65° SIMPOSIO AFI – Clinical Research & RWE Hubs
Data Evento:
11/06/2025
- 13/06/2025
Luogo Evento: Palacongressi - Rimini
L'evento
Clinical Research & RWE Hubs @ Simposio AFI 2026
David Edwards (Johns Hopkins University, 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)
Biography coming soon
Chantelle Ahlenstiel (Kirby Institute, Australia)
Biography coming soon
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 Sidney, 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)
Biography coming soon
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)
Biography coming soon
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 Zimmermann 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
Parte teorica:
-normativa allestimento preparazioni in farmacia e NBP;
-aspetti teorici nell'allestimento di capsule
Parte pratica:
-capsule;
-soluzioni idroalcoliche
CORSO AVANZATO
Parte teorica:
-impatto degli eccipienti sulla biodisponibilità delle capsule;
-aspetti teorici dell'allestimento di sospensioni orali;
-gestione delle sostanze CMR in laboratorio
Parte pratica:
-capsule con principi attivi critici;
-sospensione per uso orale
10.00 - 10.15
Apertura Convegno
10.15 - 12.00
Sessione Istituzionale
"Parlando di Galenica con..."
12.00 - 14.00
Pausa pranzo e Sessione Poster
14.00 - 16.00
Tavola rotonda
"Innovazione nel campo delle materie prime e delle tecnologie di laboratorio"
16.00 - 16.30
Coffee break e Sessione Poster
16.30 - 17.15
Comunicazione Scientifiche Orali
17.15 - 18.00
Consegna Certificazioni SIFAP
20.00 - 23.00
Cena Sociale
09.00 - 10.00
Comunicazioni scientifiche orali
10.00 - 11.45
Tavola rotonda
“Il senso della galenica: professioni sanitarie a confronto”
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”
13.00 - 13.30
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)
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).