Speakers 2019

Dr. Alan S. Harris serves as Senior Vice President of Global Life Cycle Management and the BRIC labs of Ferring Pharmaceuticals SA. He is also responsible for the BRIC labs in Brazil, Russia, India and China as well as Ferring's Development Labs in the US. Alan joined Ferring in 1984. Dr. Harris has a Ph.D in biopharmaceutics from Uppsala University, Sweden and an MBA from Ashridge, UK.

Alessandro Fioni earned his PhD in Medicinal Chemistry and Technology at the Pharmaceutical Department of the University of Parma (Italy), where he was mainly involved in the evaluation of structure-property (QSPR) and structure-activity (QSAR) relationships of new covalent enzyme inhibitors. During the PhD course, he also run MetID studies at the Medical Mass Spectrometry Department of the Uppsala University (Sweden). He started his career at the Pharmacokinetics, Biochemistry and Metabolism Department of Chiesi Farmaceutici S.p.A. (Parma, Italy) in 2009, where he is currently working as Senior Scientist. Alessandro is a DMPK team member in the discovery project teams and he is involved in the evaluation of novel technologies and formulations for inhalation administration in preclinical studies.

Anacelia Ríos Quiroz did her University studies as Industrial Pharmaceutical Chemist in the Polytechnic National Institute (IPN) of Mexico City. Afterwards, she did her Master studies in Pharmacology in the Centre of Research and Advanced Studies (CINVESTAV-Mexico City) on the field of Bioinorganic Chemistry. In 2012, she started her PhD studies in Pharmaceutical Technology in collaboration with Basel University and F. Hoffmann-La Roche Ltd., in Switzerland. She worked in the field of sub visible protein particles and has become an expert on particle counting characterization techniques. Her research increased the understanding on the applicability of emerging technologies as analytical tools for the pharmaceutical industry and serve as guideline for the implementation of related analytical methods and quality control strategies. After a Post Doc in the field of evaluation of the immunogenicity of protein particles, she joined in January 2016 the Analytical Department of Roche where she leads the Particle Lab unit.

Anand Subramony is Vice President of Novel Product Technologies at MedImmune, the global biological arm of AstraZeneca. In this role, Anand heads the function from the CTO office and oversees efforts for creating patient centric products that rely on the principles of digital health, connected devices and other novel technologies including breathomics, sensors, wearables and novel diagnostics towards enabling improved patient outcome. Before his current role, Anand headed the drug delivery and device development at Medimmune and was Principal Fellow and Head of the Novel Delivery Technologies & Therapeutics within Development at the Novartis Institute for BioMedical Research where he established and managed a high performing cross functional team. In prior roles, Anand led the Materials Science function of the Biomedical Engineering group at Alza /J&J, and was Director of Materials Science & Drug delivery at Dr. Reddy’s Laboratories With his broad experience in pharma biotech, Anand brings in innovation and scientific rigor coupled with execution excellence and sense of urgency towards product development. Anand has over 25 refereed publications and several patents in the areas of drug delivery. Anand holds an MS in Materials Sc. Engineering from IIT Bombay and PhD from Purdue University

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).

Ben Van Hove is currently Associate director Oral Solid Dosage Forms at Janssen Pharmaceutica NV, heading a team of formulation/process scientist responsible for the development of solid formulations for small molecules in the clinical stage. After completing his Master in Pharmaceutical sciences, and an additional master in Industrial Pharmaceutical Sciences at the Catholic University of Leuven, Belgium in 2001, he joined Janssen Pharmaceutica NV. He has currently 18 years of experience within the Janssen Pharmaceutical Sciences and Manufacturing Organization, responsible for the CMC activities for both the early as the late stage clinical programs. He delivered major contributions in the CMC development activities of the following commercialized programs: Yondelis IV (oncology), Zytiga tablets (oncology), Nucynta IR and ER tablets with tamper resistant properties (pain medication, Ceftobiprole (antibiotic) and he is managing multiple programs in the clinical stage.

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 Sandoz Biopharmaceuticals, being responsible for cell culture derived drug substance upstream process development including QbD process characterization and process validation concepts. Among others Corinna was responsible for the development of the cell culture process of Ilaris™ and Sandoz’s first biosimilar monoclonal antibody RituxanTM. 2010-2016 Corinna was leading the development of biosimilar drug products at Sandoz in Austria as Head of Pharmaceutical Development. She was heavily involved in the drug product development of the first biosimilar approved in US, Zarxio™, as well as of Erelzi™ and HyrimozTM. Since 2017 Corinna is heading the Medical Device Portfolio Management organisation for biopharmaceuticals at Novartis, covering a broad set of injection and alternative delivery systems for protein delivery as well as cell & gene therapy drugs.

Carsten Timpe, completed his Ph.D. thesis at the Philipps University Marburg/Germany in Pharmaceutical Chemistry. He joined Hoffmann La Roche AG in Basel in 2013 as group head in early drug development with 20 years of experience in solid dosage form development from early to late stages (at Novartis, Lilly, Schering/Jenapharm), made a job rotation to the process development section where he had responsibility for the galenical part of the AlecensaTM project. He got promoted to “Expert Scientist” in 2014 and has chaired several years the pediatric/geriatric formulation working group (PG-FWG) at Roche until now. As inventor/co-inventor of international formulation patents and author/co-author of several papers he has been invited speaker to several drug delivery conferences in Europe. He is an active in organizing seminars as a member of APV focus group “Drug Delivery”.

Martin Huelsmeyer is chemist by training and received his PhD in Structural Biology from Technical University Braunschweig, Germany. Martin started his career in academia working in Berlin at Free University and University Hospital Charité on the structural characterization of receptors implicated in autoimmune diseases. He then moved to Munich to work for biotech company Pieris discovering and developing scaffold molecules. In 2012, Martin joined Abbvie as Section Manager NBE QC Analytics. Since 2014 he is part of the Formulation development team establishing Abbvie’s robotized NBE High Throughput Formulation platform. His main responsibilities are the development of screening concepts, novel HTS analytics and operating the HTS line.

Pharmacist by training and PhD in Advanced drug delivery systems 3.5 years worked as Research Scientst at Pantec Biosolutions, Geneva Switzerland (March 2007-June 2010) Around 4 years worked as Formulation Manager at Debiopharm Group, Lausanne, Switzerland (August 2010-Feb 2014) From last 4.5 years working as Associate Director at AiCuris Anti-infective Cures GmbH, Germany Around 12 years of experience in Europe as Team Leader/Project Manager for the preformulation, formulation development of small molecules and/ or Peptides for oral, dermal and parenteral application (for small molecules and large molecules) Experience mainly includes – Development and outsourcing preformulation and formulation development of oral, topical and parenteral dosage forms for new drugs More than 17 international publications, 6 European patents and over 30 conference proceedings

Gerhard Wenz studied Chemistry from 1972 to 1979 at the Universities of Mainz and Freiburg. He received his Ph. D. in 1984 for research with Gerhard Wegner in Freiburg on the topochemical polymerization of diacetylenes. He spent another year in Freiburg at the Hermann Staudinger Institute working about discotic liquid crystalline polymers. From 1985 to 1986 he worked as a postdoc with Donald J. Cram (Nobel Prize in Chemistry1987) at the University of California in Los Angeles (UCLA) and synthesized a model for the enzyme chymotrypsin. In 1986 he moved to the Max-Planck-Institute of Polymer Research in Mainz and finished there in1993 his habilitation and accepted a position as a Professor of Macromolecular Chemistry in Karlsruhe. In the year 2000 he became full Professor of Organic Macromolecular Chemistry at the Saarland University in Saarbrücken, Germany. He chaired several collaborative research projects devoted to the utilization of bio-renewable materials, such as cellulose, starch and cyclodextrins. His research focuses on the design of programmable supramolecular structures based on polymers and carbohydrates, which are applicable for drug delivery.

Jacqueline Maximilien joined Johnson & Johnson in 2016 as a Senior Scientist in the oral dosage formulation group. Her responsibilities include development of oral solid formulations from early development through to commercial transfer. Jacqueline has been a key contributor in a multidisciplinary team tackling control strategy design and implementation at Johnson & Johnson Beerse, Belgium campus. She holds a Marie Curie funded PhD in Bionanotechnology from the Compiègne University of Technology (Sorbonne Universités).

James Meehan, Associate Principal Scientist within the AstraZeneca Device Development, holds a BEng in Medical Mechanical Engineering and an MSc in Ergonomics (Human Factors). James provides specialist Human Factors support to development and on market products. This includes leading and designing human factors programs for products, managing external vendors and reviewing/ updating AstraZeneca’s internal human factors processes.

After his Ph.D. in organic chemistry in 1990 at University of Southern Denmark and stay in the group of Professor Barry Trost at Standford University in California, he joined Health Care Discovery at Novo Nordisk. Jesper Lau has 26 years’ experience in pharmaceutical discovery and holds a broad knowledge in small molecule based therapeutics as well as a comprehensive know-how within protein engineering especially within diabetes care with particular interest in glucagon like peptide 1 (GLP-1). He was project manager for once weekly GLP-1 and inventor of semaglutide. In addition to project management Jesper Lau has been line manager since 1995 and was in 2008 appointed Vice President of Protein and Peptide Chemistry with a staff of about 75 researchers. He was promoted to adjunct professor at Fudan University in Shanghai 2016.

Prof. Johannes G. Khinast (male, 1964) is the head of the Institute for Process and Particle Engineering (http://ippt.tugraz.at/) at the Graz University of Technology and the scientific director of the Research Center Pharmaceutical Engineering (http://www.rcpe.at/). He received his Ph.D. in the area of particle technology in 1995 from the Graz University of Technology in 1995. He was then a post doctoral fellow at the University of Houston with Prof. Dan Luss. In 1998 Prof. Khinast joined Rutgers University (New Jersey, USA) as an assistant professor, where he was granted early tenure in 2003. During his period at Rutgers University Prof. Khinast received several important awards, including the Bristol-Myers Squibb Young Faculty Development Award (1999), the DuPont Young Professor Award (2000), the North American Mixing Forum Award (2000) and finally in 2001 the prestigious NSF CAREER Award. In 2005 Prof. Khinast was selected as a Marie Curie Chair of the EU, and in 2006 he was offered a professorship at the Graz University of Technology. Prof. Khinast has received significant funding for his work in process simulation, pharmaceutical process engineering and particle technology in the order of more than 30 million Euros in the last 5 years from various sources. He also has worked with a large number of pharmaceutical and equipment companies and serves an advisor for the implementation of novel technology. He has supervised more than 40 Ph.D. students and PostDocs and his publication record encompasses over 200 peer-reviewed publications and many other publications and book chapters. He also holds several patents in the area of pharmaceutical manufacturing.

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

Marc-Antoine Fabre is the Global Head of Biopharmacy in the PSO/PDP department. He graduated from a top French Engineering School in Scientific Computing at ENSHEEIT (Toulouse). He got his first experience in Modeling and Simulation (M&S) at Vatech Hydro, Vevey, Switzerland, and he improved his skills in M&S in Belgium at IMEC, where he developed, and optimized models and put forward solutions for marketing purpose. Willing to apply his competences in pharmacometrics, he went back to the University for a one-year training in pharmacokinetics (Marseilles) and attended the basic pharmacokinetics workshop of University of Manchester (Arosa, Switzerland) to understand underlying physiological processes. Since 2004, he was a junior consultant in Clinical Pharmacology&Pharmacometrics at EMF Consulting, and became a Senior Consultant in 2007. During this time he ensured state‑of‑the‑art of M&S from early to late phase in clinical development programs in different therapeutic areas such as CNS, R&I, and oncology. From 2010 to end 2015 he joined AstraZeneca, where he was one of the lead pharmacometricians. In this job, he was a representative in the IMI, DDMORE European consortium and did also contribute to support successful submission of two Oncology compounds.

Remy Vomscheid, Ph.D. has been working in the healthcare industry for the last 15 years. He coached biotech start-ups as Business Developer for Genopole, the biggest French Incubator dedicated to Life Sciences. After this, he joined Johnson & Johnson as Business Development Manager, Medical Devices & Diagnostics, EMEA and later moved to a commercial position as Regional Business Manager for LifeScan, the diabetes diagnostics franchise of J&J. Then, he led the technical development of connected & automated medical devices at Eveon, as Director of Development. As Director, Devices Development & Technologies, he currently leads the development of innovative devices at Ipsen.

Sachin Dubey is presently working with Glenmark Pharmaceuticals, Switzerland, where he is heading formulation, analytical and drug product development unit. His current responsibilities includes designing and executing product development and characterization strategies for both early and late stage products for Glenmark Biologics. Sachin earned his PhD from the University of Geneva, Switzerland and has previously worked with Novozymes Biopharma, Denmark. He has ~ 12 year of experience in biopharmaceutical formulation and analysis. His principal research interests are protein formulation, stabilization, combinational product development, analytical characterization, DOE and QbD. He also has a keen interest in practicing lean principles. He has received multiple research awards and has several publications and presentations to his credit.

Samuel Kyeremateng is a Senior Scientist in the Global Pharmaceutical Sciences Division at AbbVie Deutschland in Ludwigshafen. His research activities focus on scientific advances in the understanding of amorphous molecular solids, and development and application of models in predicting with confidence the preferred composition, manufacturing process, and stability of amorphous solid dispersion (ASD) formulations. His current responsibilities at AbbVie Deutschland include leading of the Material Science Group that supports formulation development, and mentoring doctorate research students and other scientists within the company. Samuel received his doctorate in Polymer Science in 2010 from Martin-Luther-Universität in Germany.

Dr Stephanie Greco has a PhD and a engineer diploma in physico-chemistry. She has been working for Sanofi since 2003, firstly in physical characterization of small molecules and since 10 years in process development of injectable Drug Product. She is now more specialized in the scale-up and industrial transfer biologics Drug Product.

Prof. Dr. Sven Stegemann is director, pharmaceutical business development at Capsugel, and professor of patient centric drug design and manufacturing at the Graz University of Technology, Austria. Over the course of his 21-year career at Capsugel, Dr. Stegemann has worked as an advisor to major pharmaceutical companies on ways to improve the design, development and manufacture of pharmaceutical products so they better address the individual needs of patients. In his academic role, Dr. Stegemann’s focuses his research on the rational development of patient centric drug products and their associated manufacturing technologies, as well as education and training of students and young scientists. Dr. Stegemann is the founder and chair of the AAPS Focus Group on Patient-Centric Drug Development, Product Design, and Manufacturing as well as the founder and President of the Geriatric Medicine Society e.V.. He recently started the industrial-academic collaboration partnership Patient Centric Medicine (PaCeMe) to suitable and meaningful guidance for patient centric drug product design. He is the editor of the book “Developing Drug Products in an Aging Society - From Concept to Prescribing”, a multidisciplinary approach towards patient centric drug development for the older and multimorbid patient populations.

Thomas Hoeg-Jensen has 23 years of experience in design and preparation of diabetes-related peptide and protein drug candidates, and Thomas is co-inventor of insulin degludec (Tresiba) and the basal-bolus co-formulation with insulin aspart (Ryzodeg), both of which are marketed by Novo Nordisk. Thomas is adjunct professor at University of Copenhagen, and apart from drug discovery his research has included novel protein conjugation methods, glucose binding molecules and chemoinformatics systems for chemically modified proteins.

Tim joined Chiesi in 2011 as a senior scientist. He holds a B.Sc. in Biological Sciences (2003) from the University of Lancaster and is currently undertaking a Chiesi sponsored part-time PhD at the University of Bath under Prof Robert Price. Tim began his career in respiratory therapy in 2004 and he has worked for a number of prominent companies involved with inhaled drug delivery including Sanofi-Aventis, Vectura and Novartis. During this time, he has been involved in solid state characterization, analytical development and validation and formulation design projects, primarily for Phase I clinical studies. Tim is a co-inventor of 2 Chiesi patents relating to particle engineering.

Following his PhD at Imperial College London, Graham was a NATO fellow at Harvard University where he worked with Nobel Laureate E. J. Corey. His subsequent independent academic career spanned 25 years and generated >$100 million external funding and 160 peer reviewed publications in the fields of drug discovery, drug delivery, process technology, regulatory science and medical devices. He held a number of leadership roles in the academy including pro-vice chancellor, vice provost and institute director, most recently Director of Translational Research at the Tufts Clinical and Translational Science Institute (CTSI) in Boston MA. In September 2018 Graham joined Novartis AG as Director of Innovation in the Technical Research and Development group with a specific emphasis on growing capabilities in digital medicine. Graham has been a regular consultant to the pharmaceutical and biotechnology industry and was an advisor to the FDA in the development of the biosimilars approval pathway. He has also been instrumental in establishing and advising a number of technology based startup companies who have subsequently raised >$4B in venture funding. Graham sits on several advisory and editorial boards and has been the recipient of numerous awards for scientific and technology development. He was awarded the DSc in 2006 for contributions to medicinal chemistry.

Passionate and experienced leader in Pharmaceutical and Biopharmaceutical development. Experienced in all phases of CMC development for small molecules, with emphasis on bioavailability enhancement via solid dispersions, lipid based systems and nanoparticles of poorly soluble drugs, and controlled release. Biopharma experience in Upstream and Formulation Stability of mABs. Established and ran three new R&D sites: Pharmaceutical Sciences, Searle, St Louis, Missouri, USA, , Pharmaceutical Sciences, Abbott-Abbvie, Singapore, Pharmaceutical Sciences with full processing and analytical capabilities, and Biopharma with Upstream and Downstream processes, CHO cells, and Fill Finish capabilities, Roquette, Singapore. Hands-on experience with several successfully launched commercial products. Published over 35 manuscripts in peer review journals, more than 40 abstracts, more than 10 patents, and 3 book chapters. Invited speakers at several US, International Conferences, and Symposium. Adjunct Professor at University of Connecticut, USA and National University of Singapore, Singapore. Readily synchronizes business needs with creative, economic and speedy solutions. Develops excellent networks and relationships with peers and management. . Specialties: Pharma and Biopharma, technical and people management, Development with quality, speed and economy using Roquette Solutions in Pharma and Biopharma.