PEGS China-2016-Brochure
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The document details the 3rd Annual Protein & Antibody Engineering and Development Summit, taking place from April 5-7, 2016, in Shanghai, China. It outlines the event's focus on protein and antibody engineering, analytical characterization of biotherapeutics, next-generation cancer biotherapeutics, and protein aggregation and stability, featuring numerous expert speakers and networking opportunities. Additionally, it highlights the growing prominence of China in the biopharmaceutical industry, the challenges in biotherapeutics development, and available sponsorship and exhibit opportunities.
PEGS China-2016-Brochure
- 1. Protein & Antibody Engineering Analytical Characterization of Biotherapeutics Next-Generation Cancer Biotherapeutics Protein Aggregation & Stability Seminar: Clinical and Regulatory Strategies for Domestic and Global IND and BLA Filings PEGSummitChina.com Premier Sponsor 2016 CONFERENCE PROGRAMS: Keynote Speakers Alain Beck, Ph.D., Senior Director, Antibody and ADC Physico-Chemistry, Centre d’Immunologie Pierre Fabre Andrew Bradbury, MBBS, Ph.D., Research Scientist and Group Leader, Biosciences Division, Los Alamos National Laboratory Roland Kontermann, Ph.D., Professor, Biomedical Engineering, Institute of Cell Biology and Immunology, University of Stuttgart Paul W.H.I. Parren, Ph.D., Senior Vice President Scientific Director, Genmab Weikang Tao, Ph.D., Vice President CEO, RD Center, Jiangsu Henrui Medicine Co., Ltd. Peter M. Tessier, Ph.D., Associate Professor, Chemical Biological Engineering, Rensselaer Polytechnic Institute Salvador Ventura, Ph.D., Professor, Biochemistry and Molecular Biology, Institute of Biotechnology and Biomedicine, University of Barcelona Herren Wu, Ph.D., Chief Technology Officer, MedImmune/AstraZeneca 蛋白质与抗体工程 新一代肿瘤生物治疗 蛋白质聚集和稳定性 APRIL 5-7, 2016 GRAND HYATT SHANGHAI, PUDONG SHANGHAI, CHINAPEGSCHINA CAMBRIDGE HEALTHTECH INSTITUTE’S 3RD ANNUAL Protein Antibody Engineering and Development Summit REGISTER BY JANUARY 15 SAVE UP TO $400 第 三 届 中 国 蛋 白 与 抗 体 生物药物特性分析 工 程 及 研 发 峰 会 生物制品临床和监管战略 Corporate Sponsor CambridgeHealthtechInstitute Organized by
- 2. Track 1: Protein Antibody Engineering 蛋白质与抗体工程 Features top researchers sharing their insight in the design and optimization of protein and antibody molecules, and discussing the cutting-edge technologies and creative approaches they used to overcome the challenges along the way. Track 2: Analytical Characterization of Biotherapeutics 生物药物特性分析 Showcases cutting-edge tools, techniques and approaches to evaluate structure- function relationships, determine physio-chemical properties and analyze higher order structures of novel biologics as well as biosimilars. Track 3: Next-Generation Cancer Biotherapeutics 新一代肿瘤生物治疗 Presents strategies to develop next-generation ADCs, bispecific and multi-specific antibodies, novel engineered antibodies with increased properties, as well as approaches to overcome the challenges in developing immunotherapy antibodies. Track 4: Protein Aggregation Stability 蛋白质聚集和稳定性 Invites scientists to explore the mechanisms of aggregation, predict aggregation propensity, conduct stability studies, and compare tools for the characterization and quantification of these aggregates and particles. 2 | PEGSummitChina.com PEGS China: The Quintessential Protein Antibody Engineering and Development Summit Join your peers and leading players in the worldwide biopharmaceutical industry to develop and foster collaboration among international and domestic China companies and institutions. Companies in China are increasingly being perceived as competitors and potential partners in novel biotherapeutics development. Local conglomerates are setting up biotherapeutic arms; multi-nationals are localizing research and development; innovative returnees are starting up new biotech ventures; and universities are spinning off novel ideas and training future generations in the protein sciences. All these are making China a fertile ground for the growth of novel biotherapeutics. In its third year, “PEGS China: Protein and Antibody Engineering Development Summit” returns to Shanghai for 3 days of inspiring presentations and case studies featuring the latest trends and future potential of China’s biotech industry. This year’s event is comprised of four content-driven conferences with over sixty global speakers, plus a new seminar on clinical regulatory strategies for global and domestic IND and BLA filings. In addition, dedicated exhibit hall and poster viewing hours will provide invaluable opportunities for networking, deal-making and ideas exchange. APRIL 5-7, 2016 GRAND HYATT SHANGHAI, PUDONG SHANGHAI, CHINAPEGSCHINA CAMBRIDGE HEALTHTECH INSTITUTE’S 3RD ANNUAL Protein Antibody Engineering and Development Summit Seminar: Clinical and Regulatory Strategies for Domestic and Global IND and BLA Filings 生物制品临床和监管战略 Explores opportunities and options for developing new products, and investigates strategies that have been used and that are available for successful international development. JOIN THE PEGS COMMUNITY ONLINE Tuesday AM JOINT OPENING PLENARY (T1 AND T2) Tuesday PM T1: Protein Antibody Engineering T2: Analytical Characterization of BiotherapeuticsWednesday AM Wednesday PM JOINT PLENARY SESSION (T3 AND T4 AND SEMINAR) Thursday T3: Next-Generation Cancer Biotherapeutics T4: Protein Aggregation Stability Seminar: Clinical Regulatory Challenges for Domestic and Global IND and BLA Filings CONFERENCE AT-A-GLANCE 3 Days, 4 Conferences, 1 Seminar 60+ Presentations from Industry Experts Featuring Case Studies and Unpublished Data 200+ Global Participants
- 3. PEGSummitChina.com | 3 Premier Sponsor Corporate Sponsor SPONSORSHIP EXHIBIT OPPORTUNITIES AGENDA BREAKFAST PRESENTATIONS Showcase your solutions to a guaranteed, highly-targeted audience. Package includes a 15- or 30-minute podium presentation within the scientific agenda, exhibit space, branding, registrations and use of the mailing list. INVITATION-ONLY VIP DINNER/HOSPITALITY SUITE Select your top prospects from the conference pre-registration list for an evening of networking at the hotel, or at a choice local venue. CHI will extend invitations, conduct follow-up and confirm attendees. EXHIBIT Exhibitors will enjoy facilitated networking opportunities with qualified delegates, making it the perfect platform to launch a new product, collect feedback, and generate new leads. Exhibit space sells out quickly, so reserve yours today! OTHER OPPORTUNITIES INCLUDE: • Conference Tote Bags • Badge Lanyards • Notebooks • Literature Distribution • Exhibit Hall Reception • Networking Luncheon For sponsorship and exhibit information, please contact: Companies A-K: Jason Gerardi Manager, Business Development T: 781-972-5452 E: jgerardi@healthtech.com Companies L-Z: Carol Dinerstein Director, Business Development T: 781-972-5471 E: dinerstein@healthtech.com GROUP DISCOUNTS: REGISTER 3 AND 4TH IS FREE! Discount applies to attendees from the same organization registering for the same event. All registrations must be submitted together to qualify for the discount. ALUMNI DISCOUNT - SAVE 20%: CHI appreciates your participation at our events. As a result of the great loyalty you have shown us, we are pleased to extend to you the exclusive opportunity to save an additional 20% off the registration rate. 2014-2015 ATTENDEE DEMOGRAPHICS COMPANY TYPE Biotechnical/ Commercial: 39% Services/Societies: 1% Other 10% Healthcare/ Hospital: 2% Academic: 16% Pharma: 32% GEOGRAPHIC LOCATION Europe: 13% USA: 25% Asia: 61% Other: 1% COMPANY TITLE Scientist/ Technologist: 45% Executive/Director: 32% Professor : 8% Manager: 8% Other: 7% LOOKING FOR ADDITIONAL WAYS TO DRIVE LEADS TO YOUR SALES TEAM? CHI’s Lead Generation Programs will help you obtain more targeted, quality leads throughout the year. We will mine our database of 800,000+ life science professionals to your specific needs. We guarantee a minimum of 100 leads per program! Opportunities include: • Whitepapers • Web Symposia • Custom Market Research Surveys • Podcasts
- 4. PEGS CHINA | TUESDAY,APRIL 5 4 | PEGSummitChina.com TRACK 1: PROTEIN ANTIBODY ENGINEERING TRACK 2: ANALYTICAL CHARACTERIZATION OF BIOTHERAPEUTICS TRACK 1: PROTEIN ANTIBODY ENGINEERING 10:30 Chairperson’s Remarks Mitchell Ho, Ph.D., Chief, Antibody Therapy Section, National Cancer Institute, NIH RATIONAL DESIGN AND ENGINEERING 10:35 Design Principles for Bispecific IgGs – Opportunities and Pitfalls of Artificial Disulfide Bonds Itai Benhar, Ph.D., Professor, Molecular Microbiology and Biotechnology, Tel-Aviv University We present a solution for correct pairing of heavy and light chains of bispecific IgGs, an engineered disulfide bond between the antibodies’ variable domains that asymmetrically replaces the natural disulfide bond between CH1 and CL. Bispecific IgGs where the artificial disulfide bond is placed in the CH1-CL interface are also discussed. Examples will be provided for some of these bsAbs and future directions of the study will be discussed. ND 11:05Therapeutic Enzymes for theTreatment of Leukemia: Molecular Engineering and in vitro Evolution of L-Asparaginases Manfred Konrad, Ph.D., Research Director, Enzyme Biochemistry, Max Planck Institute for Biophysical Chemistry L-asparaginases (L-ASNase) of bacterial origin are FDA-approved enzyme drugs for the treatment of acute lymphoblastic leukemia, despite eliciting adverse side effects, in particular immunogenicity. This talk highlights the rational design and molecular engineering of human homologues to replace bacterial enzymes. We developed a high-throughput screening platform to identify enzyme variants displaying improved catalytic activities, and packaged L-ASNases into microcapsules to enhance protein stability and prevent exposure to the immune system. 11:35 Expression, Structural and Functional Studies of the Human Cannabinoid Receptor CB2 Alexei Yeliseev, Ph.D., Staff Scientist, Group Leader, LMBB, NIH/ NIAAA Human cannabinoid receptor CB2 is an important target for pharmaceutical drug development. High resolution structural studies are necessary for rational design of specific ligands targeting this receptor. Furthermore, CB2 was site-specifically labeled by selectively targeting reactive cysteine residues and incorporation of unnatural functional groups through codon reassignment which allows preparation of receptor samples for various spectroscopic studies. Studies of the structural dynamics of CB2 bound to a variety of cannabinoid ligands, in detergent micelles and in lipid bilayers of various compositions are in progress. 12:05 pm Sponsored Presentation (Opportunity Available) 12:35 Networking Luncheon in the Exhibit Hall with Poster Viewing CS = Case Study ND = New Data 10:30 Chairperson’s Remarks Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd CHARACTERIZATION AND SELECTION OF COMPLEX BIOMOLECULES ND 10:35 Analytical Characterization and Control Strategies for ADC Heyi Li, Ph.D., Senior Principal Scientist and Group Leader, Biotherapeutics, Pfizer, Inc. An antibody-drug conjugate (ADC) is typically produced by chemically linking a small molecule cytotoxin (drug) with a cancer-specific monoclonal antibody. This presentation provides an overview of control strategies and analytical and biochemical characterizations for ADCs. The talk will briefly discuss the critical quality attributes (CQAs), analytical control strategies, and provide examples of characterizations of ADCs from two common conjugation chemistries (Lysine and Cysteine). The characterizations include drug-antibody ratio (DAR), drug distribution, purity/impurity and potency. 11:05 Bio-Conjugation Approaches to Generate Bispecific Antibodies Julie Q. Hang, Ph.D., Senior Scientist, Protein Chemistry, Genentech, Inc. Various forms of bispecific antibodies are generated by the expression of engineered antibodies or antibody fragments. Bio-conjugation of two bispecific Fab arms provided an efficient approach to produce a stable bispecific molecule, which carries the similar conformation and biological activities as the native F(ab’)2. We also developed an orthogonal bio-conjugation approach to produce bispecific molecules through copper-less clicking reactions. Generation of multivalent bispecific molecules was also explored in bio-conjugation. 11:35 An Integrated Approach to Candidate Selection during Biologics Drug Development Steffen Hartmann, Ph.D., Global Head, Integrated Biologics Profiling, Novartis Pharma AG The presentation will provide an overview of our integrated biologics profiling process at Novartis Biologics. The right state-of-the-art cell line development is combined with developability assessment encompassing a variety of methods from in silico tools to identify sequence liabilities to high throughput expression and biophysical profiling to ‘in vivo fitness’ assessment as well as formulation assessment and in vitro tools for assessing immunogenicity risks. This enables the organization to select the best biologics candidate for each project for further development. 12:05 pm Sponsored Presentation (Opportunity Available) 12:35 Networking Luncheon in the Exhibit Hall with Poster Viewing JOINT PLENARY SESSION 8:50 Chairperson’s Opening Remarks Mitchell Ho, Ph.D., Chief, Antibody Therapy Section, National Cancer Institute, NIH ND 9:00 Improved Methods for Designing and Evolving Antibodies Peter M. Tessier, Ph.D., Richard Baruch M.D. Career Development Associate Professor, Chemical Biological Engineering, Rensselaer Polytechnic Institute The biotech industry has seen an explosion in the development of therapeutic antibodies in the last decade. The advantages of antibodies are compelling. Nevertheless, there are many challenges associated with antibody selection and engineering that require key technical advances to simplify the rapid and reliable generation of potent antibody therapeutics. I will discuss our progress in addressing some of these challenges, including the design, evolution and selection of antibodies with high affinity, stability and solubility. ND 9:30 Engineering Principles to Generate Multivalent Antibody-TRAIL Fusion Proteins Roland Kontermann, Ph.D., Professor, Biomedical Engineering, Institute of Cell Biology and Immunology, University of Stuttgart Fusion of TRAIL to antibody fragments has been shown to allow for a targeted delivery and the selective induction of tumor cell death. We have engineered optimized single-chain derivatives of TRAIL (scTRAIL), which were employed to develop novel multivalent antibody-scTRAIL fusion proteins with improved properties. These multivalent fusion proteins were generated employing either scFv-driven homodimerization or various separate homodimerization modules. Targeting and controlled dimerization of scTRAIL fusion proteins provides a strategy to enforce apoptosis induction, together with retained tumor selectivity and good in vivo tolerance. 7:30 am Registration and Morning Coffee 10:00 Coffee Break
- 5. TRACK 1: PROTEIN ANTIBODY ENGINEERING TRACK 2: ANALYTICAL CHARACTERIZATION OF BIOTHERAPEUTICS TUESDAY,APRIL 5 | AGENDA PEGSummitChina.com | 5 1:55 Chairperson’s Remarks Yu Zhou, Ph.D., Associate Adjunct Professor, Anesthesia, University of California, San Francisco DEVELOPABILITY AND OPTIMIZATION CS 2:00 Glycooptimization of Antibodies Results in Improved Clinical Efficiency Lars Stoeckl, Ph.D., Associate Director, RD, Glycotope GmbH Glycosylation is one of the major post-translational modifications of biotherapeutics that depends on the cell line used for production. We have generated a set of glyco engineered human cell lines for the high yield production of fully human glycooptimized antibodies. Two Biobetter antibodies directed against approved targets and glycooptimized with respect to manifold improvement of anti-cancer activity, half-life elongation, removal of immunogenic components are in clinical development. Case studies including results from clinical Phase I studies will be presented. 2:30 Rational Strategy to Stabilize Early Stage Biologic Candidates to Enhance Developability and Enable SuccessfulTransfer from Research into Development Danny K. Chou, PharmD., Ph.D., President, Compassion BioSolution The goal of this presentation is to describe a platform approach to identifying the optimal solution conditions that can stabilize biologics candidates in the discovery/ candidate selection stage in a high throughput fashion, whereby, using a very limited amount of protein and commonly available equipment, the development team can assist the drug discovery team in candidate selection and re-engineering of molecules prior to transition into full-scale development. CS 3:00 Viscosity Modulation of Antibodies by Design Satish D. Singh, Ph.D., Research Advisor, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc. Proactively eliminating or mitigating development challenges can reduce the time and resources required for taking a molecule from discovery to clinic. A common development challenge for mAbs is high viscosity of their concentrated solutions. Viscosity in solution depends on intermolecular (self-) interactions, which are determined by the sequence and structural properties. Understanding the molecular origins of these interactions can help to select or design mAb candidates with low viscosity. 3:30 Sponsored Presentation (Opportunity Available) 4:00 Refreshment Break in the Exhibit Hall with Poster Viewing NEW AND EMERGINGTARGETS ND 4:40 Gypican-3 as a Liver CancerTarget for Antibody-Based Therapies Mitchell Ho, Ph.D., Chief, AntibodyTherapy Section, National Cancer Institute, NIH Glypican-3 (GPC3) is expressed in hepatocellular carcinoma. Our lab has developed human monoclonal antibodies therapeutically targeting GPC3 that inhibit Wnt/ Yap signaling pathways known to be important for liver cancer pathogenesis. Furthermore, we have demonstrated that a GPC3-targeted immunotoxin can cause regression of human liver cancer xenografts in mice. Its mechanism of action appears to involve both inhibition of cancer signaling (Wnt/Yap) and reduction in protein synthesis. 5:10Targeting the Intracellular Proteome with Antibodies against Peptide/MHC Complexes Presented on the Cell Surface: Making the IntracellularTargets Visible to AntibodyTherapy Yoram Reiter, Ph.D., Professor and Head, Molecular Immunology, Biology, Technion-Israel Institute of Technology The ability to generate T-cell receptor-like (TCRL) antibodies which bind HLA- peptide complexes on the surface of cells opens new possibilities for developing new therapeutic modalities. These antibodies can bind specifically to, and kill, the diseased cells, transforming disease-specific targets expressed inside malignant cells into targets that can be recognized on the cell surface by soluble TCRL antibodies. This approach expands the pool of novel therapeutic antibodies beyond the limits of currently available antibodies. 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing 6:40 Close of Day 1:55 Chairperson’s Remarks Heyi Li, Ph.D., Senior Principal Scientist and Group Leader, Biotherapeutics, Pfizer, Inc. EVALUATING STRUCTURE-FUNCTION RELATIONSHIPS »»2:00 KEYNOTE PRESENTATION: CUTTING-EDGE MASS SPECTROMETRY METHODS FOR ANTIBODY, BIOSIMILAR, BISPECIFIC AND ANTIBODY-DRUG CONJUGATES STRUCTURAL ASSESSMENT CS ND Alain Beck, Ph.D., Senior Director, Antibody and ADC Physico-Chemistry, Centre d’Immunologie Pierre Fabre, France A plethora of new mass spectrometry (MS) methods are used for antibody structural characterization and for biosimilarity assessment. In addition, these techniques are used to design and optimize more sophisticated and potent antibody derivatives such as ADCs (OptimADCs), bi- and multispecific antibodies, and controlled mixture of antibodies. Case studies based on state-of-the art MS methods such as Native and Ion-Mobility MS, Top-Down Sequencing, Proteomics and Sheathless Capillary Electrophoresis−Tandem MS will be presented and discussed. 2:30 Protein Bioanalytical and Biophysical Characterization and Comparability Li Shi, Ph.D., CEO, Shanghai Zerun Biotechnology Co., Ltd With the latest advances in analytical technologies, most biological products can now be extensively characterized in terms of their identity, heterogeneity and impurity profile. The currently available biophysical and bioanalytical methods can characterize the primary, secondary and to some extent, the higher order structure of proteins. This session will discuss how to assess comparability of and process consistence of protein products using biophysical and bioanalytical characterization technologies. 3:00 Be Dynamic: How Physico-ChemicalTechniques are Moving Forward to Meet Challenges in Biotherapeutics Characterization Luisa Iozzino, Ph.D., Associate Researcher, Protein Chemistry, Merck Serono S.p.A. Biotherapeutics need in-depth characterization to be entirely understood. In particular, a better comprehension of higher-order structure will lead to safer and more effective biopharmaceutical products. Traditional spectroscopic techniques can be very useful for product characterization in a “dynamic mode”. Case studies in which dynamic aspects on the structure of the product have been evaluated will be presented. 3:30 Sponsored Presentation (Opportunity Available) 4:00 Refreshment Break in the Exhibit Hall with Poster Viewing BEST PRACTICES IN PROTEIN ANALYTICS 4:40 USP Analytical Methods and Approaches for Biologics Jun Liu, Ph.D., Principal Scientific Liaison, Global Biologics, USP China USP’s USP-NF contains General Chapters and monographs that support the quality, safety, and potency of drug substances and products. This talk will explain the strategies used to prepare suitable monographs for biologics from multiple manufacturers and also highlight new test Chapters containing validated methods appropriate for many recombinant therapeutic products. ND 5:10 Analytical Sciences: Eyes and Ears of ProteinTherapeutics Ziyang Zhong, Ph.D., Vice President, Product Development, Henlius Biotech Co. Ltd. Analytical sciences is an integral part of drug RD. It provides structural and biological evidences to the progress of any project. Several examples will be given to illustrate the important roles that AS played in protein therapeutics discovery and development. These range from analysis of binding kinetics, glycan profile, to amino acid sequence confirmation. Common techniques used in protein analytics, including LC/MS, SPR, and flow cytometry, will be discussed. 5:40 Welcome Reception in the Exhibit Hall with Poster Viewing 6:40 Close of Day
- 6. TRACK 1: PROTEIN ANTIBODY ENGINEERING TRACK 2: ANALYTICAL CHARACTERIZATION OF BIOTHERAPEUTICS PEGS CHINA | WEDNESDAY,APRIL 6 6 | PEGSummitChina.com 8:30 am Registration and Morning Coffee 8:50 Chairperson’s Opening Remarks Herren Wu, Ph.D., CTO, MedImmune/AstraZeneca ANTIBODY DISCOVERY AND LIBRARY GENERATION »»9:00 KEYNOTE PRESENTATION: ATTHE CROSSROADS: GETTINGTO REPRODUCIBLE RESEARCH ANTIBODIES Andrew Bradbury, MBBS, Ph.D., Research Scientist and Group Leader, Biosciences Division, Los Alamos National Laboratory Researchers all over the world routinely use antibodies, a critical class of commercially supplied reagents that are frequently unreliable. This situation affects reproducibility in biomedical research, wastes millions of dollars annually, and may affect clinical trials. This talk will provide an overview of the problem, argue that the time has come to express antibodies recombinantly and refer to them by their sequences, and provide possible ways to get to this ideal. 9:30Therapeutic Antibody Discovery Using MultipleTools Yan Wu, Ph.D., Associate Director and Principal Scientist, Department of Antibody Engineering, Genentech, Inc. 10:00 Sponsored Presentation (Opportunity Available) 10:30 Coffee Break in the Exhibit Hall with Poster Viewing 11:10 Antibody Isotopes Diversity andTheir Biomedical Potentials Xiaoying Zhang, Ph.D., Professor, College of Veterinary Medicine, Northwest AF University Antibodies from different species (eg.: IgY, VHH, Bovine IgG, rabbit IgG, Lamprey—VLR) have different biological characters, and these may lead to special medicinal values. It is necessary to study, understand and utilize the antibodies from different species based on their unique advantages/characteristics. Such knowledge is becoming important source for antibody design, antibody engineering and antibody mimics. 11:40 Nature-Inspired Synthetic Human Ab Library Yu Zhou, Ph.D., Associate Adjunct Professor, Anesthesia, University of California, San Francisco Naïve human antibody CDR sequences were collated and used to design non-redundant synthetic CDRs matching the naturally occurring diversities. These synthetic non-redundant CDRs were inserted into the well expressing V-gene frameworks, and displayed to construct phage Ab library. Such phage Ab library was used to isolate high quality renewable antibodies (rAbs), which are essential reagents for determining how proteins function under normal and pathophysiological conditions. 12:10 pm Antibody Library Display on a Mammalian Virus: Combining the Advantages of Panning and Cell Sorting in OneTechnology Ernest S. Smith, Ph.D., Senior Vice President, Research CSO, Vaccinex, Inc. We have developed a new antibody selection technology that enables efficient expression of a library of human antibodies in full length IgG format on the surface of vaccinia virus, an enveloped mammalian virus. Various panning and magnetic bead based methods have been developed to screen the library of vaccinia-MAb virions and select recombinant vaccinia virus encoding specific antibodies. This technology ensures the selected antibodies are efficiently expressed and have favorable stability and specificity properties. 12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing 2:00 Close of Protein Antibody Engineering 8:30 am Registration and Morning Coffee 8:50 Chairperson’s Opening Remarks Joe Zhou, Ph.D., CEO, Genor BioPharma ADVANCED METHODS AND APPROACHES IN BIOTHERAPEUTICS CHARACTERIZATION 9:00 Subvisible Protein Particles Mass Calculation with Improved Accuracy Using Microflow Imaging (MFI) Joy Zhou, Ph.D., Principal Scientist Associate Director, Drug Product, Manufacturing Science Technology, Shire Pharmaceuticals Formation of subvisible particles (1–100 µm) is a major stability concern with protein therapeutics. However, particle numbers are often too low to permit for direct experimental protein content (mass) measurement. A novel, accurate, and easy-to-implement method using MFI was developed to calculate the mass of subvisible protein particles and testified with polystyrene standards and stressed mAb. This method improves estimations of protein particle mass and facilitates a better understanding of protein particle formation. 9:30 Use of Bio-Layer Interferometry (BLI)-Based Octet Platform for Biotherapeutic Drug Discovery Development Vishal Kamat, Ph.D., Scientist, Biomolecular HTS Center, Therapeutic Proteins, Regeneron 10:00 Sponsored Presentation (Opportunity Available) 10:30 Coffee Break in the Exhibit Hall with Poster Viewing COMPARABILITY AND BIOSIMILARITY ANALYSIS 11:10 Case Study of Genor BioPharma: Development and Commercialization Strategy ofTherapeutic mAb in China Joe Zhou, Ph.D., CEO, Genor BioPharma Since 2009, Genor BioPharma has generated and tested working strategy of how to build up mAb pipeline of follow-on biologics/NME based on our sciences/ technology in upstream, downstream and quality system. In this presentation, we demonstrate the positive future outlook of our current strategy using several mimic case studies such as CTA approval for GB221; comparability study approach with originators products; government funds obtained for GB221 and GB222; as well as our recent FOB commercialization through a Korea company. 11:40 Current Development in AnalyticalTools and Approaches for Characterizing Biopharmaceuticals for Comparability and Implications for Biosimilars Kate Zhang, Ph.D., Senior Director, Biopharmaceutical Development, Sanofi With the continuing progress of analytical tools, the analytical assay could generate overwhelming amount of the data. A well-designed analytical strategy is essential to ensure the success of a comparability study which addresses the critical physical and chemical characteristics of bio-therapeutics. 12:10 pm Biosimilar mAb Higher Order Structure Comparability Analysis with Luminex Beads-Based Protein Conformational Array Xing Wang, Ph.D., President, Array Bridge, Inc. Biologics Higher Order Structure (HOS) is important to its safety and efficacy but difficult to define. A novel technology is developed using antibody arrays to analyze monoclonal antibody HOS, recently the technology has been adapted to the Luminex-based platform with much improved automation and throughput. Case studies will be presented to demonstrate the application of the Luminex- based antibody array in biosimilar as well as novel mAb development. 12:40 Networking Luncheon in the Exhibit Hall with Poster Viewing 2:00 Close of Analytical Characterization of Biotherapeutics CS = Case Study ND = New Data “This conference is very successful, in my opinion, for it not only invites the top scientists in the field of therapeutic antibody, but also this event gives a chance for local companies to present their scientific achievements. I enjoyed the talks very much. Thank you again for the organization.” …Senior Scientist, Roche RD China Ltd. “Congratulations on a successful PEGS China meeting. I really enjoyed the conference and interactions with the attendees.” …Senior Scientist and Group Leader, Genentech, USA “Thanks again for such a great PEGS China in Shanghai. I really enjoyed attending this very well organized conference! A job well done!” …Director, High Throughput Biochemistry Lab, University of Zurich, Switzerland “I really enjoyed the conference and made some great contacts.” …Associate Professor, Chemical Engineering, University of Queensland, Australia
- 7. TRACK 4: PROTEINAGGREGATIONSTABILITY TRACK 3: NEXT-GENERATION CANCER BIOTHERAPEUTICS WEDNESDAY, APRIL 6 | AGENDA JOINT PLENARY SESSION THE PROMISE OF NOVEL CANCER BIOTHERAPEUTICS 2:00 Chairperson’s Opening Remarks Daotian Fu, Ph.D., General Manager, Livzon MabPharm 2:05 Developing Antibody-Drug Conjugates for theTreatment of Solid Cancers Paul W.H.I. Parren, Ph.D., Senior Vice President Scientific Director, Genmab Therapeutic antibodies have revolutionized the treatment of cancer. However, many patients still fail to respond or become resistant to targeted treatment and novel innovative approaches to improve therapy are therefore required. Chemical engineering of antibodies, fueled by recent molecular insights, is providing important opportunities for the development of more potent antibody therapeutics. The progress in two antibody-drug conjugate programs from Genmab’s portfolio will be highlighted. 2:35 Engineering the Next-Generation Antibody-Drug Conjugates for CancerTherapy Herren Wu, Ph.D., CTO, MedImmune/AstraZeneca Linking of highly potent cytotoxic warheads to tumor-targeting antibodies has the potential to attack tumors with missile-like precision and avoid toxicity to normal tissues. However, clinical observations indicate that the therapeutic window of most antibody-drug conjugates (ADCs) remains narrow. I will discuss our efforts in developing next-generation ADC technology which seeks to address the short-comings observed with current ADCs and help realize the full potential of this drug class to provide new breakthrough agents for the treatment of cancer. 3:05 Cancer Immunotherapy: Delivering the Promise Weikang Tao, Ph.D., Vice President CEO, RD Center, Jiangsu Henrui Medicine Co., Ltd. Recent breakthroughs in treating different types of advanced-stage malignancies by harnessing self immunity against neoplastic cells showed a great promise of immunotherapy for cancer treatment. Various strategies have been employed to unleash, enhance or elicit anticancer immune reactions, which include T-cell checkpoint blockade, engineered T cells, BiTE, modified cytokines and cancer vaccines. This presentation will review recent progress in cancer immunotherapy and discuss some immunotherapeutic agents discovered and developed at HengRui Medicine Co., Ltd. 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing CHALLENGES FOR NEW BIOLOGICS DEVELOPMENT IN CHINA 4:10 Update on Recent Regulatory Changes for Biologics Development in China Daotian Fu, Ph.D., General Manager, Livzon MabPharm Over the past several years, the biotech industry in China has experienced tremendous growth, both in biosimilars and innovative biologics. In the meantime, the CFDA is also going through significant reforms with respect to guidance and the reviewing process for development of both biosimilars as well as innovative biologics. In this presentation, the author intends to provide an update on the recent development in CFDA’s guidance for biologics development in China, and how the biotech industry can best position itself to take advantage of the recent regulatory changes. 4:40 PANEL DISCUSSION: Understanding the Clinical and Regulatory Pathways for New Biologics Development in China Moderator: James Cai, Ph.D., Vice President, Global Regulatory Affairs, Access Policy, Amgen Shanghai Panelists: Daotian Fu, Ph.D., General Manager, Livzon MabPharm Weidong Jiang, Ph.D., CSO, Shanghai Henlius Weikang Tao, Ph.D., Vice President CEO, RD Center, Jiangsu Henrui Medicine Co., Ltd. Scott M. Wheelwright, Ph.D., CEO, Complya Asia 5:40 Close of Day 1:00 pm Registration RESEARCH POSTER SUBMISSION Cambridge Healthtech Institute encourages attendees to gain further exposure by presenting their work in the poster sessions. To secure a poster board and inclusion in the conference materials, your abstract must be submitted, approved and your registration paid in full by February 26, 2016. DEADLINE FOR POSTER SUBMISSION: FEBRUARY 26, 2016 Reasons you should present your research poster at this conference: • Your poster will be showcased to our international delegation • Receive $50/ ¥200 off your registration • Your poster abstract will be published in our conference materials • Your research will be seen by leaders from top pharmaceutical, biotech, academic and government institutes PEGSummitChina.com | 7
- 8. PEGS CHINA | THURSDAY,APRIL 7 8 | PEGSummitChina.com TRACK 4: PROTEINAGGREGATIONSTABILITY TRACK 3: NEXT-GENERATION CANCER BIOTHERAPEUTICS TRACK 3: NEXT-GENERATION CANCER BIOTHERAPEUTICS PEGS CHINA | THURSDAY,APRIL 7 8:30 am Morning Coffee 8:50 Chairperson’s Opening Remarks Ting Xu, Ph.D., CEO and President, AlphaMab Co. IMMUNO-ONCOLOGY ANTIBODIES ND 9:00 Challenges in Developing Immunotherapy Antibodies Weidong Jiang, Ph.D., CSO, Shanghai Henlius Cancer immunotherapy is the most exciting development for cancer treatment in recent years. Immuno checkpoints are the most popular targets for antibody drug development. We have developed anti-PD1 and anti-PD-L1 antibodies via different methodologies with success and failure. Both case studies will be presented to share our experience about how to obtain therapeutic antibodies from research to preclinical validation, including in vitro functional assays, in vivo animal model efficacy studies, and importance of affinity maturation for these antibodies. 9:30 Antibody-Cytokine Heterodimeric Fusion in Oncoimmunology - Efficacy, Characterization and Mode of Action Ting Xu, Ph.D., CEO and President, AlphaMab Co. This presentation will examine strategies to booster immune status in non T-cell infiltrated tumor; cytokines for tumor immunotherapy and selection of right cytokines; as well as the design of heterodimeric antibody-cytokine fusion. Preclinical studies of two types of cytokines fusion, efficacy and mechanism will be presented. 10:00 Cancer Biotherapeutics - Affimers: A Novel Sponsored by Scaffold for Biotherapeutics Amrik Basran, Ph.D., CSO, Therapeutics, Avacta Life Sciences Affimers are a new protein scaffold with great potential for the generation of biotherapeutics. Based on the protease inhibitor Stefin A, large diverse libraries have been created by engineering in peptide loops into the scaffold backbone. Using phage display, we have identified competitive binders to a ranage of targets, including the immune check point, PD-L1. We have shown that the scaffold is amenable to being engineered with a range of half-life extension technologies, giving “IgG like” PK. 10:30 Coffee Break in the Exhibit Hall with Poster Viewing BISPECIFIC AND MULTI-SPECIFIC ANTIBODIES 11:00 COVA322: A Clinical-Stage BispecificTNF/IL-17A Fynomab for the Treatment of Inflammatory Diseases Michela Silacci, Ph.D., Director, Discovery Research, RD, Covagen AG Covagen develops bispecific FynomAbs by fusing its Fynomer binding proteins to antibodies resulting in therapeutics with novel modes of action and enhanced efficacy. FynomAbs have optimal physico-chemical and in vivo half-life properties, making them attractive as drug candidates. We will give an update about COVA322, a clinical-stage bispecific TNF/IL-17A inhibitor for the treatment of inflammatory diseases. In addition, FynomAbs with tailored anti-tumor effects will be presented. 11:30 Design of Multispecific Antibodies ModulatingT-Cell Functions for Redirected Cytotoxicity Ji Jie Gu, Ph.D., Senior Principal Research Scientist, Global Biologics, AbbVie With four DVD-Ig molecules currently in clinical development, we have furthered the DVD-Ig concept to the design of multispecific molecules to address additional unmet needs. In this presentation we will discuss: (1) improvement on DVD- Ig technology and beyond; (2) some basic structural and functional features of emerging multispecific molecules; and (3) how these molecules could be used to fine tune T cell functions for re-directed toxicity against tumor cells. 12:00 pm Bispecific AntibodyTargeting of Nanomedicines for Cancer Therapy Christopher Howard, Ph.D., Senior Research Fellow, Australian Institute for Bioengineering and Nanotechnology, University of Queensland A simple method to generate actively targeted nanomaterials using bispecific antibodies with dual specificity for nanomaterials and cancer targets such as Epidermal Growth Factor Receptor (EGFR) will be discussed. The design, expression, stability and target binding of the BsAbs will be outlined. The delivery of imaging agents and therapeutics to tumour sites using BsAb tethered nanomaterials will also be discussed. 12:30 Networking Luncheon in the Exhibit Hall with Poster Viewing 8:30 am Morning Coffee 8:50 Chairperson’s Opening Remarks Danny K. Chou, Pharm.D., Ph.D., President, Compassion Biosolution NEW FRONTIERS IN UNDERSTANDING PROTEIN AGGREGATION BEHAVIOR AND MECHANISMS OF ACTION »»9:00 KEYNOTE PRESENTATION: DESIGNING PROTEIN SOLUBILITY Salvador Ventura, Ph.D., Professor, Biochemistry and Molecular Biology, Institute of Biotechnology and Biomedicine, University of Barcelona One of the major challenges that one should face during the development of protein-based biopharmaceuticals is their inherent propensity to aggregate. Indeed, protein therapeutic agents are both stored and typically administered at very high concentrations. Under these conditions they can easily aggregate, impacting the product’s developability, stability, formulation, and immunogenicity. I will discuss how computationally-assisted design of protein structures solubility is helping us to overcome these limitations. 9:30 Using in silicoTools to Predict the Propensities for Aggregation and for Viscosity Bernhard Helk, Ph.D., Distinguished Fellow, Biologics Technical Development and Manufacturing, Novartis Pharma AG Three in silico tools and their practical application to the prediction and characterization of protein-protein-interaction are demonstrated: SAP (Spatial Aggregation Propensity) identifies hydrophobic patches and is applied to engineer mAbs and ADCs with increased stability. DI (Developability Index) predicts aggregation propensities based on SAP and net charge. SCM (Spatial Charge Map) ranks mAbs according to viscosity. Case studies for predicting crystallization and viscosity of mAbs are presented. 10:00 Sponsored Presentation (Opportunity Available) 10:30 Coffee Break in the Exhibit Hall with Poster Viewing 11:00 Understanding Protein Aggregation – Opalescence,Turbidity and Particulates Wei Wang, Ph.D., Senior Scientist, Global Biological Development, Bayer Healthcare The large number of biological candidates in the pipeline demands an efficient product development process. However, many of these candidates are prone to aggregation. Depending on the aggregation pathways/mechanisms and/or extent, an aged solution of a biological product can possess different appearances - opalescence, turbidity, and/or presence of particles. This presentation discusses the similarities and differences of these appearances and the associated possible aggregation pathways/mechanisms. 11:30 Roles of Solution Composition on ProteinThermal Unfolding and Aggregation Kinetics Jifeng Zhang, Ph.D., Head, Drug Delivery and Device Development, MedImmune Maintaining biophysical stability is an essential aspect in developing liquid formulation of therapeutic monoclonal antibody drug product. Solution conditions, e.g. pH, salt ion type and concentration, play important roles of determining antibody thermal stability and aggregation kinetics. In this presentation, the mechanistic pictures of protein-ion interactions and protein-protein interactions will be delineated to highlight their implications on thermal stability and aggregation kinetics. 12:00 pm Investigation of Product-Related Aggregation Zhenyu Gu, Ph.D., Scientist III, Analytical Sciences, Alexion Pharmaceuticals This presentation will examine the different methods for investigating protein aggregation and the potential root cause/mechanism for different aggregation. 12:30 Networking Luncheon in the Exhibit Hall with Poster Viewing CS = Case Study ND = New Data
- 9. THURSDAY,APRIL 7 | AGENDA TRACK 4: PROTEINAGGREGATIONSTABILITY TRACK 3: NEXT-GENERATION CANCER BIOTHERAPEUTICS 1:45 Chairperson’s Remarks Weidong Jiang, Ph.D., CSO, Shanghai Henlius EMERGING PLATFORMS FOR CANCERTHERAPY ND 1:50 Development of an Anti-HGF Antibody for CancerTherapy Junho Chung, M.D., Ph.D., Professor, Biochemistry and Molecular Biology, Seoul National University We developed an anti-HGF rabbit humanized antibody. In mouse xeno-graft models, this antibody effectively inhibited the growth of human glioblastoma, sarcoma and colorectal cancer cells. The pharmacokinetic property of the antibody was determined in primate and no drug-related toxicity was monitored. This antibody is now in phase I clinical trial (ClinicalTrials.gov Identifier: NCT02499224). CS ND 2:20TargetedTreatment of Cancer Using ADCs Containing Specifically Conjugated Prodrugs of Novel Cytotoxic Agents Robert Y. Zhao, Ph.D., CEO and Chairman, Hangzhou DAC Biotech, Ltd. This talk focuses on developing new generation ADCs using prodrug and specific conjugation methodology. Through the approaches of our proprietary prodrugs of novel cytotoxic agents, and novel specific linkages to the antibodies, our ADC drugs have shown much superior windows of antitumor activities both in vitro and in vivo than existing ADC drugs. This novel ADC platform would have broader applications in the treatment of cancer. CS 2:50 A Novel Engineered VEGF Blocker with a Robust Anti-Tumor Activity XiangYang Zhu, Ph.D., CEO, Huabo Biopharma (Shanghai) Co., Ltd. A VEGF trap containing the second immunoglobulin-like domain of the VEGF tyrosine kinase receptor was fused to IgG1 Fc region, and a robust upstream and downstream process has been developed to assume enough materials for multiple clinical indications. Our results showed a strong anti-tumor activity in multiple animal models, indicated VEGF-Trap-mediated blockade may be superior to that achieved by other agents, such as monoclonal antibodies targeted against the VEGF receptor. ND 3:20 GC1118, A Novel EGFR-Targeting Antibody, with a Distinct Binding Epitope and Efficacy Jonghwa Won, Ph.D., Senior Research Director, Oncology Team, Green Cross Corp./Mogam Biotechnology Institute Finding a differentiating factor is a key to position successfully into competitive, existing anti-cancer therapeutics. GC1118 has a distinct EGFR binding epitope and shows potent inhibitory activities on high-affinity EGFR ligands to which current antibodies have limited efficacy. Our study suggests that GC1118 would give prominent therapeutic effects on tumors refractory or resistant to current EGFR- targeting therapeutics. Potential hypothesis in working mechanism and clinical implications of GC1118 will be presented. 3:50 An Introduction to BoAn’s Biologic Development Platforms Changlin Dou, Ph.D., CTO Senior Director, Antibody Technology Center, Luye Pharmacy Group BoAn Biotechnology Com. is a wholly owned subsidiary of Luye group dedicated to biologic development. This talk will introduce BoAn’s platform technologies in both new antibody drug discovery and biosimilar development. 4:20 Close of Conference 1:45 Chairperson’s Remarks Jifeng Zhang, Ph.D., Head, Drug Delivery and Device Development, MedImmune AGGREGATION DURING PROCESSING AND FORMULATION 1:50 Investigating Mechanisms of Monoclonal Antibodies Particle Formation during Drug Product (DP) Processing Yuh-Fun Maa, Ph.D., Principal Engineer, Genentech, Inc. Monoclonal antibody (mAb) particle formation observed during bottom mounted mixing and filling by piston pump was investigated to understand the root-cause mechanisms leading to protein degradation. The design of the mixer and the pump plays a critical role and any designs with contacting moving parts may grind the mAb molecules to immediately form particles. The impact of grinding on protein particle formation was assessed based on shear, local heat and cavitation. 2:20 Aggregation of Proteins during Bioprocessing: Mechanisms and Management Strategies Danny K. Chou, Pharm.D., Ph.D., President, Compassion Biosolution Protein aggregation is not only a challenge in the development of drug products, it is a significant barrier to cost-effective production of purified bulk drug substance. The goal of this presentation is to give some examples of how protein aggregation affects bioprocessing (e.g., purification including viral filtration), potential mechanisms, and how one may overcome this challenge. CS ND 2:50 Detectability of Endotoxin Contaminations in Biologicals Johannes Reich, MSc, Ph.D. Student, Physical Chemistry, Universität Regensburg /Hyglos GmbH In recent presentations and publications, the issue of Low Endotoxin Recovery (Endotoxin Masking) has been discussed. Thereby, formulated drug products often contain surfactants and buffer components in order to stabilize the active pharmaceutical ingredients (API). Interestingly, such components can affect the detectability of potential Endotoxin contaminations in common detection systems. Here, we show examples of masked Endotoxin in common product matrices and the applicability of dedicated demasking procedures. 3:20 Surfactants in Biotherapeutics: Impact, Analysis and Control Satish D. Singh, Ph.D., Research Fellow, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc. Non-ionic surfactants in therapeutic protein formulations, added in small amounts, generally protect the protein from physical degradation at interfaces. The most popular surfactants are the polysorbates. The polysorbates can degrade by various mechanisms and the degradation products can also impact the stability of the protein. The importance of this excipient has led to a resurgence of interest in all questions related to their use in biotherapeutics, including analysis and control. CS ND 3:50 Stability and Formulation Challenges for Biological Drug Products Jun Xiang, Ph.D.,Vice President, Pharmaceutical Science Technology, Biotechnology Institute of Shanghai CP Guojian Pharmaceutical Co., Ltd. Proteins and antibodies are “fragile” during processes, handling, storage, etc. A good formulation is critical for the stability of biological drug product to prevent any foreseeable or unforeseeable degradation. This presentation provides an overview of the possible challenges in the formulation development for biological drug products and will share some thoughts with case studies on overcoming these challenges to achieve a successful commercial launch of drug product. 4:20 Close of Conference PEGS CHINA 2016 SCIENTIFIC ADVISORY BOARD Danny Chou, Pharm.D., Ph.D., President, Compassion BioSolution, USA Daotian Fu, Ph.D., General Manager, Livzon MabPharm, Inc., China Weidong Jiang, Ph.D., CSO, Shanghai Henlius Biotech Co., Ltd., China Wei Wang, Ph.D., Senior Scientist, Global Biological Development, Bayer Healthcare, USA Jifeng Zhang, Ph.D., Head, Drug Delivery and Device Development, MedImmune, USA Xiaoying Zhang, Ph.D., Professor, College of Veterinary Medicine, Northwest AF University, China THURSDAY, APRIL 7 | AGENDA PEGSummitChina.com | 9
- 10. 10 | PEGSummitChina.com Seminar: April 6-7, 2016 Clinical and Regulatory Strategies for Domestic and Global IND and BLA Filings WEDNESDAY, APRIL 6, 2016 1:00 pm Registration JOINT PLENARY SESSION THE PROMISE OF NOVEL CANCER BIOTHERAPEUTICS 2:00 Chairperson’s Opening Remarks Daotian Fu, Ph.D., General Manager, Livzon MabPharm 2:05 Developing Antibody-Drug Conjugates for theTreatment of Solid Cancers Prof. Paul W.H.I. Parren, Ph.D., Senior Vice President Scientific Director, Genmab Therapeutic antibodies have revolutionized the treatment of cancer. However, many patients still fail to respond or become resistant to targeted treatment and novel innovative approaches to improve therapy are therefore required. Chemical engineering of antibodies, fueled by recent molecular insights, is providing important opportunities for the development of more potent antibody therapeutics. The progress in two antibody-drug conjugate programs from Genmab’s portfolio will be highlighted. 2:35 Engineering the Next-Generation Antibody-Drug Conjugates for CancerTherapy Herren Wu, Ph.D., CTO, MedImmune/AstraZeneca Linking of highly potent cytotoxic warheads to tumor-targeting antibodies has the potential to attack tumors with missile-like precision and avoid toxicity to normal tissues. However, clinical observations indicate that the therapeutic window of most antibody-drug conjugates (ADCs) remains narrow. I will discuss our efforts in developing next-generation ADC technology which seeks to address the short- comings observed with current ADCs and help realize the full potential of this drug class to provide new breakthrough agents for the treatment of cancer. 3:05 Cancer Immunotherapy: Delivering the Promise Weikang Tao, Ph.D., Vice President CEO, RD Center, Jiangsu Henrui Medicine Co., Ltd. Recent breakthroughs in treating different types of advanced-stage malignancies by harnessing self immunity against neoplastic cells showed a great promise of immunotherapy for cancer treatment. Various strategies have been employed to unleash, enhance or elicit anticancer immune reactions, which include T-cell checkpoint blockade, engineered T cells, BiTE, modified cytokines and cancer vaccines. This presentation will review recent progress in cancer immunotherapy and discuss some immunotherapeutic agents discovered and developed at HengRui Medicine Co., Ltd. 3:35 Refreshment Break in the Exhibit Hall with Poster Viewing CHALLENGES FOR NEW BIOLOGICS DEVELOPMENT IN CHINA 4:10 Update on Recent Regulatory Changes for Biologics Development in China Daotian Fu, Ph.D., General Manager, Livzon MabPharm Over the past several years, the biotech industry in China has experienced tremendous growth, both in biosimilars and innovative biologics. In the meantime, the CFDA is also going through significant reforms with respect to guidance and the reviewing process for development of both biosimilars as well as innovative biologics. In this presentation, the author intends to provide an update on the recent development in CFDA’s guidance for biologics development in China, and how the biotech industry can best position itself to take advantage of the recent regulatory changes. 4:40 PANEL DISCUSSION: Understanding the Clinical and Regulatory Pathways for New Biologics Development in China James Cai, Ph.D., Vice President, Global Regulatory Affairs, Access Policy, Amgen Shanghai Daotian Fu, Ph.D., General Manager, Livzon MabPharm Weidong Jiang, Ph.D., CSO, Shanghai Henlius Weikang Tao, Ph.D., Vice President CEO, RD Center, Jiangsu Henrui Medicine Co., Ltd. Scott M. Wheelwright, Ph.D., CEO, Complya Asia 5:40 Close of Day THURSDAY, APRIL 7, 2016 9:00 am - 4:30 pm Clinical and Regulatory Strategies for Domestic and Global IND and BLA Filings Instructor: Scott M. Wheelwright, Ph.D., CEO, Complya Asia Drug development in China has progressed rapidly in recent years as novel therapies and biosimilars move forward in greater numbers each year. Companies are following multiple pathways to bring their products to patients in both domestic and foreign markets. In this seminar we will discuss the opportunities and options for developing new products. In particular, we will investigate the options that have been used and that are available as we evaluate strategies for international development. This course will cover the following topics: • Why do we need a strategy? • What does a development strategy include? • What are our options for domestic regulatory approval (including novel drugs, biosimilars, and imports)? • What foreign market development options are available (discussion on US, EU, Australia, South America, WHO and other options)? • What is the common technical document (CTD) and how do we prepare it? • What are our options for manufacturing and how do we evaluate and choose between them? • What are the requirements for filing IND and NDA packages in foreign markets? • Where do we go for help? • How do we build and document our strategic plan? At the conclusion of this seminar, active participants will understand: • The options for drug development within China and internationally • How to develop a coherent plan for drug development • Basic requirements for preparation of regulatory applications • How to prepare a “living” strategic plan that can be updated and adjusted to reflect company goals and to drive decision making About the Instructor: Scott M. Wheelwright, Ph.D., is an expert in developing drugs and bringing them to market in China and internationally. Dr. Wheelwright has lived in China for over five years where he has worked on numerous products under development. His previous US and international experience (he has also lived in India, Japan and Germany) includes bringing multiple drugs to market in multiple countries. He is the founder of Complya Asia, a consulting firm in China that works with Chinese firms to help them meet international standards for Quality Assurance and manufacturing. Dr. Wheelwright was one of the original founders of Innovent Biologics, a leading biosimilars company in China. Dr. Wheelwright received his Ph.D. from the University of California Berkeley and performed post-doctoral studies at the Max Planck Institute in Germany.
- 11. PEGSummitChina.com | 11 Conference Hotel: Grand Hyatt Shanghai Jin Mao Tower, 88 Century Boulevard, Pudong Shanghai, China 200121 Tel: +86-21-5049-1234 HOTEL TRAVEL INFORMATION DISCOUNTED ROOM RATE: CNY 1000/ $162 Single; CNY 1150/ $185 Double – Includes Breakfast and Wireless internet DISCOUNTED CUT-OFF DATE: March 4th , 2016 VISA REQUIREMENTS: International attendees requiring a letter of invitation for visa application to China, should first be registered and paid in-full for the conference and have reserved a room at the host hotel prior to being issued an invitation letter. Please visit the visa page on PEGSummitChina.com to complete the details required to process the invitation letter. You will receive the invitation letter via email within 7 - 10 business days. Visa processing times may vary between countries/cities. We highly recommend that you apply for your visa 3 months in advance to avoid possible delays at certain consulates/embassies. Reservations: Go to the travel page of PEGSummitChina.com ABOUT SHANGHAI: Get tips and travel guide to Shanghai China, including events, attractions, hotel etc. at the official Shanghai travel website: www.meet-in-shanghai.net Sponsoring Organizations Lead Sponsoring Publications Sponsoring Publications Web Partners PEGS CHINA 2016 MEDIA SPONSORS WHY STAY ATTHE GRAND HYATT SHANGHAI? • Complimentary wireless internet in your guest room • No commute! conference is taking place at the hotel • Daily breakfast is included in the room rate • Minutes to local and international restaurants • Close to local sites and attractions
- 12. Please refer to the Registration Code below: How to Register: PEGSummitChina.com reg@healthtech.com • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288 Please use keycode ABA F1 when registering! PRICING AND REGISTRATION INFORMATION STANDARD PACKAGE BEST VALUE! (Includes access to TWO Conferences or ONE Conference + Seminar) Early Registration Rates until January 15 $2049 $1029 Advance Registration Rates until February 26 $2199 $1099 Standard Registration Rates after February 26 and onsite $2399 $1149 BASIC PACKAGE (Includes access to ONE Conference or ONE Seminar only) Early Registration Rates until January 15 $1499 $749 Advance Registration Rates until February 26 $1699 $829 Standard Registration Rates after February 26 and onsite $1899 $999 CONFERENCE SCHEDULE Tuesday-Wednesday (April 5-6, 2016) Wednesday-Thursday (April 6-7, 2016) T1: Protein Antibody Engineering T3: Next-Generation Cancer Biotherapeutics T2: Analytical Characterization of Biotherapeutics T4: Protein Aggregation Stability S1: Clinical and Regulatory Strategies for Domestic and Global IND and BLA Filings CONFERENCE DISCOUNTS Poster Submission - Discount ($50 off): Poster abstracts are due by February 26, 2016. Once your registration has been fully processed, we will send an email containing a unique link allowing you to submit your poster abstract. *CHI reserves the right to publish your poster title and abstract in various marketing materials and products. Antibody Society Members: (20% off) CHI is pleased to offer all Antibody Society Members a 20% discount to attend. Records must indicate you are a member at time of registration. REGISTER 3 - 4th IS FREE: Individuals must register for the same conference or conference combination and submit completed registration form together for discount to apply. Alumni Discount: (20% off) Cambridge Healthtech Institute (CHI) appreciates your participation at our events. As a result of the great loyalty you have shown us, we are pleased to extend to you the exclusive opportunity to save an additional 20% off the registration rate. Just check off the box marked Alumni Discount on the registration form to receive the discount! Please note: Our records must indicate you were an attendee at a past CHI event in order to qualify. Group Discounts: Discounts are available for multiple attendees from the same organization. For more information on group rates contact David Cunningham at +1-781-972-5472 *Alumni, Antibody Society, Twitter, LinkedIn, Facebook or any other promotional discounts cannot be combined. If you are unable to attend but would like to purchase the PEGS China Summit CD for $750.00 USD (plus shipping), please visit www.PEGSummitChina.com Massachusetts delivery will include sales tax. INDUSTRY/COMMERCIAL PRICING ACADEMIC/GOVERNMENT/ NON-PROFIT PRICING Reports designed to keep life science professionals informed of the salient trends in pharma technology, business, clinical development, and therapeutic disease markets InsightPharmaReports.com Contact Adriana Randall, arandall@healthtech.com, +1-781-972-5402. Barnett is a recognized leader in clinical education, training, and reference guides for life science professionals involved in the drug development process. For more information, visit BarnettInternational.com. Complimentary news delivered to your inbox Insights on the innovation between clinical trial management and delivery of care. ClinicalInformaticsNews.com News on the data deluge in petascale computing and the tools to deliver individualized medicine. Bio-ITWorld.com Emerging Technologies in Diagnostics DiagnosticsWorldNews.com Cambridge Healthtech Institute 250 First Avenue, Suite 300 Needham, MA 02494 www.healthtech.com Fax: 781-972-5425 ADDITIONAL REGISTRATION DETAILS Each registration includes all sessions in the registered conference, posters and exhibits, food functions, and access to the conference proceedings link. Handicapped Equal Access: In accordance with the ADA, Cambridge Healthtech Institute is pleased to arrange special accommodations for attendees with special needs. All requests for such assistance must be submitted in writing to CHI at least 30 days prior to the start of the meeting. To view our Substitutions/Cancellations Policy, go to http://www.healthtech.com/regdetails Video and or audio recording of any kind is prohibited onsite at all CHI events.