Speakers 2019

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.

Alessandro Fioni earned his PhD in Medicinal Chemistry and Technology at the Pharmaceutical Department of the University of Parma (Italy), where he was mainly involved in the evaluation of structure-property (QSPR) and structure-activity (QSAR) relationships of new covalent enzyme inhibitors. During the PhD course, he also run MetID studies at the Medical Mass Spectrometry Department of the Uppsala University (Sweden). He started his career at the Pharmacokinetics, Biochemistry and Metabolism Department of Chiesi Farmaceutici S.p.A. (Parma, Italy) in 2009, where he is currently working as Senior Scientist. Alessandro is a DMPK team member in the discovery project teams and he is involved in the evaluation of novel technologies and formulations for inhalation administration in preclinical studies.

Anacelia Ríos Quiroz did her University studies as Industrial Pharmaceutical Chemist in the Polytechnic National Institute (IPN) of Mexico City. Afterwards, she did her Master studies in Pharmacology in the Centre of Research and Advanced Studies (CINVESTAV-Mexico City) on the field of Bioinorganic Chemistry. In 2012, she started her PhD studies in Pharmaceutical Technology in collaboration with Basel University and F. Hoffmann-La Roche Ltd., in Switzerland. She worked in the field of sub visible protein particles and has become an expert on particle counting characterization techniques. Her research increased the understanding on the applicability of emerging technologies as analytical tools for the pharmaceutical industry and serve as guideline for the implementation of related analytical methods and quality control strategies. After a Post Doc in the field of evaluation of the immunogenicity of protein particles, she joined in January 2016 the Analytical Department of Roche where she leads the Particle Lab unit.

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. As Head Global Analytical Characterization & Bioanalytics Andreas Seidl is responsible for characterization and comparability/similarity activities for all biosimilar projects of Sandoz/Novartis. At 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. During his career at Novartis he held different positions in analytical & pharmaceutical development, analytical characterization and quality control of biopharmaceuticals. In the early days of biosimilars he coordinated the pioneering analytical and pharmaceutical development of the first complex biosimilar Binocrit® (INN: epoetin alfa) which gained market approval in the European Union by EMA/EC in 2007 and is 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. From April 1 2019 onwards he will become the COO of Leukocare AG, a biotech company specialized on innovative formulation development of biopharmaceuticals

Dr. Anette Müllertz is professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. She is head of Bioneer:FARMA, Danish Drug Development Center, a business unit of Bioneer A/S, based on a grant from the Danish Ministry of Science and Technology given to establish research based scientific services within the area of drug development. After receiving her PhD degree in lipid nutrition at the Technical University of Denmark, she went to work for Novo Nordisk A/S, on development of structured lipids, digestive lipases and digestion models, among other projects. In 1998 she joined the University of Copenhagen. She is heading the Physiological Pharmaceutics Research Group, focusing on developing predictive biopharmaceutics tools for oral drug delivery and lipid based drug delivery systems. She has >175 publications in international, peer-refereed journals (h-factor: 48 (Google Scholar)), as well as 10 book chapters; the majority of these being within the area of biopharmaceutics. She is / has been supervising 9 post docs, 40 PhD students and numerous master students, primarily at the University of Copenhagen, but also at other universities. She has been involved in the organization of many international meetings, both in Europe and the US and has been invited to speak at international meetings on more than 50 occasions. She is a driving force in the EU sponsored Innovative Medicines Initiative Consortium Oral Biopharmaceutics Tools (OrBiTo; http://www.orbitoproject.eu), as co-lead of the API characterization work package. She was the winner of the 2005 AAPS Lipid Based Drug Delivery Award and is in the steering committee of 2 AAPS Focus Groups (FGs); The Lipid-based Drug Delivery FG (Chair 2010-12) and the QbD and Product Performance FG (Chair 2013-15).

April Kent is Medical Device, IVD & Combination Product Regulatory Affairs Manager at Amgen (a biopharmaceutical company) where she is involved in the global regulatory oversight of prefilled drug device products, standalone medical devices and IVDs/companion diagnostics (CDx), as well as planning for implementation of new legislation such as the MDR and the IVD Regulation. She is a member of the European Biopharmaceutical Enterprises (EBE) device combination product topic group and author of the August 2018 Journal of Medical Device Regulation (JMDR) focus article on combination products. Previously, April worked in the medical device industry on global regulatory submissions for medical devices containing ancillary medicinal products (drug-eluting implantable devices). She has a BSc in Chemistry and an MSc in Regulatory Affairs of Medical Technology.

As Senior Portfolio Strategy Director at Roche, Dr. Beate Bittner is leading global cross-portfolio product optimization initiatives and is an advisory member of the Lifecycle Office (Global Product Development) & iSquad Center of Excellence (Global Product Strategy) to guide lifecycle & commercial teams on multi-disciplinary aspects of formulation & device lifecycle management. Beate joined Roche in 1998 and held numerous positions of increasing responsibility including Preclinical DMPK Project Leader, Laboratory Head Preformulation, Clinical Pharmacologist, Clinical Team Leader, Research & Early Development Project Leader, and Global Development Team Leader. Since 2012, Beate has been a Lecturer at the Baden-Wuerttemberg Cooperative State University in the field of Personalized Health Care, Developing New Drugs, and Pharmacology. Beate is trained as a Pharmacist with a PhD in Pharmaceutical Technology & Biopharmaceutics from the University of Marburg, Germany, and holds a Diploma in European Market Access from the Aix-Marseille University, France.

Ben Van Hove is currently Associate director Oral Solid Dosage Forms at Janssen Pharmaceutica NV, heading a team of formulation/process scientist responsible for the development of solid formulations for small molecules in the clinical stage. After completing his Master in Pharmaceutical sciences, and an additional master in Industrial Pharmaceutical Sciences at the Catholic University of Leuven, Belgium in 2001, he joined Janssen Pharmaceutica NV. He has currently 18 years of experience within the Janssen Pharmaceutical Sciences and Manufacturing Organization, responsible for the CMC activities for both the early as the late stage clinical programs. He delivered major contributions in the CMC development activities of the following commercialized programs: Yondelis IV (oncology), Zytiga tablets (oncology), Nucynta IR and ER tablets with tamper resistant properties (pain medication, Ceftobiprole (antibiotic) and he is managing multiple programs in the clinical stage.

Biography: Bjorg Hunter holds a BSc in Design and Innovation Engineering from Technical University of Denmark and an MSc in Biomedical Engineering from Aarhus University, Denmark. Bjorg has been with GSK since graduating and has held different roles within the Device Engineering Group. In 2015 Bjorg moved into the late stage parenterals area as device lead for key GSK parenteral devices, working closely with internal GSK project teams and external partners. She progressed into leading a device management team in January 2017, where she has accountability of project management and regulatory compliance for parenteral devices.

Christian Luebbert graduated in chemical engineering at TU Dortmund University, Germany in 2014 and finished his PhD at the Laboratory of Thermodynamics by June 2018. In his PhD, he focused on the physical long-term stability of amorphous pharmaceutical formulations and successfully investigated crystallization and phase separation phenomena. Currently, the author has a Postdoc position at TU Dortmund University developing formulations for poorly water-soluble pharmaceuticals.

Corinna Sonderegger received her PhD in biochemistry and molecular biology at the University of Innsbruck/Austria in 1998. As a post-doc at The Scripps Research Institute in San Diego/California 1999-2002 she developed high-throughput cell-based drug-screening assays and performed cancer research applying virology and cell biology. In 2002 she joined Sandoz Biopharmaceuticals, being responsible for cell culture derived drug substance upstream process development including QbD process characterization and process validation concepts. Among others Corinna was responsible for the development of the cell culture process of Ilaris™ and Sandoz’s first biosimilar monoclonal antibody RituxanTM. 2010-2016 Corinna was leading the development of biosimilar drug products at Sandoz in Austria as Head of Pharmaceutical Development. She was heavily involved in the drug product development of the first biosimilar approved in US, Zarxio™, as well as of Erelzi™ and HyrimozTM. Since 2017 Corinna is heading the Medical Device Portfolio Management organisation for biopharmaceuticals at Novartis, covering a broad set of injection and alternative delivery systems for protein delivery as well as cell & gene therapy drugs.

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 Carol Thomson has had a varied career in management in the science sector and developed strong operational management and leadership skills at Thomson Reuters, where she managed the Pharmaceutical Patents Business Unit of the World Patents Index. Following this, Carol spent three years at the University of Strathclyde in a Research Business Development role and subsequently as Research Policy Manager. Carol has a degree in Genetics and PhD from the University of Sheffield.

Dimitrios Lamprou (Ph.D., MBA) is Reader in Pharmaceutical Engineering and MSc Programme Director at the School of Pharmacy in Queen's University Belfast (UK) and Visiting Researcher at University of Strathclyde (Glasgow, UK). Dimitrios has experience of teaching in Higher Education, conducting research (60+ publications, 200+ conference abstracts, 70+ Oral/Invited Presentations) and securing national and international funding (£2M+). He is Secretary at the United Kingdom and Ireland Controlled Release Society (UKICRS), external Ph.D. viva examiner for UK and International Institutions, and referees for journals, publishers and research funding bodies. His research and academic leadership have been recognised in a range of awards, including the Royal Pharmaceutical Society (RPS) Science Award for his “outstanding scientific contribution” in the field of Pharmaceutics. His group is applying aspects of Pharmaceutical Technology to a range of areas such as cancer, antimicrobial resistance and nanomedicine development. The Group Research Interests focused on four distinct areas: Biosurface Engineering, Electrospinning, Microfluidics, and Pharmaceutical 3D Printing & Bioprinting.

Dr Joshua Boateng is a Reader (Associate Professor) in Pharmaceutical Sciences and Formulation Technologies within the School of Science, University of Greenwich. He obtained his B. Pharm (First Class Hons) degree from the Kwame Nkrumah University of Science and Technology in Ghana, an MSc (Pharmaceutical Analysis) and PhD (Drug Delivery and Formulation) from the University of Strathclyde in Glasgow. Dr Boateng maintains active research interests in all the above areas with emphasis on alternative dosage forms that avoid the need for swallowing tablets or painful injections, therefore suitable for older adults and paediatric patients respectively. He has published extensively and is Editorial Board Member for the Journal of Pharmaceutical Science.

Rebecca Booth joined AstraZeneca in 2002 having gained a PhD in the synthesis and characterisation of polymerisation catalysts at UMIST (University of Manchester Institute of Science and Technology). Rebecca has worked in many areas of pharmaceutical development, initially as a senior scientist in solid state analysis, then as a pharmaceutical lead on discovery projects, and more recently as a product development lead on parenteral projects in clinical development. Rebecca now focuses on the development of complex parenterals, providing technical expertise in the design and scale up of poorly soluble drug formulations and nanomedicines.

Dr. Sebastian Braun studied at the University of Bielefeld focusing on antibiotic-resistance systems of microorganisms. After finishing his PhD in the field of analytical chemistry of endotoxins he joined the pharmaceutical industry and worked in the field of formulation and process development of Novosis AG (now Luye Pharma AG). Dr. Braun joined tesa Labtec in 2009 with a strong focus on transdermal drug delivery systems and oral films. After being formulation specialist and laboratory manager for 3 years he became head of the formulation development department. In 2018, he became head of science and technology of tesa Labtec giving his expertise in developing and manufacturing of film-shaped dosage forms to technology and non-technology departments of tesa Labtec.

Dr. Ajay Khopade is a Vice President R&D (Formulation Development) and Heading non-oral division at Sun Pharma Advanced Research Co. Ltd. (SPARCL), a pharma research and drug discovery company separated out from a leading speciality pharma Sun Pharmaceutical Industries Limited. With over 18 years of experience in pharmaceutical product development, in his current role as VP-R&D, is responsible for development of SPARC’s innovative and differentiating drug product portfolio and product life-cycle management through strategic innovation planning & road mapping. Currently he is leading a team of scientists supporting development of niche products and platform technologies. Dr. Khopade has extensive end-to-end (ideation-technology development-preclinical POC-clinical-commercial) development experience across multiple therapeutic areas in novel parenteral dosage forms. He has participated as CMC expert in the submission of number of INDs, NDAs and technology evaluation for in-licensing opportunities. He is an inventor of a platform nanotechnology in the field of oncology (Nanotecton®), ophthalmics (GFR®, SMM®and TearAct®) and depot injections protected by various IPs globally with over a dozen patents. Most of these technologies have endured clinical tests to reach into the market. Dr. Khopade has been a Humboldt post-doctoral fellow at Max Plank institute of Colloids and Interfaces, Germany. He holds a Ph.D. degree in Pharmaceutical Sciences from the University of Sagar, MP, India. His areas of interest are understanding physical chemistry of drug delivery system design.

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.

Carsten Huettermann is a Senior Pharma Application Scientist and the leader of the Pharma Application Development & Innovation Team in Europe for DuPont Nutrition & Health. In this role he is leading the pharma application lab in Bomlitz, Germany, with a team of lab technicians and scientists responsible for pharma customer and application development projects. Carsten is a chemist by training and gained a PhD in Macromolecular Chemistry from the University of Braunschweig, Germany, in 2003. His fields of expertise are polymer science and oral solid dosage forms with a focus on controlled release applications and capsules. He is author and co-author of several patents, scientific publications and presentations.

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.

Expertise: sensors technology, composites, techniques of analysis based on synchrotron light applied to life science, project management, sale & contracts, IPR management, drug delivery and bio-availability. Publications and Dissemination: About 15 papers published in different fields of expertise, manager of two European projects, lectures and lessons at University and Master’s degree course on materials, speeches at various international congresses, author of one European patent.

Gudrun Birk is a pharmacist by education and has been with Merck Life Science since 2014. She completed her Ph.D. in pharmaceutical formulation development in the field of parenteral applications at Merck Biopharma in cooperation with the University of Munich. Within Merck Life Science R&D, Gudrun focuses on the development of innovative new excipients and functional excipient systems for solid oral dosage forms. Inorganic drug carriers for solubility enhancement of APIs is one of her main areas of expertise, spanning from scientific basic research to industrial product development.

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.

Martin Huelsmeyer is chemist by training and received his PhD in Structural Biology from Technical University Braunschweig, Germany. Martin started his career in academia working in Berlin at Free University and University Hospital Charité on the structural characterization of receptors implicated in autoimmune diseases. He then moved to Munich to work for biotech company Pieris discovering and developing scaffold molecules. In 2012, Martin joined Abbvie as Section Manager NBE QC Analytics. Since 2014 he is part of the Formulation development team establishing Abbvie’s robotized NBE High Throughput Formulation platform. His main responsibilities are the development of screening concepts, novel HTS analytics and operating the HTS line.

Chemist by education; since 1992 in the pharmaceutical industry; 10 years in pharmaceutical industry in development; 10 years in Biotec (development, production, quality); since 2011 working for Losan Pharma GmbH; responsible for the strategic development and new development platforms in the drug delivery formulation and application field

Dr. Stefan Holzner, Senior Director, Head of Device Development, Takeda Stefan joined Takeda in January 2016. In his role as “Head of Device Development” which is part of “Medical Devices” he is heading a team of about 50 engineers, technicians and contractors which are focused on new product development in the area of devices, combination products and delivery systems. Stefan is a recognized leader with over 16 years of experience mostly in the medical device and pharma / biotec industry. He has a passion for innovation and improving patient & user experience. Stefan has developed and launched several products of different level of complexity. Over the years he held roles of increasing responsibility within Stryker, Baxter, Baxalta, Shire and Takeda. Stefan holds a diploma degree in Chemistry from the University of Würzburg and a Ph.D. in the area of Chemistry and material science from the University of Würzburg and the Fraunhofer Insitute for Silicate Research.

Pharmacist by training and PhD in Advanced drug delivery systems 3.5 years worked as Research Scientst at Pantec Biosolutions, Geneva Switzerland (March 2007-June 2010) Around 4 years worked as Formulation Manager at Debiopharm Group, Lausanne, Switzerland (August 2010-Feb 2014) From last 4.5 years working as Associate Director at AiCuris Anti-infective Cures GmbH, Germany Around 12 years of experience in Europe as Team Leader/Project Manager for the preformulation, formulation development of small molecules and/ or Peptides for oral, dermal and parenteral application (for small molecules and large molecules) Experience mainly includes – Development and outsourcing preformulation and formulation development of oral, topical and parenteral dosage forms for new drugs More than 17 international publications, 6 European patents and over 30 conference proceedings

Eleonora Cerasoli, Ph.D., Senior Research Scientist, Technology Group, Albumedix Eleonora’s current focus is to study the stabilisation properties of recombinant human albumin on an array of model systems. She has worked at the National Physical Laboratory on protein aggregation, peptides biophysical characterisation and interaction with membranes. Her background is biophysical chemistry (Chemistry degree, University of Rome), a PhD in Biochemistry on protein folding (Glasgow University) and post-doctoral experience in peptide design (Prof. Woolfson Lab, now Bristol University).

Feng Zhang graduated from Molecular Pharmaceutics and Drug Delivery department at University of Texas at Austin under the supervision of Dr. James W. McGinity with a Ph.D. in Pharmaceutical Science (1999). He worked at PharmaForm for 10 years, Gilead Sciences for 3 years, and then joined the College of Pharmacy at the University of Texas at Austin in January 2014. His team’s research interests include (1) characterization of the speciation of amorphous solid dispersions in aqueous media, (2) reactive melt extrusion to prepare novel dosage forms, (3) continuous melt and wet granulation using a co-rotating twin screw extruder, and (4) the impact of the molecular level interactions on the properties of amorphous solid dispersions. He has published a total of 50 peer-reviewed research article and 6 book chapters. He is also inventors on 16 issued patents.

Responsible for Excipient and Drug Delivery strategie. For the past 9 years working mainly on the development and commercialization of Liquisolid formulation strategies and Silica based amorphization strategies. Prior to this he worked as Chromatography sales and TCS manager for Alltech Associates, Inc. First working experience at the University of Leuven, taking part in the proof of concept strategies and development of analytical tools + discovering the genetic profiling of TNF as predictive tool for ‘crohn and colitis’.

Gabriele Sadowski is full professor for Thermodynamics at TU Dortmund University. She is member of the Academy of Science and Arts North Rhine-Westphalia and of the German Academy of Engineering Sciences. She is the chair of the German working party Thermodynamics and the German Representative in the European working party Thermodynamics and Transport Properties. Gabriele Sadowski is author of about 200 scientific publications in high-reputation journals in the field of chemical, biochemical and pharmaceutical engineering. The main focus of her research is studying thermodynamic properties of complex systems with particular emphasis but not restricted to those containing biological and pharmaceutical molecules. To model the thermodynamic stability of those systems she developed the currently worldwide most-used thermodynamic model PC-SAFT which was published in 2001. She received numerous awards for her work, the most-prestigious one being the Gottfried Wilhelm Leibniz Award of the German Science Foundation in 2011.

Gerhard Wenz studied Chemistry from 1972 to 1979 at the Universities of Mainz and Freiburg. He received his Ph. D. in 1984 for research with Gerhard Wegner in Freiburg on the topochemical polymerization of diacetylenes. He spent another year in Freiburg at the Hermann Staudinger Institute working about discotic liquid crystalline polymers. From 1985 to 1986 he worked as a postdoc with Donald J. Cram (Nobel Prize in Chemistry1987) at the University of California in Los Angeles (UCLA) and synthesized a model for the enzyme chymotrypsin. In 1986 he moved to the Max-Planck-Institute of Polymer Research in Mainz and finished there in1993 his habilitation and accepted a position as a Professor of Macromolecular Chemistry in Karlsruhe. In the year 2000 he became full Professor of Organic Macromolecular Chemistry at the Saarland University in Saarbrücken, Germany. He chaired several collaborative research projects devoted to the utilization of bio-renewable materials, such as cellulose, starch and cyclodextrins. His research focuses on the design of programmable supramolecular structures based on polymers and carbohydrates, which are applicable for drug delivery.

Dr Gert Fricker is Director at the Institute of Pharmacy and Molecular Biotechnology in the Faculty of Biosciences, University of Heidelberg, Germany. After studying chemistry and medicine at the University of Freiburg, Germany, and finishing his PhD in 1986, he worked as Post-Doc in the Department of Clinical Pharmacology, University Hospital Zurich, Switzerland. In 1988, he became research scientist at Sandoz Pharma AG, Basel, Switzerland. As member of the Drug Delivery Systems Department he studied mechanisms of drug permeation across barrier tissues. 1995, G. Fricker was appointed Professor at the University of Heidelberg, 2002 he became chair for Pharmaceutical Technology. In addition to his university affiliation, G. Fricker is Head of the Technology Transfer Center Biopharmacy and Analytics in Heidelberg, a service center for Pharma Industry, as well as cofounder of Heideberg Delivery Technologies GmbH, HeiDelTec, a start-up company devoted to oral peptide delivery. His main research interests are the permeation of drugs across barrier tissues with particular emphasis on intestine and blood brain barrier as well as the development of drug targeting systems by colloidal drug carriers.

Following his PhD at Imperial College London, Graham was a NATO fellow at Harvard University where he worked with Nobel Laureate E. J. Corey. His subsequent independent academic career spanned 25 years and generated >$100 million external funding and 160 peer reviewed publications in the fields of drug discovery, drug delivery, process technology, regulatory science and medical devices. He held a number of leadership roles in the academy including pro-vice chancellor, vice provost and institute director, most recently Director of Translational Research at the Tufts Clinical and Translational Science Institute (CTSI) in Boston MA. In September 2018 Graham joined Novartis AG as Director of Innovation in the Technical Research and Development group with a specific emphasis on growing capabilities in digital medicine. Graham has been a regular consultant to the pharmaceutical and biotechnology industry and was an advisor to the FDA in the development of the biosimilars approval pathway. He has also been instrumental in establishing and advising a number of technology based startup companies who have subsequently raised >$4B in venture funding. Graham sits on several advisory and editorial boards and has been the recipient of numerous awards for scientific and technology development. He was awarded the DSc in 2006 for contributions to medicinal chemistry.

Originally a physical-chemist by training, Guillaume Louit is currently responsible of the biopharmacy team of Sanofi R&D Paris site. He initially held a position in preformulation and progressively turned to more biopharmacy-related themes, encompassing the evaluation of nanoparticles by IV route, prolonged release intra-ocular and intra-articular formulations, subcutaneous and oral forms.

Héloïse Audat is a Drug Product Formulation and Process Development unit manager for Biologics in SANOFI since 2011. She worked on formulation development of several formats mAb, bi-specific, Antibody Drug Conjugate; the last few years she worked on a late project working in the industrial transfer up to submission. She previously worked in R&D in project management area. Héloïse Audat holds an engineer diploma specialized in immunology and project management

Jacqueline Maximilien joined Johnson & Johnson in 2016 as a Senior Scientist in the oral dosage formulation group. Her responsibilities include development of oral solid formulations from early development through to commercial transfer. Jacqueline has been a key contributor in a multidisciplinary team tackling control strategy design and implementation at Johnson & Johnson Beerse, Belgium campus. She holds a Marie Curie funded PhD in Bionanotechnology from the Compiègne University of Technology (Sorbonne Universités).

James is a device manager for Novartis in Basel, Switzerland. His main responsibilities include developing primary packaging systems for combination products and supporting new technologies. He has worked on a multitude of injection device platforms including pre-filled syringes, needle safety devices, auto injectors, and patch injectors. He has also helped to build and implement a renovated CCIT strategy for the Novartis Group. Before Novartis, James worked at Pfizer in their Devices Center of Excellence in Cambridge, UK (2008-2011) and Nutricia in their Advanced Medical Nutrition Division HQ in Amsterdam, NL (2011-2014). He received his PhD from the University of Florida in Materials Science & Engineering in 2007 specializing in biomaterials.

James Meehan, Associate Principal Scientist within the AstraZeneca Device Development, holds a BEng in Medical Mechanical Engineering and an MSc in Ergonomics (Human Factors). James provides specialist Human Factors support to development and on market products. This includes leading and designing human factors programs for products, managing external vendors and reviewing/ updating AstraZeneca’s internal human factors processes.

After his Ph.D. in organic chemistry in 1990 at University of Southern Denmark and stay in the group of Professor Barry Trost at Standford University in California, he joined Health Care Discovery at Novo Nordisk. Jesper Lau has 26 years’ experience in pharmaceutical discovery and holds a broad knowledge in small molecule based therapeutics as well as a comprehensive know-how within protein engineering especially within diabetes care with particular interest in glucagon like peptide 1 (GLP-1). He was project manager for once weekly GLP-1 and inventor of semaglutide. In addition to project management Jesper Lau has been line manager since 1995 and was in 2008 appointed Vice President of Protein and Peptide Chemistry with a staff of about 75 researchers. He was promoted to adjunct professor at Fudan University in Shanghai 2016.

Prof. Johannes G. Khinast (male, 1964) is the head of the Institute for Process and Particle Engineering (http://ippt.tugraz.at/) at the Graz University of Technology and the scientific director of the Research Center Pharmaceutical Engineering (http://www.rcpe.at/). He received his Ph.D. in the area of particle technology in 1995 from the Graz University of Technology in 1995. He was then a post doctoral fellow at the University of Houston with Prof. Dan Luss. In 1998 Prof. Khinast joined Rutgers University (New Jersey, USA) as an assistant professor, where he was granted early tenure in 2003. During his period at Rutgers University Prof. Khinast received several important awards, including the Bristol-Myers Squibb Young Faculty Development Award (1999), the DuPont Young Professor Award (2000), the North American Mixing Forum Award (2000) and finally in 2001 the prestigious NSF CAREER Award. In 2005 Prof. Khinast was selected as a Marie Curie Chair of the EU, and in 2006 he was offered a professorship at the Graz University of Technology. Prof. Khinast has received significant funding for his work in process simulation, pharmaceutical process engineering and particle technology in the order of more than 30 million Euros in the last 5 years from various sources. He also has worked with a large number of pharmaceutical and equipment companies and serves an advisor for the implementation of novel technology. He has supervised more than 40 Ph.D. students and PostDocs and his publication record encompasses over 200 peer-reviewed publications and many other publications and book chapters. He also holds several patents in the area of pharmaceutical manufacturing.

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.

As Head of Pharmaceutical Development Biologicals Kerstin is responsible for the early and late stage formulation and process, the parenteral primary packaging and parenteral combination product development of biologicals. She started her career 2000 at Boehringer Ingelheim and held several positions during this time.

Kerstin Egele studied chemistry at Saarland University, Germany and graduated in 2016. After two research internships in France (Université de Lorraine and Strasbourg University) and an internship in a medical analysis laboratory in Germany, she joined the Institute of Organic Macromolecular Chemistry at Saarland University as Ph. D. student. In her doctoral thesis she is now dealing with cyclodextrins and polyrotaxanes for pharmaceutical applications.

Kristiina M. Huttunen has graduated as a medicinal chemist from the University of Kuopio in Finland, from which she also received her Ph.D. in 2009 with a thesis that covered several different prodrug approaches. After her 2-year lasting postdoctoral research period at the Auckland Cancer Society Research Centre at the University of Auckland (ACSRC), in New Zealand, she returned back to Finland to the University of Eastern Finland, where she started to build up her own group called “Transporter-mediated Targeted Drug Delivery” group as an Adjunct Professor in 2014. In 2012, she was appointed as a Postdoctoral Researcher of Academy of Finland and 2015 she was raised as a Researcher Fellow of the Academy of Finland. Today, she has published nearly 40 peer-reviewed original articles and 6 peer-reviewed review articles with h-index 13. So far she has supervised 1 Ph.D. student until the end, and currently she is supervising 7 Ph.D. students, 2 of which is expected to graduate in 2019. Majority of her recent work as a group leader has been related to L-type amino acid transporter 1 (LAT1) and brain-targeting approaches to affect neuroinflammation and/or neurodegeneration, but she has gradually started to widen her views also for other transporters and other targeting tissues, such as tumors and endocrine tissues.

Leonie Wagner (born Hattler) studied Pharmacy at Univeristy of Basel. After graduating as a pharmacist she started her PhD thesis in 2014 in Prof. Dr. Jörg Huwyler’s Group in the field of Pharmaceutical Technology. In 2017 she completed the thesis with the title “Oral formulation for children - The microstructure of functionalized calcium carbonate as key characteristic to develop age-appropriate and compliance enhanced formulations”. Since December 2017 she is working as a formulation scientist at F-Hoffmann-La Roche in R&D Oral dosage forms developing formulations for early clinical phases up to market formulation. Publications:  W. Moser et al., “Efficacy and safety of oxantel pamoate in school-aged children infected with Trichuris trichiura on Pemba Island, Tanzania: a parallel, randomised, controlled, dose-ranging study,” Lancet Infect. Dis., vol. 16, no. 1, pp. 53–60, Jan. 2016. (mentioned in acknowledgments for developing the tablets)  L. Wagner-Hattler, J. Schoelkopf, J. Huwyler, and M. Puchkov, “Characterization of new functionalized calcium carbonate-polycaprolactone composite material for application in geometry-constrained drug release formulation development,” Drug Dev. Ind. Pharm., vol. 43, no. 10, pp. 1669-1676, Oct. 2017.  L. Wagner-Hattler, K. Wyss, J. Schoelkopf, J. Huwyler, and M. Puchkov, “Mouthfeel Study of Functionalized Calcium Carbonate in Orally Disintegrating Tablets” Int. J. Pharm., vol. 534, no. 1, pp. 50–59, Dec. 2017.  L. Wagner-Hattler, J. Schoelkopf, J. Huwyler, and M. Puchkov. "Stability Investigation of Fcc-Based Tablets for Oral Suspension with Caffeine and Oxantel Pamoate as Model Drugs." Drug Dev. Ind. Pharm., vol. 0, no. 0, pp. 1-9, Oct. 2018.

Expertise: Molecular biorecognition at surfaces; Self-assembling; Surface bio-functionalization; Cell biomechanics; Atomic Force Microscopy in liquid environment; Nanolithography; Fluorescence Microscopy; X-ray photoemission. Publications and Dissemination: Over 70 articles in peer reviewed journals, over 30 invited talks and lectures at International Congresses, Schools, Universities and Research Centers. Organization of 6 International Schools in NanoBioscience and 3 International Workshops.

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.

Dr. Boltri is a pharmaceutical chemist by training and completed his degree at the University of Turin, With over 25 years of experience in the Pharmaceutical Industry, Dr Boltri has held leading positions as Department Head and Director. In the current role, he is responsible for identifying new and innovative technologies as well as valuable opportunities for product development and co-development.

Mafalda Paiva has a MSc in Pharmaceutical Sciences and Quality Control, with background in nanotechnology, pharmaceutical and analytical chemistry. She works at Hovione in R&D for four years, working on analytical development, with special focus on the area of physical and performance methodologies.

• Manita Dangol is a Senior Research Fellow at the UCD Medical Device Design Group, School of Mechanical and Materials Engineering, University College Dublin, Dublin, Ireland. She completed her PhD from Yonsei University, Seoul, South Korea and was a Post-doctoral Fellow at the Western Sydney University, Sydney, Australia. She is the recipient of the prestigious Marie Skłodowska-Curie Fellowship awarded by the Centre for Research in Medical Devices (CÚRAM) Industry- Academia Training Initiative (Medtrain). Her research area of interests includes drug delivery, 3D Printing and medical device design and development.

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 Wacquet is a Drug Product Process Development Unit manager for Biologics in SANOFI since 2015. She previously worked in Industrial Affairs on support to DP filling lines (small molecules) to ensure continuous improvement/troubleshooting. She joined SANOFI in 2009 after graduation. Marie holds an engineer diploma specialized in process and chemical engineering (ENSIC, Nancy).

As the Director of Programme Development, Matt leads global cross-functional project teams from Worrell’s newest office in London. For over five years, he has specialized in shaping complex healthcare R&D programs focused on improving patient and physician outcomes and is an expert in ethnographic research, human factors and digital health technology and innovation. Prior to joining Worrell, Matt worked as a project manager and led the technology innovation program at Boston Scientific. He holds degrees in Information Systems Management and Supply Chain and Operations Management from the Carlson School of Management at the University of Minnesota.

Mattia joined Biopharma in February 2018 as International Technical Sales Executive working in the Consultancy division, providing support through desktop study, cycle audit, characterisation of the material pre- and post- process, formulation development, optimisation of the freeze drying cycle and tech transfer/scale-up. Mattia’s background includes a PhD focussed on drying mechanisms of hydrocolloids in the food industry from a microstructural point of view at the University of Birmingham. He also gained a Master’s Degree in material engineering, and a Bachelor’s Degree in industrial engineering completed at the University of Trento, Italy

Mike Hooven founded, and is CEO, of Enable Injections, Inc. He has over 30 years of experience in the medical device industry in a broad variety of technical and clinical areas. He is the founder of five medical device companies and holds over 100 issued and pending US patents. He also founded, and was former CEO, of AtriCure, Inc. (Nasdaq ATRC). He earned a BS in Physics and a Master of Science in Mechanical Engineering from the University of Michigan.

Mostafa Nakach is PhD from Toulouse University. He has prepared his thesis on stabilization and production of nanocrystalline suspension. He is also Master 2 graduate from Paris-sud 11 university in Pharmacotechnie and Biopharmacy and Pharmaceutical engineer from Ecole des Mines d’Albi . Mostafa is working within sanofi group since 31 years. His current position is a head of formulation and process development section within Biologics drug product development. His mission is to build and to manage the required skills and capabilities in order to support R&D projects development mainly for Fill&finish Commercial process development of biotech products including freeze drying.

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.

Stefan Bracht is heading the unit Disruptive Technologies in Chemical & Pharmaceutical Development of Bayer AG, Pharmaceuticals. This unit provides strategic orientation and paves the way to exploitation of new ways of working (e.g. machine learning, robotics) and also new ways of patient treatment like New Modalities beyond small and large molecules. In his previous role he was heading the department of External Technology and Innovation and overseeing all Drug Product Development with external partners including Medical Devices and Software. As a pharmacist by training he started his career in 1995 in transdermal drug delivery before he widened this expertise to many kinds of drug delivery including Early Pharmaceutical Development at the interface with Research and also Formulation Development of Large Molecules (Biologics) before moving up to his current role.

Beat holds an MSc in electrical engineering, an Executive MBA and has over 20 years of hands-on experience in the design, development, registration and lifecycle management of medical devices and combination products. The type of devices he was involved in ranges from simple pre-filled syringes, over pen-injectors, auto-injectors, patch-injectors, to complex motor-driven and connected injection systems. In 2005, Beat founded confinis, a global regulatory consulting firm based in Switzerland and the US. During this time, he has played a key role in obtaining marketing authorization for over 100 combination products in the EU and the US, including but not limited to the first and third biosimilar approved in the US. Beat is also a lead auditor regarding ISO 13485, MDD/MDR and MDSAP for a Notified Body. In 2016, he co-founded Medical Human Factors (medHF), a company specialized in evaluating the use related safety, effectiveness and usability of medical products. In 2018 he founded confinis CPM, a virtual workplace which provides clients with senior-level clinical project staff and functional service professionals to gather clinical data to sell their medical devices. Beat is also a co-author of the “Combination Products” chapter of Fundamentals of International Regulatory Affairs, Fourth Edition (RAPS) and is an expert representing Switzerland in ISO TC 84 regarding needle-based injection systems.

Nikki possesses 23 years’ experience in the pharmaceutical industry and has previously held technical leadership positions in Quadrant Healthcare, Quadrant Drug Delivery and Elan where she was responsible for the development, transfer and scale up of both early phase and late phase spray-dried inhaled and topical products intended for both European and U.S. markets. In her previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product. Nikki’s responsibilities at Quotient Sciences involve building the global formulation and manufacturing services business.

Paul Chamberlain is a biopharmaceutical product specialist, having worked on the development of therapeutic proteins since 1983, with companies such as Amgen and SmithKline Beecham. His experience with biosimilars development dates back to 2002, and includes multi-disciplinary regulatory considerations for 18 different molecular entities. He specializes in understanding structure-activity and structure-immunogenicity relationships for diverse types of biopharmaceutical modalities. He is a Member of the NDA Advisory Board (www.ndareg.com).

Ryan Donnelly graduated with a BSc (1st Class) in Pharmacy from Queen's University Belfast in 1999. Following a year of Pre-Registration training spent in Community Pharmacy, he returned to the School of Pharmacy to undertake a PhD in Pharmaceutics. He graduated in 2003 and, after a short period of post-doctoral research, was appointed to a Lectureship in Pharmaceutics in January 2004. He was promoted to Senior Lecturer in 2009, Reader in 2011 and, in 2013, to a Chair in Pharmaceutical Technology. Professor Donnelly's research is centred on design and physicochemical characterisation of advanced polymeric drug delivery systems for transdermal and topical drug delivery, with a strong emphasis on improving therapeutic outcomes for patients. His bioadhesive patch design was used in successful photodynamic therapy of over 100 patients with neoplastic and dysplastic gynaecological conditions and the patent subsequently out-licensed. Currently, Professor Donnelly's research is focussed on novel polymeric microneedle arrays for transdermal administration of "difficult-to-deliver" drugs and intradermal delivery of vaccines and photosensitisers. His work is funded by BBSRC, EPSRC, MRC, The Wellcome Trust, The Royal Society and the pharmaceutical and medical devices industries.

Rainer Jordan obtained his PhD in chemistry from the University of Mainz (Germany) and was a IAS-fellow at Kyoto University (Japan) and a PROCOPE research fellow at the CNRS in Paris (France). He performed his postdoctural studies with Prof. A. Ulman at Polytechnic University, Brooklyn, NY (USA) before he became Assistant Professor at the same University. After Habilitation in chemistry with Prof. Nuyken at TUM, Munich (Germany) he was appointed Full-Professor for Macromolecular Chemistry at TU Dresden (Germany) in 2009. His main research interests are defined polymer synthesis, functional polymers, biomaterials, polymer brushes, self-organization, colloidal polymer systems and polymer therapeutics. Together with Prof. Alexander V. Kabanov (UNC@Chapel Hill, USA) and Prof. Robert Luxenhofer he is co-founder of DelAqua Pharmaceuticals Inc. (USA) to further develop and commercialize polymer enabled drug-delivery systems.

Passionate and experienced leader in Pharmaceutical and Biopharmaceutical development. Experienced in all phases of CMC development for small molecules, with emphasis on bioavailability enhancement via solid dispersions, lipid based systems and nanoparticles of poorly soluble drugs, and controlled release. Biopharma experience in Upstream and Formulation Stability of mABs. Established and ran three new R&D sites: Pharmaceutical Sciences, Searle, St Louis, Missouri, USA, , Pharmaceutical Sciences, Abbott-Abbvie, Singapore, Pharmaceutical Sciences with full processing and analytical capabilities, and Biopharma with Upstream and Downstream processes, CHO cells, and Fill Finish capabilities, Roquette, Singapore. Hands-on experience with several successfully launched commercial products. Published over 35 manuscripts in peer review journals, more than 40 abstracts, more than 10 patents, and 3 book chapters. Invited speakers at several US, International Conferences, and Symposium. Adjunct Professor at University of Connecticut, USA and National University of Singapore, Singapore. Readily synchronizes business needs with creative, economic and speedy solutions. Develops excellent networks and relationships with peers and management. . Specialties: Pharma and Biopharma, technical and people management, Development with quality, speed and economy using Roquette Solutions in Pharma and Biopharma.

Rob Turner was employee number 1 at MedPharm and is today the creative force behind the development of many of MedPharm's unique performance tests. These performance tests assess the activity of specific customer products in translatable ex vivo environments including the unique TurChub® and ChubTur® systems for measuring product performance through nails. In addition he leads MedPharm’s Study Directors, the technical team who project manage every step of a customer's development undertaken by MedPharm. He has a background in microbiology and obtained his PhD in bio-adhesion and drug delivery at the School of Pharmacy, University of Portsmouth.

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 at Gore focused on providing unique and valued material based solutions to difficult market needs in various industries.

Ruzica Kolakovic obtained her PhD in Pharmaceutical Technology from the University of Helsinki where she studied use of nanofibrillar cellulose as novel excipient in drug delivery. She worked as a postdoctoral scientist at Åbo Akdemi in Turku, Finland focusing on application of printing as a technique for production of drug delivery systems. In 2014 she joined Janssen Pharmaceutica (Johnson & Johnson) in Belgium as scientist in preformulation group where she is responsible for developability assessment of compounds entering development pipeline. She is focused on defining the early drug development strategy through in depth understanding of the compound properties and targeted product profile.

Remy Vomscheid, Ph.D. has been working in the healthcare industry for the last 15 years. He coached biotech start-ups as Business Developer for Genopole, the biggest French Incubator dedicated to Life Sciences. After this, he joined Johnson & Johnson as Business Development Manager, Medical Devices & Diagnostics, EMEA and later moved to a commercial position as Regional Business Manager for LifeScan, the diabetes diagnostics franchise of J&J. Then, he led the technical development of connected & automated medical devices at Eveon, as Director of Development. As Director, Devices Development & Technologies, he currently leads the development of innovative devices at Ipsen.

Sabine Eichling is currently head of advanced formulation sciences. She received her PhD from the University of Heidelberg in pharmacy, prior to that she studied biotechnology. Overall she has more than 10 years’ experience in drug product formulation development for biotherapeutics.

Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is heading formulation, analytical and drug product development unit. His current responsibilities includes designing and executing product development and characterization strategies for both early and late stage products for Glenmark Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. He has ~ 12 year of experience in biopharmaceutical formulation and analysis. His principal research interests are protein formulation, stabilization, combinational product development, analytical characterization, DOE and QbD. He also has a keen interest in practicing lean principles. He has received multiple research awards and has several publications and presentations to his credit.

Samuel Kyeremateng is a Senior Scientist in the Global Pharmaceutical Sciences Division at AbbVie Deutschland in Ludwigshafen. His research activities focus on scientific advances in the understanding of amorphous molecular solids, and development and application of models in predicting with confidence the preferred composition, manufacturing process, and stability of amorphous solid dispersion (ASD) formulations. His current responsibilities at AbbVie Deutschland include leading of the Material Science Group that supports formulation development, and mentoring doctorate research students and other scientists within the company. Samuel received his doctorate in Polymer Science in 2010 from Martin-Luther-Universität in Germany.

Simon Bjerregaard is a senior research scientist at Pharmaceutical Development at Ferring Pharmaceuticals. He has extensive experience and insights within drug delivery of peptides and proteins and has over 40 publications and patents in this area. He first worked at Novo Nordisk within primarily parenteral, inhalable and oral delivery of GLP-1 analogs. For the previous 2 years Simon has been formulation responsible and/or scientific expert in various parenteral sustained release projects at Ferring Pharmaceuticals. Simon holds a Master in Pharmaceutical Science and a PhD from Copenhagen University with parenteral sustained release of proteins being the topic of the thesis.

Simon Kervyn graduated as a PhD in organic chemistry and materials from the University of Namur, Belgium in 2012. After research stays at National Institute of Materials Sciences in Tokyo and at UCLA, Los Angeles, he worked at the Coatings Research Institute in Belgium. He is now working for Datwyler as manager materials development. In this position he performs customer’s dedicated research to optimize the selection of rubber components to their applications. Furthermore, he works on the development of coated products for the Datwyler portfolio.

Degree o Master II of automation and control of industrial process (UJF, Grenoble) o Chemical process engineer (ENSIC, Nancy) Professional experiences, all as process engineer for development and optimization of pharmaceutical or chemical solid form process 1. Industrial Sanofi Winthrop site of Lisieux (Normandy): As automation process engineer, I worked in the Industrial development department to develop and implement a system (probe implementation and automaton and software programming) for the in-line follow-up of solid humidity during the fluid bed drying process. 2. Experience of about 2 years in the R&D Montpellier site of Sanofi as process engineer in PSO, Pharmaceutical Sciences department. I worked on pharmaceutical solid form process, and especially on granulation, drying and coating processes in fluid bed dryers. I developed tools for the Quality by Design, the Design of Experiments and the scale-up of these processes 3. Then, I spend 1 year as a project manager in Industrial Development department at Aspen Pharma in Normandy (Notre-Dame de Bondeville). I worked on the optimization of a vacuum drying process to remove solvent residuals during the finition step of a chemical manufacturing of the Nadroparine 4. Since my employment as a process engineer in PSO, Pharmaceutical Sciences, at Sanofi in the Montpellier R&D site (in December 2016), I have worked mainly on nanonization process and on dry roller compaction process Professional interests: o Scientific understanding of physico-chemical phenomenon o Process troubleshooting, modelisation and simulation o Development of Quality by Design and PAT tools o Scale-up and industrial transfer of processes

Dr Stephanie Greco has a PhD and a engineer diploma in physico-chemistry. She has been working for Sanofi since 2003, firstly in physical characterization of small molecules and since 10 years in process development of injectable Drug Product. She is now more specialized in the scale-up and industrial transfer biologics Drug Product.

Dr. Stephen T. Buckley is Head of Department in the Discovery ADME department at Novo Nordisk A/S, Denmark. He holds a degree in Pharmacy from Trinity College Dublin (Ireland), and a Ph.D in Biopharmaceutics and Cell Physiology from the same university. During this time, he also worked as a Visiting Fellow at the University of Southern California (USA). Prior to his current position at Novo Nordisk A/S, Dr. Buckley was a Postdoctoral Research Fellow at the University of Southern Denmark (Denmark). He is the recipient of honours and awards from the American Association of Pharmaceutical Scientists (AAPS) and the Scandinavian and German Physiological Societies. Dr. Buckley’s work is focused on understanding the various processes underlying the absorption and distribution of proteins and peptides via employment of in vitro cellular permeability models, ex vivo tissue models and binding assays. In addition to his leadership responsibilities, he is responsible at Novo Nordisk for a team tasked with identifying and evaluating novel drug delivery technologies. He is (co-) author of 20+ articles in peer-reviewed journals, 1 book chapter and 30+ abstracts, and has been invited to give numerous presentations at research institutions, international conferences and workshops.

Stephen has a proven history and wealth of experience in the consultancy environment - focused on medical device design and analysis. As Engineering Director at Crux Product Design, he has a particular interest in the use of cutting edge technology to promote evidence-based design development. Specialising in advancing the use of In- Silico techniques. He has worked extensively on the development of ‘digital twin’ models, applying state-of-the-art simulation tools to de-risk and accelerate medical device programs. Leading technical projects with a science-led, informed approach. Stephen has supported medical clients to progress a number of successful flagship products to market. In his current role he continues to promote use of engineering analysis at all stages of product development, supporting design, validation, and verification of next generation drug delivery systems.

Main interests and professional experience include development of drying processes for biopharmaceuticals, small & large molecules, drug substance & product, excipients, scale-up. Furthermore, application of Quality-by-Design in drying processes, validation and qualification of spray dryers, advantages & disadvantages of spray vs freeze drying processes, continuous manufacturing, mathematical modelling of drying processes, aseptic spray drying, particle engineering, innovative drying processes and enabling technologies. Been with Janssen since Apr-2017 and before that 10 years at Novo Nordisk (spray and freeze drying of peptides & proteins) and 8 years with GEA Niro A/S (spray drying, fluid bed drying, equipment design).

Prof. Dr. Sven Stegemann is director, pharmaceutical business development at Capsugel, and professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria. Over the course of his 21-year career at Capsugel, Dr. Stegemann has worked 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.

Thomas Hoeg-Jensen has 23 years of experience in design and preparation of diabetes-related peptide and protein drug candidates, and Thomas is co-inventor of insulin degludec (Tresiba) and the basal-bolus co-formulation with insulin aspart (Ryzodeg), both of which are marketed by Novo Nordisk. Thomas is adjunct professor at University of Copenhagen, and apart from drug discovery his research has included novel protein conjugation methods, glucose binding molecules and chemoinformatics systems for chemically modified proteins.

Tim joined Chiesi in 2011 as a senior scientist. He holds a B.Sc. in Biological Sciences (2003) from the University of Lancaster and is currently undertaking a Chiesi sponsored part-time PhD at the University of Bath under Prof Robert Price. Tim began his career in respiratory therapy in 2004 and he has worked for a number of prominent companies involved with inhaled drug delivery including Sanofi-Aventis, Vectura and Novartis. During this time, he has been involved in solid state characterization, analytical development and validation and formulation design projects, primarily for Phase I clinical studies. Tim is a co-inventor of 2 Chiesi patents relating to particle engineering.

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.

Graduated as pharmacy technician and worked 11 years for a German contract manufacturer of solid dosage forms in different departments: quality control, R&D section. Before joining Shin-Etsu she was in charge of the optimization of the production, product transfer and scale-up/validation. She joined the Shin-Etsu PFMD group in 2012 as technical sales manager. She is in charge of key account customers as well as distributors in the EMEA area.

As a Senior Consultant and Vice-President at confinis, Mr. Viky Verna currently assists medical device and pharmaceutical companies with regulatory affairs challenges. His qualifications are firstly supported by his education; specifically, a BS and a MS in Biomedical Engineering from the University of Miami, a MS in Pharmacy and a Drug Regulatory Affairs Certificate from the University of Florida, and a Global Regulatory Affairs Certification (RAC) from Regulatory Affairs Professional Society (RAPS). Mr. Verna’s experience with Combination Products started at the US Food and Drug Administration (FDA) as in investigator. Later, at the Center for Devices and Radiological Health (CDRH) of the FDA, Mr. Verna held several positions including (Acting) Branch Chief of the Respiratory, ENT, General Hospital, and Ophthalmic (REGO) devices branch which handles the compliance activities of combination products among others, including drug delivery systems. During his time at CDRH, he also served as a: - A Subject Mater Expert (SME) reviewer in the quality system working group of the Office of Compliance, where he generated and reviewed the regulatory case reports (establishment inspection report review memos) for regulatory decisions and legal compliance actions; and, - A combination product branch lead of the REGO branch. In this position, his responsibilities included training and reviewing the work of the team, as well as developing reviewing processes and techniques to be used by the office. After joining confinis, Mr. Verna has helped several companies of all sizes successfully comprehend, navigate around, and successfully comply with the US regulatory requirements for medical devices and combination products including those involving drug delivery systems. By being an expert member of the ISO technical committee (TC 84), Mr. Verna has also been leveraging his expertise and experience to help develop international standards for injection and respiratory products, infusion pumps, needles, catheters, and the likes.

Dr Vipul’s research expertise encompasses oral biologics drug delivery, with particular knowledge of overcoming the biological barriers in the gastrointestinal tract to achieve successful oral administration, in particular that of monoclonal antibodies. He received his Master of Science degree in Drug Delivery at The School of Pharmacy, University of London, where he researched oral delivery of peptide therapeutics. He then pursued a Ph.D. in Pharmaceutics at the UCL School of Pharmacy, London where his research was aimed at exploring the biological mechanisms involved in the GI stability and tissue uptake of anti-TNF-α monoclonal antibodies infliximab and adalimumab.

Franziska Edelmann did her University studies as Biochemist at the Technical University of Munich (TUM) at the Institute for Clinical Chemisty & Pathobiochemistry (Klinikum Rechts der Isar). Afterwards, she did her Master studies at the Chair of Biotechnology, TUM, on the field of protein biochemistry. In 2012, she started her PhD studies in structural biology at the Helmholtz-Center Munich (in association with TUM), where she was mainly involved in expression, crystallization and spatial structure characterization studies of protein-protein and protein-RNA complexes applying X-ray diffraction analysis. Her work enabled her to gain expertise in recombinant protein expression in various host systems, the establishment of elaborated, multi-step chromatographic protein purification approaches and various biophysical analytical methods to perform comprehensive structure-function characterization studies. In 2017 she joined Roche in Penzberg as Post Doc in Bioprocess Development (Downstream Processing) to develop new purification techniques to reduce particularly critical host cell proteins. At the beginning of this year Franziska moved on to the Analytical Department as Scientist where she supports the implementation of analytical tools to understand the Polysorbate issue