Programme 2023

Over 20 years of experience in many facets of regulatory affairs, quality compliance and quality operations within the GxP regulated environment pertaining to Emerging Technologies and Combination Products.  Regularly provides AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs regarding CMC Global Dossiers/Global Device Regulatory Strategies, EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC), 21 CFR Part 3 and Part 4 - Combination Products, CE Marking, ISO 13485:2016/MDSAP, International Regulatory Affairs, Product Development - (Design Control, Risk Management and Human Factors Engineering), Acquisitions/Divestitures and represents AbbVie as the U.S Agent regarding FDA matters for international medical device facilities.

In addition, lectures at various symposia, is the Chairman of the DIA Combination Products Committee, chairs various global combination products conferences, participates in regulatory panel discussions within the industry and is an adjunct assistant professor at USC – School of Pharmacy - Regulatory Science Programs.

Patrick Stayton serves as the Distinguished Career Professor in the Department of Bioengineering at UW.  He is the founding Director of the UW Institute for Molecular Engineering and Sciences.  His group develops new targeted prodrugs and drug delivery systems for infectious disease and cancer therapeutics. Dr. Stayton has a strong interest in translating the group’s research, has been awarded many patents, and is a co-founder of several startup companies, including PhaseRx Inc. that developed RNA therapeutics. Dr. Stayton has been elected as a Fellow of the American Institute for Medical and Biological Engineering, and has been the recipient of the Clemson Award from the Society For Biomaterials and the CRS-Cygnus Recognition Award from the Controlled Release Society. He served as Co-Chair of the GRC on Drug Carriers in Medicine and Biology in 2010.  He has also been awarded the Faculty Innovator Award, and the Distinguished Teacher and Mentor Award.

Dr. Stefan Schneid is currently the Scientific Lead Parenterals and Science Fellow in the Drug Product Development department at Bayer AG. He is responsible for scientific and strategic advancement of formulation and process development for novel biological entities, small molecules and new modalities. He is involved in development projects from the preclinical stage up to transfer to commercial production. Previously, Stefan worked as a Laboratory Head in Bayer’s parenteral formulation development group. Prior to joining Bayer, he was a R&D manager at Syntacoll, where he was responsible for developing novel formulations for drug-containing biodegradable implants. Stefan 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 holds a degree in pharmacy from the University of Munich and a Ph.D. in pharmaceutics from the University of Erlangen.

Originally training as a pharmaceutical scientist, Louise has over 15 years’ experience in drug delivery & medical devices with a focus on device technical management and regulatory strategy for EU & FDA submissions.

Louise joined GSK in May 2020 and leads the Device team within CMC Regulatory with responsibility for global regulatory and advocacy strategy (Devices) across the GSK portfolio.

With a solid background in inhalation and parenteral ‘combination products’ from concept to market through previous experience working at Pfizer, Oval Medical Technologies, and Cambridge Design Partnership, among others, Louise has a proven track record in supporting successful device submissions for different device types and markets.

Thomas completed his doctorate on liquid crystalline polymers at the University of Ulm in 1993, where he then worked as a post-doctoral researcher. He joined Robert Bosch GmbH in 1995 and was responsible for new functional materials in the Corporate Research until 2003. From 2003 to 2016, he founded and managed the newly established Bosch Lab Systems unit for automation solutions in formulation development (High-Throughput Formulation Systems). Since 2009, he has been responsible for the Engineering Pharma Service department and now additionally the new OSD Customer Center, first at Robert Bosch Packaging Technology and now at Syntegon Technology.

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

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

Carsten Timpe, studied pharmacy at  Technical University in Braunschweig, completed his Ph.D. thesis at the Philipps University Marburg in pharmaceutical chemistry. After his Ph.D. he worked several years for Jenapharm/Schering AG as a group head, moved to Lilly Forschung in Hamburg until 2007 and entered then Novartis Pharma in Basel in 2007 in special drug delivery where he then became a senior fellow. He joined Hoffmann La Roche AG in Basel in 2013 as group head in the early phase formulation group and moved two years later to the late stage function where he was also involved in several filings. Carsten got promoted to technical R&D expert scientist in 2014 and chaired until 2022 the paediatric/geriatric formulation working group at Roche. Since January 2023 he works as consultant for NGT BioPharma and for the EuPFI.

Dr. Nitin Joshi is an Assistant Professor at Harvard Medical School and an Associate Bioengineer in the Department of Anesthesiology, Perioperative 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. His lab works at the interface of chemistry, material science, biology, and medicine, to develop translatable technologies for solving medical problems across a wide range of diseases. Technologies developed by him have resulted in several 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. He is also a co-founder of Akita Biosciences, a biotech company that aims to advance a nasal spray technology developed in Dr. Joshi’s lab. He also serves as a consultant for multiple biotech companies.

Analytical project lead and research scientist in the Characterization, Formulation and Bioinformatics Team supporting the developability assessment of NBEs. Holds a master`s degree in Pharmaceutical Biotechnology from the University Ulm/Biberach, 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 20 years of experience in GMP relevant sourcing and marketing activities of pharmaceutical raw materials.

Process Engineer from GSK working on CDC mini-blend technology. Prior academic experience in the field of chemical engineering from the University of Cambridge and Massachusetts Institute of Technology.

Mark is responsible for the Health Solutions within Respiratory Digital Health at TEVA Pharmaceuticals. Over fourteen years with TEVA and prior to that sixteen with AstraZeneca. Mark has held various positions including R&D Project Leader, VP Sales & Marketing, Strategic Planning & Business Development, and Global Brand Lead. Graduated in Aeronautical Sciences and completed his MBA at Durham University, UK. During his career he has led technology & especially inhaler development teams through engineering, CMC characterisation, clinical evidence generation, registration within US, EU and International Markets and ultimately to successful global launch. Total Brand Leadership value >$2.5bn. Mark has numerous patents granted and pending in electronic communications, sports technologies, inhaled pharmaceutical development, and respiratory physiological function & predictive AI. Mark is the inventor of Digihaler®, the first FDA approved digital inhaler with built-in sensors.

Nikolai Lorenzen has worked with biophysics and formulation of biopharmaceuticals in the research organization of Novo Nordisk for + 8 years both as a specialist and leader. Nikolai received his education within protein biophysics by first taking a MSc degree partly in a Peptide & Protein Chemistry at Stockholm University, Sweden, and partly at the Interdisciplinary Nanoscience Centre at Aarhus University, Denmark. Nikolai then did his PhD studies in the research group of Professor Daniel Otzen, at Aarhus University, where he worked with protein aggregation and misfolding.

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.

Tonio is an industrial engineer with degrees from Ecole Centrale de Lyon, Lyon (France) and Darmstadt (Germany) University of Technology.

Within Device and Packaging Development at F. Hoffmann – La Roche Basel he has been working in the Device Engineering group since 2017. Besides his work as Device Team Leader and Device Engineer for Small Molecule and Smart Device projects he is the Device SPOC for sustainability. Prior to joining Roche Tonio worked within the Device Industrialization Department of Sanofi, Frankfurt (Germany).

Tatiana Marcozzi is a senior scientist in the drug product oral solid development team at Janssen Pharmaceutica. After graduating master of science in Pharmaceutical Chemistry and technology at the University of Bologna (Italy) she started working as a junior technology transfer lead, before moving into ReD. Concurrently with her job, Tatiana is doing her industrial PhD in pharmaceutical technology, in collaboration with UGent (Belgium).

Dr. Eoin O'Cearbhaill, BE, PhD, is an Associate Professor in Biomedical Engineering at the UCD School of Mechanical & Materials Engineering. Prior to joining UCD, Dr. O'Cearbhaill was a Postdoctoral Fellow at Harvard Medical School (Harvard-MIT Health Sciences & Technology Division; Dept. of Medicine, Brigham & Women's Hospital), where his research focused on the conception and development of medical devices and the delivery of next generation therapeutics, in the laboratory of Prof. Jeffrey Karp. Based on his development of a mechanical clutch needle, designed to prevent through-puncture injuries, Dr O'Cearbhaill was awarded 1st prize at the MIT Sloan BioInnovations 2012 conference. He was also part of the team that received the Institution of Chemical Engineers' Innovative Product of the Year Award 2013 for their work on developing a bio-inspired microneedle adhesive. Dr O'Cearbhaill obtained his BE (Biomedical) and PhD from NUI Galway. His doctorate focused on applying mechanical stimulation to MSCs for vascular tissue engineering applications. Subsequently, he worked for Veryan Medical, before joining Creganna-Tactx, where he worked in both manufacturing and design service roles, helping to establish their Specialty Needles Division in Marlborough, MA. Dr O'Cearbhaill's interests include: 3D Printing of Medical Devices; Medical Device Innovation, Design and Commercialisation, including minimally invasive devices and delivery systems.

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
 

Nélio Drumond is a PharmD by training with a PhD in Patient Centric Drug Product Design. He shares several years of experience in the Pharmaceutical Industry, providing scientific leadership to govern formulation and manufacturing strategies for drug product development programs during clinical stages, including their scalability and validation for commercial use. Nélio has spent the last 2 years overseeing Takeda’s external commercial manufacturing portfolio within the EMEA region and has recently joined the Global Manufacturing Sciences group in Cambridge, MA to support launch and commercialization of promising NCE’s from clinical programs. Dr. Drumond is a strong advocate for patient centric drug product design and is regularly invited to speak at various international conferences.

Since joining AstraZeneca in 2017, Kristina has focused on developing novel lipid nanoparticle (LNP) formulations for nucleotide-based therapeutics delivery and the optimization of the process from lipid synthesis to preclinical testing. In addition to this she has led an AZ interdisciplinary collaboration to create an LNP formulation that can be spray dried for functional and safe delivery of mRNA to the lungs.

Camille Dagallier is a Lab head, Senior Formulation Scientist and drug product development specialist at Sanofi, where she joined in 2015. She graduated from ESPCI in Paris, earned a master in polymer science and holds a PhD in colloid physics from the University of Fribourg, Switzerland, where she collaborated with the team of Pr. Peter Schurtenberger. She performed postdoctoral research at Stanford University with Pr. Gerald Fuller on interfaces. Empowered by scientific challenges, she strongly believes that understanding and rationalization are keys for powerful and efficient formulation and drug product development.

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

Dr Shahid Uddin is currently Head of Drug Product, Formulation & Stability within the CMC department at Immunocore.   His team is responsible for bringing research candidates into clinic and commercialisation.  Technology is focussed around developing ImmTAC® as therapeutic agents for different disease models. Prior to this he held the position of Head of Formulation at MedImmune (AstraZeneca) where he supported the biologics portfolio covering Monoclonal antibodies, Peptides, bispecifics

Felix is a pharmacist by training with a PhD in pharmacology. In 2006, he joined Boehringer Ingelheim as a trainee, focusing on launch and transfer activities of inhalative products. He took over different roles at BI microParts for development of inhalation devices as QA Head, senior project manager and lab head for design engineering. In 2010, he joined the Ger­resheimer Group as a QC head and later on quality director for large-scale manufacturing of sterile primary packaging components, i.e.RTF®- syringes and insulin cartridges. In 2015, he returned to Boehringer Ingelheim to implement structures for life cycle management of the Respimat® Plat­form Technology, including ownership of design history files for existing products and launching the new Respimat Reusable® in Europe in 2018. Currently he is the director of Device Technology in operations. He is responsible for a matrix organization that includes project management, design verification laboratories, clinical trial supply, design engineering, design control, process technology and data science approaches for life cycle of devices in operations.

Dr. Ajay Khopade is a Vice President R&D and Heading non-oral speciality division at Sun Pharmaceutical Industries Ltd (SPIL). With over 25 years of experience in pharmaceutical product development, in his current role as VP-R&D, is responsible for development of SPILs complex generic and differentiated product development and product life-cycle management. Dr. Khopade has extensive end-to-end (ideation-technology development-preclinical POC-clinical-commercial) development experience across multiple therapeutic areas in novel parenteral dosage forms. He has participated as CMC expert in the submission of number of INDs, NDAs and technology evaluation for in-licensing opportunities. He is an inventor of a platform nanotechnology in the field of oncology (Nanotecton®), ophthalmics (GFR®, SMM® Trisurf® and TearAct®), liposome and depot injections protected by various IPs globally with over a dozen patents. Most of these technologies have endured clinical tests to reach into the market. Dr. Khopade has been a Humboldt post-doctoral fellow at Max Plank institute of Colloids and Interfaces, Germany. He holds a Ph.D. degree in Pharmaceutical Sciences from the University of Sagar, MP, India. His areas of interest are understanding physical chemistry of drug delivery system design.

Professor Dimitrios Lamprou (Ph.D., MBA) is Full Professor (Chair) of Biofabrication and Advanced Manufacturing and Director at MSc Industrial Pharmaceutics at Queen’s University Belfast. He is also the Chair at United Kingdom and Ireland Controlled Release Society (UKICRS) and the Chair of the Academy of Pharmaceutical Sciences (APS) Emerging Technologies Focus Group. Dimitrios, is the author of over 140 peer-reviewed publications, has over 350 conference abstracts, has given over 140 Invited Talks in institutions and conferences across the world, and has secure Funding in excess of £2.5M. Dimitrios, has been recognised as world leader in Printing with PubMed-based algorithms placed him in the top 0.047% of scholars in the world writing about Printing in the last 10 years. Moreover, PubMed-based algorithms placed him in the top 0.51% of scholars in the world writing about microfluidics. Dimitrios, has also been named in the Stanford University’s list 2021 & 2022 of World’s Top 2% Scientists, for his research in Pharmaceutics and Biomedical Engineering. For more info, please visit our lab website at www.emergingtechnologieslab.com.

Petrick is a chemical engineer by education, who obtained his Bachelor’s and Master’s degree at the Karlsruhe Institute of Technology (KIT), Germany. During his studies where he focussed on thermal and mechanical Process Engineering, he gained first experience in the Pharma environment as an intern and master student in the Pharmaceutical Development Department at Roche in Basel. In 2018  he joined the Device and Packaging Development team, where he was working in several roles as Verification Engineer, Device Team Leader and Pre-fillable Syringe Engineer. In all mentioned roles, he was mainly focusing on Ophthalmic products.

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 21 years, John has worked for Schrödinger, LLC, as a scientific software developer and a research scientist, managing a number of products including the Materials Science Coarse-Grained product.

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.

Carsten Timpe, studied pharmacy at  Technical University in Braunschweig, completed his Ph.D. thesis at the Philipps University Marburg in pharmaceutical chemistry. After his Ph.D. he worked several years for Jenapharm/Schering AG as a group head, moved to Lilly Forschung in Hamburg until 2007 and entered then Novartis Pharma in Basel in 2007 in special drug delivery where he then became a senior fellow. He joined Hoffmann La Roche AG in Basel in 2013 as group head in the early phase formulation group and moved two years later to the late stage function where he was also involved in several filings. Carsten got promoted to technical R&D expert scientist in 2014 and chaired until 2022 the paediatric/geriatric formulation working group at Roche. Since January 2023 he works as consultant for NGT BioPharma and for the EuPFI.