The Safety Stream at PEGS will guide attendees through the process of developing a comprehensive immunogenicity and PK/PD strategy to ensure successful biologics. With a focus on novel constructs, high level science and expert advice will examine assay strategies, management of product immunogenicity, and modeling PK/PD to improve drug performance. Risk assessment and regulatory guidance to ensure clinical success and a competitive advantage will also be addressed.
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.
Celldex reported that its phase III ACT IV trial of Rintega for glioblastoma was stopped early after a recommendation from the data safety monitoring board. The control arm performed just as well as the Rintega arm, with a median overall survival of 20.4 months for Rintega patients and 21.1 months for control patients. Celldex shares fell over 50% on the news. Company executives said they are analyzing the data to understand why the control arm performed so well but currently have no explanation. Celldex has five other active programs and sufficient cash to fund operations through 2017. Its next program to report data is varlilumab, an anti-CD27 antibody.
Game Changers Cancer Immunotherapies: Checkpoint InhibitorsiData Insights
This document provides an overview and analysis of checkpoint inhibitors for cancer immunotherapy. It discusses the PD-1/PD-L1 and CTLA-4 pathways that are targeted by these drugs. Case studies are presented on the checkpoint inhibitor drugs Opdivo, Keytruda, and Yervoy, examining their development timelines, clinical trial profiles, pricing, regulation, and life cycle management. The report also analyzes the efficacy and safety of these drugs in melanoma treatment and provides insights on the global melanoma market and market potential of Opdivo and Keytruda.
Now in its second year, the World ADC Awards showcase excellence within antibody drug conjugate research.
The World ADC Awards reward the innovation, leadership, and devotion shown by the best companies, teams, and individuals in the industry. Across six categories the Awards will recognize the extraordinary endeavours, teamwork and commercial acumen that has propelled the field to the forefront of cancer research today.
Join us on October 21st, alongside World ADC San Diego, for an evening of celebration as we award prizes to the leaders in each category.
The document summarizes recent advances at Inovio Pharmaceuticals, including being selected as a top translational researcher, generating immune responses in head and neck cancer patients, and protecting animals from Zika infection. It then discusses Inovio's plans to initiate a phase III trial for its HPV immunotherapy in 1H17 after an FDA request for additional information, and its partnership with MedImmune to develop immuno-oncology combination therapies. The document provides an overview of Inovio's immunotherapy technology platform and its potential applications in infectious diseases and cancer.
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.
This document discusses direct-to-consumer genetic testing, including its purposes and benefits, current examples, and privacy concerns. It also covers genetic sequencing techniques, pharmacogenomics, and predictions for the future of personalized medicine, including increasing market size and regulatory guidelines.
Personal Genomes: what can I do with my data?Melanie Swan
Biology evolved to be just good enough to survive and genomics provides the critical next-generation toolkit for its greater exploitation. Genomics is already starting to be medically actionable and is likely to become increasingly useful over time. This presentation discusses how your genetic information is already useful today,
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.
Celldex reported that its phase III ACT IV trial of Rintega for glioblastoma was stopped early after a recommendation from the data safety monitoring board. The control arm performed just as well as the Rintega arm, with a median overall survival of 20.4 months for Rintega patients and 21.1 months for control patients. Celldex shares fell over 50% on the news. Company executives said they are analyzing the data to understand why the control arm performed so well but currently have no explanation. Celldex has five other active programs and sufficient cash to fund operations through 2017. Its next program to report data is varlilumab, an anti-CD27 antibody.
Game Changers Cancer Immunotherapies: Checkpoint InhibitorsiData Insights
This document provides an overview and analysis of checkpoint inhibitors for cancer immunotherapy. It discusses the PD-1/PD-L1 and CTLA-4 pathways that are targeted by these drugs. Case studies are presented on the checkpoint inhibitor drugs Opdivo, Keytruda, and Yervoy, examining their development timelines, clinical trial profiles, pricing, regulation, and life cycle management. The report also analyzes the efficacy and safety of these drugs in melanoma treatment and provides insights on the global melanoma market and market potential of Opdivo and Keytruda.
Now in its second year, the World ADC Awards showcase excellence within antibody drug conjugate research.
The World ADC Awards reward the innovation, leadership, and devotion shown by the best companies, teams, and individuals in the industry. Across six categories the Awards will recognize the extraordinary endeavours, teamwork and commercial acumen that has propelled the field to the forefront of cancer research today.
Join us on October 21st, alongside World ADC San Diego, for an evening of celebration as we award prizes to the leaders in each category.
The document summarizes recent advances at Inovio Pharmaceuticals, including being selected as a top translational researcher, generating immune responses in head and neck cancer patients, and protecting animals from Zika infection. It then discusses Inovio's plans to initiate a phase III trial for its HPV immunotherapy in 1H17 after an FDA request for additional information, and its partnership with MedImmune to develop immuno-oncology combination therapies. The document provides an overview of Inovio's immunotherapy technology platform and its potential applications in infectious diseases and cancer.
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.
This document discusses direct-to-consumer genetic testing, including its purposes and benefits, current examples, and privacy concerns. It also covers genetic sequencing techniques, pharmacogenomics, and predictions for the future of personalized medicine, including increasing market size and regulatory guidelines.
Personal Genomes: what can I do with my data?Melanie Swan
Biology evolved to be just good enough to survive and genomics provides the critical next-generation toolkit for its greater exploitation. Genomics is already starting to be medically actionable and is likely to become increasingly useful over time. This presentation discusses how your genetic information is already useful today,
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.
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.
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
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
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.
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.
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.
Next Generation Dx Summit 2015 - Moving Assays to the ClinicJames Prudhomme
The Next Generation Dx Summit, entering its seventh year, brings together more than 800 diagnostics professionals from across the world, providing comprehensive programming and valuable networking opportunities. Spanning from clinical diagnostics to business strategy, this year’s expanded program encompasses predictive cancer biomarkers, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, cell-free DNA, commercialization, cancer immunotherapy, and reimbursement. With widespread coverage of all the most relevant diagnostics topics, the Next Generation Dx Summit promises to be a must-attend event to hear the latest announcements and developments in this rapidly evolving field.
Seventh Annual Next Generation Dx SummitJaime Hodges
The Next Generation Dx Summit (www.nextgenerationdx.com), entering its seventh year, brings together more than 800 diagnostics professionals from across the world, providing comprehensive programming and valuable networking opportunities. Spanning from clinical diagnostics to business strategy, this year’s expanded program encompasses predictive cancer biomarkers, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, cell-free DNA, commercialization, cancer immunotherapy, and reimbursement. With widespread coverage of all the most relevant diagnostics topics, the Next Generation Dx Summit promises to be a must-attend event to hear the latest announcements and developments in this rapidly evolving field.
Make Plans to Attend the Number 1 Immunogenicity and Bioassay Event Bringing Together Industry,
Academia and Regulatory Authorities. Featuring 8 FDA Presenters!
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.
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.
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.
Microbiome & Probiotics Forum USA agenda 2017Gavin Hambrook
Here's our new look agenda for the Microbiome and Probiotics Forum in San Diego this November. What do you think?
50+ speakers
30+ sponsors
400+ attendees
Discovery on Target 2014 - The Industry's Preeminent Event on Novel Drug TargetsJaime Hodges
Cambridge Healthtech Institute's 12th Annual Discovery on Target will showcase current and emerging “hot” targets for the pharmaceutical industry, October 8 – 10, 2014 in Boston, MA. Spanning three days, the meeting will bring together more than 900 global attendees, including scientists/technologists, executives, directors, and managers from biopharma, academic, and healthcare organizations. In 2014 the event is comprised of 14 conference tracks which include Epigenetic Readers, Ubiquitin Proteasome, Big Data Discovery, GPCR Drug Discovery, RNAi-Screens-Functional-Genomics, PPI Targets, Protein-Targets, Histone-Methyltransferases-Demethylases, Drug Transporters, Maximizing Efficiency, GPCR Therapeutics, Genomics Screening, Cancer Metabolism and Membrane Production. The 2014 event will offer 200+ scientific presentations across 14 conference tracks, 1 Symposium and 15 conference short courses, 40+ interactive breakout discussion groups, an exhibit hall of 40+ companies, and dedicated poster viewing and networking sessions.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
Immunogenicity and Bioassay Summit, Baltimore, MD November 17-19, 2015David Cunningham
Thinking about attending the Immunogenicity and Bioassay Summit, but have questions? I would be more than happy to walk you through the program agenda, pricing options and answer any questions you may have. In the meantime, don’t forget about the savings deadline coming up Friday, October 16th!
Call David at 781-972-5472 if you would like to join us!
Join us in Boston this coming Fall to attend Cambridge Healthtech Institute's (CHI) 2nd Annual FAST: Functional Analysis & Screening Technologies Congress on November 17-19, 2014 and meet with a community of 250+ biologists, screening managers, assay developers, engineers and pharmacologists dedicated to improving in vitro cell models and phenotypic screening to advance drug discovery and development at 6 conferences: Phenotypic Drug Discovery (Part I & II), Engineering Functional 3D Models, Screening and Functional Analysis of 3D Models, Organotypic Culture Models for Toxicology and Physiologically-Relevant Cellular Tumor Models for Drug Discovery. Delegates have the opportunity to share insights in interactive panel discussions and connect during networking breaks. View innovative technologies and scientific research revolutionizing early-stage drug discovery in the exhibit/poster hall.
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.
CHI's Next Generation Dx Summit 2022 | August 22-24, 2022 | Washington, D.C.James Prudhomme
Advancing Diagnostics Together
We are proud to host Cambridge Healthtech Institute's Fourteenth Annual Next Generation Dx Summit which will take place in-person at the Grand Hyatt Washington, D.C. on August 22-24. The Next Generation Dx Summit is the nexus for key opinion leaders across the world to share recent progress in diagnostic advancement and technology innovation. The event provides a valuable window on how point-of-care, infectious disease, liquid biopsy and companion diagnostics are changing the standard of care. Now in its fourteenth year, the Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important topics for the industry.
CHI's Targeting Stromal Cells in Cancer and Inflammatory Diseases Conference ...James Prudhomme
This virtual meeting will highlight cutting-edge science and provide insight into recent developments towards therapeutic stromal cell targeting in cancer and chronic inflammatory diseases. View full details and register: https://www.healthtech.com/stroma-conference
More Related Content
Similar to PK/PD and Immunogenicity Conferences, May 2014, Boston, MA - part of PEGS
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.
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.
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
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
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.
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.
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.
Next Generation Dx Summit 2015 - Moving Assays to the ClinicJames Prudhomme
The Next Generation Dx Summit, entering its seventh year, brings together more than 800 diagnostics professionals from across the world, providing comprehensive programming and valuable networking opportunities. Spanning from clinical diagnostics to business strategy, this year’s expanded program encompasses predictive cancer biomarkers, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, cell-free DNA, commercialization, cancer immunotherapy, and reimbursement. With widespread coverage of all the most relevant diagnostics topics, the Next Generation Dx Summit promises to be a must-attend event to hear the latest announcements and developments in this rapidly evolving field.
Seventh Annual Next Generation Dx SummitJaime Hodges
The Next Generation Dx Summit (www.nextgenerationdx.com), entering its seventh year, brings together more than 800 diagnostics professionals from across the world, providing comprehensive programming and valuable networking opportunities. Spanning from clinical diagnostics to business strategy, this year’s expanded program encompasses predictive cancer biomarkers, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, cell-free DNA, commercialization, cancer immunotherapy, and reimbursement. With widespread coverage of all the most relevant diagnostics topics, the Next Generation Dx Summit promises to be a must-attend event to hear the latest announcements and developments in this rapidly evolving field.
Make Plans to Attend the Number 1 Immunogenicity and Bioassay Event Bringing Together Industry,
Academia and Regulatory Authorities. Featuring 8 FDA Presenters!
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.
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.
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.
Microbiome & Probiotics Forum USA agenda 2017Gavin Hambrook
Here's our new look agenda for the Microbiome and Probiotics Forum in San Diego this November. What do you think?
50+ speakers
30+ sponsors
400+ attendees
Discovery on Target 2014 - The Industry's Preeminent Event on Novel Drug TargetsJaime Hodges
Cambridge Healthtech Institute's 12th Annual Discovery on Target will showcase current and emerging “hot” targets for the pharmaceutical industry, October 8 – 10, 2014 in Boston, MA. Spanning three days, the meeting will bring together more than 900 global attendees, including scientists/technologists, executives, directors, and managers from biopharma, academic, and healthcare organizations. In 2014 the event is comprised of 14 conference tracks which include Epigenetic Readers, Ubiquitin Proteasome, Big Data Discovery, GPCR Drug Discovery, RNAi-Screens-Functional-Genomics, PPI Targets, Protein-Targets, Histone-Methyltransferases-Demethylases, Drug Transporters, Maximizing Efficiency, GPCR Therapeutics, Genomics Screening, Cancer Metabolism and Membrane Production. The 2014 event will offer 200+ scientific presentations across 14 conference tracks, 1 Symposium and 15 conference short courses, 40+ interactive breakout discussion groups, an exhibit hall of 40+ companies, and dedicated poster viewing and networking sessions.
ExL Pharma Clinical Trials Phase I and Phase IIa Conference Brochure: Phase 1...bryonmain
There is a pill or treatment for almost everything, or at least, that is how it seems. However, the amount of effort that goes into a pill or treatment before it is launched is extensive, expensive and often inefficient.
Efficiency and innovation go hand-in-hand with R&D and the development of clinical trials, however, FDA regulations and clinical trial standardization end up stifling these two key factors. This leads to drawn out processes that cost companies hundreds of millions of dollars before the drugs hit the market. Efforts have been made to increase efficiency in phase I/IIA with some companies changing their clinical trial manifestos to suit the available patient population at clinical sites, but more emphasis should be placed on creating more efficient processes for first in human studies by optimizing pharmacokinetics/pharmacodynamics, dosage selection, technological advancements to improve efficacy and structured patient mapping to increase successful trial and patient recruitment opportunities.
This program will give delegates the opportunity to share proven strategies between companies to help increase efficiency in this space and streamline processes to cut down costs. This event will bring together large and small companies and experts in this space to share best practices to decrease the financial drain theses phases have on the overall clinical trial budget. Life science corporations need the most up-to-date tools and practices to increase success by streamlining processes, sharing successful biomarker strategies, anticipating dosing quantities, and optimizing healthy or specialty patient recruitment and retention. Current strategies include patient mapping before organizing and setting up a clinical space, tailoring early phase clinical trials to patient populations, purchasing biological samples from collection companies, and trying to accelerate the process by submitting for breakthrough therapy designation.
Top Reasons To Attend
Identify Compound Development Strategies to Optimize Success in Clinical Trials
Learn Best Practices for Early Decision-Making Through Analysis of Biomarker Utility in Drug Development
Utilize Analytical Technology to Evaluate Multiple Configurations of a Small Molecule to Increase the Feasibility of Drug in Clinical Trials
Implement Adaptive Design in Proof of Concept Studies to Increase Efficiency, Decrease Time and Decrease Overall Cost
Explore the Seamless Development of Phase I to Phase II in Clinical Trials
NINE Case Studies and a Panel Session on Early Phase Clinical Trial Strategies
Immunogenicity and Bioassay Summit, Baltimore, MD November 17-19, 2015David Cunningham
Thinking about attending the Immunogenicity and Bioassay Summit, but have questions? I would be more than happy to walk you through the program agenda, pricing options and answer any questions you may have. In the meantime, don’t forget about the savings deadline coming up Friday, October 16th!
Call David at 781-972-5472 if you would like to join us!
Join us in Boston this coming Fall to attend Cambridge Healthtech Institute's (CHI) 2nd Annual FAST: Functional Analysis & Screening Technologies Congress on November 17-19, 2014 and meet with a community of 250+ biologists, screening managers, assay developers, engineers and pharmacologists dedicated to improving in vitro cell models and phenotypic screening to advance drug discovery and development at 6 conferences: Phenotypic Drug Discovery (Part I & II), Engineering Functional 3D Models, Screening and Functional Analysis of 3D Models, Organotypic Culture Models for Toxicology and Physiologically-Relevant Cellular Tumor Models for Drug Discovery. Delegates have the opportunity to share insights in interactive panel discussions and connect during networking breaks. View innovative technologies and scientific research revolutionizing early-stage drug discovery in the exhibit/poster hall.
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.
Similar to PK/PD and Immunogenicity Conferences, May 2014, Boston, MA - part of PEGS (20)
CHI's Next Generation Dx Summit 2022 | August 22-24, 2022 | Washington, D.C.James Prudhomme
Advancing Diagnostics Together
We are proud to host Cambridge Healthtech Institute's Fourteenth Annual Next Generation Dx Summit which will take place in-person at the Grand Hyatt Washington, D.C. on August 22-24. The Next Generation Dx Summit is the nexus for key opinion leaders across the world to share recent progress in diagnostic advancement and technology innovation. The event provides a valuable window on how point-of-care, infectious disease, liquid biopsy and companion diagnostics are changing the standard of care. Now in its fourteenth year, the Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important topics for the industry.
CHI's Targeting Stromal Cells in Cancer and Inflammatory Diseases Conference ...James Prudhomme
This virtual meeting will highlight cutting-edge science and provide insight into recent developments towards therapeutic stromal cell targeting in cancer and chronic inflammatory diseases. View full details and register: https://www.healthtech.com/stroma-conference
CHI's Next Generation Dx Summit | August 25-27, 2020 | Washington, DCJames Prudhomme
Next Generation Dx Summit brings together more than 800 international diagnostic professionals working in the field and offers unparalleled insight from the comprehensive programming and networking with key opinion leaders in the industry. The event is unique in the marketplace. This year the coverage spans cell- and cell-free biopsies, commercialization, reimbursement, biomarkers and companion diagnostics for immunotherapy, point-of-care testing, infectious disease, microfluidics and precision medicine. Now in its twelfth year, Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important issues for the industry.
This document provides information about the 10th Annual Immunogenicity & Bioassay Summit taking place from October 22-25, 2018 in Washington, DC. It will include conferences on immunogenicity assessment and clinical relevance, immunogenicity prediction and control, and optimizing bioassays for biologics. There will also be a symposium on immunology for biotherapeutics and a training seminar on design of experiments. The summit brings together industry, academia, and regulatory authorities to discuss challenges in the field. It provides opportunities for networking, learning about new expectations, and hearing from thought leaders and regulators.
CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DCJames Prudhomme
The document is a program for the Next Generation Dx Summit, which will take place from August 20-24, 2018 in Washington DC. The summit will include 14 conference streams covering topics like molecular biopsy, immuno-oncology, rapid testing, precision medicine and business. It will feature over 1000 scientific and technology presentations, 250 industry sponsors and exhibitors, and 90 conference programs. The summit celebrates 10 years of the diagnostics community coming together to advance developments in areas like rapid and non-invasive testing, cancer detection, and clinical sequencing.
Immuno-Oncology Course, organized by Healthcare Education ServicesJames Prudhomme
The Immuno-Oncology one-day course provides an overview of the rapidly evolving subject of immune-oncology. Delegates are offered a thorough understanding of the basics of tumor immunology as well as the essentials of immunotherapy and its application in cancer medicine. Examples of both how biologics work in the practice of oncology and of the challenges presented are demonstrated.
The program has been developed specifically to support the needs of the pharmaceutical, biotechnology and medical technology industry personnel. It is ideal for individuals with little understanding of the immunotherapy of cancer and those with an existing basic knowledge. Detailed presentations and discussion with Healthcare’s experienced and knowledgeable faculty enable thorough insight to this important subject area.
Introduction to Cancer: Focus on Solid Tumors Course, organized by Healthcare...James Prudhomme
Delegates attending this course will benefit from an introductory overview of the terminology and classification of cancer and the principle issues in its treatment. Commonly available anti-cancer drugs will be reviewed, including immunotherapies. The range of side-effects of cancer treatments will be studied in detail. Quality-of-life issues in terms of overall assessment and result interpretation will also be discussed.
Detailed consideration will be given to the treatment of major tumor types: breast, lung, upper gastrointestinal (GI), colorectal, melanoma, ovarian and prostate cancer.
Hematologic Cancers - An Introduction Course, organized by Healthcare Educati...James Prudhomme
This document provides information about a two-day hematologic cancers training program taking place in Newark, NJ in October 2017. The program will review the hematological system and provide an overview of hematologic cancers such as leukemias, lymphomas and myeloma. Experts will discuss the pathophysiology, common treatments, management challenges and complications like bone marrow transplant. Case studies and discussion are included. The program is intended for pharmaceutical and biotech personnel. Topics will include blood cell formation/maturation, cancer classification/epidemiology, diagnosis/staging, chemotherapy and clinical trials.
Overcome Operational Challenges in Biomarker-driven Clinical TrialsJames Prudhomme
Cambridge Healthtech Institute offers two back-to-back symposia on the operational aspects of precision medicine trials and the improvement of infrastructure to better support those trials. The 2nd Annual Managing Precision Medicine Trials Symposium (January 24-25, 2017) focuses on strategizing design for biomarker driven trials and novel clinical trial design. The Inaugural Sample, Lab and Diagnostics Services in Clinical Trials Symposium (January 25-26, 2017) focuses on clinical sample management and sourcing and diagnostics services.
Cambridge Healthtech Institute (CHI) is pleased to announce the Third Annual FAST: Functional Analysis and Screening Technologies Congress. Now in its third year, the FAST Congress brings you the latest technologies and research in cellular screening.
The Third Annual Phenotypic Drug Discovery meeting will return with new updates and case studies in phenotypic screening, high-content analysis, physiologically-relevant cellular models, chemical genomics and chemical proteomics. The rapidly evolving area of 3D cellular models will be addressed by two back-to-back meetings, with the Inaugural 3D Cell Culture: Organoid, Spheroid, and Organ-on-a-Chip Models meeting focusing on the new predictive cellular models for drug discovery and toxicity assessment. It will review the use of primary and stem cells, complex co-culture cell models, tumor spheroid models, novel organ-on-a-chip models for efficacy and safety screening, functional analysis, and compound profiling. The Third Annual Screening and Functional Analysis of 3D Models meeting will follow with case studies of phenotypic and high-content screening of complex 3D cellular systems for compound and target selection.
The 2014 Congress attracted more than 250 senior delegates, representing over 160 companies from 20 countries. With half of the attendees from big pharma and biotech and a third from academia and government, the FAST Congress offers exclusive networking opportunities with diverse international attendance. Please join our focused Screening event and learn from 60+ scientific presentations, an assortment of educational courses, 20+ exhibitors and your fellow expert delegates. We look forward to seeing you at the event.
Cambridge Healthtech Institute's fourth annual Clinical Trial Oversight Summit will feature four co-located conferences covering best practices and recent trends relevant to clinical research monitoring, auditing, clinical quality assurance, site management, and vendor oversight. This four-day summit will include presentations from experts, case studies, interactive breakout discussion groups, workshops, and networking opportunities. Themes throughout will include risk-based approaches to clinical trial management, implementing quality systems-based approaches to GCP compliance, ensuring reliable study data, responding to the evolving regulatory landscape, and preparing sites and clinical research partners for inspection-readiness.
Call for Posters: Functional Analysis & Screening TechnologiesJames Prudhomme
Cambridge Healthtech Institute is accepting scientific posters for their 2nd Annual FAST Congress on improving drug screening methods using 3D models and phenotypic screening. The deadline to submit an abstract for a poster is October 10, 2014. Posters on topics related to 3D cellular models, phenotypic screening, organ-specific testing, and developing assays for live tissue models are welcome. Presenters will have their abstracts published in the conference proceedings and be entered to win a cash prize.
Short Courses at CHI's Immunogenicity and Bioassay Summit 2014James Prudhomme
Cambridge Healthtech Institute (CHI) will once again offer comprehensive training at the Sixth Annual Immunogenicity and Bioassay Summit 2014. The following courses are led by well-respected professionals in the pharmaceutical industry who have much experience in helping investigators overcome their difficulties with these challenging assays and with risk assessment. Delegates will enjoy an intimate setting with their peers and instructors and have the opportunity to ask questions and exchange experiences.
Course: Development of High-Dose Biologics Dosage FormsJames Prudhomme
Course: Development of High Dose Biologics Dosage Forms will be held on May 6, 2014 in Boston, MA - part of the Biologics Formulation & Delivery Summit.
Course: Challenges and Opportunities in Protein and Peptide Drug DeliveryJames Prudhomme
When: May 4, 2014
Where: Seaport World Trade Center, Boston, MA
Proteins and peptides represent a significant segment of the therapeutics spectrum with many promising candidates under early development or in late-stage clinical trials. Several of these molecules are poised to make a substantial impact, especially in the under-represented or unrepresented categories such as neurological disorders and neurodegenerative diseases. A key challenge to be overcome with protein and peptide based biologics, however, is their effective delivery to the target site while achieving the optimum balance of stability, safety, bioavailability, and patient compliance. This short course will provide a broad overview of the opportunities and challenges in the development of the next generation of protein and peptide therapeutic delivery systems.
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
CHI’s Inaugural Biologics Formulation and Delivery Summit will provide a forum for focused discussions on current challenges and opportunities in delivery of biotherapeutics. This 2-part summit will discuss various formulation and device-based approaches for designing physiologically relevant, patient friendly, targeted biologics products.
Part 1: Formulation Strategies for Improved Delivery of Biologics (May 5-6)
Part 2: New Technologies for Biologics Delivery and Targeting (May 6-7)
Podcast: Reducing and Monitoring Bioassay VariabilityJames Prudhomme
Discussing the biggest challenges to managing bioassay variability, new tools, and strategies that researchers are using to combat it, and how procedural variation can have unwanted repercussions.
Structure-Based Drug Design for Epigenetic Targets CourseJames Prudhomme
This document announces a short course on structure-based drug design for epigenetic targets to be held on June 19, 2013 at the Revere Hotel in Boston prior to a larger conference. The course will review how structural biology has contributed to the discovery of small molecule modulators of epigenetic targets. It will focus on emerging targets such as bromodomains, methyltransferases, and lysine demethylases. Attendees can register online, by phone, or via email.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler, Verified Chapters 1 - 33, Complete Newest Version Community Health Nursing A Canadian Perspective, 5th Edition by Stamler Community Health Nursing A Canadian Perspective, 5th Edition TEST BANK by Stamler Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Study Guide Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Stuvia Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Studocu Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Test Bank For Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Pdf Download Course Hero Community Health Nursing A Canadian Perspective, 5th Edition Answers Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Ebook Download Course hero Community Health Nursing A Canadian Perspective, 5th Edition Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Studocu Community Health Nursing A Canadian Perspective, 5th Edition Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Chapters Download Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Pdf Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Study Guide Questions and Answers Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Ebook Download Stuvia Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Questions Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Studocu Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Quizlet Community Health Nursing A Canadian Perspective, 5th Edition Test Bank Stuvia
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
PK/PD and Immunogenicity Conferences, May 2014, Boston, MA - part of PEGS
1. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
Safety Stream at PEGS Boston: the essential protein engineering summit
Second Annual
PK/PD OF MULTI-DOMAIN PROTEINS
Bench to Bedside Translation of Bispecifics, ADCs,
and Antibody Fragments
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Sixth Annual
Immunogenicity for Regulatory Success
IMMUNOGENICITY FOR REGULATORY SUCCESS
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
BOSTON
the essential protein engineering summit
May 5-9, 2014
Seaport World Trade Center
Boston, MA
Non-Clinical, Preclinical and Clinical Strategies for Risk Assessment and
Smooth Interaction with the Regulatory Authorities
Second Annual
IMMUNOGENICITY PREDICTION AND MITIGATION
Risk Factors, Predictive Tools And Immune Tolerance Approaches
FEATURED PRESENTATIONS:
Shalini Gupta, Ph.D., Director, Clinical
Immunology, Amgen, Inc.
Premier Sponsor
REGISTER ONLINE NOW!
PEGSummit.com
Ira Pastan, M.D., NIH Distinguished
Investigator, Co-Chief, Laboratory of
Molecular Biology, National Cancer
Institute, National Institutes of Health
Steven J. Swanson, Ph.D., Executive
Director, Medical Sciences (Clinical
Immunology), Amgen, Inc.
Bonnie Rup, Ph.D., Research Fellow,
Immunogenicity Sciences Lead,
Pfizer, Inc.
Organized by
Cambridge Healthtech Institute
Meena Subramanyam, Ph.D., Vice
President, Translational Medicine,
Biogen Idec, Inc.
Mohammad Tabrizi, Ph.D., Head &
Senior Fellow, PK/PD, Merck
2. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
CONFERENCE-AT-A-GLANCE
CONFERENCE TRACKS:
Monday-Tuesday | May 5-6
CONFERENCE TRACKS:
CONFERENCE TRACKS:
Wednesday-Thursday | May 7-8
Thursday-Friday | May 8-9
ENGINEERING STREAM
Phage and Yeast Display
Engineering Antibodies
Engineering Bispecific Antibodies
ONCOLOGY STREAM
Antibodies for Cancer Therapy
Advancing Bispecific Antibodies
Antibody-Drug Conjugates
SHORT COURSES
THERAPEUTIC STREAM
Biologics for Autoimmune Diseases
Adoptive T Cell Therapy
Peptide Therapeutics
SAFETY STREAM
EXPRESSION STREAM
Difficult to Express Proteins
Optimizing Protein Expression
High-Level Expression of Enzymes
ANALYTICAL STREAM
Characterization of Biotherapeutics
Biophysical Analysis of Biotherapeutics
Protein Aggregation and Stability
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
BIOPROCESS STREAM
Scaling Up and Down Strategies
ADC Development & Manufacturing
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
SHORT COURSES*:
Sunday, May 4 | 10:00am - 1:00pm
SHORT COURSES*:
Sunday, May 4 | 2:00 - 5:00pm
SHORT COURSES*:
Tuesday, May 6 | 6:00 - 8:00pm
PLENARY KEYNOTE SPEAKERS
Monday, May 5
Harnessing the Patient’s Immune System to Combat Cancer
Bahija Jallal, Ph.D., Executive Vice President, MedImmune
Building Regeneron’s Pipeline: From Trap Technology to the
VelocImmune Platform to Veloci-Next
George D. Yancopoulos, M.D., Ph.D., President, Regeneron Laboratories; CSO,
Regeneron Pharmaceuticals, Inc.
Premier Sponsor
NEW THIS YEAR: PEGS MOBILE APP
The PEGS Mobile App will allow attendees to browse the agenda,
create custom schedules, navigate the exhibit hall and explore
poster presentations. Visit pegsummit.com for more information
and availability.
REGISTER ONLINE NOW!
PEGSummit.com
STAY CONNECTED
SHORT COURSES*:
Thursday, May 8 | 5:30 - 7:30pm
CO-LOCATED EVENT:*
Biologics Formulation
& Delivery SUMMIT May 5-7
Advances in molecular biology and biotechnology have
allowed for the large-scale production of effective and
potent biotherapeutic drugs. Major research issues in
protein/peptide delivery include the stabilization of
proteins in delivery devices and the design of appropriate
target-specific carriers. CHI’s Biologics Formulation
and Delivery Summit will provide a forum for focused
discussions on current challenges and opportunities in
delivery of biotherapeutics.
This multi-track summit will discuss various formulation
and device-based approaches for designing physiologically
relevant, patient friendly, targeted biologics products.
healthtech.com/Biologics-Delivery
*Separate Registration is Required
3. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
HOTEL & TRAVEL INFORMATION
Host Hotel:
Seaport Hotel
One Seaport Lane
Boston, MA 02210
Telephone: 617-385-4514
www.seaportboston.com
Convention Venue:
Seaport World Trade Center
200 Seaport Boulevard
Boston, MA 02210
Discounted Room Rate: $249 s/d
Discounted Room Rate Cutoff: March 27, 2014
Please call the hotel directly to reserve your sleeping accommodations. You will need to
identify yourself as a CHI conference attendee to receive the discounted room rate with the
host hotel. Reservations made after the cut-off date or after the group room block has been
filled (whichever comes first) will be accepted on a space and rate-availability basis. Rooms
are limited, so please book early.
Top Reasons to Stay at the Seaport Hotel:
Flight Discounts:
Special discounts have been established with American Airlines for this conference:
• Call American Airlines directly at 1-800-433-1790 and use Conference Code 7654AA
• Go to www.aa.com/group use Conference Code 7654AA in the promotion discount box
• Contact our designated travel agent Rona Meizler at 1-617-559-3735
or rona.meizler@protravelinc.com
Car Rental Discounts:
Special discount rentals have been established with Hertz for this conference.
• Go to www.hertz.com to make your reservation and use our Hertz Convention
Number (CV): 04KL0005
• Complimentary wireless internet access
(sleeping and meeting rooms)
• Located 3 miles from Logan International Airport
• Sleeping rooms and meeting space are conveniently located
across the street - so you can sleep in and not have to worry
about morning traffic
• Boston’s MBTA Silver Line public transportation is located
just outside the hotel entrance
• Call Hertz directly at 800-654-3131 and reference our Discount Number: 04KL0005
PEGS SPONSORS
Premier Sponsors
Premier Sponsor
Corporate Sponsors
Corporate Support Sponsors
THE DELIVERY EXPERTS
REGISTER ONLINE NOW!
PEGSummit.com
4. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
SHORT COURSES*
SUNDAY, MAY 4 (10:00AM-1:00PM)
SC1: Phage and Yeast Display Libraries
Andrew M. Bradbury, Ph.D., M.B., BS, Staff Scientist, Biosciences,
Los Alamos National Laboratory
James D. Marks, M.D., Ph.D., Professor, Anesthesia & Pharmaceutical
Chemistry, UCSF; Chief, Anesthesia and Vice Chairman, Anesthesia &
Perioperative Care, San Francisco General Hospital
SC2: Translational Strategies for Development of Monoclonal
Antibodies from Discovery to Clinic
Part 1: Focus on Early Discovery
Mohammad Tabrizi, Ph.D., Head, DMPK and Disposition, Merck
Gadi Bornstein, Ph.D., Associate Research Fellow, Centers for
Therapeutic Innovation, Pfizer, Inc.
Scott Klakamp, Ph.D., Principal Consultant, SKD Consulting LLC
Randall Brezski, Ph.D., Senior Research Scientist, Biotechnology
Center of Excellence, Janssen R&D, Inc.
Isabel Figueroa, Associate Principal Scientist, PK/PD, Merck
SC3: Antibody Humanization via One Hot Homology Model
(Hands-On) Workshop
Vinodh Kurella, Ph.D., Visiting Research Fellow, C3 Bioinformatics,
Harvard Medical School
SC4: Novel and Emerging Conjugation Methods for ADCs
Sean Hu, Ph.D., SVP Biotherapeutics, Dophen Biomed
,
Ramesh Baliga, Ph.D., Founder, Extend Biopharma
Florence Lhospice, Director, Pharmaceutical Operations, R&D, Innate Pharma
SC5: Introduction to Adoptive T Cell Therapies
Michelle Krogsgaard, Ph.D., Assistant Professor, NYU Cancer
Institute, NYU School of Medicine
Margo R. Roberts, Ph.D., Vice President, Research, Kite Pharma, Inc.
Christopher A. Klebanoff, M.D., Assistant Clinical Investigator, Center
for Cancer Research, National Cancer Institute, NIH
Daniel J. Powell, Jr., M.D., Assistant Professor, Pathology and
Laboratory Medicine, Perelman School of Medicine, University of
Pennsylvania
SUNDAY, MAY 4 (2:00-5:00PM)
SC6: Translational Strategies for Development of Monoclonal
Antibodies from Discovery to Clinic
Part 2: Focus on Nonclinical Development to Clinic
Mohammad Tabrizi, Ph.D., Head, DMPK and Disposition, Merck
Gadi Bornstein, Ph.D., Associate Research Fellow, Centers for
Therapeutic Innovation, Pfizer, Inc.
Scott Klakamp, Ph.D., Principal Consultant, SKD Consulting LLC
Randall Brezski, Ph.D., Senior Research Scientist, Biotechnology
Center of Excellence, Janssen R&D, Inc.
Isabel Figueroa, Associate Principal Scientist, PK/PD, Merck
Premier Sponsor
MEDIA PARTNERS
SC7: Strategy for Entering the Biosimilars Market
Zahra Shahrokh, Ph.D., CSO, STC Biologics
Magdalena Leszczyniecka, President and CEO, STC Biologics
Christopher J. Holloway, Ph.D., Group Director, Regulatory Affairs &
Chief Scientific Officer, ERA Consulting Group
Marcio Voloch, VP Process Development, Momenta Pharma
,
Kathleen M. Williams, Ph.D., J.D., Partner, Sunstein Kann Murphy &
Timbers LLP
SC8: In silico Immunogenicity Predictions (Hands-On) Workshop
Vinodh Kurella, Ph.D., Visiting Research Fellow, C3 Bioinformatics,
Harvard Medical School
SC9: Alternate Display Technologies
John Löfblom, Ph.D., Assistant Professor, Molecular Biotechnology,
AlbaNova University Center, Royal Institute of Technology (KTH)
Birgit Dreier, Ph.D., Senior Scientist, Professor Dr. A. Plückthun
Laboratory, Biochemistry, University of Zurich
Lead Sponsoring Publications
SC10: Measures to Enhance Half-Life and Stability
Javier Chaparro-Riggers, Ph.D., Associate Research Fellow, Protein
Engineering, Rinat-Pfizer, Inc.
TUESDAY, MAY 6 (6:00-8:00PM)
SC11: Overcoming the Challenges of Immunogenicity Assessment
Jim McNally, Ph.D., Senior Principal Scientist, Pharmacokinetics,
Dynamics and Metabolism, Pfizer, Inc.
Shalini Gupta, Ph.D., Director, Clinical Immunology, Amgen, Inc.
SC12: Production Challenges for Complex Biologics –
ADCs, Bispecifics & Fusion Proteins
Stefan Schmidt, Ph.D., Vice President, DSP Rentschler Biotechnology
,
Stuart Bussell, Ph.D., Director, Upstream Process Development,
Sutro Biopharma
Syd Johnson, Ph.D., Vice President, Antibody Engineering,
MacroGenics, Inc.
SC13: Design of Cancer Vaccines for Combination Immunotherapy
David E. Avigan, M.D., Associate Professor, Medicine, Harvard
Medical School; Director, Hematologic Malignancies, Beth Israel
Deaconess Medical Center
Sponsoring Publications
SC14: Next-Generation Sequencing in Antibody Discovery for End
Users
Tadas Panavas, Ph.D., Principal Scientist, Molecular Protein and
Biosciences, Janssen
John Wheeler, Ph.D., Senior Scientist, Biologics Research, Janssen
R&D, Pharmaceutical companies of Johnson & Johnson
THURSDAY, MAY 8 (5:30-7:30PM)
SC15: Antibody-Drug Conjugate Therapeutics: Potential
and Challenges
Pamela A. Trail, Ph.D., Vice President, Oncology, Regeneron
Pharmaceuticals
Robert J. Lutz, Ph.D., Vice President, Translational Research and
Development, ImmunoGen, Inc.
SC16: Protein Aggregation: Mechanism, Characterization and
Immunogenic Consequences
Elizabeth Topp, Ph.D., Dane O. Kildsig Chair and Head, Industrial and
Physical Pharmacy, Purdue University
Daniel Some, Ph.D., Principal Scientist, Wyatt Technology
Michael Marlow, Ph.D., Staff Scientist, Regeneron Pharmaceuticals, Inc.
SC17: Antibody-Based Cancer Immunotherapy
Christian Klein, Ph.D., Discovery Oncology oDTA, Pharma Research
and Early Development (pRED), Roche Glycart AG
Luis G. Borges, Scientific Director, TIU, Amgen, Inc.
REGISTER ONLINE NOW!
PEGSummit.com
Sponsoring Society
*Separate Registration is Required
TM
Web Partners
5. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
SAFETY STREAM
2nd Annual | May 5-6
PK/PD of Multi-Domain Proteins
Bench to Bedside Translation of Bispecifics, ADCs, and Antibody Fragments
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
Recommended Pre-Conference Short Courses*
Translational Strategies for Development of
Monoclonal Antibodies from Discovery to Clinic, Part 1:
Focus on Early Discovery & Part 2: Focus on Nonclinical
Development to Clinic
*Separate registration required, please see page 4 for course details.
MONDAY MAY 5
,
7:00 am Registration and Morning Coffee
»» PLENARY KEYNOTE SESSION
8:30 Chairperson’s Opening Plenary Remarks
Kristi Sarno, Chair, Greater Boston Chapter, Women in
Bio; Director, Business Development, Pfenex, Inc.
8:40 Harnessing the Patient’s Immune System
to Combat Cancer
Bahija Jallal, Ph.D., Executive Vice President,
MedImmune
With recent FDA approvals, modulation of the immune
system is now a clinically validated approach in the
treatment of some cancers. At MedImmune, the
Oncology Department is developing assets and expertise
in Immune Mediated Therapy of Cancer (IMT-C). The
challenges from a drug development perspective are
multi-fold. The talk will focus on the relevance of preclinical
models and translational science to address key issues,
including dose selection and rationale combinations.
9:25 Building Regeneron’s Pipeline: From Trap
Technology to the VelocImmune Platform to
Veloci-Next
George D. Yancopoulos, M.D., Ph.D., President,
Regeneron Laboratories; CSO, Regeneron
Pharmaceuticals, Inc.
George D. Yancopoulos, M.D., Ph.D., who is the Founding
Scientist, President, Research Laboratories and Chief
Scientific Officer of Regeneron Pharmaceuticals, one of
Premier Sponsor
REGISTER ONLINE NOW!
PEGSummit.com
the world’s top biotechnology companies, will discuss
how he and his colleagues exploited a commitment to
science and technology to start the company, withstand
years of challenges and failures, and emerge with a
pipeline of promising technologies and novel/biologics
that are beginning to bring hope to countless patients and
their families.
10:10 Grand Opening Coffee Break in the Exhibit Hall
with Poster Viewing
PK/PD, ADME AND
MOLECULAR CONSTRUCT DESIGN
11:05 Chairperson's Remarks
»»11:10 OPENING KEYNOTE PRESENTATION:
Application of PK/PD in Modality Design
Mohammad Tabrizi, Ph.D., Head & Senior Fellow, PK/PD, Merck
With scientific advances, it is now possible to rapidly and
effectively generate highly tailored and specific antibodybased therapeutics that interact with a diverse array of soluble
or cell-associated target antigens. Additionally, engineering
advances have made it possible to generate modalities that
bind two or more unique targets within a single molecular
entity or deliver potent payloads to specific targets. In this
presentation, application of PK/PD for the design of novel and
specific modalities will be discussed.
11:40 Which Parameters Do I Need to Optimize for
Design of a Successful Antibody-Drug Conjugate: A
Modeling and Simulation Approach to Understand
PK and PD Drivers of ADC Disposition and Response
Alison Betts, Modeling and Simulation Leader, Associate
Research Fellow, Translational Research Group,
Pharmacokinetics, Dynamics & Metabolism, Pfizer Global R&D
This presentation will include a review of the processes
involved in cellular and whole body disposition of ADCs,
along with novel experimental approaches to measure these
processes. It will also show a proposed mechanistic model for
predicting tumor payload concentrations of ADCs, and linkage
to tumor regression data using a pharmacodynamic model of
tumor growth and cell kill.
12:10 pm Sponsored Presentation (Opportunity
Available)
12:40 Luncheon Presentation I (Sponsorship
Opportunity Available)
therapeutic index via a compartment-specific targeting
moiety. Simple PK/PD theoretical analyses of intravenously
administered agents suggests that strong limits exist for
this approach, and we have experimentally validated key
predictions of this analysis.
2:35 Considerations for Design of Bispecific
Modalities
Isabel Figueroa, Associate Principal Scientist, PK/PD, Merck
Bi-specific antibodies (BsAb) are based on the concept that
the blockage or neutralization of two targets will result on
superior drug performance when compared to monoclonal
antibody therapy. However, their observed therapeutic
effect will depend on the kind and extent of pharmacological
interaction between the neutralization or binding of both
targets. In this talk, we discuss how the BsAb properties
theoretically impact their expected therapeutic performance.
3:05 PK Optimization and Preclinical PK of Novel
Bispecific Antibody against FIXa and X for the
Treatment of Hemophilia A
Kenta Haraya, Researcher, Chugai Pharmaceutical Co., Ltd.
A novel bispecific antibody against FIXa and X was generated
for the treatment of hemophilia A. Clinical candidate, ACE910,
was generated by improving the pharmacokinetics through
minimizing non-specific binding and reducing isoelectric point.
Preclinical study of ACE910 demonstrated long half-life and
high subcutaneous bioavailability in cynomolgus monkey.
Details of the preclinical pharmacokinetic analysis of this
bispecific antibody will be discussed.
3:35 Applying PK/PD Principles to Optimize
Development of Antibody Maytansinoid Conjugates
Joe Ponte, Ph.D., Senior Scientist, Immunogen, Inc.
This talk will address current challenges in optimizing and
developing ADCs and the role PK/PD can play in addressing
some of the concerns.
1:10 Luncheon Presentation II (Sponsorship
Opportunity Available)
4:05 Refreshment Break in the Exhibit Hall with
Poster Viewing
1:40 Session Break
4:45 Problem Solving Breakout Discussions
NEW STRATEGIES FOR BISPECIFICS
AND ADCs
2:00 Chairperson's Remarks
2:05 Limits of Tumor Targeting in Immunotherapy:
Theory & Experiment
K. Dane Wittrup, Ph.D., J.R. Mares Professor, Chemical
Engineering & Bioengineering, Massachusetts Institute of
Technology
Targeted agents such as immunocytokines are often
developed with the intention of achieving improved
5:45 Welcome Reception in the Exhibit Hall with
Poster Viewing
6:45 End of Day
6. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
SAFETY STREAM
2nd Annual | May 5-6
PK/PD of Multi-Domain Proteins
Bench to Bedside Translation of Bispecifics, ADCs, and Antibody Fragments
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
TUESDAY MAY 6
,
7:45 am Morning Coffee
PK/PD CONSIDERATIONS FOR ADCs
8:25 Chairperson's Remarks
8:30 Understanding the Insights into the ADME
of Antibody-Drug Conjugate (ADC) Impacts ADC
Development
Ben-Quan Shen, M.D., Senior Scientist, PKPD, Genentech, Inc.
Understanding the ADME of ADC plays an important role in
ADC development, given the complexity of ADC molecules.
In this talk, a variety of bioanalytical approaches, incorporating
strategies for large molecules and small molecules, will be
discussed. In addition, case studies on the ADME of a few
leading ADCs and their impacts will be presented.
9:00 Utilizing PK/PD Modeling and Simulation to
Guide the Discovery and Development of ADCs
Dhaval K. Shah, Ph.D., Assistant Professor, Pharmaceutical
Sciences, School of Pharmacy and Pharmaceutical Sciences,
University at Buffalo
The talk will introduce a diverse set of mathematical PK/PD/
TD models available to support ADC programs at different
drug development stages. It will also demonstrate the use
of mathematical models to understand ADC disposition,
to guide the discovery of ADCs, and to aid a precision
medicine approach.
9:30 PK/PD Modeling and Simulation Supporting
Preclinical and Clinical Development of ADCs
Xiang-Qing Yu, Ph.D., Principal Clinical Pharmacokineticist,
MedImmune
Antibody-drug conjugates (ADC) represent a novel approach
for cancer therapy. We have successfully used PKPD
modeling to relate PK to preclinical efficacy in order to
optimize designing preclinical toxicology studies. Furthermore,
our modeling and simulation has been utilized to help
clinical development in identify optimal dosing regimen for
cancer patients.
Premier Sponsor
10:00 Coffee Break in the Exhibit Hall with Poster
Viewing
NOVEL MODELING TECHNIQUES
FOR IN VIVO PK
10:45 Predicting the Distribution of Biologics Across
Multiple Length Scales – From Subcellular to Whole
Body PK
REGISTER ONLINE NOW!
PEGSummit.com
Greg Thurber, Ph.D., Assistant Professor, Chemical
Engineering & Biomedical Engineering, University of
Michigan
Biologics form complex interactions throughout multiple
tissues in the body that must be understood to more
efficiently develop these agents. The impact of these
interactions can affect the cellular, tissue, and organ
distribution. By incorporating these molecular events with
multiscale mechanistic models and iteratively carrying out
computer simulations alongside in vivo experiments, we will
be able to efficiently design agents and actively scale them to
the clinic.
11:15 Integration of QSPR and Mechanistic
PD Models to Predict in vivo PK/PD Profiles of
Chemically Related Compounds
Donald E. Mager, Ph.D., Associate Professor, Pharmaceutical
Sciences, University at Buffalo
11:45 Mechanism-Based PK/PD Modeling of
Antibody-Drug Conjugate Disposition and Action
Siddharth Sukumaran, Ph.D., Associate Scientist,
Pharmacokinetics and Pharmacodynamics, Genentech, Inc.
ADCs are often produced and administered as a
heterogeneous mixture of antibodies with different drug to
antibody ratio (DAR). In addition to affecting drug efficacy
and toxicity, DAR impacts drug deconjugation and proteolytic
clearance of antibody. Integrated PK/PD models were
developed by incorporating known mechanisms of ADC and
TDC disposition and action to describe and predict complex
PK and efficacy profiles. These models can be used to guide
further optimization and development.
12:15 pm Luncheon Presentation I (Sponsorship
Opportunity Available)
12:45 Luncheon Presentation II (Sponsorship
Opportunity Available)
1:15-1:45 Ice Cream Break in the Exhibit Hall
PK/PD AND COMBINATION THERAPIES
2:00 Chairperson's Remarks
2:05 PK/PD Considerations for Design of
Combination Therapies
Ayse Meric Ovacik, Senior Scientist, Biologics DMPK &
Disposition, Merck
PK/PD considerations for designs of combination therapies
include adequate drug-drug interaction evaluation. It is
particularly important to assess outcome of combination
therapy in terms of synergy and/or additivity and to inform
combination therapy design with quantitative approaches.
In this talk, we will summarize critical considerations of a
combination therapy design with a PK/PD aspect.
2:35 Bispecific Antibodies: Key Mechanistic PK/KD
Considerations Using Case Study Examples
Pratap Singh, Ph.D., Senior Principal Scientist, Pfizer, Inc.
Bispecific antibodies offer a promising approach to hit
two targets simultaneously using a single biological entity
but several challenges exist towards their successful
development. In this presentation, few case study examples
will be provided to illustrate utility of mechanistic modeling
in guiding affinity optimization, PK/PD/Tox study design and
human dose projections of bispecific antibodies.
3:05 Sponsored Presentation (Opportunity Available)
3:20 Sponsored Presentation (Opportunity Available)
3:35 Refreshment Break in the Exhibit Hall with
Poster Viewing
LINKING PK/PD AND IMMUNOGENICITY
4:15 An Integrated Analytical Strategy for Biologics
Peter Lloyd, Head, PK/PD, Biologics, Novartis
PK, PD and potential immunogenicity (IG) of therapeutic
proteins cannot be investigated in isolation. An integrated
approach is needed which takes into account the
interdependency of PK/PD/IG assays. This presentation will
focus on the use of an integrated bioanalytical strategy to
effectively interpret the behaviour of protein therapeutics.
»»4:45 CLOSING KEYNOTE PRESENTATION:
Impact of Immunogenicity on PK Profiles of Novel
Large Molecule Constructs
Vibha Jawa, Ph.D., Principal Scientist, Clinical Immunology,
Amgen
An assessment of immunogenicity in single dose
and multiple dose studies on clearance of novel drug
constructs will be discussed and compared to fully human
monoclonal antibodies.
5:15 End of Conference
Recommended Tuesday Dinner Short Course*
Overcoming the Challenges of Immunogenicity
Assessment
*Separate registration required, please see page 4 for course details.
7. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
SAFETY STREAM
6th Annual | May 7-8
Immunogenicity for Regulatory Success
Non-Clinical, Preclinical and Clinical Strategies for Risk Assessment and Smooth Interaction with the Regulatory Authorities
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
Recommended Pre-Conference Short Course*
Overcoming the Challenges of Immunogenicity
Assessment
*Separate registration required, please see page 4 for course details.
WEDNESDAY, MAY 7
7:00 am Registration and Morning Coffee
ASSAYS, INTERPRETATION AND STANDARDS
8:00 Chairperson's Opening Remarks
Meena Subramanyam, Ph.D., Vice President, Translational
Medicine, Biogen Idec, Inc.
8:10 Latest Trends in Neutralizing Antibody Detection
and the Clinical Relevance of Immunogenicity
Assessment
Shalini Gupta, Ph.D., Director, Clinical Immunology, Amgen, Inc.
This talk will provide a summary of an AAPS white paper
currently being compiled that focuses on NAb assay strategy
selection for biologicals with varied mechanisms of action. In
addition, the clinical relevance of immunogenicity assessment
will be presented via case studies.
8:40 International Bioassay Standardization for the
Quantification of Neutralizing Antibodies
Michael G. Tovey, Ph.D., INSERM Director, Research,
Laboratory of Biotechnology and Applied Pharmacology,
ENS-Cachan
Validated standardized assays are key to obtaining reliable
data and regulatory approval, in particular for cell-based
assays recommend by regulatory authorities for the detection
of neutralizing anti-drug antibodies. The EMA initiative to
establish a common assay and the E.U. initiative ABIRISK
to develop common validated cell-based assays for the
quantification of immunogenicity will be presented.
9:10 Drug Tolerance: Validation vs. Real Life Data and
Interpretation
Premier Sponsor
REGISTER ONLINE NOW!
PEGSummit.com
Holly Smith, Principal Research Scientist, Toxicology, Eli Lilly & Co.
Many ADA assay methods are designed to minimize ADA
interference either through assay format selection or
inclusion of sample treatment steps such as acid dissociation.
During validation, the ADA assay is characterized for its
“drug tolerance”This presentation will discuss validation
.
of drug tolerant assays, the limitations of drug tolerance
evaluations, and the importance of confirming drug tolerance
in sample results.
9:40 Evaluation of Immunogenicity for Enzyme
Replacement Biotherapeutics
Yongchang Qiu, Ph.D., Group Director and Head,
Bioanalytical and Biomarker Development, Shire, Inc.
This talk will outline the challenges of setting up and validating
anti drug assays (ADAs) and neutralizing antibody assays
(Nabs), and provide advice on data analysis, record keeping
and submitting findings to the regulatory authorities.
10:10 Coffee Break in the Exhibit Hall with PosterViewing
IMMUNE COMPLEXES AND
HYPERSENSITIVITY
11:10 Case Study on Identification and Potential
Impact of Immune Complexes
Binodh Desilva, Ph.D., Executive Director, Bioanalytical
Sciences & Biologics, Bristol-Myers Squibb
This presentation will describe immune complexes that
have been observed regarding their frequency and where
they form, and attempt to provide an explanation for their
occurrence. It will discuss methodologies for identifying
and characterizing them, their relationship with tox results
and their long term impact with complement deposition in
the issues.
11:40 Assessment of Biotherapeutic Drug
Allergenicity
Robert G. Hamilton, Ph.D., D.ABMLI, F
.AAAAI, Professor of
Medicine and Pathology, Johns Hopkins University School of
Medicine
This lecture will overview the basic pathophysiology at the
basis of the immediate type hypersensitivity response and
methods for assessing the presence and relative level of
drug specific IgE antibody. Recent consensus guidelines will
be overviewed that suggest an approach for validation of the
IgE antibody assay in the absence of a positive drug-specific
human IgE antibody serum.
12:10 pm Sponsored Presentation (Opportunity
Available)
12:40 Luncheon Presentation I (Sponsorship
Opportunity Available)
1:10 Luncheon Presentation II (Sponsorship
Opportunity Available)
1:40 Session Break
INTERESTING CASE STUDIES
2:00 Chairperson's Remarks
Holly Smith, Principal Research Scientist, Toxicology, Eli Lilly & Co.
2:05 The Evaluation of Immunogenicity in Remsima
Clinical Studies: From Development to Global
Regulatory Approval
Alex Kudrin, M.D., MBA, MRCP MFPM, Vice President &
,
Head,Global Development, Celltrion, Inc.
The presentation will cover the data generated to support
recent EU approval of the biosimilar infliximab and challenges
that needed to be addressed throughout the development of
the product. In addition, some switch-related immunogenicity
and safety data will be presented.
2:35 Pre-Existing Antibodies
Mary Birchler, Investigator, Clinical Immunology,
GlaxoSmithKline, Inc.
Pre-existing antibodies in treatment-naïve subjects have been
often detected during clinical ADA assessments. However,
limited information on prevalence, physiological effect, and
impact on post treatment ADA induction is available. This
talk will address pre-existing antibody characterization and
implications for immunogenicity management and strategies
during clinical studies.
3:05 Sponsored Presentation (Opportunity Available)
3:20 Sponsored Presentation (Opportunity Available)
3:35 Refreshment Break in the Exhibit Hall with
Poster Viewing
4:20 Problem Solving Breakout Discussions
5:20 Networking Reception in the Exhibit Hall with
Poster Viewing
6:30 End of Day
THURSDAY, MAY 8
7:45 am Breakfast Presentation (Sponsorship
Opportunity Available) or Morning Coffee
IMMUNOGENICITY RISK ASSESSMENT
8:30 Chairperson's Remarks
Binodh Desilva, Ph.D., Executive Director, Bioanalytical
Sciences & Biologics, Bristol Myers Squibb
8:35 Strategy for Immunogenicity Risk Assessment
Meena Subramanyam, Ph.D., Vice President, Translational
Medicine, Biogen Idec, Inc.
The risk of clinical consequences of immunogenicity can
be effectively mitigated with a comprehensive evaluation
of therapeutic-specific and patient-population specific risk
factors. This talk will focus on investigating the potential risk
8. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
SAFETY STREAM
6th Annual | May 7-8
Immunogenicity for Regulatory Success
Non-Clinical, Preclinical and Clinical Strategies for Risk Assessment and Smooth Interaction with the Regulatory Authorities
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
factors, characterizing their effects on immunogenicity in
non-clinical and clinical studies, understanding the nature of
concerns and potential data requirements, and development
of a risk management plan.
9:05 Case Study on Re-Assessment of
Immunogenicity Risk Based on Clinical Data
Eric Wakshull, Ph.D., Senior Scientist and Group Leader,
Bioanalytical Sciences, Genentech, Inc.
Initial clinical immunogenicity evaluation plans are often
based upon an immunogenicity risk assessment that
includes a myriad of molecule and patient factors, but
prior to any clinical experience. Clinical data can and
should modify this assessment. This talk will present a
case study of a structurally novel biotherapeutic whose
risk-based assessment was changed following analysis of
immunogenicity data derived from early clinical trials.
9:35 Impact of Immunogenicity on Clinical
Endpoints
Kyra J. Cowan, Ph.D., Scientist, BioAnalytical Sciences,
Genentech, Inc.
Premier Sponsor
REGISTER ONLINE NOW!
PEGSummit.com
The value of immunogenicity data lies in the integration
of that data with safety, pharmacokinetics, and efficacy
endpoints. A clinical trial was designed and executed to
evaluate the safety and efficacy of different dose levels and
dosing regimens of a biotherapeutic for age-related macular
degeneration. This talk will describe the approaches taken
for the analysis of anti-therapeutic antibodies (ATAs) in
patient sera for this study, and how the results informed the
interpretation of ATA impact on clinical endpoints.
10:05 Coffee Break in the Exhibit Hall with PosterViewing
COMBINATION THERAPY AND COMPLEX
MIXTURES OF DRUGS
11:05 Combination Biologic Therapy Development:
Impact on Immunogenicity Evaluation
Lakshmi Amaravadi, Ph.D., Senior Director, Translational
Medicine, Biogen Idec, Inc.
Assessment of potential interferences of one biologic on the
other need to be evaluated in the analytical assays to ensure
appropriate interpretation of the data and outcomes in
preclinical and clinical studies. In this presentation, one such
example of a combination biologic evaluation in a preclinical
setting with assay evaluations and impact on immunogenicity
as a monotherapy vs. combination therapy will be discussed.
11:35 Non-Biologic Complex Drugs and
Immunogenicity: Copaxone and Regulatory
Considerations for Complex Drugs
J. Michael Nicholas, Ph.D., Vice President, Specialty Life
Cycle Initiatives, Teva Pharmaceuticals
Nonbiologic Complex Drugs (NBCD) comprise a complex
heterogenous mixture of closely related, macromolecular
components that cannot be isolated, quantified, and/or fully
characterized. COPAXONE®, a NBCD, is a highly complex
heterogeneous mixture of synthetic proteins /polypeptides
with immunomodulatory activity. This case study will
examine immunogenicity profiles of NBCDs and implications
for the regulatory science of complex drugs.
12:05 pm Luncheon Presentation (Sponsorship
Opportunity Available) or Lunch on Your Own
12:35 End of Conference
9. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
6th Annual | May 8-9
Immunogenicity Prediction
and Mitigation
SAFETY STREAM
Risk Factors, Predictive Tools and Immune Tolerance Approaches
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
THURSDAY, MAY 8
»»KEYNOTE SESSION: IMMUNOGENICITY
REDUCTION AND CONTROL
1:30 pm Chairperson’s Opening Remarks
Bonnie Rup, Ph.D., Research Fellow, Immunogenicity
Sciences Lead, Pfizer, Inc.
1:40 Measures to Control Immunogenicity to
Interferon Beta
Florian Deisenhammer, Ph.D., Clinical Department of
Neurology, Innsbruck Medical University
We have learned a few lessons as to which factors contribute
to immunogenicity of different recombinant preparations
of Interferon beta (IFNb), such as route and frequency
of administration, drug formulation including pegylation,
aggregation, affinity of antibody binding and binding site. Also,
patients’ characteristics influence immunogenicity outcomes.
How these factors contribute to controlling immunogenicity
will be discussed.
2:10 New Approach to B and T Epitope Removal
from Immunotoxins with Retention of High
Cytotoxic Activity
Ira Pastan, M.D., NIH Distinguished Investigator, Co-Chief,
Laboratory of Molecular Biology, National Cancer Institute,
National Institutes of Health
Recombinant Immunotoxins are hybrid proteins that kill
cancer cells. RITs have produced complete remissions in
over 50% of patients with drug resistant Hairy Cell Leukemia
with impaired immune systems, but are less active in
patients with normal immunity. I will describe new highly
active immunotoxins predicted to have low immunogenicity
in humans as a result of experimental approaches for the
identification and removal of B and T cell epitopes.
2:40 Sponsored Presentation
Sponsored by
Speaker to be Announced
3:10 Refreshment Break in the Exhibit
Hall with Poster Viewing
4:00 Problem Solving Breakout Discussions
Premier Sponsor
5:00 Close of Day
Recommended Thursday Dinner Short Course*
Protein Aggregation: Mechanism, Characterization and
Immunogenic Consequences
*Separate registration required, please see page 4 for course details.
REGISTER ONLINE NOW!
PEGSummit.com
FRIDAY MAY 9
,
7:45 am Continental Breakfast in the Exhibit Hall
with Poster Viewing
PREDICTION OF IMMUNOGENICITY
8:30 Chairperson's Remarks
Steven J. Swanson, Ph.D., Executive Director, Medical
Sciences (Clinical Immunology), Amgen, Inc.
8:35 Mathematical Modeling of Immunogenicity
for Candidate Selection and Prediction of Effect on
Clinical Efficacy
Tim Hickling, Ph.D., Associate Research Fellow,
Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.
Early prediction of the incidence of ADAs to therapeutic
proteins will facilitate candidate selection and clinical trial
design. This model integrates key parameters for such
predictions: ADA incidence and magnitude, and the impact
of ADAs on PKPD. Initial attempts at model validation
with clinical data will be described as well as application
of this approach to selecting clinical drug candidates and
predicting immunogenicity.
9:05 Immunogenicity Prediction Studies with a
Recently Terminated Factor VII Analogue Project
Kasper Lamberth, Ph.D., Head, Immunogenicity Prediction &
Tolerance, Novo Nordisk A/S
The development of an rFVIIa analogue (Vatreptacog alfa) was
recently discontinued due to the development of ADAs in a
phase 3 trial. This analogue has three mutations compared
to endogenous rFVIIa. We applied different immunogenicity
prediction tools, in silico algorithms and different formats of
ex vivo T cell assays to identify an immunogenicity prediction
platform capable of distinguishing between the analogue and
the endogenous molecule.
9:35 Integrated Application of a Risk Assessment
Toolkit for Investigation of an Immunogenic
Monoclonal Antibody Therapeutic
Bonnie Rup, Ph.D., Research Fellow, Immunogenicity
Sciences Lead, Pfizer, Inc.
This presentation reviews nonclinical and clinical findings,
addresses assessment of potential underlying causes;
application of ADA characterization; in silico, and in vitro
dendritic and T cell cellular assays; and how the observations
fit in with potential increased immunogenicity risk associated
with some biotherapeutic targets. This study demonstrates
growing benefits to developing a predictive and investigative
tool kit.
10:05 Coffee Break in the Exhibit Hall with Poster
Viewing
IMMUNOGENICITY REDUCTION AND
TOLERANCE INDUCTION
10:50 Recent Advances with Immune Tolerance
Induction for Enzyme Replacement Therapy
Sue Richards, Ph.D., Global Deputy and Head, Clinical
Laboratory Sciences, DSAR, SANOFI/Genzyme
As we gain more experience, the effect of antibodies
becomes more evident. With inborn errors of metabolism,
patients receiving replacement therapy can be at higher
risk for developing antibodies, some associated with
clinical consequences. Strategies have been investigated to
mitigate unwanted immune responses to provide improved
therapeutic benefit. Recent advances and case studies using
immune tolerance induction for ERT will be discussed.
11:20 Immune Tolerance Induction in Hemophilia A
Mice Treated with Factor VIII Fc Fusion Protein
Sriram Krishnamoorthy, Ph.D., Scientist, Preclinical and
Clinical Development (Hemophilia), Biogen Idec, Inc.
Many hemophilia A patients treated with therapeutic factor
VIII (FVIII) produce Nabs to the product, thus rendering this
therapy ineffective. Methods to identify immunodominant
epitopes in FVIII and the generation of T cell clones against
FVIII have helped modulate this undesirable response. Novel
approaches to induce tolerance using IgG fusion proteins and
specific T regulatory cells will be discussed.
11:50 Reverse Vaccination via S.C. Route to Mitigate
Immunogenicity
Sathy Balu-Iyer, Ph.D., Associate Professor, Pharmaceutical
Sciences, SUNY-University at Buffalo
This presentation will explain the principle of reverse
vaccination via the sc route to mitigate immunogenicity of
therapeutic proteins. It will outline the primate studies and
the disease models investigated and describe the types of
aggregate identified, providing evidence for small aggregates
acting as adjuvants.
12:20 pm Luncheon Presentation (Sponsorship
Opportunity Available) or Lunch on Your Own
12:50 Session Break
10. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
6th Annual | May 8-9
Immunogenicity Prediction
and Mitigation
SAFETY STREAM
Risk Factors, Predictive Tools and Immune Tolerance Approaches
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
RISK FACTORS FOR IMMUNOGENICITY
1:35 Chairperson's Remarks
Sue Richards, Ph.D., Global Deputy and Head, Clinical
Laboratory Sciences, DSAR, SANOFI/Genzyme
1:40 Understanding the Immune Response against
Erythropoiesis Stimulating Agents that Can Lead to
Pure Red Cell Aplasia
Steven J. Swanson, Ph.D., Executive Director, Medical
Sciences (Clinical Immunology), Amgen, Inc.
Anti-erythropoietin antibodies associated with cases of
antibody-mediated PRCA have different characteristics than
those observed in subjects that do not have PRCA. PRCAassociated antibodies tend to be of the IgG4 subclasss,
have a higher circulating level, bind to the protein region
of erythropoietin, and are more likely to have neutralizing
capability. This underscores the value of developing and
validating clinically relevant assays.
2:10 Designing and Engineering a Protein
Therapeutic for Topical Treatment of Ocular Surface
Inflammatory Disorders to Have Low Immunogenic
Potential
Joseph Kovalchin, Ph.D., Associate Director, Pharmacology,
Eleven Biotherapeutics, Inc.
A novel protein therapeutic was designed and engineered for
topical treatment of ocular surface inflammatory disorders,
with low immunogenic potential. This entailed computer
algorithms to suggest amino acid sequences with low
HLA binding potential. These were correct as shown by in
vitro T cell assays. Animal studies suggested that topical
administration results in lower immune response to the drug,
probably due to low systemic exposure.
PHYSIOLOGICAL EFFECTS OF
PROTEIN AGGREGATION:
Special Shared Session with Protein Aggregation
and Stability
2:40 Are Aggregates Really Immunogenic?
Relevance of Current in vitro and in vivo Test
Systems in Understanding Physiological Immune
Response to Aggregated Particles
Narendra Chirmule, Ph.D., Executive Director, Clinical
Immunology, Amgen Inc.
Protein aggregates resulting from self association may
potentially activate the early phase of the immune system.
This talk evaluates the threshold of immune response
to the number and size of particles and the relevance of
the readout in such assays to the performance of a real
time formulation. The impact of immune modulation due
to diseased state and concomitant medications on the in
vitro assay readout is also evaluated.
3:40 Biological Impact of Aggregates:
Immunogenicity, Biodistribution, in vivo
Response
Vasco Filipe, Ph.D., Research Scientist, ADOCIA
The correlation between aggregates and immunogenicity
has been known for several decades, but the most
immunogenic type of aggregates and mechanisms behind
aggregate-related immunogenicity are not yet known. Two
different studies will be presented: (i) the biodistribution of
IgG1 monomers vs aggregates upon subcutaneous (SC)
and intravenous (IV) administration in mice was monitored
and their propensity to stimulate an early immune
response was measured; (ii) the immunogenicity of
different type of IgG1 aggregates was tested in immune
tolerant transgenic mice.
4:10 End of Conference
3:10 Aggregation of Human Recombinant
Monoclonal Antibodies Enhances Their
Presentation by Dendritic Cells in vivo
Sebastian Spindeldreher, Ph.D., Director, Biologics Safety
and Disposition, Novartis Pharma AG
Subvisibleproteinaceous particles are present in all
therapeutic protein formulations and their impact on
immunogenicity is the focus of intense discussions.
In order to interrogate the early dendritic cell-driven
events that initiate CD4 T cell dependent humoral
adaptive immune responses, aggregated monoclonal
antibodies were tested in dendritic cell cultures. In this
talk I will elute on the specific changes we observed in
peptide presentation.
Premier Sponsor
“Over the past few years PEGS has managed to become the “go to” meeting in the protein engineering space.
As other meetings have shrunk, PEGS has grown, and there’s a good reason for that.”
CEO and Co-Founder, Adimab LLC; Co-Founder, Arsanis; Professor, Bioengineering, Dartmouth College
REGISTER ONLINE NOW!
PEGSummit.com
11. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
PK/PD of Multi-Domain Proteins
SPONSOR & EXHIBITOR INFORMATION
CHI offers comprehensive packages that can be customized to your budget and
objectives. Sponsorship allows you to achieve your goals before, during, and long after
the event. Packages may include presentations, exhibit space and branding, as well
as the use of delegate lists. Signing on early will maximize your exposure to qualified
decision-makers and drive traffic to your website in the coming months.
Podium Presentations – Available Within the Main Agenda!
Showcase your solutions to a guaranteed, targeted audience. Package includes a 15or 30-minute podium presentation within the scientific agenda, exhibit space, on-site
branding, access to cooperative marketing efforts by CHI, and more.
Immunogenicity for Regulatory Success
Breakfast & Luncheon Podium Presentations
Immunogenicity Prediction and Mitigation
Opportunity includes a 30-minute podium presentation. Boxed lunches are delivered
into the main session room, which guarantees audience attendance and participation.
A limited number of presentations are available for sponsorship and they will sell out
quickly. Sign on early to secure your talk!
SPONSOR & EXHIBITOR INFORMATION
REGISTRATION INFORMATION
Additional branding and
promotional opportunities
are available, including:
• Mobile App
• Hotel Room Keys
• Footprint Trails
• Staircase Ads
• Conference Tote Bags
• Literature Distribution (Tote Bag
Insert or Chair Drop)
Looking for additional ways
to drive leads to your sales
team? One move can make
all the difference!
CHI’s Lead Generation Programs will
help you obtain more targeted, quality
leads throughout the year. We will mine
our database of 800,000+ life science
professionals to your specific needs. We
guarantee a minimum of 100 leads per
program! Opportunities include:
• Whitepapers
• Web Symposia
• Custom Market Research Surveys
• Padfolios
• Program Guide Advertisement
• Podcasts
Advertising opportunities such as marketing
and promotional emails are also available.
Invitation-Only VIP Dinner/Hospitality Suite
Sponsors will select their top prospects from the conference pre-registration list for
an evening of networking at the hotel or at a choice local venue. CHI will extend
invitations and deliver prospects, helping you to make the most out of this invaluable
opportunity. Evening will be customized according to sponsor’s objectives (i.e. purely
social, focus group, reception style, plated dinner with specific conversation focus).
Focus Group
CHI will gladly provide you the opportunity of running a focus group on-site. This
exclusive gathering can be useful to conduct market research, collect feedback on a new
product idea, and collect marketing intelligence from industry experts on a specific topic.
User Group Meeting/Custom Event
Co-locate your user group meeting or custom event. CHI will help market the event,
manage logistical operations, develop the agenda, and more. CHI can handle the
entirety of the meeting or select aspects.
Exhibit
Premier Sponsor
Exhibitors will enjoy facilitated networking opportunities with qualified delegates,
making it the perfect platform to launch a new product, collect feedback, and generate
new leads. Exhibit space sells out quickly, so reserve yours today!
New Product Showcase
Exhibitors have the opportunity to showcase their new product in the main exhibit hall.
CHI will promote your new product through the event website, the program guide, preshow marketing campaigns, press releases, and more.
REGISTER ONLINE NOW!
PEGSummit.com
For more information, contact:
Companies A-K
Jason Gerardi
Business Development Manager
781-972-5452
jgerardi@healthtech.com
Companies L-Z
Carol Dinerstein
Director, Business Development
781-972-5471
dinerstein@healthtech.com
2014 Exhibitors & Sponsors (As of December 10, 2013)
Abpro Labs
Accelrys
Aldevron
AllCells
Antibody Solutions
Appropriate Technical Resources
Aragen Bioscience
Avacta Life Sciences
AxioMx
Bioneer
BioProcess Technology Consultants
BiOptix
Bio-Rad Laboratories
Blue Sky Bioservices
Brookhaven Instruments
Catalent
Cellular Technology Limited (CTL)
Chemical Computing Group
Cobra Biologics
Core Informatics
Cube Biotech GmbH
DiscoveRx
DNA2.0
FortéBio, A division of Pall Life Sciences
FujiFilm Diosynth Biotechnologies, Inc.
Gen9, Inc.
GENALYTE, Inc.
Genedata
GenScript
Gyros
IBA GmbH
Integral Molecular
IntelliCyt
Isogenica
KBI BioPharma, Inc.
Lonza
Lucigen
MaxCyte
NBE-Therapeutics Ltd.
Novozymes
OriGene Technologies, Inc.
PerkinElmer
Pf énex, Inc.
Precision Antibody
Precision for Medicine
Premas Biotech
ProteinSimple
Proteos
Quanta BioDesign, Ltd.
Retrogenix
RheoSense, Inc.
Sapidyne Instruments
Selexis
SensiQ
Soluble Therapeutics
TA Instruments
TECAN
Teknova
Terumo Medical Corporation
The Chemistry Research Solution
Thomson Instrument Company
Vaccinex
Wyatt Technology Corporation
Xbrane Bioscience
12. REGISTER BY
MARCH 28 AND
SAVE UP TO $200!
COVER
BOSTON
How to Register: PEGSummit.com
the essential protein engineering summit
reg@healthtech.com • P: 781.972.5400 or Toll-free in the U.S. 888.999.6288
Please use keycode SFW when registering
SHORT COURSE PRICING
CONFERENCE-AT-A-GLANCE
HOTEL & TRAVEL
SHORT COURSES
SAFETY STREAM
(Includes access to Short Courses only)
Commercial
Academic, Government, Hospital-affiliated
Single Short Course
Two Short Courses
Three Short Courses
$699
$999
$1199
$349
$599
$699
The latest industry news, commentary
and highlights from Bio-IT World
CONFERENCE PRICING
PK/PD of Multi-Domain Proteins
PREMIUM PACKAGE BEST VALUE! (Includes access to all conferences Monday-Friday, excludes Short Courses)
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
Advance Registration until March 28, 2014
Registration after March 28, 2014
SPONSOR & EXHIBITOR INFORMATION
STANDARD PACKAGE (Includes access to 2 conferences, excludes Short Courses)
REGISTRATION INFORMATION
Advance Registration until March 28, 2014
Registration after March 28, 2014
$3,099
$3,249
$2,499
$2,699
Advance Registration until March 28, 2014
Registration after March 28, 2014
I. Monday-Tuesday, May 5-6
$1,699
$1,849
II. Wednesday-Thursday AM, May 7-8
A series of diverse reports designed to
keep life science professionals informed
of the salient trends in pharmaceutical
technology, business, clinical development,
and therapeutic disease markets.
For a detailed list of reports, visit
InsightPharmaReports.com, or contact
Rose LaRaia, rlaraia@healthtech.com,
$1,299
$1,399
+1-781-972-5444.
$849
$899
III. Thursday PM-Friday, May 8-9
Phage and Yeast Display
Engineering Antibodies
Engineering Bispecific Antibodies
Antibodies for Cancer Therapy
Advancing Bispecific Antibodies to the Clinic for Oncology
Antibody-Drug Conjugates
Biologics for Autoimmune Disorders
Adoptive T Cell Therapy
Optimizing Protein Expression
High-Level Expression of Enzymes
Characterization of Biotherapeutics
Biophysical Analysis of Biotherapeutics
Protein Aggregation and Stability
PK/PD of Multi-Domain Proteins
Immunogenicity for Regulatory Success
Immunogenicity Prediction and Mitigation
Scaling Up and Down Strategies
ADC Development & Manufacturing
CONFERENCE DISCOUNTS
Poster Submission - Discount: ($50 off) Poster abstracts are due by
March 14, 2014. 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.
Protein Society Members: (20% off) CHI is pleased to offer all Protein
Society Members a 20% discount to attend. Records must indicate you
are a member at time of registration.
PEGSummit.com
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.
Peptide Therapeutics
Difficult to Express Proteins
REGISTER ONLINE NOW!
Innovative management in clinical trials
$1,629
$1,729
BASIC PACKAGE (Includes access to 1 conference, excludes Short Courses)
Premier Sponsor
Receive a FREE eNewsletter by signing up
at chimediagroup.com
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) CHI appreciates your past participation at PEGS.
Through loyalty like yours, CHI has been able to build this event into a must-attend
for senior-level decision makers. 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!
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, Protein Society, Twitter, LinkedIn, Facebook or any other promotional
discounts cannot be combined. Discounts not applicable on Event Short Courses.
Cambridge Healthtech Associates™
(CHA™) uses its collaborative model to
improve the speed and economics of life
sciences R&D, leveraging its consulting,
technology evaluations and communities.
Visit www.chacorporate.com.
ADDITIONAL REGISTRATION DETAILS
Each registration includes all conference
sessions, 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.