Programme 2021

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.

Andrea Benassi got its PhD in Physics in 2009 at University of Modena and Reggio Emilia (Italy). After almost 10 years of academic research in Italy, Switzerland and Germany, in the field of applied physics and engineering, he moved to corporate research. He joined Chiesi R&D Labs in 2015 as a product and process designer, his work is mainly focused on dry powder inhalers and pressurized metered dose inhalers covering aspects of both device design and drug product manufacturing.

Heinrich Haas has more than 20 years of experience in academic research and industrial pharmaceutical development. After he received his Ph.D. in physical chemistry, Dr. Haas researched lipid membranes and organized biomolecular systems. His professional focus is on colloidal/nanoparticulate formulations for targeted drug delivery with therapeutic and diagnostic applications. Before joining BioNTech RNA Pharmaceuticals GmbH (former Ribological GmbH), he was responsible for a variety of projects in biopharmaceutical research and development, ranging from the exploration of novel colloidal therapeutic and diagnostic carriers to up-scaling and development of market-compliant manufacturing methods for liposome products. After joining BioNTech RNA Pharmaceuticals GmbH in 2010, he helped build the formulation development and analytics unit, which develops formulations for delivery of RNA and small molecules. He has an active record of publications in peer-reviewed journals and patent applications in the field of drug delivery.

Karsten Flügel studied pharmacy at the Goethe University in Frankfurt, Germany. He joined the Pharmaceutical Development at Merck KGaA in 2016 to pursue his PhD in Pharmaceutical Technology and works since 2020 as a Postdoctoral Researcher. He gathered advanced expertise about amorphous solid dispersions and their formulation and process development with a special focus on the influence of mechanical properties. Karsten’s current research focuses on the optimization and scale-up of processes for the manufacturing of solid oral dosage forms by applying mechanistic mathematical models.

Professor Ryan Donnelly holds the Chair in Pharmaceutical Technology at Queen’s University Belfast and is Director of QUB’s interdisciplinary research programme Materials & Advanced Technologies for Healthcare (MATCH). His personal research is centred on design and physicochemical characterisation of advanced polymeric drug delivery systems for transdermal and intradermal drug delivery, with a strong emphasis on improving patient outcomes. He is currently developing a range of novel microneedle technologies through independent research, but also in collaboration with several major pharma partners. He has obtained substantial UK Research Council, charity and industrial funding and authored over 300 peer-reviewed publications (H-index = 58), including 6 patent applications, 6 textbooks, 23 book chapters and approximately 250 full papers. He has been an invited speaker at numerous national and international conferences. Professor Donnelly is Europe/Africa Editor of Drug Delivery & Translational Research and the Controlled Release Society’s Communications Chair. He has won the Academy of Pharmaceutical Science’s Innovative Science Award (2020), Evonik’s Resomer Award (2018), the Controlled Release Society’s Young Investigator Award (2016), BBSRC Innovator of the Year and the American Association of Pharmaceutical Scientists Pharmaceutical Research Meritorious Manuscript Award (2013), the GSK Emerging Scientist Award (2012) and the Royal Pharmaceutical Society’s Science Award (2011).

Carolin is a pharmacist by training and studied pharmacy at the University of Freiburg. She spent her PhD student's time at Merck Healthcare KGaA on the topic of amorphous solid dispersions. After a PostDoc period within the department of Pharmaceutical Technologies/Drug-Delivery & Innovation, she is now responsible for Material Profiling/Powder Characterization as lab head and initiative project lead.

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.

Dr. Olivier Brass earned a Ph.D. in 1992 from University of Lyon, Fr , in the biophysical and molecular interaction field in collaboration with Industrial and Academic partners (CNRS, INSERM and INSA labs). He worked with different Pharma and Biotech companies focusing on pharmaceutically active proteins. This included responsibilities in Research, Development, Quality control and Industrial Operation of API formulation (molecules, recombinant and purified proteins, and microorganisms). In 2001 he joined Sanofi Pasteur, Marcy l’Etoile, Fr, where he held various positions as project leader and team manager in R and IO. Since 2006, he had focussed on Formulation project from R&D to IO and specifically international corporate project for Vaccine stability prediction and stabilisation strategies for regulatory purposes. He led several initiatives enabling the formulation of different kind of vaccines (molecular, macromolecular, particle adjuvant, splitt and lived attenuated virus).

Dan is Halo Lab’s Director of Sales. He started his career as a protein biophysicist and has over fifteen years of experience developing and applying novel analytical methods to understanding and optimising biologic stability and solubility. For the last ten years he has been developing, marketing and selling biophysical tools and equipment to scientists across the world.

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.

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.

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).

Stefan Schneid is currently a laboratory head in the formulation development department at Bayer AG. In this function, he develops formulations and processes for novel biological entities and small molecules, and is involved in development projects from pre-clinical stage up to transfer to commercial production. Previously Dr. Schneid worked as R&D Manager at Syntacoll GmbH in Saal, Germany, where he was responsible for the development of novel formulations and analytical methods for drug-containing biodegradable implants for parenteral application. Until 2010, he was a post-doctoral research fellow in the Freeze Drying Focus Group at the University of Erlangen, and spent one year as a visiting scientist in Prof. Michael Pikal’s lab at the University of Connecticut. Stefan Schneid holds a degree of pharmacy from the University of Munich, and received his Ph.D. in Pharmaceutics from the University of Erlangen in 2009 for his dissertation thesis titled “Investigation of Novel Process Analytical Technology (PAT) Tools for Use in Freeze-Drying Processes”. He developed and optimized the formulation and manufacturing process of various predominantly lyophilized pharmaceuticals including proteins, peptides, vaccines and small molecules.

Scientist with >11 years of research experience in discovery and development of peptides, proteins and antibody-based modalities. • Developed novel technologies and platforms for high-throughput discovery, engineering and development of peptides, proteins and antibodies. • Experience in multiple selection platforms (yeast two-hybrid, yeast display and phage display), molecule types (small molecules, peptides, small-proteins, different antibody modalities (multispecifics, radionuclide conjugates and CAR-T) and disease portfolios (solid cancers and hematological malignancies). • Worked in various cross-functional teams in different capacities: Proven skills in design of experiments; data generation, analysis, interpretation and presentation; writing and revising manuscripts, proposals and grants; supervision of project, MSc and PhD students; and collaboration with internal and external groups. • Good and relevant publications (7 published, 1 in Cell Chemical Biology, 6 patent applications and 5 manuscripts under preparation), given 30+ talks, presented 22 posters, attended 30+ conferences and workshops, and won 25 awards and scholarships. • Big picture thinker with good understanding of pharmaceutical drug development, R&D strategic management, and corporate organization and interactions.

Robert studied pharmacy at the University of Leipzig, Germany and received his PhD from the University of Regensburg, Germany in the field of Pharmaceutical Technology for his work on active drug targeting with functionalized nanoparticles. In 2015 he joined the Chemical and Pharmaceutical Development of Merck KGaA as Principal Scientist and works as Associate Director in the department of Pharmaceutical Technology since 2019. His current focus lies on the formulation and process development for poorly soluble compounds and modeling & simulation of pharmaceutical processes for manufacturing of solid oral dosage forms. Robert is author of several peer reviewed publications.

Jace Blackburn is a Smart Device Engineer at Genentech where he oversees development of Connected Device Platforms to improve the patient experience and enable new digital strategies for the business. He holds multiple certifications in Product Management and brings expertise on the development of software as a medical devices, connected devices, and digital combination products. He holds a degree in Chemical and Biological Engineering from the University of Colorado Boulder and is currently pursuing a Masters in Bioinformatics from Johns Hopkins University.

As Head of Pharmaceutical Development Biologicals Kerstin is responsible for the early and late stage formulation and process, the parenteral primary packaging and parenteral combination product development of biologicals. She started her career 2000 at Boehringer Ingelheim and held several positions during this time.

Gabriele Sadowski is full professor for Thermodynamics at TU Dortmund University. She is member of the Academy of Science and Arts North Rhine-Westphalia and of the German Academy of Engineering Sciences. She is the chair of the German working party Thermodynamics and the German Representative in the European working party Thermodynamics and Transport Properties. Gabriele Sadowski is author of about 200 scientific publications in high-reputation journals in the field of chemical, biochemical and pharmaceutical engineering. The main focus of her research is studying thermodynamic properties of complex systems with particular emphasis but not restricted to those containing biological and pharmaceutical molecules. To model the thermodynamic stability of those systems she developed the currently worldwide most-used thermodynamic model PC-SAFT which was published in 2001. She received numerous awards for her work, the most-prestigious one being the Gottfried Wilhelm Leibniz Award of the German Science Foundation in 2011.

Dr. HONG Shiqi is a senior biopharma scientist at Roquette, based out of Roquette’s Global Biopharma Center of Excellence in Singapore. In her role, Dr. Hong specializes in formulation development and focuses on developing new solutions to extend the shelf life of therapeutic proteins. She possesses over a decade of cross-functional industrial experience in drug product development, including substantial knowledge in supporting early stage drug development of small molecules. Dr. Hong earned her PhD in Pharmaceutical Sciences from the National University of Singapore.

Dr. Ranjit Dhenge works as Investigator in the Product Development and Supply department of GlaxoSmithKline (GSK) (Ware, UK). He is also Associate Fellow at GSK. His current focus is on platform and process development of dry granulation operation (roller compaction). This involves developing small scale prediction tools, modelling framework and application of tools into the projects. The work also involves technical troubleshooting and process de-risking. Ranjit has completed a PhD at The University of Sheffield, UK in 2012. After PhD, he joined Nestle in York, UK, as a Product Technologist. He worked on extruded-confectionery product development using Continuous Twin Screw Extrusion. Before joining GSK in 2016, Ranjit also worked as Post- Doctoral Researcher at The University of Sheffield (2014-16) as a where he was actively engaged in the research activities in the area of Continuous Pharmaceutical Granulation with special attention to formulation science and process development.

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.

Aaron Stewart is an Associate Principal Scientist at Lonza in Bend, Oregon. He works on internal research and development initiatives to support global product development. His primary areas of expertise are in amorphous solid dispersion formulation development with an emphasis on in vitro testing models and design, PBPK modeling and drug pharmacokinetics. Aaron has been with Lonza since 2011. He graduated with a M.S in chemistry from the University of Oregon.

Rob Gelissen is a Business Development representative for Drug Delivery and Packaging for W.L. Gore & Associates (GORE). Rob has a Mechanical Engineering and Business Economics background and lives in the Netherlands. During his 30-year working experience he fulfilled several commercial roles in different industries and last 6 years his focus is on European Business Development in the parenteral packaging market. In this role he explores and grows new opportunities in the Drug Delivery & Packaging market by matching the customer needs with Gore’s unique capabilities in Fluor Polymers.

Timo has more than 20 year experience in the pharmaceutical industry predominately in Outsourcing or Offering of third part development and manufacturing services. Currently he is Head of Business Development & Marketing at tesa Labtec. Previously he was Head of Licensing and CMO at Acino International and CMO manager for complex drug delivery forms and their secured supply chain at Aesica Pharmaceuticals. Prior to his CMO focus he was involved many years in licensing, project management of generic developments at Galenicum Health and Helm AG. He holds a PhD in organic and analytical chemistry from University of Hamburg, Germany.

Rosario has over 20+ years of experience in driving R&D, commercial, and operational excellence through business acumen and scientific leadership with roles of increasing responsibility in development, scale-up, transfer, and launch preparation of generic, complex generic and branded products as well as products following a 505b2 regulatory pathway at Merck, Novartis, TEVA and Sandoz. This includes development of active pharmaceutical ingredients and drug products including small molecules, synthetic polypeptides and proteins in various dosage forms (Parenterals, solid oral dosage forms, transdermals, films, etc) and drug-device combination products for a wide gamut of therapeutic areas. Currently at Sandoz Rosario is Head of Scientific Affairs based in Princeton, NJ responsible for external partnership product development with speed-to-market philosophy leading to timely product submissions (NDAs, 505(b)(2)s, and ANDAs), approvals and on-time launches. Rosario oversees technical due diligence evaluating CMC and bio-analytical aspects of new product opportunities amenable to co-development, in-licensing or acquisition. Moreover, he advances pipeline strategy and leads team for identification, evaluation and prioritization of internal/external robust tuneable technology platforms. Prior to joining Sandoz, Rosario worked at TEVA Pharmaceuticals as Site Head / Head of Development for Sterile Products in Pomona, New York. He also worked at Novartis as global project leader for API/drug product, Global Quality by Design Network Leader, and led various global teams: QbD training, Specification Setting Strategy and Regulatory CMC team focused on streamlining CMC processes for small molecules/ biologics development projects. In addition, he worked at Merck Research Laboratories API Division supporting the development of synthetic pathways and scale-up of chemical processes for early- to late-stage drug candidates. Recognized for scientific innovation: 35 research publications, 100+ presentations, and book contributions on formulation, analytical and physical chemistry, process analytical technology (PAT), Quality by Design (QbD), and other topics. Co-Editor (Book): HPLC for Pharmaceutical Scientists.

Ijeoma Uchegbu obtained her PhD from the School of Pharmacy, University of London. Ijeoma is Professor of Pharmaceutical Nanoscience at the UCL School of Pharmacy, University College London (UCL), UCL’s Pro-Vice Provost for Africa and The Middle East, the Provosts’ Envoy for Race Equality and Chief Scientific Officer of Nanomerics Ltd. Nanomerics is a UCL spin out company, which was founded by Ijeoma and Andreas G. Schätzlein (http://www.nanomerics.com/). Nanomerics recently licensed NM133 to Iacta Pharmaceuticals. Nanomerics also recently won first prize for its Molecular Envelope Technology at the Royal Society of Chemistry’s Emerging Technologies Competition 2017 in the Health category. Ijeoma has been awarded various prizes for her work, notably the UK Department for Business Innovation Skills’ Women of Outstanding Achievement in Science Engineering and Technology award (http://www.theukrc.org/women/women-of-outstanding-achievement/2007-collection/professor-ijeoma-uchegbu), the Royal Pharmaceutical Society’s Pharmaceutical Scientist of the Year 2012 and the Academy of Pharmaceutical Sciences Innovative Science Award 2016. Ijeoma was elected to the Controlled Release Society College of Fellows in 2013 and was made an Eminent Fellow of the Academy of Pharmaceutical Sciences in 2013. Ijeoma is the editor of three books, a named inventor on 11 granted patents and has authored over 120 peer reviewed journal articles and book chapters. Ijeoma’s research has been featured on BBC Woman’s Hour and more recently in The Guardian.

Matthew Clemente currently serves as the Vice President of Device Development at Novo Nordisk where he leads a development organization focused on the commercialization of drug delivery devices. He previously served as the Senior Director of Systems Engineering & Technology at Eli Lilly & Company, responsible for the leadership of the research and development organization driving the engineering and design of Eli Lilly’s delivery, device and connected solutions portfolio. From October of 2015 as the Chief Technology Officer and Director at Eli Lilly, he lead the technical development of their Connected Care Diabetes Ecosystem and an emerging portfolio of electromechanical delivery devices, applications and algorithms that served a variety of therapeutic areas and formulations. Prior to Lilly Matthew served as Director of Advanced Drug Delivery Systems at Unilife Corporation where he built and managed an integrated engineering and science organization focused on mechanical, electromechanical, digital and container closure systems for prefilled, preassembled, wearable drug delivery applications. Prior to Unilife, Matthew held a variety of roles of increasing responsibility at multiple Johnson & Johnson companies, where he primarily served in the new product development of insulin pumps at Animas Corporation for J&J’s Diabetes Care Franchise. By way of education, Matthew obtained a Bachelor of Science in Biomedical Engineering from the University of Miami and an MBA in Finance from Villanova University.

Korinde van den Heuvel is senior product developer at DFE pharma since April 2014. In this role she contributed on multiple OSD projects but currently mainly focusing on 3D printing of pharmaceutical tablets. Prior to working at DFE pharma she worked for 10 years at Synthon in formulation development developing various generic plus OSD forms such as ODT, IR and MR tablets and capsules. Korinde holds a master degree of Organic chemistry from the Radboud University in Nijmegen, The Netherlands.

Lynne Isopi is a Principal Scientist in Vaccine Drug Product Development in MSD. She heads a group that develops stabilizing formulations and drug product manufacturing processes for vaccine programs. She is responsible for projects from pre-clinical development through technical transfer to the commercial site. She has also developed process improvements for inline vaccines. She is an expert in stabilization of labile live viruses and viral vectors. Her accomplishments include development of a universal formulation for adenovirus-vectored vaccines has been implemented widely across the field. Prior to her 22 years at MSD, she developed stable reagent formulations for diagnostic assays at the Roche Diagnostics Group.