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 comprises four content-driven conferences with over sixty global speakers, plus a new 1-day 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.
This document summarizes discussions from a conference on continuous biomanufacturing. Key presentations discussed Amgen's goal of 5 g/L productivity using intensified processes, and the FDA's support for continuous manufacturing. Conference participants also discussed different continuous approaches like steady-state perfusion and dynamic perfusion. Integrating upstream and downstream processes continuously is an area still needing investigation. The best approach depends on a company's existing infrastructure and product portfolio.
The conference will provide an interactive networking forum to both further develop and answer your queries through a vibrant exhibition room full of technology providers showcasing their technologies and other solutions, poster presentation sessions, expert led case study presentations, a high-level panel discussion, a round table discussion session, and interactive Q&A sessions from a 40-strong speaker faculty examining topics on 4 separate tracks outlined below.
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...
The document summarizes the challenges of identifying appropriate quality raw materials for pharmaceutical applications in an evolving regulatory environment. It discusses regulatory considerations for raw materials, proposed quality attributes for different applications, and strategies for selecting suppliers and materials. The presentation notes that regulations require risk assessment and mitigation for raw materials, but there are no clear quality standards for many "non-regulated" materials. It promotes working with expert suppliers who can provide transparency, standardization, and information to facilitate regulatory compliance.
PEGS Europe Protein & Antibody Engineering Summit 2014 Agenda
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
•500 attendees
•150 technical presentations
•70+ scientific posters
•40+ sponsors & exhibitors
•Dedicated networking opportunities
•Exclusive exhibit & poster hours
•Interactive roundtable, breakout & panel discussions
MDC Connect: In-Silico Drug Design - what to do, what not to do - project dri...
The document discusses exploiting medicinal chemistry knowledge to accelerate drug discovery projects through in silico drug design techniques. It provides an agenda for a presentation covering problem statements around long development times, sources for design ideas like literature and patents, techniques for 2D and 3D molecular design including QSAR and docking models, and examples of applying these methods to specific drug targets. The presentation aims to explain how to analyze data rigorously and refine compound designs to find drug candidates faster.
What's new this Year?
NEW LOCATION - Hong Kong.
PLASMA FRACTIONATION TECHNOLOGY WORKSHOP.
REGULATOR’S FORUM - meet Global and Asian regulatory experts for plasma and blood products.
GLOBAL EMERGING MARKETS Self Sufficiency Case Studies: China, India, Iran and more.
INSIGHTS to the first South East Asian plasma fractionation plant.
No other Bioplasma event can get you one-to-one access to senior decision-makers from both the international and regional Bioplasma industry.
This document is a letter from researchers to the European Commissioner for Health and Consumer Policy and a Scientific Committees Management Officer. The researchers welcome new guidance from SCENIHR on performing risk assessments but raise concerns about the "Klimisch loophole" which allows industry studies following GLP and OECD guidelines to be weighted more strongly than independent studies. They ask the Commission to remove references to Klimisch and OECD guidelines from guidance documents and instead prioritize peer-reviewed, independent studies.
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
Employing Innovative Platform Manufacturing and Biosafety Testing for your Ge...MilliporeSigma
Watch the webinar here: https://event.on24.com/wcc/r/2003970/F5AFA4FE6C60AD00635D4D15BADB5D8E?partnerref=slideshare
As gene therapies and gene-modified cell therapies show increasing promise, the need for innovative and proficient viral vector manufacturing continues to grow. Concurrently, increased regulatory guidance governing the manufacturing and testing of viral vectors adds complexity and increases the timelines to successfully produce high-quality virus ready for clinical use.
This webinar will address how the implementation of both manufacturing templates and platform characterization and safety assays can increase the likelihood of success in process validation and reduce risk in the timeline to commercialization for your gene therapy product. Using adeno-associated virus (AAV) as a case study, we will demonstrate how our validated, templated process for production can reduce the need for qualification inherent in niche manufacturing workflows and anticipate forthcoming needs for process performance qualification. This webinar will also highlight benefits from a new, platform assay offering for characterization and safety testing of AAV. Because these assays are pre-qualified, they reduce the variability inherent in assay validation and subsequently the time needed to establish readiness for regulatory compliance.
While these developments increase the standardization across the manufacturing and testing workflows, they remain flexible to clients' needs and are created to be scalable and as future-proof as possible, allowing for adaptability as the regulatory landscape of gene therapies evolves.
In this webinar, you will learn:
● The unit operations in AAV manufacturing that are ideal for templating
● How the manufacturing workflow can be targeted to reduce variability in testing and improve readiness for commercial production
● How platform assays can ease the burden of assay qualification and improve overall commercialization timelines
We have 13 research and development projects within:
• Research
• Oncology
• Respiratory, Inflammation and Autoimmunity
• Cardiovascular and Metabolic Disease
• Antibody Discovery and Protein Engineering
• Pathology
• Biopharmaceutical Development
• Cell Culture and Fermentation Sciences
• Formulation Sciences
• Analytical Biotechnology Science
This document provides a biography for Phillip B. Maples, Ph.D., the Executive Director of Laurus Bio, LLC. It outlines his over 30 years of experience in cell and gene therapy development, including designing and building over 10 GMP manufacturing facilities. It also lists his roles and accomplishments at various biotech companies, including developing cell and gene therapies for cancer and inherited diseases and leading clinical trials.
This document summarizes discussions from a conference on continuous biomanufacturing. Key presentations discussed Amgen's goal of 5 g/L productivity using intensified processes, and the FDA's support for continuous manufacturing. Conference participants also discussed different continuous approaches like steady-state perfusion and dynamic perfusion. Integrating upstream and downstream processes continuously is an area still needing investigation. The best approach depends on a company's existing infrastructure and product portfolio.
The conference will provide an interactive networking forum to both further develop and answer your queries through a vibrant exhibition room full of technology providers showcasing their technologies and other solutions, poster presentation sessions, expert led case study presentations, a high-level panel discussion, a round table discussion session, and interactive Q&A sessions from a 40-strong speaker faculty examining topics on 4 separate tracks outlined below.
Identifying Appropriate-Quality Pharmaceutical Raw Materials in an Evolving R...MilliporeSigma
The document summarizes the challenges of identifying appropriate quality raw materials for pharmaceutical applications in an evolving regulatory environment. It discusses regulatory considerations for raw materials, proposed quality attributes for different applications, and strategies for selecting suppliers and materials. The presentation notes that regulations require risk assessment and mitigation for raw materials, but there are no clear quality standards for many "non-regulated" materials. It promotes working with expert suppliers who can provide transparency, standardization, and information to facilitate regulatory compliance.
PEGS Europe Protein & Antibody Engineering Summit 2014 AgendaNicole Proulx
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With two consecutive years of 40% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
•500 attendees
•150 technical presentations
•70+ scientific posters
•40+ sponsors & exhibitors
•Dedicated networking opportunities
•Exclusive exhibit & poster hours
•Interactive roundtable, breakout & panel discussions
The document discusses exploiting medicinal chemistry knowledge to accelerate drug discovery projects through in silico drug design techniques. It provides an agenda for a presentation covering problem statements around long development times, sources for design ideas like literature and patents, techniques for 2D and 3D molecular design including QSAR and docking models, and examples of applying these methods to specific drug targets. The presentation aims to explain how to analyze data rigorously and refine compound designs to find drug candidates faster.
What's new this Year?
NEW LOCATION - Hong Kong.
PLASMA FRACTIONATION TECHNOLOGY WORKSHOP.
REGULATOR’S FORUM - meet Global and Asian regulatory experts for plasma and blood products.
GLOBAL EMERGING MARKETS Self Sufficiency Case Studies: China, India, Iran and more.
INSIGHTS to the first South East Asian plasma fractionation plant.
No other Bioplasma event can get you one-to-one access to senior decision-makers from both the international and regional Bioplasma industry.
This document is a letter from researchers to the European Commissioner for Health and Consumer Policy and a Scientific Committees Management Officer. The researchers welcome new guidance from SCENIHR on performing risk assessments but raise concerns about the "Klimisch loophole" which allows industry studies following GLP and OECD guidelines to be weighted more strongly than independent studies. They ask the Commission to remove references to Klimisch and OECD guidelines from guidance documents and instead prioritize peer-reviewed, independent studies.
As medical understanding of the genotype/phenotype correlation of a disease becomes clearer, genetic testing can be expected to become a mainstay in the clinical setting. While the application of genetic testing to the clinical setting is very much in line with the larger medical goals of preventative and personalized medicine, there are many unanswered questions with regard to genetic testing.
Speakers: Dr. Mansoor Mohammed, Genomics Portraits Inc., Dr. Brian Underdown, Managing Director, MDS Capital, Dr. June Carroll, Sydney G. Frankfort Chair in Family Medicine Mt.Sinai Hospital, Dr. Peter N. Ray, Head, Molecular Genetics Department of Paediatric Laboratory Medicine. HSC Professor, Molecular and Medical Genetics, University of Toronto
Quality for Biologics ' New ReportCritical quality attributes, process and change control, product variation, characterisation, and regulatory concernsSales of biologics grew by 20% in 2007, far faster than sales of small molecule drugs, which grew by not much more than 5%. The number of biologics being launched is also growing very rapidly, accounting for more than 25% of launches in 2007. But biologics are not like small molecules ' they are more complex to develop, test and produce. Any change in production may have a direct effect on both safety and efficacy. Making sure that development, testing and production is done correctly can be expensive, but getting it wrong can be even more expensive and may be disastrous for patients and for the companies involved.This unique 300 page report can help you to understand the processes involved ' knowledge that can save time and money and even make the difference between success and failure. The report covers all aspects of the subject including' Critical quality attributes ' Manufacturing process parameters' Process analytical technology' Physicochemical analysis,' Bioassays, ' Formulation and specifications' Product- and process-related impurities' Aggregation ' Non-clinical testing' Clinical development, ' Post-marketing period' Regulatory authority expectations' Risk management ' Comparability concernsQuality for Biologics is edited by Dr Nicole Lyscom and is written by senior industry experts from leading companies and organisations including:UCBUCB-CelltechEli LillyAmgenRocheParexel ConsultingGenentech
Domainex, a contract research organization, announced a collaboration with Sigma-Aldrich to advance the study of epigenetic proteins involved in cancer and stem cell biology. Through the collaboration, Domainex will use its protein expression technology to produce domains of epigenetic proteins to develop biochemical assays, while Sigma-Aldrich will use the proteins to develop monoclonal antibodies. These tools will help researchers study the function of these important proteins. Funding from the UK Technology Strategy Board will support the work.
This presentation summarizes Islet Sciences' strategy to address diabetes through early diagnosis, protection of insulin-producing cells, and transplantation of encapsulated porcine islets. Key points include developing a diagnostic test to detect beta cell DNA in blood to identify diabetes at an early stage, using Lysofylline to protect insulin cells from immune attack, and transplanting encapsulated pig islets to treat diabetes without immunosuppression. The company has partnerships with academic institutions and received grants to support its work. Financial statements show $3.5M in assets and $4.3M in liabilities as of January 2015.
The Future of Bioprocessing – What you need to know.MilliporeSigma
One of the hottest topics in the biopharmaceutical industry today is “continuous bioprocessing”. Buzzwords such as “process intensification”, “next generation bioprocessing”, “process optimization”, and “integrated, connected manufacturing” are prevalent in industry conference programs and biopharma trade publications. This is no surprise considering that by 2025, it is expected that 20 percent of revenue from molecules that are still in the pipeline today will come from drugs manufactured with next generation technologies. It is estimated that roughly 35 percent of today’s commercial molecules will utilize process intensification methods within the next 5-10 years.
But what actually is next generation bioprocessing? How are industry players defining next generation bioprocessing and how will they pursue and successfully implement this approach? And is continuous bioprocessing always the ultimate end goal drug manufacturers around the globe are, or should be, striving for?
In this dedicated supplement, experts from both biologics manufacturers and from MilliporeSigma provide their insights and perspectives on the on-going paradigm shift towards next generation bioprocessing occurring in today’s and tomorrow’s biopharma landscape.
Key Organics is a UK-based contract research organization with over 28 years of experience in synthetic organic chemistry. They provide integrated drug discovery and development services from hit identification through pre-clinical development. Their services include custom synthesis, focused library design and synthesis using in-house fragment libraries and computational tools, hit-to-lead and lead optimization chemistry, process research and development, and delivery of pre-clinical batches. They emphasize transparent communication with customers and flexibility to adapt to changing project needs and timelines.
Jacqueline Shan is the Chief Scientific Officer and Co-Founder of Afexa Life Sciences, which was spun off from the University of Alberta in 1992 as CV Technologies Inc. Afexa focuses on discovery research and product development of herbal medicines and natural health products using a biotech model. Afexa's lead product COLD-FX is now Canada's #1 selling brand for cold and flu remedies and natural supplements. COLD-FX has experienced strong annual growth rates and was an official sponsor of the 2010 Winter Olympics. Afexa utilizes a proprietary technology called ChemBioPrint for natural product fingerprinting to enable discovery and standardization of its polymolecular botanical therapeutics. Clinical trials of
The document discusses opportunities for cooperation and partnership in biotechnology between India and other countries. It notes that the Indian biotech industry has grown significantly in recent years but still has room for growth. Key opportunities for partnerships include contract research, manufacturing of biogenerics, clinical trials, and bioinformatics. The document outlines India's strengths in these areas like a skilled workforce, low costs, and bio-resources that make it an attractive partner for global biotech companies.
This document provides information about the 20th Annual Superbugs & Superdrugs conference on tackling antimicrobial resistance that will take place on March 19-21, 2018 in London. The conference will feature presentations on funding and regulatory approaches for new antibiotic development, strategies to combat resistant pathogens, and research on novel antibiotic candidates and alternatives. A half-day workshop on March 21st will provide an overview of using animal models in pre-clinical drug development.
ALTUM piedāvājums uzņēmējdarbības uzsācējiem. Biznesa plāna sagatavošanaEkonomikas ministrija
ALTUM piedāvājums uzņēmējdarbības uzsācējiem. Biznesa plāna sagatavošana
Olita Untāla, Latvijas Attīstības finanšu institūcija ALTUM
2014. gada 24. aprīlis , Smiltene
Ben Kreimer is a journalism technologist at the University of Nebraska-Lincoln's Drone Journalism Lab who explores using drones and sensor platforms to gather data and interpret physical environments. He focuses on conceptualizing creative drone applications to support mission-driven projects and organizations. Recently, Ben spent six months in India collaborating with journalists, archaeologists, and a filmmaker, and some of his aerial photos were published by The Times of India.
Demo Day presentation at theClubhou.se in Augusta, GA for Startup Day Across America with presentations from seven Augusta Startup Companies created at theClubhou.se and Georgia Regents University, including Blackbox.email, Camellix, Sumo Bot League, E3 Embedded Systems, Dylanpickups, txtcam, Humble Finance, and Sand Hill Endeavors. Attendees included Congressman John Barrow and multiple Venture Capital investors.
Latvijas Investīciju un attīstības aģentūras atbalsta programmas uzņēmējiemEkonomikas ministrija
Latvijas Investīciju un attīstības aģentūras atbalsta programmas uzņēmējiem
Linda Grīnfelde, LIAA Klientu apkalpošanas nodaļas
vadītāja
2014.gada 24.aprīlis, Smiltene
This document discusses customer relationship management (CRM) and its key elements and processes. It outlines the main components of CRM as customer knowledge, relationship strategy, communication, individual value proposition, and sales force automation. The core CRM processes include customer acquisition, interaction management, retention, attrition, and defection. It provides details on how each of these processes work and their importance for building and maintaining customer relationships.
Digital Campaign for Samsung by Changxing WangChris Wang
This digital marketing campaign targets 16-35 year olds in the United States who are adventurous, technology-oriented, and stylish. The campaign aims to increase sales, boost key word click rates, and enhance website traffic for Samsung Galaxy Note 3. It will launch a "Design Your Day" video and encourage people to create their own videos, with the best video winner receiving a role in the next Samsung commercial and other rewards. Tactics include posting on YouTube, working with bloggers, using social media, and Google AdWords to promote the campaign and drive traffic to the product website. The estimated budget is $25,400.
Flea markets attract a culturally diverse range of people selling goods that reflect their ethnic backgrounds. Vendors of different races and ethnicities set up booths to sell region-specific items, such as a Chinese woman selling porcelain or an African man selling tribal clothing. Understanding and embracing cultural diversity is important, as it gives people a better perspective on how different groups can coexist and form a community.
Latvijas Investīciju un attīstības aģentūras pakalpojumi uzņēmējiemEkonomikas ministrija
Latvijas Investīciju un attīstības aģentūras pakalpojumi uzņēmējiem
Evija Piebalga, Latvijas Investīciju un attīstības aģentūra
2015.gada 26.novembris, Daugavpils
Alan Burradell is currently the Principal owner of Burradell Construction, a residential remodeling construction company located in San Francisco, CA. Burradell Construction provides quality residential remodels and renovations.
This project aims to increase awareness of the social and emotional issues faced by students with disabilities. It will explore how trauma and disabilities can impact brain development and function, potentially causing issues with emotional regulation, memory, language, and other areas. The project also discusses providing teacher training to help them better understand and support students with disabilities. It will involve workshops to discuss topics like the brain, trauma, and building social emotional skills. The goal is to develop a more inclusive school environment.
Kas jāņem vērā, uzsākot uzņēmējdarbību un domājot par eksportu ārpus Latvijas Ekonomikas ministrija
Kas jāņem vērā, uzsākot uzņēmējdarbību un domājot par eksportu ārpus Latvijas
Ginta Purmale
Projektu vadītāja, Eksporta veicināšanas nodaļa
Ārējais tirdzniecības veicināšanas departaments
2014.gada 24.aprīlis, Smiltene
Pašvaldību uzņēmējdarbības atbalsta instrumenti
Maija Kamoliņa, Vides aizsardzības un reģionālās attīstības ministrija
Video: https://youtu.be/zU_MogrsJSE
Forums "Atbalsts uzņēmējiem"
2016.gada 9.novembris, Rīga
This 3-day event is the meeting place for international and domestic scientists to share case studies and project updates, showcase new techniques and form collaborations that pave the way towards the future of China’s biopharmaceutical industry.
PEGS Boston the essential protein engineering summitNicole Proulx
With record-breaking attendance in 2015, PEGS Boston attracts an international delegation of nearly 2,000 participants including conference delegates, speakers, exhibitors, sponsors and guests representing over 30 countries.
Participants value the in-depth short courses, access to 22 conferences, and wide-ranging presentations delivering new unpublished data, case studies, innovation and insight.
The vast exhibit hall will be packed with 125 exhibiting companies and more than 200 research posters on display providing valuable viewing of innovative new technologies, as well as abundant networking with biopharma researchers and industry representatives.
Pegs Europe 2015 Protein & Antibody Engineering SummitNicole Proulx
PEGS Europe is the largest European event covering all aspects of protein and antibody engineering. With three consecutive years of 35% growth in attendance, and another year of expanded program coverage, this year’s event will feature:
700 attendees
175 technical presentations
125 scientific posters
Dedicated networking opportunities
Exclusive exhibit & poster viewing hours
Interactive roundtable, breakout & panel discussions
The document summarizes the 14th Annual PepTalk conference organized by Cambridge Healthtech Institute. The conference will be held from January 19-23, 2015 in San Diego, CA and will feature over 1,200 international participants from industry, academia and government. It will include 20 conferences, 13 short courses, 325 speaker presentations, 80 roundtable discussions, 100 exhibitors and 125 research posters on topics related to protein engineering, antibody therapeutics, formulation, production, analytics and purification. A keynote speech will be given by Dr. John Yates from The Scripps Research Institute on advances in proteomics. The conference provides numerous opportunities for education, innovation and networking in the protein science field.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Global Engage is pleased to announce the 2018 Precision Medicine & Biomarkers Leaders Summit USA taking place on May 7-8th in Boston, MA. The event is part of our highly successful Drug Discovery Series which includes conferences on Biologics, Medicinal Chemistry, NASH, Pharmaceutical R&D IT and the Human Microbiome amongst others. It is also the sister meeting of the European Precision Medicine Summit which has run successfully since 2013.
PEGS Korea 2015 the essential protein engineering summitNicole Proulx
PEGS is Cambridge Healthtech institute (CHI)’s flagship biologics meeting, and is widely considered the industry’s leading event on protein and antibody engineering. Its successful accolades include an annual attendance of over 1800 participants at the PEGS Summit in Boston; a record attendance of over 500 attendees at PEGS Europe this year; a successful launch of PEGS China in 2014, and now, the announcement of the first PEGS Korea to be launched in September 2015.
The 3-day Inaugural PEGS Korea will bring together an international faculty consisting of scientists, engineers and executives from all over the world to share their expertise and experiences in protein and antibody engineering, particularly in developing next-generation therapeutics including ADCs, bispecifics, and immunomodulating antibodies.
This document provides information about an upcoming Immuno-Oncology conference, including workshops, speakers, and program details. The conference will take place September 25-27, 2018 in London and will feature discussions on novel targeted cancer therapies. It will include workshops on strategic intelligence in immuno-oncology and the microbiome's role in cancer immunotherapy. The two-day main conference will discuss topics like immune checkpoints, oncolytic viruses, bispecific antibodies, and combination therapies. It aims to foster thought-provoking discussions in this space.
The only event in Asia bringing global oligonucleotide and peptide leaders together to discuss current strategies and trends to accelerate promising molecules from research to commercialization.
2nd Annual Oncology Asia
Date: 7 – 9 September 2015 | Sheraton Miyako, Tokyo, Japan
www.oncologyasia.com
The 2nd Annual Oncology Asia zeroes in on the latest cutting edge developments in oncology drug discovery and late phase strategies to get oncology drugs to market faster! Under the Drug Discovery track, this conference will discuss latest immune checkpoint inhibitor combinations, preclinical development trends, novel biomarkers and oncology drug development case studies in Asia. Under the late phase track, it will discuss pricing for success, global and regional commercialization case studies, healthcare policy updates and pricing for success.
Find out about the latest drug discovery trends along with latest strategies for global and regional commercialization at the ONLY senior industry gathering focused on advancing cutting edge oncology R&D and commercialization strategies for Asia in Tokyo, Japan!
The document discusses future prospects and challenges for biotherapeutics. It begins by defining biotherapeutics as products produced using living cells or organisms, such as recombinant hormones, vaccines, monoclonal antibodies, growth factors, and gene and cell therapies. It then contrasts biotherapeutics, biosimilars, and generics. The document outlines the complex manufacturing process for biotherapeutics and challenges in characterizing their large, complex structures. It concludes by discussing switching and interchangeability studies required to demonstrate a biosimilar is as safe and effective as the reference biologic.
Biologics World Taiwan 2016 (email me at justin.dejesus@imapac.com) Justin Barin de Jesus
The ONLY biopharmaceutical
gathering in Taiwan
Emphasizes on new business collaborations, demonstrate state-of-the-art developments and to propel Taiwan's biotech firms onto the world stage.
CHI's Bioassays for Immuno-Oncology Symposium, Oct. 23, 2017 in Washington, DCJames Prudhomme
Biological assays demonstrating drug characteristics such as potency, mechanism-of-action, and stability, are one of the most critical components of an FDA biologic submission. However, with more complex mechanisms-of-action, immunotherapies add a layer of difficulty to bioassay selection and development. At Cambridge Healthtech Institute's Inaugural Bioassays for Immuno-Oncology symposium, experts in bioassays for immuno-oncology therapies will discuss selection, development, and standards for bioassays and immunoassays. Special attention will be given to understanding the mechanism-of-action for immunotherapies, whether they be antibody- or cell-based. Overall, this one-day immersive symposium will outline a product life cycle approach for developing and implementing biological assays from preclinical studies to clinical development. This symposium is part of the Immunogenicity & Bioassay Summit.
Clinical Research Informatics World 2015Jaime Hodges
The document provides information about the "Clinical Research Informatics World 2015" conference to be held on May 6-7, 2015 in Boston, MA. It includes details about keynote speakers, sessions, sponsors and registration. The conference will focus on topics such as leveraging new technologies and analytics to advance clinical trials, using existing data sources to support trials, and cross-industry data sharing. Sessions will provide case studies and discuss strategies for areas like establishing big data strategies, bringing patient centricity to trials, and innovating clinical trial processes with new technologies.
Pressure BioSciences is presenting their pressure cycling technology instruments and consumables. Their flagship product is the Barocycler 2320EXTREME instrument, which uses high pressure cycling to prepare biological samples for analysis. They have over 270 PCT systems installed worldwide and publications highlighting the advantages of PCT in biopharma sample preparation from discovery to clinical use. The company is poised for growth with their exclusive marketing agreement with SCIEX, expanded sales team, and focus on the multi-billion dollar biopharma market.
CHI's Immunogenicity and Bioassay Summit 2015James Prudhomme
This document summarizes an upcoming conference on immunogenicity assessment and clinical relevance for biopharmaceutical products. The conference will take place November 17-18, 2015 in Baltimore, MD and will include keynote speakers from the FDA and industry. It will feature sessions on regulatory expectations, preclinical studies and risk assessment, different assay formats and technologies, and challenges with immunogenicity assessment. Short courses on related topics will also be offered. The document provides an agenda with session topics, speaker names and affiliations, and descriptions of presentation topics.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
This expanding series attracts the leading authorities worldwide working in companion diagnostics, biomarkers, immuno-oncology, liquid biopsies, AI and other facets of precision medicine. It has been praised for its stimulating, interactive and engaging environment where it brings together a multi-disciplined community of researchers, leaders and innovators whose aim is to develop groundbreaking and impactful treatments for patients.
10th Annual Bioassays and Bioanalytical Method Development Conference Report ...Doranelly (Dolly) Koltchev
The 10th Annual Bioassays and Bioanalytical Method Development Conference brought together scientists from industry, academia, and regulatory agencies to discuss trends in cell-based assays and bioanalysis. Presentations evaluated new technologies and their impact on bioassay methods and workflows. Regulatory perspectives on draft guidance were provided. Discussions focused on strategies to develop sensitive and reproducible bioassays, challenges in validating assays for clinical samples, novel technologies to expedite drug development, and ensuring continuity of data through assay transfers. The conference provided a forum for collaborative discussions around critical issues in bioanalytical method development.
PEGS - the essential protein & antibody engineering summitJames Prudhomme
Over 1,600 participants will gather in Boston’s historic Seaport District for open forum discussions and collaboration in the areas of protein & antibody engineering, oncology, expression, analytical, safety, and - new this year- bioprocessing and therapeutics programming.
Join your peers and colleagues in San Francisco to gain insight and perspective on why molecular liquid biopsies have the potential to become a fulcrum in the future of precision medicine.
Attracting over 3,300 drug discovery and development professionals from over 40 countries in 2015, the Tri-Conference has grown into a diverse event, focusing on Molecular Medicine, specifically on Discovery, Genomics, Diagnostics and Information Technology.
With a 23 year history, this year’s expanded coverage includes additional programs on Molecular Diagnostics for Infectious Disease, Precision Medicine and Cancer Immunotherapy, as well as two new symposia on Companion Diagnostics and the Commercialization of Molecular Diagnostics.
PepTalk: The Protein Science Week is an annual gathering where industry experts from around the world convene to share case studies, unpublished data, breakthroughs and solutions that support and enhance research, and to gain new perspectives on the evolution of biologics.
The 2015 Bioprocessing Summit plans to unite 750+ attendees from 30+ countries for five days of inspiring presentations and solutions. The Bioprocessing Summit brings together international leaders to discuss today's bioprocess issues from cell line selection to manufacturing. The Summit provides practical details in a relaxed, congenial atmosphere that promotes information exchange and networking.
This leading bioprocess meeting is hosted in Boston each summer. Hundreds of bioprocess professionals come together each year at the Summit to share practical solutions for today’s bioprocess challenges with researchers from around the world.
Spanning five days, the 2015 meeting includes 12 conference programs, 8 training seminars and 10 short courses.
World Preclinical Congress 2015 BrochureNicole Proulx
The World Preclinical Congress (WPC; formerly the
World Pharma Congress), now in its 14th year, is making
a commitment to focus predominantly on preclinical
research and highlight the challenges and opportunities
in early drug discovery and development. World
Preclinical Congress 2015 brings together some of
the hottest topics being discussed in the pharma/
biotech world and provides a unique forum for scientists
and clinicians to exchange ideas and collaborate to
overcome some of the translational challenges. This
coincides with the event moving to Boston, now a
premier hub for preclinical activity and alliances.
TCGC The Clinical Genome Conference 2015Nicole Proulx
Bio-IT World and Cambridge Healthtech Institute are again proud to host the Fourth Annual TCGC: The Clinical Genome Conference, inviting stakeholders impacting clinical genomics to share new findings and solutions for advancing the applications of clinical genome medicine.
PEGS the essential protein and antibody engineering summit Nicole Proulx
PEGS - The Essential Protein Engineering Summit is the premier event for antibody and protein science research and the biologics industry, with more than 1,800 participants in attendance from over 30 countries. Join us in Boston this May 4-8, 2015 to share insights and best practices with colleagues, connect and form new collaborations during copious networking opportunities, learn from world-renowned thought leaders, discover industry trends and find solutions to current challenges. PEGS is knowledge-sharing at its best.
12th Annual Molecular Diagnostics Conference Part of TRI-CON 2015Nicole Proulx
CHI's flagship diagnostics event, "Molecular Diagnostics: Executive Strategies for Success" taking place February 16-18, 2015 in San Francisco, CA. In its twelfth year this is the leading event for the industry featuring experts on business strategy, platform development, regulation and reimbursement who will outline the steps needed to take to achieve commercial success in the current environment.
This year's 3rd Annual TCGC: The Clinical Genome Conference, held June 10-12, 2014 in San Francisco, is a three-day event that weaves together the science of sequencing and the business of implementing genomics in the clinic. It uniquely illustrates the mutual influence of those areas and the need to therefore consider the needs, challenges and opportunities of both - from next-generation sequencing and variant interpretation to insurance reimbursement and electronic health records - throughout the entire research process.Learn more at http://www.clinicalgenomeconference.com
Probing the northern Kaapvaal craton root with mantle-derived xenocrysts from...James AH Campbell
"Probing the northern Kaapvaal craton root with mantle-derived xenocrysts from the Marsfontein orangeite diatreme, South Africa".
N.S. Ngwenya, S. Tappe, K.A. Smart, D.C. Hezel, J.A.H. Campbell, K.S. Viljoen
Search for Dark Matter Ionization on the Night Side of Jupiter with CassiniSérgio Sacani
We present a new search for dark matter (DM) using planetary atmospheres. We point out that
annihilating DM in planets can produce ionizing radiation, which can lead to excess production of
ionospheric Hþ
3 . We apply this search strategy to the night side of Jupiter near the equator. The night side
has zero solar irradiation, and low latitudes are sufficiently far from ionizing auroras, leading to a lowbackground search. We use Cassini data on ionospheric Hþ
3 emission collected three hours either side of
Jovian midnight, during its flyby in 2000, and set novel constraints on the DM-nucleon scattering cross
section down to about 10−38 cm2. We also highlight that DM atmospheric ionization may be detected in
Jovian exoplanets using future high-precision measurements of planetary spectra.
Lunar Mobility Drivers and Needs - ArtemisSérgio Sacani
NASA’s new campaign of lunar exploration will see astronauts visiting sites of scientific or strategic
interest across the lunar surface, with a particular focus on the lunar South Pole region.[1] After landing
crew and cargo at these destinations, local mobility around landing sites will be key to movement of
cargo, logistics, science payloads, and more to maximize exploration returns.
NASA’s Moon to Mars Architecture Definition Document (ADD)[2] articulates the work needed to achieve
the agency’s human lunar exploration objectives by decomposing needs into use cases and functions.
Ongoing analysis of lunar exploration needs reveals demands that will drive future concepts and elements.
Recent analysis of integrated surface operations has shown that the transportation of cargo on the
surface from points of delivery to points of use will be particularly important. Exploration systems will
often need to support deployment of cargo in close proximity to other surface infrastructure. This cargo
can range from the crew logistics and consumables described in the 2023 “Lunar Logistics Drivers and
Needs” white paper,[3] to science and technology demonstrations, to large-scale infrastructure that
requires precision relocation.
TOPIC: INTRODUCTION TO FORENSIC SCIENCE.pptximansiipandeyy
This presentation, "Introduction to Forensic Science," offers a basic understanding of forensic science, including its history, why it's needed, and its main goals. It covers how forensic science helps solve crimes and its importance in the justice system. By the end, you'll have a clear idea of what forensic science is and why it's essential.
Transmission Spectroscopy of the Habitable Zone Exoplanet LHS 1140 b with JWS...Sérgio Sacani
LHS 1140 b is the second-closest temperate transiting planet to the Earth with an equilibrium temperature low enough to support surface liquid water. At 1.730±0.025 R⊕, LHS 1140 b falls within
the radius valley separating H2-rich mini-Neptunes from rocky super-Earths. Recent mass and radius
revisions indicate a bulk density significantly lower than expected for an Earth-like rocky interior,
suggesting that LHS 1140 b could either be a mini-Neptune with a small envelope of hydrogen (∼0.1%
by mass) or a water world (9–19% water by mass). Atmospheric characterization through transmission
spectroscopy can readily discern between these two scenarios. Here, we present two JWST/NIRISS
transit observations of LHS 1140 b, one of which captures a serendipitous transit of LHS 1140 c. The
combined transmission spectrum of LHS 1140 b shows a telltale spectral signature of unocculted faculae (5.8 σ), covering ∼20% of the visible stellar surface. Besides faculae, our spectral retrieval analysis
reveals tentative evidence of residual spectral features, best-fit by Rayleigh scattering from an N2-
dominated atmosphere (2.3 σ), irrespective of the consideration of atmospheric hazes. We also show
through Global Climate Models (GCM) that H2-rich atmospheres of various compositions (100×, 300×,
1000×solar metallicity) are ruled out to >10 σ. The GCM calculations predict that water clouds form
below the transit photosphere, limiting their impact on transmission data. Our observations suggest
that LHS 1140 b is either airless or, more likely, surrounded by an atmosphere with a high mean molecular weight. Our tentative evidence of an N2-rich atmosphere provides strong motivation for future
transmission spectroscopy observations of LHS 1140 b.
Hydrogen sulfide and metal-enriched atmosphere for a Jupiter-mass exoplanetSérgio Sacani
We observed two transits of HD 189733b in JWST program 1633 using JWST
NIRCam grism F444W and F322W2 filters on August 25 and 29th 2022. The first
visit with F444W used SUBGRISM64 subarray lasting 7877 integrations with 4
BRIGHT1 groups per integration. Each effective integration is 2.4s for a total effective exposure time of 18780.9s and a total exposure duration of 21504.2s (∼6 hrs)
including overhead. The second visit with F322W2 used SUBGRISM64 subarray
lasting 10437 integrations with 3 BRIGHT1 groups per integration. Each effective
integration is 1.7s for a total effective exposure time of 17774.7s and a total exposure
duration of 21383.1s (∼6 hrs) including overhead. The transit duration of HD189733
b is ∼1.8 hrs and both observations had additional pre-ingress baseline relative to
post-egress baseline in anticipating the potential ramp systematics at the beginning
of the exposure from NIRCam infrared detectors.
Dalghren, Thorne and Stebbins System of Classification of AngiospermsGurjant Singh
The Dahlgren, Thorne, and Stebbins system of classification is a modern method for categorizing angiosperms (flowering plants) based on phylogenetic relationships. Developed by botanists Rolf Dahlgren, Robert Thorne, and G. Ledyard Stebbins, this system emphasizes evolutionary relationships and incorporates extensive morphological and molecular data. It aims to provide a more accurate reflection of the genetic and evolutionary connections among angiosperm families and orders, facilitating a better understanding of plant diversity and evolution. This classification system is a valuable tool for botanists, researchers, and horticulturists in studying and organizing the vast diversity of flowering plants.
This an presentation about electrostatic force. This topic is from class 8 Force and Pressure lesson from ncert . I think this might be helpful for you. In this presentation there are 4 content they are Introduction, types, examples and demonstration. The demonstration should be done by yourself
Testing the Son of God Hypothesis (Jesus Christ)Robert Luk
Instead of answering the God hypothesis, we investigate the Son of God hypothesis. We developed our own methodology to deal with existential statements instead of universal statements unlike science. We discuss the existence of the supernaturals and found that there are strong evidence for it. Given that supernatural exists, we report on miracles investigated in the past related to the Son of God. A Bayesian methodology is used to calculate the combined degree of belief of the Son of God Hypothesis. We also report the testing of occurrences of words/numbers in the Bible to suggest the likelihood of some special numbers occurring, supporting the Son of God Hypothesis. We also have a table showing the past occurrences of miracles in hundred year periods for about 1000 years. Miracles that we have looked at include Shroud of Turin, Eucharistic Miracles, Marian Apparitions, Incorruptible Corpses, etc.
A slightly oblate dark matter halo revealed by a retrograde precessing Galact...Sérgio Sacani
The shape of the dark matter (DM) halo is key to understanding the
hierarchical formation of the Galaxy. Despite extensive eforts in recent
decades, however, its shape remains a matter of debate, with suggestions
ranging from strongly oblate to prolate. Here, we present a new constraint
on its present shape by directly measuring the evolution of the Galactic
disk warp with time, as traced by accurate distance estimates and precise
age determinations for about 2,600 classical Cepheids. We show that the
Galactic warp is mildly precessing in a retrograde direction at a rate of
ω = −2.1 ± 0.5 (statistical) ± 0.6 (systematic) km s−1 kpc−1 for the outer disk
over the Galactocentric radius [7.5, 25] kpc, decreasing with radius. This
constrains the shape of the DM halo to be slightly oblate with a fattening
(minor axis to major axis ratio) in the range 0.84 ≤ qΦ ≤ 0.96. Given the
young nature of the disk warp traced by Cepheids (less than 200 Myr), our
approach directly measures the shape of the present-day DM halo. This
measurement, combined with other measurements from older tracers,
could provide vital constraints on the evolution of the DM halo and the
assembly history of the Galaxy.
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
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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%
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program! Opportunities include:
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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.