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.

Kristiina M. Huttunen has graduated as a medicinal chemist from the University of Kuopio in Finland, from which she also received her Ph.D. in 2009 with a thesis that covered several different prodrug approaches. After her 2-year lasting postdoctoral research period at the Auckland Cancer Society Research Centre at the University of Auckland (ACSRC), in New Zealand, she returned back to Finland to the University of Eastern Finland, where she started to build up her own group called “Transporter-mediated Targeted Drug Delivery” group as an Adjunct Professor in 2014. In 2012, she was appointed as a Postdoctoral Researcher of Academy of Finland and 2015 she was raised as a Researcher Fellow of the Academy of Finland. Today, she has published nearly 60 peer-reviewed original articles and 10 peer-reviewed review articles with h-index 17. So far she has supervised 2 Ph.D. student until the end, and currently she is supervising 8 Ph.D. students. Majority of her recent work as a group leader has been related to L-type amino acid transporter 1 (LAT1) and brain-targeting approaches to affect neuroinflammation and/or neurodegeneration, but she has gradually started to widen her views also for other transporters and other targeting tissues, such as tumors and endocrine tissues.

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).

Satu Lakio is Pharmaceutical Development Director at Nanoform. She has got her bachelor, master and PhD degrees from University of Helsinki, Finland. Her PhD research was focused on enhancing understanding of pharmaceutical powder processing including various Process Analytical Technology (PAT) tools. Dr Lakio did her postdoctoral period at Monash University in Melbourne, Australia focusing on inhalation powder research. She has previously worked in several positions at academia and as an Associate Principal Scientist at AstraZeneca in Gothenburg, Sweden and Senior Development Manager at Orion Pharma, Finland. She also has a long history of working in community pharmacies. Dr Lakio holds an adjunct professorship in University of Helsinki and University of Eastern Finland (Pharmaceutical technology) and she has supervised several under and postgraduate as well as PhD students over the years. Her research covers pharmaceutical powder characterization and processing from inhalation powders to coated tablets. Dr Lakio has substantial experience of working in the field of continuous tablet manufacturing. Currently her focus research area is pharmaceutical development of nanoformed particles.

Bernardo leads application and business development and is one of the Halo Labs’ founders. He was previously CEO and CTO and played a pivotal role in bringing over $6M in federal grant funding. Prior to starting Halo Labs, Bernardo was a Postdoctoral Associate at Cornell University, where he also obtained his M.S. and Ph.D. degrees in Mechanical Engineering. His wide range of technical experience includes particle analysis, detection and manipulation, drug delivery devices, microfluidics, nanophotonics and bioenergy production. In 2012, Bernardo was named one of Philadelphia’s top 30 under 30 entrepreneurs, the same year Halo Labs was named Philadelphia Life Science Startup of the year by the Greater Philadelphia Alliance for Capital and Technologies.

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.

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).

David Grant is the Head of Device Development at Enesi Pharma Ltd, leading the development of its needle-free delivery technologies for the administration of room-temperature stable, solid-dose, vaccines as part of Enesi’s ImplaVax® vaccination technology – designed to deliver immunity irrespective of target, disease, geography or socioeconomic class. Since studying Physics at the University of Cambridge, UK, David has 15 years’ of experience of working with game-changing technologies and over 10 years’ experience in the field of injectables, conducting extensive research into the injection dynamics of solid doses.

Dr. Boltri is a pharmaceutical chemist by training and completed his degree at the University of Turin, With 30 years of experience in the Pharmaceutical Industry, Dr Boltri has held leading positions as Department Head and Director. In the current role, he is responsible for identifying new and innovative technologies as well as valuable opportunities for product development and co-development.

Dr. Frederic Dargelas, PhD, MBA, Director, Head of Business Development and Alliance Management, at DelSiTech, with a 20-year career in the international biopharmaceutical industry, has extensive R&D and business development experience as a former Business Manager and Development Manager for Orion Pharma. Dr. Dargelas has also held a variety of management positions in prominent pharmaceutical companies such as GSK, accruing expertise in drug delivery technologies, product development, industrialization and manufacturing of small molecule drugs, biologics and vaccines as well as strategic collaborations in the pharma/biotech industry.

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.

Alex Vasiev, PhD, has a wide range of experience in medical and biomedical R&D, and is a passionate problem solver. Before joining Oval, he worked in academia and consultancy with a primary focus on the interface of engineering and biological systems. Dr Vasiev has been involved in the development of everything from smart stem cell microniches to patch pumps, inhalers and several high-viscosity autoinjectors. As a Manager of Device Development at Oval Medical, he has led various projects, guiding technical teams and device development programmes. He graduated with an MEng in mechanical engineering with aeronautics, and a PhD in biomedical engineering from the University of Glasgow (UK).

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.

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.

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. 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

Bharathi Vellalore is a Pharmaceutical Scientist with >12 years of cross-functional research experience in discovery and development of cyclic peptides, small-proteins, antibody-based molecules and cell therapy products for diagnostic and therapeutic applications. Before joining Janssen Drug Product Development, he conducted postdoctoral research in the Saskatoon Translational Cancer Research Cluster and Janssen Biotherapeutics. Bharathi earned his MSc and PhD in Biochemistry from the University of Saskatchewan, Canada (2017) and BTech in Biotechnology from Anna University, India (2008).

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.

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).

Twinkle Christian is a Process Development Scientist in the Drug Product Technologies group at Amgen. She has 15 years of industry experience in formulation development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. Twinkle’s expertise encompasses high concentration formulation and drug delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography. She is an adjunct instructor at California State University, Channel Islands & University of California, Santa Barbara. Twinkle holds a Master’s in Biochemistry and Molecular Biology and was employed at Alza (Johnson & Johnson) and VaxGen prior to Amgen.

David co-founded Enesi Pharma in September 2017 and as CEO as has led the business through a period of rapid growth and establishment to become one of the world’s most exciting companies involved in vaccine delivery and vaccination strategy using Enesi’s ImplaVax® technology, irrespective of target, disease, geography or socioeconomic class. Prior to Enesi, he was Chief Business Officer of Circassia Pharmaceuticals, and a member of its Senior Management Team with global group responsibility for all M&A, partnering and licensing activities. Before joining Circassia, David was CEO and co-founder of Prosonix, a particle engineering-enabled respiratory product company, taking it from its establishment in 2006, raising more than £25 million from leading international life sciences investors and institutions over several financing rounds, through to its successful sale in 2015 to Circassia for £100 million. He has more than 27 years of business development and licensing experience concerning cutting-edge technologies in high growth, complex, IP-rich environments, with a prime focus on the pharmaceutical industry. David holds a degree in Chemical Engineering from the University of Birmingham, UK

Sudhakar Garad received his Ph.D. from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr, M.S Nagarsenker. Soon after completion of his Ph.D., he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his Ph.D, he was selected as a post-doctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers. After his post-doctoral fellowship, he worked with Vertex pharmaceutical for a period of three years as Senior Investigator in formulation development group. After Vertex, he joined Novartis as a Group Head. He worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Sudhakar is working as a Global head of Chemical and Pharmaceutical profiling (Discovery Pharmaceutics) and Disease Area Head (New Indications) at Novartis. His primary role is collaborate with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies to expedite molecules into tox and clinical studies. He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). He has many publications, book chapters and patents. In last 20 years of his career he has taken more than 200 new chemical entities in clinical studies across dozen disease areas ( CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration. He serves as a technical R and D expert to research Disease Area for hematology, hepatology and kidney disease area.

Dr. Anne Moore graduated with a degree in Biochemistry University College Cork. She completed a PhD in HIV vaccine immunology with Professor Kingston Mills. Dr. Moore subsequently embarked upon post-doctoral work on defects in immune responses in HIV-infected individuals in the Wistar Institute in Philadelphia and further work on recombinant vaccines against viruses such as HIV and Ebola virus in Dr. Gary Nabel's lab then at the University of Michigan. As a senior immunologist in Prof. Adrian Hill's group in the University of Oxford, she developed several T cell inducing vaccine candidates against malaria and TB and was involved in clinical trials of these and other vaccine candidates in Oxford and malaria endemic areas in Africa. She was a Lecturer in Pharmacology, based in the School of Pharmacy, in early 2007. In 2016 she worked for 10 months with the vaccine biotech company, Vaxart, South San Francisco while on sabbatical. Here she worked on tablet-based oral vaccines for a range of therapeutic and prophylactic vaccine. In September 2018, she took a position as Senior Lecturer in Biochemistry and Cell Biology.

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. 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

Professor Daryl Williams graduated with a B.Sc. (Hons) in Physical Chemistry from University of Melbourne, Australia and a M.Sc. in Polymer Science from Lehigh University, USA before coming to Imperial College London complete his PhD. He is founder and Managing Director of Surface Measurement Systems and the Professor of Particle Science in the Department of Chemical Engineering at Imperial College. DRW has published over 100 papers in refereed journals and been granted international 5 patents. His research interests include the surface and bulk characterisation of complex organic solids, including especially biopharmaceutics, foods, pharmaceuticals and polymers as well as their manufacture using spray drying, crystallisation, freeze drying, milling and granulation. The Surface and Particle Engineering Laboratory at Imperial College he leads has 4 Postdoctoral research fellows and 11 PhD students. In 2019 he was awarded the Geldart Medal by the Institution of Chemical Engineers and in 2020 the Royal Society of Chemistry named him as Chemistry World Entrepreneur of the Year. His research current work includes investigating porous complex materials in range of industrial applications including their manufacture, performance and stability

Professor Jayne Lawrence provides leadership to all aspects of NoWCADD research, whilst also leading technical projects. Jayne is also Head of the Division of Pharmacy and Optometry. Jayne’s research is focused on the delivery of drugs and biomolecules using colloidal structures and is particularly interested in understanding how molecular structure influences intracellular delivery using a range of analytical techniques.

Dr. Nitin Joshi is an Instructor of Anesthesia at Harvard Medical School and an Associate Bioengineer in the the Department of Anesthesiology, Peripoperative and Pain Medicine at the Brigham and Women’s Hospital. After obtaining his PhD degree in Biomedical Engineering from Indian Institute of Technology Bombay, India, he did his postdoctoral fellowship at the Brigham and Women’s Hospital with Dr. Jeffrey Karp. Dr. Joshi’s main research focus is drug delivery and biomaterials. Technologies developed by him have resulted in 10+ granted and pending patents and technology disclosures, with most licensed to biotech companies and one already advancing through clinical trials. Dr. Joshi’s research work has been published in top tier journals, including Nature Communications, Science Advances, Nanotoday, Biomaterials, and Journal of Controlled Release, and has been highlighted by multiple media outlets and scientific journals around the world. He has received multiple awards for his work, including MIT’s Technology Review Magazine (TR35) India Award, Lockheed Martin Innovation Award, and Boston Patent Law Association (BPLA) 2020 Invented Here! Featured Honoree Award.

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.

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

Shogo Warashina studied agricultural and life science at University of Tokyo in Japan. In 2012, he received master on his study of cellulose chemistry. He joined Shin-Etsu in Japan from 2012 and was in charge of development of cellulose derivatives. His responsibilities include the research of solid dispersion with HPMCAS. In 2019, he change his role to technical sales manager in EU and is working in Wiesbaden, Germany.

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.

I am presently working with Ichnos Sciences, Switzerland (A part of Glenmark Pharmaceuticals SA, Switzerland) and heading three major functions for the company – formulation, analytical, and drug product development groups. I have more than 15 years of experience in this area with > 10 years in an industrial setting (with previous global experience with Novozymes A/S Denmark and Glenmark Pharmaceutical SA Switzerland). Twelve products developed by me and my team are currently in clinical trials including many of the products evaluated and developed together with Nova Laboratories, The UK. These products are in different markets including the USA, EU, and Asia – this gave us very rich hands-on experience. In addition, I have 12 PCT patent, 22 publications in high impact journals like Journal of Controlled Release, Molecular Pharmaceutics, etc., 7 book chapters, and have been invited speaker on the topic in several international conferences (> 60). Industry and academia have equally recognized my contribution with 20 research awards including prestigious industry awards from Glenmark (Best innovation team – won twice), Merck (Innovation cup), Novartis (International bio camp) and the Swiss Society of Pharmaceutical Sciences (Best publication).

Sarah Stevens, Ph.D. is the Vice President, Drug Development Sciences at Quotient Sciences. Sarah is responsible for global leadership of the Drug Development Consulting team, and the design of differentiated, integrated programs of work for pharma and biotech clients. Sarah qualified as a PhD Pharmacist and then completed post-doctoral research at the University of Strathclyde in Glasgow prior to starting her career in industry. Over the last 15 years, Sarah has held a range of scientific and leadership roles within CDMO organizations, most recently at AMRI where Sarah led development and commercial sites both in the UK and US and was responsible for Drug Product Development.

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.

Martin Hofsäss studied pharmacy at the Goethe University, Frankfurt am Main, Germany. After obtaining his license as a pharmacist in 2016, he joined the lab of Prof. Dr. Jennifer Dressman for his PhD studies in pharmaceutical technology. His work focused on in vitro release testing as an alternative to establishing bioequivalence of drug products in vivo. In June 2020, he joined BASF’s Development Pharma Solutions R&D team as a PostDoc for digital formulation development working on new features for BASF’s virtual formulation assistant ZoomLabTM.

Dr. Elijahu Berkovich is a scientist with over 10 years of pharmaceutical industry experience. Elijahu brings the unique ability to identify and explore medical unmet needs, propose novel therapeutic solutions, develop concepts and test them in preclinical models and in human. His wide experience spans across R&D (from idea to commercial), Due Diligence of new projects and business opportunities (internal and external), Marketing and Medical/Scientific Affairs. Elijahu serves as the Head of Emerging Science and Innovation at Clexio Biosciences where he is responsible for ideation, scouting and pipeline creation. Prior to his role as Head of Emerging Science and Innovation at Clexio, Elijahu was a Senior Director at Teva Pharmaceuticals, holding various positions within Global R&D and Medical Affairs. Elijahu holds a bachelor degree in Biochemistry and Food Science (with highest distinction) from the Hebrew University of Jerusalem and a M.Sc. and Ph.D. (with distinction) in Molecular and Cellular Biology from the Weizmann Institute of Science. Elijahu completed his Post-doctoral fellowship in the Hematology/Oncology Department at St. Jude Children’s Hospital, Memphis, TN, where he focused his research on Oncology and DNA damage response and published peer-reviewed articles in top tier journals.

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.

David co-founded Enesi Pharma in September 2017 and as CEO as has led the business through a period of rapid growth and establishment to become one of the world’s most exciting companies involved in vaccine delivery and vaccination strategy using Enesi’s ImplaVax® technology, irrespective of target, disease, geography or socioeconomic class. Prior to Enesi, he was Chief Business Officer of Circassia Pharmaceuticals, and a member of its Senior Management Team with global group responsibility for all M&A, partnering and licensing activities. Before joining Circassia, David was CEO and co-founder of Prosonix, a particle engineering-enabled respiratory product company, taking it from its establishment in 2006, raising more than £25 million from leading international life sciences investors and institutions over several financing rounds, through to its successful sale in 2015 to Circassia for £100 million. He has more than 27 years of business development and licensing experience concerning cutting-edge technologies in high growth, complex, IP-rich environments, with a prime focus on the pharmaceutical industry. David holds a degree in Chemical Engineering from the University of Birmingham, UK

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.

Tony Listro is Vice President, Technology of Foster Delivery Science, Inc., a CDMO focused on drug delivery and highly regulated medical device applications based on polymer processing technologies. He is responsible for the continued research and development of new melt extrusion technologies as well as guiding Foster’s team of engineers and scientists in the contract development and manufacturing of specific formulations and dosage forms for clients in the pharmaceutical industry. Tony is an expert in the areas of polymer materials and polymer processing. He has worked on blending active pharmaceutical ingredients with polymers for various drug delivery applications including oral and implantable for more than 15 years. Tony holds both a BS and MS in Plastics Engineering from the University of Massachusetts in Lowell, MA, and an MBA from the University of Massachusetts in Amherst, MA. He holds two issued US patents and has authored and/or co-authored 20 publications. Tony is a member of the Society of Plastics Engineers, Controlled Release Society, and AAPS.

Born behind the iron curtain (East Germany) Mechanical Engineering at Dresden Technical University (East Germany) PhD Mechanical Engineering at EPFL (Switzerland) 8 years of experience in Finite Element Simulations in various industries 6 years in medical device industry, leading Product Support and Process Engineering departments 10 years in Swiss watch industry, responsible for mechanical engineering and R&D for quartz movements and Swatch watches Now director of development at Sensile Medical in Olten Switzerland, a Gerresheimer Company.

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.

Scott Brown has over 30 years of experience in device development and combination products. He currently leads Merck’s Device Development group. He has a long history of successfully introducing products to the market and has played a key role in the successful development and commercialization of over 19 products. He joined Schering Plough in 1998 to start a Device Development group in support of the growing need for combination products. While building and leading this group he has also been the recipient of Schering Plough’s President’s Award for Development in 2003, Merck’s Presidential Fellowship Award in 2012 and New Jersey’s Thomas Edison Patent Award for the development of Merck’s next generation dry powder inhaler. Prior to joining Schering-Plough/Merck, he collaborated with engineers and scientists at MIT and Therics to develop a 3D printing machine used for complex tissue implants and oral dosage forms. Prior to this he worked for the UK based PA Consulting Group as a medical device and general technology consultant for many organizations including Biogen, Upjohn, J&J Ethicon, Amgen, Bayer, Alcon, Smith and Nephew, Abbott, Nycomed, Cardiac Pacemakers Inc., Chrysler, Ford and General motors. His academic background includes an MS in Engineering Management, and BS degrees in both Mechanical Engineering and Psychology.

Harvard-trained ophthalmologist, Dr. Mandell founded LayerBio with the aim of developing a drug-eluting IOL for cataract surgery. He is co-inventor of Oyster Point Pharma’s OC-01 treatment for dry eye disease and Aldeyra’s reproxalap eye drop for ocular inflammation. He has personally contributed to more than a dozen Investigational New Drug (IND) applications and overseen the conduct of numerous Phase 1 through Phase 3 clinical trials in the field of ophthalmology. He currently serves as strategic advisor to Aramis Biosciences, a Harvard spin-off developing novel therapies for eye disease and as Medical Monitor for the National Eye Institute at the National Institutes of Health.

Stefan Bracht is heading the unit Disruptive Technologies in Chemical & Pharmaceutical Development of Bayer AG, Pharmaceuticals. This unit provides strategic orientation and paves the way to exploitation of new ways of working (e.g. machine learning, robotics) and also new ways of patient treatment like New Modalities beyond small and large molecules. In his previous role 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.

Matthew Clemente currently serves as the Corporate Vice President Delivery Systems Engineering 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.

I am presently working with Ichnos Sciences, Switzerland (A part of Glenmark Pharmaceuticals SA, Switzerland) and heading three major functions for the company – formulation, analytical, and drug product development groups. I have more than 15 years of experience in this area with > 10 years in an industrial setting (with previous global experience with Novozymes A/S Denmark and Glenmark Pharmaceutical SA Switzerland). Twelve products developed by me and my team are currently in clinical trials including many of the products evaluated and developed together with Nova Laboratories, The UK. These products are in different markets including the USA, EU, and Asia – this gave us very rich hands-on experience. In addition, I have 12 PCT patent, 22 publications in high impact journals like Journal of Controlled Release, Molecular Pharmaceutics, etc., 7 book chapters, and have been invited speaker on the topic in several international conferences (> 60). Industry and academia have equally recognized my contribution with 20 research awards including prestigious industry awards from Glenmark (Best innovation team – won twice), Merck (Innovation cup), Novartis (International bio camp) and the Swiss Society of Pharmaceutical Sciences (Best publication).

Moein Moghimi is a Professor of Pharmaceutics and Nanomedicine (School of Pharmacy) and Affiliated Professor (Translational and Clinical Research Institute) at Newcastle University (UK); Adjoint Professor at the Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado-Denver Medical Center (USA); co-founder and advisory board member of S. M. Discovery Group Inc. (USA) and S. M. Discovery Group Ltd. (UK); Associate Editor of Molecular Therapy (The American Society of Gene and Cell Therapy, Cell Press); and Editor-in-Chief of the Journal of Nanotheranostics (Basel). His earlier appointments have included Professor and Chair in Pharmaceutics at the School of Medicine, Pharmacy and Health, Durham University, UK (2016-2017); Full Affiliate Member/Professor at the Methodist Research Institute, Houston Methodist Hospital Systems, Houston, Texas, USA (2013-2017); Visiting Professor at Università Degli Studi Di Padova, Padova, Italy (2015); Professor of Nanomedicine (at the Department of Pharmacy), Professor of Pharmaceutical Nanotechology (at the NanoScience Center), and Founder/Director of the Center for Pharmaceutical Nanotechnology and Nanotoxiocology, University of Copenhagen, Denmark (2008-2016); and Honorary Professor of Nanomedicine at the Multidisciplinary Research Center, Shantou University, China (2008-2010). Prof. Moghimi’s research is centred on fundamental and translational aspects of nanomedicine engineering and performance, with the overall goal of advancing fundamental understanding of biological barriers in relation to nanoparticle performance and safety, and within the context of precision medicine applicable to cancer, cardiovascular diseases, immune disorders, and disease of the central nervous system. As to date, Prof. Moghimi has published >300 research papers, reviews, book chapters, proceedings, and patents/patent applications. His work is highly cited in scientific literature (>22,000 citations as to date), and he is widely reported in general, local and professional press and serves on editorial board of >20 international journals including Advanced Drug Delivery Reviews, Journal of Controlled Release and Nanomedicine (UK).

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.

Dr Fiona MacDougall is Director of Biopharmaceutics at BDD. A registered pharmacist, she has more than 20 years’ experience in formulation development, with a focus on modified 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.

Mafalda Paiva is Group Leader of Analytical Methodologies and Method Development, in Hovione’s R&D Analytical Development, since 2019. She has a broad expertise in analytical characterization methodologies within pharmaceutical development, with special focus towards in vitro performance characterization. Mafalda joined Hovione in 2014 in R&D Drug Product Development group, as an analytical chemist, supporting the development of amorphous solid dispersions programs. She has two MSc, in Pharmaceutical Sciences and in Quality Control, both from Pharmacy Faculty – University of Porto. Prior to joining Hovione, Mafalda conducted research studies in nanotechnology, pharmaceutical and analytical chemistry areas.

João Henriques is a Biological Engineer by training. He specialized in process monitoring and control for pharma and biopharma processes before joining Hovione in 2008 as a PAT specialist. João has been working as a Formulation and Process Development Scientist since 2013. He has supported development and validation of spray drying, jet-milling, roller compaction and tableting projects. João is currently the Group Leader for Particle Design and Formulation at the Drug Product Development Area.

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.

Luis is a Lecturer at the Department of Chemical Sciences at the University of Limerick (Ireland), Course Director in the BSc in Industrial Biochemistry programme and a Principle Investigator at the Bernal Institute. He is a Funded Investigator at SSPC (the SFI Research Centre for Pharmaceuticals), Principle Investigator at PMTC (Pharmaceutical Technology Centre) and has been awarded grants as PI/Co-PI from various funding agencies (EU H2020, Science Foundation Ireland, Enterprise Ireland). Luis studied Biochemistry at undergraduate level before obtaining his PhD in Chemical Engineering at the University of Lisbon (Portugal). Following his PhD, Luis worked in the pharmaceutical industry for almost 2 years (Hovione FarmaCiência, Portugal) before joining SSPC in UL as a Postdoctoral Researcher and as a Senior Research Fellow later on. Luis worked in different institutions (academia and industry) and countries (Ireland, Portugal and Sweden) focusing his research on Particle Engineering Technologies, Continuous Nanocrystallization and (Bio)Pharmaceutical Processing.

David Brayden is Full Professor of Advanced Drug Delivery at the School of Veterinary Medicine, University College Dublin (UCD) and he is also a Senior Fellow of the UCD Conway Institute of Biotechnology. David is a pharmacologist and spent 10 years as a senior scientist at Elan Pharmaceuticals. He is the author or co-author of more than 200 research publications and patents in the areas of oral peptide delivery and nanomedicine. He is currently a co-lead Principal Investigator in the Science Foundation Ireland Centre for Medical Devices (CURAM II). Prof. Brayden was elected as a Fellow of both the Controlled Release Society (2012) and the American Association of Pharmaceutical Scientists (2017).

Dr Garry Laverty is a Senior Lecturer in Pharmaceutics at the School of Pharmacy Queen’ University Belfast. His research focuses on using peptide nanomaterials, primarily self-assembled hydrogels and nanotubes, for drug delivery and biomaterial applications with support as Principal Investigator from several sources including the EPSRC (EP/S031561/1), MRC (MC_PC_18060), Wellcome Trust (07618/Z/17/Z), Innovate UK (32-08/520268133) and Royal Society (RG150171, IE1609880). He has authored 42 publications relating to peptides and their use within the drug delivery and biomaterial fields. Garry was previously a Visiting Researcher at Bing Xu’s lab (Brandeis University, Department of Chemistry, Waltham, MA, USA), a world-leading group researching the use of peptide nanomaterials in biomedicine.

Rick is currently the SVP of CMC at QED Therapeutics, Origin Bioscences and Calcilytix Therapeutics all BridgeBio Companies. Prior to joining BridgeBio, Rick served as VP of Pharmaceutical Development Services at WuXi STA, where he provided scientific leadership in formulation development and GMP manufacturing. From 2004 to 2015, Rick was Global Head of Chemical and Pharmaceutical Profiling (CPP) at Novartis. His responsibilities included all small molecule therapeutics across the Novartis portfolio. He also lead and developed novel drug delivery technologies for small molecules and large molecules. Rick has also led R&D groups at Vertex Pharmaceuticals, Symbollon Pharmaceuticals, Biogen, and Bausch & Lomb.

A high performing, energetic leader, Andrea offers over 25 years’ experience in the life science sector. Having acquired a novel blend of technical and commercial expertise in global healthcare organisations across Pharma, Consumer Health, Medical Device, Biotech and Life Sciences, Andrea is uniquely positioned to lead leon and its clients into the next stage of development.

Prior to joining MedinCell in 2008, Dr Christophe Roberge graduated with a PhD in polymer science from the Institut National de la Recherche Scientifique in Montreal, QC and held the position of Technical Director in a medical device company based in Montreal. He has been involved in many projects at MedinCell, aimed at designing long-acting formulations - based on the BEPO® technology platform - for a wide variety of pharmaceutical active compounds, from the proof of concept phase to more advanced development steps

Stephen Tindal holds a bachelor’s degree in chemistry and analytical science from Loughborough University, and specializes in forensic data analysis. He has worked at Catalent for 34 years (16 years in the USA between 2003 and 2019) and is now based at Swindon, UK. Stephen has held leadership positions in Formulation Development, Process Development and both Clinical and Commercial Operations at FDA & EMA regulated facilities. Stephen is part of Catalent’s Science and Technology Team where he leads the technical support in Europe. This S&T team are available for customer consultation in order to define the right path for any oral program, or to connect/engage other experts as needed.

Philippe Lienard obtained his PhD in organic chemistry at the CNRS, French National Research Center, in Pr Husson’s team, in 1991. After having performed a post-doc in the prestigious Pr Oppolzer’s laboratory in Switzerland, he joined SYNTHELABO in 1993 in chemical development. He occupied several positions including Head of Pilot Plant for 12 years. In 2003, He was expatriated in the USA for 3 years for SANOFI, as Chemical Development Director. Back to France in 2006, he has been working within early Pharmaceutical Sciences Department for 10 years and he’s currently Pre Development Science leader for several programs at the interface of Research and Development.

Prof. i.R. (apl.), Universität Kiel Visiting Lecturer (Lehrbeauftragter) Fachhochschule Lübeck (University of Applied Science) Scientific advisor of the CIB (Centrum für industrielle Biotechnologie, c/o Fachhochschule Lübeck). Longtime scientist at Forschungszentrum Borstel (Borstel Research Center) Receipt of several grants (DFG, EU, BMBF, Clinique La Prairie, Leibniz-Gemeinschaft) Mitglied im redaktionellen Beirat von: BMC Biochemistry, Open Glycoscience, Anti-Infective Agents in Medicinal Chemistry, International Journal of Antibiotics, World Journal of Biological Chemistry, Envilen, Scientific Reports Award: Deutscher Innovationspreis der Bioregionen 2013: (www.biodeutschland.org/innovationspreis.html) Nominated for "Springer Galenus von Pergamon Preis 2016"

Dr. Vyakarnam is cofounder and CEO of Oculinea Inc – a preclinical stage ocular drug delivery company with over 20 years of experience in combination products, medical devices and biomaterials. Previously he headed Global R&D - Medical Devices and Pharma Solutions for the then newly created Lubrizol Life Sciences business unit (A Berkshire Hathaway Co) for nearly four years. Prior to that he was at Johnson & Johnson for nearly seventeen years and most recently as Director R&D at Advanced Technologies & Regenerative Medicine. He directed research and was responsible for several product development projects leading to successful product launches or clinical trials for J&J operating companies - Ethicon, DePuy and Cordis. Dr. Vyakarnam is an inventor of over 35 US issued patents/ applications and received numerous awards including Johnson & Johnson’s Philip B. Hofmann Award for Scientific Excellence.

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.

Arul Joseph leads the Pharmaceutical Development and Clinical Supply Chain function at Avanir Pharmaceuticals. He has 15 plus years of experience in chemistry, manufacturing, and controls (CMC) development and prior to Avanir has held roles of increasing responsibility at Gilead Sciences, Merck, and Schering Plough. Before joining the pharmaceutical industry, he conducted postdoctoral research at the Scripps Research Institute in La Jolla, CA. Arul earned his PhD in Organic Chemistry from the University of Maryland in College Park, MD, and an MBA in Strategy and Finance from New York University's Stern School of Business in New York, NY

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.

Twinkle Christian is a Process Development Scientist in the Drug Product Technologies group at Amgen. She has 15 years of industry experience in formulation development across diverse modalities and has led the advancement of multiple programs from early discovery to clinical trials and commercialization. Twinkle’s expertise encompasses high concentration formulation and drug delivery of biologics, investigating protein-protein interactions, and macromolecular crystallography. She is an adjunct instructor at California State University, Channel Islands & University of California, Santa Barbara. Twinkle holds a Master’s in Biochemistry and Molecular Biology and was employed at Alza (Johnson & Johnson) and VaxGen prior to Amgen.

David is currently the VP of Research at Insmed, Inc, where he is part of a team developing novel, targeted therapies to help serve the critical unmet needs of patients battling serious rare diseases. Prior to joining Insmed in 2018, David worked at Aradigm (1996 to 2018) covering all phases of product development and led the development of preclinical research, CMC activities and intellectual property. Prior to joining Aradigm, David worked at Genentech, Inc. (1988 to 1996) developing and characterizing the delivery of protein aerosols to the airways, culminating with the approval of Pulmozyme® rhDNase for the management of cystic fibrosis in 1993. David holds a chemical engineering degree from MIT (SB) and UC Davis (MS) and a pharmacy degree from the University of Sydney (PhD).

Sudhakar Garad received his Ph.D. from the Bombay College of Pharmacy, University of Mumbai, India in 1998 in Pharmaceutical Drug Delivery Technology with Dr, M.S Nagarsenker. Soon after completion of his Ph.D., he worked with Pfizer, India for less than a year in clinical research. Taking into consideration his excellent credentials during his Ph.D, he was selected as a post-doctoral fellow at the University of Connecticut to understand micro-environmental properties above dissolving surface of the polymers. After his post-doctoral fellowship, he worked with Vertex pharmaceutical for a period of three years as Senior Investigator in formulation development group. After Vertex, he joined Novartis as a Group Head. He worked with Novartis for 9 years and joined as a Director of formulation development at Cubist Pharmaceuticals/Merck for 2.5 years. Currently Sudhakar is working as a Global head of Chemical and Pharmaceutical profiling (Discovery Pharmaceutics) and Disease Area Head (New Indications) at Novartis. His primary role is collaborate with research colleagues and build the right biopharmaceutical properties into new chemical entities, if not enable them via solubility/dissolution enhancement technologies to expedite molecules into tox and clinical studies. He is also responsible for enabling research, clinical and commercial molecules via novel delivery technologies (Brain targeting, permeability enhancement, TI improvement etc). He has many publications, book chapters and patents. In last 20 years of his career he has taken more than 200 new chemical entities in clinical studies across dozen disease areas ( CVM, Oncology, ATI, MS, Respiratory, NS, GI, Antibacterial, Tropical diseases, HCV etc), via oral, parenteral, inhalation and transdermal route of administration. He serves as a technical R and D expert to research Disease Area for hematology, hepatology and kidney disease area.

Bharathi Vellalore is a Pharmaceutical Scientist with >12 years of cross-functional research experience in discovery and development of cyclic peptides, small-proteins, antibody-based molecules and cell therapy products for diagnostic and therapeutic applications. Before joining Janssen Drug Product Development, he conducted postdoctoral research in the Saskatoon Translational Cancer Research Cluster and Janssen Biotherapeutics. Bharathi earned his MSc and PhD in Biochemistry from the University of Saskatchewan, Canada (2017) and BTech in Biotechnology from Anna University, India (2008).

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.