W. Raiziss professor of biochemistry and biophysics and then moved to UCSF in 2011.
Dr. DeGrado was one of the original scientists involved, while at the University of Pennsylvania, in the discovery and subsequent development (see recent mechanistic studies) of Brilacidin and the larger Innovation Pharmaceuticals’ (patent successor to PolyMedix) Host Defense Protein (HDP)-mimetic platform.
Dr. DeGrado’s work laid the foundations for PolyMedix’s core lead drug development programs and product candidates. Both PMX-30063 antibiotic, the world’s first small molecule mimetic of host defense proteins intended for systemic use, and PMX-60056 heptagonist, a new reversing agent for heparin and Low Molecular Weight Heparins, are based on pioneering discoveries originally made by Dr. DeGrado.
He was the scientific founder of and Chief Scientific Advisor for PolyMedix, an emerging biotechnology company at the time developing new therapeutic drugs for serious, life-threatening acute cardiovascular and infectious disease. He was a Professor of Biochemistry and Biophysics at the University of Pennsylvania School of Medicine in Philadelphia, PA, and a member of the National Acad
Based on his work at PolyMedix, he was named the 2008 recipient of the prestigious Ralph F. Hirschmann Award in Peptide Chemistry. The award recognizes a person who has made outstanding contributions in the chemistry, biochemistry, or biophysics of peptides.
His published research includes contributions to the fields of protein design, synthesis of peptidomimetics, and characterization of membrane-active peptides and proteins, most notably the M2 protein.
The M2 proton channel from Influenza A virus. DeGrado’s early work with the groups of Robert Lamb and Larry Pinto established the overall structure and mechanism of the M2 proton channel, which is the target of the anti-influenza drugs, amantadine and rimantadine. A decade later their crystallographic, and NMR structures defined the fine details of the binding site for these drugs and explained the mechanism of the growing problem of amantadine-resistance. With Michael Klein, Robert Lamb and Larry Pinto, DeGrado extensively characterized the physiological properties of many drug-resistant mutants of the channel, identified those most likely to lead to resistance, and designed new drugs to address the problem of drug-resistant forms of influenza A virus.
Dr. DeGrado was one of the original scientists involved, while at the University of Pennsylvania, in the discovery and subsequent development (see recent mechanistic studies) of Brilacidin and the larger Innovation Pharmaceuticals’ (patent successor to PolyMedix) Host Defense Protein (HDP)-mimetic platform.
In 2017, at a lecture, Dr DeGrado has referred to Brilacidin, a promising immunomodulatory drug candidate currently being evaluated in mid-stage clinical trials. Brilacidin, based on insights gleaned from frog peptides, is a successful example of de novo protein design, described as: "the process of using peptide sequences that are not existent in, but inspired by nature" to build molecules as potential innovative therapeutics with novel attributes and applications. As to drug development, such novel synthetic design strategies of proteins ("the workhorses of all living creatures"
allow for improved pharmacokinetic properties and enhanced target specificity. Dr. DeGrado has co-authored over 370 articles (list of publications), holds more than 25 patents, and is a member of the National Academy of Sciences, elected in 1999. In 2003, he was presented (pdf) with the Merrifield Award by the American Peptide Society. He received The Protein Society's Stein and Moore Award in 2015 and, most recently, was presented with the 2017 Biopolymers Murray Goodman Memorial Prize.
Michael L. Klein, is Laura H. Carnell Professor of Science, Director of the Institute for Computational Molecular Science, and Dean of the College of Science and Technology at Temple University in Philadelphia, USA.
He was previously the Hepburn Professor of Physical Science in the Center for Molecular Modeling at the University of Pennsylvania and worked with PolyMedix and instrumental in PolyMedix obtaining the patent titled, "Facially Amphiphilic Polymers as Anti-infective Agents" (developed into Brilacidin) allows compositions of matter and uses for a number of series of antimicrobial compounds for antibiotic and other anti-infective applications. to develop acute care products for drug resistant bacteria and acute cardiovascular disorders based on biomimetics - novel non-peptide small molecule drugs that mimic the activity of proteins. PolyMedix’s compounds are designed with a proprietary computational drug design technology licensed from the University of Pennsylvania, and are based on the work of Drs. William DeGrado, Michael Klein, and Gregory Tew.
PolyMedix has developed novel small molecule antibiotic drug candidates by mimicking the activity of the host defense proteins, one of the oldest and most effective antimicrobial defense systems present in virtually all living creatures. Unlike many antibiotic drugs which act on biochemical targets and to which bacterial resistance readily develops, PolyMedix’s antimicrobial compounds have the potential to be rapid acting broad-spectrum antibiotic drugs because they appear to work biophysically by a novel mechanism that targets and disrupts bacterial cell membranes. These new antibiotics compounds are active against Gram-positive, Gram-negative and drug-resistant bacteria, as well as have antifungal and antiviral properties. Laboratory testing has shown their mechanism of action is associated with a low incidence for the development of resistance.
Klein obtained a B.Sc. from the University of Bristol in 1961, followed by a Ph.D. in 1964. He was a researcher at the National Research Council 1968-1987, and joined the faculty of the University of Pennsylvania in 1987.
Klein's research in computational chemistry, particularly statistical mechanics, intermolecular interactions, and modelling of condensed phases and biophysical systems, is among the most highly cited in the field. He received the Aneesur Rahman prize in 1999, which is the highest honor given by the American Physical Society for work in computational physics, and was elected to the United States National Academy of Sciences in 2009.
Richard W. Scott, Ph.D., Vice President, Research at Fox Chase Chemical Diversity Center (FCCDC),a company focused on providing medicinal chemistry/chemical biology support to basic research programs. Our goal is to assist researchers to develop their fundamental research into bona fide drug discovery programs.
Dr. Scott has spent over 28 years in the pharmaceutical industry and has extensive experience in multiple disciplines including microbiology, anti-infectives, acute coronary care, neurobiology and animal model development. He began his career as a Principal Investigator in Central Research Development at E.I. Dupont deNemours and then moved to Cephalon, Inc. in 1991 where he held positions of increasing responsibility prior to becoming Vice President of Neurobiology. He led groups involved in recombinant expression of target gene products, establishment of transgenic and gene-targeted animal models of neurodegenerative disease processes, and drug discovery in signal transduction pathways. In 2002, he co-founded PolyMedix, a company focused on the development non-peptidic mimics of the host defense proteins for infectious disease and cardiovascular disorders. He led the research team responsible for the identification and selection of the clinical lead compound, brilacidin, that successfully completed a Phase 2 clinical study for treatment of acute bacterial skin and skin structure infections (ABSSSI) and identified a potent antagonist of heparin and low molecular weight heparins (delparantag) that also reached Phase 2 clinical study. Additional programs in the research group that were supported by grants from the NIH, NSF and Departments of Defense included the development of antimicrobial mimetics for treatment of Gram-negative infections, oral and disseminated Candidiasis, malaria and food-borne infections. Dr. Scott is an author on over 67 peer-reviewed journal articles and book chapters, and is an inventor on 8 US patents.
Gregory N. Tew, Ph.D.: Professor, Polymer Sciences and Engineering, at the University of Massachusetts. Dr. Tew is one of the original scientific founders of PolyMedix's technology. His research focuses on a number of topics including the design of simple, small synthetic oligomers that capture the biological activity of proteins, such as host defense peptides. He has successfully designed a number of molecular scaffolds that show potent broad spectrum antimicrobial activity and at the same time have minimal toxicity against mammalian cells. Dr. Tew is a founding member of the American Chemical Society Polymer Division, and a Fellow and member of the Defense Science Study Group. He has over 100 peer-reviewed publications and has received several prestigious scientific awards including the PECASE, which is one of the highest honors given by the U.S. federal government for young scientists. Dr. Tew received his Ph.D. in materials science from the University of Illinois.
Henry S. Heine, Ph.D.: Research Microbiologist at University of Florida's Institute of THerapeutic Innovation and Biodefense/Bioterrorism Therapeutic Countermeasures Laboratory
Senior Scientist at Ordway Research Institute in New York. Dr. Heine is currently a member of the American Society of Microbiology and voting member of the CLSI Subcommittee on Veterinary Antimicrobial Susceptibility Testing. He is a former member of the White House Task force for WMD Medical Countermeasures (BARDA-Bio WG) and FDA-CDER Anti-Infective Drugs Advisory Committee. His research focuses on the development and testing of both in vitro and in vivo animal model systems for evaluation of therapeutics against many of the CDC select agent class A and B bacterial pathogens. In addition, Dr. Heine has designed and evaluated non-human primate trials and provided advice and support for meeting the FDA's "animal rule" as the regulatory path to indication approval. Dr. Heine received his Ph.D. in microbiology from the Uniform Services University Health Sciences in Maryland.
Dr. Heine has been a Research Microbiologist at USAMRIID for 11 years and continued at Ordway. Research has involved developing standardized methodology for establishment of susceptibility ranges of licensed and investigational antibiotics and efficacy aerosol-challenge animal models of infection for key strains of Biowarfare/Bioterrorism bacterial agents. At the request of the FDA the Clinical Laboratories Standards Institute (CLSI, formally, National Committee for Clinical Laboratory Standards, NCCLS) helped to establish and standardize this testing criteria for Biowarfare/Bioterrorism bacterial agents.
An important aspect and interest is the development and use of relevant animal models of infection for the BW/BT agents. Understanding the pathogenesis and disease history as it relates to human disease and using these models for advancement of therapies. The design of effective treatment regimens for antibiotic and other therapeutic interventions against any of the potential bacterial BW/BT agents present unique challenges. Most importantly, the traditional drug development paradigm is not applicable in this instance, given the (fortunate) paucity of naturally occurring human cases. Application of pharmacokinetic/pharmacodynamic (PK/PD) principles can assure that animal studies are designed in a manner that preserves their predictive value. Dr Heine has overseen numerous murine model efficacy trials and several non-human primate testing trials and regularly interacts with the FDA in the labeling of indications for antibiotics against the various BW/BT bacterial pathogens. Many of these studies have required application of GLP practices.
Additional interests include: bacterial physiology, applied immunology (immunomodulation therapies), pathogenesis, and Mycobacteriology.
Dr. Heine serves on the editorial board for the peer-reviewed journals Antimicrobial Agents and Chemotherapy and Applied and Environmental Microbiology. He is currently an active member of the American Society for Microbiology He served as a voting member and now as an advisor to the CLSI veterinary antimicrobial susceptibility testing committee (CLSI-VAST). While at USAMRIID he served on the “Public Health Emergency Medical Countermeasures Enterprise) (PHEMCE) which oversees advanced research, development, procurement, and stockpiling of medical countermeasures (e.g. vaccines, medicines, diagnostics, and other necessary medical supplies).
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