Konzept partners with biotech companies and investment funds to navigate the complexities of nonclinical development, regulatory strategy, and R&D operations — efficiently and with scientific rigor.
Schedule an Introductory CallDr. Brotz is an entrepreneurial R&D leader and drug development consultant with 25 years of experience advancing therapeutics from discovery through Phase 3 development and NDA approval. His expertise spans toxicology, in-vivo pharmacology, DMPK, clinical pharmacology, translational research, diagnostics, and regulatory affairs.
He has led programs across small molecules, biologics, antibody-drug conjugates (ADCs), radioligand therapeutics, gene therapies, and in-vitro diagnostics. His career includes senior leadership roles at Achaogen (NDA filing for ZEMDRI), VIA Pharmaceuticals (End-of-Phase 2a meeting, FDA Carcinogenicity Assessment Committee), and Renovis (3 INDs including a 505(b)(2) filing), as well as staff scientist positions at the National Cancer Institute, NIH.
Through Konzept, Dr. Brotz leads nonclinical and regulatory strategy for client programs spanning oncology, CNS, infectious disease, metabolic disorders, and rare diseases. Recent project highlights include 3 ADC INDs filed within 18 months and leading a radioligand therapeutics program from lead optimization through IND. He is a consummate planner and collaborative leader of in-house and geographically distributed virtual teams with an extensive track record managing large portfolios of CROs, CMOs, and consultants.
Dr. Brotz received his Ph.D. in animal physiology/neuroscience from the University of Tübingen, Germany and completed his postdoctoral training with Carla Shatz at UC Berkeley.
Integrated consulting services for biotech companies and investment funds at every stage of drug development.
End-to-end drug development strategy from discovery through Proof of Concept and beyond. Target product profile development, gap analyses, and integrated development plans with realistic budgets and timelines for resource-constrained environments.
Nonclinical program design and execution for small molecules, biologics, ADCs, radioligand therapeutics, and gene therapies. Toxicology, pharmacology, DMPK, and CMC oversight including CRO selection, qualification, site visits, and study management.
IND, NDA, and 505(b)(2) filing strategy and document preparation. FDA meeting packages (Type A, B, C, Pre-IND, EOP2). Interactions with US and EU regulatory agencies including EMA Scientific Advice, MHRA, and international CTAs.
Implementation of virtual R&D operations for companies without in-house infrastructure. Project management, vendor qualification, CRO/CMO portfolio management, and cross-functional team leadership across geographically distributed organizations.
Scientific and technical due diligence for investment funds and licensing teams evaluating biotech assets. Fast-turnaround assessments of nonclinical and clinical data packages, development risk, and competitive landscape.
Biomarker strategy, translational pharmacology, and clinical-nonclinical bridging. Lead optimization and candidate selection support. Exploratory data analysis for preclinical and clinical datasets including PK/PD and imaging endpoints.
Consulting for emerging biotech companies and investment funds. Program lead, nonclinical expert, and regulatory strategist on client project teams across all therapeutic modalities. Creating development strategy for small molecules, biologics, ADCs, radioligand therapeutics, and gene therapies. Designing and executing nonclinical studies through CROs. Drafting and reviewing INDs, NDAs, and FDA meeting packages. Conducting gap analyses and due diligence. Acting VP roles at client companies including R&D Operations leadership at a neurodegeneration startup.
Led Development Sciences function (clinical pharmacology, pharmacometrics, DMPK, toxicology, diagnostics). Completed nonclinical development for plazomicin (ZEMDRI®), enabling NDA filing. Led In Vitro Diagnostic team for pivotal Phase 3 antibiotic study. Managed NDA subteam and successful US/EU regulatory interactions including juvenile tox study waiver.
Oversaw preclinical R&D including discovery, IND-enabling, and translational research for cardiovascular/metabolic programs. Led Phase 2a efficacy analyses for VIA-2291. Obtained FDA agreement on Phase 3 progression (EOP2a meeting) and favorable Carcinogenicity Assessment Committee ruling. Secured in-licensing deals from Roche.
Led preclinical department (25+ staff, $7M budget). Filed 3 INDs including 505(b)(2). Supported pain programs from discovery through Phase 2 PoC resulting in top-5 pharma partnership. Established stage-gate drug discovery paradigm and governance committees.
Staff Scientist and Head of Microscopy & Digital Imaging Facility, Experimental Immunology Branch, National Cancer Institute, Bethesda, MD.
A sampling of recent program work across modalities and therapeutic areas.
Program leadership for oncology ADC portfolio including nonclinical strategy, IND preparation, and FDA interactions. Fast-track designation granted.
Strategic and operational leadership from lead optimization through IND-enabling studies for an oncology radioligand therapeutic program.
Development strategy, budget, and timeline for a gene therapy program in spinal cord injury including oncolytic adenovirus with immune-stimulatory payload.
IND-enabling nonclinical program design and execution for a first-in-class host-targeted antiviral therapeutic.
Program leadership, nonclinical and regulatory roles including due diligence, asset transfer, and US regulatory strategy.
Nonclinical study design and execution for novel insulin formulations and long-acting peptide hormone replacement therapy.
Whether you are an early-stage biotech seeking IND-enabling strategy, an investment fund performing due diligence, or a development-stage company needing nonclinical or regulatory support — I welcome the opportunity to discuss how Konzept can help.
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