Anand Subramony is Vice President of External innovation and Novel Technologies at AstraZeneca. In this role, Anand leads various cross functional teams and initiatives in the areas of nanomedicine, targeted therapy, new modalities, and digital technologies including sensors/diagnostics. His group is also responsible for the next generation FutureLab®, lab automation, and evaluating novel technologies. Before his current role, Anand headed the drug delivery and device development at Medimmune. Prior to that, he was Principal Fellow and Head of the Novel Delivery Technologies & Therapeutics at the Novartis Institutes for BioMedical Research (NIBR, Cambridge, MA) where he established and managed a high performing cross functional team. In other roles, Dr. Subramony led the Materials Science function of the Biomedical Engineering group at Alza /J&J (Mountain View, CA), and was Director of Materials Science & Drug delivery at Dr. Reddy’s Laboratories (Bridgewater, NJ) With his broad experience in pharma biotech, Dr. Subramony brings innovation and scientific rigor coupled with execution excellence and sense of urgency towards drug development to create patient centric products. Dr. Subramony holds an MS in Materials Sc. Engineering from IIT Bombay and PhD from Purdue University and was a research scientist at the University of Washington, Seattle before taking up industrial positions. He has several refereed publications and patents in the areas of drug delivery, nanomedicine, and devices.

Dr. Patrick Garidel is currently employed as Head of Pharmaceutical and Protein Science at Boehringer Ingelheim Pharma GmbH & Co. KG. His activities are focused on the development biologics from the downstream process to drug product (liquid and solid formulations, freeze-drying). His expertise covers: development of drug delivery system and formulations, packaging/devices, process development, bio-analytic and protein purification. He is responsible for the establishment of innovative platform technologies for e.g. powder inhalation, gene therapy, in silico based predictive tools for molecule properties, particle analytics. Additionally, he is interested in the development of new concepts and strategies for protein purification, stabilisation, delivery and protein/colloid chemistry in general. PG studied chemistry and biotechnology at the University of Kaiserslautern, pharmaceutical sciences and regulatory affairs at the University of Strasbourg. He has a PhD in biophysics. During his university career, he took over various academic positions at the Institute for Pharmaceutical Technology and Biopharmacy, Physical Chemistry at the Martin-Luther-University Halle-Wittenberg, DESY/Hamburg, Rutgers University and Hospital for Special Surgery/New York.

Matthias Erber is heading a laboratory in the Parenteral Drug Delivery group within Formulation Development at Bayer AG since 2015. Together with his lab-team, he develops innovative injectable formulations and drug product manufacturing processes for both small molecules and biologics, i.e. conjugated mABs. He is currently majorly working in the area of oncology. The role as CMC representative in global project teams gives him the opportunity to be involved in all stages of drug product development until launch. Matthias is a licensed pharmacist and holds a PhD in pharmaceutical technology from the University of Erlangen-Nuremberg. His work there was focused on special freeze-drying applications (spray-freeze-drying/cryopelletization) of blood coagulation-related proteins as well as nanoparticulate drug delivery.

Bastiaan has been active in the field of drug delivery for the last 20 years. He has led projects covering dry-powder formulation development, inhaler design and development, and auto-injector design and development, as well as the associated stages of clinical and regulatory evaluations. In addition, he led the initial clinical evaluation of urologic diagnostic tests at NovioGendix (now MDxHealth) and has held senior management positions at Focus Inhalation, Akela Pharma, Oval Medical and Bespak. Bastiaan has degrees in Biology and Biopharmaceutical Sciences from Leiden University (The Netherlands) focusing on polymeric drug delivery systems for formulation of proteins and peptides. He currently leads the Business Development activities of the Drug Delivery Sector at Cambridge Design Partnership

Matthew Clemente currently serves as the Vice President of Device Development at Novo Nordisk where he leads a development organization focused on the commercialization of drug delivery devices. He previously served as the Senior Director of Systems Engineering & Technology at Eli Lilly & Company, responsible for the leadership of the research and development organization driving the engineering and design of Eli Lilly’s delivery, device and connected solutions portfolio. From October of 2015 as the Chief Technology Officer and Director at Eli Lilly, he lead the technical development of their Connected Care Diabetes Ecosystem and an emerging portfolio of electromechanical delivery devices, applications and algorithms that served a variety of therapeutic areas and formulations. Prior to Lilly Matthew served as Director of Advanced Drug Delivery Systems at Unilife Corporation where he built and managed an integrated engineering and science organization focused on mechanical, electromechanical, digital and container closure systems for prefilled, preassembled, wearable drug delivery applications. Prior to Unilife, Matthew held a variety of roles of increasing responsibility at multiple Johnson & Johnson companies, where he primarily served in the new product development of insulin pumps at Animas Corporation for J&J’s Diabetes Care Franchise. By way of education, Matthew obtained a Bachelor of Science in Biomedical Engineering from the University of Miami and an MBA in Finance from Villanova University.

Assistant Professor at Graz University of Technology, Austria and Principal Scientist / Department Head, Advanced Products and Delivery at Research Center Pharmaceutical Engineering (RCPE), Graz, Austria. Amrit is trained in pharmaceutics, and has a broad interest in physical chemistry of formulations and pharmaceutical material engineering. He has long standing activities and an interest in screening, engineering, stabilization and characterization of pharmaceutical solids intended for oral and inhalation routes. His current work also involves predictive knowledge/model development for physical and chemical stability of pharmaceutical solids utilizing material science principles. Recently, he is working towards advancing the predictive knowledge of in vitro biopharmaceutics methodologies via elucidation of multi-factorial physical and chemical process governing drug dissolution and release from conventional to advanced solid dosage forms.

Andreas Abend, PhD is currently a Director in the Pharmaceutical Sciences Department of MSD’s Research Labs. His group provides analytical support for formulation development as well as GLP and GMP testing. During his 20-year career at MSD, Andreas supported drug product and API development and provided technical support for in-line products. Andreas is the co-leader of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Dissolution Working group, and a member of the Biopharmaceutical Technical Committee of the Product Quality Research Institute. Prior to joining MSD, Andreas was a postdoctoral fellow at the Institute for Enzyme Research in Dr. Perry Frey’s lab at the University of Wisconsin, Madison WI. He got his PhD in Organic Chemistry from the Universität Karlsruhe TH in Germany under the supervision of Dr. Janos Rétey.

- Studied chemistry at RWTH Aachen University - Received doctorate in organometallic chemistry and polymerization catalysis at the group of Prof. Jun Okuda, RWTH Aachen University in 2013 - Joined Shin-Etsu as technical manager and head of the application laboratory in Wiesbaden, Germany, 2014. Development of solid dosage applications with Shin-Etsu cellulose ether excipients and the technical support of customers with laboratory studies. - Changed role within Shin-Etsu to technical sales director 2017. Responsible for Shin-Etsu’s technical activities in the EU, MEA and LATAM.

Andreas Seidl is Chief Operating Officer of LEUKOCARE AG, a Munich based biotech companying providing innovative formulation development approaches for proteins, viral vectors and medical devices. In this role he is responsible for R&D activities, IP and quality management. Before he held different positions at Novartis in analytical & pharmaceutical development, analytical characterization and quality control of biopharmaceuticals. Before he joined Leukocare he was Head Global Analytical Characterization & Bioanalytics and was responsible for characterization and comparability/similarity activities for all biosimilar projects of Novartis. He developed concepts for demonstration of physicochemical and biological comparability of biosimilars in comparison with their originator or reference products as well as after process changes. In the early days of biosimilars he coordinated the pioneering analytical and pharmaceutical development of the first complex biosimilar Binocrit® (epoetin alfa) which gained market approval in the European Union by EMA/EC in 2007 and was since then working on the development of the next wave of biosimilars such as mAbs and fusion proteins. In recent years he contributed to the approval of biosimilar versions of adalimumab, rituximab, infliximab, etanercept, filgrastim and peg-filgrastim. A special focus area of his scientific work is the investigation of aggregation and particle formation phenomena and the impact on immunogenicity. Andreas Seidl is a chemist by training and got his PhD from the University of Constance/Germany in the area of protein analytics and mass spectrometry.

Andy has over 15 years’ experience in the pharmaceutical and drug delivery industry. He currently leads a team of 120 scientists working on formulation development, clinical manufacturing and pharmaceutical analysis projects. Dr Lewis is dedicated to overcoming drug delivery challenges, including solubility enhancement, controlled release and transmucosal delivery of proteins and peptides. He is a member of the Academy of Pharmaceutical Scientists of Great Britain, and is currently Secretary of the Controlled Release Society.

Anna Luczak, Ph.D., is a Senior Scientist at Bristol-Myers Squibb in the Global Analytical Science and Technology group within Quality organization and currently manages Analytical and Quality related projects, compendia compliance, and method lifecycle management and also focuses on developing and using novel spectroscopic techniques to detect bio-pharmaceutical counterfeits in support of corporate security investigations. Anna also works on developing novel fingerprinting methods for elucidation of secondary structure of biologics for bio-process related applications and eventually filing. Anna received her Ph.D. in Analytical Chemistry from New Jersey Institute of Technology under the direction of Prof. Zafar Iqbal where she studied Raman spectroscopy for various pharmaceutical applications. Before joining BMS in 2014, she worked at Johnson and Johnson where she lead process improvements of existing products including scale-up and technology transfer to the supplier’s site. Anna has been a co-chair of SciX Pharmaceutical Analysis Section for the past 5 years. Lastly and most importantly, Anna, is a young mother to Maria and Amelia that reads and listens to books and podcasts constantly to help her shape the young minds of her girls and make them realize they are really, really smart.

Dr. Anne Moore graduated with a degree in Biochemistry University College Cork. She completed a PhD in HIV vaccine immunology with Professor Kingston Mills. Dr. Moore subsequently embarked upon post-doctoral work on defects in immune responses in HIV-infected individuals in the Wistar Institute in Philadelphia and further work on recombinant vaccines against viruses such as HIV and Ebola virus in Dr. Gary Nabel's lab then at the University of Michigan. As a senior immunologist in Prof. Adrian Hill's group in the University of Oxford, she developed several T cell inducing vaccine candidates against malaria and TB and was involved in clinical trials of these and other vaccine candidates in Oxford and malaria endemic areas in Africa. She was a Lecturer in Pharmacology, based in the School of Pharmacy, in early 2007. In 2016 she worked for 10 months with the vaccine biotech company, Vaxart, South San Francisco while on sabbatical. Here she worked on tablet-based oral vaccines for a range of therapeutic and prophylactic vaccine. In September 2018, she took a position as Senior Lecturer in Biochemistry and Cell Biology.

Professor Arwyn T. Jones, Professor of Membrane Traffic and Drug Delivery, and Director of Reseach Cardiff school of Pharmacy and Pharmaceutical sciences, Cardiff University. Before gining his first indpendent position at Cardiff he gained a PhD in protein-crystallography at Birkbeck College, University of London and undertook postdoctoral research at the University of Liverpool, Harvard University and EMBL-Heidelberg, as EMBO and Alexander von Humboldt fellow. His reserach focuses on endocytic pathways that govern the fate and efficacy of drug delvery vectors such as antibodies, peptides and nanoformulation, together with their associated cargo. He has global connections within this remit and strong associations with pharmaceutical companies He sits on the editorial boards of Journal of Controlled Release, Membranes and Gwerddon.

Benoit Koumurian is a process engineer graduate from National School of Chemical Industry of Nancy, France (ENSIC). He also completed a Universitary Diploma of Technology in physical measurement and material characterization at the university of Paris Diderot. Benoit is working within Sanofi group since 2 years. His current position is process engineer in Formulation and Process Development section within Biologics Drug Product Development. His principal field of working is to develop the “fill & Finish” process of biologics, from thawing to freeze-drying, and transfer from lab scale to pilot and commercial.

BA has a broad experience of industrial drug development from more than 30 years of work with Astra and AstraZeneca. During this period BA has had various line and project management positions. Presently BA is a Senior Principal Scientist with emphasis on biopharmaceutics., In this role BA is leading biopharmaceutics research and product development support on a global basis. In addition, as one of the most senior scientists in AZ Pharmaceutical Development BA is also a member of the global pharmaceutical product leadership team. BA is an internationally recognised scientist and he has published more than 100 papers in the area of oral biopharmaceutics and drug delivery. BA is presently an adjunct Professor in Biopharmaceutics at Uppsala University. BA initiated and has been leading a major european private public partnership project OrBiTo in oral biopharmaceutics area ( http://www.orbitoproject.eu). BA is also a member of the focus group for BCS and biowaivers within FIP.

Birger Brodin is full professor and head of the research group "CNS Drug Delivery and Barrier Modelling" at the Department of Pharmacy, the Faculty of Health Sciences. He is worckpakage leader in the Danish research network RIBBDD and in the European network IM2PACT (an IMI network under Horizon 2020). Birger Brodin was trained as Lic. Scient. (PhD) in Cellular Physiology at the Department of Biological Chemistry A (the Ussing-lab) at the August Krogh Institute, University of Copenhagen, under the guidance of Robert Nielsen. After his degree in 1995, he worked for three years on a project on ion channel control in tight epithelial tissues (financed by the Carlsberg Foundation). Subsequently, Birger Brodin in 1998 was employed at the former School of Pharmacy as a research assistant , and began to study the role of membrane transport proteins in drug absorption. In 2000 Birger Brodin was employed as a research associate professor, in 2002 for tenured associate professor and in 2008 Birger Brodin was appointed group leader. His work has included characterization of cell models of the barrier tissues in the body, the study of transporters role in uptake and excretion of drugs and regulation of transporter activity. His work currently. focuses mainly on how drugs and endogenous substrates penetrate the blood-brain barrier, and how transport proteins affect this process.

Charles Evans has been with MedPharm for over 10 years as part of the formulation and analytical development teams and leads MedPharm’s rigorous approach to developing formulations from proof of concept to robust commercial products. He has many years expertise in all types of topical, inhalation and transdermal formulations and played a key role in the development of MedPharm’s proprietary MedSpray® technology currently under license to customers to enhance their products' performance.

Christian Lotz studied Physical Chemistry at the University of Bochum and did his doctorate in Physical Chemistry at the University of Essen. He started his Industry career at Lipoid GmbH, a GMP manufacturer of parenteral grade phospholipids, in the sales department with technical and regulatory support functions. Since April 2015 Christian is working as BD Director EMEA and lately as General Manager EMEA at Pfanstiehl, world’s leading manufacturer of low endotoxin and high purity GMP parenteral grade carbohydrate based excipients, providing commercial and technical support to the EU customer base. Christian has 16 years of experience in GMP relevant sourcing and marketing activities of pharmaceutical raw materials.

Clare is experienced in researching and analysing the medical industry – with a particular interest in drug delivery. She has worked with very small and early-stage start-ups as well as big pharma & biotech, and market-leading medtech companies. Her expertise includes unmet needs exploration through structured interviewing, as well as technology scouting, and market strategy. She is keen to draw on the experiences of users and key stakeholders, both to validate applications of existing products or drive innovation of new concepts.

Claus-Michael Lehr is a Professor at Saarland University as well as co-founder and head of the department Drug Delivery at the Helmholtz Institute for Pharmaceutical Research Saarland (HIPS). Lehr has also been the co-founder of Across Barriers GmbH and acts as CEO of PharmBioTec GmbH, a not-for-profit contract research subsidiary of Saarland University. The research theme of his team is non-invasive drug delivery across biological barriers, in particular, the epithelia of the gastrointestinal tract, the skin, and the lungs. Recently, this has expanded to microbial barriers. He is (co)author of more than 350 papers with >12.000 citations (h‐index = 66). Recently, the British magazine “The Medicine Maker” rated him, for the third time, as one of the top 100 most influencing drug researchers in the world.

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. He started his professional career in 1990 at Schering AG, Berlin-Germany. From 2007 to 2013, Dr. Clemens Günther was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects. After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals. Meanwhile Dr. Clemens Günther has gained about 30 years experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.

For the past five years, Dan has been leading programs to develop new oral therapeutics at PureTech Health and its affiliates. These currently include PureTech’s lymphatic targeting program and Entrega Biosciences, a PureTech affiliate, which is developing hydrogel dosage forms for the oral delivery of therapeutic peptides. Dan received a PhD in Medical Engineering from the Harvard-MIT Division of Health Sciences and Technology (thesis co-advisors Paula Hammond, ChemE, Bob Langer, Institute). Subsequently, he spent his postdoctoral fellowship developing nanoparticle vaccines at École Polytechnique Fédérale Lausanne (co-advisors Melody Swartz, Jeffrey Hubbell) in Switzerland.

David Lyon received his B.S. in Chemistry from Western Washington University and Ph.D. in Inorganic Chemistry from the University of Oregon. Following a Post-Doctoral stint at the California Institute of Technology, David joined Bend Research as a Research Chemist. During his tenure at Bend Research he held positions of increasing responsibility culminating in the role of Senior Vice President, Research prior to the company’s acquisition by Capsugel and, subsequently, Lonza. He currently serves as a Sr. Fellow, Research advising internal and external collaborations in bioavailability enhancement technologies, inhaled therapies, highly potent compounds and biomanufacturing.

Dr Dennis Douroumis is a professor in Pharmaceutical Technology and Process Engineering at the University of Greenwich His research activities focus on three main areas: (a) Continuous manufacturing processes for the development of medicinal products, (b) 3D printing technologies for novel medical devices, and (c) Nanomaterial synthesis and surface modification for cancer treatment. Furthermore, his group works on QbD approaches based on HME processing such as solid state synthesis of cocrystals, solid dispersions and extrusion granulation. Dennis has established several national and international collaborations with world-class colleagues/researchers including industrial funded projects and several EU grants. He has received a prestigious award for his “Outstanding Scientific Contribution” in Pharmaceutical Processes and invited to deliver the Award Lecture, sponsored by AstraZeneca. He has joined the Editorial Boards of seven international journals including the Wiley’s Editorial Board for the edition of a series in “Advances in Pharmaceutical Technology”. Dennis has published more than 100 full papers, 4 patents, 6 book chapters and 2 book editions.

Dr Vivek Trivedi graduated with a BPharmacy (1st Class) in 2002. After a short stint in industry, he enrolled for MSc in Pharmaceutical Science in 2003. He worked as a development scientist in Phoqus Pharmaceutical Ltd after completing his masters before returning back to university to undertake a PhD in 2007. His PhD topic involved the development of novel drug delivery systems for the oral delivery of biomolecules. He graduated in 2010 and, was appointed as a Lecturer in Formulation Science in the University of Greenwich, where he stayed until April 2019 before moving to the University of Kent. Dr Trivedi's research is centred around two areas; solubility improvement of BCS II drugs and oral delivery of biomolecules. His interests strongly revolve around the use of green processing methods, in particular, supercritical carbon dioxide to develop suitable strategies for drug delivery. He is currently working on a delivery platform known as Solid Core Drug Delivery System (SCDDS) for the delivery of biomolecules. This entails incorporation/immobilisation of biomolecules onto inorganic host materials which can potentially improve their thermal and chemical stability. These biologics on the inorganic hosts are then coated with the suitable excipients to target them to lower intestine and provide sustained release. He is also interested in the preparation of cyclodextrin-drug complexes and determining solid-liquid transition of pharmaceutical actives and APIs in supercritical CO2. He has attracted funding from various industrial sources as well as Royal Society and Royal Society of Chemistry to conduct research in areas summarised above.

Dr. Marco Emgenbroich studied chemistry at the Heinrich-Heine University of Düsseldorf in Germany. He join a graduate school program on "Molecular Physiology" for PhD candidates and early 2003 he received his doctorate degree in organic and macromolecular chemistry in Düsseldorf as well. After a postdoctoral fellowship in the biomedical applications of polymer matrices he started his industrial career in the biotech field, where her worked on drug delivery of peptides and proteins for parenteral drug applications. Early 2011 he joined the R&D department of LTS Lohmann Therapy Systems in Germany, where he was responsible for the late stage development program and the global launch of a transdermal patch in the CNS field. Since 2015 he is responsible for the pharmaceutical development activities at LTS working on collaboration projects in the area of transdermal therapeutic systems and oral thin films.

Michael Black has a BSc in Biological Chemistry from the University of Ulster and a PhD in Organic Chemistry from the University of Edinburgh, Scotland. Following a post Doc at the University of Florida, USA he entered the pharmaceutical industry at Boots Pharmaceuticals, developing new chemical entity APIs. After this he moved to Knoll AG, Germany as Product Manager for bulk Ibuprofen. Further steps included technical marketing at BASF, Germany, Business Development at Budenheim, Germany and since 2014 he is Head of Sales Pharma for galenIQ™ at BENEO-Palatinit in Germany.

Sharareh Salar-Behzadi held her diploma in Pharmacy and PhD in Pharmaceutical Technology from University of Vienna, Austria. Her experience covers a broad range, including formulation and process development for production of solid dosage forms. She works as Principal Scientist at Research Center Pharmaceutical Engineering (RCPE) GmbH since 2012 and as lecturer at Department of Pharmaceutical Technology and Biopharmacy, University of Graz. An important research focus of her is the development of patient-centric pharmaceutical products with advanced stability, based on lipid-based excipients.

Tony Listro is Vice President, Technology of Foster Delivery Science, Inc., a CDMO focused on drug delivery and highly regulated medical device applications based on polymer processing technologies. He is responsible for the continued research and development of new melt extrusion technologies as well as guiding Foster’s team of engineers and scientists in the contract development and manufacturing of specific formulations and dosage forms for clients in the pharmaceutical industry. Tony is an expert in the areas of polymer materials and polymer processing. He has worked on blending active pharmaceutical ingredients with polymers for various drug delivery applications including oral and implantable for more than 15 years. Tony holds both a BS and MS in Plastics Engineering from the University of Massachusetts in Lowell, MA, and an MBA from the University of Massachusetts in Amherst, MA. He holds two issued US patents and has authored and/or co-authored 20 publications. Tony is a member of the Society of Plastics Engineers, Controlled Release Society, and AAPS.

Dr. Ferdinand Brandl studied pharmacy in Regensburg, Germany. After receiving his PhD in pharmaceutical technology, he was a postdoctoral fellow at the Massachusetts Institute of Technology, Cambridge, MA, USA. Before joining BASF, he was a research associate at the Department of Pharmaceutical Technology, University of Regensburg, Germany. Since 2016, he is part of R&D for pharmaceutical excipients and drug formulations at BASF.

Gregoire Schwach joined F.Hoffmann-La Roche Ltd back in 2015 in Basel, Switzerland, in the department of Pharmaceutical Development and Supplies – Biologics Europe. As head of drug delivery, Gregoire is overall responsible for the implementation of advanced drug delivery technologies in the Roche pharma development portfolio. He is working with sterile products, and his current focus areas are within long acting delivery in ophthalmology and parenteral drugs. Before joining Roche, Grégoire worked more than 10 years in various drug development positions at Ferring Pharmaceuticals A/S in Copenhagen, Denmark, most lately with 6 years as director of early stage development. He has also experience from the medical device industry as former head of polymer development with Phusis biodegradable materials in France.

Heinrich Haas has more than 20 years of experience in academic research and industrial pharmaceutical development. After he received his Ph.D. in physical chemistry, Dr. Haas researched lipid membranes and organized biomolecular systems. His professional focus is on colloidal/nanoparticulate formulations for targeted drug delivery with therapeutic and diagnostic applications. Before joining BioNTech RNA Pharmaceuticals GmbH (former Ribological GmbH), he was responsible for a variety of projects in biopharmaceutical research and development, ranging from the exploration of novel colloidal therapeutic and diagnostic carriers to up-scaling and development of market-compliant manufacturing methods for liposome products. After joining BioNTech RNA Pharmaceuticals GmbH in 2010, he helped build the formulation development and analytics unit, which develops formulations for delivery of RNA and small molecules. He has an active record of publications in peer-reviewed journals and patent applications in the field of drug delivery.

James has over 12 years’ experience focusing on the formulation sector. Working at Croda he has focused on formulating with Croda’s current range of surfactants, oils and other speciality chemicals used in formulated products from paints to pharmaceuticals to engine lubricants. James lead the new surfactant and formulation development teams, focusing on formulation science to develop new green and sustainable surfactants. Over the last 5 years James has switched focus to the understanding and development of excipients for the pharmaceutical sector, with particular interest on the role of the excipient type and quality on the stability and delivery of drugs in numerous dosage forms. James has an overarching interest in understanding the intricacies of formulation from what seem like such “simple” blends of material on paper, which is why he represents Croda on the SCI Formulation Forum in the UK.

Jan holds a PhD in Chemistry and did his diploma studies in Business Chemistry at the Heinrich-Heine University in Düsseldorf. He started his career in the pharmaceutical industry at Sanofi in 2014, where he held different positions in API manufacturing, within the CMC organization & Drug Device Combination Manufacturing. After a short stint at Boehringer Ingelheim as Manager Device Development Jan joined Roche in April 2018 as a Product Care Leader responsible for the lifecycle management of co-packed devices in the small molecules portfolio.

Jatin Patel is currently a Senior Director, CMC at Constellation Pharmaceutical in Cambridge, USA where he is responsible for developing formulation strategies, managing clinical supply logistics, identifying regulatory roadblocks and managing vendor relations. He received his Ph.D. in Pharmaceutics from the University of Iowa in 1991. During his tenure in the Pharmaceutical Industry, Jatin has been instrumental in launching several oral products with a focus on patient centric design, expediting development through predictive tools and creative strategies to meet global regulations. Previously, Jatin worked at Bristol-Myers Squibb where he headed the commercial oral product development function and led the development and technology transfer team for their flagship oral product (Eliquis® Tablets).

Jean-René Authelin has an Engineer degree in chemical Engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s he founded the Physical Quality function, dedicated to the API crystallization, drying, polymorphism where he was the Global head in Rhone Poulenc Rorer, Aventis and finally Sanofi . In 1988, JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug polymorphism, amorphous solids physics, drug stability, crystallization, nanoparticles engineering and processing, drying , milling; spray drying, fluid bed granulation, roller compaction, freeze drying. JR Authelin cooperated with very famous scientists like Prof J.Villermaux, P de Gennes (Nobel price of Physics 1991). Jean René Authelin is the author or co-author of 14 publications or book chapters and the co-inventor of 9 patents

I am a Biochemist with a PhD (from faculty of Medicine, Lisbon) in Biomedical Sciences with focus on biophysics studies of bioactive compounds and lipid particles with +7 years of experience in drug discovery & development, assay development and protein/virus characterization. After a pos-Doc Virology (Institute Pasteur, Paris), I am currently applying my knowledge in Vaccine development as a Scientist at Johnson&Johnson - Janssen Vaccines and Prevention (Drug Product Development Department). In the Formulation Science and Technology team we are responsible to work closely with research and pre-clinical teams in order to efficiently bring our protein and adenovirus-based vaccines from pre-NME to early-stage development supporting with formulation and early stability studies. I have great passion for integrative data analysis and processing and I have been implementing new data analysis approaches and image-based analytic technologies at our vaccine development workflow for easier, faster and more discriminative decision and interpretation.

Joel is a technical lead for the engineering team with multidisciplinary knowledge spanning mechanical design, physics, materials and biological systems. Joel has worked on a range of medical technology including neurosurgical equipment, injection devices, asthma inhalers and cardiovascular stents. Joel’s scientific approach to design is based on understanding and leveraging the fundamental physics governing the performance of devices and formulations.

John earned a MSc from the University of Waterloo in theoretical chemistry and a PhD from the University of Pennsylvania in computational chemistry. Following post-doctoral research in computational chemistry at the University of British Columbia, he worked for Procter & Gamble studying surfactants structures in solution. For the last 18 years, John has worked for Schrödinger, LLC, as a scientific software developer and a research scientist, managing a number of products including the Materials Science Coarse-Grained product.

Dr Jonas Fransson is Director of Drug Product Development at Swedish Orphan Biovitrum AB, Stockholm, Sweden. He is trained at Uppsala University and received a Ph.D in pharmaceutics in 1996. Since then he has held various positions in the areas of formulation development and manufacturing focusing on product development of biologics. He has worked in a number of development projects covering conventional injectables, ophthalmic delivery, injection devices and lyophilization development. Dr Fransson is now at Sobi AB responsible for formulation, packaging and device development. Jonas is also engaged in various academic/industry collaborations and is chairman of the NextBioform consortium focusing on innovative methods for biological pharmaceuticals meeting end-user needs. Dr Fransson is also active in Sweden Drug Delivery.

Kristin Lehmkemper is a senior scientist in the Global Pharmaceutical R&D Division at AbbVie Deutschland. She supports drug product development as a member of the Material Science and Physical Pharmacy Group of the NCE Formulation Sciences department. Within this function, she applies thermodynamic and mathematical models for estimating preferred compositions, preparation technologies, processing conditions, and packaging requirements for the development of pharmaceutical formulations. Kristin graduated in biochemical engineering at TU Dortmund University and completed her doctorate at Laboratory of Thermodynamics (TU Dortmund) in collaboration with AbbVie investigating the physical stability of amorphous pharmaceutical formulations.

Dr. Boltri is a pharmaceutical chemist by training and completed his degree at the University of Turin. With almost 30 years of experience in the Pharmaceutical Industry, Dr Boltri has held leading positions as Department Head and Director. Extensive experience in Formulation Development for various dosage forms, with a focus on oral drug delivery and bioavailability enhancement. 15+ original/innovative products developed from prototype profiling to commercial scale. In the current role, Dr. Boltri supports Company processes leading to identify and develop new and innovative technologies as well as valuable opportunities for product development and co-development.

Dr. Magdalena Obarzanek-Fojt is currently Drug Product Leader within Cell and Gene Technical Development at Novartis. She formerly worked at EMPA – the Swiss Federal Laboratories for Materials Science and Technology in St. Gallen, Switzerland. Her main expertise are: •Pharmaceutical development for cell and gene therapies, •Cell and molecular biology •Tissue engineering After graduating from the University of Life Sciences in Poznan, Poland in 2005, she obtained a Postgraduate Fellowship at ETH Zurich, Switzerland, where she deepened her knowledge in molecular biology. After that, she obtained a Doctoral Fellowship at University of Lausanne, Switzerland, where she further specialized in molecular biology of the human cell and she developed a model system for rare skin genetic disorder using lentiviral vectors. During her Post-Doctoral training at EMPA, she worked in multiple projects related to tissue engineering, 3D in vitro systems for drug testing; foreign body response to drug delivery biodegradable microparticles, hydrogels and carbon-nanotubes based biomaterials. After joining Novartis in 2015, she focused on cell and viral-vector final drug products and formulation development and she contributed to multiple CGT IND/IMPD filling, including BLA filing for Kymriah, the first approved ATMPs in the US. Magdalena is a member of APV Drug Delivery Focus Group, as an expert for ATMPs.

Mara van Haandel is Innovation Manager of DFE Pharma as of August 2013. In this role Mara is responsible for setting the innovation strategy and its implementation. She is line responsible for the R&D team product development and application. Since 2003 Mara held various R&D roles at Royal FrieslandCampina, as product developer, project manager and new product development manager. Mara obtained an MSc in Food Technology at the University of Wageningen, The Netherlands.

Marie Leman graduated from ESPCI engineering school (Ecole Supérieure de Physique et de Chimie Industrielle of Paris) and holds a PhD in physico-chemistry. Her PhD focused on the development of high-throughput tools for directed evolution. After her PhD, Marie worked for a microfluidics consulting startup and joined Sanofi group 3 years ago. Her current position is formulation scientist in Formulation and Process Development section within Biologics Drug Product Development. Her principal field of work is ADC formulation and transfer from lab scale to commercial.

Mike has been in Human Factors for over 20 years. He initially worked for Johnson and Johnson in the area of diabetes and blood glucose meters. After this he was Human Factors Manager for Teva Pharmaceuticals before joining Boehringer as Human Factors Engineer in Ingelheim. During this time he has been responsible for introducing processes and procedures and interpreting HF regulatory guidance and standards for combination products.

Dr Mike Tobyn is a Research Fellow in Materials Science and Engineering within Bristol-Myers Squibb, Moreton, leading a transatlantic team covering early to late phase products, and manufactured products. His team studies API and excipient properties and their interaction with pharmaceutical processes. He has been at BMS for 13 years, following jobs in Academia and working with a company from start-up to IPO. He has published more than 75 papers in the area of formulation and Pharmaceutical Materials Science. The understanding of the complex interactions in Pharmaceutical Materials Science has led Mike to investigate techniques of data analysis as it pertains to R&D and production, of small and large molecules. 2018 saw the publication of the book he edited with Dr Ana Ferreira and Professor Jose Menezes entitled “Multivariate Analysis in the Pharmaceutical Industry” covering the technical and regulatory aspects of MVA and associated techniques.

Agathe Buffard studies Cognitive Sciences and Human Factors in France. Agathe started her career in the software development field as user experience engineer at Volvo Trucks and Alstom in France from 2012 to 2014. In 2014, she had the opportunity to join the human factors team at Novartis in Switzerland as human factors engineer. There, Agathe has gained expertise in various medical devices and combination products, including pumps, auto-injectors, pen injectors, (prefilled) syringes with safety systems. She has managed several types of user studies (contextual inquiries in patients’ home, formative studies, human factors validation studies) with patients, lay caregivers and healthcare professionals.

• Master and PhD in mechanical engineering with a specialization in numerical simulation at Technical University Darmstadt (TUD) • Research Assistant at TUD (2009-2014): Development of simulation methods for aviation, automotive and medical engineering industries • Senior Simulation Engineer at Sanofi (2014-Today): o Integration of state-of-the-art simulation methods o Manage collaborations with internal and external partners related to parenteral drug delivery o Supervision of all critical simulation activities within device development

1) Experience: a) 2016 – ... : Lek Pharmaceuticals d.d., Novartis; Senior Scientist i) Role: (1) Biological drug product development of late phase (2) Novartis innovation ambassador (3) New technologies projects (4) Subject matter expert on mixing process b) 2011 – 2016: National Institute of Chemistry, Slovenia and University of Oxford, UK; PhD student i) Role (1) Optimization of recombinant protein isolations from insect cell systems. (2) All-atom modelling of proteins and their interactions (with membranes, ions) (3) Intermolecular interactions: Microscale thermophoresis, surface plasmon resonance (4) Electron microscopy (Cryo-EM, TEM) Notable publications: Structure and lipid binding properties of the kindlin-3 pleckstrin homology domain; Dec 14, 2016 Biochemical Journal How to Study Protein-protein Interactions; Mar 2016 Acta Chim Slov. An optimized protocol for expression and purification of murine perforin in insect cells; Jul 18, 2015 J Immunol Methods Perforin and human diseases; May 2014 Subcellular Biochemistry

PhD in Solid State NMR followed by 7 years of preformulation, polymorph screening, form selection and crystallization of small molecules, as well as product development R&D. Currently developing Advanced data analytics solutions for small molecules and biologics using R, Python Spotfire and Streambase.

Ijeoma Uchegbu is Professor of Pharmaceutical Nanoscience at the UCL School of Pharmacy, University College London (UCL), UCL’s Pro-Vice Provost for Africa and The Middle East and Chief Scientific Officer of Nanomerics Ltd. Nanomerics is a UCL spin out company, which was founded by Ijeoma and Andreas G. Schätzlein (http://www.nanomerics.com/). Nanomerics recently licensed NM133 to Iacta Pharmaceuticals and NM127 to Virpax Pharmaceuticals. Nanomerics also recently won first prize for its Molecular Envelope Technology at the Royal Society of Chemistry’s Emerging Technologies Competition 2017 in the Health category. Ijeoma has been awarded various prizes for her work, notably the UK Department for Business Innovation Skills’ Women of Outstanding Achievement in Science Engineering and Technology award (http://www.theukrc.org/women/women-of-outstanding-achievement/2007-collection/professor-ijeoma-uchegbu), the Royal Pharmaceutical Society’s Pharmaceutical Scientist of the Year 2012 and the Academy of Pharmaceutical Sciences Innovative Science Award 2016. Ijeoma was elected to the Controlled Release Society College of Fellows in 2013 and was made an Eminent Fellow of the Academy of Pharmaceutical Sciences in 2013. Ijeoma is the editor of three books, a named inventor on 11 granted patents and has authored over 180 peer reviewed journal articles and book chapters. Ijeoma’s research has been featured on BBC Woman’s Hour and more recently in The Guardian.

Professor Khuloud T. Al-Jamal is a Chair of Drug Delivery & Nanomedicine, King’s College London. She is also a registered pharmacist at the General Pharmaceutical Council. She started her academic career as a lecturer at King’s College London in 2011. She has completed her pre-registration pharmacy training at The University College London Hospital and was awarded the Overseas Research Award Scheme (ORSA) Scholarship from The University of London (2000-2004) to complete her PhD in Drug Delivery from The School of Pharmacy, University of London (currently known as UCL-School of Pharmacy). She was awarded the prestigious CW Maplethorpe Research and Teaching Postdoctoral Fellowship from The University of London (2005-2007) to explore the use of cationic dendrimers as anti-angiogenic agents for growth inhibition of solid and metastatic tumours. She has developed an extensive experience in designing and developing novel nanoscale delivery systems including dendrimers, liposomes, quantum Dots (QDs), polymers, viral vectors, chemically functionalised carbon nanotubes and graphene oxide. Her current work involves pre-clinical translation of novel nanomaterials designed specifically for drug, protein, nucleic acids and radionuclide delivery for therapeutic or diagnostic applications. She was awarded and is managing a number of research projects funded by The Royal Society, Worldwide Cancer Research, EPSRC, BBSRC, FP6, FP7 and ITN Marie Curie research programmes. In February 2012, she was awarded the BBSRC New Investigator award exploring the use of chemically functionalised carbon nano-needles as vectors for delivering therapeutics across the BBB. In 2012, she was awarded the prestigious Royal Pharmaceutical Society Science Award in recognition for her outstanding scientific achievements in the field of Nanomedicine. In 2019, she received the CRS Nanomedicine and Nanoscale Delivery Award. She is a three-time winner of the Wellcome Trust Image Award (2014-2016). She is a management board member and is on the steering committee of the London Centre of Nanotechnology and the Children Brain Tumour Drug Delivery Consortium. She is on the Editorial Board of Biomaterials Science (RSC), Scientific Reports (Nature Publisher) and Journal of Drug Targeting.

Qizhi (Rachel) Hu joined Cristal Therapeutics in 2011 and currently serves as senior scientist formulation and project leader. In this role, she supports the development of Cristal’s clinical-stage product CPC634 and the proprietary CriPec® polymeric technology platform, as well as leads projects in collaboration with industrial and academic parties. Rachel received her B.S. degree in Pharmaceutical Sciences from Peking University Health Science Center (China), M.S. degree in Drug Innovation from Utrecht University (the Netherlands) and Ph.D. in Nanomedicines from Twente University (the Netherlands).

René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the school of pharmacy at University of Copenhagen, Denmark, in 1998 and his PhD in biopharmaceutics from the same institution in 2002. Dr. Holm joined Lundbeck in 2001 and changed to Janssen in 2016. Dr. Holm has worked within pharmaceutical development, formulations for non-clinical testing in drug discovery, physical chemistry and material science covering both small and large molecules and is now responsible for the functional unit ensuring development of all non-solid formulations for Janssens small molecule value stream. Dr. Holm is (co-) author of more than 185 original articles in peer-reviewed journals and patents in the field of biopharmaceutics, preformulation, formulation and physical pharmacy and is a honorary professor in physical chemistry at the Department of Science and Environment, University of Roskilde, Denmark

Present research activities of Cornelus (René) van Nostrum include the design, synthesis and characterisation of polymers for hydrogels, micelles, microspheres and nanoparticles, and their application as drug delivery devices and as absorbants for toxins. Dr. van Nostrum obtained his M.Sc. in Chemistry in 1990 and the Ph.D. degree in 1995 in the group of Prof. Dr. R.J.M. Nolte, both at the University of Nijmegen. Starting in August 1995 he worked as a postdoctoral fellow at Philips Research Laboratories in Eindhoven. In 1997 he accepted an employment as assistant professor at the department of Polymer Chemistry and Coating Technology of the Eindhoven University of Technology, where he was involved in polymer synthesis for coating applications. In October 1999 he joined the department of Pharmaceutics of the Utrecht University as assistant professor, and was promoted to associate professor in October 2004. Dr. van Nostrum received the Dutch Innovative research Vidi grant and a personal grant from Utrecht University in the framework of the High Potentials program. In 2014 he was awarded the Thomson Reuters Highly Cited Researcher award, in recognition of ranking among the top 1% of researchers for most cited documents in his field.

Dr Richard Green is Senior Director within the Parenterals Centre of Excellence group at Pfizer based in Sandwich, UK, responsible for the design and development of innovative small molecule parenteral products from Research through to Regulatory approval and commercialisation. As well as sterile injectables, he has experience with a wide range of technologies including immediate and modified release products, paediatrics, abuse deterrence formulations, and also continuous manufacturing for solid dosage forms. Previous positions within Pfizer have included technology assessment for drug delivery, responsibilities for biopharmaceutics and Discovery support to screen, select and define the drug delivery strategy for candidates early in development, and a range of project leadership, technology and licensing roles. Richard is a member of the PCoE Leadership team which as well as Sandwich, includes groups in the USA, India and Australia to apply state of the art predictive tools and models to design and develop drug product formulations and robust manufacturing processes for Pfizer’s small molecule parenteral portfolio. Richard is a member of the Industry Steering group for the National Formulation Centre, and has previously represented Pfizer on the Medicines Manufacturing Industry Partnership Technology & Innovation Team. Richard obtained both his pharmacy degree and PhD in the transdermal delivery of peptides from the University of Wales.

Rob Steendam, PhD, is co-founder and Chief Technology Officer at InnoCore Pharmaceuticals, a biopharmaceutical drug delivery company specialized in the development of long-acting and minimally invasive parenteral drug delivery products for the treatment of chronic and site-specific diseases. At InnoCore he heads the development of InnoCore’s innovative biodegradable polymeric sustained release drug delivery technologies and oversees the execution of InnoCore’s partnered drug delivery product development programs. He is an inventor of several patents related to novel biodegradable multi-block copolymers and their application in parenteral drug delivery and drug eluting implants. Prior to founding InnoCore in 2004, he worked for Polyganics, a venture capital funded biosurgical start-up company, where he played a key role in developing the company and managed the pre-clinical and clinical development of novel bioresorbable implants and tissue regeneration products in the fields of peripheral nerve repair and general surgery. He holds a master of science in Polymer Sciences and a PhD in Pharmaceutical Technology and Biopharmacy, both from the University of Groningen in The Netherlands.

Ronny Reinberg is the VP Technology Affairs at Intec Pharma, responsible for the R&D unit and the Tech Transfer activities. Ronny joined Intec Pharma in 2009 and since then has been involved in the evolution of the technology from lab scale to commercial capabilities. Prior to Intec Pharma, Ronny was a part of TEVA’s generic R&D division and developed several complex projects, utilizing various pharmaceutical manufacturing technologies.

Russell Hornung (Russ) - Business Development Russ Hornung is a Business Development representative for Drug Delivery and Packaging for W.L. Gore & Associates. Russ began his career at with a BSEE (Electrical Engineering) from The Pennsylvania State University and went to work at Westinghouse as a design & new product development engineer. He later transitioned into new business development representative while studying MSEE at Johns Hopkins University. Russ returned full-time to receive his MBA from the Katz Graduate School of Business, University of Pittsburgh. Since 1996, Russ has held various Product Management and Business Development positions focused on providing unique and valued material based solutions to difficult market needs in various industries.

Rémy's background is "Design", he studied in the french and german-speaking part of Switzerland and owns two degrees in Graphic & Communication Design and one in Interaction & Interface Design. Rémy started his career in the communication and advertising industry in early 2000, before switching to digital product and service design 10 years later. He left the classic "world of communication and digital design" to join the Human Factors Engineering team at Roche Basel in 2016. Enthusiastic about interactions beyond screens, Rémy work since to improve the user experience of Roche drug delivery devices, mostly in the context of administration by non-professional users.

Dr. Sachin Dubey is presently working with Ichnos Sciences, Switzerland as deputy director and head of formulation, analytical and drug product development unit. His current responsibilities include designing and executing product development and characterization strategies for both early and late stage products for Ichnos Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Glenmark Pharmaceuticals, Switzerland and Novozymes Biopharma, Denmark. He have ~ 12 year of experience in biopharmaceutical formulation and combinational product development. Twelve products developed by him and his team are currently in different clinical trial, he has overseen production of >75 drug product/diluent/diluent for clinical trial 1-3. He have extensive experience with regulatory submissions in USA, EU and India. He have 9 PCT patent applications, ~ 20 publications in high impact journals like Journal of Controlled Release etc., 6 book chapters and ~ 60 presentations to his credit. He also have received 19 research awards including prestigious industry awards/recognitions from Glenmark (Best innovation team – won twice), Merck (Innovation cup), Novartis (International biocamp) and Swiss Society of Pharmaceutical Sciences (Best publication).

Dr. HONG Shiqi is a senior biopharma scientist at Roquette, based out of Roquette’s Global Biopharma Center of Excellence in Singapore. In her role, Dr. Hong specializes in formulation development and focuses on developing new solutions to extend the shelf life of therapeutic proteins. She possesses over a decade of cross-functional industrial experience in drug product development, including substantial knowledge in supporting early stage drug development of small molecules. Dr. Hong earned her PhD in Pharmaceutical Sciences from the National University of Singapore.

Sudhakar Garad received his Ph.D. from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr, M.S Nagarsenker. Soon after completion of his Ph.D., he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his Ph.D, he was selected as a post-doctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers. After his post-doctoral fellowship, he worked with Vertex pharmaceutical for a period of three years as Senior Investigator in formulation development group. After Vertex, he joined Novartis as a Group Head. He worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Sudhakar is working as a Global head of Chemical and Pharmaceutical profiling (Discovery Pharmaceutics) and Disease Area Head (New Indications) at Novartis. His primary role is collaborate with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies to expedite molecules into tox and clinical studies. He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). He has many publications, book chapters and patents. In last 20 years of his career he has taken more than 200 new chemical entities in clinical studies across dozen disease areas ( CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration. He serves as a technical R and D expert to research Disease Area for hematology, hepatology and kidney disease area.

Prof. Dr. Sven Stegemann is professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria. Dr. Stegemann has worked over the course of 27 years for the pharmaceutical industry, acting as an advisor to major pharmaceutical companies on ways to improve the design, development and manufacture of pharmaceutical products so they better address the individual needs of patients. In his academic role, Dr. Stegemann’s focuses his research on the rational development of patient centric drug products and their associated manufacturing technologies, as well as education and training of students and young scientists. Dr. Stegemann is the founder and chair of the AAPS Focus Group on Patient-Centric Drug Development, Product Design, and Manufacturing as well as the founder and President of the Geriatric Medicine Society e.V.. He recently started the industrial-academic collaboration partnership Patient Centric Medicine (PaCeMe) to suitable and meaningful guidance for patient centric drug product design. He is the editor of the book “Developing Drug Products in an Aging Society - From Concept to Prescribing”, a multidisciplinary approach towards patient centric drug development for the older and multimorbid patient populations.

Study of Genetics (M.Sc.) followed by a PhD in molecular biology at the department of Molecular Biology of the Paris Lodron University of Salzburg. After conclusion of my PhD studies in 2016 I moved to Tirol (Austria) to work in the Pharmaceutical Development Department of the Sandoz GmbH (Novartis).

With a broad expertise in the field of amorphous solid dispersions Thomas provides a deep understanding of formulation development and process optimization in the expanding field of hot melt extrusion. He has a strong background in pharmaceutical industry including industrial development, GMP manufacturing, clinical supply, research & development. Thomas is a pharmacist by education and holds a PhD in Pharmaceutical Technology.

Torsten Kneuss studied Business Administration and Engineering. Since 1999 he has been working with pharmaceutical packaging materials, medical devices and combination products, including several years within the field of quality control, development, operations, and pharmacovigilance. Since November 2017 he is, as a Quality Manager Combination Products, responsible for devices and combination products within Bayer AG.

• Twinkle Christian is a Process Development Scientist in the Drug Product Technologies group at Amgen. She has 14 years of industry experience in formulation development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. Twinkle’s expertise encompasses high concentration formulation and delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography. She is an adjunct faculty at California State University, Channel Islands. Twinkle holds a Master’s in Biochemistry and Molecular Biology and was employed at Alza (Johnson & Johnson) and VaxGen prior to Amgen.

PhD in Physics, University of Heidelberg, Germany Scientist at Bayer AG, Central Research, Leverkusen, Germany Bayer Technology Services GmbH, Leverkusen, Germany Nanotechnology in various fields of material science from 1995 to 2009. Then became a Senior scientist at various Bayer locations between 2010 an 2017. Since 2017 he has been Group Head Formulation Technology: Invite GmbH, Leverkusen Operational director of the Drug Delivery Innovation Center (DDIC) Setup and leading academic cooperations (PhD theses) between Bayer AG and various universities: New approaches in drug formulation and manufacturing

Dr. Alan S. Harris serves as Senior Vice President of Global Life Cycle Management and the BRIC labs of Ferring Pharmaceuticals SA. He is also responsible for the BRIC labs in Brazil, Russia, India and China as well as Ferring's Development Labs in the US. Alan joined Ferring in 1984. Dr. Harris has a Ph.D in biopharmaceutics from Uppsala University, Sweden and an MBA from Ashridge, UK.

Louise is Head of Regulatory Affairs at Cambridge Design Partnership, a full-service product development consultancy based in Cambridge, UK and Palo Alto, Tx. Originally training as a pharmaceutical scientist at Nottingham University, UK she has over 10 years’ experience in drug delivery and medical device development with a particular focus on device technical management and regulatory strategy for EU and FDA submissions. With a solid background in developing inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer Ltd, UK and Oval Medical Technologies, UK, among others, Louise has a proven track record in supporting successful device submissions (and DHF remediations) under FDA, CE and other regulatory authorities.

Richard Featherstone is Research Director, Human Factors Research and Design for Emergo by UL. Based in Cambridge UK, Richard has nearly 20 years of experience of usability research with a special interest in combination products such as autoinjectors and breath-actuated inhalers. Prior to his usability work, Richard worked for 20 years in a variety of roles in the pharmaceutical industry, and pioneered some of the early work on using observational data to compare outcomes for different types of pharmaceutical devices. He speaks internationally on the application of human factors to medical devices and leads Emergo’s human factors activities in Europe. Richard has more recently been instrumental in developing human factors testing methodologies for connected devices such as mobile apps and electromechanical autoinjectors for some of the world’s largest pharmaceutical and software companies.

Dr. Christoph Brandenbusch studied Chemical Engineering at the Department of Biochemical and Chemical Engineering at TU Dortmund, (Germany) 2003-2007. He finished his Ph.D. thesis in the field of downstream processing in whole-cell biocatalysis in 2011. Since 2012 he works as a group leader at the Laboratory of Thermodynamics, Department of Biochemical and Chemical Engineering, TU Dortmund (Germany). His main research fields include: Novel strategies for protein purifications in pharmaceutical bio-processes (e.g. precipitation, aqueous two-phase extraction) including hybrid-modeling approaches therefor. The development of physical-sound models for the identification of excipients and excipient mixtures in high-concentration biopharmaceutical formulations.

Guillaume Brouet is Vice-President, Analytical, Regulatory and Scientific Affairs for Aptar Pharma. He has 25 years of experience in the development and qualification of drug delivery systems as well as analytical and formulation development. He has spoken previously at multiple respiratory and nasal drug delivery conferences. Mr Brouet graduated from Ecole Supérieure de Chimie Organique et Minérale (ESCOM, Paris, France) and earned an Msc in Physical Chemistry, which he obtained at the University of Houston, TX, US.

David Ward is Intertek’s Formulation and Manufacturing Lead for Intertek Melbourn. He has worked in the pharmaceutical and device development sectors for over 20 years across innovative pharma companies and device design and product development, specializing in formulation, analysis and clinical production approaches for orally inhaled and nasal drug products. He has worked across many device types including pMDI, DPIs, nasal products and nebulisers.

John Majewski is a Device Development Engineer at Gilead Sciences in Foster City, CA. He joined Gilead in April 2018, where he develops drug-device combination products with a focus on patient-centered design. His experience ranges from early technical feasibility to commercial device support. John has expertise in injection, respiratory, and nasal devices across multiple therapeutic areas. Prior to joining Gilead, he worked at Teva Pharmaceuticals designing novel inhaler technologies and at Dexcom Inc. in manufacturing and process development for next generation continuous glucose monitors. John holds a Bachelor’s degree in Biomedical Engineering from the University of Virginia and a Master’s degree in Medical Device Engineering from UC San Diego.

Bernhard Müllinger (Vice President Inhalation Technology at Vectura Group plc) has 24 years of experience in respiratory drug delivery and development of highly differentiating drug/device combination products. At Vectura he leads the development of inhalation device platforms and is responsible for device strategy and has successfully developed drug/device combination products for the EU and US markets. He is very experienced in drug formulation development, definition of dosing strategy and clinical trials with respiratory drug development. Before joining Vectura, he worked at Activaero GmbH in respiratory drug delivery and clinical development, at Inamed GmbH in respiratory contract research, at the Clinical Research Group at the Asklepios Clinics on pulmonary diagnostic technologies and at the HelmholtzZentrum Munich on optimization of particle deposition and environmental research. Bernhard is currently member of the ISAM board (The International Society for Aerosols in Medicine).

Dr. Akhtar is Associate Professor at Faculty of Pharmacy and Alternative Medicine, the Islamia University of Bahawalpur, Pakistan. He did PhD (Pharmaceutics) in year 2014 from the Islamia University of Bahawalpur, Pakistan including six months of PhD research at School of Pharmacy, Queen’s University Belfast, UK that was fully funded by HEC Pakistan under IRSIP program. In the year 2018 he completed one-year postdoc from Institute of Pharmaceutical Science, King’s College London, UK where he joined Drug Delivery and Nanomedicine research group. His postdoc fellowship was fully funded by PHEC, Government of Punjab, Pakistan. He is a registered Pharmacist with Punjab Pharmacy Council, Punjab, Pakistan. He is also HEC Approved PhD Supervisor and currently supervising PhD and MPhil scholars in the area of Pharmaceutics and Nanotechnology in Drug Delivery. He has published more than 30 research and review articles in National and International peer reviewed journals of good impact. He has more than 15 years of university teaching, research and professional experience. He has presented research in many national and international conferences as Oral / Digital Poster / Poster presentations. He is reviewer of many research journals.

Christian Jones is Chief Commercial Officer at Nanoform, an innovative nanoparticle medicine-enabling company. Nanoform works together with pharma and biotech partners globally to reduce clinical attrition and enhance their molecules formulation performance through its best-in-class CESS® nanonization™ technology. Christian is a chemist by training and formerly led global Business Development for Prosonix Ltd. His work helped to transform their offering from a crystallization platform into a particle engineering/drug delivery business, which was later sold for $100 million. Christian’s previous experience also includes senior commercial roles within CDMOs through his work at Dr Reddy’s Laboratories and Johnson Matthey, where he led their particle engineering strategy as Commercial Director for European API development and manufacturing.

Steven Ross is a research associate in pharmaceutical processing at the University of Greenwich and principal scientist at Cubi-Tech Extrusion whose current work revolves around the screening, formulation development and manufacture of multi-component drug systems such as cocrystals, salts, solid dispersion and ODTs. Steven obtained his PhD at the university of Greenwich where he also works as a research associate specializing in Hot-Melt extrusion processing of multi-component systems, with the primary focus of improving development strategies, making them more economical and environmentally friendly. In tandem with this role, He also serves as Cubi-Tech extrusiosns principal scientist, working on commercializing novel multi-component system development strategies. In these short 4 years Steven has published over 15 research and review articles based around the subject of multi component systems, hot-melt extrusion and other drug delivery mechanisms. Steven has also delivered a number of presentations and lectured on the subject of pharmaceutical processing at a number of international conferences and training symposiums.

Andreas Bernkop-Schnürch was educated in pharmacy at the Institute of Pharmacy (M.Sc.) and in microbiology and genetics at the Institute of Microbiology and Genetics (D.Sc.), University of Vienna, finishing his doctorate in 1994. In 2003 he was appointed to a chair in pharmaceutical technology at the University of Innsbruck, Austria. From 2006 to 2013 he served as dean of the Faculty of Chemistry and Pharmacy at the University of Innsbruck. His research interest is in the area of mucoadhesive polymers, nanocarriers, peptide drug delivery and self-emulsifying drug delivery systems (SEDDS). He developed thiolated polymers (thiomers) and zeta-potential changing nanocarrier systems. Dr. Bernkop-Schnürch is author of over 450 research articles and reviews as well as editor and (co-)author of several books. He is the founder of Mucobiomer GmbH (now part of the Croma-Pharma Holding), Thiomatrix GmbH and Green River Polymers GmbH.

Josef Hartl received his Master in Biochemistry from the University of Regensburg and is currently finishing this PhD at the University of Halle. He is also located in the group of Patrick Garidel at the Early Stage Development department of Boehinger Ingelheim in Biberach. His professional interests focus on Protein-Protein Interaction at high protein concentration, and the prediction of viscosity of different high concentration formulations. His current projects include the development of technics for characterization of weak protein-protein self-interactions and the determination of protein characterisitics e.g. the solution conformations, protein hydration and dipol-dipol interaction.

Davide Mercadante is a medical engineer with 10+ years of experience within multiple areas of device and combination product development, including design & development, design quality assurance, verification & validation engineering, quality control and supply chain quality. He received his bachelor’s and master’s degree in medical engineering from the Second University of Rome, where is focus was on medical device design and development. Davide has a Lean Six Sigma Green Belt and he currently works at Biogen in the Device Development Quality group where he is the quality project lead for both the Risk Management Continuous Improvements and Combination Product DHF 21CFR Part 4 Final Rule enhancement projects. He also has been instrumental with the integration of software as a medical device into the existing Quality Management System.

Mr. Hassett has 30+ years’ experience in the medical device industry. In that time, he has functioned as Global VP Sales, Marketing, and Business Development for IVAC Corporation, Medication Delivery Devices, Safety Syringes Inc., ROVI Contract Manufacturing and other innovative delivery system companies. His responsibilities included commercialization of infusion pumps, injectable devices with prefilled syringes, wearable devices, and autoinjectors. He has injectable device experience in multiple markets including acute and home care as well as 15 years of experience specifically in Pharmaceutical and Biotech space. He holds a BS degree from Georgia State University in Atlanta, GA.