Director of Research & Development
Dr. Amy Han is an accomplished contributor to the Drug Discovery and Development industry. Dr. Han, a 20-year veteran, is currently directing ADC effort at Regeneron Pharmaceuticals. Prior to Regeneron, she held numerous senior scientific positions at leading pharmaceutical companies like Dupont Merck, Dupont Pharmaceutical, BMS, Incyte, and Progenics. She has led and managed multiple drug discovery and development programs, covering multi-therapeutic areas from initiation through to clinical trial stages. During her tenure at Regeneron, Dr. Han also discovered novel cytotoxic payloads for cancer and non-cytotoxic payloads for beyond cancer, as well as novel linker platform for large/small molecular conjugations and stability in vitro and in vivo. Dr. Han has led and made critical contributions on ADC programs; she also has authored 60+ patents, and have presented at numerous domestic and international conferences. In addition to her technical accomplishments, she has also managed teams, both internal as well as remote teams in domestic and internationally based Contract Research Organizations (CROs).
Director, Next Generation Antibody Drug Conjugates
Dr Phillips earned his Ph.D. from the University of Glasgow, performed postdoctoral studies and the NCI and was an Assistant Professor at the Medical College of Georgia prior to joining Abbott/Abbvie. At Abbvie Dr Phillips has been involved in multiple ADC programs including a number that have entered clinical development. These include depatuximab mafadotin, Abbvie’s first ADC, where he served as the lead biologist and ABBV-155, Abbvie’s first in-class BCL-XL inhibitor ADC for which he served as Project Director. Dr Phillips current role is as Director, Next Generation Antibody Drug Conjugates.
Translational Sciences Group Leader
Anton Rosenbaum, PhD, currently leads the Clinical Immunology and Bioanalysis Mass Spectrometry group within Clinical Pharmacology and Safety Sciences organization at AstraZeneca. He supports a variety of preclinical and clinical stage programs at various stages of development of innovative small molecule and biotherapeutics (e.g., peptides, bispecifics, ADCs) across the portfolio of diverse therapeutic areas (oncology, cardiovascular, metabolic, renal and respiratory disorders). Anton’s expertise is focused on quantitative bioanalysis and drug metabolism of biotherapeutics and small molecule drugs as well as identification and quantification of clinically relevant biomarkers and their application to drug development. Additionally, Anton serves as both a functional representative and Translational Sciences Lead representing both his core functional area and Translational Sciences at global teams. Anton possesses significant expertise in regulated bioanalysis of biotherapeutics and small molecules, GLP/GCP, PK, ADA, drug metabolism, biomarker assays, cell biology and analytical chemistry. Prior to joining MedImmune/AstraZeneca, Anton was Senior Scientist at Centers for Therapeutic Innovation at Pfizer Inc. where was a Biology Lead for both CVMD and oncology programs. In his role at Pfizer, Anton led metabolomic research in non-alcoholic steatohepatitis. Prior to joining Pfizer, Anton obtained his postdoctoral training at Genentech Inc. where he championed application of mass isotopomer distribution analysis for the understanding metabolic pathways important in cancer in response to signaling pathway modulation. Anton obtained his PhD in Biochemistry and Structural Biology from the Weill Graduate School of Cornell University where his research focused on chemical biology dissection of intracellular cholesterol homeostasis.
Head of Advanced Analytics for Development
Antonio Triolo is currently the responsible of the Laboratory of Advanced Analytics for Development, involved in the delivery of advanced analytical and spectroscopic services in support of R&D Projects inside the Menarini Group. The application fields vary from deep structural characterization of pharmaceuticals and biologics, to trace identification of their impurities, degradants and metabolites, making use of techniques based on LC/GC-MS and NMR. He is author of publications in the fields of mass spectrometry, pharmaceutical analysis, bioanalysis, medicinal chemistry and drug metabolite identification.
Chief Medical Officer
Dr. Arturo Molina, an oncologist, has led scientific innovation and driven clinical programs forward for over twenty years. With his extensive experience interacting with the FDA and other global regulatory bodies, he has led the development of hematological and oncologic clinical candidates from phase I through phase III and through post-marking trials. He joins Sutro from his former role as VP of oncology and scientific innovation at Johnson & Johnson’s California Innovation Center where he was involved in the evaluation of novel biologics and small molecules, with a focus on immuno-oncology. While working for Johnson & Johnson, Dr. Molina oversaw the approval of Zytiga® in a multitude of countries for metastatic castration resistant prostate cancer indications. Previously, Dr. Molina served as chief medical officer and executive vice-president of Cougar Biotechnology where his leadership efforts advanced the company’s abiraterone program, Zytiga®, from phase I into several global phase III studies. He played a substantial role in the diligence efforts which led to the near $1B acquisition of Cougar by Johnson & Johnson. Dr. Molina has also held leadership positions at Biogen Idec where he led the hematology/oncology clinical development team and oversaw the post-approval label expansion of Rituxan® in front-line follicular lymphoma and diffuse large B-cell lymphoma (DLBCL). Dr. Molina was a faculty staff physician and adjunct professor in hematology/bone marrow transplantation and medical oncology/therapeutics research at the City of Hope Comprehensive Cancer Center. Dr. Molina received his M.D. and M.S. degrees from Stanford University School of Medicine in Stanford, CA. He is board certified in internal medicine and medical oncology and has an active California medical license. He additionally has earned distinction as a Fellow of the American College of Physicians.
Ajinomoto Bio-Pharma Services
Brian worked at Seattle Genetics back in the early days (2000 until 2005) working on the vcMMAE and mcMMAF drug linkers for ADC technology, which resulted in the current commercial success with Adcetris, and many more compounds in clinical trials. He was the first person to ever synthesize the MMAE drug molecule. In 2005, Brian went to the University of British Columbia to finish his PhD in chemistry, focusing on the synthesis of natural product toxin molecules. He then started work at Agensys in early 2011 and built a Chemistry group with capabilities to perform novel ADC-relevant drug-linker synthesis. Currently Brian is a Director at Ajinomoto.
Cexiong (Winston) Fu has more than 10 years of experience in the development of various biotherapeutics modalities, receiving his Ph.D from North Carolina State University and B.S form Peking University. Winston is currently an analytical product owner at Takeda and is responsible for defining the research to development transition strategy for all new biotherapeutic candidates within Shire/Takeda and for supporting developability assessment, analytical development plan and CMC activities. Prior to joining Shire/Takeda in 2018, Winston has worked in Abbvie and Pfizer on biologics ADME, biosimilar analytical characterization, and ADC characterization and bioanalysis.
University of Kentucky
Dr. Ng is currently working as an associate professor of pharmaceutical science in College of Pharmacy, University of Kentucky at Lexington. He is also the founder and president of the NewGround Pharmaceutical Consulting LLC. Dr. Ng is a fellow of the American College of Clinical Pharmacology. Before that, he had hold several academic/industry positions as an assistant professor in pediatric, Perelman School of Medicine, University of Pennsylvania and full member research investigator in Abramson Cancer Center of the University of Pennsylvania. He also served as the Director of Clinical Pharmacokinetics and Pharmacodynamic division at Cancer Therapy and Research Center in San Antonio TX and involved in the early clinical development of many anti-cancer drugs. Dr. Ng has authored over 100 peer-reviewed research articles, book chapters, patent, and conference communications, and many of those were related to cancer research. Furthermore, he had given many invited lectures on a variety topics related to advanced modeling/simulation technologies and model-based preclinical/clinical anti-cancer drug development. Finally, Dr. Ng served as a primary investigator of several cancer-related research grants with a total of over 1.2 million USD direct costs in the past five years.
Vice President of Discovery Research
Dr. Leamon is Vice President of Research at Endocyte, Inc., a Novartis company. He received an ACS-certified B.S. degree in Chemistry from Baldwin Wallace University (1988) and a Ph.D. in Chemistry from Purdue University (1993). Dr. Leamon has spent over 30 years working in the drug delivery field and is credited for conducting the groundbreaking experiments in folate-targeted technology as well as for exemplifying this novel therapeutic approach for treating cancer. Dr. Leamon has published 90 articles and is an inventor on more than 45 issued or submitted patents involving drug targeting, including those which cover vintafolide and etarfolatide. In 2015 he was the recipient of the 2015 American Chemical Society, George and Christine Sosnovsky Award for Cancer Research. Prior to joining Endocyte in February 1999, Dr. Leamon was employed in the pharmaceutical industry where he conducted discovery research in the field of peptide, oligonucleotide, liposome and DNA drug delivery for GlaxoSmithKline, Inc. and Ionis Pharmaceuticals, Inc. As the head of Endocyte’s Discovery team for the past 20 years, Dr. Leamon remains active in the research and development of targeted radioimaging, radio-, (RLT), chemo- (SMDC) and immuno-therapeutic medicines, including CAR T approaches, for the treatment of cancer and inflammatory diseases. To date, his efforts have yielded 8 clinically investigated agents.
The Scripps Research Institute
Christoph Rader studied biochemistry in Germany and Switzerland where he received his PhD from the University of Zurich in 1995. Following postdoctoral training at The Scripps Research Institute in La Jolla, CA (TSRI-CA), he was appointed Assistant Professor at TSRI-CA in 1999. In 2003, he was recruited as Senior Scientist to the National Cancer Institute, National Institutes of Health in Bethesda, MD (NCI, NIH). He rejoined The Scripps Research Institute in Jupiter, FL (TSRI-FL) as Associate Professor with Tenure in 2012. In 2018, he was appointed Associate Dean of the Skaggs Graduate School of Chemical and Biological Studies at TSRI, a top ten PhD program in chemistry, biochemistry, and biology. All three Rader laboratories have focused on antibody drug and target discovery for cancer therapy with a specific interest in the development and application of antibody engineering and conjugation technologies including phage display, mammalian cell display, homogeneous antibody-drug conjugates (ADCs), chemically programmed antibodies, bispecific antibodies, and chimeric antigen receptor (CAR) T-cell therapies. Several antibodies developed in the Rader laboratories have reached preclinical and clinical investigations. Christoph Rader has authored >120 peer-reviewed journal articles and is named inventor on >25 issued and pending patent families.
Associate Director, Conjugation Process Development
Damon Meyer received his Bachelor’s degree in Chemistry from Pomona College, and his Ph.D. from the University of California at Davis. Working first at Hybritech, Inc. then NeoRx Corp., he developed antibody-enzyme conjugates and antibody-streptavidin conjugates for the delivery of oncolytics and radionuclides to tumors. Joining Seattle Genetics in 2000, Dr. Meyer worked on antibody-drug conjugates for preclinical studies, studied the affinity of auristatins for tubulin, and the relationship between affinity and cytotoxicity. Dr. Meyer helped develop the commercial conjugation manufacturing process for Adcetris and the Phase I clinical conjugation process for an anti-CD33-pyrrolobenzodiazepine dimer engineered-cysteine ADC.
President & Founder
Independent Consultant - 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.
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.
Dr Samineni earned her Ph.D. from the University of Cincinnati, prior to joining Genentech. At Genentech, Dr. Samineni has served as a lead clinical pharmacologist in the global development teams for multiple therapeutic modalities i.e. small molecules, large molecules and antibody-drug conjugates (ADC) across a range of linker-drug technologies. These include Kadcyla and Polatuzumab vedotin, Genentech’s first vc-MMAE ADC. Dr. Samineni’s current role is as Scientist in the department of Clinical Pharmacology.
Founding Principal Scientist
Ed Ha has worked on ADC’s since 1999. Ed’s was a team-member of Genentech’s initial in-house ADC group. Fortunately, he followed the T-DM-1 project from Early Discovery to Process Development/CMC collaborating with Immunogen and Seattle Genetics. Ed has worked with nearly all of the ADC payload and conjugation classes (Auristatins, PBD’s, Tubulysins, CC-1065’s, Nemorubicins, dPEG’s, etc..) After almost a decade at GNE, Ed joined Igenica to initiate & build full in-house ADC capabilities, under David Jackson. Igenica developed an ADC platform with site-specific and homogenous conjugation tools. In order to explore hydrophilic payloads, Ed moved to Solstice Biologics synthesizing and conjugating oligonucleotide payload-linkers with antibodies. In 2018, he returned to the East Coast as Founding Principal Scientist at Angiex, where they are targeting the tumor vasculature via a wide-spectrum of ADC technologies.
Director, CMC Process Engineering & BioConjugation
Engin Ayturk, is a Director at Mersana Therapeutics, leading the CMC Process Engineering and BioConjugation departments and responsible for the development, scale-up and cGMP manufacturing, late-stage characterization and validation of novel antibody drug conjugate (ADC) technology platforms. Previously as a Senior Manager at Biogen, Dr. Ayturk led the Cambridge Process Biochemistry (PBC) small and pilot scale purification and bioseparation development teams and was responsible for the development of purification processes for clinical and commercial biologics programs. During his tenure at Pall Life Sciences, as a Sr. R&D Manager, Dr. Ayturk led the BioPharm Applications R&D Integrated Continuous BioProcessing team and the Filtration Groups for the development and commercialization of next generation novel bioprocess platforms and technologies. In addition to his primary focus on product, process and technology development, characterization, scale-up and tech transfer and cGMP manufacturing, Dr. Ayturk brings a strong emphasis on process modeling, bioprocess economics and the development of process control strategies for various technologies and is well recognized for cross-functional team leadership, internal/external collaborations and partnerships, and CDMO/CMO management. Dr. Ayturk holds M.Sc. and Ph.D. degrees both in Chemical Engineering and previously worked as a Research Assistant Professor at Worcester Polytechnic Institute (WPI) and has numerous business certifications on project and people management, agile product development and innovation coaching modules.
Head of Bio-Organic Team & Chemistry, Manufacturing, Control & Project Manager
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.
Senior Director, External Supply
Dr. Firelli Alonso is a Senior Director at Pfizer, Inc. She heads the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. Fi has more than 33 years of combined experience in research, development, and cGMP production of biological products and vaccines, and more than 10 years of experience in outsourcing, project / contract management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and vaccine development, biotherapeutics and vaccine process development and cGMP production, project management, technology transfer, outsourcing, and budgets and operations. She obtained her Ph.D. in Microbiology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University Center for Advanced Biotechnology and Medicine. Prior to working for Wyeth / Pfizer in 1996, Fi was at The Salk Institute (Government Services Division), a vaccine contract manufacturer for the U.S. Army.
Gail Lewis Phillips
Senior Scientist - Translational Oncology
My laboratory studies receptor tyrosine kinases as targets for development of anti-cancer therapeutics, with emphasis on the HER2/erbB2 pathway. Our early research efforts focused on the role of HER2 in HER2-amplified breast cancer, and the biological effects of antibodies directed against HER2. This work led to the development and approval of both Trastuzumab and Pertuzumab. More recently, we developed antibody-drug conjugates (ADCs) designed to selectively deliver potent cytotoxic agents to HER2-positive tumor cells. One of these ADCs, trastuzumab emtansine (T-DM1) was FDA-approved in February 2013. We are currently exploring use of T-DM1 in other cancers that overexpress HER2 as well as investigating new HER2-directed ADCs utilizing cytotoxic agents with different mechanisms than DM1. My lab also performs studies to evaluate activity of novel anti-cancer agents, as free drugs and ADCs, as well as novel antibody formats, for other Oncology indications.
Lawrence Berkley National Labs
Dr. Gang (Gary) Ren, a staff scientist and group leader in the Molecular Foundry, Lawrence Berkeley National Laboratory, received his BS and MS in theoretical physics in 1990 and 1993 and PhD in material science in 1997. He joined Drs. Alok Mitra and Mark Yeager at the Scripps Research Institute in 1997, and then joined Dr. Wah Chiu’s groups at Baylor College of Medicine in 2003 as postdoc and research associate. Dr. Ren started his own research group at UCSF in 2006, and then moved his group to Lawrence Berkeley National Laboratory since 2010. His research focused on the technology development about 3D structure determination from each individual macromolecule. His group is supported by the funds from US Department of Energy, NIH and Pharmaceutical companies. He has published more than 80 peer-reviewed articles, and currently services as editorial board member of Scientific Reports and associate director of CASSS.
Senior Manager - Technical Business Development
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.
Hans Georg Lerchen
Chief Scientist - Medicinal Chemistry
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.
Global Bioconjugation Technology Consultant
Sartorious Stedium Biotech
Ian Schwartz joined Sartorius Stedim Biotech in December 2016 as a Process Development Consultant and is Sartorius’ bioconjugate subject matter expert. Ian has over 12 years of experience in the biotechnology industry and specializes in antibody drug conjugate (ADC) and downstream protein purification 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 13 years in the biotechnology industry, Ian leads Sartorius’ bioconjugate platform and supports process development and scale up of biological and bioconjugate processes for Sartorius’ customers.
Hillary Schuessler earned her PhD in Chemistry from the University of Virginia. At UVA, she gained expertise in proteomics analysis using mass spectrometry and transitioned this expertise to GlaxoSmithKline, where she used mass spectrometry to characterize over 15 different biopharmaceutical drug products. Since joining GSK, Hillary has gained CMC analytical experience, including comparability, structure-function studies and CQA elucidation over a product's lifecycle.
National Center for Advancing Translational Sciences
Jacob Roth completed his undergraduate education at Goshen College, where he double majored in Molecular Biology and Chemistry. After graduation, he joined the lab of Dr. Matthew Hall at the National Center for Advancing Translational Sciences (NCATS), NIH as a post-baccalaureate researcher. At NCATS, he developed methods for the high-throughput study of bio therapeutics and their combinations with small molecules, with a focus on ADCs. He plans to pursue an MD/PhD at the Albert Einstein College of Medicine.
Project Director – Oncology Discovery
James Purcell is a Principal Research Scientist within the Oncology Discovery organization of AbbVie, based out of Redwood City California. His current research focuses on developing novel antibody drug conjugates (ADCs) in particular ADC target biology, pharmacology and investigating new drug/linker technologies. He has helped to progress antibody based biologics from bench into Phase 1 development as part of AbbVie (e.g., LRRC15-ADC, ABBV-085) and during his time at Abbott/Facet Biotech (e.g., TweakR mAb, enavatuzumab). Prior experience involved the preclinical and translational evaluation of the first small molecule kinesin spindle protein inhibitor (Ispinesib) that progressed into clinical trials (Cytokinetics/GSK). James holds a PhD from the Center for Cancer Research and Cell Biology at Queens University, U.K., as well as a M.S. in Molecular Medicine and B.S. in Biochemistry from Trinity College, Ireland.
Dr. Jay Harper received his Ph.D. in Cell & Developmental Biology from Harvard University in 2000 and conducted postdoctoral research on the initiation of the angiogenic switch with Marsha Moses, Ph.D. in the Vascular Biology Department at Boston Children’s Hospital. After joining Genzyme in 2006, he worked on advancing the anti-TGFb antibody, GC1008, through the pipeline and into clinical trials for cancer. Additionally, he helped build their antibody-drug conjugate (ADC) capabilities through both core capability development as well as by leading specific ADC project teams. He joined MedImmune/AstraZeneca in 2011 and since then has used his experience to progress AstraZeneca’s ADC platform and advance preclinical research programs towards the clinic. He has been the project lead for a number of ADC projects and his team is helping to evaluate novel ADC technology to incorporate into AstraZeneca’s next gen ADCs. Most recently, to enhance the therapeutic index of ADCs, he’s been collaborating with the AstraZeneca Translational Medicine team to characterize biomarkers from the tumor microenvironment that can be used to stratify patients and/or identify rational combinations based on the impact of ADCs on tumor biology. He is the co-inventor on a number of patents, has been invited to chair sessions and speak at various conferences and is either a lead author or a co-author on several journal articles, reviews and book chapters.
Head of Disease Area, Oncology & Technical Development Novel Biologic Entities,
Senior Manager - Global Program & Translational
Before joining the Novartis Technical R&D Portfolio Management team in 2017 as Disease Area Head responsible for the CMC development of the Oncology & Immuno-Oncology programs and heading a group of Technical Project Leaders, Dr Lohrmann has been Senior Global Program Manager at Translational Clinical Oncology of the Novartis Institutes for BioMedical Research, leading clinical ADC and Immuno-Oncology programs since 2015. Prior to this role, Jens Lohrmann was pivotal in developing and establishing Novartis’ ADC CMC strategy as a Technical Project Leader at the Biologics Technical Development and Manufacturing Unit since 2010. Before joining Novartis, Dr Lohrmann worked at the biotech start-up Genovac/Aldevron, focusing on development of various customized antibody services such as genetic immunization and antibody purification. He received his Ph.D from the Albert-Ludwig’s-University in Freiburg, Germany. Prior to his doctoral thesis, he enrolled at Universities in Germany and Australia.
Jeremy Duvall is Associate Director of Discovery Chemistry at Mersana Therapeutics in Cambridge, MA. At Mersana, he leads a group focused on the discovery and development of novel payloads and related ADC platforms. Prior to joining Mersana, he was a Research Fellow and Director of Medicinal Chemistry at Ensemble Therapeutics and a Senior Group Leader at the Broad Institute of MIT and Harvard.
Senior Principal Scientist/LC-MS Technical Integration Lead
Bristol Myers Squibb
Dr. Wang is the Lead, LC-MS Technical Integration/Sr. Principal Scientist in the Bioanalytical Sciences/Translation Medicine Department at Bristol-Myers Squibb. Dr. Wang graduated from Beijing University (China) in 1987 and received his Ph.D. in analytical chemistry at Michigan State University in 1994. Following postdoctoral training at the National Institutes of Health (NIH) in Maryland USA, he joined GSK in 1996 and then Bristol-Myers Squibb in 1997. Dr. Wang has 20+ years of experience in discovery and regulated bioanalysis in pharmaceutical industry. Dr. Wang has contributed in high throughput bioanalysis and bioanalytical chromatography. In recent years, Dr. Wang has been leading a group of scientists in developing ligand binding and LC-MS/MS hybrid assays for ADC bioanalysis in an LBA and LC-MS integrated approach. Currently, Dr. Wang serves as the coordinator of Regulated Bioanalysis Interest Group at ASMS and a sub-team lead of AAPS ADC bioanalysis committee.
Executive Vice President, Emeritus & Distinguished Fellow
Dr. Lambert graduated from Christ’s College, University of Cambridge (England, UK), with a degree in Natural Sciences in 1972. He then went on to earn a Ph.D. in Biochemistry (1976) from the University of Cambridge, working on enzyme structures under the supervision of Professor Richard N. Perham. Dr Lambert’s postdoctoral training was at the University of California, Davis, working on ribosome structure in the laboratory of Dr Robert R. Traut (1976-1980), and at the University of Glasgow, Scotland working on the arom multienzyme complex in the laboratory of Dr John R. Coggins (1980-1982). In 1982, Dr. Lambert joined the Dana-Farber Cancer Institute, Harvard Medical School, working on the ImmunoGen-funded programs to develop antibody-drug conjugates (ADCs) and immunotoxins as anti-cancer therapeutics. Dr. Lambert joined ImmunoGen in 1987 when the company established independent research laboratories in Cambridge, Massachusetts. After working in a variety of roles at the company, Dr. Lambert served as Chief Scientific Officer from 2008 until 2015. In 2016, he became a Distinguished Research Fellow at the company until his retirement at the end of 2017. He served on the Executive Committee of the company as Executive Vice President, Research, from 2008 until 2016, followed by a year (2017) on the Executive Committee in an Emeritus capacity. During Dr Lambert’s tenure in leadership roles at ImmunoGen, the company invented the ADC technology that resulted in the Genentech/Roche drug, Kadcyla® (approved in 2013 for treating HER2+ breast cancer), as well as numerous other ADCs taken into clinical development. One of these is ImmunoGen’s promising drug candidate, mirvetuximab soravtansine, an ADC currently in a phase 3 trial for the treatment of platinum-resistant ovarian cancer. Dr Lambert is the author/co-author of over 120 peer-reviewed scientific publications. In 2016, Dr Lambert was elected as a Fellow of the American Institute for Medical and Biological Engineering (AIMBE). In 2018, he was appointed as an Honorary Professor of Queen’s University, Belfast, Northern Ireland, UK.
John Vallerie Douglas
I have over 20 years of experience in biopharmaceutical R&D specializing in the application of mass spectrometry to protein characterization. I currently lead a mass spectrometry core group at Seattle genetics that is dedicated to developing robust, quantitative MS-based approaches for the characterization of relevant molecular critical quality attributes in ADCs. In order to support accelerated clinical development timelines, MS methodologies for product characterization should perform well in high-throughput environments and, automated data analysis approaches should be put in place to facilitate fast turnaround of actionable data. My talk will describe how we have taken MS based approaches for comprehensive characterization and distilled them down to operationally simple, highly sensitive kit methods that can be quickly and scalably deployed in a fast paced high-throughput lab to support early clinical development.
Cancer Research Institute
Dr. Jun Tang joined the Clinical Accelerator program in January 2017 as a senior research analyst, where he has been leading the intelligence support to novel immuno-oncology (IO) combination therapy clinical trials. In this program, Jun analyzes the landscape of the clinical IO development, identifies promising IO combination therapies, collaborates with leading clinical investigators to test these combinations in clinical trials, supports due diligence requests from nonprofit and industry partners, and also publishes analyses in leading academic journals. To date, work from Dr. Tang at CRI has been published in Annals of Oncology and Nature Reviews Drug Discovery. Dr. Jun Tang received a PhD in translational medicine from Icahn School of Medicine at Mount Sinai and completed a research fellowship in Memorial Sloan Kettering Cancer Center. He has 33 publications, including 8 first-author papers and 2 corresponding-author papers in journals including Science Advances, Nature Communications, PNAS, and Nature Reviews Drug Discovery.
Technical Services Antibody Drug Conjugate Operations Manager
Dr. Katherine Mikulka has a Ph.D. in Materials Science Engineering and is currently a Manager of Technical Services in support of Oncology Operations at Pfizer. She has been working with clinical and commercial ADC’s at Pfizer, including Mylotarg and Besponsa, for more than 10 years.
Karim Malek joined ImmunoGen in May 2016 and is currently the lead physician on the mirvetuximab soravtansine program. Prior to joining ImmunoGen, Karim was chief of hematology and oncology at the Steward Medical Center in MA. Karim completed his training in hematology and oncology in Paris, France and Boston, MA.
Kathryn joined Spirogen in February 2018 as an analytical scientist where she develops and delivers analytical and QC services for small molecules and ADCs. This includes the development of assays for pharmacokinetics, enzyme activity, DNA-PBD (pyrrolobenzodiazepines) interaction and peptide mapping. Kathryn gained experience in proteomics and quantitative LC-MS/MS during her postdoc in the Target Discovery Institute at the University of Oxford (2014-2018) working with Paul Brennan, Kilian Huber and Benedikt Kessler. Prior to this, Kathryn completed her PhD in Chemical Biology and MChem in Pharmaceutical Chemistry at the University of Leicester. Under the supervision of Paul Cullis, Glenn Burley and Andrew Tobin, her PhD research focused on developing chemical tools to understand several kinases in the P. falciparum parasite.
Director, Clinical Assay Group
Dr. Kirkovsky is a Director in the La Jolla Clinical Assay Group at Pfizer. He received his PhD degree in Organic Chemistry from Moscow State University (Russia). His PhD work focused on the preclinical and clinical evaluations of antitumor drugs from the class of diazoketones. After completing a postdoctoral training in prostate cancer drug development at the University of Tennessee (Memphis, TN), he joined Biogen (Cambridge, MA) where he worked in the DMPK department focusing on preclinical ADME studies and clinical bioanalysis for cardiovascular and oncology indications. In 2002, he joined Anadys Pharmaceutical in San Diego as a Group Leader and then a Director of DMPK. He established and led a DMPK group that provided a broad spectrum of ADME evaluations of small molecule drug candidates for HCV and oncology indications. He also served as a Project Leader on the NS5B HCV program. In 2007, Dr. Kirkovsky joined Pfizer in St. Louis, where he led a preclinical in vivo and a non-GLP bioanalytical groups that supported preclinical development of small molecule drug candidates for inflammation projects. He also served as an ADME lead on the program evaluating new peptides as a potential modality for a broad spectrum of therapeutic applications. In 2010, Dr. Kirkovsky joined the Clinical Assay Group (CAG) in Pfizer in La Jolla supporting Oncology programs including small molecule, ADC ad Nanoparticle drug candidates. Research interests include preclinical and clinical ADME evaluations and bioanalysis of a broad spectrum of drug candidates, with recent special emphasis on ADCs and Nanoparticles.
Director, Preclinical Development Epochal Precision Anti-Cancer Therapeutics (EPAT), OBG
Keiji Furuuchi, PhD is currently leading Preclinical development as a director, EPAT (Epochal Precision Anti-Cancer Therapeutics), Eisai, Inc, since merger of immunotherapy development and pharmacology development in April, 2018. Prior to the position, he was assistant professor at Thomas Jefferson University and he joined antibody development in the Morphotek since 2009. Currently, his department conducts various preclinical evaluation for various projects in EPAT.
Beacon Targeted Therapies
Letrishka Anthony leads the research and analysis team for Beacon ADC Trials Intelligence. Letrishka's first and second degrees are in chemistry and drug development which has helped her lead the recent introduction of clinical and preclinical drug data intelligence for the Beacon ADC data service. Letrishka continues to innovate in the field of analytics and informatics for scientists involved in antibody drug conjugate research
Head of Process & Analytical Development
Lisa spent seventeen years with Monsanto working on both agricultural and pharmaceutical projects followed by seven years at Pfizer focused on analytical control strategies and transfer to manufacturing. With over 25years of experience in both organic synthesis and analytical sciences, Lisa has had the opportunity to contribute to many projects ranging from discovery to full development, but none have been exciting as the emergence of ADCs. Lisa joined SAFC in January of 2010 as an Analytical Project Lead responsible for ADCs. Lisa also has an extensive chromatography background with experience in integrated LC/MS screening systems. Lisa is currently the Senior Manager of Process and Analytical Development group. Lisa is originally from the St Louis area and lives on a small farm where they raise cattle and show pigs
Senior Medical Director
Louie Naumovski is a Senior Medical Director at AbbVie Biotherapeutics. Louie is a physician-scientist with extensive oncology drug development expertise. His interests include early clinical and pre-clinical development of novel oncology drugs and translating preclinical science into clinical proof of concept.
Chief Scientific Officer
Dr. Nasoff is currently the Chief Scientific Officer at the Center Of Innovation (COI) in San Diego, California. He received his PhD in microbial genetics from the University of Maryland, followed by postdoctoral training in organic synthesis at the University of Colorado, where he participated in the start-up of Amgen. Dr. Nasoff moved to Boston to join the Genetics Institute as a principal scientist in 1984. In 1987 he relocated to San Diego where he became the research director for several biotechnology companies that developed a diverse number of technology platforms and therapeutic products. For 13 years he was the Director of Biologics at GNF (a subsidiary of Novartis) where he worked closely with Novartis Biologics on the development of multiple human therapeutics. His career spans 35 years in the biotechnology industry during which he has authored 50 patents and 30 publications.
Chief Scientific Officer
Mark Bilodeau is Chief Scientific Officer at Tarveda, with more than 20 years of experience in medicinal chemistry and drug discovery. Previously, he was Senior Director of Medicinal Chemistry at Merck & Co. Inc., where he developed a broad background in drug discovery for the oncology, pain, neuroscience, ophthalmology, and cardiovascular therapeutic areas. Dr. Bilodeau received a B.S. in Chemistry from Boston College and a Ph.D. in Organic Chemistry from Harvard University. He conducted postdoctoral studies at the Memorial Sloan-Kettering Cancer Center.
Mark Frigerio received his PhD from University College London in 2003. His post graduate research in the laboratory of Professor Karl Hale was synthesising antitumour macrolide Bryostatins resulting in the enantioselective formal total synthesis of Bryostatin 7. His drug development experience includes working as team leader at KuDOS Pharmaceuticals on targeting the DNA-PK and ATM kinases involved in double strand DNA-damage repair pathways implicated in the treatment of cancers as well as at Pharminox developing G-Quadruplex binders targeting the non-canonical forms of DNA and also developing next-generation Temozolomide analogues designed to overcome the alkylation resistance mechanisms. Mark joined PolyTherics in 2012 and his current role focusses primarily on leading the design and early development of Antibody Drug Conjugates (ADCs) including applications of Abzena’s ThioBridge™ conjugation technology platform for the production of stable and homogeneous ADCs.
Dr. Stroh is currently Senior Director, Clinical Pharmacology at CytomX Therapeutics following several previous positions across the industry of increasing responsibility. He has his PhD in Chemical Engineering from Cornell University.
Chief Scientific Officer
Maureen is an expert in the discovery and development of targeted biological therapies. She has published over 100 peer-reviewed manuscripts. Maureen also holds numerous patents, the majority of which are under active preclinical and clinical development by biotechnology companies. Prior to joining Forbius, Maureen was Principal Research Officer and Section Leader at the Canadian National Research Council (NRC). While at NRC, Maureen served as a Scientific Leader of NRC's Biologics Program, a pan-Canadian network of over 10 research teams. Under her leadership, this program established a successful track record in developing innovative protein therapeutics. Maureen is the recipient of many awards, including the prestigious Gervais-Dionne Award (2012) for her work on “New Cancer Targets and Matching Antibodies for Diagnostic and Therapeutic Use”. Maureen received her Ph.D. in Biochemistry from the University of Alberta and completed post-doctoral training at the laboratory of Drs. Michael Sporn and Anita Roberts where TGF-β proteins and their relation to carcinogenesis was newly-discovered.
Senior Vice President - Chemistry, Manufacturing & Controls
Michael Kaufman, Ph. D. is Senior Vice President of CMC at Mersana Therapeutics. He is responsible for all CMC functions related to ADC development, including development and manufacturing activities for antibody, payload-linker, drug substance, and drug product. Previously, Dr. Kaufman served as Vice President, Technical Development at Biogen, Inc. Before Biogen, Dr. Kaufman spent 10 years at Millennium/Takeda, most recently as Vice President, Pharmaceutical Sciences. Before that, he spent 15 years at Merck and Co., Inc. serving in various roles. Dr. Kaufman received a B.S. in Chemistry from the State University of New York, Stony Brook and a Ph.D. in Physical Organic Chemistry from the University of California, Berkeley. He is the author of over 30 published articles and is named on 10 patents, and has lectured widely in the areas of preformulation, process development, and formulation.
President & Chief Executive Officer
NJ Biopharmaceuticals LLC
Naresh Jain, Ph.D is President & CEO of NJ Biopharmaceuticals LLC
Associate Director Research & Development
Nazzareno Dimasi Ph.D. is Associate Director R&D at AstraZeneca where he works on innovative biopharmaceutical research in antibody engineering, multispecific antibodies and antibody-drug conjugates.
Chief Scientific Officer
Nicholas Keen, Ph.D., is chief scientific officer of Bicycle Therapeutics. He joined Bicycle from Novartis, where for the past five years he served as the Cambridge (US) head of oncology research. During his tenure at Novartis, Nick was responsible for leading research from basic target identification and drug discovery through to enabling early clinical trials. Under his leadership, the group delivered multiple new therapies to the clinic spanning the range from novel allosteric small molecule inhibitors of previously intractable targets, to advanced biologic therapies. His team was also responsible for publishing many basic discoveries in cancer biology, and for building industry leading platforms in whole genome scale target identification and in modelling the diversity of human clinical trials in mice. Prior to his time at Novartis, Nick led the early lead generation group for oncology at AstraZeneca’s US research site with a particular focus on epigenetic regulation, and before this held positions of increasing responsibility in AstraZeneca’s UK oncology research group. During his time at AstraZeneca he delivered multiple agents to the clinic and was instrumental in the acquisition of KuDOS Pharmaceuticals leading to the registration of Olaparib (a first in class PARP inhibitor) for the treatment of BRCA mutant cancers. Nick completed his undergraduate studies at the University of Cambridge in natural sciences, his graduate studies with the Imperial Cancer Research Fund in Cambridge (now merged with The Cancer Research Campaign to form Cancer Research UK), and his post-doctoral studies at the Laboratory of Molecular Biology in Cambridge UK.
Lab Head / Scientific Specialist
Patrick Dennler, Ph.D. (born 1986) studied pharmaceutical sciences at the Swiss Federal Institute of Technology (ETH, Zurich, Switzerland). During his graduate studies in the group Prof. Schibli at the Paul Scherrer Institute (Switzerland) and the ETH, he focused on the development of an enzymatic method for the site-specific modification of proteins. Among different projects, he established a novel chemo-enzymatic approach to generate homogeneous antibody drug conjugates (ADCs) in collaboration with Innate Pharma S.A. (Marseilles, France). Patrick Dennler began his industrial carrier as a senior scientist in process development at Lonza in Visp (Switzerland) in 2015. He currently leads the bioconjugation process development lab as a scientific specialist. His activities focus on the development and scale-up of bioconjugation processes, including their manufacture under GMP for clinical and commercial supply.
Vice President Chemistry & Distinguished Fellow
Vice President, Chemistry Senior Distinguished Research Fellow Seattle Genetics, Inc.
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.
President & Chief Executive Officer
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.
Research Professor of Cardiothoracic Surgery &, by courtesy, Medicine & Surgery (Emeritus)
Stanford University School of Medicine
Dr. Morris (Emeritus Research Prof., Stanford School of Medicine was the Global Head of Transplant [Tx] Discovery Research & Head of Tx Translational Medicine [Novartis AG]) led his teams to discover new uses of, patent, &/or to first publish 6 1st-in-class drugs. Drugs in these classes have been approved for > 9 indications (25 MM patients treated) generating cumulative sales of approx. $80 BB (No royalty income for Dr. Morris).
Clinical Research Fellow in Lymphoma
Adam Gibb trained in Newcastle-Upon-Tyne in the 1990s and has been working with Professor John Radford as a Clinical Research Fellow in Lymphoma at The Christie, Manchester, since 2009. As a part of a busy clinical research team consisting of over ten physicians and research nurses seeing over 100 patients per week, he is a sub-investigator in a portfolio of over 30 currently recruiting clinical trials, the majority early phase with novel agents. He has multiple publications in the field of lymphoma including first author of the BREVITY study of brentuximab vedotin in older/frailer Hodgkin patients. Outside of work he enjoys bouldering, mountain biking and esoteric electronica of the 1990s
With in-depth knowledge of the latest industry trends, I have extensive experience in antibody drug conjugate (ADC) technology, including Bi-functional ADC constructs, novel drug linker screening, analytical testing methods, and bioconjugation process development and scale-up. My last 10 years at Abbvie/Abbott has given me great experience with two ADC drugs in humans trials, including StemCentrx ADC process development work. . Prior to Abbvie, I conjugated with the Mylotarg pioneers at Coulter Pharmaceuticals in 1999, then moved to Eos Biotechnology, were we had one of the first ADC development contracts with Seattle Genetics. Eos Biotechnology was acquired by Protein Design Labs, which eventually was acquired by Abbott/Abbvie.
Sabra Hanspal is a Senior Scientist at AbbVie in the manufacturing sciences downstream purification group. She started at AbbVie in 2016 in process R&D where worked on the process development and characterization of several early-phase ADC programs. Sabra then transitioned into her current role in manufacturing sciences where she is responsible for technical support of all commercial and near-commercial ADC drug substance processes, including technology transfer, scale-up, and process validation support. Sabra holds a PhD in chemical engineering from the University of Virginia and a B.S. in chemical engineering from Umass Amherst.
Scott T. Tagawa, MD, MS is the Richard A. Stratton Associate Professor in Hematology and Oncology, an Associate Professor of Clinical Medicine & Urology at Weill Cornell Medicine, and an Associate Attending Physician at NewYork-Presbyterian – Weill Cornell Medical Center. After earning his BS from Georgetown University, Dr. Tagawa received his MD at the University of Southern California School of Medicine. After completing his Internship and Residency training there, he became Chief Resident and subsequently underwent fellowship training in Hematology and Medical Oncology, being appointed Chief Fellow for his final two years. He had the opportunity to train with international leaders in Genitourinary (GU) Oncology. In August 2005, he was appointed Assistant Professor of Medicine at Mount Sinai School of Medicine, serving as Associate Program Director for the Fellowship Training Program. As Director of Genitourinary Oncology for the Division of Hematology and Oncology and Director of Medical Oncology for the Deane Prostate Health and Research Center, Dr. Tagawa took the lead in developing genitourinary clinical trials. He was recruited to Weill Cornell Medical College in 2007. His research covers clinical and translational investigations in genitourinary tumors and thrombosis in malignancy. As the Medical Director of the Genitourinary Oncology Research Program, Dr. Tagawa leads clinical trials in the areas of prostate, bladder, and kidney cancer as well as the prevention and treatment of thrombosis with cancer. He specializes in drug development in prostate cancer with a particular interest in prostate-specific membrane antigen (PSMA) theranostics. Dr. Tagawa also serves Medical Director of the Meyer Cancer Center Cancer Clinical Trials Office, Associate Director of Clinical Research for the Division of Hematology and Medical Oncology, and Chair of the Clinical Study Evaluation (scientific review) Committee for cancer. He was promoted to Associate Professor of Clinical Medicine and Urology in 2013. Dr. Tagawa is the WCMC principal investigator for the Alliance for Clinical Trials in Oncology (formerly CALGB), serving on the Board of Directors and as a funded member of the Genitourinary Committee. He is currently a member of the Clinical Practice Guidelines Committee of the American Society of Clinical Oncology (ASCO). Additionally, he serves on the editorial boards of many journals, is a member of numerous national and international medical and scientific societies, and has been named on multiple “top doctor” award lists.
Principal Scientist - Analytical Sciences
Scott Henry received his bachelor’s degree in Chemical Engineering from the University of Colorado, Boulder and his Ph.D. in Bioengineering from the University of Washington. He is experienced with a variety of therapeutic proteins and bioconjugates including antibodies, antibody drug conjugates and oligonucleotides. His expertise includes method development and transfer, product characterization, and comparability studies. Scott has supported projects from proof of concept research through pivotal clinical trials, and helped set effective CMC development and integrated product control strategies.
Seema Kumar is currently Associate Director and DMPK senior project representative at EMD Serono Inc. (a business of Merck KGaA, Germany). In her role, Dr. Kumar is responsible for overall drug disposition characteristics of NBE portfolio including PK, ADME, bioanalytical (BA) and immunogenicity strategy through the different discovery and development stages. Previously, Dr. Kumar led regulated Bioanalytical group in BioMedicine Design-Pharmacokinetics and Dynamics Metabolism department at Pfizer. The group provided regulated (GLP/GCP) BA support including assay development, validation and sample analysis for PK, ADA and Nab assessments for pre-clinical and clinical development of Pfizer’s large molecule programs. Prior to joining Pfizer, Dr. Kumar had served at roles of increasing responsibility as Director of Quality Control and Director of CLIA certified Clinical Bioanalytical Lab at XBiotech USA Inc. Dr. Kumar holds a Ph.D. in Biophysical Chemistry from Johns Hopkins University and has published several publications in peer-reviewed journals and contributed to several book chapters. Dr. Kumar has given numerous talks in various national and international scientific conferences and meetings and is an active member of IQ consortium ADC working group.
Shawn Novick has been working in the BioPharmaceutical Industry for 30 years. She spent the first half of her career focused on assay development and product characterization at Immunex and Amgen, and the second half leading the Quality Control group at Seattle Genetics. She has worked on an array of Biotherapeutics, including Antibody-Drug-conjugates (ADCs), and has helped drive a number of the products to become commercially available, such as Leukine®, Enbrel®, Bexxar®, Vectibix®, Adcetris®, and others. Shawn is an active contributor in international symposia. She has led multiple workshops, presented numerous times, and chaired sessions at key industry CMC-Regulatory meetings.
Director & Clinical Scientist
Sri Ghatta, PhD, Director, Clinical Research Scientist, Genmab, has over 15 years of industrial experience where he has managed many clinical studies of Antibody Drug Conjugates and novel antibodies. He leads several strategic programs, focused on developing science and operations at Genmab. Dr. Ghatta was the recipient of funding from the American Heart Association. He has authored 14 manuscripts and speaker/chair at several national and international conferences. Dr. Ghatta received his PhD from North Dakota State University, Fargo and Masters in Clinical Research and Organization management from Drexel University, Philadelphia.
University of Tennessee
Professor Subhash C. Chauhan, Ph.D. in Major Reproductive Endocrinology from Central Drug Research Institute (CDRI), Lucknow, India, with a B.S in Zoology, Botany and Chemistry from H.N.B. Garhwal University, Srinagar, Garhwal, India and M.S in Zoology, with Honors from same Institute. Research Associate, Department of Endocrinology, SGPGIMS, Lucknow, India (1997 -1998). Senior Research Fellow (SRF) and Junior Research Fellow (JRF) in Division of Endocrinology CDRI, Lucknow, India (1992 –1997). Research Associate awarded by Council for Scientific & Industrial Research (CSIR) 1998, Research Associate awarded by Indian Council of Medical Research (ICMR) 1997, are just to mention some of the awards he received. Scientific Officer (Electron Microscopy), Department of Pathology, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS), Lucknow, India (1998 – 1999). Post-Doctoral Research Associate in Department of OB /GYN Medical College of Ohio (MCO), Toledo, Ohio USA, (1999–2001). Research Associate and post-doctoral Fellow in Department of Biochemistry and Molecular Biology, University of Nebraska Medical Center (UNMC), Omaha, Nebraska from the year 2001-2005. Research area of Interest includes Developing Molecular Markers for Early Cancer Diagnosis and Targeted Therapy for Cancer Treatment. He has worked around 8years in Cancer Biology Research Center, Sanford Research/USD, Department of OB/GYN and Basic Biomedical Science Division as Scientist and Associate scientist. While maintaining my productive research endeavors, I have an ardent passion for teaching. At UTHSC as a Professor, I have been involved in mentoring more than seven students that include undergraduates, summer trainees, and international exchange postdoctoral fellows. Additionally, I am a coordinator of Drug Delivery and Biochemistry Courses, which are designed for graduate, PharmD and medical students. In particular, my contributions are towards mentoring and teaching students by introducing them to the joys of discovery and the deeper understanding gained through problem-based learning, active and evidence-based learning, original research and creative scientific projects. Most of my direct and indirect mentees have been successfully publishing impactful articles that have been presented at various conferences and symposia. This includes the Undergraduate and Graduate symposia in which they secured prestigious awards such as The Corner Stone Club award in System Service Excellence (2010), “Outstanding Mentored Academic Inductee 2013-2014 (UTHSC)”, Outstanding Achievement Award (Society of America Asian Scientist in Cancer Research 2018, SAASCR, USA), “Shri R. J. Kinarivala Cancer Research Award 2018-2019 (The Gujarat Cancer & Research Institute and The Gujarat Cancer Society)”, etc. In addition, my research led to several patent/licenses (US9642925 B2, CA 2735631, etc.). This demonstrates my substantial and consistent commitment to my mentees with transformative educational and scholarly experiences. My research publications in high impact journals and substantial funding repertoire including current funding, personnel and financial administration, active and regular participation in teaching, dynamic involvement in university and outreach services, demonstrate my excellence in all four areas (scholarship, teaching, service and administration). Professor Subhash C. Chauhan, guided five graduate students for PhD degree. He served as a graduate student committee member for 7 students and also involved in mentoring a junior faculty member and four postdocs. With over 57 visiting professorships and invited lectures, 6 event organization and various editorial appointments. Applied for four US Provisional Patents for developing a novel anti-cancer drug and one patent is already approved. One product is pending for technology transfer to Advance Orthomolecular Research (a Canada based company). Professor Subhash C. Chauhan has submitted 103 Peer-reviewed journal articles, 150 presentations, 11 books and book chapters and 1 edited Book(s). Professor Subhash C. Chauhan has society memberships in American Association for Cancer Research (AACR), American Association for Advancement of Science (AAAS), Perinatal Research Society (PRS), South Dakota Academy of Science (SDAS).
Research & Development
Tom Nittoli has over 20 years of experience in the pharmaceutical industry and is currently Director of R&D Chemistry. Dr. Nittoli joined Regeneron in 2010 to advance conjugated antibodies and proteins from discovery to development. Since joining Regeneron, he has developed a variety of small molecules for protein conjugation, lead diverse teams of discovery ADC scientists, and lead cGMP synthesis and conjugation campaigns. Prior to Regeneron, Dr. Nittoli held positions at Pfizer, Wyeth, and CIBA-Giegy. He holds a PhD from the department of chemistry SUNY Stony Brook in the lab of Scott Sieburth and was a post-doctoral fellow at UPenn in the labs of Amos B. Smith, III and Ralph Hirshmann.
Chief Scientific Officer
Dr. Lowinger joined Mersana in 2008, bringing nearly 15 years of global scientific leadership and drug discovery experience in the pharmaceutical and biotech industries. Over the course of his career at Bayer Pharmaceuticals in the US, Japan and Germany, he contributed to the discovery of more than 15 preclinical and clinical drug candidates in the areas of oncology, asthma, inflammation, virology, obesity and diabetes. Most notably, Dr. Lowinger is a co-inventor of the pioneering anti-angiogenic agent Nexavar (sorafenib), approved for the treatment of renal and hepatocellular cancer, as well as Stivarga (regorafenib), approved for the treatment of metastatic colorectal cancer. Dr. Lowinger has published more than 40 scientific papers and is a co-inventor on more than 40 patents. He has a B.Sc. (Hons.) in Chemistry and a Ph.D. in Organic Chemistry from the University of British Columbia and was a Merck Postdoctoral Fellow at the Ohio State University in the lab of Professor Leo A. Paquette. He currently serves on the Scientific Advisory Board of Keystone Symposia.
Chief Scientific Officer
Tony Polverino, Ph.D., joined Zymeworks in September 2018 and currently serves as Executive Vice President of Early Development and Chief Scientific Officer. Prior to joining Zymeworks, from 2015 until 2018, Dr. Polverino was at Kite Pharma, Inc., which was acquired by Gilead Sciences, Inc. in 2017. While at Kite he served as the interim Chief Scientific Officer and before that as Vice President of Research. During his tenure, Yescarta®, Kite's lead chimeric antigen receptor (CAR)-T cell therapy, was approved for relapsed or refractory B cell lymphoma, and multiple programs were advanced to the clinic. Dr. Polverino also assembled an innovative chimeric antigen receptor discovery and development team. Prior to Kite, he was at Amgen Inc. from 1994 to 2014, serving in a number of research leadership roles of increasing responsibility. While at Amgen he managed and advanced numerous research programs utilizing multiple therapeutic modalities, including immunotherapy, oncolytic viruses, bispecific antibodies, antibody-drug conjugates, and small molecules. He also played a key role in the development of over 12 novel antigens for antibody therapeutics. Dr. Polverino earned his undergraduate degree in pharmacology from Adelaide University and his Ph.D. in biochemistry from Flinders University, both in Adelaide, Australia.
Vice President, Clinical Development for Non-Breast Indications
Trishna Goswami, MD, MBA is a board certified hematologist/oncologist and VP of Clinical Development for Multi-Indications at Immunomedics, Inc. She is responsible for the clinical development of sacituzumab govitecan in non-breast cancer indications such as bladder cancer and multiple solid tumor indications. She has over 15 years of experience in clinical research in both the academic and pharma settings including development of multiple hematologic assets including immunotherapy at MedImmune/AstraZeneca. She believes thoughtful scientific inquiry backed by a passion to improve patient care is the tenet of successful drug development. In her free time, Dr. Goswami enjoys adventures with her husband, daughter and 2 dogs.
Vice President, Development
Ying Buechler joined Ambrx recently as Vice President of Development. In this role, she is responsible for protein therapeutics process development and manufacturing. Previously, she was Executive Director of Biologics Development and Manufacturing at aTyr Pharma, where she led the team comprising upstream and downstream process development, analytical and formulation development functions for more than 7 years, including the successful execution of development and manufacturing activities for multiple clinical programs. Prior to that, she was with Ambrx from 7 years and served as director of process development and characterization. She has over 20 years of biotech industrial experience on therapeutic protein development and manufacturing. She received her Ph.D. in Chemistry from University of California, San Diego.
• Multifaceted investigator with more than 15 years of Oncology drug discovery experience spanning both large and small molecule therapeutics • Proficient in targeted drug research and development in diverse therapeutic platforms: Functional tumor drivers including RTKs and non-receptor TKs, growth factors, GPCRs, cell-cycle checkpoint kinases, tumor associated antigens (TAA) • Proven ability to lead monoclonal antibody projects, including functional blocking antibodies and armed antibodies such as ADC and CAR-T • Expertise in the discovery and validation of novel and differentiated TAAs (tumor associated antigens) as well as functional cancer targets (discovered majority of MedImmune Oncology TAA pipeline)
Brian Safina, Ph.D., serves as vice president for Bolt Biotherapeutics, where he leads chemistry and bioconjugation toward developing novel immuno-oncology therapeutics. He joined Bolt in 2018 with over a decade of medicinal chemistry experience at Genentech. Dr. Safina has made significant contributions to the discovery of multiple clinical candidates in the areas of oncology, immunology and neuroscience. Dr. Safina holds a Ph.D. in organic chemistry from the University of California, San Diego, where he worked in the laboratories of K.C. Nicolaou
VP of Business Development & Marketing
Vice President & Global Head of Translational Sciences
Chief Science Officer & Vice President - Translational Medicine
Dr. Boyle is a senior executive with 28 years of pharmaceutical and biotechnology industry experience including leadership roles in private start-up and multinational companies. He is an Associate Professor of Medicine at UCLA David Geffen School of Medicine and Director of the DGSOM CTSI Accelerator. He currently serves as Chief of Translational Medicine at BioAtla, LLC. He is a founder of AnaptysBio [ANAB; NASDQ], a therapeutic antibody company based on somatic hypermutation technology, where served as President and Chief Science Officer. Before AnaptysBio, he was the Chief Scientific Officer for Auxeris Therapeutics and was Vice President of Biology at Protein Pathways. Prior to these roles, Dr. Boyle was at Amgen, Inc. for over 11 years, and was involved in the discovery and development of novel protein and small molecule candidate therapeutics. He was formerly Director of Discovery Research and led the basic research effort as part of the preclinical and clinical development of OPG and derivative RANKL antagonists. His research in this area helped to define the RANK-RANKL signaling pathway, and he led the discovery and characterization of AMG 162 (Denosumab®), a RANKL-targeted human monoclonal antibody therapeutic approved in the U.S. and E.U. for osteoporosis (Prolia®) and for bone metastasis and skeletal related events (Xgeva®). Dr. Boyle was instrumental in organizing and leading the research effort behind their rheumatology franchise, and in developing a corporate partnership with Abgenix, which resulted in the isolation of AMG 162 and Amgen’s first antibody IND filing. Dr. Boyle holds a Doctoral degree in Experimental Pathology from the UCLA School of Medicine and was a Howard Hughes Medical Institute Postdoctoral Fellow of the Life Sciences Research Foundation, at the Salk Institute in La Jolla.
Associate Director - Downstream Process Development
Tae Kyo Park
Chief Executive Officer
IntoCell : CEO LegoCehm Biosciences: CTO/Executive VP LG Life Sciences: Project Leader Memorial Sloan Kettering Cancer Center: Postdoctoral Researcher Yale University: Postdoctoral Researcher MIT: Ph.D (Bioorganic Chemistry) Seoul National University: Bs & Ms (Chemistry)
Ajinomoto Bio-Pharma Services
R&D Biological Senior Manager
Vice President - Process Development & Head of Chemistry, Manufacturing & Controls
Chief Business Development Officer
LegoChem Biosiences is a clinical stage biotech with expertise in medicinal chemistry and it has extended its expertise to ADC and developed next-generation site-specific ADC platform with novel linker that improves stability of ADCs in blood circulation, effectively prevents premature drug release, efficiently facilitates liberation of the drug at targeted tumor cells along with differentiated payload technology with superior efficacy and reduced toxicity that show significant improved therapeutic index.
Sales & Scientific Consultant
NOF America Corporation
Dr. Roberts has 20+ years of pharmaceutical research, development and corporate development experience. He is President of MAC B Consulting and is a Sales and Scientific Consultant at NOF America Corporation. Prior to becoming a consultant, Dr. Roberts was VP, Business Development and Corporate Officer of publicly traded Chelsea Therapeutics, Inc. He led the sale of Chelsea Therapeutics to H. Lundbeck A/S in 2014 for $658M. Prior to Chelsea Therapeutics, Dr. Roberts was Director of Business Development for their Nektar Therapeutics’ Molecule Engineering technology and completed a number of transactions with large and specialty pharmaceutical companies. Prior to this he was Manager of Biopharmaceutical Research at Shearwater Corporation where he led and was successful in the development of preclinical drug candidates from initial stages of research through Phase I clinical study, including invention of Movantik™, a treatment for opioid-induced constipation, subsequently licensed to AstraZeneca in a billion-dollar deal. Dr. Roberts obtained his Ph.D. in Materials Science from the University of Alabama in Huntsville and B.S. in Chemical Engineering from Pennsylvania State University.
Floris van Delft
Chief Scientific Officer
Business Development Manager
Dr Matteo Piazza joined Cerbios in 2017 as Business Development Manager for contract manufacturing activities for ADCs and recombinant proteins. Previously he held several positions in the field of Bioconjugation and Recombinant Proteins with academic institutions, ADC Bio Ltd, Nanotheter Discovery Science Ltd. (NDS) and Alpha-O-Peptides AG. His work focused on Antibody Drug Conjugates with multiple payloads, scaffolds and conjugation chemistries. He holds a PhD in industrial biochemistry with several publications on peer reviewed journals.
Senior Technology Manager, Biologics
Justin Sweeley is the Novasep's Senior Technology Manager for Biologics in North America. He has a Bachelor degrees in Molecular Biology, Chemistry, and Biochemistry from the University of Colorado at Boulder and also completed a PhD in Chemical and Biological Engineering from Colorado State University. Justin joined Novasep in 2018. He has 9 years of experience with process development in the pharmaceutical industry and prior to joining Novasep was as a senior scientist working on cGMP technology transfer for ADC projects Justin has a wide experience in Antibody Drug Conjugate process and analytical development, and a specific expertise in DoE based process development, and QbD based process validation.
Senior Medical Director
Chief Science Officer
Chief Scientific Officer, Member Board & Executive Vice President
Professor Pahl has 20 years’ experience in research and teaching and excellent expertise in biochemistry, pharmacology and toxicology. In 2008 he joined industry to pursue drug development for inflammatory and autoimmune diseases at Nycomed and Takeda. In 2012 he joined Heidelberg Pharma as the CSO extending his expertise to the area of oncology and antibody-drug conjugates. Since 2016 he is also CSO of Wilex, the mother firm of Heidelberg Pharma. Professor Pahl continues to be adjunct Professor for pharmacology and toxicology at the University of Erlangen-Nuremberg
Arnima has been working in the field of oncology diagnostics and therapeutics for 12 years. She joined Oxford BioTherapeutics in San Jose, CA in 2011 as an Antibody Specialist and held several positions, currently working as Scientific Manager. She has been working on early validation of novel proteins that are discovered at OBT in Oxford, UK and their preclinical development as targeted therapies. She has worked on multiple antibody programs, two of them are in clinical trials as ADCC and ADC therapeutics. She has been project lead for several ADC and IO programs at OBT, applying her expertise in monoclonal antibody and bispecific antibody generation, engineering, and development as therapeutics. Prior to OBT, she was working at Arbor Vita Corp. and was responsible for development of characterization of antigens and antibodies against various HPV targets that led to the development of a diagnostic product. She received her PhD in Biology from University of Delhi with National Merit scholarship.
Chief Scientific Officer
Chief Executive Officer
Senior Scientist Conjugation Process Development
Scott Hilderbrand is a Senior Scientist leading the pre-clinical Conjugation Development group at ImmunoGen. Prior to joining Immunogen in 2016, he spent 10 years at Massachusetts General Hospital as a Principal Investigator in the Center for Systems Biology. Scott has a Ph.D. in chemistry from MIT and completed his post-doctoral training at MGH/Harvard Medical School.
Vice President of Commercial Development & Technical Founder
Title: Vice President of Commercial Development & Technical Founder Dr. Italia earned his Ph.D. with an impressive publication track-record from Boston College as one of the first members in the Chatterjee Lab, where he pioneered the development and applications of universal genetic code expansion platforms. His work forms the core technology of BrickBio, a company formed with the financial support of Tiger Gene LLC. The technology enables the incorporation of unique unnatural amino acids in both eukaryotes and E. coli which can be used to augment protein function as effective therapeutics. Dr. Italia’s current role at BrickBio revolves around the implementation of his technology into relevant clinical applications and the integration of the technology into partner company’s workflows at commercial scale. Furthermore, Dr. Italia has expanded and validated BrickBio’s commercial capabilities, attaining strategic investment from a large antibody manufacturer with long term partnership agreements.