12-15 November, 2018
Marriott Marquis & Marina, San Diego, CA

Expert Speakers

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Ahmed Bassyouni,
Independent Consultant

Over 15 years of experience in the pharmaceutical/biotech industry working in regulatory affairs, validation, quality assurance and quality control in a GMP environment. Experienced in commercial processes as well as clinical development. Knowledgeable in ICH, US and EU regulations and guidance documents. Highly experienced in project management, US and ex-US regulatory submissions, aseptic processing, change control, and validation (equipment, facilities/utilities, cleaning, and sterilization). Highly motivated and possess strong problem solving and communication skills, as well as, the ability to lead teams.

Alex Lazar
Director Analytical & Pharmaceutical Sciences
ImmunoGen

Alex Lazar is the Head of the Analytical and Pharmaceutical Sciences department at ImmunoGen, Inc.  Alex is responsible for the development of assays for immunoconjugates and their components (antibodies, linkers, and cytotoxic agents) and development of formulations for antibodies and immunoconjugates.  Alex received his Ph.D. in Analytical Chemistry from Brigham Young University in 1998, after which he completed his post-doctoral training at Oak Ridge National Laboratory.  He worked as a Senior Scientist at biopharmaceutical companies (Zycos, EMD Pharmaceuticals) until 2004, when he joined ImmunoGen. Since then, his work has been focused on the development of immunoconjugate biotherapeutic products.  Alex attended national and international scientific conferences, where he gave several presentations related to his work with maytansinoid ADCs.

Alexander Staudacher
Post-doctoral Research Scientist
University of South Australia & University of Adelaide

Dr. Alex Staudacher is a Post-doctoral Research Scientist in the Translational Oncology Laboratory, Centre for Cancer Biology, University of South Australia and SA Pathology.  Dr. Staudacher's work has focused on the dead-tumour cell-specific antibody APOMAB.  This work includes radiolabeling the antibody with PET-emitting radionuclides for non-invasive PET imaging or labeling the antibody with beta-emitting or alpha-emitting radionuclides as a therapeutic in mouse tumour models.  His work now focuses on whether ADCs of APOMAB could be effective in controlling tumour growth in pre-clinical cancer models.

Alison Armour
Chief Medical Officer
Endocyte

Dr. Alison Amour joined the company as Chief Medical Officer in August 2015. Prior to joining Endocyte, led the global strategic development of small molecule receptor tyrosine kinase therapy in breast and lung cancer at Novartis, GSK, and AZ. Before joining industry in 2004, Dr. Amour established herself as a thought leader in medical and radiation oncology and has doctorate on the specific targeting of tumors with radionuclide therapy. She practiced for many years at the Beatson Oncology Center in Glasgow. Dr. Amour graduated with a B.Sc. in biochemistry and M.B.,Ch.B. medical degree from Glasgow University Scotland in 1987. She practiced in acute hospital medicine for several years before specializing in both radiation and medical oncology. She holds an MSc in clinical oncology and FRCR at the Royal College of Radiologists London, UK. She was recently awarded the prestigious FRCP award for contribution to the field on medicine and oncology from the Royal College of Physicians in London. She lives in Indianapolis with her husband and daughter and is a keen portrait artist.

Aman Singh
PKPD Scientist
Janssen Pharmaceuticals

Aman Singh is a PK-PD Scientist in the Biologics Development Sciences department at Janssen Pharmaceuticals. Prior to joining Janssen in September 2017 Aman was a PhD candidate at the University of Buffalo. During his PhD Aman was involved in researching systems pharmacology, pharmacometrics and PK-PD modelling for ADCs and other novel biologics.

Amy Han
Director, Chemistry
Regeneron Pharmaceuticals

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).

Scientific Program – Day 2

Wednesday, November 14

16.30 | Novel Non-Cytotoxic ADCs for Potential Treatment of Atherosclerosis

Andreas Pahl
Chief Scientific officer
Heidelberg Pharma

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

Scientific Program – Day 1

Tuesday, November 13

17.00 | Antibody Targeted Amanitin Conjugates (ATACs)

Antoine Yver
Executive Vice President & Global Head of Oncology
Daiichi Sankyo

28 veteran of global pharma, most recently for 7 years global head development onco for AstraZeneca until joining Daiichi Sankyo in early 2016 to unleash the power of world class Japanese chemistry and protein engineering

Scientific Program – Day 1

Tuesday, November 13

17.30 | Daiichi Sankyo DXd ADC Technology: DS-8201 & U3-1402: Clinical Validation of an ADC Design Meant to Deliver a By-Stander Effect

April Wheeler
Manager
MilliporeSigma

April Wheeler joined MilliporeSigma in 2017 in the Technology Management group covering North America. She supports biopharmaceutical processes, with a focus on tangential flow filtration (TFF) and clarification. She has over 11 years of experience in the biopharmaceutical industry in Process Development, Tech Transfer, and Clinical Manufacturing Support roles at multiple companies. April received her B.S. in Biology at Indiana University.

Scientific Program – Day 2

Wednesday, November 14

07.00 | Breakfast Briefing: Complete Single-Use ADC Technology from Development Through Scale-Up

Armin Storz
Sales Manager
Bausch & Stroebel

In 1987, Armin Storz started at Bausch+Stroebel Ilshofen as an employee in the technical field. After having finished his economist degree in 2000 he started in the international sales and project managing department where he was involved in many high tech projects for the pharmaceutical industry. With his excellent experience in primary packaging machines, Armin Storz has since then made significant contributions to technological developments and accompanied numerous projects from the first inquiry to the SAT  (site acceptance test). Since 2000, he has been in charge of the North American territory as a Area Sales Manager.

Arturo Molina
Chief Medical Officer
Sutro BioPharma

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.

Bethany Powell Gray
Senior Research Associate, Sullenger Lab, Department of Surgery
Duke University Medical Center

Dr. Bethany Powell Gray received her Ph.D. in Biological Chemistry from the University of Texas Southwestern Medical Center studying peptide-targeted therapies for the treatment of lung cancer. During graduate school, she received both a University of Texas Chemistry/Biology Interface Fellowship and a Cancer Prevention Research Institute of Texas (CPRIT) training award. Dr. Powell Gray then joined Bruce Sullenger’s lab at Duke University Medical Center as a postdoctoral associate, focusing on aptamer-targeted therapeutics and imaging agents and receiving a Department of Defense (DoD) Prostate Cancer Research Program Postdoctoral Training Award. Currently, Dr. Powell Gray is a senior research associate in the Sullenger lab, where she continues to develop novel aptamer therapeutics and imaging modalities

Cecile Chalouni
Senior Scientist
Genentech

Dr Cecile Chalouni is currently Principal Scientific Researcher at Genentech, an affiliate of Roche healthcare company, located in the bay area. Since she joined Genentech in 2007, she has been supporting the imaging of projects in drug development, in areas such as oncology, immunotherapy, immunology and infectious diseases.  Prior to joining Genentech, Cecile was the Technical Director of the confocal imaging facility at Yale University School of Medicine, She received a Ph. D in Immunology from Pierre et Marie Curie University, in Paris.

Bob Lutz
Chief Development Officer
Forbius

Bob is Chief Development Officer of Forbius and brings extensive experience in the development of antibody-based therapeutics. Prior to joining Forbius, Bob held various R&D roles over a 23 year span at ImmunoGen, Inc, where most recently he was Vice President of Translational Research and Development, with responsibility for all early stage antibody drug conjugate (ADC) development programs. In addition, Bob was a member of ImmunoGen’s portfolio research committee, served on numerous alliance committees supporting the R&D programs of ImmunoGen’s licensed partners, and was ImmunoGen’s research lead on Genentech’s trastuzumab emtansine (Kadcyla®) program.  Earlier, Bob was part of ImmunoGen’s Apoptosis Technology Inc subsidiary where he led the research collaboration leading to the discovery of the BH3 domain of the BCl-2 family of death regulatory proteins. Bob is also the principal consultant for Crescendo Biopharma Consulting where he provides strategic, tactical and operational input to emerging biotech and pharma. Bob earned his Ph.D. in Biochemistry from Brandeis University and was a research and postdoctoral fellow at the Eleanor Roosevelt Institute in Colorado.

Brad Stringer
Associate Scientific Fellow, Molecular Pathology
Takeda

Dr. Stringer is currently an Associate Scientific Fellow at Takeda Pharmaceuticals based in Boston, MA.  He began his career in 2001 at Millennium Pharmaceuticals in the Molecular Pathology department. For the past several years, Dr Stringer’s lab at Takeda has been focused on ADC target discovery and validation, including target tissue mapping, tissue cross reactivity, patient selection assays, pharmacodynamic assays and biomarker discovery. Dr Stringer received his PhD in 1993 from Oklahoma State University in the areas of biochemistry and cell biology. His post doctoral work includes an NIH fellowship at the Harvard T.H. Chan School of Public Health and the Brigham and Women’s/Faulkner hospital in Boston in the areas of immunology, cancer biology, and anatomic pathology.

Brian Clark
Principal Consultant,
GMP Operations Consulting

Brian Clark is the Vice President of Manufacturing and previously served as Executive Director of Quality at ImmunoGen Inc.  Prior to ImmunoGen, Brian served as an independent consultant and owner at GMP Operations Consulting where he provided CMC regulatory, Quality, Manufacturing / Outsourcing support to numerous international biotechnology companies.  He has also held senior technical operations, development and program leadership management roles at biotechnology companies including Genzyme, Alkermes, Altus Pharmaceuticals, Agenus and Therion Biologics

Brian Mendelsohn
Director, ADC Chemistry
Ajinomoto BioPharma 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 BioPharma Services.

Scientific Program – Day 1

Tuesday, November 13

18.00 | Development of a Novel Chemical Site-Specific ADC Conjugation Platform

Charlie Johnson
Chief Executive Officer
ADC Biotechnology

Charlies Johnson is the Chief Executive Officer at ADC Bio. Charlie has been in Management and growth of Strategic Business Units for multiple Contract Manufacturing Organisations over 20 years in the Pharmaceutical sector. Business planning and implementation across CRAMs and Generics sectors, specialising in oncology CMO services

Chawita (Jelly) Netirojjanakul
Senior Scientist,
Amgen

I received a B.Sc. in chemistry from MIT, conducting research in the laboratory of Prof. John Essigmann (MIT) and Prof. Steve Ley (Cambridge).  After graduation, I received Gates Cambridge Scholarship to pursue my interest in science policy and commercialization studying an M.Phil. in Technology Policy at University of Cambridge, UK.  I returned to science and conducted Ph.D. research under the supervision of Prof. Matthew Francis in the chemistry department at UC Berkeley with a focus on "development and applications of well-defined antibody and antibody fragment bioconjugates."  I joined Amgen in 2014 to pursue my passion in designing and developing hybrid molecule therapeutics.

Chen Fang
Senior Scientist, Bioconjugation Development
Goodwin Biotechnology

Chen Fang, PhD is a Senior Scientist, Bioconjugation Development at Goodwin Biotechnology, where he performs proof-of-concept, process development, and manufacturing of bioconjugation and protein modification processes. Dr. Fang completed his BS in Materials Science and Engineering in 2001 at Shanghai Jiao Tong University, where he went on to complete his MS degree in Materials Science. From there, Dr. Fang attended the University of Washington where he completed his PhD in Materials Science and Engineering. As a post-doc, Dr. Fang worked at the Oliver Press Lab at the Fred Hutchinson Cancer Research Center, where he refined his expertise in the synthesis characterization and pre-clinical evaluation of antibodies, antibody-drug conjugates, radio-immuno-conjugates, bispecific antibodies, and nanoparticles.

Christian Rohlff
Chief Executive Officer
Oxford Biotherapeutics

Dr Rohlff became Chief Executive of Oxford BioTherapeutics in 2004, after founding the company and acquiring key targeting technology, bioinformatics data and intellectual property. He brings more than 20 years of experience in the international biotechnology industry to OBT. Following his PhD in Pharmacology from Georgetown University, he held a number of positions at the US National Cancer Institute. Prior to joining OBT, he held a number of positions of increasing seniority with Oxford Glycosciences, and led the company’s partnerships in oncology with Pfizer, GSK, Bayer, Wyeth, Takeda, Oxford University and the FDA.

Corinna Palanca-Wessels
Medical Director, Clinical Development
Seattle Genetics

Corinna is Medical Director, Clinical Development at Seattle Genetics. She has been at Seattle Genetics since 2013. She studied at the University of Washington and received a Bachelor of Scince, Biolohu, Doctor of Philosophy, Molecular and Cellular biology and doctor of Medicine. Served as Seattle Cancer Care Alliance site PI for Phase I CD79b Antibody Drug Conjugate Study (NCT01290549; industry sponsor Genentech/Roche; top accruing study site, presented data in oral sessions at ASH 2012 and ICML 2013 meetings; lead author for article published in Lancet Oncology; reviewed & signed final CSR as Principal Investigator)

Dale Miles
Senior Scientist
Genentech

Dr. Miles is a senior scientist in the Department of Clinical Pharmacology at Genentech.  He leads clinical pharmacology efforts across the late stage oncology portfolio in heme, including polatuzumab vedotin, an ADC in clinical development for the treatment of NHL.  Dr. Miles also leads the Pharmacology Subteam for polatuzumab vedotin, and is responsible for developing and implementing nonclinical strategies to support this molecule.  Prior to Genentech, Dr. Miles was an Executive Director at Exelixis Inc. supporting the clinical pharmacology for small molecule oncology drugs.  Prior to Exelixis, he worked at Pharmacyclics Inc. as a Director of bioanalytical chemistry.  Dr. Miles has published 30 peer-reviewed papers in the field of bioanalytical, drug metabolism and pharmacokinetics. Dr. Miles obtained his PhD and MS degrees in Chemical Engineering from Arizona State University, and his BS degree from Brigham Young University.

Daryl Drummond
Chief Scientific Officer & Head of Research
Merrimack Pharmaceuticals

Dr. Drummond currently serves as the Senior Director of Nanotherapeutics for Merrimack Pharmaceuticals, leads the nanotechnology efforts at Merrimack and was one of the principle inventors for many of Merrimack's nanotechnology-based drugs and platform technologies. MM-398, a nanoliposomal formulation of irinotecan is currently in Phase III clinical trials and MM-302, and ErbB2-targeted pegylated liposomal doxorubicin is currently in Phase I trials in metastatic breast cancer.  At Merrimack he leads a broad multidisciplinary team of chemists, biologists, pharmacologists, and biophysicists.  Daryl joined Merrimack in October of 2009 following the merger of Merrimack with Hermes Biosciences.  Dr. Drummond received a Ph.D. degree in Biochemistry from Indiana University in 1997, with an emphasis on membrane biochemistry and biophysics.   He later joined Hermes Biosciences in 2000 as an Associate Director of Liposomal Research and Development following a post-doc in the laboratory of the renowned father of current liposome drug delivery systems, Demetrios Papahadjopoulos.  Overall, Dr. Drummond has more than 20 years of experience in the research and development of advanced drug delivery systems, including four unique drugs that have been tested in various clinical trials, eight issued patents or patent applications, and more than 50 peer reviewed publications focused on lipid-based nanotherapeutics.

David Lee
Senior Director, Analytical Chemistry
Mersana Therapeutics

David is a Senior Director at Mersana Therapeutics where he leads the Analytical Chemistry department in support of platform technology and pipeline advancement, CMC-related analytical development and DMPK.  Prior to joining Mersana, David was at AbbVie Bioresearch Center where he led a team of scientists in analytical development and characterization of monoclonal antibodies, bispecifics and ADCs at early and late stages of of the pipeline.

David Satijn
Vice President, Antibody Products
Genmab

David Satijn holds a PhD in Molecular Biology from the University of Amsterdam. He was a Post-Doctoral Research Fellow at the department of Immunology, University of California San Diego where he studied T and B cell development. He became an Assistant Professor at the University of Amsterdam where he worked on the role of epigenetic elements and the stable production of recombinant antibodies. In 2006, he joined Genmab, and currently he develops the strategy and supervises Target Discovery, Antibody drug conjugate (ADC) technologies, Antibody Discovery Programs and Novel Antibody Products. David Satijn is based in Genmab Utrecht, the Netherlands and serves in the position Vice President, New Antibody Products.

David Tice
Director, Research & Development
MedImmune

Dr. David Tice has over 17 years of biopharmaceutical research experience. He spent the last 14 years at MedImmune, a subsidiary of Astrazeneca, where he currently heads the Antibody Drug Conjugate research group. Throughout his tenure at MedImmune, David has led several preclinical/clinical phase programs employing various therapeutic approaches including monoclonal antibodies, immunoconjugates, peptide mimetics, and RNAi targeting various molecules important in the development of cancer.  Prior to this experience David worked at Genentech, Inc. where he focused on genomics-based target discovery and monoclonal antibody targeting in cancer.  David began his training at the University of Virginia where he received his PhD.

Dengfeng Liu
Associate Director
MedImmune

Dr. Dengfeng Liu graduated from UC Santa Barbara with Ph.D degree on mass spectrometry. After graduation, Dr. Liu  has had over 13 years of extensive experience in biotech / pharmaceutical field and had worked for Medimmune, Amgen, Novartis and Gilead Science. Dr. Liu has solid training and considerable experience in analytical method development, method qualification / validation, method transfer, protein structure characterization, critical quality attributes (CQA) analysis, regulatory filing, and CRO/CMO management etc. Currently, Dr. Liu is an Associate Director at Medimmune focusing on ADC, Bispecific antibody, fusion protein, and mRNA analytical development.

Dian Su
Scientist
Genentech

Dian is a Scientist in Drug Metabolism and Pharmacokinetics (DMPK) at Genentech. Her primary interest is focused on small molecule drug metabolism in discovery stage. In this role, her responsibilities include: 1) developing new generation assays for metabolite identification (Met ID) to improve the throughput and tackle challenges associated with drug metabolite ID; 2) exploring deep understanding of metabolite formation and biological impact, and establish structure−activity relationship (SAR) for drug metabolites. Prior to Feb 2017, Dian was a scientist in the BioAnalytical Sciences-Assay Development & Technology Department (BAS-ADT) at Genentech. In this role, her major interest lied in biotransformation and bioanalysis of antibody-drug conjugates (ADCs) using immunoaffinity capture, high-pressure liquid chromatography (HPLC) and mass spectrometry (MS) strategies. Before joining Genentech in 2012, Dian held a postdoctoral position at the NIH Proteomics Research Resource for Integrative Biology in Pacific Northwest National Laboratory. She earned her Ph. D. in Chemistry in 2010 from Washington University in St. Louis under the direction of Michael L. Gross and John-Stephen A. Taylor. Dian has published her recent research on ADC biotransformations in Analytical Chemistry and Bioconjugate Chemistry. Her earlier research was published in multiple journals including J. Am. Chem. Soc. (JACS) and Proc. Natl. Acad. Sci. (PNAS). She has served as a co-chair for conference workshops and peer reviewer for several scientific journals

Ed Ha
Principal Scientist
Angiex

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.

Edit Tarcsa
Director, DMPK-BA
AbbVie

Head of DMPK-BA at ABC: Responsible for overseeing non-regulated bioanalytical support for biologics projects (mAb, DVD, ADC) across all AbbVie therapeutic areas. Research focused on developing novel bioanalytical methodologies (LBA, LC/MS, hybrid) to characterize biologics PK, immunogenicity and ADC clearance mechanisms.  Prior to Abbvie, completed a Postdoctoral fellowship in cell biology at Harvard Medical School, an NIH fellowship at NIAMS, Bethesda,  and received a PhD in biochemistry from the University Medical School of Debrecen, Hungary

Eunice Wang
Assistant Professor
Roswell Park Cancer Institute

Eunice S. Wang, MD, is Chief of the Leukemia Service and Professor of Oncology in the Department of Medicine at Roswell Park Cancer Institute, Buffalo, New York. She is also an Associate Professor in the Department of Medicine, School of Medicine of Biomedical Sciences at the State University of New York at Buffalo (SUNY-UB). Dr. Wang earned her medical degree from the Keck (University of Southern California) School of Medicine. She completed internship and residency in internal medicine at Yale-New Haven Hospital followed by clinical and research fellowships in hematology-oncology at Memorial Sloan Kettering Cancer Center in New York. Dr. Wang maintains an active clinical practice with portfolio of early phase clinical trials in acute leukemias and myeloid malignancies. She also leads a translational laboratory focused on preclinical studies of novel agents targeting the marrow microenvironment. She is a prior recipient of a NIH Cancer Clinical Investigator Team Leadership Award (CCITLA) and a Mentored Research Scholar award from the American Cancer Society. Dr. Wang serves on the National Comprehensive Cancer Network (NCCN) Clinical Practice treatment guidelines panels for Acute Myeloid Leukemia and Acute Lymphocytic Leukemias.

Melanie Derde
Head of Analytical, Bioconjugation
Novasep

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.

Gail Lewis Philips
Senior Scientist
Genentech

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.

Giorgio Salciarini
Technical Business Development Manager
BSP Pharmaceuticals

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.

Glenn Petrie
Senior Scientific Advisor
EAG Laboratories

A Senior Scientific Advisor (SSA) at EAG Laboratories, Dr. Glenn Petrie has more than 25 years of experience in biopharmaceutical drug development. As a director at a major CRO he served as team leader in the development, Chemistry Manufacture and Control (CMC) design and IND submissions for a wide variety of biopharmaceuticals (monoclonal antibodies, drug conjugates, enzymes, peptides, etc.). He is a subject matter expert in the analysis of proteins including UPLC, LC/MS/MS, ELISAs and CE.  As an SSA Dr. Petrie has been instrumental in the growth of EAG’s Biotech Group over the last 3 years creating a state-of-the- art laboratory. Dr. Petrie received his B.A. in Biochemistry from Rice University and his doctorate in Biochemistry from the University of Illinois Urbana-Champaign, as well as post-doctoral work at the Mayo Clinic.

Greg Sacha
Senior Research Scientist
Baxter Healthcare

Gregory A. Sacha, Ph.D., is a senior research scientist in research and development at Baxter Healthcare with 18 years of experience in the pharmaceutical industry.  Dr. Sacha currently leads a group of scientists in formulation and process development for parenteral products with a focus on the formulation of large molecules and lyophilization.  His research interests include formulation variables affecting the stability of large molecules, thermal analysis of pharmaceutical formulations, and factors affecting scale-up of lyophilization processes.  Dr. Sacha’s list of publications includes topics in parenteral product packaging and pre-filled syringes.

Hirokazu Suzuki
Researcher, Biologics & Immuno-Oncology Laboratories
Daiichi Sankyo

Hirokazu Suzuki Biologics & Immuno-Oncology Laboratories, PhD in Science. ADC project research team leader, Member of basic research for  novel target discovery of ADC. Joined Daiichi Sankyo in 2015.

Ian Schwartz
Process Development Consultant
Sartorius Stedim 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.  

Scientific Program – Day 1

Tuesday, November 13

12.05 | Lunch Seminar: Platforming Antibody Drug Conjugate Process Development & Manufacturing Using Single Use Technologies

Jack Sadowsky
Scientist
Genentech

Jack earned his Bachelor’s degree in Chemistry from Pomona College in 2000 and his Ph.D. in Chemistry from the University of Wisconsin – Madison in 2006.  His graduate work focused on the development of non-natural, oligomeric (beta-peptide) inhibitors of protein-protein interactions, leading to the identification of the first molecules in this class to potently antagonize members of the Bcl-2 protein family.  Following graduate studies, Jack joined the department of Pharmaceutical Chemistry at UCSF as a postdoctoral fellow where he worked on methods for probing and structurally characterizing allosteric sites on protein kinases with small molecules and peptides.  Jack then joined the startup company Carmot Therapeutics as a Scientist where he helped lay the foundation for a novel, high-throughput small molecule lead discovery technology called Chemotype Evolution.  In 2013, Jack joined Genentech as a Scientist where he works in the Protein Chemistry department leading the antibody-drug conjugation lab.  His current research interests are focused on chemical aspects of the development of next-generation ADCs and other bioconjugates, including new stable connection chemistries, cleavable linkers, novel payloads beyond traditional cytotoxics, and prodrug strategies.

Scientific Program – Day 2

Wednesday, November 14

17.00 | Amunix XTEN® Polypeptides & THIOMAB™ Antibodies to Enable Site-Specific High-DAR ADCs with Acceptable Pharmacokinetics & Efficacy

Jennifer Richardson
Vice President, Pharmacology & Toxicology
CytomX

Dr. Jennifer Richardson heads the pharmacology, toxicology and bioanalysis functions at CytomX Therapeutics, which she joined in 2011. From 2007 to 2011 she served as Director of Preclinical Development at Arca biopharma and its merger partner Nuvelo, where she helped advance a range of biological, small molecule and oligonucleotide-based assets through preclinical and clinical stage development. Prior to that she served as Associate Director for Preclinical Development at Abgenix, focusing on the pharmacological evaluation of mAb and ADC therapeutics, and as a Sr. Scientist for oncology drug discovery at Millennium Pharmaceuticals. Before entering the biopharmaceutical industry Dr. Richardson was an Instructor and Harvard Medical School-affiliated postdoctoral fellow at the Dana Farber Cancer Institute. Dr. Richardson received her PhD from Leicester University and her BSc from the University of York and has been a Diplomat of the American Board of Toxicology since 2011.

Jian Wang
Senior Principal Scientist, Bioanalytical Sciences
Bristol Myers Squibb

Dr. Wang is a Sr. Principal Scientist in the Bioanalytical Sciences 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.

Jimmy Bao
Executive Vice President, Antibody Discovery & Therapeutics
Abmart

Jimmy Bao, Ph.D., Research Investigator, currently Executive VP of Antibody Discovery and Therapeutics at Abmart (Shanghai) Co., Ltd, has broad research interest in immune-oncology and immunobiology. Dr. Bao has over 18 years of drug development experience in novel therapeutics including antibodies, ADCs, recombinant proteins, and DNA vaccines etc for the treatment of cancer, ophthalmic diseases, rare diseases, complement-dysregulatory, and autoimmune diseases. Dr. Bao received training in medicine and pharmacology from Shanghai Medical University, obtained Ph.D. from Karolinska Institute and completed his postdoc in Columbia University Center for Neurobiology and Behavior in the laboratory of Dr. Kandel, year 2000 Nobel laureate in Physiology or Medicine. Since 1998, Dr. Bao has worked mostly in California in a number of biopharmaceutical companies including GSK (“GSK”), Catalyst Biosciences (“CBIO”), MacuSight, Inc., and Quassia Biopharma, Co., in positions with increasing responsibilities from drug discovery, research and development, to regulatory filing and clinical studies. Dr. Bao has been involved in research and development of a number of drug candidates including MPL, the adjuvant used in GSK’s HPV vaccine Cervarix®.

John Harlan
Principal Research Scientist
AbbVie

Dr. John E. Harlan is a Principle Research Scientist in Pharmaceutical Discovery at AbbVie, Inc., located in North Chicago, Illinois.  As part of Protein Sciences in Global Biologics Research, his lab is actively exploring next-generation antibody-drug conjugation technologies.  In addition, his team is involved with the production and characterization of protein therapeutic candidates across multiple therapeutic areas.  He received his Ph.D. degree in Biochemistry from the Department of Biochemistry and Molecular Biology at the University of Chicago, and did his post-doctoral training with Steve W. Fesik in the Structural NMR department at Abbott Laboratories.

John Lambert
Executive Vice President, Emeritus & Distinguished Fellow
ImmunoGen

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.

Scientific Program – Day 1

Tuesday, November 13

07.25 | Honorary Chair

Johnny Yin
Principal
Johnny Yin Biotechnology Consulting

Johnny has 17 years of Biotechnology industry experience. Johnny is a knowledgeable preclinical R&D expert who has seen all stages of antibody drug discovery and development, including GMP manufacturing. Johnny’s specific and extensive experience in antibody target validation and drug discovery, combined with additional experience in pharmacology and translational medicine allows him to effectively evaluate the performance of early stage biologics, elucidate their clinical relevance, and see them evolve into late stage therapeutics in order to add value to the organization's program. Most recently Johnny was with Astellas Pharma US, designing and engineering biochemical and cell biology assays for the purpose of characterizing the performance, behavior, and mechanism of action of antibody-drug conjugates and its subunits (naked mAb's, free drugs, and linker technology).

Jon Roffey
Senior Group Leader
Cancer Research UK

Jon, a medicinal chemist by training, has more than 20 years drug discovery and commercial exploitation experience gained in the biotech and academic sectors.  He has worked in therapeutic areas covering CNS, obesity, Parkinson’s disease and cancer therapies, directly contributing to the development of multiple candidate drugs and late stage clinical agents.  In 2015 Jon joined CRUK Commercial Partnerships (previously CRT) most recently establishing CRUK’s largest drug discovery alliance, a major 5-year alliance with Celgene, to develop mRNA translation therapeutics.  He also played a major role in the formation of Azeria Therapeutics, where he is head of drug discovery with responsibility for all pre-clinical drug discovery operations.  Jon was also involved in the development and commercialization of CRT’s CDK11 antibody drug conjugate platform technology, recently licensed to Glythera where he also a member of their scientific advisory board.  Prior to CRUK Commercial Partnerships Jon was a senior group leader at CRT Discovery Laboratories in the oncology setting against targets including FOXA1, CDC7 and aPKC providing project leadership from target validation through to preclinical candidate nomination.  Earlier in his career Jon was employed at Spirogen, where he established the first proof of concept for Spirogen’s ADC platform.  Jon started his career in medicinal chemistry at Vernalis working on CNS targets for the treatment of obesity and Parkinson’s disease, delivering multiple candidate drugs for clinical evaluation.

Jun Tang
Senior Analyst
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.  

Karen Cha
VP, Early Development
Halloran Consulting Group

Karen Cha is a Regulatory Affairs (RA) consultant with 21 years of broad RA experience including 9 years in Quality Assurance. She has filed over 20 original Investigational New Drug applications (INDs) for various product types, many of those with smaller companies in early development where she led IND efforts covering all areas - nonclinical, CMC and clinical as well as regulatory operations. She has focused on biologics for oncology (monoclonal antibodies and antibody-drug conjugates) for the past 11 years with the last 8 years heading up Regulatory Affairs at the former affiliate of Astellas Pharma, Agensys, Inc. where she filed 7 original INDs for ADC products. Karen holds graduate degrees in Biomedical Science and Business Administration from Boston University.

Karim Malek
Medical Director
ImmunoGen

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.

Kyeong-Hoon
Senior Vice President, Head of R&D
Alteogen

  • 1988-1993 LG Chem, research scientist
  •  1993-1998 Boston University, PhD
  •   1998-2006 Harvard Medical School, research fellow/instructor in medicine
  •   2006-2007 Jungsan Biotechnology, chief scientist
  •   2007-2009 KT&G Life Sciences, CSO
  •   2010-2017 Gachon University/Gil Medical Center, research professor
  •   2017       Alteogen, Head of R&D Center

Laurie Tatalick
Consultant
Laurie Tatalick Consulting

Laurie Tatalick obtained her BS and Doctor of Veterinary Medicine from The Ohio State University. She then completed a combined Veterinary Pathology Residency and PhD program at Washington State University with a focus on immunology and animal models of human diseases.  She has a passion for translational medicine, applied pathology and toxicology with a goal of understanding the on- and off-target safety profile and mechanisms of toxicity of novel therapeutics moving through early research and into clinical development.  Laurie has been involved with bringing over ten ADC’s with different targets, linkers and payloads from research into clinical development.

Leo Kirkovsky
Director, Clinical Assay Group
Pfizer

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.

Leslie Sharp
Vice President, Immuno-Oncology
BioAtla

Dr. Leslie Sharp has extensive experience in the biotechnology and pharmaceutical industry.  Most recently Dr. Sharp was an industry consultant, providing expertise on portfolio strategy, drug discovery, translational research, and early clinical development of biological therapies for cancer to both biotechnology and pharmaceutical companies.  She previously served as Associate Director of Oncology at the Genomics Institute of the Novartis Research Foundation and at positions of increasing responsibility including as director level Associate Research Fellow at Pfizer.  Dr. Sharp has led multiple discovery and early clinical development programs in oncology biologics and has particular expertise in immunomodulatory antibodies and antibody-drug-conjugates.  Dr. Sharp earned her Ph.D. from the University of California, San Diego focusing on the role of signaling pathways in T cell development. Her post-doctoral work at The Scripps Research Institute examined the role of T cells in wound healing.

Lisa McDermott
Senior Manager, Process & Analytical Development Group
MilliporeSigma

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.  

Luc Desnoyers
Senior Director, Translational Sciences
CytomX

Dr. Luc Desnoyers is the Senior Director of Translational Sciences at CytomX Therapeutics Inc. He received his Ph.D. in Biochemistry from the University of Montreal. After postdoctoral training in the laboratories of Drs. Brown and Goldstein at UT Southwestern in Dallas, TX, Dr Desnoyers joined Genentech where he worked on the development of cancer therapeutics for 14 years. In 2011 he joined CytomX Therapeutics as the head the department of Oncology and then initiated the department of Translational Sciences.  For the past 20 years he has worked on multiple aspects of cancer therapeutics including target identification and validation, antibody and ADC development, efficacy and safety evaluation, biomarker and diagnostics strategy generation and implementation, and clinical development. He is an author of > 20 scientific publications, book chapters and an inventor on >1500 patent applications and 144 issued patents. For the past seven years he has focused on the application of the Probody platform to the antibody-drug conjugate modality.

Marc Robillard
Chief Executive Officer
Tagworks Pharmaceuticals

Marc Robillard is founder and CEO of Tagworks Pharmaceuticals, a spin-out of Philips Healthcare, originating from its molecular imaging expertise. Tagworks develops and applies in vivo chemistry to improve the efficacy of cancer therapies and to enable novel approaches in companion diagnostics. Prior to spinning out in 2011 he worked at Philips Research on molecular imaging and drug delivery and at Kreatech Diagnostics on microarray detection. Marc obtained his MSc and PhD in bio(in)organic chemistry at, respectively, the University of Groningen and the Leiden Institute of Chemistry, The Netherlands.

Mariya Pavlyuk
Global Clinical Lead
Pierre Fabre

Mary Robinette
Principal Project Engineer
MilliporeSigma

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).

Scientific Program – Day 2

Wednesday, November 14

07.00 | Breakfast Briefing: Complete Single-Use ADC Technology from Development Through Scale-Up

Mark Frigerio
Director, Chemistry UK
Abzena

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.

Matthew Sung
Senior Scientist,
Pfizer

Matthew is a Senior Scientist in the Oncology Research & Development group within Pfizer’s Worldwide Research and Development (WRD) organization.  At Pfizer, Matthew leads the pre-clinical development of novel antibody therapeutics.  Matthew is an alumnus of the Pfizer WRD Postdoctoral Training Program where he studied mechanisms of ADC resistance.  Matthew received his B.S. in Applied Biology from Rose-Hulman Institute of Technology and subsequently completed his Ph. D. in Pharmacology at Weill Cornell Graduate School of Medical Sciences.

Michael Kaufman
Senior Vice President, CMC
Mersana

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.

Milos Dokmanovic
Biologist
US Food & Drug Administration

Dr. Milos Dokmanovic is a product quality reviewer for monoclonal antibody-based products in clinical testing and commercial licensure. He joined US Food and Drug Administration, Office of Biotechnology Products, in 2007, as IOTF Fellow and has published research articles on identification of mechanisms of action and therapeutic resistance for monoclonal antibody therapies. Dr. Dokmanovic received his B.Sc. from University of Belgrade in 1996, Ph.D. from University of Illinois at Chicago in 2003 and holds RAC certification since 2013.

Muctarr Sesay
Chief Scientific Officer & Vice President, Bioconjugation Development
Goodwin Biotechnology

Muctarr Sesay, PhD is the Chief Scientific Officer and Vice President of Bioconjugation Development at Goodwin Biotechnology. Dr. Sesay has over 20 years of industrial experience in bioconjugation and modification of biological molecules and small molecules, and over 15 years of experience in the biotechnology sectors. Prior to joining Goodwin in 2002, Dr. Sesay supervised many projects in R&D, Process Development, and manufacturing of biologics at Life Technologies (now Thermo-Fisher), Kirkegaard and Perry Laboratories (KPL), and Elusys Therapeutics. After receiving his PhD in Biochemistry from the University of London, England, Dr. Sesay worked for about 3 years as a postdoctoral candidate at the University of Maryland, College Park in Protein Purification and Characterization.

Nathan Tumey
Professor, Pharmacy & Pharmaceutical Sciences
Binghamton University

L. Nathan Tumey joined Binghamton University in 2017, following 15 years of experience in the pharmaceutical and biotechnology industry. He received his PhD in chemistry from Duke University in 2001, under the supervision of Michael Pirrung. His research emphasis was on the medicinal chemistry of LpxC inhibitors as antibacterial agents against gram negative bacteria. Following his PhD, Tumey joined Athersys, Inc. in Cleveland, Ohio, where he was responsible for hit-to-lead development for multiple medicinal chemistry programs, most notably the development of two novel series of antagonists for CRTH-2 as a potential treatment for asthma. In 2006, Tumey joined Pfizer, Inc. where he led a multidisciplinary team of scientists developing inhibitors of IRAK-4, a kinase involved in the innate immune response which is critical to signaling from Toll-like receptors. Under his leadership, the team from Pfizer was able to develop highly selective sub-nM inhibitors of the enzyme that showed promise in preclinical models of inflammation.

In 2010, Tumey embarked on a significant career transition, moving away from small-molecule medicinal chemistry and joining a newly formed team of scientists at Pfizer tasked with developing next-generation antibody-drug conjugates (ADCs) as potential treatments for cancer. In this role, Tumey has built a significant skill set and reputation in the area of ADC stability, bioanalysis and design. Most importantly, he has striven to bring the rigor of small molecule medicinal chemistry into the challenging field of targeted drug delivery. Research in Tumey’s lab has led to new methods for monitoring and optimizing ADC stability, new chemical release strategies for therapeutically active payloads and better understanding of factors that drive ADC PK. This work has been widely recognized in the ADC community. For example, his work describing efforts to mitigate the rapid metabolism of a tubulysin ADC was selected as the cover article for the November 2016 issue of ACS Medicinal Chemistry Letters.

At Binghamton, Tumey’s research focuses on the application of antibody-drug conjugates and related modalities for the treatment of auto-immune diseases and rare diseases. Additionally, his lab investigates bioconjugate stability, non-antibody targeting techniques and mechanism of payload-release from bioconjugates.

Nazzareno Dimasi
Associate Director, Research & Development
MedImmune

Nazzareno Dimasi Ph D is Associate Director R&D at MedImmune where he works on innovative biopharmaceutical research in the area of antibody engineering, multispecific antibodies and antibody-drug conjugates.

Phil Howard
Chief Scientific Officer
Spirogen

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.

Philipp Spycher,
PSI Founder Fellow
Paul Scherrer Institute

Dr. Spycher is a PSI Founder Fellow at the Paul Scherrer Institute (PSI) Villigen (Switzerland) since end of 2017 working on the site-specific modification of native antibodies. He studied at the University of Basel (Switzerland) Nanoscience and at ETH Zurich (Switzerland) Biomedical Engineering with a focus on drug delivery and targeting. During his doctoral studies at ETH Zurich, he worked on protein and materials engineering for the site-specific immobilization of proteins onto micro-patterned surfaces using enzymes. He then performed a post-doc at PSI Villigen on chemical and site-specific modification of antibodies and fragments for diagnostic and therapeutic applications. Dr. Spycher has over 8 years of experience with ADCs and materials engineering, he is particularly interested in the development of improved drug delivery and targeting systems.

Rakesh Dixit
Vice President, Research & Development, Global Head of Biologics Safety Assessment
MedImmune

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.

Scientific Program – Day 1

Tuesday, November 13

08.10 | Keynote: Strategies for Improving Therapeutic Index & Minimizing On & Off-Target Toxicities of Highly Potent ADCs

Ravi Chari
Vice President, Chemistry & Biochemistry
ImmunoGen

Ravi Chari has nearly 30 years of experience in the field of Antibody-Drug Conjugates (ADCs).  Following a postdoctoral fellowship at Yale Medical School, he joined the Dana-Farber Cancer Institute/Harvard Medical School in 1986 as a research scientist, where he initiated work on the targeted delivery of cytotoxic drugs to tumor cells.  Subsequently he joined ImmunoGen, where his group designs potent cytotoxic compounds for ADCs.  His group has developed the maytansinoid payload class, including the one used in the FDA-approved ADC Kadcyla®, and more recently the IGN payload class. His group also develops novel linkers for ADCs. Ravi is an inventor on 88 issued US patents, and an author on more than 50 peer-reviewed publications. He was appointed a Fellow of the American Institute for Medical and Biological Engineering (AIMBE) in 2016.

Renu Singh Dhanikula
Senior Investigator
Bristol Myers Squibb

Innovative and result-oriented research professional with diversified and global experience in drug discovery and development. Experience working in a CRO, medium size as well as multinational pharmaceutical company in various therapeutic areas (Diabetes, Cardiovascular, Oncology and CNS). Self-motivated, proactive, creative and organized scientist with ability to productively work across teams and organizations.

Richard Denk
Head, Sales Containment
SKAN

Richard Denk is working at the company SKAN AG, headquartered in Allschwil  in the position Head Sales Containment. Mr. Denk founded 8 years ago the expert Containment group of the ISPE D / A / CH. The Containment Group published the Containment Manual Mr. Denk was responsible for in September 2015. Mr. Denk has spent nearly 20 years with the subject production of highly active / highly hazardous substances and has developed the containment pyramid.

Richard Silva
Senior Director, Process Development, CMC
ImmunoGen

Richard is a Senior Director of Chemical Process Development at ImmunoGen. Prior to joining ImmunoGen in 2012 Richard was a Director of Clinical Development at Concert Pharmaceuticals. Richard has also help position of responsibility at Genzyme and Vertex pharmaceuticals. Richard Received his Ph.D in Organic Chemistry in 1997 from Dartmouth College. He was also a Post-doc at Boston College.

Richard Wooster
Chief Scientific Officer
Tarveda

Richard Wooster is President of R&D and Chief Scientific Officer at Tarveda Therapeutics. Previously he was Vice President and Discovery Performance Unit Head in Oncology at GlaxoSmithKline. During his academic career he discovered the breast cancer susceptibility gene BRCA2, and was one of the founders of the Cancer Genome Project at the Welcome Trust Sanger Institute where, among many achievements, mutations in BRAF were first discovered and he developed the COSMIC mutation database and web site.

Rick Powers
Chief Consultant
ADC Consulting

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.

Robert Iannone
Head of Research & Development, Chief Medical Officer
Immunomedics

Robert Iannone, M.D., M.S.C.E., is the Head of Research & Development and Chief Medical Officer at Immunomedics. Robert oversees and leads all clinical development, regulatory, pre-clinical, translational research and medical affairs strategies and activities of the Company. Dr. Iannone has more than thirteen years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

Scientific Program – Day 1

Tuesday, November 13

07.40 | Keynote: 2018-2019: Overcoming Challenges of Maximizing the Clinical Therapeutic Window of Antibody Drug Conjugates (ADCs)

Samuele Cazzamalli
Research Scientist
Philochem

Samuele Cazzamalli (Italian, 16 December 1990) studied Medicinal Chemistry at the Universitá degli Studi di Milano. He performed his PhD at ETH Zurich in the group of Professor Dario Neri with a focus on non-internalizing antibody- and small molecule-drug conjugates for the treatment of cancer.

Scott David Collins
Associate Director, Pharmacology
Mersana

Scott David Collins is a pharmacologist with 12 years’ experience. Since the beginning of 2018 Scott has held the position of Senior Manager in Pharmacology at Mersana. Prior to joining Mersana Scott worked for AstraZeneca and Novartis. Scott received a BSc (Hons) from the University of Manchester

Scott Miller
Senior Scientific Advisor
CARBOGEN AMCIS

Scott earned his Ph.D. in Chemistry at UC Irvine and conducted post-doctoral research at the ETH Zürich. With over 20 years industry experience in the pharmaceutical and contract manufacturing industry, he has expertise in preclinical R&D through cGMP validation of API processes and has contributed to multiple IND, ANDA, and NDA filings. Scott joined CARBOGEN AMCIS in February 2012. He is currently responsible for the Antibody Drug Conjugate business expansion in Switzerland.

Shweta Singh
Senior Scientist
CytomX

Shweta joined CytomX Therapeutics in December 2013, where she has been working on the preclinical development of drug conjugates using the ProbodyTM technology. Prior to joining CytomX, Shweta worked on multiple antibody programs in early discovery, including novel IO targets at Compugen and ADCs and effector function armed antibodies for immunology and oncology at Takeda and Nuvelo. She received her PhD. in Biochemistry from the University of Kent, Canterbury and her bachelor’s degrees in Physiology from University of Wales, Cardiff.

Shyra Gardai
Director of Immunology
Seattle Genetics

Shyra Gardai is a Senior Immunologist with 15 years of experience focused on innate immunity and inflammation. Shyra has directed multiple discovery projects focused on novel target identification for autoimmune and neurodegenerative disorders resulting in the identification and development of small and large molecule therapeutics. Prior to joining Seattle Genetics as an Associate Director in 2013 Shyra has held positions of responsibility at Second Genome, Elan Pharmaceuticals and Janssen. Shyra received her PhD in Innate Immunity from the University f Colorado Anschutz Medical Campus.

Thomas Lecocq
Associate Director, CMC Project Management
CytomX

Stefan Luedtke
Project Manager
Baxter Healthcare

Stefan Luedtke, Ph.D., is a project manager at Baxter Healthcare with 4 years experience in the pharmaceutical industry. Dr. Luedtke is managing interdisciplinary teams in the areas of - technology transfer, analytical testing, process development, and project management.

Timothy Lowinger
Chief Scientific Officer
Mersana Therapeutics

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.

Scientific Program – Day 1

Tuesday, November 13

19.00 | Chair’s Closing Remarks

07.30 | Chair’s Opening Remarks

Scientific Program – Day 2

Wednesday, November 14

09.10 | High DAR ADCs with a Controlled Bystander Effect: From Concept to Clinical Experience

08.00 | Chair’s Opening Remarks

Tinya Abrams
Senior Investigator
Novartis

Tinya Abrams is a research pharmacologist at Novartis in Cambridge, MA with extensive preclinical drug development experience in Oncology.   Her focus is on integrating target biology, PK/PD/efficacy relationships and safety readouts to identify and optimize lead therapeutics for clinical assessment.  Her experience spans from small molecule inhibitors to biologics approaches, with a special interest in antibody conjugates therapeutics. Tinya received her doctorate in Endocrinology/Molecular Cell Biology at the Univ. of California, Berkeley.  She then joined SUGEN to discover novel kinase inhibitors, eventually leading to the identification and advancement of Sutent® for the treatment of GIST and Renal cell carcinoma.  Tinya then joined the Chiron Corp. to further pursue kinase and mitotic inhibitors before joining Novartis, where she leads a team of in vivo pharmacologists to support Oncology research programs.  

Tok Han
Director & Team Leader, Oncology Operations
Pfizer

Tok Han is the Director and Team Leader of Oncology Operations at Pfizer. Tok has implemented disposable technologies for ADC manufacturing since 2000. He is responsible for manufacture of commercial and clinical ADCs,  Mylotarg (Gemtuzumab Ozogamicin), Besponsa (inotuzumab ozogamicin), PTK7, GD3, and NGHER-2.  

Scientific Program – Day 1

Tuesday, November 13

18.30 | Lessons Learned from Commercial Scale Manufacturing of Approved ADC

Trevor Hallam
Chief Scientific Officer
Sutro Biopharma

Dr. Trevor Hallam has more than 25 years of experience in pharmaceutical discovery and development.  He joined Sutro Biopharma as CSO in late 2010.  Since then Dr. Hallam has shaped Sutro's biochemical synthesis technology to generate a disruptive discovery and manufacturing platform for novel best-in-class bispecific and antibody-drug conjugate protein therapeutics.  Prior to Sutro, Dr. Hallam has held several senior R&D positions in the US and Europe, most recently Vice President Biologics, Vice President U.S. Medical Affairs, and Vice President, Research and Pre-clinical Development at AstraZeneca.  He began his pharmaceutical career in the UK working for Smith Kline & French followed by senior management positions at Glaxo and Roche.  Dr. Hallam conducted his post-doctoral training in the laboratory of Timothy Rink MD DSc at the Physiological Laboratory, University of Cambridge after receiving his Ph.D. in Biochemistry from King's College, University of London.

Scientific Program – Day 2

Wednesday, November 14

08.40 | Rapid, Precise Design & Systematic Evaluation of Protein SAR to Create Optimized Homogeneous Product Candidates

Letrishka Anthony
Senior Analyst, Beacon
Hanson Wade

Ying Buechler
Vice President Process Development
Ambrx

Dr. Yun Bai is senior director of process sciences and manufacturing at Ambrx Inc. and responsible for process development including cell culture, purification, conjugation process development as well as analytical assay development, formulation development for biological products, process transfer to contract manufacturing organizations and support tox and clinical manufacturing at CMO sites for products derived from both microbial and mammalian expression systems. Dr. Bai has worked in biotech industry for 18 years, with 11 years at Ambrx, 4 years at Eli Lilly and 3 years at Epicyte Pharmaceutical. She holds B.A, M.S. and Ph.D degrees in Chemical Engineering, specializing in Biochemical Engineering.

Bernhard Stump
Leader, ADC, Research & Development
Lonza

Bernhard Stump, Ph.D (born 1978) studied biology at the Swiss federal institute of technology (ETH, Zurich, Switzerland) and obtained his Ph.D. from the same institution with Prof. Diederich in 2007. During his graduate studies dealing with structure-based design of novel antiprotozoal agents, he collaborated with Prof Krauth-Siegel at the University of Heidelberg, Germany and Prof Brun at the Swiss Tropical Institute in Basel, Switzerland. He then held a Swiss National Science Foundation postdoctoral fellowship at the Scripps Research Institute with Prof Sharpless working on in-situ click chemistry on acetylcholine receptor proteins Bernhard Stump began his industrial carrier in process development at Lonza in Visp (Switzerland) in 2009. His activities focused on the development and scale-up of bioconjugation processes, as well as the support of bioconjugates manufacturing under GMP for clinical as well as commercial supply.  After two years in program management for bioconjugate, small-molecule cytotoxics, and polymer API projects, he is now leading the bioconjugation process development group at Lonza Visp

Michael Roberts
Scientific Consultant
NOF CORPORATION

Bruce Hart
Regulatory Affairs Consultant
Formerly with Seattle Genetics

Thomas Beuhler
Thomas Bühler, Sales Group Leader for the North American market
Bausch + Strobel

In 2000, Thomas Bühler started at Bausch+Stroebel Ilshofen to complete an apprenticeship program in business administration. After having finished his apprenticeship in 2002 he started in the international sales and project managing department where he was involved in many high tech projects for the pharmaceutical industry. With his excellent experience in primary packaging machines, Thomas Bühler has since then made significant contributions to technological developments and accompanied numerous projects from the first inquiry to the SAT  (site acceptance test). Since 2010, he has been in charge of the North American territory as a sales group leader.

Thomas Bühler
Sales Group Leader for the North American market

In 2000, Thomas Bühler started at Bausch+Stroebel Ilshofen to complete an apprenticeship program in business administration. After having finished his apprenticeship in 2002 he started in the international sales and project managing department where he was involved in many high tech projects for the pharmaceutical industry. With his excellent experience in primary packaging machines, Thomas Bühler has since then made significant contributions to technological developments and accompanied numerous projects from the first inquiry to the SAT  (site acceptance test). Since 2010, he has been in charge of the North American territory as a sales group leader.

Dr Rob Noel
Business Dev Director
ADC Biotech Ltd

Xinfang Li
Vice President of Process Development and CMC
MabPlex International

Xinfang Li, PhD is the Vice President of Process Development and CMC at MabPlex International. Dr. Li has more than 20 years of experience in Biologics. Prior to MabPlex she served as the Head of Downstream Product Purification at Immunogen. Along with her experience at Immunogen, Dr. Li holds multiple patents and publications in antibody drug conjugate preparation and purification technologies. In addition to her commercial experience, she is an expert in viral clearance. Xinfang obtained her PhD in Molecular Biology and Biochemistry from Peking University in Beijing, China. From there, she went on to pursue her Post doctorate at Harvard University in Boston, MA.