Roberto Nitsch graduated in Medical Biotechnology from the University of Naples (Italy), where he also obtained his PhD in Molecular Genetics. He later moved to Vienna, where he focused on mouse genetics and cancer biology, and more recently on recessive genetics. He then shifted his research topic to genome engineering with CRISPR/Cas9 and joined AstraZeneca in 2014, where he was responsible for the CRISPR mouse models for drug discovery and oncology. Since 2017, he has been Associate Director in the Clinical Pharmacology and Safety Sciences, pioneering CRISPR safety assessments. Today, Roberto is the Director of Gene Therapy at AstraZeneca, and he is working towards the generation of safer CRISPR medicines.

Rajiv Gangurde, Ph.D., is Vice President of Technical Operations for Cell and Gene Therapy at Parexel, USA. In this role, Rajiv works closely with biopharma and biotech companies all over the world, guiding various stages of drug development and manufacturing in the areas of gene editing and cell therapy. He is a recognized subject-matter-expert for regulatory submissions to FDA and EMA.

Rajiv has nearly two decades of experience in biopharmaceutical development, harnessed in the biotechnology hub of Massachusetts, USA. Before joining Parexel, Rajiv served as Chief Technology Officer at SparingVision, an ocular gene therapy company, where he led all activities related to bioprocess and analytical development, manufacturing, and quality. Before SparingVision, Rajiv was Senior Director and Head of Chemistry, Manufacturing and Controls (CMC) at Voyager Therapeutics. In this role, he was responsible for CMC strategy and management of the company’s entire gene therapy portfolio for neurological disorders. Prior to Voyager, Rajiv was Director of Bioprocess Development and Manufacturing at Genocea Biosciences, where he led upstream and downstream process development and biochemistry groups for early- and late-stage recombinant-protein-based therapeutic vaccines. Prior to Genocea, Rajiv served as Head of Protein Sciences at LakePharma (now part of Curia), leading therapeutic protein production efforts for pre-clinical studies. Rajiv obtained his Ph.D. in Life Sciences from Mumbai University and did postdoctoral research at the Department of Biochemistry at the New Jersey Medical School and at the Department of Molecular and Cellular Biology at Harvard University.

Francesco Cicirello, currently, serves as Senior Director of Global Quality Compliance BioNTainer at BioNTech, bringing extensive experience in quality leadership within the biopharmaceutical sector. Previously, Francesco

was Senior Director of Quality Assurance at Evelo Biosciences in Cambridge, Massachusetts and prior to that, served as Site Quality Head at Adaptimmune in the UK.

Earlier in his career, Francesco worked as an Expert Inspector at the Therapeutic Goods Administration (TGA) in Australia, playing a key role in regulatory oversight. He has contributed significantly to international regulatory harmonization, holding several elected roles within the Pharmaceutical Inspection and Cooperation Scheme (PIC/S), including Chairperson of the Working Group that revised PIC/S Annex 2, Deputy Chair of the Subcommittee on Harmonization, and PIC/S representative at the EMA Inspectors Working Group. Francesco also served on the PIC/S Coordinating Committee for Human Blood, Tissues, Cells & ATMPs. He authored the PIC/S Annex 2A & 2B, and contributed to the revision of EU Annex 1 and the PIC/S transposition of Annex 16.

Francesco holds a degree in Chemistry and Pharmaceutical Technology from the University of Florence, an MSc in Oncology Pharmacology from the University of Milan, and an MSc in Cosmetic Production from the University of Siena. He is an active member of the PDA ATMP Board, as well as the ISPE Community of Practice in ATMP.

Gideon Kersten has almost 40 years of experience in development of vaccines and other biopharmaceuticals. His special interests are in characterization and formulation of these products.

He studied (bio)chemistry (master) at Leiden university and has a PhD on nanoparticulate delivery of subunit vaccines (1990, Utrecht university). Most of his carreer he worked at the Institute for Public Health (RIVM) in the Netherlands. He was involved in the development of new vaccines and improving existing ones. These included vaccines against polio, influenza, RS virus, Neisseria meningitidis type B and pertussis. He was responsible for formulation development and vaccine characterization. Adjuvant development and delivery systems were a substantial research activity. He published on liposomes, polymeric nanoparticles, outer membrane vesicles, virosomes and alum- based adjuvants.

Since 2012 he holds a special professorship in vaccine development at the Leiden university in the Netherlands. In 2017 he became Chief Scientific Officer of Intravacc, a vaccine R&D institute originating from the Institute of Public Health.

In 2020 he joined Coriolis Pharma, a contract research organization located in Martinsried, near Munich and dedicated to the characterization and formulation of biologics. At Coriolis he is a scientific reviewer and scientific advisor.

He has published more than hundred peer reviewed scientific papers and several book chapters and supervised 10 PhD students, covering subjects such adjuvants and delivery systems, needle free vaccination and in vitro alternatives for animal testing.

Irini is a scientist at Roche, where she supports early-stage gene therapy and biologics programmes. She earned her PhD in Oncology from the University of Oxford and has experience in both academic and industrial research. Irini has contributed to a variety of interdisciplinary projects centred around stimuli-responsive drug delivery systems and investigational therapies for breast and prostate tumours. For the past three years, her primary focus has been on the formulation development of gene therapies.

Chaminda Salgado is the CMC Innovation Lead at the Coalition for Epidemic Preparedness Innovations (CEPI), where he leads several CMC projects, as well as the analytical call for proposals, aligned with CEPIs 100 day mission to disrupt the next potential pandemic. Chaminda also contributes to the ATMP working group at The British Pharmacopoeia, providing guidance to cell and gene therapy developers.

Previously, Chaminda had numerous CMC leadership positions in small Biotech, Contract manufacturing and research as well as at GSKs cell and gene therapy group.

With over two decades of experience, Chaminda has consistently advanced the field of large molecule CMC through innovative strategies and a deep understanding of the quality and regulatory landscape.

Telmo serves as the Process and Technology Lead for mRNA, and is a key member of the External Innovations team for Cell and Gene Therapies at Lonza. In this role, he ensures Lonza maintains its leading position in the Cell and Gene space by scouting innovative technologies and processes. He also spearheads both external and internal projects, guiding them from research and development through to manufacturing.

Prior to joining Lonza, he was a manager and group lead for the TechRun RNA printer at CureVac SE, where he oversaw the process and technical development of automated platforms for mRNA production. Telmo holds a Master's degree in Biological Engineering and a Doctoral degree in Immunology and Infectious Diseases.

Dr. Mark Dickman obtained his PhD at the Krebs Institute at the University of Sheffield prior to joining a biotechnology company, Transgenomic LTD, where he developed analytical techniques, including DNA/RNA chromatography. Mark joined the department of chemical and biological engineering in 2003. He has over 25 years' experience in the development and application of analytical techniques to analyse nucleic acids. In particular, he focusses on the development of novel biological mass spectrometry and HPLC methods to characterise mRNA therapeutics/vaccines.

Dr. Roland Pach holds a PhD in molecular parasitology at the University Fribourg analyzing the intracellular trafficking of transgenic RNA in human pathogens.

Prior Roche, he was leading the Analytical Development department at Berna Biotech (former Swiss Vaccine and Serum Institute) and the QC department of Bio-Process Development at Merck Serono.

Roland is the global CMC Analytical Technical Lead in the cancer vaccines and cell- & gene therapy (CGT) area of Roche more than 10 years. In his assigned area, he represents Roche in external development projects, industrial consortiums like CGT BioPhorum and numerous due diligences of in-licensing candidates or companies in the CGT fields.

In his second role at Roche as global technical development leader, he had led successfully new formats like immunotoxins from pre-clinics into entry to human (EiH).

After receiving a PhD in Biochemistry, Matevz Korenc continued as a team leader in Knauf insulation, where he managed the analytical support and material development in the EMEA region. Matevz joined Sartorius BIA Separations in 2021 as a project manager and two years later became fully active in in-line lysis machine development and GMP implementation. He is also an acrobatic basketball performer, never found in his comfort zone.

Dr. Rahul Kaushik is the Founder of Gene Therapy Consultancy, a firm dedicated to accelerating the preclinical development of AAV-based gene therapies. With a mission to democratize specialized AAV knowledge and overcome critical developmental barriers, Dr. Kaushik and his team of AAV experts strive to expedite the delivery of life-saving treatments to patients. Dr. Kaushik possesses extensive expertise in AAV-based in vivo gene therapy product development across diverse disease areas. He has significantly contributed to advancing AAV and Lentiviral-based platform technologies and programs for gene silencing and supplementation strategies within various organizations. With over 16 years of experience, Dr. Kaushik has authored numerous high-impact publications and is committed to advancing effective gene therapies for human diseases through the utilization of advanced viral vectors and improved manufacturing processes.

Miloud G. NICHANE currently serves as GMP Auditor and Head of Process Validation at LFB. He holds a PhD in Molecular and Cellular Biology, with a doctoral thesis focused on brain development and architect genes. Over the years, Miloud has built a dynamic career across the pharmaceutical landscape, contributing to both global leaders such as GlaxoSmithKline and the Bill & Melinda Gates Foundation, as well as innovative biotech pioneers like Legend Biotech.

Driven by a strong commitment to advancing the Belgian and broader European life sciences ecosystem, Miloud has worked on a diverse range of therapeutic modalities—including plasmids, mRNA, monoclonal antibodies, blood-derived proteins, and CAR-T T lymphocytes. His multidisciplinary experience offers a unique perspective on the vast potential of modern biomedicine.