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.

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.

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.

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.

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.

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.

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.

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.

Born in Upper Austria where I attended elementary and grammar school. 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.

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.

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.

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.