La prenotazione camere sarà disponibile dopo l’apertura delle iscrizioni al 66° Simposio AFI.
La prenotazione camere sarà disponibile dopo l’apertura delle iscrizioni al 66° Simposio AFI.
David Edwards (SC Therapeutics, US)
David A. Edwards is a long-standing professor of the practice of biomedical engineering at Harvard University (2002-2019), currently Associate in the John Paulson School of Engineering & Applied Sciences at Harvard University, Adjunct Professor at Johns Hopkins Medical School, and founder and CSO of Sensory Cloud Inc. A pioneer of aerosol medicine and biophysics, David's previous companies have led to the FDA-approved Inbrija (inhaled L Dopa for Parkinsons), edible packaged food (2014 Time Magazine Invention of the Year, currently on the US market as Foodberries) and airway hygiene (2020 Time Magazine Invention of the Year, currently on the US market as FEND). Sensory Cloud is pioneering aerosol products that resolve endemic dehydration of the upper airways for the treatment of respiratory illnesses such as refractory chronic cough. David has won multiple international awards for his scientific and translational work, and is a member of the US National Academy of Engineering, the US National Academy of Inventors, and the French National Academy of Engineering (Académie nationale d'ingénieurs), as well as a Chevallier des arts et des lettres from the French Ministry of Culture. He is the author of multiple books including Creating Things That Matter (Holt), winner of the 2018 Nautilus Book Award for the category of creativity.
Justin Hanes (Johns Hopkins University, US)
Dr. Hanes the Lewis J. Ort Professor and founding Director of the Center for Nanomedicine at the Johns Hopkins University School of Medicine, where he holds faculty appointments in the departments of Ophthalmology (primary), Biomedical Engineering, Chemical & Biomolecular Engineering, Neurosurgery, Oncology, and Physiology, Pharmacology & Therapeutics. A member of the National Academy of Engineering, National Academy of Medicine and National Academy of Inventors of the US, and inductee into the EU Academy of Sciences, he is an expert in the areas of advanced drug and gene delivery systems and pharmaceutical formulation, polymer and lipid nanoparticles, nanoparticle-tissue interactions, nanoparticle and drug transport in biological fluids and tissues, and drug delivery for a wide array of diseases affecting nearly all parts of the body. He is the most recent recipient of the Thomas T. Mercer Joint Prize in pharmaceutical aerosols and inhalable materials from AAAR and ISAM. He is an inventor on more than 180 US patents and patent applications focused in the area of advanced delivery systems that make drugs and gene therapies safer and more effective. Technologies he developed with co-inventors have served as the basis for the launch of several companies, including Advanced Inhalation Research (acquired by Alkermes), Civitas Therapeutics (acquired by Acorda Therapeutics), Kala Pharmaceuticals (Nasdaq: KALA), GrayBug Vision (Nasdaq: GRAY; acquired by CalciMedica), NovusBio (private) and Novus Vision (private). He is also a founder of Theraly Pharmaceuticals (acquired by D&D Pharmatech), Theraly Fibrosis (acquired by D&D Pharmatech), Neuraly (acquired by D&D Pharmatech), Spiral Therapeutics (private), Ashvattha Therapeutics (private), and Orpheris (acquired by Ashvattha Therapeutics). Dr. Hanes has helped these companies raise more than $1 billion USD and to create multiple FDA-approved drugs and more than two dozen products that have been tested, or are currently being tested, in human clinical trials. Dr. Hanes is a Venture Partner at Catalio Capital Management, where he has served as an advisor since the genesis of the company, including as Chief Scientist of the Nexus II fund. He has served on the scientific advisory boards for pharmaceutical companies, including Genentech in the Drug Delivery Division and ReCode Therapeutics, and he is a past chair of the Gene and Drug Delivery Study Section of the National Institutes of Health. He has served as the President of the Controlled Release Society and he is a fellow of several scientific societies. Dr. Hanes has received multiple school-wide teaching awards at the Johns Hopkins University.
Chantelle Ahlenstiel (Kirby Institute, Australia)
A/Prof Ahlenstiel leads the RNA Silencing Group at the Kirby Institute, UNSW, Sydney, where her research team develops short interfering (si)RNA molecules to treat virus infections. She completed postdoctoral training at the Vaccine Research Center, NIH, USA and the Kirby Institute, UNSW. Dr. Ahlenstiel has developed an RNA therapeutic design pipeline and applied this to develop RNA therapeutics targeting acute and chronic virus infections, including HIV, SARS-coronavirus, EBV, HPV, HTLV-1, and influenza, with a focus on respiratory delivery.
Mercedes Gonzalez-Juarrero (Colorado State University, US)
Dr. Mercedes Gonzalez Juarrero obtained her bachelor’s and master's degrees in Biology from Universidad Complutense de Madrid, and her doctoral degree from Universidad Autónoma de Madrid. Her early professional career commenced at INIA in Madrid, followed by a research scholarship at the Plum Island Animal Disease Center (USDA-ARS) in New York, where she contributed within a distinguished, international scientific community engaged in the study of the African Swine Fever virus. Subsequently, she conducted research in Nairobi, Kenya, at the International Laboratory for Research on Animal Diseases, and resided in Ethiopia, thereby expanding her global scientific perspective.
In 1999, Dr. Gonzalez Juarrero joined Colorado State University (CSU) as a postdoctoral researcher. She currently serves as a Professor in the Department of Microbiology, Immunology, and Pathology (MIP-CSU). Her laboratory specializes in investigating immune pathogenesis and developing aerosol therapies for mycobacterial diseases, with particular focus on tuberculosis (TB) and non-tuberculous mycobacterial (NTM) infections. Her research endeavors aim to enhance antimicrobial efficacy, elucidate immunopathological mechanisms, and improve therapeutic strategies for multidrug-resistant infections through innovative experimental animal models. Her laboratory assesses the efficacy, toxicity, and pharmacokinetics of immunomodulators and antibiotics, in addition to exploring immune cell dynamics during disease progression and treatment. She leads a collaborative team dedicated to both scientific research and the training of graduate and undergraduate students, thereby fostering the development of the next generation of scientists.
Nathalie Heuzé-Vourc’h (National Institute of Biomedical Research, France)
Nathalie Heuzé‑Vourc’h is a Research Professor (DR1) at Inserm in the Research Centre for Respiratory Diseases (Inserm U1100, CEPR) in Tours, France. She leads the team “Pharmcology of Inhaled Pharmaceuticals”, which focuses on the inhalation and intranasal delivery of biologics—especially monoclonal antibodies—for the treatment of respiratory diseases. Her work spans formulation, aerosolization, deposition, and preclinical pharmacology, with strong emphasis on bridging experimental models to clinical development.
Trained in oncology and respiratory immunobiology, she carried out postdoctoral work at UCLA in pulmonary and critical care medicine and gained early experience in therapeutic antibodies in a US‑based biotech start‑up. Recruited by Inserm in 2005, she developed an internationally recognized expertise in inhaled biotherapeutics and has co-authored over 80 peer‑reviewed publications and book chapters. She has coordinated numerous national and European projects in aerosol‑based biopharmaceutical development and serves as a scientific expert for the European Commission and consultant to pharmaceutical companies. She is also the deputy director of the national institute of Health Technologies at Inserm.
Shrirang Karve (Sanofi, US)
Shrirang Karve, Ph.D is Global Head of Drug delivery and formulations at mRNA center of excellence, Sanofi with 12+ years of experience working on mRNA platform. Previous roles include serving as Head of delivery and formulations at Translate Bio as well as holding managerial positions at Shire Pharmaceuticals and Dicerna.
Shrirang is co-inventor on 128 patent families with more than 150 granted patents worldwide and has coauthored 23 scientific publications. Shrirang received his Ph.D. from New York University and has an ALM degree from Harvard University.
Philip Kuehl (Aptar Pharma, US)
Philip Kuehl is the Director of Science and Technology at Aptar Pharma. He holds a bachelor’s degree in biochemistry from Hamline University in St. Paul, MN and a PhD in Pharmaceutical Sciences from The University of Arizona, College of Pharmacy in Tucson Arizona. Dr. Kuehl is an Adjunct Professor at the University of New Mexico College of Pharmacy. Dr. Kuehl is responsible for science and innovation within Aptar Pharma including intranasal, pulmonary and dermal applications. Philip has over 20 years of experience in drug development from early proof of concept to NDA. He has supported five approved inhalation products over 20 IND’s and one DMF. Dr. Kuehl’s research interests are in the area of inhalation formulation and its effects on deposition, pharmacokinetics and pharmacodynamics. Philip is the author/co-author on over 90 peer reviewed manuscripts, over 150 abstracts, two book chapters and three patents.
Philip Kwok (University of Sydney, Australia)
Dr Philip Chi Lip Kwok is a Senior Lecturer in Pharmaceutical Sciences in the School of Pharmacy, The University of Sydney. He obtained his Bachelor of Pharmacy degree with First Class Honours and PhD degree from this university in 2002 and 2007, respectively. He was an assistant professor in the Department of Pharmacology and Pharmacy at The University of Hong Kong from 2011-2017, after which he returned to The University of Sydney as a Lecturer in Pharmaceutical Sciences. He specialises in the engineering, physicochemical characterisation, and electrostatics of pharmaceutical aerosol formulations for inhalation. Dr Kwok is the theme leader of Therapeutics and Global Health Systems in FungiSphere, a multidisciplinary research node within the Sydney Institute for Infectious Diseases. He is a member of the New South Wales Ministry of Health Poisons Advisory Committee, advising the State Health Secretary on the scheduling of drugs/chemicals and regulatory legislation matters.
Vivek Lal (Alveolus Bio, US)
Dr. C. Vivek Lal, MD, FAAP, is a double board-certified physician-scientist and entrepreneur specializing in biotic-driven therapeutics. He is a tenured Professor, Executive in Residence at the University of Alabama at Birmingham (UAB) and Director of the Microbiome & Discovery Labs, where his research focuses on therapeutics development for chronic lung diseases.
Dr. Lal is the Founder and CEO of resbiotic®, a precision microbiome company developing clinically validated, product-level therapeutics and supplements, and Founder of Alveolus Bio, a biotechnology company advancing inhaled biotherapeutics for respiratory diseases. His work bridges translational science and commercialization, with multiple patents, clinical trials, and partnerships focused on bringing first-in-class microbiome-based therapies to patients globally.
David Lewis (Oz-UK Ltd, UK)
Dr David A. Lewis is an experienced scientist and entrepreneur in the field of inhalation drug delivery. He holds a B.Sc., M.Sc., and Ph.D., and is a founding director of Oz-UK Limited and 3Di Solutions Limited, providing independent scientific and technical expertise to the pharmaceutical industry.
Dr Lewis has over three decades of experience in aerosol science and inhaled product development across academia, industry, and independent research organisations. His career includes the establishment of the Chiesi Research Centre in Chippenham in 2009, where he founded and led advanced research activities in inhaled therapies. Earlier in his career, he was involved in a University of Bath spin-out that contributed to the formation of Vectura Limited.
His work focuses on the application of first principles, experimental science, and predictive methodologies to understand and interpret pMDI system behaviour. His research interests include formulation science for pulmonary drug delivery, device and actuator design, and the development of semi-empirical approaches to support robust interpretation of performance data.
Sara Maloney (RTI International, US)
Dr. Sara E. Maloney is a Research Chemist and Principal Investigator in the Engineering and Advanced Technology Division of RTI International, an independent research institute in Research Triangle Park, NC, dedicated to improving the human condition through science-based solutions. She earned her PhD in Analytical Chemistry from the University of North Carolina at Chapel Hill, where her research focused on the development of nitric oxide-releasing biopolymers for biomedical applications, including wound healing, catheter-related bloodstream infections, and cystic fibrosis. At RTI, she leads a multidisciplinary team advancing the formulation and delivery of inhaled and intranasal therapeutics and vaccines, with a particular focus on the treatment and prevention of pulmonary infections. She serves as a Principal Investigator on multiple NIAID-funded programs aimed at developing novel approaches for nasal and inhaled drug and vaccine delivery for tuberculosis and pulmonary NTM infections. Her work spans early-stage research through preclinical testing, supporting the development of next-generation delivery platforms designed to improve patient access, compliance, and therapeutic efficacy. Dr. Maloney is an active member of the American Association of Pharmaceutical Scientists (AAPS), the International Society of Aerosols in Medicine (ISAM), and the European Respiratory Society (ERS). She served as the Vice Chair for the AAPS Inhalation and Nasal Community from 2024 to 2026, where she helped foster collaboration and innovation in the field.
Koen Raemdonck (Ghent University, Belgium)
Koen Raemdonck(1981) obtained a PhD in Pharmaceutical Sciences in 2009 at Ghent University, Belgium. He was a visiting postdoc in the group of Jean-Christophe Leroux (ETH Zürich) in 2015. In 2016, he was appointed as Assistant Professor at the Ghent Research Group on Nanomedicines where he was promoted to Full Professor in 2021. He (co-)authored >100 published items (articles, reviews, proceedings) and is listed as inventor on 7 (pending) patent applications. Since 2011, he has been (co-)promotor of 18 successfully defended PhD theses at Ghent University. Koen is vice president of the Executive Council of the recently established Controlled Release Society (CRS) BeNeLux and France Local Chapter as well as group leader and Steering Committee member within the Cancer Research Institute Ghent (CRIG). He serves as Editorial Board member of the Journal of Controlled Release. The research of Prof. Raemdonck is mainly focused on exploring novel bio-inspired approaches for delivery of macromolecular therapeutics across intra-and extracellular biological barriers. His expertise includes the design and optimization of nanoformulations for RNA therapeutics and the detailed assessment of their behavior both in extracellular fluids and inside cells. At Ghent University he is leading the Lung Delivery group, aiming to design novel strategies for inhalation therapy of RNA drugs, for which he was awarded a prestigious ERC Consolidator Grant in 2021.
Rémi Rosière (InhaTarget Therapeutics, Belgium)
Remi ROSIERE is a pharmacist by training and obtained a PhD degree at ULB (Université libre de Bruxelles) where he still has a position of lecturer. He has been the lead researcher in charge of the Inhatarget spin-off project since its beginning. This project led to the launch of the pharma start-up InhaTarget Therapeutics that he co-founded in 2019. Remi is the current CSO of InhaTarget Therapeutics and responsible for all R&D aspects of the company.
Remi specializes in drug formulations for inhalation (e.g. advanced drug delivery systems, controlled-release formulations, carrier-based and carrier-free formulations, particle engineering, nanomedicine) and non-clinical development (analytical development, in vitro and in vivo studies, animal models). He has published about 20 peer-reviewed papers in internationally recognized journals, about 10 abstracts and conference proceedings. He is involved in 7 patent family applications.
Xian-Ming Zeng (Transpire Bio, US)
Xian-Ming Zeng, Ph.D., has over 25 years of experience in leading multidisciplinary teams in the development and commercialization of inhalation products. He has held global R&D leadership roles at Ivax, Teva, and Lupin in the UK and US, and led the successful development of multiple orally inhaled and nasal drug products for the UK/EU and US markets. Dr. Zeng also has had a distinguished academic career, having worked at King’s College London as a Maplethorpe Postdoctoral Fellow and a Visiting Professor, followed by being appointed as the Professor of Pharmaceutics and Director of Research at Medway School of Pharmacy, University of Kent, UK. His academic research has led to the publication of a textbook, a book chapter, and over 50 peer-reviewed research papers on inhalation drug delivery. Dr. Zeng is a regular invited speaker at many national and international conferences. He currently serves as a board advisor for BioFlorida, USA.
Katharina Schindowski (Biberach University, Germany)
Since 2010: appointed as Professor for Molecular Pharmacology at Biberach University of Applied Science, Biberach/Germany, research focus intranasal and inhalative delivery of biopharmaceutics via the airways
2008-2010 Scientist at the CNS research and development department (development of an anti-amyloid immunotherapy) of Boehringer Ingelheim Pharma/Germany
2005-2007 Junior group leader (neuropathology in a murine tau model) at INSERM U837/France (DFG fellowship funded from Deutsche Forschungsgemeinschaft)
2003-2005 Post-Doc (development of models to screen tau kinase inhibitors) at Sanofi Pharma/France (Marie-Curie Industry Host fellowship funded from the European Commission)
2001-2003 Post-Doc (role of neurotrophic factors in stroke) at Heidelberg University/ Dep. for Neuroanatomy
1997-2001 PhD thesis (neuroimmunology in Alzheimer’s disease) at Frankfurt University/ Dep. for Pharmacology
1996-1997 Diploma thesis (regulatable immune gene therapy) at German Cancer Research Center Heidelberg
13:00 - 18:00 | Laboratori Precongressuali
CORSO BASE: ASPETTI NORMATIVI E CAPSULE
Parte teorica:
-normativa allestimento preparazioni in farmacia e NBP;
-aspetti teorici nell'allestimento di capsule
Modera Prof. Umberto Musazzi
Prof. Giovanni Filippo Palmieri
Dott.ssa Cristina Porcu
Parte pratica:
-capsule;
-soluzioni idroalcoliche
Dr. Marco Fortini
Prof. Giovanni Filippo Palmieri
Dott.ssa Cristina Porcu
Prof. Nicola Realdon
Dr. Alberto Ramella
CORSO AVANZATO: ASPETTI TEORICO-PRATICI DI CAPSULE E SOSPENSIONI ORALI
Parte teorica:
-impatto degli eccipienti sulla biodisponibilità delle capsule;
-aspetti teorici dell'allestimento di sospensioni orali
Modera Prof. Umberto Musazzi
Prof.ssa Antonella Casiraghi
Prof.ssa Lucia Zema
Parte pratica:
-capsule preparate utilizzando materie prime complesse;
-sospensione per uso orale
Prof.ssa Antonella Casiraghi
Dr. Marco Fortini
Dr. Alberto Ramella
Prof. Nicola Realdon
Prof.ssa Lucia Zema
Previsto per entrambi i corsi un Coffee Break dalle ore 15:00 alle ore 16:00
10.00 - 10.15
Apertura Convegno
Prof.ssa Paola Minghetti, Presidente SIFAP
Prof.ssa Chiara Leardini, Magnifica Rettrice, Università degli Studi di Verona
Prof. Giuseppe Lippi, Preside della Facoltà di Medicina, Università degli Studi di Verona
Prof. Cristiano Chiamulera, Presidente Corso di studi in Farmacia, Università degli Studi di Verona
Dr. Federico Realdon Ordine dei Farmacisti della Provincia di Verona
Dott.ssa Elena Vecchioni Federfarma Verona
10.15 - 12.00
Sessione Istituzionale
"Parlando di Galenica con..."
Modera Prof.ssa Paola Minghetti, Presidente SIFAP
Dr. Andrea Mandelli, Presidente Federazione Ordini dei Farmacisti Italiani
Dr. Marco Cossolo, Presidente Federfarma
Dr. Arturo Cavaliere, Presidente SIFO
Dr. Luigi D’Ambrosio Lettieri, Presidente Fondazione Cannavò
Dr. Eugenio Leopardi, Presidente UTIFAR
Dr. Francesco Ferro Russo, Presidente FENAGIFAR
Dott.ssa Eugenia Cogliandro, Presidente Commissione Farmacopea Europea
Dr.ssa Giovanna Scroccaro, Direttore Direzione Farmaceutico, protesica e dispositivi medici Regione Veneto
Conferimento Premi Marcello Marchetti
12.00 - 13.30
Pausa pranzo
13.30 - 14.00
Walking Poster
14.00 - 16.00
Tavola rotonda
"Innovazione nel campo delle materie prime e delle tecnologie di laboratorio"
Moderano Dr. Marco Fortini e Dr. Bruno Bizzaro
Magistra: nuova interfaccia per gli utilizzatori ed integrazione con dispositivi di produzione - Dr. Stefano Barontini, Galeno Sistemi
L’essenzialità della camera sterile: il ruolo strategico degli specialisti della galenica - Dr. Massimiliano Cecchi, Consulente Phamm Engineering
Medical Dispenser: confezionamento personalizzato dei medicinali per migliorare l’aderenza terapeutica - Dr. Alessandro Crespi, Farmalabor
Xeo filler. Dalla mente alla macchina: l’innovazione galenica del riempimento polveri attraverso intelligenze integrate - Dr. Adalberto Fabbriconi, Gamma Pharmacy Equipment
Attivi complessi e forme intelligenti: tecnologie galeniche per il drug delivery personalizzato - Dott.ssa Rosalba Lombardo, Acef
Sistemi farmaceutici innovativi per la somministrazione orale - Dott.ssa Tatiana Selleri, Fagron
16.00 - 16.40
Coffee break e Sessione Poster
16.40 - 17.50
Galenica senza confini: esperienze che ispirano il futuro
Moderano Dr. Salvatore Messana e Dr. Annunziata Lombardi
Uno sguardo alla preparazione Galenica in Francia - Dr. Fabien BRUNO, Farmacéutico, Farmacia Delpech Paris
Uno sguardo alla preparazione Galenica in Spagna - Dr. Izaskun Malo, Farmacéutica formulista, MÁLAGA
Uso responsabile degli antimicrobici: anche il farmacista preparatore può contribuire? - Dr. Federico Zerbinato, Farmacista di Comunità
17.50 - 18.30
Consegna Certificazioni Farmacista Preparatore
Prof.ssa Paola Minghetti - Presidente SIFAP
Dott.ssa Francesca Rauzi - Vicepresidente Unifarm
20.00 - 23.00
Cena Sociale presso Yard Restaurant, in collaborazione con 
08.45 - 09.45
Comunicazioni Scientifiche orali
Moderano Dr. Salvatore Messana, Dr. Armando Vellano e Dr. Cosimo Violante
Desmopressina: gocce nasali per il trattamento del diabete insipido negli animali - Eleonora Beatrici - Farmacia San Lorenzo, Trento
Metronidazolo base in sospensione pediatrica: adattamento di una formulazione di riferimento e personalizzazione galenica - Gaia Cresci - Farmacia Comunale n.1, San Miniato, PI
Trattamento della cheratite neutrofica con un collirio galenico di insulina 1 UI/ml - Emanuela Elisei - Farmacia Azienda Ospedaliera Santa Maria, Terni
Formulazione di una lozione a base di ivermectina e silicone per il trattamento delle pediculosi del capo resistenti - Matteo Favero - Farmacia Favero, Udine
Pectina LM a gelificazione calcio-dipendente in compresse orosolubili mucoadesive di budesonide per esofagite eosinofila - Margherita Marchio - Farmacia Nenna, Orsogna, CH
09.45 - 11.45
Tavola rotonda
“Il senso della galenica: professioni sanitarie a confronto”
Moderano Dott.ssa Cristina Porcu e Dr. Alberto Ramella
Cannabis e sistema endocannabinoide: dall'empirismo alla farmacologia razionale - Prof. Maurizio Massetti, Medico AST Ascoli Piceno
Gymnasium galenico: L'apprendimento formulativo dei medici - Prof. Beniamino Palmieri, Associato di Chirurgia Generale UNIMORE in quiescenza, ideatore e coordinatore del Network Secondo Parere
Il bambino non è un piccolo adulto: il ruolo della galenica nella terapia pediatrica - Prof. Angelo Pietrobelli, Professore Ordinario di Pediatria Generale e Specialistica, Università degli Studi di Verona
La galenica nella dermatologia del 2026: dove continua a fare la differenza - Dr. Fabrizio Presta, Medico Specialista in Dermatologia e Venereologia
I colliri allestiti in farmacia: uso nelle patologie croniche e a supporto dell’attività operatoria - Dr. Guido Prigione, Direttore del reparto di Oculistica Ospedale P. Pederzoli di Verona
11:45 - 12:00
Coffee Break
12:00 - 13.00
Sessione interattiva
“Tutto quello che avreste voluto sapere sulla galenica e non avete mai osato chiedere”
Dr. Marco Fortini
Prof.ssa Paola Minghetti
Prof. Umberto Musazzi
Dott.ssa Cristina Porcu
Dott. Cosimo Violante
13.00 - 13.30
Conferimento Premi Pierandrea Cicconetti - Conclusione Congresso
Stefano Aliberti (University, Germany)
Stefano Aliberti is Professor of Respiratory Medicine at Humanitas University and chief of the Respiratory Department at the Humanitas Research Hospital, Milan, Italy where he is also leading the Bronchiectasis and Non-Tuberculous Mycobacteria Programs. His major clinical and research interests are both acute and chronic respiratory infections. He has extensive experience in epidemiological and clinical research in pneumonia since early-2000s when he was working for the Community-Acquired Pneumonia Organization. He has extensively published clinical and translational research papers on community-acquired pneumonia, especially in the field of clinical failure, cardiovascular events and antimicrobial resistance. He received the Young Researcher Award in Respiratory Infections from the European Respiratory Society for his contribution on community-acquired pneumonia. Over the past 20 years he has been heavily involved in acute and chronic respiratory infections, including bronchiectasis and non-tuberculous mycobacteria. He co-chairs the European Bronchiectasis Registry (EMBARC) and chairs both the Italian Bronchiectasis Registry and the Italian Registry of Pulmonary Non-Tuberculous Mycobacteria. He is also chair of the ERS END-COVID CRC. Prof. Aliberti published more than 350 peer-reviewed articles especially on respiratory infections over the past 20 years and he was part of different international task forces to produce guidelines on bronchiectasis, COVID-19 and severe pneumonia, as well as statements on tuberculosis. Prof. Aliberti has been heavily involved in different international societies over the past decade, including the European Respiratory Society, the American College of Chest Physicians, and the European Cystic Fibrosis Society, in different educational and scientific committees.
Janice Glines
(Vertex Pharmaceuticals, US)
Janice Glines, MBA, is an Associate Director of Regulatory CMC at Vertex Pharmaceuticals where for the past four years, in partnership with multiple external collaborators, she’s led the global Regulatory CMC strategy for an inhaled mRNA product being developed to treat Cystic Fibrosis.
Previous roles in her 15-year biopharma career span pharmaceutical manufacturing, process development, and quality assurance disciplines, on early-stage clinical development products through commercial, across small molecule, biologics, and cell & gene therapy modalities. At Biogen she supported multiple programs in the Multiple Sclerosis therapeutic area, while at Agios and Servier she worked on medicines to treat Acute Myeloid Leukemia.
Janice earned her BA in Biology from Boston University and later returned to her alma mater where she completed her MBA in Health Sector Management.
DISTANZA DALLA SEDE DEI LAVORI CONGRESSUALI
Murat Ali
(Phillips Medisize, US)
Murat Ali (MEng, PhD, CEng) is Associate Director, Device Development at the Phillips Medisize Global Innovation and Development Centre (GID UK). He leads device development programs focused on inhalation device–drug combination products, guiding projects from early concept through to clinical trials, and transfer to production.
His hands on expertise includes concept generation, product design, risk management, design verification and validation, test equipment design and qualification, and design transfer into regulated manufacturing environments. Murat has delivered inhaler platforms to clinical trials and supported their successful scale up and launch.
An advocate for strong cross functional teams, Murat fosters collaboration across R&D, clinical, regulatory and manufacturing stakeholders to ensure robust, user centric device solutions that meet quality and regulatory expectations.
Andrea Casazza
(Chiesi Farmaceutici Italy)
Andrea Casazza is the Global Head of Technical Development, R&D at Chiesi Farmaceutici S.p.A., with over 25 years of experience in the pharmaceutical industry. Throughout his career, he has led the development of innovative products for multiple therapeutic areas and patient populations, delivered through oral, injectable, and inhalation routes.
He is recognized for strong leadership in managing complex projects and for a strategic approach based on the integration of multidisciplinary expertise. He has successfully coordinated diverse teams of analysts, formulators, engineers, chemists, and device experts, operating effectively in industrial environments of varying scales.
Over the course of his professional activity, he has made significant contributions to the development and approval of numerous medicines for the European and U.S. markets, ensuring high standards of quality and innovation in R&D processes. Attention has always been devoted to continuous scientific development and to the growth of new generations of professionals.
Main professional experience:
Since 2022: Global Head of Technical Development, R&D, Chiesi Farmaceutici S.p.A.
2017–2022: Head of Chemistry Manufacturing & Controls, R&D, Chiesi Farmaceutici S.p.A.
2010–2017: Head of Drug Product Development, R&D CMC, Chiesi Farmaceutici S.p.A.
2009–2010: Leader, Early Development Group, R&D Pharmaceutical Development, GlaxoSmithKline
2002–2009: Head of Developability, Physical Properties & Biopharmaceutics, GlaxoWellcome
2000–2002: Manager, Analysis and Pre formulation, Inpharzam SA
Melanie Ott
(Gladstone Institute, US)
Melanie Ott, M.D., Ph.D. is the director and a senior investigator at the Gladstone Infectious Disease Institute, a senior vice president of Gladstone and a professor of medicine at the University of California San Francisco. She studied under Nobel laureate Harald zur Hausen in Heidelberg/Germany and has been recognized for her contributions to HIV Cure research and the pathogenesis of hepatitis C and Zika virus infections. Since January 2020, she has pivoted part of her efforts to SARS-CoV-2 research. This work is focused on studying SARS-CoV-2 variants and harnessing the host response for new therapeutics using organoid technology. Her lab also develops new rapid diagnostics based on CRISPR and mobile phone technologies. She is the Program Director for the HOPE Collaboratory, a multi-disciplinary group of researchers from around the world and is an elected member of the Association of American Physicians (AAP) and a fellow of the American Academy of Microbiology (AAM).
Michael Goller
(Transpire Bio, US)
Dr Goller is a globally recognized leader in the field of respiratory pharmaceutical product development, with an international career spanning 25+ years at Transpire Bio, Sandoz, Lupin, Teva, Chemo, IVAX and Quadrant Healthcare. He has directed multiple projects that led to filings and approvals in the US and Europe, across drug delivery systems (DPI, MDI, SMI and nebules) and therapeutic areas (asthma/COPD to innovative biopharmaceuticals) culminating in significant revenue generation.
John Pritchard
John is now a private consultant specialising in strategic approaches to developing respiratory devices, drugs and digital health. In addition, he is Chairman of Nebu-flow and of Cardiff Scintigraphics, and sits on 4 Scientific Advisory Boards. At different stages in his career across GSK, 3M, AZ and Philips, he has worked on pMDIs, DPIs and nebulized products, having been associated with the launch of 11 major products. He also sits on the UN Committee that makes recommendations on the medical uses of propellants covered by the Montreal Protocol. In April 2018, John received the Charles Thiel award for outstanding research and discovery in respiratory drug delivery from Virginia Commonwealth University.
Stephen Stein (CGT Pharma Consulting, US)
Stephen Stein is a leading expert in the development and characterization of orally inhaled drug products with 30 years of experience in the industry and a track record of commercializing inhaler products. He has an extensive knowledge of pMDI and DPI devices and formulations. He has more than 20 granted US patents and numerous others granted worldwide and more than one hundred peer reviewed publications or conference presentations. He recently started CGT Pharma Consulting LLC to assist companies seeking to develop and commercialize inhaler products.
Ana Fortuna (University of Coimbra, Portugal)
Ana Fortuna (PharmD, PhD) obtained the PhD degree in Pharmaceutical Sciences, specialty of Pharmacology, in 2011, at the Faculty of Pharmacy of University of Coimbra (FFUC) and acquired the European Certified Pharmacologist (EuCP), in 2022, from the Federation of European Pharmacological Societies (EPHAR) and European Association for Clinical Pharmacology and Therapeutics (EACPT).
She is currently an Associate Professor at FFUC in the area of Pharmacology and Pharmaceutical Care, an integrated researcher at the Coimbra Institute for Biomedical Imaging and Translational Research of University of Coimbra (CIBIT) and member of the International Nasal Research Group.
Her scientific work has driven translational advances in nose-to-brain drug delivery systems, aiming to enhance treatment options for neurological and psychiatric disorders including epilepsy, Alzheimer's disease, and depression. She has led multidisciplinary preclinical studies incorporating in vitro, ex vivo, in vivo models to investigate the pharmacokinetics and therapeutic efficacy of intranasal formulations, addressing key clinical challenges such as efficient brain targeting, bypassing the blood-brain barrier, and minimizing systemic side effects.
In clinical pharmacology, her research group focuses on therapeutic drug monitoring and the development of population pharmacokinetic models to support precision medicine approaches in epilepsy, depression and schizophrenia. This work facilitates individualized treatment regimens and informs clinical decision-making, improving patient outcomes.
Fortuna’s work contributes substantially to bridging experimental research with clinical application, creating social and economic value through innovation in drug delivery and personalized pharmacotherapy.
Alyn Morice (University of Hull, UK)
Alyn Hugh MORICE M.D., F.R.C.P., FBPhS graduated from Cambridge University and was appointed Foundation Chair and Professor and Head of Respiratory Research Group, Hull York Medical School, University of Hull in 1998. Respiratory Medicine was formed with the objective of becoming a internationally recognised centre for research into chest disease. Cough has been described as the Cinderella symptom of respiratory disease and has been his main research interest. He has pioneered investigation into the epidemiology, diagnosis and therapeutics of cough culminating in the production of national and international guidelines. This continues with his appointment as chair of the ERS task force on the nomenclature of chronic cough. His research on the neuronal mechanisms has radically altered our understanding leading to the concept of cough hypersensitivity. This has been translated through randomised controlled trials in man demonstrating novel tussive pathways (TRPA1) and therapeutic advances (opiates and P2X3 antagonists). This has led to a paradigm shift in clinical management. The immense social and economic morbidity of cough has been revealed in epidemiology studies. Whilst overlapping with other respiratory disease, it is now recognised as a distinct condition (the cough hypersensitivity syndrome) which is stimulating the burgeoning pharmacological developments in the field. Prof Morice was awarded the BTS medal in 2025 for his contribution to chronic cough management.
Fabien Barbirato (Sanofi, France)
I am accountable for leading the mRNA CMC platform team at Sanofi/Marcy l'Etoile and coordinating activities in relation with mRNA platform version evolution and Life Cycle Management in order to ensure a continuous platform performance improvement and to ultimately achieve a sustainable mRNA platform competitiveness.
I joined Sanofi Pasteur in 2007 at Marcy l’Etoile as Head of the MTech Bacteriology platform encompassing LCM and Investment projects. In 2013, I served as MTech site Head in Toronto before to move to the Process Sciences and Technology group of Global MTech as External Innovation Head.
Prior to joining Sanofi Pasteur, Fabien held numerous positions at DSM as scientist and project leader dealing with strain and fermentation process development activities and later at Rhodia (Solvay) as Head of Biotransformation and Biocatalysis laboratory, encompassing screening, process development and support to production activities.
I graduated as Biochemical Engineer of INSA (Toulouse, France) in 1992. I hold a PhD in Microbiology and conducted post-doctorate research in Wageningen University (The Netherlands) on Molecular Biology.
Valentina Fainardi (University of Parma, Italy)
Graduated in Medicine and Surgery in 2008 and specialized in Pediatrics in 2014, she is currently an Assistant Professor of Pediatrics at the University of Parma (Italy). During her PhD, her experience at Imperial College London fostered international collaborations, particularly in the field of pediatric asthma. Her research interests focus on pediatric respiratory and allergic diseases. As a regional coordinator for the Italian Society of Pediatric Respiratory Diseases, she actively collaborates on primary prevention projects addressing pollution and smoking.
MODULO I – 28 OTTOBRE 2025
Lezione 1 – Sviluppo Farmaceutico e Quality by Design – docente Marco Adami
Lezione 2 – Introduzione a GMP e Sistema Qualità Farmaceutico – docente Alessandro Regola
Il Modulo I si è tenuto il giorno 28 ottobre 2025 dalle ore 14.00 alle ore 17.30
MODULO II – 4 NOVEMBRE 2025
Lezione 3 – Gestione del Rischio per la Qualità – docente Silvia Garzon
Lezione 4 – Knowledge Management – docenti Marco Adami e Alessandro Regola
Il Modulo II si è tenuto il giorno 4 Novembre 2025 dalle ore 14.00 alle ore 17.30
MODULO III – 11 DICEMBRE 2025
Lezione 5 – Organizzazione Aziendale e Personale – docente Danilo Ratti
Lezione 6 – La Persona Qualificata – docente Lino Pontello
Il Modulo III si è tenuto il giorno 11 Dicembre 2025 dalle ore 14.00 alle ore 17.30
MODULO IV – 27 GENNAIO 2026
Lezione 7 – La documentazione GMP e del Sistema Qualità – docenti Adriana Logambino e Rosamaria Stilo
Lezione 8 – Data Integrity – docente Giovanni Martinetti
Il Modulo IV è tenuto il giorno 27 Gennaio 2026 dalle ore 14.00 alle ore 17.30
MODULO V – 3 MARZO 2026
Lezione 9 – Gestione delle Modifiche – docente Giovanni Martinetti
Lezione 10 –Deviazioni, Reclami, Richiami, Resi – docente Luca Sala
Il Modulo V è tenuto il giorno 3 Marzo 2026 dalle ore 14.00 alle ore 17.30
MODULO VI – 21 APRILE 2026
Lezione 11 – Gestione dei fornitori di materiali e servizi – docente Rita Brusa
Lezione 12 – Ispezioni e audit – docente Chiara Piacenza
Il Modulo VI si è tenuto il giorno 21 aprile 2026 dalle ore 14.00 alle ore 17.30
MODULO VII – 13 MAGGIO 2026
Lezione 13 – Taratura, Manutenzione e Qualifica – docente Fabio Platini
Lezione 14 – Convalida Sistemi Computerizzati – docente Pierluigi Agazzi
Il Modulo VII si è tenuto il giorno 13 maggio 2026 dalle ore 14.00 alle ore 17.30
MODULO VIII – 7 LUGLIO 2026
Lezione 15 – ore 14.00: Le GMP nella Produzione di API ed eccipienti, docente Piero Iamartino
Lezione 16 – ore 16.00: Le GMP nella Produzione di Prodotti Sperimentali (IMP), docente Luciano Gambini
Il Modulo VIII si è tenuto il 7 luglio 2026 dalle ore 14.00 alle ore 17.30
MODULO IX – 29 SETTEMBRE 2026
Lezione 17 – ore 14.00: Il trasferimento tecnologico (technology transfer), docente Giuseppe Colombo
Lezione 18 – ore 16.00: La convalida di processo, docente Claudia Bianchi Carnevale
Il Modulo IX si è tenuto il giorno 29 settembre 2026 dalle ore 14.00 alle ore 17.30