Speaker Bios: Oral Delivery of Peptides, Oligonucleotides and Proteins-Virtual Symposium

Dr. Filippos Kesisoglou, MSc, PhD

Filippos Kesisoglou is a Distinguished Scientist at Merck & Co., Inc., (Rahway, NJ) where he is currently leading the Biopharmaceutics efforts in the Pharmaceutical Sciences department. Filippos has more than 18 years of experience in the fields of biopharmaceutics and formulation development, pharmacokinetics, PBPK and IVIVC modeling as related to clinical, drug product development and CMC regulatory applications across modalities including oral peptide delivery. He has been a key contributor to several new drug applications. He has authored/co-authored 90 manuscripts/book chapters and more than 80 conference abstracts/podium presentations in several national/international meetings in the fields of biopharmaceutics, PBPK modeling, formulation development and drug delivery. Filippos has been involved over the years in several cross-industry and academia consortia. He is currently serving as an Editor for Journal of Pharmaceutical Sciences and on the Editorial Advisory Board for the AAPS Journal and Pharmaceutical Research. In 2017 he was elected a Fellow of the American Association of Pharmaceutical Scientists (AAPS).

 

Dr. Liping Zhou, PhD

Dr. Liping Zhou is currently a senior director at AstraZeneca Boston R&D center. She is heading the Advanced Drug Delivery – Boston team, developing preclinical and clinical formulations supporting AstraZeneca internal synthetic modality pipeline projects. Dr. Zhou has 20+ years of post-PhD technical and managerial experience in research and development functions in the biotechnology/pharmaceutical industry. She has diversified expertise especially in pre formulation, formulation development and drug delivery technologies focusing on small molecules, peptides, and nucleic acids. She has been actively involved in preclinical and clinical programs, life-cycle management and due diligence projects in multiple therapeutical areas as well as efficiently and strategically managing external collaborations in the US, Europe and Asia. Dr. Zhou’s previous employment includes but not limited to Novartis, Ipsen, and Ra Pharmaceuticals (now UCB). She co-authored more than 20 scientific publications in the leading biomedical journals and book chapters. Dr. Zhou received her Ph.D. degree in Chemistry from University of Connecticut and her bachelor’s degree from Peking University.

 

Dr. Manuel Sanchez-Felix, PhD

Dr. Manuel Sanchez-Felix is the VP of the Drug Delivery Search & Evaluation Group at Halozyme. He is a scientific leader with over 20 years of experience in drug discovery and development where he co-invented products and contributed to the successful development and launch of various patient centric pharmaceutical products.  

Previously he was at Novartis where he led a cross-functional group from Discovery and Development that have evaluated and implemented external Novel Delivery Technologies for many different types of modalities. He is also part of initiatives designed to promote innovation within Novartis. His previous position at Novartis involved heading a group of scientists at the interface between Research and Development, establishing physicochemical and biopharmaceutical properties, and combining this information to initiate development strategy and formulation design. Prior to joining Novartis, Manuel was at Eli Lilly & Company for 20 years. 

His area of expertise includes Biopharmaceutics, drug delivery and patient-centered formulation design. Areas of drug discovery where he has developed products include CNS, infectious diseases (specifically TB), oncology, regenerative, cardiovascular and metabolic diseases. 

Dr. Sanchez-Felix received his B.Sc. Honors degree and Ph.D in Chemistry from the University of Surrey, UK. He is also an Adjunct Professor in the Department of Industrial and Physical Pharmacy at Purdue University (West Lafayette, IN) and a Fellow of the Royal Society of Chemistry. Recently, he has joined the Advisory Board for the Biomedical Program at Middlesex Community College.

 

Dr. David Brayden

David Brayden is a Full Professor (Advanced Drug Delivery) at University College Dublin (UCD) and the UCD Conway Institute of Biotechnology. Following a Ph.D. in Pharmacology at the University of Cambridge, UK (1989), and a post-doctoral research fellowship at Stanford University, David joined Elan Biotechnology Research in 2001 and managed of several of Elan's Joint-Venture collaborations with biotech companies. In 2001, he joined UCD and was appointed Full Professor in 2014.  He is currently a Co-Lead Investigator in “CURAM”, Science Foundation Ireland’s Centre for Medical Devices (www.curamdevices.ie ) and is Coordinator of the Horizon Europe “BUCCAL-PEP consortium (https://buccal-pep.eu/). David is a Fellow of the CRS and of the AAPS and is the Chief Editor of Frontiers in Drug Delivery.  In 2021, he was appointed to Ireland’s National Research Ethics Committee (Clinical Trials A).  https://people.ucd.ie/david.brayden 

 

Dr. Vipul Yadav

Dr. Yadav joined Intract in 2016 as Director of R&D where he was leading the development of a new oral biologics delivery platform in immuno-inflammatory diseases. He has been Intract’s Chief Executive Officer since 2022.  Prior to joining Intract, he spent 6 years at University College London researching basic mechanisms of enzymatic degradation and tissue transcytosis of peptide and antibody therapeutics across the different segments of the GI tract. He received his Master of Science in Drug Delivery at The School of Pharmacy, University of London, and a Ph.D. in Drug Delivery from University College London.

 

Dr. Karthik Nagapudi

Karthik Nagapudi got his PhD degree in polymer science from Georgia Institute of Technology in 1999 under the supervision of Dr. Haskell Beckham.  He did his postdoctoral work in the lab of Dr. Elliot Chaikof in Emory University.  After his postdoctoral work, he joined Merck Research Labs in the physical measurements group in January of 2003.  In 2006 he moved to the preformulation group in Amgen Inc.  In 2011 he became the head of the solid-state group in Amgen.  In July of 2014, he moved to Genentech  as a senior scientist in the Small Molecule Pharmaceutics group.  He was promoted to Distinguished Scientist in 2018 and to Executive Director in 2023.  He is currently the group head for the synthetic molecule pharmaceutics group in Genentech.  His primary research interests are in the areas of Drug delivery technologies, Biopharmaceutics, Mechanochemistry, application of advanced solid-state NMR methods in pharmaceutical analysis, and understanding thermodynamics of phase behavior in pharmaceuticals.  He has published over 90 papers and has 8 patents to his name.

 

Dr. John Gleeson

Dr. John Gleeson is an Associate Principal Scientist in Merck’s Pharmaceutical Science and Clinical Supply division. At Merck, John supports the pre-clinical to clinical formulation development of both small molecule and peptide programs. John leads efforts on intestinal permeability models and IVIVC. John earned his PhD in Drug Delivery from University College Dublin under the supervision of Prof. David Brayden. He carried out Postdoctoral research in “Gut-on-a-Chip” at Cedars-Sinai Medical Center, and pediatric oral drug delivery at Carnegie Mellon University with Prof. Kathryn Whitehead. He has authored/co-authored over 20 manuscripts in the field of oral drug delivery with over 800 citations.

 

Dr. Thomas Von Erlach, PhD

Thomas von Erlach, PhD co-founded Vivtex and joined as its Chief Scientific Officer when Vivtex was formed as a MIT spin-off in 2018. Prior to that he led the interdisciplinary efforts around gastrointestinal model systems for oral drug delivery applications at the Laboratory of Prof. Robert Langer and Prof. Giovanni Traverso at MIT. Dr von Erlach obtained his PhD from Imperial College London in Bioengineering and a BSc and MSc in Biochemistry and Biotechnology from ETH Zurich in Switzerland. His research interest include advanced in vitro models for drug development, oral drug delivery and gastrointestinal pharmacology. His work is published in several high impact journals such as Nature Materials, Nature Biomedical Engineering, and Nature Communications.

 

Dr. Sharat Singh, PhD

Sharat Singh brings over 25 years of experience as a dynamic and innovative scientific leader to his role at Biora Therapeutics, where he is focused on development of the company’s ingestible drug-device combination product candidates.

Dr. Singh previously held scientific leadership roles at Aclara Biosciences, Prometheus Laboratories, and Nestle Health Sciences, where he established partnerships with leading biotech/pharmaceutical companies and conducted multiple phase I/II clinical trials in both oncology and gastrointestinal disease.

Dr. Singh is the key inventor of multiple platform technologies (CEER, ANSER, eTag, and LOCI) and has authored over 100 patents. In his academic career, Sharat conducted inter-disciplinary research as a postdoctoral fellow at Columbia University. He holds a PhD in Chemistry from IISc, Bangalore, and has authored over 100 manuscripts and presentations

 

Dr. Puneet Tyagi, PhD

Puneet Tyagi is an Associate Director with the Dosage Form Design and Development group at AstraZeneca, based in Maryland, USA. Puneet leads a team of scientists in the area of biologics formulation development, with a focus on long-acting formulations, transdermal delivery, and oral delivery of biologics. Puneet received his bachelor’s and master’s degrees in pharmaceutical sciences from India, and his PhD from the University of Colorado. Puneet Tyagi is co-inventor of several U.S. and international patents and has published extensively in the field of drug delivery.

 

Dr. Nigel Davies

Nigel joined AZ in 2008 as a Senior Scientist in biopharmaceutics in Pharmaceutical Development (Göteborg, Sweden) having responsibilities for a number of clinical and life-cycle management projects. Since transitioning to the Advanced Drug Delivery group in the Innovative Medicine Early Development function in 2014, Nigel has pioneered AstraZeneca’s efforts into the delivery of mRNA therapeutics as well as oral delivery of macromolecules resulting in a number of assets progressing from early pre-clinical evaluation to CDID (and even clinical testing).  Before joining AstraZeneca, Nigel had almost 20 years tenure in academia at Universities in New Zealand and Australia, leading research groups focusing on developing novel delivery systems for macromolecules. Over the years, Nigel has published over 70 articles in peer-reviewed journals, has supervised to completion 18 PhD students and is regularly invited to give talks at high profile conferences. Nigel continues to provide depth and breadth to the scientific input impacting the wider project portfolio as well as striving to identify and develop novel systems (both internally and via external collaborations) to overcome the challenges associated with the delivery of macromolecules in order to advance AZ’s New Modalities portfolio.

 

Dr. Stephen T. Buckley, PhD

Dr. Stephen T. Buckley is Scientific Vice President of Advanced Drug Delivery at Novo Nordisk A/S, Denmark. In addition to his leadership responsibilities, he is responsible at Novo Nordisk for a cross-organizational team of scientific experts tasked with identifying and evaluating novel drug delivery technologies. He holds a degree in pharmacy from Trinity College Dublin (Ireland), and a Ph.D in biopharmaceutics and cell physiology from the same university. During this time, he also worked as a Visiting Fellow at the University of Southern California (USA). Prior to joining Novo Nordisk A/S, Dr. Buckley was a Postdoctoral Research Fellow at the University of Southern Denmark (Denmark). He is the recipient of honors and awards from the American Association of Pharmaceutical Scientists (AAPS) and the Scandinavian and German Physiological Societies. He is (co-) author of 25+ articles in peer-reviewed journals (including Science, Science Translational Medicine and Nature Biotechnology), 1 book chapter and 30+ abstracts, and has been invited to give numerous presentations at research institutions, international conferences and workshops.

 

Dr. Douglas Johns, PhD, FAHA

Douglas Johns, Ph.D, FAHA joined Merck Translational Medicine in 2017 after working in Merck Cardiometabolic Discovery for 8 years. While in Discovery, Doug led the oral PCSK9 team and upon joining Translational Medicine, led the clinical development team for MK-0616. Doug currently provides clinical pharmacology support for the MK-0616 program, which is currently in Phase 3. Doug obtained a BS and MS in Biology from Baylor University, and a PhD in Physiology from the University of Michigan. Doug completed postdoctoral fellowships at the University of Michigan and Boston Medical Center.