Speakers 2020

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.

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 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.

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

Dr 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.

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 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.

• 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

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.