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Konzept Drug Development Consulting

Berkeley, California, 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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Immunology
Biology
Drug Discovery
CNS/Neurology
Antibiotic Development
Pain
Spinal cord injury
Neurodegenerative diseases
Neuropathy
Cardiovascular
Medical Devices
Atherosclerosis
Infectious Disease
Alzheimers Disease
Pediatrics
Multiple sclerosis (MS)
Amyotrophic Lateral Sclerosis (ALS)
In vivo Drug Efficacy Testing
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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
Immunology
Drug Discovery
CNS/Neurology
Antibiotic Development
Pain
Repeated dose Toxicology 14, 28, 90 days
Spinal cord injury
Neurodegenerative diseases
Neuropathy
Cardiovascular
biomarker
Atherosclerosis
Infectious Disease
Alzheimers Disease
Multiple sclerosis (MS)
Nonhuman Primate
Amyotrophic Lateral Sclerosis (ALS)
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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Immunology
Drug Discovery
CNS/Neurology
Antibiotic Development
Pain
Spinal cord injury
Neurodegenerative diseases
Neuropathy
Cardiovascular
Inflammatory Bowel Disease
Medical Devices
biomarker
Atherosclerosis
Infectious Disease
Alzheimers Disease
Multiple sclerosis (MS)
Autoimmune disease
Amyotrophic Lateral Sclerosis (ALS)
Grant Writing
Price on request
  • 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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Immunology
CNS/Neurology
Antibiotic Development
Pain
Spinal cord injury
Neurodegenerative diseases
Neuropathy
Cardiovascular
Medical Devices
Infectious Disease
Alzheimers Disease
Multiple sclerosis (MS)
Autoimmune disease
Amyotrophic Lateral Sclerosis (ALS)
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
Immunology
Drug Discovery
CNS/Neurology
Antibiotic Development
Pain
Spinal cord injury
Neurodegenerative diseases
Neuropathy
Cardiovascular
biomarker
Atherosclerosis
Infectious Disease
Alzheimers Disease
Multiple sclerosis (MS)
Stroke
CT imaging
FDG-PET imaging
Spotfire
Amyotrophic Lateral Sclerosis (ALS)
Clinical Pharmacology
Price on request
  • 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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Immunology
Biology
Drug Discovery
CNS/Neurology
Antibiotic Development
Pain
Neurodegenerative diseases
Neuropathy
Cardiovascular
biomarker
Atherosclerosis
Infectious Disease
Alzheimers Disease
Amyotrophic Lateral Sclerosis (ALS)
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
Pain
Repeated dose Toxicology 14, 28, 90 days
Cardiovascular
Infectious Disease
Alzheimers Disease
Safety Pharmacology
Reproductive Toxicology
Genotoxicity
Nonhuman Primate
ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
Price on request
  • 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 Molecule Drugs
Nonhuman Primate
In vivo Pharmacology Studies
Price on request
  • 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
Immunology
Drug Discovery
CNS/Neurology
Antibiotic Development
Pain
Neuropathy
Experimental autoimmune encephalomyelitis (EAE)
Cardiovascular
Atherosclerosis
Infectious Disease
Alzheimers Disease
Multiple sclerosis (MS)
Stroke
Autoimmune disease
Nonhuman Primate
Amyotrophic Lateral Sclerosis (ALS)
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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CNS/Neurology
Pain
Cardiovascular
Infectious Disease
Project Management
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Marketing, Communication & Graphic Design Services
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Editorial and Writing Services
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Regulatory Affairs Services
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Animal Models and Studies
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Clinical Research
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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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