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.

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.

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.

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.

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.

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

Martin Smith

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.

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.

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. 

Antiksha Joshi 

Antiksha Joshi is an independent consultant and industry leader with a deep passion for helping businesses master regulatory compliance while improving operations. With over two decades in the life sciences industry, she has worked with pharmaceutical, biotech, and manufacturing organizations across the globe, successfully guiding them through complex regulatory landscapes and building quality systems that work in the real world. She has a proven track record of helping businesses pass USFDA, MHRA, and TGA audits, all while strengthening their internal processes and culture of quality.

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. CAT, Astrazeneca, Medimmune, Oxford BioMedica, Becton Dickinson, BioPhorum, Multiple client molecules, Previously CSO at biosimilar startup.

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.

Gilberto Dalmaso 

With over 40 years of experience in pharmaceutical microbiology and sterility assurance, Gilberto Dalmaso 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.

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), supporting pharmaceutical and biopharmaceutical process development and regulatory compliance. Author and co-author of multiple technical publications, Renato is now retired and works occasionally as an independent technical consultant.

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.

He is Principal Investigator of competitive research projects and has gained academic experience in Italy and abroad. He collaborates with academic and clinical institutions at the international level and is a member of leading scientific societies in the field.

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.
Solid experience in defining and driving regulatory strategies, change management, project management, production processes for sterile, non-sterile products and APIs, technology transfer processes, and introduction of new products.