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Konzept Drug Development Consulting

Berkeley, CA, US

Dr. Brotz is a drug discovery and development consultant working with emerging biopharmaceutical companies on drug development strategy, R&D operations and due diligence projects. He has over 15 years of experience in the biopharmaceutical industry, where he led small molecule development from discovery through phase 3. Having fostered a strong entrepreneurial spirit during his career in small company environments, Dr. Brotz is uniquely positioned to understand and address the specific challenges and needs of his clients.

Selected Publications

  • Gaztanaga, J., Farkouh, M., Rudd, J.H.F, Brotz T.M., Rosenbaum, D., Venkatesh, M., Taub, R, Tardif, J.-C.; Tawakol, A., Fayad, Z.A.: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effect of VIA-2291, a 5-Lipoxygenase Inhibitor, on Vascular Inflammation in Patients After an Acute Coronary Syndrome. Atherosclerosis (2015) 240 (1):53-60.
    -... Show more »

Dr. Brotz is a drug discovery and development consultant working with emerging biopharmaceutical companies on drug development strategy, R&D operations and due diligence projects. He has over 15 years of experience in the biopharmaceutical industry, where he led small molecule development from discovery through phase 3. Having fostered a strong entrepreneurial spirit during his career in small company environments, Dr. Brotz is uniquely positioned to understand and address the specific challenges and needs of his clients.

Selected Publications

  • Gaztanaga, J., Farkouh, M., Rudd, J.H.F, Brotz T.M., Rosenbaum, D., Venkatesh, M., Taub, R, Tardif, J.-C.; Tawakol, A., Fayad, Z.A.: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Effect of VIA-2291, a 5-Lipoxygenase Inhibitor, on Vascular Inflammation in Patients After an Acute Coronary Syndrome. Atherosclerosis (2015) 240 (1):53-60.
  • Tardif, J-C.; L'Allier, P.L.; Ibrahim, R., Grégoire, J.C., Nozza, A., Cossette, M., Kouz, S. Lavoie, M-A., Paquin, J., Brotz, T.M., Taub, R., Pressacco, J.: Treatment with 5-Lipoxygenase Inhibitor VIA-2291 (Atreleuton) in Patients with Recent Acute Coronary Syndrome. Circulation Cardiovasc. Imaging 3 (2010): 298-307.
  • Stoll, S., Delon,J., Brotz ,T.M., Germain, R.N.: Dynamic imaging of T cell - dendritic cell interactions in lymph nodes. Science 296 (2002): 1873-1876.
  • Packard,B.Z., Komoriya, A., Brotz,T.M., Henkart,P.A.: Caspase 8 activity in membrane blebs after anti-Fas ligation. J. Immunology 67 (2001): 5061-5066.
  • Mansfield,E., Chae,J.J., Komarow,H.D., Brotz,T.M., Frucht,D.M. Aksentijevich,I., Kastner,D.L.: The familial Mediterranean fever protein, pyrin, associates with microtubules and colocalizes with actin filaments. Blood 98 (2000): 851-859.
  • Oertner,T.G., Brotz, T.M., Borst, A.: Mechanisms of dendritic calcium signaling in fly neurons. (2001) J. Neurophysiol., 85: 439-447.
  • Huh,G.S., Boulanger,L.M., Du.H., Riquelme, P.A., Brotz, T.M., Shatz,C.J.: Functional requirement for class I MHC in development and plasiticity of connections in the central nervous system. Science 290 (2000), 2155-2159.
  • Chen,H.T., Bhandoola,A., Difilippantonio,M.J., Zhu,J. Brown,M.J., Tai,X., Rogakou,E.P., Brotz,T.M., Bonner,W.M., Ried,T., Nussenzweig,A.: NBS1 and H2AX respond to RAG-induced DNA double strand breaks in developing thymocytes. Science 290 (2000), 1962-1964.
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Preclinical Study Design
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Drug Development Consulting
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  • Program and project management for drug discovery and development projects
  • Creating of development strategy, development plans, target product profiles, timelines, and project budgets
  • Leading internal, distributed and virtual project teams
  • Due diligence
  • Program and project management for drug discovery and development projects
  • Creating of development strategy, development plans, target product profiles, timelines, and project budgets
  • Leading internal, distributed and virtual project teams
  • Due diligence
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Cardiovascular
ALS
Biology
Drug discovery
Development
CNS/Neurology
neuroscience
Neuroscience
Antibiotic Development
Antibiotics
Pain
Neuropathic Pain
Alzheimers
spinal cord injury
neurodegenerative disorders
neurodegenerative diseases
neuropathy
multiple sclerosis
cardiovascular
medical devices
Diagnostic
autoimmune
Atherosclerosis
Infectious Disease
Infectious Disease
Alzheimers Disease
Pediatrics
Preclinical Efficacy Studies
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  • Selection and management of CROs for non-clinical studies, including toxicology, ADME/PK, animal models, and biomarker development
  • Study management including protocol development, study monitoring, and report review
  • Selection and management of CROs for non-clinical studies, including toxicology, ADME/PK, animal models, and biomarker development
  • Study management including protocol development, study monitoring, and report review
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Rabbit
Mouse
Rat
Dog
Cardiovascular
ALS
Drug discovery
Development
neuroscience
Neuroscience
Antibiotic Development
Antibiotics
Pain
Neuropathic Pain
Repeated dose Toxicology 14, 28, 90 days
spinal cord injury
neurodegenerative disorders
neurodegenerative diseases
neuropathy
multiple sclerosis
cardiovascular
biomarker
autoimmune
Atherosclerosis
Infectious Disease
Alzheimers Disease
Non-human primates
Regulatory Affairs Consulting
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  • Drafting and reviewing of regulatory documents including:
  • INDs, NDAs, Investigator Brochures, Meeting Briefing Packages, PSPs, PIPs, Annual Reports, Tabulated Summaries (CTD)
  • Drafting and reviewing of regulatory documents including:
  • INDs, NDAs, Investigator Brochures, Meeting Briefing Packages, PSPs, PIPs, Annual Reports, Tabulated Summaries (CTD)
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ALS
Drug discovery
Development
CNS/Neurology
neuroscience
Antibiotic Development
Antibiotics
Pain
Neuropathic Pain
spinal cord injury
neurodegenerative disorders
neurodegenerative diseases
neuropathy
multiple sclerosis
cardiovascular
inflammatory Bowel Disease
medical devices
Autoimmune
biomarker
Diagnostic
autoimmune
Atherosclerosis
Infectious Disease
Central Nervous System
Infectious Disease
Alzheimers Disease
Grant Writing
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  • Drafting, reviewing and formatting of applications for grants and government contracts (e.g. NIH, BARDA, DARPA)
  • Drafting, reviewing and formatting of applications for grants and government contracts (e.g. NIH, BARDA, DARPA)
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Cardiovascular
ALS
Development
CNS/Neurology
neuroscience
Neuroscience
Antibiotic Development
Antibiotics
Pain
Neuropathic Pain
Alzheimers
spinal cord injury
neurodegenerative disorders
neurodegenerative diseases
neuropathy
multiple sclerosis
cardiovascular
medical devices
Autoimmune
Diagnostic
autoimmune
Infectious Disease
Alzheimers Disease
Clinical Data Collection, Analysis and Management
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  • Exploratory analysis of clinical efficacy and biomarker data
  • Exploratory analysis of clinical efficacy and biomarker data
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GraphPad Prism
Cardiovascular
ALS
Drug discovery
CNS/Neurology
neuroscience
Neuroscience
Antibiotic Development
Antibiotics
Pain
Neuropathic Pain
Alzheimers
spinal cord injury
neurodegenerative disorders
neurodegenerative diseases
neuropathy
multiple sclerosis
cardiovascular
biomarker
autoimmune
Atherosclerosis
Infectious Disease
Infectious Disease
Cardiac Function
Alzheimers Disease
stroke
CT imaging
FDG-PET imaging
Spotfire
Clinical Pharmacology
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  • Phase 1 strategy and planning
  • Assessing need for specialty studies including human mass-balance and drug-drug interaction studies
  • Estimating and setting human dose
  • Oversight of Pharmacometrics projects (Modeling & Simulation)
  • Phase 1 strategy and planning
  • Assessing need for specialty studies including human mass-balance and drug-drug interaction studies
  • Estimating and setting human dose
  • Oversight of Pharmacometrics projects (Modeling & Simulation)
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Cardiovascular
ALS
Biology
Drug discovery
CNS/Neurology
neuroscience
Neuroscience
Antibiotic Development
Antibiotics
Neuropathic Pain
Alzheimers
neurodegenerative disorders
neurodegenerative diseases
neuropathy
cardiovascular
biomarker
autoimmune
Atherosclerosis
Infectious Disease
Alzheimers Disease
Pain
Toxicology
Price on request
  • Outsourcing and oversight of toxicology studies
  • Protocol development and report review
  • Data interpretation
  • Outsourcing and oversight of toxicology studies
  • Protocol development and report review
  • Data interpretation
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Rabbit
Mouse
Rat
Dog
Drug discovery
neurotoxicity
CNS/Neurology
Neuroscience
Antibiotics
Pain
Neuropathic Pain
Alzheimers
Repeated dose Toxicology 14, 28, 90 days
neurodegenerative disorders
cardiovascular
Infectious Disease
Safety Pharmacology
Reproductive Toxicology
Genotoxicity
Non-human primates
ADME and DMPK Studies
Drug Metabolism and Pharmacokinetics
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  • Outsourcing and oversight of ADME/PK studies including:
  • PK, in-vitro metabolism, in-vitro drug-drug-interaction, mass-balance studies
  • Outsourcing and oversight of ADME/PK studies including:
  • PK, in-vitro metabolism, in-vitro drug-drug-interaction, mass-balance studies
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Mouse
Rat
Dog
Drug discovery
Small Molecules
Non-human primates
In vivo Pharmacology Studies
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  • Outsourcing and oversight of animal models of disease
  • Protocol development, data interpretation and report review
  • Outsourcing and oversight of animal models of disease
  • Protocol development, data interpretation and report review
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Mouse
Rat
Dog
Cardiovascular
ALS
Drug discovery
CNS/Neurology
neuroscience
Neuroscience
Antibiotic Development
Antibiotics
Pain
Neuropathic Pain
Alzheimers
neurodegenerative disorders
neuropathy
multiple sclerosis
Experimental Autoimmune Encephalomyelitis (EAE)
cardiovascular
Autoimmune
autoimmune
Atherosclerosis
Infectious Disease
Infectious Disease
Alzheimers Disease
stroke
Pain
Stroke
Non-human primates
Drug Development Project Management
Price on request
  • Leading internal, distributed and/or virtual project teams
  • developing project strategy, timelines and budgets
  • Leading internal, distributed and/or virtual project teams
  • developing project strategy, timelines and budgets
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Neuropathic Pain
neurodegenerative disorders
cardiovascular
Infectious Disease
Project Management & Consulting Services
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Animal Models and Studies
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Clinical Research
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Scientific Communication
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Editorial Support
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Regulatory Affairs Services
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Clinical Laboratory Services
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Pharmacology & Toxicology
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In vivo PK/PD Studies
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Drug Discovery & Development
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Drug Development
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