The Global Drug Delivery & Formulation Summit is grateful to the highly experienced scientists that make our scientific advisory board who offer their expertise to ensure only the most pertinent and validated topics are on the programme, promoting learning and exchange of ideas for all participants.
Director Medical Device Safety, Medical Device Safety Officer
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
Head of formulation and Process Development
Head of Process, Purification and Pharma Development
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
Dr. Stefan Bracht
Vice President Head of Disruptive Technologies
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.
Executive Director Competence Center, Global Device & Packaging Development (GDPD)
Corinna Sonderegger received her PhD in biochemistry and molecular biology at the University of Innsbruck/Austria in 1998. As a post-doc at The Scripps Research Institute in San Diego/California 1999-2002 she developed high-throughput cell-based drug-screening assays and performed cancer research applying virology and cell biology.
In 2002 she joined Novartis/Sandoz in Austria, developing cell culture derived drug substance processes. Among others Corinna was responsible for the development of Ilaris™ and Sandoz’s first biosimilar monoclonal antibody RituxanTM.
2010-2016 Corinna was leading the development of biosimilar drug products, especially sterile liquid formulations in syringes, as Head of Pharmaceutical Development. She was heavily involved in the development of the first biosimilar approved in US, Zarxio™.
2017-2020 Corinna was leading the Medical Device Portfolio Management organisation for parenteral drugs at Novartis, a global team of Project Leaders developing drug-device combination products like prefilled syringes and autoinjectors.
Since Jan. 2021 Corinna leads the Competence Center for Medical Devices, including Human Factors Evaluation team, Risk Mgmt & Control Strategy, Analytical Laboratories for functional testing, and driving new development approaches.
John D. Higgins
John received a BS in biochemistry from Albright College and his Ph.D. in synthetic organic chemistry from Brown University. After completing a Postdoctoral Fellowship at the Sloan-Kettering Cancer Institute in NYC in the departments of Positron Emission Tomography and Neurology, he joined the Medicinal Chemistry Discovery group at Johnson Matthey Biomedical. There he made several significant contributions to early research projects on new Pt- antitumor drugs and peptide-based diagnostic radio-imaging agents. After nearly a decade as a discovery med chemist, he moved on to drug development in positions of increasing responsibility at J&J and Sanofi-Aventis. He and his teams have specialized in the areas of drug delivery, solid state chemistry and biomaterials in relation to improving the bioperformance of therapeutic agents. Towards this end, he has led the successful implementation of a wide range of methodologies into drug discovery space including prodrug design for enhanced solubility/permeability, miniaturized polymeric amorphous dispersions and nanoparticle technologies.
John currently is Distinguished Scientist, Discovery Pharmaceutical Sciences department at Merck’s Discovery Center in South San Francisco. In this multidisciplinary role, he is responsible for oversight of the biopharmaceutical and drug delivery aspects of Merck’s discovery programs (small molecules, peptides, biologics) as well as the identification of new enabling technologies for burgeoning areas such as oral peptide and ophthalmic gene delivery. Over his over 32 year pharma career, he is co-inventor on 13 US Patents and author of numerous and diverse publications and book chapters in the fields of organic, solid state & medicinal chemistry and drug delivery.
John also currently serves as an Adjunct Associate Professor at the University of Pennsylvania School of Medicine, where he regularly teaches classes in various aspects of drug discovery and development.