development
Connecting Teams to Drug Development Partners
Drug development follows different rules than research and discovery.
It requires validated processes, regulatory compliance, reproducibility, and operational scale. At this stage, execution matters as much as scientific insight, and working with the right partners can reduce risk, timelines, and costly rework.
I connect biotech companies to partners that support:
Clinical Development
Find the fastest route to your pivotal trial. Design a clinical development path that stays credible and robust over time.
My partners support:
- Clinical trial strategy and study design aligned with regulatory expectations
- Operational oversight and patient safety
- Data analysis, reporting and documentation
01
STRATEGY
Competitor and market landscape analysis for clinical trials
Clinical trial design and protocol optimization
Budget and resource planning
Operational risk review and mitigation
Clinical development program structuring across phases
02
REGULATORY
Regulatory strategy for local and global clinical trials
Risk-based quality management and GCP compliance
Inspection readiness and regulatory compliance support
03
OPERATIONS
Project management: planning, timelines, coordination and support.
Oversight of protocol deviations and corrective actions (CAPA)
Safety oversight and pharmacovigilance compliance
04
DATA MANAGEMENT & ANALYSIS
Data management creation, review, plans validation, and query systems (eCRF, eTMF)
Clinical data analysis, biostatistics and analysis reporting
05
MEDICAL WRITING
Investigator’s Brochure (IB), Clinical Study Reports (CSRs), briefing books, Clinical evaluation reports, protocols, informed consent form, peer-reviewed manuscripts…
SuccesSful projects
Clinical project management and regulatory execution for a COVID-19 program
This partner supported a biologic clinical program for COVID-19 in Austria, providing end to end clinical operations and regulatory execution. Their role covered clinical project management, protocol development, medical writing, and data and document management. This included literature reviews, preparation of the final study protocol and informed consent forms, development of study specific manuals, and overall project planning. They also coordinated multidisciplinary teams and third party vendors, built and maintained eCRF and eTMF systems, and managed safety reporting, quality oversight, and risk mitigation. Through this structured approach, the clinical program was executed efficiently and in line with regulatory expectations.
Clinical investigation planning and oversight for a medical device
This team supported a clinical program for a cardiovascular medical device targeting aortic stenosis across Europe. Their role included clinical project management, protocol development, medical writing, and data and document management. This covered literature reviews, preparation of the clinical investigation plan, investigator’s brochure, informed consent forms, and other regulatory submission documents and study manuals. They also led project planning, team coordination, and eCRF development, maintained the eTMF, and managed safety oversight including SAE and SADE reporting.
Bioanalysis
Generate bioanalytical data that is reliable, reproducible, and trusted by regulators. Achieve in-depth characterization for early-stage research, preclinical and clinical studies.
My partners support:
- Characterization of biologics and small molecules using mass spectroscopy, chromatography, sequencing, and cell-based assays
- Studies for active pharmaceutical ingredient (API) that support candidate selection, robust development, and FDA and EMA expectations
01
BIOLOGICS
Characterize IgG antibodies, multi-specific antibodies, antibody drug conjugate (ADCs) and nanobodies
Fusion proteins
Enzymes, hormones
AAVs
02
SMALL MOLECULE
Characterize spent media, metabolites, vitamins and neurotransmitters
03
STUDIES
Biosimilar studies
Developability studies
Lead and clone selection
Forced degradation studies
03
ANALYTICAL
Primary structure analysis: protein sequence analysis, DNA/RNA sequencing
Product quality and impurity profiling: amino acid modifications, charge heterogeneity, CE analysis
Structural integrity and stability: aggregation analysis, higher order structure characterization
Functional activity: bioactivity studies, cell based assays, SPR analysis
Post translational and chemical modifications
Serum and plasma assays,
SuccesSful projects
Assessing how protein modifications impact the functional activity of therapeutic antibodies
A central challenge in biologics development is that protein modifications can accumulate during manufacturing or stress conditions and compromise activity without obvious structural warning signs. To address this, the team implemented an integrated workflow combining peptide mapping by LC-MS to detect post translational modifications with a cell based potency assay to assess functional activity. They identified increased deamidation at specific sites and demonstrated that these modifications correlated with a clear loss of functional activity. This approach supports more informed development decisions, stability assessments, and comparability studies across therapeutic antibody programs.