6.02.2023 AFI – PDA Italy Chapter – Giornate ANNEX 1
L'evento
ISCRIZIONE SINGOLA ALLA GIORNATA DEL 6 FEBBRAIO 2023
Il 25 agosto 2022 è stata rilasciata la versione finale dell’Annex 1 che entrerà in vigore nell’agosto 2023 ad eccezione del punto 8.123 (liofilizzazione), che ha termine di attuazione il 25 agosto 2024. L’implementazione dei requisiti richiesti per raggiungere la compliance nei tempi prestabiliti è la nuova sfida a cui l’industria farmaceutica deve rispondere, trovando soluzioni e risorse in tempi brevi.
DRYCE
Soluzioni per il trasporto a temperatura controllata in ambito farmaceutico
Per Backman (Emmace, Sweden)
Dr Bäckman earned a PhD in Thermochemistry from the University of Lund in 1991 and joined Astra Draco in Lund in 1995 following post-doctoral positions at University of Virginia and University of Lund. From 1995 to 2006, Dr Bäckman held several positions within Astra Draco/AstraZeneca in Lund, mainly focusing on the interface between preclinical and clinical development of inhaled medicines. In 2006, he joined Novo Nordisk A/S in Denmark as head of department for inhalation product characterization. Between 2011 and 2016, Dr Bäckman was Principal Scientist at AstraZeneca in Mölndal, Sweden, focusing mainly on research activities related to developing and implementing models that integrate deposition, clearance, dissolution, uptake and systemic disposition of orally inhaled products. In 2016, Dr Bäckman joined Mylan Pharma UK to lead the development of inhalation biopharmaceutics. Dr Bäckman is currently the co-chair of the PQRI sponsored working group responsible for the development of the inhalation biopharmaceutical classification system (iBCS). As from May 1, 2018, Dr Bäckman is responsible for Physiologically Based Biopharmaceutical Modelling (PBBM) at Emmace Consulting AB, Sweden and also the owner and main adviser at Per Backman Consulting AB, Sweden.
Jan de Backer (FLUIDDA, USA)
Jan De Backer graduated from Delft University of Technology, The Netherlands as aerospace engineer. He attained an MSc degree in aerodynamics and specialized in applied biomedical computational fluid dynamics leading to a PhD from the University of Antwerp, Belgium. He is an alumnus of the MBA programs at London Business School, London and Columbia Business School, New York. Dr. De Backer has received several awards for his innovative research in the field of airway modeling in respiratory and sleep medicine. His work has been published in international journals. Dr. De Backer founded FLUIDDA in 2005 and he has held the position of Chief Executive Officer since 2007.
David Cipolla (Insmed, USA)
David is the VP of Research at Insmed Incorporated, where he is part of a team developing novel, targeted therapies to help serve the critical unmet needs of patients battling serious and rare diseases. Prior to joining Insmed in 2018, David worked at Aradigm (1996 to 2018) covering all phases of product development and led the development of preclinical research, CMC activities and intellectual property. Prior to joining Aradigm, David worked at Genentech, Inc. (1988 to 1996) developing and characterizing the delivery of protein aerosols to the airways, culminating with the approval of Pulmozyme® rhDNase for the management of cystic fibrosis in 1993. David holds a chemical engineering degree from MIT (SB) and UC Davis (MS) and a pharmacy degree from the University of Sydney (PhD).
Lea Ann Dailey (University of Vienna, Austria)
Lea Ann Dailey is a pharmacist by training and completed her PhD at the Philipps University of Marburg, Germany, on the topic of biocompatibility testing of polymeric nanoparticles for the controlled release of drugs in the lung. She continued working in the field of formulation science for inhalation therapies at Nektar Therapeutics (now Novartis, San Carlos, CA, USA), followed by positions at King’s College London, UK, the Martin Luther University Halle-Wittenberg, Germany, and the University of Vienna. Her research has focussed on the design of dosage forms for the delivery of anti-infectives to the lung as well as the biocompatibility assessment of novel excipients for inhaled products.
David Edwards (Harvard University, USA)
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.
Carsten Ehrhardt (Trinity College Dublin, Ireland)
Carsten is Professor in Pharmaceutics and Biopharmaceutics at the School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin (TCD). In 2013, he was elected Fellow of TCD. Carsten’s research focuses on the disposition and epithelial transport of drugs following their administration to the lungs using in vitro and ex vivo models. Moreover, he is interested in molecular origins of airways disease. Carsten has edited 1 book and (co-) authored >110 peer-reviewed publications and over 250 abstracts. He is the recipient of honours and awards from the German Pharmaceutical Society (DPhG), American Physiological Society and Galenus Foundation. Carsten serves as Associate Editor of Journal of Aerosol Medicine and Pulmonary Drug Delivery and Section Editor of European Journal of Pharmaceutical Sciences and is a member of the Editorial Boards of European Journal of Pharmaceutics and Biopharmaceutics, Pharmaceutics, and Pharmaceutical Research.
Ben Forbes (King’s College London, UK)
Paul Hagedoorn (University of Groningen, NL)
Research & Development of drug formulations for the pulmonary route and inhalation systems focusing on dry powder inhalers. More than 30 years experience in the field of inhalation and (co)author of more than 100 publications in peer reviewed journals and 4 patents.
Author of 5 books and the Care Atlas about "Inhalation technology and instruction"
- Co-inventor of the Novolizer, Genuair, Twincer and the Cyclops.
- Scientific advisor and board member at the IMIS (Inhalation Medication Instruction School) foundation.
- Board member of the Medical Aerosol group (MAD)
- Board member of the Inhalation Research Workgroup (IRW)
- Board member of Inhalation Institute of the Netherlands (IIN)
- Member of the Medication Adherence Expertise Center Of the northern Netherlands (MAECON)
Michael Hindle (Virginia University, USA)
Dr. Mike Hindle is the Peter R. Byron Distinguished Professor in the Department of Pharmaceutics at Virginia Commonwealth University. He has a Pharmacy degree and a Ph.D. in Pharmaceutical Technology, both from the University of Bradford, UK. Dr. Hindle joined the VCU School of Pharmacy in April 1997.
He has published over 130 peer reviewed papers, 1 book chapter and served as co-editor of 5 books. He has received funding from NIH, FDA and the Bill and Melinda Gates Foundation together with the pharmaceutical industry. He serves on the editorial board of the Journal of Aerosol Medicine and Pulmonary Drug Delivery and the AAPS PharmSciTech Journal. He is a chartered member of the NIH Drug and Biologic Therapeutic Delivery study section and has served on over 30 NIH review panels.
He holds 10 U.S. patents and 5 E.U. patents some of which have been licensed to two companies. He was inducted as a Fellow of National Academy of Inventors in 2023. Dr. Hindle is co-inventor of a series of technologies that seek to significantly improve pharmaceutical aerosol delivery to the lungs and his research is particularly focused on challenging patient populations such as infants and children, in which he combines in silico computational fluid dynamics (CFD) with in vitro characterization studies to improve inhalation drug delivery.
Jenny Lam (University College London, UK)
Dr Jenny Lam is an Associate Professor of Pharmaceutics at the UCL School of Pharmacy, UK. Jenny obtained her MPharm and PhD from The University of Nottingham, where she investigated the use of non-viral vectors for gene delivery. She was then awarded the Maplethorpe Fellowship, continued her research in nucleic acid delivery at King’s College London. In 2009, she joined the University of Hong Kong as Assistant Professor, and returned to the UK in 2022. Jenny’s research is focused on the development of novel delivery system for RNAs and biologics, with special interest of using particle engineering methods to produce aerosol formulations for respiratory diseases. She is the principal investigator of many competitive grants. She has published over 90 peer-reviewed articles and filed a number of patent applications on pulmonary drug delivery systems. In 2020, she was awarded the DDL Emerging Scientist Award which recognised her significant accomplishment and innovation in inhalation science.
Federico Lavorini (University of Florence, Italy)
Federico Lavorini is Professor of Respiratory Medicine and Head of the Respiratory and Critical Care Unit, Careggi University Hospital, Florence, Italy. His research interests are cough and aerosol medicine. He is a member of the Aerosol Drug Management Improvement Team, and of the Respiratory Effectiveness Group. Federico Lavorini is Co-Chair of the European Respiratory Society /International Society of Aerosol in Medicine Taskforce on inhaled therapy and devices. Federico Lavorini has published over 150 peer-reviewed papers and 80 of them are in the field of aerosol medicine. He has extensive experience in both academic and industrial pharmaceutics, and still retains a strong link with the pharmaceutical industry. He is one of the inventors of an inhaled powder formulation of an antitussive drug. Federico Lavorini is Associate Editor of the Respiratory Physiology and Pathophysiology, Frontiers in Physiology. He acts as Board member of the Journal of Aerosol Medicine and Pulmonary Drug Delivery.
Pavan Muttil (University of New Mexico, USA)
Dr. Pavan Muttil is a tenured Associate Professor and serves as the Chair of the Department of Pharmaceutical Sciences at the University of New Mexico in the United States. The Muttil laboratory's research is focused on the formulation development of vaccines and drugs using needle-free delivery systems and their preclinical evaluation in animal models. These needle-free delivery systems include dry powders for pulmonary delivery and microneedles for transdermal administration. Additionally, his laboratory has studied various biologics stabilization techniques to reduce cold-chain dependence during storage and transportation. Dr. Muttil has received funding from multiple agencies to support his research endeavors, including the Bill and Melinda Gates Foundation, the National Institutes of Health (USA), and the Department of Defense (DoD-USA).
Amrit Paudel (RCPE, Austria)
Dr. Amrit Paudel is an associate professor at Graz University of Technology and scientific leader of formulation drug delivery at Research Center Pharmaceutical Engineering (RCPE), Graz, Austria. Amrit worked in the discovery pharmaceutics team of Bristol-Myers Squibb. He completed his Ph.D. in 2013 in the drug delivery and disposition group at the University of Leuven, Belgium. He is the recipient of the Young Investigator Award of 2014, issued by the APGI. Dr. Paudel has a broad interest in the physical chemistry of formulations, drug delivery, and pharmaceutical material engineering. His current work involves predictive knowledge/model development for the stability and biopharmaceutics attributes of pharmaceutical products. In addition, design and engineering of an oral, pulmonary and diverse long acting drug delivery, are of his key interests.
Eride Quarta (University of Parma)
Eride Quarta is Assistant Professor at Food and Drug Department of University of Parma. She got her industrial PhD in Drug Sciences, Biomolecules and Health Products in 2020 at University of Parma (IT) in collaboration with the SME PlumeStars who designs and develops orphan medicinal products.
During the PhD she worked at CUPIDO project European Union’s Horizon 2020 to develop inhalable biocompatible and biodegradable nanoparticles that can self-assemble and encapsulate an active biomolecule for cardiovascular disease exploiting lung-to-heart route.
Her research interests are solid dosage forms for controlled and site-specific drug delivery especially of biologics in nano and micro system for pulmonary, nasal and oral administration.
She has published more than 20 original papers, and she is the inventor of 2 patents. Eride Quarta won the EUFEPS Woman in Pharmaceutical Science Award 2021 and was awarded as Best Innovator of 2022 by the Italian Association of Women Inventors and Innovators for the WO patent “Powder composition based on microparticles embedding nanoparticles for the delivery of therapeutic/diagnostic compounds”.
Regina Scherliess (University of Kiel, Germany)
Prof. Dr. Regina Scherließ (*1979) is a professor for Pharmaceutics and Biopharmaceutics, vice-dean for research of the Faculty of Natural Sciences at Kiel University (since 2022) and chair of the Department of Pharmaceutics at Kiel University, Germany. As such she leads the research unit in Pharmaceutics and is responsible for all teaching in Pharmaceutics and Biopharmaceutics at Kiel University. She is a pharmacist and received her Dr. rer. nat. (doctor of natural sciences) in 2008 for a work on “Formulation of inhalation combination products by co-precipitation”. In 2015 she finished her “habilitation” working on “Mucosal vaccination via the respiratory tract”. During her academic education she had research stays in Denmark, the US, New Zealand and Australia. She also received several young researcher awards including The Pat Burnell New Investigator Award 2010 of the Aerosol Society and is member of the DDL scientific committee (since 2015). She also is member of the board of the priority research area KiNSIS (Kiel Nano Interface and Surface Sciences) at Kiel University (since 2020). Her research interests include disperse systems and nanoparticles, stabilisation of biomolecules and particle engineering in spray drying, and formulations for mucosal vaccination with a focus on respiratory (nasal and pulmonary) dry powder delivery. She is a co-founder of the Nasal Research Focus Group, a research consortium from academia and industry focusing on nasal drug delivery.
Hugh Smyth (University of Texas at Austin, USA)
Hugh D. C. Smyth is the Alcon Centennial Professor, College of Pharmacy, The University of Texas at Austin. He is also an Adjunct Associate Scientist at the Lovelace Respiratory Research Institute, Albuquerque, NM. Dr Smyth oversees and multidisciplinary laboratory funded through NIH, FDA, and industry that focuses on engineering new drug delivery systems with an emphasis on drug delivery to the airways. He has over 300 published works which have been cited over 7500 times. Dr Smyth is editor of 3 books, and an inventor on numerous patents or patent applications. He has a Pharmacy and a Ph.D. degree from the University of Otago, New Zealand. He has been faculty at The University of North Carolina at Chapel Hill, and The University of New Mexico. He was the American Association of Pharmaceutical Scientists (AAPS) New Investigator award winner for Pharmaceutics and Pharmaceutical Technologies in 2007. He also received the PhRMA Foundation New Investigator Award in pharmaceutics in 2007. He gave the DDL Annual Lecture in 2022. He was the Editor in Chief of Drug Development and Industrial Pharmacy from 2014-2022. Dr. Smyth has started several companies resulting from technologies discovered in his laboratory including Respira Therapeutics, Nob Hill Therapeutics, Via Therapeutics, and Cloxero Therapeutics which are now advancing these technologies for clinical use.
Nicolas Tsapis (Paris-Saclay University, France)
Nicolas Tsapis did his PhD on model biological membranes at ENS (Paris, France). In 2001, he went to Harvard University as a post-doctoral fellow with Prof. David A. Edwards and David A. Weitz. There he studied the drying process of droplets containing colloidal particles from a fundamental and applied point of view. In October 2003, he joined the team of Prof Elias Fattal as a CNRS researcher (Univ Paris-Sud, France). His research activity focuses on three main topics: Contrast agents for theranostics, spray drying from fundamentals to therapeutic applications and nanomedicines. In 2009, he obtained the CNRS bronze medal and in 2014 he was appointed CNRS research director. Since 2020, he is the vice-director of Institut Galien Paris-Saclay. He is the co-author of about 140 publications and 8 patents among which one led to the founding of Imescia (https://imescia.com/).
Daniela Traini (Macquarie University, Australia)
Dr Traini is Professor in Respiratory Science and NHMRC Investigator (2020-2024) at the Faculty of Medicine, Health, and Human Sciences (Department of Biomedical Sciences), Macquarie University, based at the Respiratory Technology Group, Woolcock Institute of Medical Research. She has over 25 years of experience in inhalation drug development, with a focus on particle engineering, drug delivery and in vitro models. After working in the pharmaceutical industry for 8 years, she completed her PhD in Pharmaceutics in 2005 at the University of Bath (UK). From 2005 to 2021, Dr. Traini led a distinguished research team at the University of Sydney. Since 2021, she has continued her impactful research at Macquarie University. She has published over 300 peer reviewed articles and gained 18$M in grant awards.
Keertan Dheda (University of Cape Town, South Africa)
Keertan Dheda is a hospital-based respiratory physician and clinician scientist with professorial appointments at the University of Cape Town and the London School of Hygiene and Tropical Medicine. His research work has focussed on the pathogenesis, diagnosis and management of respiratory infections including TB, and his clinical interest includes difficult to treat asthma. He serves or has served on several international academic and advisory bodies including those of the WHO, NIH, Wellcome Trust, and the editorial boards of the American Journal of Respiratory and Critical Care Medicine, Lancet Respiratory Medicine, and the British Medical Journal. He has published over 391 peer-reviewed manuscripts (H index of 100) and is a co-inventor on 6 patents related to diagnostics and vaccines.
Benjamin Myatt (Kindeva UK)
Ben is a Senior Product Development Engineer within R&D at Kindeva Drug Delivery. He is a formulator whose work focusses on next generation low GWP propellants; evaluating and developing current and new inhalation formulations, technologies and device platforms. He also develops new test methodologies and novel apparatus to measure, understand and enable pMDI product development.
Ben is a Chartered Mechanical Engineer and a member of the Institute of Mechanical Engineers. Prior to joining Kindeva, Ben gained a master’s degree in mechanical engineering from Loughborough University followed by PhD research in the thermofluids and optical diagnostic groups focusing on pMDI atomisation using non-contact laser based and high-speed imaging techniques for investigation of pMDI internal two-phase fluid flows, atomisation and spray plume dynamics.
Ben’s goal is to delve deeper into the science of pMDIs, to understand and improve pMDI drug delivery and efficiency to enable new pMDI products and ultimately improved therapeutic outcomes.
Noémi Stefánia Csaba (University of Santiago de Compostela, Spain)
Noémi Csaba received her Ph.D. in Pharmacy in 2005, from the University of Santiago de Compostela, Spain and completed her postdoctoral training at ETH Zürich, Switzerland (2005-2007). She joined the University of Santiago de Compostela in 2008, where she currently holds a faculty position in Pharmaceutical Technology at the School of Pharmacy. Since 2016, she also acts as the director of the “Natural Polymers and Biomimetics” research unit at the Center for Research in Molecular Medicine and Chronic Diseases – USC, Santiago de Compostela. At present, she is principal investigator of several international and national research projects on transmucosal drug delivery and nanomedicine, with more than 20 years of background experience in the field. She authored > 80 research articles and book chapters and she is the main inventor of 7 international patent families related to mucosal drug delivery technologies and biomaterials.
Francesca Ungaro (University of Napoli Federico II, Italy)
Francesca Ungaro is Associate Professor in the field of Drug Delivery at the Department of Pharmacy, School of Medicine of University of Napoli Federico II, Italy. She received her Degree in Pharmacy in 1999 and a Ph.D. in Pharmaceutical Sciences in 2003, all from the University of Napoli Federico II. Since 2000, Prof Ungaro’s research activity has been focused on the design and development of innovative drug delivery systems, especially nano-/micro-particles. Research in the nanotechnological field is now oriented toward the development of tailored nanoparticles to overcome biological barriers, with a special focus to pulmonary delivery. Her long-lasting experience in the field is witnessed by the coordination of several multicentre projects aimed to harness drugs, antimicrobials and nucleic acids for local treatment of lung inflammation and infection.
David Lechuga (Astrazeneca, US)
Dr. David Lechuga-Ballesteros, Head of Innovation, Inhalation Product Development, AstraZeneca Pharmaceuticals,leading scientist in material sciences and particle engineering. Education: B.S., National University of Mexico, 1984: Ph.D. Pharmaceutics, University of Michigan. Dr. Lechuga has contributed to the development of several medicines: Exubera, inhaled insulin for the treatment of diabetes; Bevespi, Breztri and Airsupra, co-suspension pMDI to treat COPD and asthma. He has co-authored over 100 publications including peer-reviewed articles, book chapters and abstracts. He is named as an inventor in over fifteen patents describing new drug crystal forms, novel formulations, or specialty processing equipment. He has served in the Editorial Advisory Board of the Journal of Pharmaceutical Sciences, Pharmaceutical Research, and Molecular Pharmaceutics. Served as guest editor of a special issue featuring advances in respiratory and nasal drug delivery and co-editor of a book on biotechnology and pharmaceutical applications of drying technologies.
Barzin Gavtash (Kindeva, UK)
Barzin earned his Ph.D. in Mechanical Engineering specialising in thermofluids, in collaboration with Chiesi Farmaceutici SpA and Loughborough University, on computational fluid dynamics (CFD) simulations of metered-dose inhalers (MDIs). Post-Ph.D. in 2016, he engaged in postdoctoral work with 3M UK PLC, Loughborough University, and Innovate UK, developing nose-to-brain drug delivery systems and establishing predictive engineering pipelines for product development. Joining Kindeva Drug Delivery in 2018, Barzin has held various technical and managerial roles, culminating as the head of MDI commercial strategy after earning an MBA from Imperial College London in 2022. His research interest focuses on applications of predictive engineering and transport phenomena to life sciences and in particular, to design and optimise next-generation drug delivery devices.
Tomaso Guidi is a pharmaceutical professional with extensive experience in drug development and formulation. He graduated from the University of Bologna (Italy) with a degree in Pharmaceutical Chemistry and Technologies. His career journey began at GSK, followed by Aptuit, before joining Chiesi Farmaceutici in 2014, where he has held various roles within the Pharmaceutical Development sector, currently serving as the Head of Formulation and Process Development. In this role, he leads the design of formulations and processes across the entire drug product portfolio, ranging from Solid Oral Dosage Forms, Inhalation Products, Lung Surfactants, Sterile Liquids and Biologics. He has had the chance to evaluate and implement numerous formulation technologies supporting the development of these dosage forms.
His expertise lies in taking NCEs from preclinical stages and bringing them quickly to clinics and throughout all drug development stages, up to the market launch and LCM. In recent years, his interest has shifted towards Inhaled Biologics.