Senior Director, Biologics CMC and developability
Pierre Fabre Laboratories
Alain Beck is Senior Director, Biologics CMC and developability, Pierre Fabre Laboratories. He is associated editor of mAbs (www.tandfonline.com/loi/kmab20) and mAbDesign scientific advisor board chairman (www.mabdesign.fr). He has contributed to the R&D of immuno-oncology mAbs, clinical stages mAbs and ADCs in oncology (dalotuzumab/IGF-1R licensed to Merck; telisotuzumab and telisotuzumab vedotin/cMet, licensed to AbbVie; h515H7/CXCR4 and W0101 ADC/IGF-1R), peptides and vaccines (BBG2Na/RSV, P40-ELA/ melanoma). He has published +210 papers and reports on mAbs, biosimilars, biobetters, ADCs, bsAbs, Fc-fusions, protein scaffolds, structure/function relationships, stability, comparability and developability (h-index: 45; +7300 citations). He was involved in more than 260 scientific meetings (AIS, ASMS, BAS, CASSS, EAC, HPLC, IBC, IMSC, ISC, PEGS, SEP, WADC, WBC) as chairperson, invited plenary/ keynote speaker, panelist, moderator, advisor, and organizer as well as to meetings and workshops with regulatory agencies (ANSM, EMA, EDQM/PhEur, FDA, PEI, WHO). He was ranked 6/50 global antibody industry influencers (www.antibodysociety.org).
Tuesday 5th March 2019
17.00 | Chair’s Closing Remarks
08.10 | Riding the ADC Rollercoaster: In-Depth Review of Current ADC Field, as well as Insights on Hotspots of Innovation
08.00 | Chair’s Opening Remarks
Wednesday 6th March 2019
16.30 | Chair’s Closing Remarks
08.50 | Chair’s Opening Remarks
Copenhagen University Hospital
In my present position, I perform basic research in antibody drug conjugate (ADC) targeting of cancers (sarcoma). My responsibilities include general experimental work (both in vivo and in vitro) as well as defining/choosing strategies for progressing our projects. The ultimate goal is to support and optimize a uPARAP targeting ADC, so it may become of interest for biotech/medical companies that have the capacity to take our research-drug into clinical development.
Chief Scientific Officer
Andrew C Huang has developed a robust and proprietary technology platform for the manufacturing antibody drug conjugates (ADC) utilizing the Covalent Thiol Conjugation Technology. The resulting RC48 of China 1st ADC has entered the Phase-II and III Clinical Trials. In this presentation, he will share with audience on the deep analysis of causes for the recent failed and discontinued ADCs and the strategies to develop a better one. The presentation will be illustrated with data and images from the molecular, cellular and animal model studies using the novel ADCs. Andrew Huang was SVP and CSO for ADC research and development since 2013. Prior to joining MabPlex, Huang served as a biomedical researcher at UCLA for 17 years, engaging on molecular medicine, including brain aging, diabetes, stem cells and protein folding research. He published near 100 research articles, journal reviews, book chapters and patents etc.
Dr Antony Bigot holds a PhD in Organic Chemistry from The Orsay University (France). After a post-doctoral position at The Scripps Research Institute in San Diego with Pr K.C. Nicolaou, he joined Sanofi (at that time Rhône-Poulenc Rorer) in 1999 on Vitry-Sur-Seine site as Medicinal Chemist. He then successively hold different positions in Medicinal Chemistry (1999-2004), then in Chemical Process Development (2004-2016). Since July 2016, he his Head of Pre-Development Science Synthetic Chemistry France. His main focus are designing SMART synthesis of small-molecule payloads and linkers to be used in ADCs.
Director, Research and Development
Arnaud Delobel is the R&D Director at Quality Assistance. As the head of the R&D Department, he is responsible for supervising internal R&D projects, aiming at implementing new analytical technologies that will ultimately be provided by Quality Assistance to their customers. He is also supervising the work of Scientific Managers who identify market needs with input from the Management, Regulatory Affairs Manager and external experts, and from any relevant data gathered by Quality Assistance, and that are responsible for interpreting and translating this intelligence into developing new R&D services.
Scientist Medicinal Chemistry
After a master degree in organic chemistry in France, Arnaud began his career in oncology working under the supervision of Malcolm Stevens (inventor of temozolomide) at the University of Nottingham. He then joined the CRUK gene targeting group led by Prof David Thurston and Dr Philip Howard and obtained a PhD in medicinal chemistry from UCL. Arnaud was amongst the first employees to join Spirogen, where he helped establish the pyrrolobenzodiazepine ADC technology platform. Arnaud is Spirogen lead chemist on the tesirine program, originally developing the synthetic route, followed by management of manufacturing campaigns for Spirogen and its licensees. In this endeavour, a robust supply chain had to be established with contract manufacturing organisations to scale-up the 34 steps synthesis, eventually delivering quantities of GMP-material large enough to support multiple phase I clinical trials. Arnaud’s current interests include ADC payload properties and design, as well as a broader understanding of the emerging rules governing the field of ADCs.
GMP Operations Consulting
Brian Clark is Principal at GMP Operations Consulting, LLC, and provides interim executive leadership, CMC strategy, manufacturing and quality strategy and operational support to biopharmaceutical companies worldwide. GMP Operations Consulting focuses on biopharmaceuticals with additional expertise in regenerative medicine, cell therapies and antibody drug conjugates. Previously, Brian was at ImmunoGen Inc. from 2011 to 2016, most recently serving VP Manufacturing and Norwood Site Head and, prior to that, as Executive Director, Quality. Prior to joining ImmunoGen, Brian was an individual consultant for several years in his current practice. Brian previously served in senior Operations and Development leadership roles at Altus Pharmaceutical, Alkermes, Therion Biologics, Antigenics (now Agenus) and Genzyme Tissue Repair. Brian obtained his MBA in General Management from Boston University and his BS in Biology from the University of Massachusetts.
Monday 4th March
09.00 | Scale Up, Outsourcing & Managing Complex Supply Chains
Senior Principal Scientist
Cathy Zhang is a Senior Principle Scientist in Oncology Research Unit at Pfizer (San Diego, California). Cathy leads a group focusing on developing preclinical tumor models and performing preclinical enabling studies for IND or NDA programs. She also works with internal and external partners to establish strategies toward patient stratification and novel combinations to aid clinical trial designs. Cathy has authored or co-authored over 20 peer-reviewed research articles in scientific journals.
Professor of Hematology & Team Leader
Cancer Research Center Lyon
Charles Dumontet is a Team Leader at the Cancer Research Center Lyon. His group studied the mechanisms of action of monoclonal antibodies that are targeting cancer cells. We also study the mechanism of resistance towards these biomolecules in order to increase the activity of therapies based on monoclonal antibodies in patients with hematological malignancies or solid tumors.
Monday 4th March
09.00 | Conjugate Diversity: Past, Present & Future
Conor Barry is the Head of Analytical Sciences at MedImmune/Spirogen having originally joined the company in 2013. He manages the set up and running of the analytical and QC department that supports the ADC R&D program and additional is one of the key relationship managers with CMO/CRO partners. Prior to this he was a Research Associate and Laboratory Manager at the University of Oxford.
Bramhill Biological Consulting
Dr. Bramhill has over 20 years experience in biologics, both in large biopharma and startup biotech companies. He has experience in isolating and improving antibodies using phage display and is an inventor on library design techniques for small scaffolds. He also has experience in diverse expression systems for producing antibodies, antibody fragments and different scaffolds. He has taught numerous technical courses for over 10 years at international conferences.
Workshop A (Full Day)
Monday 4th March
9.00 | Primer Course: Introduction to the Design, Discovery & Development of ADCs (FULL DAY)
Assistant Professor of Pharmaceutical Sciences
State University of New York at Buffalo
Prof. Dhaval K. Shah is an Associate Professor of Pharmaceutical Sciences at the State University of New York at Buffalo. Prior to becoming the faculty Prof. Shah served as a Principle Scientist in the ‘Translational Research-Modeling & Simulation’ group at Pfizer Inc. His research focuses on understanding the determinants for the absorption, distribution, metabolism, and elimination (ADME) of protein therapeutics. His lab uses the principles of Pharmacokinetics-Pharmacodynamics (PK-PD) Modeling & Simulation to support the discovery, clinical translation, and late phase development of novel biologics like engineered antibodies, multi-specific proteins, immuno-oncology agents, engineered T cells, and antibody-drug conjugates. He has developed several pioneering systems PK/PD models for ADCs, and continue to develop mechanism models to understand and improve pharmacological behavior of ADCs.
Monday $th March
13.00 | PK/PD Based Strategies to Improve the Therapeutic Index of ADCs
Douglas is a Staff Scientific Research at Genentech. As a proven leader in the PK/PD department, Douglas provides leadership, strategic thinking and technical support for the pharmacokinetic, pharmacodynamic and laboratory assessment of drug candidates and marketed products. Douglas has led numerous teams and am passionate about leading cross-functional and multi-disciplinary teams in early stage characterization through IND and into clinical development.
Tuesday 5th March 2019
16.30 | Preclinical Pharmacokinetics & Pharmacodynamics of DCLL9718A: an Antibody Drug Conjugate for the Treatment of Acute Myeloid Leukaemia
Director, Biochemistry Discovery
Dr. Albone is currently Director, Biochemistry Discovery at Morphotek, Inc., a wholly-owned subsidiary of Eisai, Inc. His group’s research focuses on early-stage development of therapeutic antibodies and antibody-drug conjugates for oncologic applications, including development of unique site-specific conjugation platforms and novel payloads. He has 20 years of experience in biologics research in both large pharma and early-stage biotechnology firms. He received his BS in Chemistry and PhD in Biochemistry from the University of Rochester.
Head, Bio-Organic, Chemistry Team
Eric Lacoste is ADC Team Leader and Head of the Bio-Organic lab within Sanofi. He has in charge the supervision of process development for Protein Conjugates to support research programs and up to commercial launch readiness .He also oversees cGMP manufacturing and is responsible for process transfer to internal partners or CMO. Eric Lacoste holds a PhD in Organic Chemistry and joined sanofi in2007 to develop ADC process research.
Director, Project Leader
Gavin Bennett is Director, Project Leader at Bicycle Therapeutics in Cambridge, UK, responsible for the development of the BT5528 programme. Bicycle Therapeutics is developing novel constrained bicyclic peptide (Bicycle) peptides. One application of the technology is the development of Bicycle Drug Conjugates for Oncology, allowing targeted delivery of cytotoxic payloads. Gavin has a PhD in Pharmacology from King’s College London and has worked across therapeutic areas, including oncology, inflammation and CNS disease, developing small molecules, large molecules (antibodies) and now mid‐sized molecules (bicyclic peptides). Prior to Bicycle Therapeutics, Gavin led preclinical and pharmacology programmes for companies such as Cellzome, UCB‐Celltech, RhonePoulenc Rorer.
Technical Business Development Manager
Giorgio is part of the Business Unit, with responsibility of coordinating Business Development activities He joined BSP Pharmaceuticals in 2008 as Manufacturing Manager than moved to BD in 2014. Prior to joining BSP Pharmaceuticals, Giorgio has achieved a significant experience in Manufacturing and Operation at Bristol Mayers-Suibb where developed his professional and technical growth. Giorgio holds a degree in Pharmaceutical Chemistry and Technologies from the University of Perugia.
University of Michigan
Greg Thurber is the Assistant Professor of Chemical and Biomedical Engineering at the University of Michigan. Prior to joining the University of Michigan in 2014 Greg was an Instructure at the Center for Systems Biology and Research Fellow at Harvard Medical School. Greg received his PhD in Chemical Engineering at Massachusetts Institute of Technology.
Monday 4th March
09.00 | Designing Effective ADCs through Pharmacokinetic Modelling and PK/PD Experiments
Wednesday 6th March 2019
16.00 | Single-Cell Pharmacokinetics & Pharmacodynamics of Biologics: Designing Effective Antibody Drug Conjugates & Checkpoint Inhibitors
Chief Scientific Officer
Dr. Adams is Chief Scientific Officer of Sesen Bio, a clinical stage company developing antibody-toxin fusion proteins for the treatment of cancer. In this role he is responsible for guiding the development of the company’s pipeline assets. Before moving to biotech, Dr. Adams was the Director of Biological Research and Therapeutics and previously co-led the Developmental Therapeutics Program at the Fox Chase Cancer Center, an NCI designated comprehensive cancer center in Philadelphia. Dr. Adams is an immunologist with over 30 years of experience in developing antibody-based agents for the treatment and detection of cancer. He received a Ph.D. in Immunology from the University of California at Davis in 1991. He joined Fox Chase Cancer Center in Philadelphia where he led a laboratory focused on developing antibodies and antibody-drug conjugates for the treatment of breast, ovarian and renal cancer. Dr. Adams serves on the Editorial Boards of Cancer Immunology Research, MAbs and Cancer Biotherapy & Radiopharmaceuticals. He has served on the Scientific Advisory Boards of a number of biotechnology companies including Endo Pharmaceuticals, Symphogen, Avipep, Viventia Bio, AvidBiologics, Xerion, Fabrus, Integral Molecular and YM Biosciences.
Head of Toxicology
DABT Board-certified toxicologist with ~ 20 years experience in academic research and Drug Discovery/Development. Expertise in various drug modalities (small molecule, mAb, antibody drug conjugate, bispecific T-cell engagers) in various therapeutic areas (Oncology, immuno-oncology, infectious disease, and vaccine). Successfully led nonclinical development of several anti-cancer agents from the early discovery to clinical proof of concept and registrations (BLA.) Extensive involvement in discovering novel targeted therapeutics in oncology and immunotherapy and nonclinical portfolio management.
Principal Scientist Protein Engineering
Hans-Georg Lerchen is a Principal Scientist in the Medicinal Chemistry unit of Bayer AG, Pharmaceuticals Division. With a 28 years background in MedChem he is author or co-author of 73 patents or patent applications and 16 publications. His current research focus is drug delivery systems, prodrugs and in particular antibody drug conjugates.
Associate Director & Senior Scientist, Development Toxicology
Board certified toxicologist with 16+ years of experience in biotechnology/pharmaceutical industry. Experienced in nonclinical safety development of large and small molecules of all development stages (discovery to marketing approval). Successful track record of regulatory filings and interactions. Experienced in leading multidisciplinary project teams.Specialties: Preclinical safety assessment of small and large molecules in immunology, oncology and cancer immunotherapy areas; early safety assessment of novel targets and safety de-risking; cardiovascular safety
Process Development Consultant
Ian Schwartz joined Sartorius Stedim Biotech in December 2016 and is Sartorius’ global bioconjugate technical subject matter expert. Ian has over 14 years of experience in the biotechnology industry and specializes in bioconjugate process development, technology transfer and manufacturing. Ian began his career at Biogen and has moved onto positions of increasing responsibility at ImmunoGen, MedImmune and most recently Agensy, a former affiliate of Astellas Pharmaceuticals, where he started up and led the ADC process development, tech transfer, and manufacturing support group for a number of years. With more than 14 years in the biotechnology industry, Ian supports, in his current role, process development and scale up of bioconjugate processes for Sartorius’ customers and is Sartorius’ internal bioconjugate subject matter expert liaison to R&D.
Dr. Vlahov received his PhD in synthetic organic and structural chemistry from Ruhr University, Bochum, Germany. Before joining Endocyte, he was the head of discovery chemistry at Ivax Corp in Miami, Florida. Prior to that, he held various positions, including visiting scientist at Hercules, Inc.; senior research scientist at the University of Konstanz, Germany; research scientist at the Institute of Organic Chemistry, Bulgarian Academy of Sciences; and research associate at the University of Iowa. Dr. Vlahov’s main scientific interest is the design and synthesis of complex biologically active molecules. In the past 18 years, as the head of Endocyte’s Discovery Chemistry department, Dr. Vlahov has been active in the discovery of personalized targeted therapies of cancer and autoimmune diseases. His research efforts are aimed toward discovery of novel small molecule drug conjugates, linker systems, spacer units, and highly potent warheads. To date, these programs led to the development of seven clinically investigated agents. Dr. Vlahov is an Alexander von Humboldt Fellow and recipient of George and Christine Sosnovsky Award for Cancer Research.
Project Leader, Biology
Ludwig Maximillian’s University
Jonas Helma is a Scientist at the Ludwig Maximillian’s University in Munich. Jonas research focus’s on cell-based assay development with recombinant antibodies, protein engineering, technology development, site-specific antibody conjugates, IP management, lecturing.
HPAPI Project Services Limited
Justin Mason-Home is an organic chemist with extensive health, safety, environmental and chemical engineering experience in senior technical, legal and commercial aspects of the pharmaceutical, biochemical, chemical and other industries. He has held senior positions and worked globally in potent biopharmaceutical occupational health and safety global environmental consulting, board level positions in a biotechnology company and corporate environmental management. Mr Mason-Home has worked on multiple ADC projects and specialises in technical complex and strategic projects, including unique experience in managing sensitive highly potent and toxic biopharmaceutical compound matters.
Monday 4th March
13.00 | Occupational Health & Safety in Delivering ADC Projects
Development, Analytical Chemistry
Analytical and Formulation Scientist with advanced graduate degree and several years of broad industrial CMC experience supporting projects evolving from pre-clinical to development and through pivotal late stage. Expertise with several analytical and biophysical techniques and their application for characterization of bio-therapeutics.
Speaker to be confirmed
Senior Analyst, Beacon
Wednesday 6th March 2019
15.30 | Review of the ADC Clinical Pipeline
Dr. Ling Xu obtained her Ph.D. from University of Colorado at Boulder, where she was trained as an enzymologist. She has over 17 years’ experience with mass spectrometry application in the areas of characterization and quantification of both small and large molecules. She worked as a Senior Research Associate at a proteomic mass spectrometry central lab at University of Toronto for five years. She has been working at Millennium Pharmaceutical/Takeda Boston for over nine years leading bioanalysis of antibody drug conjugates. Before that, she did research at Brigham Woman Hospital /Harvard School of Medicine for around a year as a Research Associate on structural elucidation of bioactive small molecules that activate the resolution of acute inflammation. Dr. Ling Xu joined Mersana Therapeutics, Inc. in 2017.
Principal Project Engineer
Mary Robinette has over 25 years of process engineering experience in the chemical and pharmaceutical industry. Mary started her career with MilliporeSigma 14 years ago as project engineer supporting pharmaceutical new products. Mary is responsible for new process scale-up, process equipment/facility design and capital project management. Mary has been the lead process engineer for design, construction and commissioning of our ADC Commercial facility opened in 2015. Mary holds a BS in Chemical Engineering and is certified as Project Management Professional (PMP).
Associate Director Parenteral Development
Matthias Winzer, Associate Director Parenteral Development at Merck/Germany. Matthias is biotechnology engineer by training. In his current role he is head of the early phase formulation development team in Mercks healthcare division. Over the last years he has worked in discovery and early development projects on formulation and characterization of injectables as principle scientist, CMC-leader and associate director. Matthias has also served as a link between discovery and early clinical supply of biologics and ADCs. He filled several other positions at Merck before such as development engineer in late stage formulation and process development of biologics, biotech CMO manager for a marketed antibody brand and spent an extended period at the swiss Merck site in Corsier-sur-Vevey as project manager biotech process science. Before he joined Merck in 2001, Matthias worked at the biotech start-up ProThera/Germany (meanwhile acquired as Wacker-Biotech) with a focus on characterization of therapeutic recombinant proteins, at the Hans-Knoell-Institute/Germany in microbial biofilm research and at BASF Ludwigshafen/Germany in the field of PAT technologies for large scale fermentation processes.
Head of Analytical, Bioconjugation
Experience: Melanie joined Novasep in March 2016. She has 8 years of experience in biologicals analysis, protein purification and production of bioactive proteins, ADC analytical labs set up and ADCs analysis. Skills: Chromatography (HPLC-SEC/IEX/HIC/RP, GC, FPLC, method development), fluorimetry, flow cytometry, spectroscopy (UV/VIS, CD, IR), protein/ADC mass spectrometry, electrophoresis, ELISA, microscopy, microbiology, cell culture and bioburden.
Chief Executive Officer
Mr. Michael F. Pehl is President and Chief Executive Officer of Immunomedics, Inc. Mr. Pehl has more than 20 years of experience in hematology and oncology and has launched multiple blockbuster drugs in that space including Revlimid, Pomalyst, and Abraxane. Prior to joining Immunomedics in December 2017, Mr. Pehl spent 11 years at Celgene Corporation, serving as General Manager Germany, Vice President Central Europe, Head of Hematology Europe and subsequently as Head of Global Marketing and finally as President of Hematology & Oncology. Previously, Mr. Pehl served 14 years at Amgen, Inc., where he held various commercial leadership positions in oncology, rheumatology and nephrology in Germany and for Amgen Europe in Switzerland. Mr. Pehl received a Diploma in Molecular Biology from Ludwig-Maximilians-University Munich, Germany.
Tuesday 5th March 2019
08.40 | Keynote: Making Sacituzumab Govitecan Foundational Therapy for High Unmet Need Indications
Vice President, Development
Nancy Levin joined Triphase in 2015 with more than 20 years’ experience in the biotechnology industry, and technical expertise in clinical and translational pharmacology and nonclinical development. Nancy was Vice President of Therapeutics Product Design Group at Intrexon Corporation (2013-2014), where she oversaw the conception and development of novel therapeutic partnering opportunities enabled by Intrexon’s proprietary cell- and DNA-based technologies. Prior to this, Nancy held positions of increasing responsibility at Pfizer (CovX Research, 2005-2013), X-Ceptor Therapeutics (2003-2004), MitoKor (2001-2003), and Trega Biosciences (1999-2001). Nancy’s biotechnology experience began at Genentech (1993-1996), followed by Amgen (1996-1999), where she led multiple discovery and target validation projects. Her breadth of therapeutic area expertise includes oncology, metabolic and cardiovascular diseases, dermatology, inflammation, endocrinology, and rare/ultra-rare genetic diseases. She has led programs from discovery into clinical proof-of-concept employing multiple therapeutic modalities including small molecules, antibody-drug and -peptide conjugates, peptides, proteins, and antibodies. She earned a Ph.D. in Endocrinology at the University of California San Francisco, followed by post-doctoral training in the Fishberg Research Center for Neurobiology at The Mount Sinai School of Medicine in New York, NY.
Seattle Genetics, Inc
Nomalie Jaya received her Ph.D. in Biochemistry and Molecular Biophysics from the University of Arizona where she studied protein-protein interactions between molecular chaperones and their substrates. She worked at Corixa Corp. for 6 + years in the Analytical Biochemistry dept. prior to joining Seattle Genetics as a Characterization Scientist. Currently she leads the Capillary Electrophoresis group within the Analytical Sciences dept. She has served as the Analytical Lead for both early and late phase clinical programs. Her technical expertise is primarily in physicochemical methods development, and product characterization including mAbs and antibody-drug conjugates (ADCs).
University of Bielefeld
Norbert Sewald was born in Munich in 1961 and studied Chemistry at the Technical University of Munich. Having finished his PhD thesis in Organic Chemistry in 1991 he joined the group of Sir JE Baldwin at the Dyson Perrins Laboratory, University of Oxford from 1991 to 1992. In 1998 he finished his habilitation at the University of Leipzig and became Full Professor of Organic and Bioorganic Chemistry at Bielefeld University in 1999. His research interests lie at the borderline between Chemistry and Life Sciences. The research activities of the Sewald group comprise chemicallymodified bioactive peptides, natural product isolation, natural product total synthesis, antibody–drug conjugates and peptide–drug conjugates, peptide–protein and peptide–DNA interactions, molecular tools for proteome research, enzymatic halogenation and structure determination with NMR and molecular dynamics calculations.
University of Cambridge
Pedro MSD Cal has a PharmD (2010) and PhD in Pharmaceutical Sciences (2014). He is an expert in Chemical Biology with nearly 10 years of experience working in different universities and institutions (University of Lisbon, University College of London and University of Cambridge). He has nearly 20 publications, leading to about 800 citations, 2 book chapters, 2 patent applications and a h-index of 12. Recently he is interested on technology transfer/science entrepreneurship and he is part of a team of researchers that is about to spin-off some of the research that our group is developing at Gonçalo Bernardes’ laboratories
Wednesday 6th March 2019
09.00 | Exploring Site Directed Mutations on Native Antibodies to Allow Payload Conjugation
Chief Scientific Officer
Dr Howard is a Founding Scientist and Chief Scientific Officer at Spirogen. He has been conducting research into the pyrrolobenzodiazepine (PBD) family of antitumor antibiotics for twenty years in both academia and industry. Philip has worked as a part of a multi-disciplinary team, supported by Cancer Research UK and Spirogen, on the synthesis, biological evaluation and development of the PBD dimers. Since 2008 he has been working on the development of the PBDs as payloads for antibody-drug conjugate therapy with a number of leading companies including, Seattle Genetics, Stemcentrx, ADC Therapeutics, Genentech, Regeneron and Tanabe Research Laboratories USA Inc. Dr Howard designed the tesirine payload (SG3249) and the warhead SG3132 released by the talirine payload. His work at MedImmune is focused on the further development of their PBD-ADC platform. At the time of writing, more than 12 PBD-ADCs, arising from Spirogen collaborations, are the subject of Phase I, Phase II, and Phase III clinical trials.
Vice President & Global Head, Biologics
Dr. Dixit conducted extensive graduate and post-graduate training in Toxicology–Biochemistry with both Indian and US Institutions (Case Western Reserve University, Medical College of Ohio, University of Nebraska) and is board certified in Toxicology from the American Board of Toxicology, Inc. since 1992. Rakesh served as a Senior Toxicologist with Midwest Research Institute between 1987 and 1992. In December 1992, Rakesh joined the Department of Safety Assessment, Merck and Co., Inc, West Point, PA where he served in various management positions. During his about 14 years with Merck, Rakesh contributed to the successful filings of many blockbuster drugs. For about a year, Rakesh was associated with Johnson and Johnson PRD, La Jolla/Alza as Senior Director of Toxicology. In Aug 2006, Rakesh joined MedImmune, Inc. (an AstraZeneca Biologics company) as Senior Director (R &D) & Global Head of Biologics Safety Assessment, Experimental Pathology, and Laboratory Animal Medicine. In his current position as a Vice President of R &D since 2010, Rakesh is responsible for providing guidance on research and development of biological products; including nonclinical toxicology/safety support for all AstraZeneca-MedImmune biologics products, including monoclonal antibodies and vaccines. Rakesh has published more than 60 papers in renowned international journals and has given over 100 invited lectures/presentations/workshops in national and international meetings. Rakesh is one of the most invited speakers in the biotechnology industry. Rakesh’s areas of expertise are mainly in the area of pharmaceuticals and biologics drug development, safety assessment of small molecule drugs, biologics, vaccines and in exploring mechanisms of toxicity and biologics pharmacological activity. Rakesh has helped to bring several blockbuster pharmaceuticals to the market while working at Merck. Rakesh a recognized expert in safety and pharmacology biomarkers and their applications.. Rakesh is the Editor-in-chief of Toxicology Mechanisms and Methods and Associate Editor for Toxicology Applied Pharmacology, and Journal of Toxicology and Environmental Health. Rakesh was selected by his pharmaceutical peers as the 100 Most Inspiring People in Pharmaceutical Industry by PharmaVOICE in 2015. Rakesh also serves as an expert reviewer and in appointed committee for many programs managed by the prestigious U.S. National Academy of Sciences and US National Institutes of Health, including National Cancer Institute.
Tuesday 5th March 2019
16.00 | Keynote: Lessons Learned from the Successful & Failed ADCs in Cancer Treatment: Moving Forward & Creating the Best Magic Bullets
Executive Director, Translational Medicine
Rebecca Mosher is Executive Director, Translational Medicine at Mersana Therapeutics, where she has worked since 2016. She trained as a pathologist and has worked in the area of biomarkers and translational research at large and small companies.
Head of Global Medial Affairs
Dr. Safaei brings extensive experience in the development and commercialisation of novel therapeutics for haematological and solid cancers, gained with several world-leading biopharmaceutical companies. In his current role, Dr. Safaei holds the position of Head of Global Medical Affairs at Nordic Nanovector (NNV) where he is responsible for building a team of field-based Medical Science Liaisons (MSL) in the US and Europe, developing strong relationships with global experts and partnerships with clinical centres of excellence for non-Hodgkin’s lymphoma (NHL), as well as designing and implementing medical education programmes to raise awareness of Nordic Nanovector’s technology and Betalutin® prior to launch. Prior to joining NNV he was the Head of Medical Affairs Europe for Seattle Genetics and managed medical affairs and clinical development activities of pipeline products in solid and liquid cancers. Prior to this, Dr. Safaei served as Director, Medical Development, Immuno-Oncology and Scientific Communications, Haematology at AMGEN Europe. Dr. Safaei is trained in Internal Medicine and holds a Medical Degree from the University of Goettingen, Germany.
VP R&D and Product Development
Steve Coats serves as AstraZeneca/MedImmune’s VP R&D and Product Development Team Leader. His work focuses on interacting with external investigators to initiate clinical trials that are investigator led at academic institutes. Dr. Coats is also a product development team leader where he leads oncology project teams in early phase 1 and phase II clinical development for MedImmune’s antibody drug conjugates and immune-oncology programs. Prior to joining MedImmune in 2005, Dr. Coats worked at Amgen, Inc. starting in 1996 and helped initially set up a cell cycle group and then became one of the first scientists in the newly formed cancer biology department. Dr. Coats earned his bachelor’s degree in zoology from the University of New Hampshire in 1985. Following his undergraduate degree, he worked as a research assistant for three years in the pulmonary department at Beth Israel Hospital and Children’s Hospital in Boston. He earned his Ph.D. in molecular and cell Biology in 1993 Vanderbilt University’s Department of Cell Biology. The focus of his graduate work was on the role that PDGF receptors and ligands play in regulating signal transduction pathways and the cell cycle. He continued his cell cycle research during his post-doctoral work from 1993-1996 at the Fred Hutchinson Cancer Research Center in Seattle. While at the Fred Hutchinson Cancer Center he investigated the role that cyclin-CDK complexes play in regulating G1/S and G2/M transition points and he focused much of his research on examining the regulation of the cell cycle by the CDK inhibitor p27Kip1.
Senior Scientist, Bio Development
Senior Scientist in BioDevelopment Sanofi R&D, previously Head of the formulation group at Sanofi Vitry from 2011 to 2018. Worked 6 years at LFB Biotech (2006-2011) in charge of the innovation platform for drug delivery and head of the formulation dept. Previously, held various positions at Flamel Technologies (13 years) as project leader and pilot unit manager. Co-inventor of Medusa® technology for sustained release of proteins. Ph.D in material science from University of Montpellier, France / Engineer in chemistry from the Ecole Nationale Superieure de Chimie de Paris, France.
Ulf Grawunder is CEO of NBE-Therapeutics, a Swiss Biotech company that he founded in 2012 and which focuses on the development of "next-generation" antibody-drug conjugates for cancer therapy. Prior to that, Ulf had co-founded 4-Antibody in 2004, a Swiss therapeutic antibody engineering company, where he initially served as CEO and later as CSO, until the company was sold to US-based Agenus. Ulf is a Biochemist who did his PhD in the area of B cell Immunology at the Basel Institute for Immunology. After this he did several years of post-doctoral research at Washington University School of Medicine, St. Louis, and the University of Southern California, Los Angeles. After that he returned to Europe to continue research as principal investigator at the Basel Institute for Immunology, and the University of Basel, Switzerland, before he started his first Biotech company, 4-Antibody. Ulf also holds a Diploma of Technology Entrepreneurship from the University St. Gallen, School of Business, Switzerland (HSG, Hochschule St. Gallen), and he is part if the teaching faculty of the European Center for Pharmaceutical Medicine (ECPM) at the University of Basel, Switzerland. Ulf is advisor of a number of national and international organizations, including the scientific advisory board of the Bavarian Immunotherapies Network, BayImmuNet, Germany (www.bayimmunet.de), the jury of Venturekick, Switzerland (http://www.venturekick.ch), and the Board of the Swiss Biotech Association (SBA, www.swissbiotech.org).
Associate Principal Scientist
Following his D.Phil in organic synthesis at Oxford University and Post Doc at Indiana University Will joined AZ at Macclesfield in 2006. He has developed a strong track record in process design and scale up working from grams to tonnes, including biocatalysis and flow chemistry. For the last four years he has been working in New Modalities and he is currently working on AstraZeneca’s antibody drug conjugate (ADC) platform, with accountability for early phase payload synthesis. In this role he is developing the commercial routes and processes for ADC payloads, whilst supporting the manufacture of clinical trial material. He is an Honorary Lecturer at the University of Manchester in the Division of Pharmacy.
Vice President, Therapeutic Proteins
For the past 5 years, William Olson has served as Vice President, Therapeutic Proteins at Regeneron Pharmaceuticals. A primary area of responsibility is to generate novel monoclonal antibodies as potential new therapeutic product candidates using the VelocImmune mouse platform. He also spearheads efforts to conjugate VelocImmune antibodies with small-molecule drugs and positron-emitting isotopes for therapy and molecular imaging. His prior industry experience includes Progenics Pharmaceuticals, Johnson & Johnson and MicroGeneSys. He received his doctoral training at the Massachusetts Institute of Technology.
Wednesday 6th March 2019
09.30 | Cytotoxic & Steroid ADCs for Cancer & Inflammation
Senior Research Fellow
Yiqing Feng received her Ph.D. degree in Biophysics from University of Pennsylvania and completed a postdoctoral research program at University of Illinois at Urbana-Champaign. She has since worked at Monsanto, Pharmacia, Pfizer, and Centocor/Janssen/J&J before joining Eli Lilly and company. Dr. Feng is currently in Lilly Biotech to discover innovative biotherapeutics in order to improve quality of life for patients.