Speakers 2020

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.

Brian K. Meyer is a Principal Scientist in New Technologies, Vaccine Drug Product Development, Bioprocess Research and Development, Merck Research Laboratories in West Point, Pennsylvania. Dr. Meyer’s current research focuses on developing novel vaccine drug products and vaccine delivery. He has a PhD in Biochemistry, Microbiology, and Molecular Biology from the Pennsylvania State University and a B.S.E in Biomedical Engineering from Tulane University.

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.

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.

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.

Chris McConville is a Senior Lecturer in Pharmaceutics, Formulation and Drug Delivery. His previous experience within the pharmaceutical industry and academia has provided him with expertise in preformulation, dosage form design, drug delivery and analysis. He believes that for most diseases we currently have some excellent drug candidates; but in some cases we just choose to administer them incorrectly. Therefore, there is a need to improve the way in which we deliver certain drugs to the body. His research is focused on the design, formulation and characterisation of novel dosage forms and delivery devices to improve therapeutic outcomes for patients, while reducing systemic toxicities and improving their quality of life during treatment.

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.

Denis SPITZER is the founding Director of the NS3E laboratory, Mixed Research Unit between the French-German Research Institute of Saint-Louis, the CNRS and the University of Strasbourg (UNISTRA). He is the author of 130 scientific publications and 70 research reports for Defence. He is the inventor of the SFE (for Spray Flash Evaporation) technology. This technology permits the nanostructuring of many organic compounds used in different domains such as energetics, pharmaceutics and cosmetics. This technology was several times patented at international level. To understand better on a fundamental point the SFE process, he conducts currently many investigations on theoretical level such as on-line metrolgy and AFM-TERS on the obtained nanoparticles. The work on SFE induced also the founding by Denis SPITZER in 2018 of the SPINOFRIN company specialized in the nanostructuring of pharmaceutics and cosmectics. The different research works conducted Denis SPITZER to receive numerous research awards including, in 2015, the Grand Prix Lazare Carnot of the French Academy of Science.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

• 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.

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.

Philippe Lienard obtained his PhD in organic chemistry at the Orsay University, France, in Pr. Husson team in 1991. After having performed a post-doc in Pr. Oppolzer’s laboratory, he joined Sanofi in 1993 in chemical development. He occupied several positions within chemical development including Head of Pilot Plant on various French and USA Sanofi sites. He has been working within pharmaceutical sciences for 10 years as Head of Early Development Unit and now, he’s currently CMC project manager for a department of Pre. Development Science at the interface of the research and the development unit for several research programs.

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.

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

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.

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

Yash Kapoor is a Principal Scientist at Merck Research Laboratories. As a member of the Sterile Formulation Science, he is involved with parenteral drug product development for small molecules. An engineer by training, he not just designs and executes experiments but also has a keen interest in the area of physiological mathematical modeling. Yash has authored research and review articles in peer-reviewed journals and is a member of AAPS and CRS. His areas of interest focus on sterile & oral formulation development, intradermal, transdermal, ocular drug delivery technologies, pharmacokinetics, controlled release from degradable & non-degradable polymeric systems along with impact of self-assembled particulate systems such as microemulsions/liposomes and 3D printing for medical use. Prior to joining Merck, Yash worked in the eye care industry (Alcon, A Novartis Company) developing novel contact lenses with controlled release properties along with tunable surface chemistries. Yash got his PhD degree in Chemical Engineering from University of Florida at Gainesville in Fall-2008.

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.

- 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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).

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.

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.

Clare has more than 15 years’ experience of researching and analysing the medical technology, pharma and biotech industry. Her expertise includes unmet needs exploration through structured interviewing and in-depth desk research, commercial due diligence and market strategy. She draws on the experiences of users and key stakeholders to validate applications of existing products and drive innovation of novel products. Her recent projects include investigating potential applications for a newly developed respiratory rate monitor, assessing potential patient profiles and user scenarios for a large-volume injection device concept and determining optimal routes to the UK market for a Korean dental product company.