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.

Angela Lopez del Rio is a biomedical engineer holding a PhD focused on data preprocessing and quality diagnosis in deep learning-based in silico bioactivity prediction from the Polytechnic University of Catalonia (Spain).  Currently, she works as a Scientist at Boehringer Ingelheim in the Pharmaceutical Development Biologicals department, giving data science support in different projects and developing algorithms for the analysis of subvisual particles. Prior to joining BI, she has worked as a data scientist for biomedical-related projects at the Polytechnic University of Catalonia, as a scientific software developer in the computer-aided drug design start-up Mind the Byte and as a teacher at the TechInstitute.

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™.

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.

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.

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.

Samuel Kyeremateng is a Principal Research Scientist at AbbVie, Germany. His team focuses on scientific advances in material characterization and modelling to support drug product development, especially amorphous solid dispersion formulations.

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.

Stefanie Dohrn is a Principal Research Scientist at AbbVie, Germany. She supports drug product development, primarily amorphous solid dispersion formulations via material characterization and thermodynamic modeling.

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.

Sara holds a Bachelor of Science (BSc) in Biomedical Engineering from the Science and Research University of Tehran (Iran), a Master of Science (MSc) in Biomedical Engineering from Graz University of Technology (Austria), and a Ph.D., in Chemical and Process Engineering from Graz University of Technology (Austria). She has several years of experience working in different R&D (Research & Development) projects at the technical university of Graz and RCPE and recently started as a product application specialist at DFE Pharma.

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.

Alexandre Gil Ph.D. is EU Business Development Director at STA Pharmaceutical, a WuXi AppTec company (WuXi STA) responsible for leading the business development for Drug Substance and Drug Product in Europe.

Prior to joining WuXi STA in 2021, Alexandre was engaged from over 20 years in various research and management positions at Pierre Fabre, Ethypharm, Virbac and Sanofi. Alexandre earned his Ph.D. in Pharmaceutical Sciences from Paris XI University, France.

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.

Philipp Hebestreit is a certified pharmacist and obtained Doctor’s degree at the Humboldt University, Berlin. He has been with BASF for 17 years.

As regional technical service manager he is responsible to support R&D and introduce BASF innovations like new excipients and biopharmaceutical ingredients (e.g. Kolliphor® P 188 Bio) and Services (e.g. ZoomLab™ https://info-mypharma.basf.com/) to European customers.

Besides these activities, he is member of a new Biopharma Ingredients group supporting customers in their bioprocessing and therapeutic protein formulation challenges.

Dr. Patrick Duffy is the R&D Team Leader and Manufacturing Manager for the ViatelTM bioresorbable polymer portfolio at Ashland, supporting customers with key excipients/materials and technical solutions in the development of extended-release parenteral drug delivery formulations, medical devices, tissue engineering scaffolds and cosmetics. 

He joined Ashland as part of the Vornia Ltd. acquisition in 2018 where he previously held the same responsibilities. During his time at Vornia Ltd., he played a key role in the development of the company’s major intellectual property platform for production of bioresorbable polymers. He has extensive knowledge of bioresorbable polymer design, chemistry and processing technologies used in medical applications. This experience comes from working on large research and commercial projects delivering bioresorbable polymer-based solutions for orthopedic, cardiovascular, neurological, oncology, wound-care, dental, ophthalmic, regenerative medicine and wider drug delivery technologies.

Dr. Duffy has authored or co-authored several research/review articles on polymer design for medical applications. He obtained his B.Eng., M.Sc. and Ph.D. from University College Dublin (UCD), Ireland.

Mark Parry has worked with Intertek Melbourn for 20 years after graduating from Cambridge University and currently works as the Technical Director. Mark has worked in a range of pharmaceutical analysis and formulation development areas with a particular focus on inhaled and nasal drug products.

Mostly working in the pre-approval stages, Mark’s background includes extensive experience with product and formulation development, as well as method development and validation, stability studies, and pharmaceutical development activities for a wide range of clients across the pharmaceutical industry.

Mark currently works as the Technical Director, supporting the wide range of analytical, formulation and product development activities across the company.

Christian Schneider received his PhD in chemical engineering at the Helmholtz Center Berlin in the Institute for Soft Matter and Functional Materials.

Chris is a new business developer with focus on the EVA & LDPE material product lines at Celanese Corp. He joined Celanese 11 years back and is now responsible for customer-focused developments in medical and pharmaceutical applications in EMEA. Chris has over 12 years of experience in research and product development of polymers and polymer colloids. His functional experience includes research, product & application development, analytical method development and customer tech support.

Prof. Dr. Sven Stegemann is professor of patient centric drug design and manufacturing at the Graz University of Technology. Over the course of his 29-year career in the pharmaceutical industry, he has worked as an advisor to major pharmaceutical companies on ways to improve the formulation design, development and manufacture of pharmaceutical products including advanced drug delivery and manufacturing technologies and controls. In his academic role, he 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.

Andy has over 16 years’ experience in the pharmaceutical and drug delivery industry. He currently leads a team of 120 scientists working on formulation development, clinical manufacturing and pharmaceutical analysis projects. Dr Lewis is dedicated to overcoming drug delivery challenges, including solubility enhancement, controlled release and transmucosal delivery of proteins and peptides. He is a member of the Academy of Pharmaceutical Scientists of Great Britain and has served on the board of directors of the Controlled Release Society, most recently as secretary.

Lena Mareczek studied pharmacy at the Goethe University in Frankfurt, Germany. She joined the Pharmaceutical Development at Merck KGaA in 2020 to pursue her PhD in Pharmaceutical Technology and her research focuses on material characterization of pharmaceutical powders.

Dr Gert Fricker is Director at the Institute of Pharmacy and Molecular Biotechnology in the Faculty of Biosciences, University of Heidelberg, Germany.

After studying chemistry and medicine at the University of Freiburg, Germany, and finishing his PhD in 1986, he worked as Post-Doc in the Department of Clinical Pharmacology, University Hospital Zurich, Switzerland. In 1988, he became research scientist at Sandoz Pharma AG, Basel, Switzerland. As member of the Drug Delivery Systems Department he studied mechanisms of drug permeation across barrier tissues.

1995, G. Fricker was appointed Professor at the University of Heidelberg, 2002 he became chair for Pharmaceutical Technology and director of the Institute of Pharmacy and Molecular Biotechnology. In addition to his university affiliation, G. Fricker is head of the Steinbeis Technology Transfer Center Biopharmacy & Analytics in Heidelberg, a service center for Pharma Industry, as well as cofounder of Heidelberg Delivery Technologies GmbH, HeiDelTec, a start-up company devoted to oral peptide delivery. His main research interests are the permeation of drugs across barrier tissues with particular emphasis on intestine and blood brain barrier as well as the development of drug targeting systems by colloidal drug carriers.

Heinrich has his professional focus on development of pharmaceutical products in the field of nanotechnology and drug & RNA delivery. In his Ph.D. in the group of Prof. Dr. Helmuth Möhwald at Johannes-Gutenberg Universität Mainz and academic career in Italy and Brazil he researched lipid membranes and organized bio-molecular systems. Having moved to pharmaceutical industry he developed nanoparticle products with application in cancer, inflammatory diseases autoimmune diseases and other indications. At BioNTech, he is the scientific lead of the formulation and analytics department, which develops RNA therapeutics based on a broad scope of delivery technologies..

Nick DiFranco, MEM, is the Global Market Segment Manager for Oral Treatments at Lubrizol Life Science Health (LLS Health). In his role, Nick coordinates a multi-disciplinary team offering excipients and services for controlled release and solubility enhancement in oral solids and liquids, including Carbopol® and Apinovex™ polymers. Prior to this role, Nick held positions as an Applications Scientist and Market Manager at Lubrizol supporting long-acting drug delivery and CDMO services. Nick holds a B.S. in Biomedical Engineering (Biomaterials focus) and a Master of Engineering and Management degree from Case Western Reserve University.

Joey Glassco, MBA, is the Senior Global Market Manager for Parenteral Drug Delivery at Lubrizol Life Science Health (LLS Health).  Joey has served as Marketing Director for CDMO division since 2017 and has been involved in pharmaceutical excipient new business development since 2013. Prior to joining the LLS Health, she spent nearly 15 years in marketing roles in various Lubrizol business units. Joey also has over 10 years of experience in finance at Lubrizol, Ford Motor Company, and The Franklin Mint. She received Bachelor of Science degrees in Finance and Accounting from Juniata College and her M.B.A from the Smeal College of Business at Pennsylvania State University.

Robert W. Lee, PhD, is the President of the CDMO Division of Lubrizol Life Science Health (LLS Health). In this role, Dr. Lee is responsible for product and business development along with providing strategic direction and managing the division. Before joining LLS Health, Rob held senior management positions at Novavax, Inc., Lyotropic Therapeutics, Inc., and Imcor Pharmaceutical Co. He holds BSs in Biology and Chemistry from the University of Washington and a PhD in Physical Bioorganic Chemistry from the University of California, Santa Barbara. Rob has published more than three dozen articles and five book chapters plus holds 11 issued patents and 15 provisional or PCT patent applications. He has over 30 years of experience in pharmaceutical research and development of both therapeutic drugs and diagnostic imaging agents. Rob maintains strong academic ties, including an appointment as Adjunct Associate Professor of Pharmaceutical Chemistry at the University of Kansas in the early 1990s, serving as a reviewer for both the International Journal of Pharmaceutics and Journal of Pharmaceutical Sciences, and serving on the Editorial Board for the Journal MOJ Bioequivalence & Bioavailability, The Scientific Pages of Nanotechnology, and The Journal of Analytical and Pharmaceutical Research.

Dr Wenqian Chen currently works as an assistant professor at the Department of Pharmacy of the National University of Singapore (NUS) (https://pharmacy.nus.edu.sg/team/asst-prof-chen-wenqian/). His main research interest is the purification and formulation of biomolecules such as proteins and peptides. Before joining NUS, Dr Chen obtained his undergraduate and PhD degrees in chemical engineering at Imperial College London (UK).

Dr Suha Dadou is currently a Postdoctoral Research Fellow at School of Pharmacy, Queen’s University Belfast. Her main research interest is in the utilisation of Hot Melt Extrusion, Quality by Design and Process Analytical Technology in the continuous manufacture of oral solid dosage forms and fixed dose combinations. Dr Dadou obtained her BPharm from Aleppo University, MSc in Pharmaceutical Technology from the Jordanian University of Science and Technology and PhD in Pharmaceutical Sciences from University of Greenwich.

Dr Shahid Uddin is currently Head of Drug Product, Formulation & Stability within the CMC department at Immunocore.   His team is responsible for bringing research candidates into clinic and commercialisation.  Technology is focussed around developing ImmTAC® as therapeutic agents for different disease models. Prior to this he held the position of Head of Formulation at MedImmune (AstraZeneca) where he supported the biologics portfolio covering Monoclonal antibodies, Peptides, bispecifics and other proteins.  He has extensive experience in pre-formulation/formulation, forced degradation, delivery of biologics both for early and late stage programmes.

Harshal is part of our global medical division based out of Boston, with more than a decade of experience in medical device development, product life cycle strategy, and innovation management. He has significant expertise in oncology patient journey, economics of cancer care and innovations in oncology. He has a Bachelor of Mechanical Engineering degree from Nirma Institute of Technology in India, an MBA from Syracuse University, New York, and he recently completed a post graduate program in cancer biology and therapeutics development from Harvard Medical School.

Ravi is the co-founder and CEO of Intact Therapeuetics, a venture-backed biopharma startup spun out of Stanford University, focused on targeted therapies for diseases of the gastrointestinal tract. Prior to Intact, he led marketing and medical affairs at Transcend Medical, working on a novel minimally invasive glaucoma implant, up until its sale to Alcon/Novartis for a total deal value of >$500 M. He began his career working in research and development for Guidant Corporation, developing best-in-class technologies for cardiac and vascular surgery. He received a BS in Mechanical Engineering, an MS in Management Science & Engineering, and fellowship training in Biodesign (biomedical innovation), all from Stanford University.

Soren Skov is the Human Factors lead for Novartis connected device development and the link to a digital ecosystem. He comes to the world of pharma product development with a background in psychology, Danish design and medical device startups. When not working on the marriage of human behaviour and technology, Soren can be found gently falling down mountain sides, floating in a river or in front of a pizza oven.

His research activities focus on emerging technologies including: (a) 3D printing technologies for pharmaceutical dosage forms or novel medical devices (microneedles, bioresorbable scaffolds), (b) Continuous manufacturing processes for the development of medicinal products, and (c) Nanomaterial synthesis and surface modification for cancer treatment.  Furthermore, his group works on a wide range of 3D printing technologies such as SLS, SLA/DLP, FDM and microextrusion.

Furthermore, his group works on QbD approaches based on extrusion processes 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/UK grants. He received the prestigious award of Eminent Fellowship of the Academy of Pharmaceutical Sciences for the excellence in the pharmaceutical sciences over a prolonged period with an emphasis on advocacy and leadership.  He has also received a prestigious award for his “Outstanding Scientific Contribution” in Pharmaceutical Processes and invited to deliver the Award Lecture, sponsored by AstraZeneca.

Mechanical Engineer with more than 12 years of experience in new product development comprising medical devices, combination products, and consumer products. Currently working as Drug delivery systems development lead, responsible for leading the technical development of the products for US & EU market.

Erik Oude Blenke obtained his PhD from University of Utrecht in the Netherlands, writing his thesis on Lipid Nanoparticles for Intracellular Delivery of RNA Therapeutics. After a short time at ProQR Therapeutics in Leiden, the Netherlands, where he worked on inhaled delivery of oligonucleotides, he moved to AstraZeneca R&D in Gothenburg, Sweden at the end of 2018. At the department of Advanced Drug Delivery in Pharmaceutical Sciences, he worked on several projects in the Moderna collaboration, exploring mRNA therapeutics for various targets. He has also been closely involved in the development of AstraZeneca’s internal delivery platform and is currently part of a team working of further optimization of LNP formulations for new applications, such as therapeutic gene editing, vaccines and others.

Tiffany has been in the pharmaceutical industry for 8 years developing medical devices end to end, primarily in the combination product space. She has worked end-to-end from the early phases of development to lifecycle management. From her studies in Organizational psychology, she has always had an understanding of what motivates people and why they do what they do.

Dimitrios Lamprou (Ph.D. MBA) is Professor & MSc Programme Director at Queen's University Belfast (UK). Is also the Chair at United Kingdom and Ireland Controlled Release Society (UKICRS) and the Chair of the Academy of Pharmaceutical Sciences (APS) Emerging Technologies Focus Group. Dimitrios, is the author of over 120 peer-reviewed publications, has over 300 conference abstracts, has given over 120 Invited Talks in institutions and conferences across the world, and has secure Funding in excess of £2.5M. He has been recognised as world leader in Printing with PubMed-based algorithms placed him in the top 0.1% of scholars in the world writing about Printing in the last 10 years. His research and academic leadership have been recognised in a range of awards, including the Royal Pharmaceutical Society Science Award and the Scottish Universities Life Sciences Alliance Leaders Scheme Award. Dimitrios expertise is in Emerging Biopharmaceutical & Pharmaceutical Technologies (e.g., 3D Printing & Bioprinting, Microfluidics, and Electrospinning) in the manufacturing of Drug Delivery Systems & Medical Implants. For more info, please visit the www.lamproulab.com.

Beat U. Steffen is the Founder, Chairman & CEO of confinis. He has more than 25 years of experience in combination product and medical device development, manufacturing, quality management, and regulatory affairs. He worked in the industry and was responsible for many development projects from the first idea to successful market authorization and commercialization

He founded confinis in 2005. confinis provides professional services and advice to clients in the medical device, pharmaceutical and biotech field and has particular expertise and experience in combination products. In 2016 he co-founded Medical Human Factors (medHF), a company specialized in evaluating the use related safety, effectiveness and usability of medical products. Besides that, he works as a freelance Lead Auditor with a focus on ISO 13485, ISO 15378, MDSAP (Medical Device Single Audit Program) and Regulation (EU) 2017/745 (MDR) for two Notified Bodies / Auditing Organizations. He is also a lecturer regarding MDR as well as combination products at the University of Berne (MAS in Medical Device Regulatory Affairs and Quality Assurance) and design control at the Berne University of Applied Sciences. He is also an active expert representing Switzerland in ISO TC 84 and ISO TC 76.

As an (industrial) pharmacist, I started working in a public pharmacy directly after my studies. After 1 year, I moved to the industry and took up different rolls in QA, Production and Engineer at Alcon Puurs, Belgium. After 5 years, I started working for the Novartis Device and Development organization taking care of the transfer and industrialization of technologies. My experience on a manufacturing site helped me in getting a better understanding about the challenges coming along with transfer processes. As of January 2021 I’m leading one of the device portfolio groups in the Global Design and Packaging Development group.

In my spare time, I like to go for a run or play a tennis game. I am interested in music and play the guitar and the piano (just started).

Robin Curtis is a Senior Lecturer in the School of Chemical Engineering and Analytical Science at the University of Manchester.  Before joining Manchester, he did post-doctoral work supervised by Michael W. Deem at Rice University and University of California at Los Angeles, and completed his PhD under the supervision of John M. Prausnitz and Harvey W. Blanch at University of California at Berkeley.  He is a trained biochemical engineering with expertise in molecular approaches to understand protein solution behaviour directly relevant to downstream bioprocessing unit operations and liquid formulations.   Current projects focus on developing novel approaches for predicting shelf stability of biopharmaceuticals using chemical stress, investigating methods for supercharging proteins to enhance their resistance against aggregation, and understanding the relationship between dilute solution properties and concentrated solution behaviour, such as rheology, phase separation, and particle formation.

Adrian Funke is pharmacist by training and holds a PhD in Pharmaceutical Technology. He has more than 20 years of experience in pharmaceutical development at Bayer covering all stages of formulation and process development from Research to Commercial Manufacturing.

In his current role, he is leading an interdisciplinary team supporting Quality by Design, Process Understanding, Process Intensification, Continuous Manufacturing, and Modeling & Simulation in all development projects within Chemical & Pharmaceutical Development.

Dunja Šilić is working as a Senior Product Development Scientist at Pliva Croatia (part of Teva). She obtained the title of Master of Pharmacy from the University of Zagreb (Croatia) in 2011 and since then she has been working as a formulation scientist, developing oral and parenteral dosage forms. Dunja is a PhD student at the University of Greenwich (UK) and the topic of her research is the application of hot-melt extrusion to the synthesis of complex cocrystals.

Andreas Fischer holds a position as senior principal scientist at Xspray Pharma. He has more than 20 years’ experience of working with innovating and developing new pharmaceutical products at small to medium sized companies. Andreas has managed product development over the whole cycle from innovation to regulatory submissions, and patent prosecution and litigation. With his general understanding of pharmaceutical development, he has contributed to the approval of three marketed products on the US and European markets.

Dr. Boltri is a pharmaceutical chemist by training and completed his degree at the University of Turin.

With more than 30 years of experience in the Pharmaceutical Industry, Dr Boltri has held leading positions as Department Head and Director.  Dr. Boltri has extensive experience in formulation development for various dosage forms, with a focus on oral delivery and bioavailability enhancement.

In the current role, Dr. Boltri supports Company processes leading to identify new and innovative technologies as well as valuable opportunities for product development and co-development.

Thomas manages a multidisciplinary R&D team offering products & services in chemical process and analytical development as well as in discovery of new excipients and active molecules.

He previously held positions as R&D manager at DRT (Firmenich) and Minafin Groups.

He holds a PhD in organic chemistry from Pierre et Marie Curie University (Paris).

Fiona is Director of Biopharmaceutics at BDD. A registered pharmacist, she has more than 20 years’ experience in formulation development, with a focus on controlled release and chronotherapeutics. Fiona has extensive expertise in vivo evaluation of novel formulations. Through her work in this area, she has gained an in depth understanding of how different formulations will perform in man which she uses to guide intelligent formulation design. Fiona has a PhD and degree in Pharmacy from the University of Strathclyde.

• 25+ years of experience in Business Development, Strategic Planning, Venture Management in the global pharma industry with both drug delivery and specialty pharma
• Former SVP for Antares Pharma, senior management roles at various organization including Enzon, Kashiv, Noven, & Union Carbide.

• 15+ years of experience in Complex Product R & D includes top companies like Roche, Kashiv & Amneal.
• Key specialization area includes formulation, processes, drug delivery technologies for NCE molecules, 505b2 & complex generics.
• Development of platform technologies like BIOMAXX, GRANDE & KRONOTEC.
• Inventor on 30+ Patents