About

Laura I.
Salazar-Fontana, PhD

Expertise immunogenicity, CMC comparability, regulatory strategy

I am a basic research scientist specialized in regulatory science/affairs with over 15 years of experience in immunogenicity and chemistry, manufacturing, and controls (CMC) aspects of biotherapeutics development. I acquired my regulatory experience as FDA quality and immunogenicity reviewer at the Center of Drug Evaluation and Research (CDER). My dynamic nature propelled me to move into the developers side, first as translational sciences lead within the Genzyme-Sanofi clinical testing laboratory group, and later on as CMC regulatory affairs director responsible for defining the strategy, content, and timelines for FDA and EMA regulatory submissions for biotherapeutics, including cell and gene therapy, peptides, oligonucleotides, and biosimilar products.

Prior to joining the FDA, I spent over 14 years as scientist in the fields of biochemistry, molecular biology, and immunology. First as a doctoral student at the Autónoma University of Madrid (UAM, Spain), where I obtained my PhD, before pursuing a post-doctoral fellowship at the National Institutes of Health, (NIH, USA) completed by two years as post-doc/assistant professor at the Center for Cancer and Immunology Research, Children’s National Medical Center, part of Georgetown University School of Medicine (GWU, USA).

As of 2020, I have been consulting for biotechnology and pharma companies, directly through my Swiss-based company, LAIZ Regulatory Science Consulting SARL, and as cofounder of the Immunogenicity Integrated platform side-by-side Paul Chamberlain.

My approach is to apply solid scientific principles and current regulatory guidelines to identify risks that can delay approval of new biologics or result in drug shortages due to poorly executed post- manufacturing changes. I specialize in those quality aspects of recombinant products that can compromise their overall benefit:risk profile.

Starting at the candidate selection stage, I specialise in immunogenicity and quality aspects of durg development. My goal is to orient clients to get through the multiple clinical developmental stage-gates while avoiding regulatory road blocks.

I am a scientific advisor for Chiesi Pharmaceuticals and Immuneed, member of the European Immunogenicity Platform and guest lecturer at the European Center of Pharmaceutical Medicine (ECPM), Faculty of Medicine at the University of Basel, Switzerland.

Katerina Alexakis, PhD

Collaborators

Expertise CMC, regulatory writing, clinical trials management, medical devices

LinkedIn

I have a diverse background in basic research, regulatory science and clinical research, spanning more than 12 years of professional experience in various roles. I hold a PhD from Drexel university and postdoctoral training as research fellow at the National Institutes of Health (NIH, USA) and FDA (USA).

While working at the FDA, in the Center of Biologics Evaluation and Research (CBER), I had a dual role as a research scientist and a chemistry, manufacturing, and controls (CMC) reviewer. In my regulatory role, I had the opportunity to review multiple regulatory applications, including 510(k) original submissions for medical devices, and participated in surveillance inspections. In my scientific role, I focused on pharmacogenomics and the impact of synonymous mutations and codon optimization on the function and immunogenicity of proteins biopharmaceuticals.

Since 2020, I work at the Centre Hospitalier Universitaire Vaudois (CHUV, Lausanne, Switzerland), in regulatory strategy and clinical research roles. My desire to keep evolving lead me to start collaborating with LAIZ Regulatory Science Consulting, providing CMC and clinical regulatory writing support for biotherapeutics submissions to FDA and EMA.

I am always guided by scientific principles and solid knowledge of regulatory directives and guidelines, to provide tailored solutions to clinical trial management (GCP) and quality related aspects (CMC).

Sophia Prophete-Hyppolite

Expertise regulatory operations, global submission planning

LinkedIn

I am a seasoned Regulatory Operations leader with over 20 years of experience in global regulatory submissions across multiple therapeutic areas, including oncology, rare diseases, CNS, and infectious diseases. I have held senior leadership roles in pharmaceutical and biotech companies and founded my own LLC, SopReg Consulting.

As LAIZ Regulatory Science Consulting collaborator, I provide expert regulatory operation services and global submission planning, vendor collaborations, and compliance with FDA, EMA, Health Canada, and PMDA regulations for submission of electronic files.

I follow a detail-oriented approach to delivered high-quality regulatory submissions through operational excellence, continuous learning, and innovation in regulatory operations.