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Konzept Drug Development Consulting

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Berkeley, California, US

About Konzept Drug Development Consulting

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... 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., Gr├ęgoire, 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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Our Services (22)


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Preclinical Study Design

Price on request
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Drug Development Consulting

Price on request
  • 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 CNS/Neurology Pain Cardiovascular Infectious Disease Pediatrics Spinal cord injury Neurodegenerative diseases Neuropathy Atherosclerosis Alzheimers Disease Multiple sclerosis (MS) Amyotrophic Lateral Sclerosis (ALS) Biology Drug Discovery Antibiotic Development Medical devices Show 17 more tags Show less

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In vivo Drug Efficacy Testing

Price on request
  • 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 Non-human primates (NHP) Immunology CNS/Neurology Pain Cardiovascular Infectious Disease Spinal cord injury Neurodegenerative diseases Neuropathy Atherosclerosis Alzheimers Disease Multiple sclerosis (MS) Amyotrophic Lateral Sclerosis (ALS) Repeated dose Toxicology 14, 28, 90 days biomarker Drug Discovery Antibiotic Development Show 21 more tags Show less

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Regulatory Affairs Consulting

Price on request
  • 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 CNS/Neurology Pain Cardiovascular Infectious Disease Spinal cord injury Neurodegenerative diseases Neuropathy Inflammatory Bowel Disease Atherosclerosis Alzheimers Disease Multiple sclerosis (MS) Autoimmune disease Amyotrophic Lateral Sclerosis (ALS) biomarker Drug Discovery Antibiotic Development Medical devices Show 18 more tags Show less

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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 Pain Cardiovascular Infectious Disease Spinal cord injury Neurodegenerative diseases Neuropathy Alzheimers Disease Multiple sclerosis (MS) Autoimmune disease Amyotrophic Lateral Sclerosis (ALS) Antibiotic Development Medical devices Show 14 more tags Show less

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Clinical Data Collection, Analysis and Management

Price on request
  • Exploratory analysis of clinical efficacy and biomarker data
  • Exploratory analysis of clinical efficacy and biomarker data
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GraphPad Prism Spotfire Immunology CNS/Neurology Pain Cardiovascular Infectious Disease Spinal cord injury Neurodegenerative diseases Neuropathy Atherosclerosis Alzheimers Disease Multiple sclerosis (MS) Stroke Amyotrophic Lateral Sclerosis (ALS) biomarker CT imaging FDG-PET imaging Drug Discovery Antibiotic Development Show 20 more tags Show less

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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 CNS/Neurology Pain Cardiovascular Infectious Disease Neurodegenerative diseases Neuropathy Atherosclerosis Alzheimers Disease Amyotrophic Lateral Sclerosis (ALS) biomarker Biology Drug Discovery Antibiotic Development Show 14 more tags Show less

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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 Non-human primates (NHP) CNS/Neurology Pain Cardiovascular Infectious Disease Alzheimers Disease neurotoxicity Repeated dose Toxicology 14, 28, 90 days Safety Pharmacology Reproductive Toxicology Genotoxicity Drug Discovery Show 16 more tags Show less

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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 Non-human primates (NHP) Drug Discovery Small molecules Show 6 more tags Show less

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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 Non-human primates (NHP) Immunology CNS/Neurology Pain Cardiovascular Infectious Disease Neuropathy Experimental autoimmune encephalomyelitis (EAE) Atherosclerosis Alzheimers Disease Multiple sclerosis (MS) Stroke Autoimmune disease Amyotrophic Lateral Sclerosis (ALS) Drug Discovery Antibiotic Development Show 19 more tags Show less

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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

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Editorial and Writing Services

Price on request
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Drug Discovery & Development

Price on request
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Pharmacology & Toxicology

Price on request
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Clinical Laboratory Services

Price on request
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Project Management

Price on request
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Drug Development

Price on request
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In vivo PK/PD Studies

Price on request
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Marketing, Communication & Graphic Design Services

Price on request
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Regulatory Affairs Services

Price on request
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Clinical Research

Price on request
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Animal Models and Studies

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Tilmann Brotz

Principal Consultant

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