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.

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.

Chaminda Salgado (Chimmy) is an accomplished CMC leader with over 21 years CMC experience (at GlaxoSmithKline and CRO, spanning DNA Vaccines, Biopharms and ATMPs). Leading activities from pre-

candidate selection through to commercial launch and beyond, he has manufacturing experience spanning the lifecycle of assets. As Study Director and involvement in Clinical studies he also has expertise in GLP and GCP.

Beginning his career in the defence sector (Porton Down, Salisbury UK) he developed a natural instinct for QbD in ensuring all development activities are aligned to the final desired product. Throughout his career he has ensured that sophistication is dialled up during development, with a track record for identifying and implementing automation and disruptive technologies, with the aim of simplifying technically complex methods, enabling those in late stage clinical/commercial manufacturing to focus on Quality.

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).

Aleš Štrancar has served as the Managing Director of Sartorius BIA Separations since its inception in 1998. He is a pivotal inventor of the CIM Convective Interaction Media® monolithic columns technology and has co-invented numerous analytical methods for pDNA, mRNA, AAV, Adeno, and other viruses. Aleš has co-developed several DSP processes, including pDNA for Boehringer Ingelheim and AAV for AveXis/Novartis. He is the author or co-author of over 100 scientific papers on separation and purification technologies and holds several granted patents.