TRAINERS
Empowering Biotech Excellence Through Experience
Led by international biotech leaders with experience in Merck, Amgen, Genzyme, Lonza, Catalent, Menarini, Fujifilm Diosynth, NHS, and more.
Our trainers bring 30+ years of expertise in GMP manufacturing, bioprocessing,
molecular biology, synthetic biology, and regulatory sciences.
Trainers
Leonardo Sibilio
Biopharma professional with more than 20 years of experience in Process Development and GMP Manufacturing in CDMOs and R&D in monoclonal antibodies, recombinant proteins, and viral vectors. Experience in Menarini Biotech, IBI-Lorenzini, Reithera.
Alfredo Martinez
Biopharma professional and CSO of the Biotech Academy in Rome with more than 30 years of experience in leading CDMOs in several fields, such as monoclonal antibodies, recombinant proteins, viral vectors., and DNA. Experience in Merck-Serono, Amgen, Genzyme, Menarini, 3P Pharmaceuticals
Alessandro Manni
Alessandro Manni, a chemist by training, has spent 15 years in progressively senior roles within the pharmaceutical Quality sector.
In 2018, he transitioned to full-time consultancy, specializing in GMP compliance.
While his primary focus is on auditing, his passion for training remains a strong part of his professional engagement.
Igor Gorsky
Proven track record in building Validation organizations, establishing and implementing validation policies and training programs. Direct personal interface with FDA, MHRA, ANVISA and other regulatory organizations. Strong technical skills and extensive publication history along with strong interpersonal and communication skills.
Sam Denby
A physiologist (Oxford University) and Doctor of Biochemical Engineer (UCL) Sam has 25 years’ experience in the Biopharma Industry covering USP, DSP analytics and stability for Protein Therapeutics and Viral Vectors from platform development through early phase and marketed products to supply chain experience. Previously CSO at biosimilar startup.
Dario Cecchi, Ph.D.
Master of Science in Molecular and Industrial Biotechnologies and Ph.D. in Biomolecular Sciences at the University of Trento. Currently employed at the Microscale Robotics Laboratory at the Biorobotics Institute of Sant'Anna School for Advanced Sciences in Pisa. Expert in engineering approach of synthetic biology and DNA assembly, genetic circuit design, in vivo and in vitro protein expression, liposome preparation, and artificial cells.
Gilberto Dalmaso
With over 40 years of experience in pharmaceutical microbiology and sterility assurance, Gilberto has led innovations recognized by the FDA and European authorities, introducing pioneering rapid and parametric microbial approaches. He is currently CE & Global Life Science Advisor at GDM Pharma Consulting, supporting international pharmaceutical companies with compliance audits, risk assessments, process development, QbD-based strategies, and professional training for major regulatory agencies.
Martin Smith
Providing Bioprocess consultancy support across a range of modalities from monoclonal antibodies, viral vectors, recombinant proteins, cultivated meat and more.. Experience in Lonza, Merck, Menarini Biotech UK, Catalent.
Ronan O'Kennedy
Bioprocess Development of mammalian and microbial derived therapeutics, cell culture, fermentation, process scale up, tech transfer, Quality by Design, multivariate statistics, process control, process monitoring, academic collaboration. Experience in GSK, Fujifilm Diosynth Biotechnologies.
Andrea Conidi Ph.D.
Ph.D. in Biomedical Sciences at the K.U.Leuven (Belgium), Andrea moved to the department of Cell Biology at the Erasmus MC (the Netherlands) and recently joined the private sector. Expert in R and Python to analyze, intersect and visualize functional omics (genomics and proteomics) data.
Renato Lorenzi
Renato Lorenzi holds a Master of Science in Food Technology & Microbiology from the University of Milan and has over 35 years of experience in bioprocess development, scale-up, and separation technologies, including TFF, chromatography, and virus clearance. He served for 18 years as Senior Biomanufacturing Engineer and EMEA Technology Focal Point for TFF at Merck (MSAT Department).
Antiksha Joshi
Antiksha Joshi is an independent consultant and industry leader with over two decades in the life sciences industry, she has worked with pharmaceutical, biotech, and manufacturing organizations across the globe. She has a proven track record of helping in USFDA, MHRA, and TGA audits.
Saba Khan
Highly experienced Senior Scientist with over 15 years of experience in research, academic,
commercial and public sector environments (University of Manchester, NHS). Expertise on scientific projects, research studies or laboratory operations.
Joseph Lovecchio
Joseph Lovecchio is a tenure-track Assistant Professor of Biomedical Engineering at Campus Bio-Medico University of Rome. His research focuses on tissue engineering and regenerative medicine, with particular emphasis on bioreactor systems, 3D scaffolds, and innovative methods for assessing phenotypic differentiation.
Eleonora Piccini
Senior Quality & Regulatory professional and EU Qualified Person with 23+ years extensive background in Quality Systems in pharmaceutical, biotech, medical devices, nutritional-food environments.
Proven track record in Head of Quality roles, QP responsabilities, GMP/GxP compliance, quality management systems, direct personal interface with AIFA, EMA, MHRA, ANVISA and other regulatory organizations.
Registered Office
Nexantia Biotherapeutics S.r.l.
Viale di Trastevere 141, 00153 Rome Italy
P.IVA: IT17204271005
SDI: 5RUO82D
