Mr. Pietro Virgilio has more than 25 years professional experience in the design of pharmaceutical facilities, especially in isolator technology, containment processes, decontamination and sterilization. He has been working for different equipment manufacturers and engineering companies, all in the GMP regulated business. Pietro’s current position is Process Manager for Biopharma applications at Exyte Italy.
Over 30 years of professional work experience. He mainly worked for Pharmaceutical Industry, Fine Chemicals and Health Safety Environment (HSE). The working experiences in manufacturing companies (Geropharm and DOW/Lepetit), allowed to him to extend his knowledge to the process technology development and to deal with the daily life of the production work. The knowledge of these problems allows to improve the design activity by considering the production needs.About safety and environment, the long experience inside the Italian National Institute for Safety and Health (now INAIL) allowed Giorgio to go through many aspects of the industrial safety. Member of the International Society Pharmaceutical Engineering (ISPE). Several times speaker in ISPE courses and conferences.
Stefano Butti studied Mechanical Engineering at university of Milan and graduated in 2000. ISPE member since 2002 he participated as speaker to different congress and seminar on Containment and Micronisation topic both for HPAPI and Sterile application as well as published different articles on technical newspaper.
He worked as project and process manager in the Chemical and Pharmaceutical business following Containment and Micronisation system installation worldwide. He also took direct role in the definition of containment system upgrade and optimization for the handling of products with OEL down to ng level with successful results. Also few projects where combination of sterile and toxic compound handling were successfully coordinated during the nearly 20 years spent in this business.
He Joined FPS company in 2008 starting as Technical Sales Manager and he is now head of the Sales group for the company Containment and Micronisation system provided worldwide.
Justin Mason-Home is a Fellow of the Royal Society of Chemistry, with over 20 years’ experience in supporting pharma companies manage potent drug safety. He is a pharma insider, is published and a frequent chair/presenter at international HPAPI conferences. Justin formed HPSL in 2017, offering a high-level, practically focussed and pragmatic resource, to support (bio)pharma companies design, develop and deliver potent and HPAPI projects; from R&D, scale-up and formulation development, right through to full scale manufacturing. Mr Mason-Home has been involved in and worked on potent and highly potent API projects over more than 22 years and specialises in technical complex and strategic projects, including unique experience in managing sensitive highly potent and toxic biopharmaceutical compound matters.
As Affygility Solutions’ Founder and CEO, Dean does much more than wrestle industrial hygiene pumps, he leads people, teams, and companies in solving their toughest potent compound safety challenges. With over 35 years of professional experience, Dean created and led the vision for OEL Fastrac – the award-winning online platform for obtaining high-quality OEL and ADE monographs. Additionally, Dean has performed numerous potent compound safety assignments throughout the world, helping these companies greatly improve their potent compound safety systems.
As an invited speaker, Dean has spoken at numerous events throughout the world including the HPAPI Summit, CPhI, AIHce, and many others. Dean is an American Board of Industrial Hygiene CIH, and is a member of AIHA, BOHS, ISPE, and SCHC. Dean is also a Fast Company executive board member.
Pharmaceutical professional with over 30 years experience. Lemaire's career started with GlaxoWelcome in various production process engineering roles in OSD, Fines Chemicals and steriles prior to transfer into their Produce Technology Division PTD where he was instrumental in the introduction and development of true process integrated containment technology into the Inhalation Division, which subsequently won GSK’s prestigious Chief Executive Award for Safety. Before joining the Dec Group, he merged his co-founded UK containment company with Jetpharma, a world leading CMO for contract micronization where he was technical director of the micronizing and containment equipment division prior to its sale in 2008 to the Dec Group
Carolina Bonifacio is a pharmaceutical consolidated professional with over 15 years of experience in the sector, both sterilized and oral solid dosage forms, with extensive experience in handling of highly potent compounds. Currently leading the Development team at both Spanish finish product Siegfried sites, Barberà del Vallès and El Masnou. Prior to joining Siegfried, Carolina held different positions of increasing responsibility in technology transfer and scale up at Novartis. She has a Pharmacy Degree at Salamanca University, Spain and a Pharmaceutical Technology and industrial Pharmacy Master in the University of Barcelona.
Hermann Schmidt studied process technology and bio process engineering at the University of Applied Sciences in Nuernberg Germany and works as operations director of the Pharma & Lab division at Hosokawa Alpine AG in Augsburg, Germany. He has been working in the field of powder handling and grinding sector for Pharma products more than 30 years and has extensive experience with various aspects of GMP and containment production subject. His experience ranges from smallest R&D systems up to multi-ton cell culture media plants including powder handling, containment, cleaning and sterile processes.
Fabio is responsible of Environment, Health and Safety at BSP Pharmaceuticals S.p.A., Latina Italy, a Contract Development and Manufacturing Organization focused on anticancer product, small molecules and ADC compounds. He is a Pharmaceutical Chemist and has over 25 years of experience in pharmaceutical industries as Serono, Bristol-Myers Squibb and Intervet, in Manufacturing, Quality Assurance, Technical Operations and EHS.
Dr. Martina Breuer holds PhD in Pharmacy and has been with Aenova for many years. After positions as Head of QA and Qualified Person, she is since 2021 Head of Operations at the Aenova site in Münster. She is subject matter expert in cleaning validation and handling of High Potent Products.
Martin Kohan has done his BSc/MSc in Biochemistry from La Plata National University, Argentina; MSc in Pharmacology and PhD in Medical Sciences both from the Hebrew University of Jerusalem, Israel. Over 9 years of industry experience in the field of Toxicology conducting and managing over 900 hazard assessments, including calculation of exposure limits and/or determination of exposure control bands of drug substances and of their intermediates for Teva (2010 to 2018) and AstraZeneca (2018 to present). Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), and Member of the UK Register of Toxicologists and of the British Toxicology Society.
Tara is the Occupational Hygiene Manager for SafeBridge Europe, the European operation of SafeBridge Regulatory & Life Sciences Group which specialises in occupational health and hygiene consulting to the pharmaceutical industry. She holds a Certificate of Operational Competence from the BOHS and has master’s degrees in both Environmental Science and Occupational Health and Ergonomics. Tara has over 18 years’ experience in the broad field of occupational hygiene and joined SafeBridge in 2020.
Helena Camps is R&D Director at the Moehs group of companies, a world leader in generic APIs, based in Barcelona. A graduate of the Autonomous University of Barcelona (UAB) in Organic Chemistry, she has worked her entire career at Moehs. She is also responsible for Regulatory Affairs, and leads the company's HPAPI manufacturing unit. She lectures at the UAB as part of the Moehs-sponsored Master’s Degree Program
Ronnie Miranda is a Process Chemist at Moehs group involved in the process development and process validation of Highly Potent APIs. He graduated in Chemistry at the Autonomous Unversity of Barcelona and specialized in Industrial chemistry and advanced chemical research. During a master’s degree in fine chemical industry, he joined Moehs group in which has developed all his young career. He is now finishing an Industrial PhD in Highly Potent API manufacturing.
Stefania Vergura is Ph.D. graduated in Chemistry. She worked for 8 years in academic research in organic stereochemistry, spectroscopy, total synthesis, and homogeneous catalysis. She joined Novartis Pharma in Stein where she is currently working as validation expert. Her competences include: providing technical expertise and facilitated establishment of Quality sisk assessment, support site validation planning in compliance with all GxP regulations, SOPs, HSE and other company guidelines. Her focus is mainly in the cleaning validation for shared equipment in solids production.
Filippo Saleri is graduated in Pharmacheutical Chemistry and Technology at State University of Milan (Università degli Sudi di Milano) in 2016 and the same year passed the bar exam for pharmacist. Since 2016 he worked in QA department of manufacturing plants for Zambon, GSK and Monteresearch covering different roles as QA specialist, GMP auditor for self-inspection and qualification of API and excipient suppliers. In 2021 he joined Recordati as Quality Assurance for CMO managing all quality related topic regarding subcontracted production, evaluation of new suppliers and set-up for the manufacturing (Agreements, Tech-Transfer, qualification etc). Currently he is working in Ferring, with the role of Subject Matter Expert for CMO, with a focus on a global project for the implementation of the new ERP system worldwide and in specific the successful integration of all CMO process.
Marco Alberio is a Mechanical Engineer with more than 18 years of Experience in pharmaceutical engineering fields. His experience has been mainly spent in "FDA approved" sterile manufacturing facilities as Engineering Director. He managed full GxP revamping, implementation of new pharmaceutical facilities and he was involved in more than 25 ANDAs filings as well as in their scale up processes. In 2019 he became shareholder and Engineering director of Pharmaprocess. Mission of the company is to serve pharmaceutical facilities, proposing GxP state of the art solutions with its 4 Business Units: Pharmaceutical Engineering, Commissioning & Validation, Auditing & GMP Compliance, Computer system Validation. Starting from 2021 the new company Ramp S.r.l. has been established to complete our portfolio including Turnkeys solutions.
Over 20 years of experience in development and manufacturing of pharmaceuticals including process development and manufacturing, regulatory submissions, analytical method development and validation. Responsible for definition and management of contractor activities related to development and manufacturing of drug substances and drug products at all stages from pre-clinical development, clinical and commercialization. Experience includes program management and innovation management in contract manufacturing at Lonza AG for drug substance development, validation and manufacturing for clinical phases and commercialization. Vice Director of CAPEX project for the construction of new innovative HAPI production plant. Most recently responsible for development of diagnostic (positron emission tomography/PET) and therapeutical radiopharmaceutical drug candidates including technology transfer to clinical sites and cold kit development.
Giorgia is an NPI Program manager at Abbvie with ten years of experience providing scientific and technological support for high potent production. Specializing in feasibility study and new product introduction, Giorgia uses that experience to guarantee high standards of containment and handling of new compounds. By focusing on delivering breakthrough treatments that make an impact on people’s lives, Giorgia has been able to put the master’s degree in chemical engineering earned at University of Naples “Federico II” and Managerial Development Program Master accomplished at LUISS Business School to good use.
Salvatore is a specialist in Occupational Health & Safety (OH&S) and an expert in hazardous materials handling, new containment equipment design/containment improvement and containment assessment. Salvatore joined Abbvie (previously Abbott) Campoverde (Italy) in 2003, covering on early 5 years different supervision roles in the Drug Product Manufacturing plant. In 2008 he joined the EHS Department as OH&S Inspector and in 2020, as temporary assignment, he joined the Global EHS Technical Operations as EHS Technical Support and New Product Introduction Lead. Since May 2021, is the EHS New Product Introduction Spv & Environmental Lab. Spv of the Campoverde site. In early 2021 has obtained the ISO17025 accreditation for the Abbvie environmental laboratory of Campoverde site.Salvatore has a MSc in Chemistry from University of Naples “Federico II“ and he is qualified by Italian Association of Industrial hygienists (AIDII).
David O’Connell is the Director of Scientific Affairs at PCI Pharma Services, an integrated full service provider expertly delivering a seamless transition from development to commercialization. After graduating from Glasgow Caledonian University with a BSc. in Applied Bioscience, David spent seven years as a Supervisory Scientist working for Aptuit in Edinburgh before moving to Penn Pharma as Head of Formulation Development in 2009. Here he played a vital part in the design of the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2013 David took on the role of Director, Pharmaceutical Development at the PCI site in Tredegar and in 2017 became PCIs Director of Scientific Affairs.
