ABOUT
Meet our expert team
Our team applies evidence-based methodologies to help organizations optimize performance, reduce risk, and capitalize on emerging opportunities.
Grounded in rigorous analysis and industry best practices, we facilitate comprehensive change initiatives that align operations, talent, and technology with long-term goals. Clients value our disciplined approach, transparent communication, and unwavering commitment to delivering results that withstand market fluctuations.
Laura I. Salazar-Fontana, PhD
Partner | Regulatory, CMC, and clinical strategy
Dr. Laura I. Salazar-Fontana is a former FDA CMC/Immunogenicity Reviewer and a recognized specialist in the immunogenicity of biopharmaceuticals, with 29+ years spanning research, product development, and regulatory strategy. She applies a risk-based approach to the evaluation, characterization, and mitigation of unwanted immune responses across biotherapeutics, including Cell & Gene Therapies, complex biologics, biosimilars, peptides, and oligonucleotides. At FDA she contributed to the drafting of existing immunogenicity guidance on analytical method validation (FDA, 2019) and risk assessment principles (FDA, 2014). As a former translational and regulatory lead and now an independent consultant to biotech and pharma, she prepares Immunogenicity Risk Assessments and Integrated Summaries of Immunogenicity supporting filings from First-in-Human studies through marketing applications. Laura is founder of LAIZ Regulatory Science Consulting® Sàrl, founder of the Immunogenicity Integrated® platform, expert consultant at NDA Partners and ProPharma Group, and a member of the European Immunogenicity Platform (EIP) and American Association of Pharmaceutical Scientists (AAPS).
-
Laura’s consulting work focuses on the design and implementation of end-to-end regulatory and immunogenicity strategies, including:
Immunogenicity Risk Assessment (IRA) and Integrated Summary of Immunogenicity (ISI)
Risk-based regulatory strategy for analytical validation
Product quality control and comparability evaluation (NME, biosimilars, and generics)
EU & US regulatory strategy and agency interactions (FDA, EMA)
Biomarker qualification and validation
Analytical and bioanalytical method development and validation (ADA, NAb, PK, PD)
New Advanced Methodologies (NAMs) and platform-based product development approaches
-
Laura applies a risk-based, science-driven approach to immunogenicity and regulatory strategy, bridging translational science, product quality, and regulatory strategy from early-stage risk assessment and bioanalytical method design through late-phase development, regulatory submission, and post-marketing life-cycle management. She is valued for helping sponsors navigate FDA and EMA expectations for novel and complex modalities, from first-in-human studies through marketing applications.
Annick de Vries, PhD
Partner | Pre-clinical testing, bioanalysis, and translational science
Annick de Vries, PhD, is a life science leader with a wealth of experience supporting Pharma and Biotech with their immunogenicity programmes, pre-clinical toxicity and over-arching translational interpretation.
Her career in assay development started at Wyeth, later Pfizer, in 2008. Annick gained wide experience in supporting pharma/biotech as CSO at Sanquin, 2015-2025, where she instigated offering regulated bioanalysis services. The offering ranged from target identification, pre-clinical studies via regulated bioanalysis to phase IV support. Annick and her team, often in collaboration with academic groups and clinicians, published broadly on immunogenicity; from designing immunogenicity tests to real world data. Recently as fractional CSO at Immuneed she extended her expertise in using human blood into the pre-clinical toxicity space.
Helping her in the interpretation of the impact of the immunogenicity is her knowledge of and being KOL in Therapeutic Drug Monitoring (TDM) of biologics and as chair of International Association of TDM and Clinical Toxicology (IATDMCT) TDM of Biologics Committee. She has published widely on the impact of immunogenicity on the PK, which is more often than not quite a limited effect.
Annick is KOL in home-sampling and how to optimise bioanalysis/diagnostic testing in small volumes. It is in this capacity she is a member of the advisory board of the Innovative Health Initiative consortium COMFORT.
-
Annick is experienced in the design, development, and implementation of end-to-end bioanalytical and immunogenicity strategies, ensuring they are scientifically sound and aligned with evolving global expectations.
Pre-clinical immune toxicity assessment
New modalities including oligo therapeutics, innate immune activation
Assay development and validation (ADA, NAb, PK, PD, Biomarkers)
Science-based strategy for analytical set-up (moving away from titre to S/N)
Biomarker development, qualification and validation (CoU)
New Advanced Methodologies (NAMs)
Immunogenicity considerations for biosimilars
Clinical relevance
-
Annick is pragmatic and to the point and favors a fit-for-purpose approach that ensures the selected assay generates the information needed for decision-making. She translates complex scientific challenges into actionable strategies.
Arno Kromminga, PhD
Partner | Translational & Bioanalytical Science
Dr Arno Kromminga is a seasoned scientist, investor, board member and entrepreneur in drug development processes and clinical research. He is a leading authority in immunogenicity and regulated bioanalysis, with a distinguished track record in advancing biopharmaceutical development across a wide range of modalities, including monoclonal antibodies, biosimilars, recombinant proteins, and mRNA-based therapeutics. With decades of experience spanning contract research organizations, biotechnology companies, and strategic advisory roles, he supports global development programs by integrating scientific excellence with regulatory strategy. His work bridges early-stage risk assessment through late-phase clinical development and regulatory submission, ensuring that immunogenicity and bioanalytical strategies are both scientifically sound and aligned with evolving global expectations. Arno is member of scientific societies and co-founder and member of the European Immunogenicity Platform (EIP). Arno is also investor and member of Scientific Advisory Boards at some companies and can help with due diligence.
-
Arno’s advisory work focuses on the design and implementation of end-to-end bioanalytical and immunogenicity strategies, including:
Immunogenicity risk assessment
Advanced approaches to immunogenicity testing beyond traditional paradigms (tiered approaches, CP, S/N)
Assay development and validation (ADA, NAB, PK, Biomarker)
Neutralizing antibody (NAb) assay design and validation challenges
Regulatory alignment with EMA, FDA, and international guidelines
Immunogenicity considerations for biosimilars and biobetters
Emerging challenges in mRNA therapeutics, including innate immune activation
Clinical relevance
He is also an active contributor to scientific dialogue within the bioanalytical community and has supported publications aligned with journals as author and editor.
-
Arno combines deep technical expertise with a pragmatic, solution-oriented mindset. His advisory philosophy is centered on:
Fit-for-purpose assay design aligned with development stage
Early identification and mitigation of immunogenicity risks
Integration of multidisciplinary data streams
Translating complex scientific challenges into actionable strategies
He is particularly valued for his ability to guide organizations through scientific uncertainty, ensuring robust and efficient development pathways for innovative therapeutics.