PhiladelphiaPharmaceuticalSymposium

Immuno-Oncology 2.0Philadelphia Pharmaceutical Symposium 2018

Saturday, December 8th Crowne Plaza King of Prussia, PA 19406

Organized by

SYMPOSIUM THEMEThe goals for SAPA-GP’s Philadelphia Pharmaceutical Symposium include highlighting cut-ting-edge scientific breakthroughs, fostering collaboration and the exchange of scientific ideas among pharmaceutical and academic professionals. This year’s symposium will focus on Immu-no-Oncology therapy. We are privileged to present a panel of esteemed researchers from both academia and industry to showcase the recent breakthroughs in immuno-oncology therapies.

More details of this symposium are available on SAPA-GP’s website (http://sapa-gp.org/sapagp/)

Keywords: CAR T-cell Therapy, PD-1 Inhibitors, Cancer Epigenetics, Emerging Platforms

SAPA-GP HISTORYThe Greater Philadelphia (GP) area is one of the major homes for the world pharmaceutical in-dustry. It hosts more than half of the world’s top-ten pharmaceutical companies, and many mid/small pharmaceutical/biotech companies as well as academic institutions. The Sino-American Pharmaceutical Professionals Association - Greater Philadelphia (SAPA-GP) was established in 2002 to serve the rapidly growing pharmaceutical/biotech/healthcare community in the GP area.

To promote pharmaceutical sciences and biotechnology

To contribute to public health education by raising public awareness

To facilitate scientific and business cooperation between US and China

To foster career development of pharmaceutical professionals

SAPA-GP MISSION

MORNING Breakthroughs in Immuno-Oncology Therapies

Carl H. June, M.D. Director of Center for Cellular Immunotherapies, Profes-sor of Pathology and Laboratory Medicine, University of Pennsylvania, Direc-tor of Parker Institute for Cancer ImmunotherapyCAR T-cell immunotherapy for human cancerKatrin Rupalla, Ph.D., M.B.A. Global Head of Oncology Regulatory and Tran-sition Head China Development, BMSOpdivo Development and China MarketScot W. Ebbinghaus, M.D. VP and Therapeutic Area Head for Oncology Late Stage Development, Merck Research LaboratoriesKeytruda: A Journey of Immuno-Oncology Drug Development

9:15-10:25 a.m.Keynote Speaker

10:25-11:15 a.m.

11:15-12:05 p.m.

12:05-1:30 p.m. Lunch Break

1:30-2:20 p.m.

2:20-3:10 p.m.

3:10-4:00 p.m.

4:00-4:10 p.m.

Liang Deng, M.D., Ph.D. Physician Scientist, Associate Member, Head of Me-morial Hospital Laboratory, Memorial Sloan Kettering Cancer CenterRational Engineering of Vaccinia Virus for Cancer ImmunotherapyMichael Kalos, Ph.D. VP of Immuno-oncology and Oncology Cellular Thera-pies, JanssenCombination Strategies for CAR T TherapyJean-Pierre Issa, M.D. Director of Fels Institute for Cancer Research and Mo-lecular Biology, Professor of Medicine, Temple UniversityTargeting Gene Silencing in CancerClosing RemarksJing Yang, Ph.D. Senior Principal Scientist, Cardiovascular Discovery Biology, BMS

AFTERNOON Emerging Immuno-Oncology Platforms

AGENDA9:00-9:05 a.m.

9:05-9:10 a.m.

9:10-9:15 a.m.

Opening Remarks Haifeng Cui, Ph.D. GSK Fellow, Scientific Director, GSKIntroduction to SAPA-GPJing Yang, Ph.D. Senior Principal Scientist, Cardiovascular Discovery Biology, BMSIntroduction to Life Sciences Pennsylvania (LSPA)Christopher P. Molineaux, B.A. President & CEO, Life Sciences PA

Session Chair: Haifeng Cui, Ph.D. GSK Fellow, Scientific Director, GSK

Session Chair: Hanghang Zhang, Ph.D. Associate Scientist, Medical Student, Temple University

SPEAKERS

Liang Deng, M.D., Ph.D. Physician scientist, Associate Member Head, Memorial Hospital Laboratory MSKCC

Dr. Liang Deng received her B.S. degree from the University of Rochester, and her Ph.D. and M.D. degrees from Memorial Sloan Kettering Cancer Center (MSKCC) and Weill Cornell Medical College. She is currently an Associate Member and Associate Attending Physician at MSKCC. She is a board-certified dermatologist specializing in melanoma and viral-associated skin malignancies. Her laboratory research has been focusing on studying virus-host interaction and the development of vaccinia-based cancer immunotherapeutics. She has published more than 20 papers on vaccinia virus as either first author or senior author. Her recent work demonstrated that intratumoral injection of inactivated modified vaccinia virus Ankara (MVA) turns “cold” tumors into “hot” tumors, which results in enhanced responsiveness to immune checkpoint blockade (ICB) therapy. Based on these findings, her research program focuses on developing recombinant MVA and vaccinia virus to elicit strong “in situ vaccination” effects either used alone or in combination with ICB. Her research has been supported by the NIH, the Dermatology Foundation, American Skin Association, Parker Institute for Cancer Immunotherapy, Technology Development Award at MSKCC, and IMVAQ Therapeutics, a biotech company she and her colleagues at MSKCC co-founded.

Scot W. Ebbinghaus M.D. Vice President and Therapeutic Area Head, Oncology Late Stage Development, Merck Research Laboratories

Dr. Scot Ebbinghaus joined Merck Research Labs Late Stage Oncology Development in 2007. He is currently Vice President and Therapeutic Area Head for Late Stage Oncology Development with responsibilities for overseeing the Keytruda (pembrolizumab) development program as well as responsibility for the development of Lynparza (olaparib) and selumetinib in collaboration with Astra Zeneca. Prior to joining Merck, Dr. Ebbinghaus was an Associate Professor at the University of Arizona in the Department of Medicine, Section of Hematology/Oncology.

Dr. Ebbinghaus earned his M.D. degree from the University of Missouri-Kansas City, completed his residency in Internal Medicine and his fellowship in Hematology-Oncology at the University of Alabama-Birmingham. Dr. Ebbinghaus has published over 40 manuscripts, and 5 book chapters in the field of Oncology. In addition to current responsibilities at Merck, Dr. Ebbinghaus is an attending physician at Fox Chase Cancer Center in Philadelphia in the Thoracic Oncology unit.

Jean-Pierre Issa, M.D. Director, Fels Institute for Cancer Research and Molecular Biology, Professor of Medicine, Temple University

Dr. Issa received his undergraduate training and his M.D. from the American University of Beirut followed by residency in internal medicine at Good Samaritan Hospital and fellowship in Medical Oncology at the Johns Hopkins Oncology Center in Baltimore. He was on the faculty at Johns Hopkins from 1994-1999, at the

University of Texas M.D. Anderson Cancer Center from 1999-2011, and at Temple University School of Medicine from 2011, where he is currently Professor of Medicine and Director of Fels Institute for Cancer Research and Molecular Biology.

Dr. Issa’s laboratory has made significant contributions to the understanding of epigenetics in the pathophysiology and treatment of cancer. Some of his lab’s discoveries include the effects of aging (1994) and inflammation (2000) on promoter DNA methylation, the CpG Island Methylator Phenotype (1999), methylation-independent gene silencing in cancer by Polycomb group proteins (2008), and a link between epigenetics and the microbiome in colon cancer (2014). Starting in 2000, his group initiated laboratory research directed clinical trials that showed that low doses of hypomethylating drugs specifically target DNA methylation and are optimal in the treatment of leukemias. This work contributed to the FDA approval of decitabine in 2006, and led to a large number of epigenetic therapy clinical trials in different malignancies. His current research focuses on mechanisms of epigenetic alterations in aging and cancer, translation of epigenomic studies for precision medicine, development of drugs for reprogramming the epigenome, and clinical trials of epigenetic therapy in cancer.

Dr. Issa’s research has been recognized by numerous awards including a Sidney Kimmell Foundation Scholar Award in 1997, election to the American Society of Clinical Investigation in 2003, an American Cancer Society Clinical Research Professorship in 2007, the Faculty Achievement Award in Basic Research from MD Anderson in 2007, the Rosenthal Award from the American Association for Cancer Research in 2011, and election to the American Association of Physicians in 2015.

Carl H. June, M.D. Director, Center for Cellular Immunotherapies Professor of Pathology and Laboratory Medicine Director, Parker Institute for Cancer Immunotherapy

Dr. Carl H. June is the Richard W. Vague Professor in Immunotherapy, Director of the Center for Cellular Immunotherapies and Director of the Parker Institute for Cancer Immunotherapy in the Perelman School of Medicine at the University of Pennsylvania.

Background – Dr. June is a graduate of the Naval Academy in Annapolis, and Baylor College of Medicine in Houston, 1979. He had graduate training in Immunology and malaria with Dr. Paul-Henri Lambert at the World Health Organization, Geneva, Switzerland from 1978-79, and post-doctoral training in transplantation biology with Dr. E. Donnell Thomas at the Fred Hutchinson Cancer Research Center in Seattle from 1983-1986. He is board-certified in Internal Medicine and Medical Oncology. He founded the Immune Cell Biology Program and was head of the Department of Immunology at the Naval Medical Research Institute from 1990 to 1995. He rose to Professor in the Departments of Medicine and Cell and Molecular Biology at the Uniformed Services University for the Health Sciences in Bethesda, Maryland before assuming his current position at the University of Pennsylvania as of February 1, 1999.

Research – Dr. June’s pioneering work is being widely recognized as a major turning point that is delivering on the long-held promise of cancer gene therapy. Carl June has made paradigm-shifting contributions to the field of cellular immunology, with potentially field-changing implications for the clinical treatment of advanced leukemia and by extension, other cancers. In basic science studies, Dr. June’s laboratory discovered the CD28 pathway that controls T

cell growth, and in later translational studies, his laboratory developed robust T cell culture systems that permits the growth of central memory T cells. He has since applied these culture systems to develop groundbreaking cell-based approaches for immunotherapy of cancer and HIV infection, with unprecedented results called chimeric antigen receptor T cells (CAR T cells), these modified immune cells have proven effective at eliminating cancer in some patients, and offer great hope for this emerging strategy in cancer immunotherapy. This groundbreaking work is credited as the first successful and sustained demonstration of the use of gene transfer therapy to turn the body’s own immune cells into weapons aimed at cancerous tumors, and is considered as a landmark breakthrough in treating blood cancers that have stopped responding to conventional therapies.

Results from the first trial testing CARs for cancer were reported in 2011 in three patients with advanced leukemia. The results were striking and indicate for the first time that CAR T cells are the first successful application of the principles of synthetic biology to humans. They have since treated more than 100 patients with advanced leukemia in adults and children with similar success. Perhaps most informative is that each year, Science magazine announces the top 10 breakthroughs in all fields of science and engineering and in 2013, “Cancer Immunotherapy” was selected as the #1 breakthrough. Additionally, CART19, invented in the June laboratory, was recently designated as a “Breakthrough Therapy” by the FDA, based on a 92% remission rate in refractory leukemia. This is the first therapy ever developed entirely in an academic setting to receive “breakthrough designation” by the FDA. Engineered T cells developed in the June Laboratory are the first successful example of synthetic biology to enter clinical medicine and clinical trials, and are now being developed for widespread use by Novartis and many other pharmaceutical and biotechnology companies, indicating that his work is seminal in advancing biomedical research for the benefit of patients.

In 2014, Dr. June published groundbreaking work using genetically edited cells that was accomplished with zinc finger nucleases. The adoptive transfer of T cells with targeted gene deletion of the ccr5 gene locus was used to induce a state of acquired genetic resistance to HIV in patients with advanced HIV/AIDS infection. This is the first example in humans that targeted gene modification can be used to knock in a disease resistance gene.

Awards and Honors – Dr. June’s numerous awards include the 1997 Dexter Conrad Award (the Navy’s highest award for scientific achievement), 1997 Frank Brown Berry Prize in Federal Medicine, 2002 Leukemia and Lymphoma Society Lifetime Achievement Award, 2005 Federal Laboratory Award for Excellence in Technology Transfer, 2006 election to American Association of Physicians, 2012 election to Institute of Medicine on the first the first attempt, 2012 Clinical Research Forum’s Top 10 Distinguished Clinical Research Achievement Award, 2012 Cancer Research Institute William B. Coley Prize, 2012 ASH Ernest Beutler Prize, 2013 Philadelphia Award, 2013 Society for Immunotherapy of Cancer Richard V. Smalley Award, 2014 American Association of Immunologists Steinman Award for Human Immunology Research, 2014 AABB Karl Landsteiner Memorial Award, 2014 Taubman Prize for Excellence in Translational Medical Science, 2014 Hamdan Award for Medical Research Excellence (Cell Therapy), election to the American Academy of Arts and Sciences in 2014, 2015 Hubert J.P. Schoemaker Leadership Award from Pennsylvania BIO, 2015 American Society for Blood and Marrow Transplantation E. Donnall Thomas Prize, 2015 Clinical Research Forum Top 10 Clinical Research Achievement Award, 2015 AACR-Cancer Research Institute Lloyd J. Old Award in Cancer Immunology, 2015 Paul Ehrlich and Ludwig Darmstaedter Prize, 2015 AAMC Award for Distinguished Research in the Biomedical Sciences, and the 2016 Clinical Research Forum Top 10 Clinical Research Achievement Award.

Michael Kalos, Ph.D. Vice President, Immuno-oncology and Oncology Cellular Therapies, Janssen

Dr. Michael Kalos is a graduate of the University of Minnesota Medical School, where he received his Ph.D. from the department of Microbiology with an emphasis in Genetics. He completed postdoctoral fellowships at the Fred Hutchinson Cancer Research Center where he played an early role in the development of genetic approaches to redirect lymphocyte specificity. In 1997 Dr. Kalos joined Corixa Corporation, where he engaged in the pre-clinical immunological evaluation of novel cancer vaccines for prostate and lung cancer. In 2004, Dr. Kalos was recruited to City of Hope where he established a GLP-level laboratory focused on the development of biomarker strategies to evaluate T cell immunotherapies. In 2008, Dr. Kalos was recruited to the University of Pennsylvania School of Medicine where he established the Translational and Correlative Studies Laboratory, focused on development and implementation of an integrated biomarker infrastructure as part of the institution's T cell immunotherapy program. Data from his laboratory played an instrumental role in the clinical evaluation and development of the CTL019 program, and has led to a series of high-impact and field-leading publications. In October 2013, Dr. Kalos joined Eli Lilly and company as Chief Scientific Officer for Cancer Immunobiology. At Eli Lilly, Dr. Kalos was responsible for establishing and developing a robust and product focused immunotherapy strategy and program. In March of 2018 Dr. Kalos joined Janssen as Vice President, Immuno-oncology and Oncology Cellular Therapies, where he is responsible for developing and leading an integrated Immunotherapy program focused on next-generation and transformative immune therapies. Dr. Kalos is an internationally recognized expert in T cell immunotherapy. He has co-authored multiple articles in high-impact journals and book chapters in the field of cancer immunotherapy, and serves as an advisory member for multiple international immunotherapy consortia and societies.

Katrin Rupalla, Ph.D., M.B.A. Global Head of Oncology Regulatory Transition Head, China Development at BMS China

Dr. Katrin Rupalla is currently the Global Head of Oncology Regulatory at Bristol Myers Squibb and Transition Head China Development, located in NJ, USA. She moved recently from Shanghai, China, where she was the local Head of China Development at BMS China for the last 2.5 years. Prior to this Katrin was the Regulatory Head for extended Europe including 35 countries responsible for obtaining the licences for the whole BMS portfolio including Yervoy and Opdivo. She started her career in 1997 by joining Hoffmann-La Roche where she held various positions including the global regulatory leadership for the Far East Region including China for the whole Roche portfolio, and later had the global regulatory responsibility for the development of oncology projects such as rituximab, capecitabine, bevacizumab and obinutuzumab. In 2006, she joined Celgene International, responsible for the strategic oversight of all Celgene development projects including lenalidomide, nab-paclitaxel, azacitidine and thalidomide from an EU regulatory perspective. She is a pharmacist by training and obtained her Ph.D. in Neuropharmacology from the Philipps University in Marburg, Germany. She has a post-graduate degree in Pharmaceutical Medicine from the University of Basel, Switzerland and an M.B.A from Jones International University, Colorado.

MORE EVENTS BY SAPA-GPSTAY TUNED FOR 2019...

ACKNOWLEDGEMENTS

Tiger Bee

Yue Hu

Fang Shen

Zhiyun Wen

Qiangnan Zhang

David Cragin

Xianhua Li

Mengjie Si

Zhenhua Wu

Xinjun Zhang

Haifeng Cui

Yin Liang

Hao Sun

Di Wu

Han Dai

Yue Liu

Hui Wang

Jing Yang

Pengbo Guo

Yangsi Ou

Jin Wen

Hanghang Zhang

Organizing Committee Members

Program DirectorsHaifeng Cui Hanghang Zhang

Art Design and Brochure EditingPengbo Guo Junyang Xian Di Wu

SPONSORS

“Every drug can be made and every disease can be treated” through building the open-access platform with the

most comprehensive capabilities and technologies in the global healthcare industry.

Our Vision

Global Platform. One Vision.

Small MoleculeDrug R&D andManufacturing

Biologics R&Dand

Manufacturing

Genomicsand

Data Platform

Cell Therapyand

Gene Therapy

Drug R&D andMedical Device

Testing

In-vitroand

Clinical Diagnostics

WuXi AppTec Group

WuXi AppTec（603259.SH）

WuXi Biologics（02269.HK）

WuXi NextCODE WuXi Diagnostics

PO Box 5199, Limerick, PA 19468 | rockland-inc.com | 800.656.7625

WE ADVANCE LIFE SCIENCE TO FOSTER A BETTER WORLD

Rockland is a frequently referenced antibody manufacturer that collaborates with leading organizations such as the National Cancer Institute, St. Jude Children’s Research Hospital, and Lankenau Institute for Medical Research to develop high quality antibodies and antibody-based tools.

• Extensive line of antibodies and reagents• Multi-assay validated products• Custom antibody production & assay development• Published staff scientists• Trial size antibodies

RELIABILITY, SPECIFICITY, & SENSITIVITY

板 块 职位 Job title

成都总院（Chengdu Headquarters）

临床Clinical Development

临床中心负责人 Head of Clinical Research Center生物统计总监 Director, Biostatistics数据管理总监 Director, Data Management

临床药理总监/副总监 Director/Associate Director, Clinical Pharmacology

资深医学总监/总监 Senior / Medical Director

药物警戒总监 Director, Pharmacovigilance

临床运营总监 Director, Clinical Operation医学写作总监/副总监 Director/Associate Director, Medical Writing

创新小分子Innovative Small

Molecule

创新制剂总监 Director, Formulation Development

毒理总监 Director, Toxicology药效总监 Director, Pharmacology

资深/药化总监 Sr. Director/Director, Medicinal Chemistry计算化学总监 Director, Computational Chemistry

生物Biologics

生产执行总监 Executive Director, Biologics Production

生产质量管理总监 (QA总监) Director, Biologics QA细胞培养工艺总监 Director, Biologics Process Development (Cell Culture)

纯化工艺总监 Director, Biologics Process Development (Purification)

细胞治疗总监 Director, Cellular Immunotherapy

研发质量研究总监 (Bioassay) Director, Bioassay Development

生物发现总监 (噬菌体) Director, Biologics Discovery (Phage Display)

生物发现总监 (杂交瘤) Director, Biologics Discovery (Hybridoma)细胞系构建总监 Director, Cell Line Development

制剂Formulation

仿制药固体制剂总监 Director, Oral Generics Formulation Development

注射剂总监 Director, Injectable Generics Formulation Development

膜材总监 Director, Multi-layer Coextruded Film Packaging Development

NDDS总监 Director, New Drug Delivery Systems

化学Chemistry

合成工艺总监 Director, Chemical Process

医学信息Medical Information

临床医学总监 Medical Director

创新靶点与项目立项研究总监 Director, Novel Target Nomination

天津分院（Kelun Tianjin）制剂

Formulation仿制药固体制剂总监 Director, Oral Generics Formulation Development

化学Chemistry

合成工艺总监 Director, Chemical Process

油料总监 Director, Pharmaceutical Oil

分析Analytical Chemistry

分析总监 Director, Analytical Chemistry

苏州分院（Kelun Suzhou）

制剂Formulation

仿制药固体制剂总监 Director, Oral Generics Formulation Development

注射剂总监 Director, Injectable Generics Formulation Development

分析Analytical Chemistry

分析总监 Director, Analytical Chemistry

美国分院（Kelun USA, Cranbury, NJ）

生物Biologics

细胞治疗总监 Director, Cell Therapy

生物发现总监 (噬菌体) Director, Biologics Discovery (Phage Display)生物发现总监 (杂交瘤) Director, Biologics Discovery (Hybridoma)

商务拓展Business Development

国际BD总监 Executive Director/Director, Business Development (Boston)

Talent Recruitment

Please send your resume to:

hui.wang@kluspharma.com

www.kelun.com

WeChat

www.AlliancePharmaCo.com

Your Trusted Partner

CORE CAPABILITIESIn Pharmaceutical Development

or email

FIND OUT MORE

specializing in bioanalytical services

• Immunoassay-based bioanalysis for biopharmaceutical PK/TK, immunogenicity, and biomarkers

• Cell-based assays to monitor biomarkers and cell proliferation

• LC-MS/MS based bioanalysis of drugs, drug-related metabolites, and biomarkers.

• LC-MS/MS based protein characterization and quantitation

• In vivo rodent PK/TK (AAALAC accredited vivarium)

• Drug testing and clinical biomarker assay (CLIA accredited lab)

• LC-MS/MS based agrochemical and food ingredient analysis

• GxP Biorepository service for short and long-term storage of a broad selection of sample types and materials

610.296.3152info@alliancepharmaco.com

Alliance Pharma is a Contract Research Organization (CRO)

for drug discovery and development of both small molecules and biopharmaceuticals.

Our extensive and diverse expertise includes:

Please call us at

and visit