ENHANCING SPEED & QUALITY IN CELL & GENE THERAPY MANUFACTURING FOR THE DACH REGION

Dr. Siani is a seasoned bioprocessing leader specializing in viral‑vectored vaccines and gene therapies. Since joining Nouscom in 2020, she has rapidly advanced the development and manufacturing of neoantigen-targeting cancer vaccines. Promoted to SVP of Technical & CMC Development in July 2024, she oversees all technical, quality, and regulatory aspects of clinical-stage programs.

With a PhD in Industrial Biotechnology from the University of Naples Federico II and an executive MBA from Luiss Business School, Dr. Siani brings deep academic grounding and strategic vision. She previously led GMP manufacturing teams at Reithera and Advent/Advaxia Biologics, securing manufacturing authorizations and delivering multiple viral‑vector production campaigns.

At Nouscom, she plays a pivotal role in advancing NOUS-209 (MSI colorectal cancer), ensuring clinical readiness and scalable, compliant supply chains through late-stage development. Her expertise bridges technical innovation, regulatory compliance, and cross-functional execution—critical to delivering next-generation viral vaccines to patients.

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Prof. Cathomen is a leading authority in genome editing and cell & gene therapy, heading the Institute for Transfusion Medicine and Gene Therapy at Freiburg University Medical Center. His group advances CRISPR‐Cas, TALEN, and other nuclease platforms to develop safer, more precise genome-editing therapies—particularly for hematopoietic and immune cells targeting HIV, rare immunodeficiencies, and cancer. With over 300 publications and pioneering safety evaluation methods for clinical gene editing, Prof. Cathomen combines deep molecular insight with translational impact.

Dr. Alessandro Linciano leads the MSAT (Manufacturing Science & Technology) function for Cell & Gene Therapy at Novartis’ Swiss sites, driving technical operations and process development for advanced therapeutic modalities. With a PhD in Molecular Biology, he has overseen tech transfers, scale-up, and GMP readiness of complex platforms—including viral vectors and gene-modified cells.

In his current role, Alessandro integrates rigorous scientific principles and automation to ensure robust, compliant, and scalable manufacturing processes that support global clinical and commercial launch readiness. He partners closely with global development, clinical, and manufacturing teams to strengthen platform technologies and accelerate time-to-patient.

With a strong academic background and hands-on leadership in CGT process modernization, Alessandro is shaping the future of advanced therapy manufacturing at Novartis.

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Dr. Henrieta Fraser is an accomplished biopharmaceutical executive with over two decades of experience in advanced therapies, including cell and gene therapy, oncology, and immunology. Until recently, she served as Vice President of Technical Operations at Achilles Therapeutics, where she was responsible for leading end-to-end CMC and manufacturing strategy for the company’s personalized T cell therapy programs.

At Achilles, Dr. Fraser oversaw the development, scale-up, and GMP production of next-generation autologous cell therapies, playing a key role in driving the company’s clinical progress and manufacturing innovation. Her leadership bridged early-stage development and commercial-readiness, integrating cutting-edge platforms with regulatory rigor.

Previously, she held senior positions across biologics and advanced therapy companies in the UK and Europe, consistently championing innovation, quality, and cross-functional collaboration.

Dr. Fraser holds a PhD in Biochemistry and remains a sought-after advisor and speaker in the field of cell and gene therapy manufacturing and CMC strategy.

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Thomas Villiger has been a lecturer in bioprocess technology at the University of Applied Sciences Northwestern Switzerland since August 2019. Before joining FHNW, he held various positions in the area of bioprocess development and manufacturing at Merck, Novartis and Biogen. His main research focus is on the development and optimization of biopharmaceutical processes (mAbs, proteins and viral vectors), process analytical technologies and mathematical modeling.

Thomas Villiger completed his master's degree in chemical and bioengineering in 2010 at ETH Zurich. He carried out his PhD in the group of Prof. Morbidelli at the Institute of Chemical and Bioengineering of ETH Zurich from 2011 to 2015.

Alois Jungbauer is a Professor in the Department of Biotechnology at the University of Natural Resources and Life Sciences, Vienna (BOKU). He specializes in Downstream Processing, Protein Technology, and Bioprocess Engineering. He is also the study director for the PhD program in Bioprocess Engineering and the area head of Bioprocessing Engineering.

Dr. Jan Spanholtz initiated Glycostem's research in its start-up phase in 2007 and is currently its Chief Scientific Officer (CSO). Spanholtz has over 15 years of expertise in research on stem cell biology and immunology at universities and within biotech companies. He is the author of various peer-reviewed research articles and inventor of Glycostem's proprietary technology platform to generate oNKord®from umbilical cord blood stem cells. For Glycostem, he has set up and managed several national and international collaborations and spearheaded the clinical translational efforts of Glycostem's NK-cell product, oNKord®. Spanholtz developed the core IP strategy for Glycostem as inventor of the feeder cell-free NK-cell culture method from cord blood stem cells: a synthetic culture medium for NK-cells. He was also part of several other patent applications in the field of stem cell research.

Volker Huppert is a graduate bioprocess engineer from RWTH Aachen University. Among his achievements are participation in the set up of a quality system for a medical device/biotechnology company and development of several clinical-level reagents, disposable tubing sets and process software for cell separation and cell culture medical devices. He contributed to both the tubing set and process software development of a leading cell therapy-manufacturing device. Additionally, he managed projects and teams developing cell-manufacturing procedures for hematopoietic stem cells and Natural Killer cells. Huppert has published 12 papers in peer reviewed journals over the past 20 years while working for a leading biotechnology company and is co-inventor of 9 patent families, including methods for T cell depletion of hematopoietic stem cell products, NK-cell transduction and NK-cell proliferation.