Our Vision

Our vision is to improve patient care using integrated approaches involving laboratory models, mathematical models and machine-learning/Al methods to reduce time to bringing new therapies to market and to optimize treatments for patients after regulatory approval.

Our tools include quantitative wet laboratory models made of human-tissue, non-linear dynamical systems, and non-linear mathematical models, which we wrote from scratch and coded, for drug discovery development.

Our physician dominated team uses clinical and pathophysiologic know-how, the mathematics of topology and morphism mapping and category theory, to map disease response from the preclinical models to patients, so that readouts in our preclinical models will give precise rates of responses expected in patients, not just in terms of how many patients respond to therapy, but how fast, and the optimal duration of such therapy, and the doses to minimize failure and resistance to therapy. Thus, we can forecast clinical responses in early preclinical development, and then design adaptive clinical trials de novo, including the biomarkers of therapeutic response, duration of therapy, thereby de-risking time (decades), money (millions), and clinical trial patients’ lives (unquantifiable).

We also design combination therapy regimens using factorial design to find best companion drugs and doses for therapeutics.

Our motto summarizes it all. Quantify. Predict. Cure.

Meet Our Leadership Team

Tawanda Gumbo, M.D.
President & CEO, Founder

 

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Tawanda Gumbo, MD, is a physician scientist, rising to the rank of Professor of Medicine. Medical School was at the University of Zimbabwe, Residency in Internal Medicine at Case Western Reserve University, and Fellowship in Infectious Diseases at the Cleveland Clinic, in Cleveland, Ohio.

Dr. Gumbo developed several preclinical and clinical laboratory models for fungal, parasitic, bacterial and viral infections, the human immune system, and cancer. He has also developed several mathematical models for translation from the laboratory to patients in the area of therapeutics and quantitative translational pharmacology, and for characterizing disease progression and the immune system in patients based on next generation sequencing and other ‘omics.

He has received research funding for decades from the US NIH, and other private-public funders. Dr. Gumbo is the recipient of numerous awards. His research work has been used to identify optimal doses of the three currently licensed antifungal drugs called echinocandins, anti-TB compounds by the WHO Global TB Program and by national TB programs in numerous countries, the design of new anti-TB drug regimens for children and adults, treatment of non-tuberculous mycobacteria, and together with his team recently identified and characterized safe inhibitors of the fundamental physiologic pathway, sonic hedgehog signaling, and the role of inhibitory immune checkpoints in TB.

He holds several patents for diagnostics, and for monoclonal antibodies that bind to FCER1. Dr. Gumbo is also a published poet and novelist. He also writes the introduction chapter to anti-infective therapy chapter, and the treatment of mycobacterial infections chapter in Goodman & Gilman’s The Pharmacological Basis of Therapeutics, referred to as the “Bible of pharmacology. He has authored about 200 scientific publications on PubMed: VIEW HERE

David Howe, PhD.
Vice President & CSO / COO

 

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Dr. David Howe is an industry veteran with more than 25 years experience in the pharmaceutical industry. Dr. Howe received his PhD in Medicinal Chemistry from the University of Michigan, MSc in Medicinal Chemistry from the University of Michigan and a BSE in Aerospace Engineering from the University of Michigan.

His doctoral research involved the investigation of the enzymatic mechanisms of novel biological targets to design new antibacterials for gram-negative bacteria. Dr. Howe has experience in both drug discovery and drug development covering drug substance characterization and analytical development for GLP activities formulation development and characterization, drug metabolism, bioanalytics, metabolite identification, pharmacokinetics, toxicokinetics and model based drug development (pharmacokinetics/pharmacodynamices).

Dr. Howe has held senior scientific and management positions at Pfizer, Vertex Pharmaceuticals and AstraZeneca. In these positions, he participated drug discovery and development teams supporting drug metabolism, pharmacokinetics, and PK/PD for antibacterial programs and various disease areas and led the functions of drug metabolism (ADME), pharmacokinetics, pharmacokinetic/pharmacodynamics and bioanalysis. He has a number of successful drugs in portfolio that he has contributed to including Lyrica (Pregabalin), Kalydeco, Telzir & Incivek. In addition to his experience in discovery and non-clinical development Dr. Howe has experience in the design and support of clinical trials through Phase III for antibacterials.

Meet Our Scientific Team

Shruti Athale, PhD.

 

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  1. PhD in immunology
  2. Dr. Athale has worked on immunological aspects of various infectious diseases like vaccinia virus, influenza vaccine and TB.
  3. With Dr. Gumbo was instrumental in development of hollow fiber system using peripheral blood monocytes (PBMCs) to study the role of innate / adaptive immunity as well as the role of different immune checkpoints
  4. Study of early immune response induced by inactivate influenza vaccines in vitro and in vivo
  5. Developed a strategy that is safe and effective against smallpox by using modified Ankara virus (MVA) in mouse models and (iv) Investigate, the role of neutrophils in systemic lupus erythematosus (SLE).
  6. She has 15 years of experience in developing disease models. She had developed mouse models for vaccinia virus infection/ challenge, developed chimeric mouse models as well as mouse model of arthritis.
  7. Expertise in immunology, specifically using various immunological assays like immunophenotyping, antibody biding assays, cell sorting and experience in several disease models

Claude Bernal

 

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  1. Bachelor of Science in Chemistry, University of Texas
  2. LCMS Specialist for Bioanalytical Chemistry analysis
  3. Expertise in HPLC, GC, wet chemistry analysis, and separation techniques
  4. Pharmaceutical industry experience with sample analysis such as raw materials, in-process, R&D, finished products, stability, & CMC. 
  5. Experience working with sample types that include skin care, cannabis, DEA controlled substances, oral dose, aerosols, drug products for injection, and others. 
  6. Former company Lead Chemist and Team Leader

Moti Chapagain, M.D., PhD.

 

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  1. MD, PhD; Physician and bench scientist
  2. Extensive training and experience in work with both DNA and RNA viruses and parasites
  3. Has published dozens of seminal papers on epidemiology, molecular pathogenesis, diagnosis and treatment of important human viruses including human polyomavirus JC (JCV), West-Nile virus (WNV) and dengue virus.
  4. Explored role of serotonin receptor blocker risperidone against JCV and roles of minocycline and tumor necrosis factor a receptor 2 in WNV and is expert in virus culture, characterization and quantification
  5. Expert in laboratory hollow fiber models of tuberculosis, Mycobacterium avium-complex, Mycobacterium abscessus, and Mycobacterium kansasii

Alma Gallardo

 

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  1. Bachelors of Biology, Texas Woman’s University 
  2. Background in neurophysiology research & experience with cell culture and treatment of B35 Neuroblastoma cells
  3. Studies in the actin filaments of dendrites targeting Alzheimer’s disease. 

Tawanda Gumbo, M.D.

 

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  1. Medical Doctor, Residency in Internal Medicine, and fellowship in Infectious Diseases; Diplomate of the American Board of Internal Medicine [Infectious Diseases and Internal Medicine), and clinician.
  2. Developed a number of drug-development tools and drugs in his portfolio, including the mouse model of disseminated Candida glabrata (a disease he also wrote seminal clinical descriptions in patients), and disease models for microsporidisosis (a parasite).
  3. Developed several variants of the hollow fiber system for different infections, cancers, and the human immune system, including bringing the model for tuberculosis before US and European regulatory bodies and the World Health Organization.
  4. Developed new mathematical tools for translation from the lab to patients for a number of infections based on category theory, including time-to-extinction mapping.
  5. Developed new mathematical tools for spatial mapping of networks and physiological systems as complex adaptive systems mapped to histopathology and gross anatomy too for translation, as they evolve in time, based on dynamical systems, chaos theory, and bifurcation theory
  6. One of the pioneers in use of machine learning in the early 2000s in pharmacometrics, diagnostics, and identification of predictors of outcome
  7. Has developed and patented a monoclonal antibody and antibody-directed liposome against FCER for inhalation
  8. Has developed and patented diagnostic biomarkers starting in preclinical models and translating them to patient outcomes in phase 1-Ill studies based on proprietary mathematical models
  9. Discovery of the role of TREM-1, neuroendocrine system, and inhibitory immune checkpoints in mycobacterial immune evasion
  10. Dr. Gumbo has won numerous awards, including being named among ,1000 most inspiring Black scientists of all categories: VIEW HERE

David Howe, PhD.

 

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  1. PhD in Medicinal Chemistry, an MSc in Medicinal Chemistry, and a BSc in Aerospace Engineering
  2. Over 25 years experience in both drug discovery and drug development, including at companies such as Vertex Pharmaceuticals, Pfizer, AstraZeneca Tanabe Research and LuminaCare Solutions, a mixture of startup, small, medium, and large biotech and pharma companies.
  3. Helped develop a number of successful drugs in his portfolio, including Lyrica (Pregabalin), Kalydeco, Telzir and Incivek.
  4. Developed diagnostics at LuminaCare Solutions
  5. Special modeling skills in pharmacometrics, modeling and simulations
  6. Special modeling skills Monte Carlo simulations expertise
  7. Special modeling and simulations to develop biomarkers
  8. Advanced Quantitative structure-activity relationship (QSAR) modeling and simulations
  9. Standard PK/PD modeling

Thearith Koeuth

 

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  1. Trained network administrator and molecular technique scientist
  2. Recombinant DNA Techniques: DNA cloning, Constructing vectors for gene expression and gene knockout, Primer and probe designs, TaqMan single-nucleotide polymorphism (SNP typing), cDNA synthesis and PCR, Sanger DNA sequencing to verify sequence integrity and mutation, gDNA-RNA isolation, TaqMan Real-Time quantitative PCR qPCR).
  3. Co-inventor of rep-PCR patent, a method for bacterial DNA fingerprinting by PCR
  4. Special mammalian and bacterial cell culture techniques, Cryopreservation, Selecting monoclonal cell lines, cell transfection, isolation of peripheral blood mononuclear cells (PBMCs), in vitro cell stimulations, Large scale human macrophage cell cultures.

Jotam Pasipanodya, M.D., DrPH

 

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  1. Clinical epidemiologist; physician scientist with quantitative skills in pharmacometrics, including machine-learning approaches applied to decision- and implementation sciences; clinical translation across global health
  2. Developed concepts of concentration-dependent antagonism/synergism using machine-learning algorithms for interaction detection, feature-selection and rule ensembles
  3. Developed and pioneered approaches for incorporating machine-learning methods in clinical translations, decision-and implementation sciences
  4. Use non-parametric adaptive grid (NPAG) to identify factors driving pharmacokinetic (PK) and pharmacodynamic (PD) variability across heterogenous patient groups
  5. Pioneered the use of machine learning methods, such as MARS with stochastic gradient boosting, as means for more efficient covariate selection during pop PK/PD modeling
  6. Recently, has been applying Langevin equations to identify the criticality signatures of dynamical systems to explain emergent properties, such as drug resistance or abhorrent lung damage.
  7. Has built integrated mathematical models for estimating therapy duration and time-to-cure using bacterial kill slopes, pop PK/PD and optimal multi-drug regimen selection.

 

Swati Patel, M.S. Biotechnology

 

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  1. Lab Scientist, Lead QC Development Manager
  2. Education: Bachelor’s in Microbiology, Master’s in Biotechnology
  3. 11 years of experience of Clinical Microbiology Lab and Pharmaceutical Microbiology QC Lab
  4. Cloning of Pigment Producing Genes.
  5. Expertise in performing routine and specialized testing in bacteriology, including Multi Drug Resistance Bacteria, Carbapenem Resistance Bacteria and ESBL resistance bacteria & Expertise in ruling out bioterrorism organisms.
  6. CLIA and CAP Compliance.
  7. Worked in Pharmaceutical as a QC Microbiology Supervisor.
  8. Experienced with cGMP systems and the CFR, to address quality systems, production batch records and manufacturing requirements to maintain compliance with these guidelines.
  9. Contamination control functions, facility design, cleanroom classification, and supervised the Aseptic and Non-Aseptic Manufacturing and testing facility, from an environmental monitoring aspect, to ensure the facility and equipment are functioning under a state of control, with sterile processes remaining within current FDA and EU Aseptic processing guidelines. 

Praedicare Africa Team

 

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Our Departments

Quality Control & Quality Assurance

Pharmaceutical Chemistry, Manufacturing & Controls

Molecular Biology & Technology Development Lab

Hollow Fiber System & Experimental Therapeutics Labs

Quantitative Preclinical & Clinical Sciences

Clinical Trials: FIH, Phase I-IV

Data Protection Security

Business Development & Partnerships

Business Manager

Interested in learning more?

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