Dr. Ajay Khopade is a Vice President R&D and Heading non-oral speciality division at Sun Pharmaceutical Industries Ltd (SPIL). With over 20 years of experience in pharmaceutical product development, in his current role as VP-R&D, is responsible for development of SPILs complex generic and differentiated product development. Before this, he was with SPARC, a SPILs spun off company where he responsible for SPARC’s innovative and differentiating drug product portfolio and product life-cycle management through strategic innovation planning & road mapping. 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® Trisurf® and TearAct®), liposome 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.

Andreas Bernkop-Schnürch is serving as the Head of the Department of Pharmaceutical Technology at the University of Innsbruck. He is a leading researcher and inventor in the field of drug delivery, nanotechnology and biomaterials. He is author of >500 research articles and reviews.

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).

In her role as Product Optimization Franchise Leader, Beate drives the development of strategic options and the commercial value assessment for product optimization opportunities across the Roche portfolio (i.e. improved administration route & frequency, innovative drug delivery technologies, formulation & device line extensions). Activities include leading global cross-company strategic initiatives in matters relating to product optimization (i.e. drug administration strategy, fixed dose combinations, subcutaneous drug delivery, global device strategy, cross-therapeutic area technology platform strategy). In her previous roles as Senior Portfolio Strategy Director and Product Optimization Director, Beate provided scientific and strategic guidance to project and commercial teams for multi-functional aspects of product optimization and did lead product evaluation teams to prepare and conduct product optimization programs, including regulatory and health economic strategies, target product profiles, nonclinical and clinical studies, technical plan, and business case. 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, Global Development Team Leader and Global Project Leader. Since 2012 Beate is 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.

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 about 20 years of experience in GMP relevant sourcing and marketing activities of pharmaceutical raw materials.

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 Novartis/Sandoz in Austria, developing cell culture derived drug substance processes. Among others Corinna was responsible for the development of Ilaris™ and Sandoz’s first biosimilar monoclonal antibody RituxanTM.

2010-2016 Corinna was leading the development of biosimilar drug products, especially sterile liquid formulations in syringes, as Head of Pharmaceutical Development. She was heavily involved in the development of the first biosimilar approved in US, Zarxio™.

2017-2020 Corinna was leading the Medical Device Portfolio Management organisation for parenteral drugs at Novartis, a global team of Project Leaders developing drug-device combination products like prefilled syringes and autoinjectors.

Since Jan. 2021 Corinna leads the Competence Center for Medical Devices, including Human Factors Evaluation team, Risk Mgmt & Control Strategy, Analytical Laboratories for functional testing, and driving new development approaches.

Dr. Fatima Bennai-Sanfourche is working as Senior Manager for QA&RA Compliance for Medical Devices and eHealth at Bayer AG. Previously she worked in the medical affairs and Pharmacovigilance department at Bayer as Director, Medical Device Safety Global Pharmacovigilance/Medical device Safety officer. She has more than 15 years of experience in the quality management and Regulatory Affairs of medical devices field, and over 20 years of supervisory and leadership experience including hiring, training and performance evaluation. She studied Biology with a focus on Biochemistry, Immunology and Pharmacology, and did her PhD in Pharmacology and Pharmacochemistry in Strasbourg in France. She started her professional life with more university-oriented areas doing research and development in France, Sweden and Germany with a focus on cerebrovascular diseases, such as stroke, regulation of hypertension and development of immunoassays. She moved then from academia to private industry. She was working for more than 20 years in biotechnology, pharmaceutical, in-vitro diagnostic and medical device industry on a management level and was responsible as a team leader for project management with scientific focus, quality management and regulatory affairs tasks. In her current position by Bayer AG her focus is ensuring the regulatory compliance as well as high product quality of medical device and eHealth components of the Pharmaceuticals pipeline and portfolio. She is also responsible for Ensuring compliant use of medical devices and medical software tools in the context of clinical investigations and clinical trials, incl. accordance with medical device Good Clinical Practice (GCP). She is also leading the project of the implementation of euMDR for PH-Bayer AG. She was nominated in 2019 by the European Commission as EFPIA observer for the PMSV (Post-Market Surveillance and Vigilance) subgroup (GROW.D4) responsible for the implementation of these process according the medical Device regulation. The period of nomination is of five years starting on 01 March 2019

Dr Ogris is a professor for Pharmaceutical Sciences at the University of Vienna. He studied Biotechnology and graduated from the University of Live Sciences in Vienna. After a Postdoctoral stay at the CRC Institute of Cancer Research, University of Birmingham/UK, he joined the Ludwig-Maximilians-University Munich as a work group leader with a research focus on cancer gene therapy. In 2013, he was appointed as a full professor at the University Vienna, where he founded and heads the MMCT lab. The lab has a strong focus on the development of macromolecular formulations for targeted drug and nucleic acid based therapies for cancer and uses multimodal imaging to study their pharmacokinetics and pharmacodynamics.

Dr. Helen Hou joined the Department of Small Molecule Pharmaceutical Sciences at Genentech (South San Francisco, California) in 2015. In her current role as a Senior Scientist, she is responsible for drug product development to allow fast-entry into human and the definition of market-image formulation/process. Prior to joining Genentech, Helen worked in several industrial positions at Allergan (2013 –2015), AbbVie (2008 – 2013), and Amgen (2006 – 2007), specialized in development of oral solid dosage forms and sterile product for ophthalmology. Helen received her Ph.D. in materials science and engineering from the University of Minnesota in 2006, where she did research in development of novel intranasal formulation for the treatment of epilepsy. Her primary research interests include understanding the effect of solubilizing additives on the manufacturability and release behavior of high-energy solids, and designing in vitro models for the prediction of in vivo performance of supersaturating solid dosage forms.

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

Jeffrey T. Blue has been with Merck more than 26 years.  Through his career, Jeff has led the Vaccine Drug Product Development and New Technologies Department.   Jeff’s department is responsible for the development of both in‑line and pipeline programs and spans both early and late stage vaccine development.  Jeff has supported live virus, oncolytic, subunit, conjugate, and mRNA vaccines.  His department is responsible for technology transfer of the drug product formulation and process to the final commercial sites.   In addition to pipeline support, his department is also responsible for supporting novel innovative technologies for drug product development including new drying technologies, novel adjuvants, and alternative delivery for vaccines and biologics (i.e., Patch technology, ID and oral delivery, pulsatile and controlled release formulations, Lyospheres etc.).  

Through his leadership, the innovative technologies are being advanced to clinical development and recently gained manufacturing support for implementation into Merck’s vaccine pipeline.   He has published multiple book chapters and various articles on vaccine drug product development and lyophilization.  Over the course of his career within Merck, he has championed the development and successful launch of Varivax®, Zostavax®, and ProQuad® vaccines.   He has also played an integral role in the development of the Ebola Zaire Vaccine that Merck has recently licensed (Ervebo®).  Jeff has been a key leader on multiple cross-functional teams, engaged in key integration teams for vaccine strategy, is involved in multiple due diligence activities and continues to champion external collaborations to advance Merck’s vaccine pipeline.

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 20 years, John has worked for Schrödinger, LLC, as a scientific software developer and a research scientist, managing a number of software products. For the last few years he has worked on applying modelling to drug formulation.

Prof Joshua Boateng is Professor in Pharmaceutics and Drug Delivery 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. He is internationally recognized in the areas of advanced wound dressings and mucosal drug delivery systems and has published extensively in these areas. He is Editorial Board Member for the Journal of Pharmaceutical Science and also undertakes consultancy-based research with companies.

Martin Huelsmeyer is chemist by training and received his PhD in Structural Biology from Technical University Braunschweig, Germany. After positions in Berlin at the Free University and the University Hospital Charité he moved to Munich to work for biotech company Pieris discovering and developing scaffold molecules.

In 2012, Martin joined AbbVie. He is currently part of the NBE Formulation development team establishing AbbVie’s robotized High Throughput Formulation platform. In this context he is responsible for the design of screening concepts, establishing novel miniaturized HTS analytics and conceiving innovative data evaluation approaches. He is dedicated to excipient properties and leads strategic development initiatives.

Matthias G. Wacker is an Associate Professor in the Department of Pharmacy of the National University of Singapore (NUS). Initially, he studied Pharmacy at Goethe University in Frankfurt (Germany) where he obtained his doctoral degree in pharmaceutical technology. As a principal investigator, he has joined Jennifer Dressman and Jörg Kreuter in the Institute of Pharmaceutical Technology, Goethe University. There he accomplished his habilitation exploring the rational design of nanocarriers and was awarded the Venia legendi in pharmaceutical technology. Before joining NUS, he headed the Department of Pharmaceutical Technology and Nanosciences of the Fraunhofer Institute for Molecular Biology and Applied Ecology in Frankfurt. Currently, he serves the European Journal of Pharmaceutics and Biopharmaceutics and the Journal of Pharmacy and Pharmacology of the Royal Pharmaceutical Society as an editorial board member. Further, he is a scientific advisor to the Journal of Pharmaceutical Sciences editors and was guest editor for the Beilstein Journal of Nanotechnology and Frontiers in Chemistry. He was honored with the Eudragit® Best Paper Award (2014) and the Phoenix Pharmaceutics Science Award (2017) in recognition of his research excellence. From 2020-2025, he is a member of the General Chapters – Dosage Forms Expert Committee and the Expert Panel on New Advancements in In-Vitro Product Performance Testing of the United States Pharmacopeial Convention. His research focuses on the development and characterization of various types of formulations following a quality-by-design approach. His group develops biopredictive performance assays and physicochemical characterization methods for oral dispersions and injectables such as long-acting depot formulations or nanomedicines.

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.

Mikolaj Milewski is a Principal Scientist at MSD in the Biopharmaceutics group (Pharmaceutical Sciences department) with 10+ years of pharmaceutical research experience. He assesses biopharmaceutics risk for small-molecule oral programs and large-molecule injectable programs through use of in vitro, in silico, and in vivo methods. His areas of interest span oral and parenteral formulations, drug delivery systems, and biopharmaceutics. Prior to joining MSD Mikolaj earned his PhD degree in Pharmaceutical Sciences in Dr. Audra Stinchcomb’s laboratory from the University of Kentucky in Lexington. He is an active member of AAPS and the Subcutaneous Drug Delivery and Development Consortium.

Naila El Kachai is a pharmacist and holds a PhD in Formulation and Physical Chemistry from the Université Paris-Sud. In her previous position, she worked at Stallergenes (Paris, France) in the development of protein formulations for subcutaneous delivery. In 2016, she joined Sanofi (Paris, France), where she currently work as a Lab Head in the Biologics Drug Product Development Department. Naila has a great experience in formulation of multi-specific antibodies; she is leading formulation and drug product development of several projects in this field.

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 and IP & innovation management at the University of Koblenz-Landau. 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

Paulina Fischer is a PhD student in the NBE High Throughput & Advanced Formulation Sciences Department at AbbVie. The research of her PhD project, a collaboration with the Paris Lodron Universität Salzburg, focuses on the development of oxidation stress assays for automated high throughput formulation screenings.

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 Synthelabo in 1993 in chemical development. Then, he occupied several positions within Sanofi 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 in Vitry site and now, he’s currently CMC project leader for a department of Early Development at the interface of the research and the development unit for several research programs

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.

Stefan Bracht is heading the unit Drug Delivery Innovation in Chemical & Pharmaceutical Development of Bayer AG, Pharmaceuticals. This unit provides strategic orientation and paves the way to exploitation of drug delivery and device technologies to expand the druggable target space via delivery of new modalities . In his previous role he has created with his team a digital transformation roadmap for CMC development and also formerly 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.

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.

Pauline Henrica Maria Janssen is a Product Application Specialist in OSD at DFE Pharma. She has been working on application development of excipients based upon fundamental knowledge of excipients and powder physics. She joined DFE Pharma beginning of 2017 and worked as a product developer on multiple OSD and DPI projects. As analytical expert, she supported in the design of experiments to understand products and its usage. Pauline holds a Master’s Degree (cum laude) in Physical Chemistry from the Radboud University in Nijmegen, with an additional specialization in Science, Management and Innovation (2016). Current research interests are in continuous manufacturing, powder flow, powder mixing, and material characterization.

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

Steve Amoussou-Guenou is a Global Technical Developer with Roquette, Inc. In this role Steve looks after all aspects of technical support with Roquette Pharma customers, including helping them in the use of Roquette excipients for their pharmaceutical development projects, offering technical guidance in formulation/process development, quality and regulatory affairs and contributing to the development of innovative solutions.

Steve has more than 12 years of professional experience in Pharmaceutical industry.

Before joining Roquette in 2016, Steve worked for 8 years for a diverse range of organizations, including big pharma, research institute and CDMO type of companies.

In this role, Steve was responsible for leading pharmaceutical development and technology transfer projects, managing communication with internal and external stakeholders and business development.

He is a qualified industrial pharmacist and holds the Master of Science’s degree from Laboratory of Pharmaceutical Industrial Technology – University of Bordeaux 2, France.

Dr. Stephen T. Buckley is Director and Head of Oral Delivery Technologies at Novo Nordisk A/S, Denmark. In addition to his leadership responsibilities, he is responsible at Novo Nordisk for a cross-organizational team of scientific experts tasked with identifying and evaluating advanced drug delivery technologies. 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 joining Novo Nordisk A/S, Dr. Buckley was a Postdoctoral Research Fellow at the University of Southern Denmark (Denmark). He is the recipient of honors and awards from the American Association of Pharmaceutical Scientists (AAPS) and the Scandinavian and German Physiological Societies. He is (co-) author of 25+ articles in peer-reviewed journals (including Science and Science Translational Medicine), 1 book chapter and 30+ abstracts, and has been invited to give numerous presentations at research institutions, international conferences and workshops.

Jinling Chen Ph.D. is the SVP, Pharmaceutical Development Services at STA Pharmaceutical, a WuXi AppTec company (WuXi STA) responsible for drug product formulation R&D and manufacturing from preformulation, phase I through commercial launch.

Prior to joining WuXi STA, Jinling was engaged in various research and management positions at Zeneca, BMS, and Lexicon Pharmaceuticals. Jinling earned her Ph.D. in Physical Chemistry from Monash University, Melbourne, Australia. Inventor of over 20 patents.

Heinrich Martens, VP Regulatory Affairs, with more than 15 years of experience working in Regulatory Affairs / Medical Devices. In his carrier, Heinrich Martens, was leading and being responsible for the various Regulatory Affairs projects – e.g. implementation of the Medical Device Regulation, leading and building up RA teams.

Leading an international team, across the globe, and being in contact with Authorities, Notified Bodies and Regulators – is one of his key topics, within his current role.

James has over 14 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 8 years James has focused on understanding and development of excipients for the pharmaceutical sector, with particular interest on the role of the excipient type and quality on the stability in both small and large drug molecule formulations.

Vanessa Havenith studied Mineralogy at RWTH Aachen University in Aachen, Germany. In 2012, she received her doctorate for her studies on diagenetic evolution of upper Rotliegend II sandstones of a tight gas field in East Frisia. She entered SE Tylose GmbH & Co. KG as technical and laboratory manager in Wiesbaden, Germany, in 2012. Her responsibilities include the development of new products of Shin-Etsu cellulose ether derivatives and the technical support of customers worldwide in the area of building materials, paints and oilfield applications. In 2021 she changed to the area of pharma applications at SE Tylose, responsible for focusing on researches for novel applications and SE Tylose’s technical activities in the EU and LATAM.

Salvatore Mercuri serves as associate director of NPI & MSAT at Lonza’s site in Monteggio, Switzerland, which is Lonza’s European Center for Excellence for Particle Engineering, specializing in particle size control through micronization. Salvatore’s expertise includes the development of highly potent active pharmaceutical ingredients (HPAPIs) and the formulation of of modified-release solid oral dosage forms. He joined Micro-Macinazione SA in 2013, prior to its acquisition by Lonza, and has held positions of increasing authority. Salvatore graduated with a degree in Industrial Pharmacy before earning his Ph.D. in Biopharmaceutics and Pharmacokinetics, both from the University of Parma. He completed postdoctoral work in the Department of Pharmacy at the University of Parma, focusing on modified-release dosage forms.

Driton is a pharmacist and currently a Senior Lecturer in Pharmaceutics at the Institute of Pharmaceutical Science, King’s College London. Driton’s research interests centre around overcoming the biological barriers to improve drug delivery and enable non-invasive delivery (particularly via the oral route) of biologics, which currently require injections. As part of this, he has specific interests in drug delivery systems, including nanomedicines, for mucosal delivery. He is also interested in drug delivery in mucosal diseases (e.g. Inflammatory Bowel Disease) and how such diseases influence drug absorption and delivery. Finally, aspects of Driton’s research relate to the creation of improved (more predictive) in vitro mucosal models for use in drug discovery and delivery research. The overarching aim of Driton’s activity is to improve patient outcomes through translational drug delivery research.

Dr. Sebastian Braun worked in the field of transdermal and dermal drug delivery for 15 years at different companies. A molecular biologist by training with a PhD in analytical chemistry and molecular biology, he started his career at a transdermal drug delivery company with a fundamental understanding of the biological workings of the skin. Spending the last 15 years at different transdermal and dermal drug delivery companies in various positions including head of formulation development, head of manufacturing and head of science and technology, he is now focused on microneedle development and manufacturing.

Sebastian Kube is a trained biochemist and leading the digitalization efforts within Pharmaceutical Development Biologicals at Boehringer Ingelheim. Joining BI as a protein modeler, he worked on the implementation of computational methods to predict drug product developability. Later, after working as a drug product lead in preclinical development, Sebastian switched career tracks. He now works as a subject-matter expert in cross-functional data integration projects and on the strategic planning and implementation of digital tools and infrastructure.

Lorenzo Gentiluomo completed with honor his PhD in pharmaceutical technology at the Ludwig Maximilian University of Munich and his master in bio-molecular chemistry at La Sapienza University of Rome. He conducted his doctorate work at Wyatt Technology, which was focused on the prediction and characterization of therapeutic protein aggregation. Afterwards, he joined Coriolis Pharma  where he worked on the drug development of biotherapeutics (e.g., mAbs, peptides, AVVs, mRNA). Recently, he joined Lonza  acting as an Associated Principal Scientist and Analytical Project leader.