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.
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!
Make Plans to Attend the Number 1 Immunogenicity and Bioassay Event Bringing Together Industry,
Academia and Regulatory Authorities. Featuring 8 FDA Presenters!
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)
Educating the Next Generation Pharmacist for Industry. The Panjab University ...Ajaz Hussain
The Panjab University Pharmaceutical Science Oration 2014: Educating the Next Generation Pharmacist for Industry.
“The dream begins with a teacher who believes in you, who tugs and pushes and leads you to the next plateau, sometimes poking you with a sharp stick called ‘truth’.“
Plato, the Republic
What are the most influential ideas, concepts, and developments introduced by ‘pharmaceutical scientists’ over the last 50 years?
How have these ideas/concepts introduced into practice?
How can we improve?
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!
Make Plans to Attend the Number 1 Immunogenicity and Bioassay Event Bringing Together Industry,
Academia and Regulatory Authorities. Featuring 8 FDA Presenters!
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)
Educating the Next Generation Pharmacist for Industry. The Panjab University ...Ajaz Hussain
The Panjab University Pharmaceutical Science Oration 2014: Educating the Next Generation Pharmacist for Industry.
“The dream begins with a teacher who believes in you, who tugs and pushes and leads you to the next plateau, sometimes poking you with a sharp stick called ‘truth’.“
Plato, the Republic
What are the most influential ideas, concepts, and developments introduced by ‘pharmaceutical scientists’ over the last 50 years?
How have these ideas/concepts introduced into practice?
How can we improve?
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
An overview of our Technology Accelerator business model. We describe a hybrid model leveraging minimally-dilutive funding and experienced pharmaceutical management to “de-risk” and drive projects to IND. Our area of expertise is prodrugs and infectious diseases (www.tsrlinc.com).
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
How to develop and evaluate a pro instrument - pubricaPubrica
PRO or Patient-reported outcome is a relatively novel method to evaluate the outcome of any treatment by clinician or researcher (in clinical trial) purely based on the inputs got from the patient alone.
Full Information : https://bit.ly/2VPA4uX
Reference : https://pubrica.com/services/data-analytics-machine-learning/
Why pubrica?
When you order our services, we promise you the following – Plagiarism free, always on Time, outstanding customer support, written to Standard, Unlimited Revisions support and High-quality Subject Matter Experts.
Contact us :
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-74248 10299
Related Topics:
Literature gap and future research
Meta-Analysis in evidence-based research
Biostatistics in clinical research
Scientific Communication in healthcare
Tags:
Medical writing service | Scientific communication services | Scientific research services | Clinical trials | Publication services | Scientific Manuscript editing services | healthcare data analytics services
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.
Need for an Integrated approach to Formulation Research and Knowledge ManagementAjaz Hussain
1. Confidence in Generics: Need for an Integrated
approach to Formulation Research and Knowledge
Management (Ajaz Hussain)
2. Mechanism for an integrated approach to Formulation
Research, Knowledge Management, & Knowledge
sharing with FDA & Industry (Steve Byrn)
3. Integrated approach for evolving standards for
formulation design - case example NTI's (Ken Morris)
4. Integrated approach for evolving standard for analytical
characterization - case example excipient variability
(Eric Munson)
Visioning the Next Decade: NIPTE-FDA CollaborationAjaz Hussain
NIPTE Seminar at US FDA, 16 March 2016.
QBR as an Organizing Principle for the Proposed NIPTE Center of Excellence for Pharmaceutical Formulations (CEPF)
On FDA’s Guidance on Pharmaceutical Process Validation (2011)lAjaz Hussain
Connectors between Culture – Metrics – Continued Process Verification in Process Validation?
Confidence is a critical quality attribute. CGMP violations erode confidence and increase nocebo effects. Currently – “breaches in assurance of data integrity” is a global concern. Have exposed the prevailing ‘regulator heterogeneity’. Re-building ‘epistemic trust” is difficult generally; more so with US FDA. Some thoughts on how to ....
An overview of our Technology Accelerator business model. We describe a hybrid model leveraging minimally-dilutive funding and experienced pharmaceutical management to “de-risk” and drive projects to IND. Our area of expertise is prodrugs and infectious diseases (www.tsrlinc.com).
Good Regulators of Pharmaceuticals (GRP) 22 October 2014Ajaz Hussain
Sharing thoughts on what makes a Good Regulator of Pharmaceuticals with pharmacy students at the Universities of Minnesota and Iowa. A point of emphasis on "we all are regulators" is explained and three areas for learning - (a) Systems and Integrative Thinking, (b) Argumentation and (c) Behavioral Economics described.
I hope you, the viewers, will also find some value in reviewing these slides. If you are a student and have some questions please feel free to drop me a email (a2zpharmsci@msn.com).
Design is to do good not just be and look good: Bad Design is Smoke, Good Des...Ajaz Hussain
Design is to do good not just be and look good. "Design means being good, not just looking good." ~ Clement Mok. "A small change at the beginning of the design process defines an entirely different product at the end." ~ Jonathan Ive. "User-centered design means understanding what your users need, how they think, and how they behave - and incorporating that understanding into every aspect of your process." ~ Jesse James Garrett.
Compared to “one factor at a time” experiments, increased experimental efficiency, accounting interactions, multivariate predictive capability, minimization, maximization, optimization, graphical illustration for enhanced communication of complex topics.
"Design is intelligence made visible." -- Alina Wheeler
Critical Path Initiative Challenges: FDA ACPS Meeting 19 October 2004Ajaz Hussain
Each section within P2 can have an impact on the other P2 sections and similarly other sections of a submission and to CGMP’s By recognizing this as a complex design system that involves multiple attributes, goals, constraints, multidisciplinary design teams (subsystems), different degrees of uncertainty, risk tolerance, etc., we wish to find opportunities to identify robust designs and design space that provides a sound basis for risk assessment and mitigation
How to develop and evaluate a pro instrument - pubricaPubrica
PRO or Patient-reported outcome is a relatively novel method to evaluate the outcome of any treatment by clinician or researcher (in clinical trial) purely based on the inputs got from the patient alone.
Full Information : https://bit.ly/2VPA4uX
Reference : https://pubrica.com/services/data-analytics-machine-learning/
Why pubrica?
When you order our services, we promise you the following – Plagiarism free, always on Time, outstanding customer support, written to Standard, Unlimited Revisions support and High-quality Subject Matter Experts.
Contact us :
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-74248 10299
Related Topics:
Literature gap and future research
Meta-Analysis in evidence-based research
Biostatistics in clinical research
Scientific Communication in healthcare
Tags:
Medical writing service | Scientific communication services | Scientific research services | Clinical trials | Publication services | Scientific Manuscript editing services | healthcare data analytics services
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.
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.
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.
CHI’s Thirteenth Annual High-Content Analysis meeting, the premier event showcasing the latest advancements in HCA applications and technologies, returns to San Diego with a new program. Over the years we have observed the technology mature and its adoption spread into many areas of compound screening/evaluation and functional analysis. The High-Content Analysis meeting will focus on the next steps of technology development, including screening of 3D and physiologically relevant complex models, ultra-high resolution and high-throughput imaging, more advanced image analysis and data management, and new assays and applications. The co-located Second Annual Phenotypic Screening meeting will address the advantages of phenotypic screening vs. target-based screening, and focus on assay development, selection of physiologically relevant models and subsequent target identification, as well as case studies of phenotypic screens from leading pharma. Join the original High-Content Analysis event and get access to two tracks featuring a cutting-edge scientific agenda, expanded exhibit hall and technology showcases, and an offering of technology demonstrations and dinner courses.
PepTalk: The Protein Science Week is one of the largest gatherings of protein science researchers in the United States, and when you bring together some of the most influential people in the field - big things happen!
PepTalk: The Protein Science Week January 19-23, 2015, offers an array of education, innovation and networking programs. Over 300 high-caliber speakers share case studies, unpublished data, breakthroughs and solutions that support and enhance your research. Ample networking opportunities allow you to connect with colleagues and peers from around the world and gain new perspectives on the evolution of biologics. Choose between 20 Conferences, 13 Short Courses, 3 Training Seminars, 80+ BuzZ Session Discussion Roundtables, and dedicated exhibit hall and poster viewing hours to create a custom agenda that fits your research and networking needs!
Dear Ladies & Gentlemen,
Hope all is well, Glad to share details with you of our upcoming conference “6th Biosimilars 2015” taking place on 10th & 11th March 2015, The Kensington Close Hotel, Wrights Lane, London, UK. Please find attached the updated agenda for the same with this email.
In case you and your colleagues would like to book as delegate there is a discounted price now :-
Introductory Offer (3 delegate places for the price of 2):- A huge saving of £ 600
Super Early Discount (Till 26th December 2014):- Conference Delegate Pass (£ 600 + VAT per delegate)
We can also offer some other sponsorship packages which include speaking opportunities/ branding etc. For some sample packages on the same please email me and I can call you to discuss the options further.
For any further assistance please feel free to contact me anytime. I look forward to a positive response from your end.
Best Regards,
Deepak Raj
Delegate and Sponsorship Sales
Virtue Insight
Gsm - + 91 9171350244;
- Discover new methods for managing clinical next-gen data with insights from Pfizer, Boston Children’s Hospital and AstraZeneca
- Uncover and critique the latest technologies out there for you to use in clinical trials. Mayo Clinic, Merck and Harvard Medical School let you into their trade secrets
- Hear the genomics strategies that Roche, Millennium and Regeneron are using for discovery and validation of clinically actionable biomarkers
-Bristol-Myers Squibb, Takeda and Partners Healthcare the role that NGS can play when implementing an effective strategy in the lab to speed up CDx development
- Learn how to integrate molecular details into medical decision making, with fresh data from Washington University School of Medicine and Genzyme
Significance of BA/BE studies in drug research and evaluation of different as...inemet
PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com
Abstract is available at http://www.pharmaconnectme.com
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.
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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.
CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DCJames Prudhomme
Next Generation Dx Summit has grown to more than 1,000 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 tenth year, Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important issues for the industry.
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.
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 course reviews the hematological system and provides an overview on the spectrum of hematologic cancers. The expert teaching team, comprising currently practising physicians, guides course attendees through the pathophysiology of Hematologic Cancers - An Introduction such as leukemias, lymphomas and myeloma. Common treatments and management of these malignancies are discussed as well as the challenges these treatments present to patients. The issues and complications of bone marrow and stem cell transplant are also reviewed. Case studies and open discussion form an integral part of the program.
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.
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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.
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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.
PK/PD and Immunogenicity Conferences, May 2014, Boston, MA - part of PEGSJames Prudhomme
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.
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.
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
Join us on June 19 in Boston, MA, for this short course to be held prior to the start of CHI's Structure-Based Drug Design conference. This introductory course on drug design for epigenetic targets will focus especially on emerging targets such as bromodomain (readers), methyltransferase (writers) and lysine demethylase (erasers).
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
1. Technologies and Strategies for Safe and Efficacious Products in the Clinic
Join 250+ of Your Peers
Keynote Speakers:
Plus! 4 Short Courses
ImmunogenicitySummit.com
Immunogenicity
Assessment &
Clinical Relevance
Immunogenicity
Prediction &
Mitigation
Optimizing
Bioassays for
Biologics
Conferences
NOVEMBER 17-19, 2015 • HILTON BALTIMORE • BALTIMORE, MD
Maura C. Kibbey, Ph.D.,
Senior Scientific Liaison,
Biologics Biotechnology,
United States Pharmacopeia
Valerie Quarmby, Ph.D.,
Staff Scientist, BioAnalytical
Sciences, Genentech, Inc.
Amy Rosenberg, Ph.D.,
Director, Therapeutic Proteins,
FDA/CDER
Xiaobin (Victor) Lu, Ph.D.,
Xiaobin (Victor) Lu, Ph.D.,
CMC Reviewer, Division of
Cellular Gene Therapies,
OCTGT, CBER, FDA
Register By August 21 Save up to $400!
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2. 2 | ImmunogenicitySummit.com
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your talk.
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10 Reasons to Choose CHI’s
Immunogenicity and Bioassay Summit 2015
1. 7 FDA experts on a range of topics: presentations,
breakout discussions and a short course
2. Addresses the real challenges in
immunogenicity assessment
3. Risk assessment strategies
4. Immunogenicity for biosimilars: from the FDA,
from Europe, and an industry case study
5. Models for immunogenicity prediction
6. Impact of impurities, aggregates and SVPs
7. Deimmunization and tolerance mechanisms:
including a clinical case study
8. Showcases advanced technologies for
bioassay development
9. Explores potency testing for gene and cell therapies
10. Provides solutions for bioassay development for
molecules with multiple modes of action
PLUS:
Choice of 12+ interactive breakout discussions: to help you iron out your immunogenicity and bioassay challenges
4 Short courses: assay development; risk assessment and regulatory strategy, and bioassay design and analysis
3. ImmunogenicitySummit.com | 3
Short Courses*
Monday, November 16
1:30 – 4:30 pm SC1: Basics of ImmunogenicityTesting
Instructors:
Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
Amy Loercher, Ph.D., Manager, Clinical Immunology, GlaxoSmithKline
This interactive session will enable attendees to work out a basic immunogenicity preclinical and clinical testing strategy for various molecules
including bi-functional and other novel scaffolds. Areas of difficulty will be discussed with specific case studies. Attendees are encouraged to
contribute with their own experiences and to bring questions for discussion or submit to the meeting organizers in advance.
The following topics will be covered:
• Current common industry practices
• Basic issues regarding screening, confirmatory and titer assays
• Assay methodologies and various technologies
• Current approaches to data analysis and cutpoints
• Preclinical and clinical considerations
• Common problems
5:30 – 8:30 pm Dinner SC2: Challenges of Immunogenicity Assessment
Instructors:
Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
Amy Loercher, Ph.D., Manager, Clinical Immunology, GlaxoSmithKline
This interactive session of intermediate level will focus on the potential challenges of immunogenicity testing in preclinical and clinical
development and present case studies demonstrating how they can be handled. Attendees are encouraged to contribute with their own
experiences and to bring questions for discussion or submit to the meeting organizers in advance.
The following topics will be covered:
• Challenges and approaches to resolve commonly encountered issues
• Multi-domain binding proteins
• Pre-existing ADAs
• Emerging trends in the development of neutralizing antibody assays
• Cross reactivity to endogenous proteins
• Clinical implications of ADAs
Wednesday, November 18
6:30 – 9:30 pm Dinner SC3: Immunogenicity Risk Assessment and Regulatory Strategy
Instructors:
Joao Pedras-Vasconcelos, Ph.D., Biotech Quality and Immunogenicity Reviewer, Office of Biotechnology Products, CDER-FDA
Paul Chamberlain, NDA Advisory Board
The objective of this short-course is to illustrate the rationale for, and application of, the regulatory approach to identifying, evaluating and
mitigating immunogenicity-related risks for different product types. The agenda is designed to encourage interaction between the presenters and
the participants in sharing experience of application of a multi-disciplinary, integrated approach.
The following topics will be covered:
• Regulator’s perspective
• Overview of multi-disciplinary, integrated approach to identifying,
evaluating and mitigating immunogenicity-related risks
• Examples that illustrate the “why” and “how to” for different
product types / risk levels:
• Bacterial-derived proteins
• Enzyme replacement therapies
• Bone morphogenic proteins
• Allogeneic cell-based therapies
• Yeast-derived glycoproteins
• PEGylated uricase
• Novel antibody constructs
6:30 – 9:30 pm Dinner SC4: Strategic Bioassay Design and Analysis
Instructor:
Liming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli Lilly and Company
This course will focus on the fundamentals of statistics and simple methodology that are routinely applied in bioassay laboratories.
Covered topics will include review of statistical concepts and calculations, study design, assessing bioassay measurement quality and
comparative studies.
The following topics will be covered:
• Uniqueness of bioassay, especially cell-based potency assay
• Considerations in bioassay development and validation
• Bioassay measurements and calculations
• Quality control of bioassay performance
• Comparative studies for bioassay development and transfer
*Separate registration is required.
“ This is a great meeting to get up to date information and
hear regulatory feedback and industry experiences.”
- Senior Director, Ultragenyx
4. 4 | ImmunogenicitySummit.com
Immunogenicity Assessment Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results
TUESDAY, NOVEMBER 17
7:30 am Registration and Morning Coffee
8:30 Chairperson’s Opening Remarks
Lakshmi Amaravadi, Ph.D., Senior Director,Translational Medicine, Biogen Idec, inc.
KEYNOTE PRESENTATION:
8:35 A Harmonized Approach to Interpretation and Reporting
of Clinical Immunogenicity Data
Valerie Quarmby, Ph.D., Staff Scientist, BioAnalytical Sciences,
Genentech, Inc.
A recent “White Paper” (Shankar et al 2014 AAPSJ) has
provided a common set of terms and definitions to describe
clinical immunogenicity data. The paper also provides a
harmonized approach to the interpretation of immunogenicity results
in the context of pharmacokinetics, efficacy, and safety. Industry-wide
use of these recommendations will enable the clinical relevance of
immunogenicity to be assessed consistently.
REGULATORY EXPECTATIONS REGARDING
IMMUNOGENICITY ASSESSMENT FOR
INNOVATORS AND BIOSIMILARS
9:05 How Product Quality Attributes of Biotherapeutics Affect
Immunogenicity: A Regulatory Perspective
William Hallett, Ph.D., Product Quality Immunogenicity Reviewer,
CDER/OPQ/OBP FDA
Several quality attributes of biopharmaceuticals can significantly impact its
immunogenic potential. Critical quality attributes of biopharmaceuticals that
affect immunogenicity include molecular structure, glycosylation, aggregates,
subvisible particulates, mechanism of action, etc. Manufacturing changes
made during product life cycle, e.g. scale up, fermentation, raw materials,
formulation, dosage form, etc. may affect a product’s immunogenic potential.
This presentation discusses the regulatory perspective on product quality
management and its effect on immunogenicity.
9:35 Regulatory Perspectives on Setting up the Clinical
Immunogenicity Study for a Biosimilar
Susan Kirshner, Ph.D., Associate Chief, Laboratory of Immunology, Therapeutic
Proteins, Biotechnology, CDER/FDA
10:05 Multiplexing Immunogenicity Assays
with the MSD U-PLEX® Platform
Laure Moller, Ph.D., Director, Scientific Support North America,
Meso Scale Discovery
Sponsored by
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
11:15 Lessons Learnt from the European Experience Regarding
Biosimilars and Immunogenicity
Paul Chamberlain, NDA Advisory Board
The experience gained during the 10-year period following the implementation
of the EU biosimilars pathway indicates that a suitably cautious approach
was applied, insofar as no immunogenicity-related issues have emerged for
the approved applications of the different biosimilar products. In some cases,
product quality-related issues were identified in the pre-authorization setting
as being potential relevant for heightened risk of immunogenicity and were
duly taken into account for the biosimilarity decision.
11:45 Experiences with Immunogenicity Assessment in
BiosimilarTrails with a Monoclonal Antibody
Niklas Czeloth, Ph.D., Head, Biosciences, Biosimilars, Boehringer Ingelheim
Immunogenicity assessment of biosimilar products is an important aspect
of the overall development process while the experience with monoclonal
antibody biosimilars still remains limited. The presentation will share
experiences in setting up immunogenicity assays for a biosimilar product and
will discuss on relevance of differences observed for the same product in two
independent trials using healthy volunteers.
12:15 pm Sponsored Presentations (Opportunities Available)
12:45 LUNCHEON PRESENTATION:
Immunogenicity of Oligonucleotides
Sponsored by
Marie-Soleil Christin-Piché, Ph.D., Scientific Director, Immunology,
Charles River Montreal
End User to be Announced
1:45 Session Break
PRECLINICAL STUDIES AND RISK ASSESSMENT
2:15 Chairperson’s Remarks
Theo Rispens, Ph.D., Senior Scientist, Immunopathology, Sanquin
2:20 Strategies for Immunogenicity Risk Assessment
Bonita Rup, Ph.D., Biotechnology Consultant, Bonnie Rup Consulting LLC
Immunogenicity risk assessments typically consider an established set of
risk factors relating to the product and recipient population, and treatment
regimens. As the number of biopharmaceuticals under development increase,
competitive and regulatory risk should also be considered. To assure the
value of these assessments, it is important to continuously re-examine the
“generally accepted” risk factors, particularly to better understand how they
interact and determine how to improve their reliability. This presentation will
overview the current practices of risk assessment and mitigation and discuss
potential options for continuous improvement.
2:50 Case Studies in Non-Clinical ImmunogenicityTesting with
Fit for Purpose Assays: Isotype Control Assays for Overcoming
Target Interference
Michael Partridge, Ph.D., Staff Scientist, Bioanalytical Sciences, Regeneron, Inc.
The industry standard for ADA detection, the bridging immunoassay, requires the
production of specific reagents and may be susceptible to target interference.
We evaluated fit for purpose assays in non-clinical studies as alternatives for ADA
detection.These methods included bridging assays that detect ADA generated to
the constant regions of mAb drugs as well as ELISAs.This presentation will discuss
the advantages and limitations of these approaches in several non-clinical studies.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Choosing an Appropriate ADA Assay for Preclinical Studies:
Comparison of Different ADA Assays in NHP Case Studies
Jianyong (Jerry) Wang, Ph.D., Scientist, Biochemical and Cellular
Pharmacology, Genentech, Inc.
Sensitive and fast ADA testing methods play important roles in preclinical
studies. Different plate-based ADA assays were compared in multiple NHP
studies involving bispecific antibodies, IgG1 and IgG4 mAbs. The attractive
features and limitations of each method, and critical factors on assay
development will be discussed to provide a general guidance for selecting an
appropriate ADA assay for preclinical studies.
4:30 Problem Solving Roundtable Discussions
Table1: Meeting Regulatory Expectations
Moderator: William Hallett, Ph.D., Product Quality Immunogenicity
Reviewer, CDER/OPQ/OBP FDA
Table 2: Challenges in Developing NeutralizingAntibody (Nab)Assays
Moderator:YulingWu, Ph.D., Principal Scientist,Translational Sciences, MedImmune
Table 3: OvercomingTarget Interference in ADA assays
Moderator: Jim McNally, Ph.D., Associate Director, PDM Immunogenicity
Expert, EMD Serono
Table 4: Dealing with Pre-Existing Positive ADA Activity
November 17-18, 2015
5. ImmunogenicitySummit.com | 5
Immunogenicity Assessment Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results
Moderator: Lakshmi Amaravadi, Ph.D., Senior Director, Translational Medicine,
Biogen Idec, Inc.
Table 5: Critical Issues in ADA Assay Validation
Moderator: Amy Loercher, Ph.D., Manager, Clinical Immunology, GSK
5:30 Welcome Reception in the Exhibit Hall with Poster Viewing
6:30 End of Day One of Immunogenicity Assessment Clinical
Relevance
WEDNESDAY, NOVEMBER 18
7:30 am Registration and Morning Coffee
8:00 am Chairperson’s Remarks
Jim McNally, Ph.D., Associate Director, PDM Immunogenicity Expert, EMD Serono
DIFFERENT ASSAY FORMATS ANDTECHNOLOGIES
FOR IMMUNOGENICITY ASSESSMENT
8:05 Replacing Legacy ADA Assays with New and Better
Methods to Support Routine Patient Care
Yongchang Qiu, Ph.D., Senior Director, Head, Bioanalytical and Biomarker
Development, Research Nonclinical Development, Shire
Legacy ADA testing used to support early clinical trials are often limited by
technologies and guidance available at that time and can be very complex with
many methods. As a result, these assays have presented many challenges,
such as slow turn-around time and high cost, for ADA testing to support
routine patient care. Here we present our effort on development of new and
better assays to replace legacy methods and address “data continuity” issues
before and after method switch.
CHALLENGES WITH
IMMUNOGENICITY ASSESSMENT
8:35 A Neutralizing Antibody Assay Based on a Reporter of
Antibody Dependent Cell-Mediated Cytotoxicity
Yuling Wu, Ph.D., Principal Scientist, Translational Sciences, MedImmune
Immunogenicity assessment is an essential component of safety evaluation in
biopharmaceutical clinical development. Benralizumab (MEDI-563, anti-IL5Rα
mAb) is a humanized afucosylated mAb against IL5Rα with enhanced effector
function. It potently induces ADCC (antibody-dependent cell-mediated cytotoxicity)
of eosinophils and basophils.To support benrulizumab clinical development, we
developed an ADCC cell-based neutralizing antibody (NAb) assay to detect NAbs
against benrulizumab in human serum.This study presents the development,
optimization and characterization of an ADCC cell-based NAb assay.
9:05 Evaluation of Pre-Existing Antibodies: How Meaningful is
the Investigation?
Lakshmi Amaravadi, Ph.D., Senior Director, Translational Medicine, Biogen
Idec, Inc.
Pre-existing antibodies have been detected in many clinical programs and
have been receiving increased attention in the last decade. It is important
to appropriately characterize the pre-existing antibody reactivity in the
immunogenicity program in order to identify treatment emergent anti-drug
antibodies appropriately, to quantify the titer response, and more importantly
to understand if there is any clinical risk associated with such pre-existing
antibodies. In order to further our understanding of this key aspect of
immunogenicity evaluation an AAPS sub-committee has been assembled. The
presentation will discuss some key findings from this committee. Some case
studies will also be discussed.
9:35 Experiences with Confirmatory Assays, False Positives and
Negatives, and Cutpoint Determination
Amy Loercher, Ph.D., Manager, Clinical Immunology, GlaxoSmithKline
This presentation will focus on difficulties that may be encountered with
confirmatory assays, false positive and false negative assay signals and
various approaches to cutpoint determinations. Case studies will be
presented that examine strategies for immunogenicity assessments of
biopharmaceuticals for both soluble and membrane-bound cellular targets.
10:05 Sponsored Presentations (Opportunities Available)
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
CLINICAL CASE STUDIES ON
SPECIFIC BIOTHERAPEUTICS
FEATURED PRESENTATION:
11:10 ImmunogenicityTesting in PatientsTreated with Anti-TNF:
What is the Best Measure of Clinical Response?
Theo Rispens, Ph.D., Senior Scientist, Immunopathology, Sanquin
Anti-drug antibody (ADA) formation to therapeutic monoclonal
antibodies such as adalimumab and infliximab (anti-TNF) is
associated with lower drug levels and clinical non-response.
Controversy exists about the clinical consequences of ADA
formation, which partly arises from the use of different assays and testing
strategies. This presentation will focus on the relationship between
concentrations of the drug (PK), anti-drug antibodies and clinical response, as
well as the characteristics of ADA responses to these drugs.
11:40 Immunogenicity and Clinical Relevance Assessment Enabling
the Approval of a Subcutaneous Formulation of Herceptin
Rebecca Elliott, MSc, Manager, BioAnalytical Sciences, Genentech, Inc.
The assessment of immunogenicity (antibodies against Herceptin® or
recombinant human hyaluronidase) was one of the secondary objectives of
a randomized, multi-center, open-label Phase III study. This demonstrated
non-inferiority of a fixed-dose subcutaneous formulation of Herceptin® when
compared with an intravenous formulation based on pharmacokinetics and
efficacy in patients with HER2-positive early breast cancer. Exploratory
analyses were performed to investigate any potential correlation of
immunogenicity to pharmacokinetics, efficacy, and safety.
12:10 pm Rapid ADA Response against a C5a Receptor
Antagonist Impacting PK and PD
Per Holse Mygind, Ph.D., Senior Scientist, Immunogenicity Assessment,
Novo Nordisk
A first generation antibody therapeutic against the C5a receptor was
developed to treat patients with chronic autoimmune diseases. A rapid and
significant ADA response was detected in a large number of patients. These
discoveries contributed to the development of a second generation antibody
against the C5aR receptor. The presentation will provide details on the
analytical strategies, assays applied and ADA characterizations, as well as the
impact on clinical measures of pharmacokinetics and pharmacodynamics.
12:40 End of Immunogenicity Assessment Clinical Relevance
November 17-18, 2015
Lead Sponsoring Publications Web Partners
Sponsoring Publications
6. 6 | ImmunogenicitySummit.com
Immunogenicity Prediction Mitigation
Identification of Risk Factors and Tolerogenic Approaches
WEDNESDAY, NOVEMBER 18
1:00 pm Conference Registration
2:00 Chairperson’s Opening Remarks
Stephan Kontos, Ph.D., Co-Founder, Director, Research, Anokion
RISK ASSESSMENT
2:05 Evaluating Relative Risk of Immunogenicity of
Biotherapeutics with Chemical Modifications and Impurities
Marisa Joubert, Ph.D., Senior Scientist, Process Development, Amgen, Inc.
We have investigated the potential biological impact of different product
quality attributes, including oxidation of amino acid residues and the level of
host cell impurities, in an in vitro comparative immunogenicity assessment
(IVCIA) assay. The results highlight the relative risk of immunogenicity of
product specific factors and point to a dependency on multiple parameters
including the type of attribute, amount of attribute, the presence of multiple
attributes, and the immune status and medication regimen of the individual.
FEATURED PRESENTATION
2:35 Development of Mechanistic Models for the Prediction of
Immunogenicity Outcomes in the Clinic
Tim Hickling, Ph.D., Associate Research Fellow,
Pharmacokinetics, Dynamics and Metabolism, Pfizer, Inc.
This presentation will describe a mathematical approach to
quantitatively forecasting the outcome of immunogenicity in
clinical trials. A generic model will be described that incorporates
immunogenicity risk assessment data, e.g. Epitopes, patient HLA-type,
ADA assay characteristics (Sensitivity/Drug-tolerance). A case study will
be presented with fitted clinical data to demonstrate predictive capability.
Application of this approach in the context of inflammatory disease and to
other therapeutic areas will be discussed.
3:05 Relevance of Animal Models for Immunogenicity Prediction
Jack Ragheb, Ph.D., Principal Investigator, Therapeutic Proteins, CDER/FDA
The immunogenicity of therapeutic proteins in humans cannot be assessed by
testing these drug products in non-human species as the immune system can
distinguish orthologous proteins as foreign and will mount an immune response.
The recent advent of humanized mice may represent a relevant preclinical model
for in vivo testing of the human immunogenicity of a therapeutic protein.The
qualification of such a model should lead to identification of critical attributes
responsible for immunogenicity, permitting the design of suitable control
strategies that ensure product quality and mitigate risk.
3:35 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break in the Exhibit Hall with Poster Viewing
FACTORS CONTRIBUTINGTO IMMUNOGENICITY
4:30 Innate Immune Response Modulating Impurities in
Therapeutic Proteins
Daniela Verthelyi, M.D., Ph.D., Chief, Immunology Lab, CDER/OBP/FDA
Therapeutic proteins can contain impurities derived from the cell substrate and
the manufacturing process that have the potential to activate innate immune
cells fostering product immunogenicity. This talk will describe different
approaches for the detection of innate immune response modifying impurities
in therapeutic proteins and discuss how that may inform immunogenicity risk
assessments, particularly in the context of comparability exercises.
5:00 Immunogenicity ofTherapeutic Proteins: Impact of
Aggregates, Glycosylation and Other Post-Translational
Modifications.
Naren Chirmule, Ph.D., Vice President, Scientific Research, Biocon
During the manufacturing of protein therapeutics several post translational
modifications occur, the majority of which have been attributed to
immunogenicity risk potential. A systematic analysis of various critical
quality attributes such as aggregation, glycosylation etc. has been studied.
This presentation will focus on comparing the impact of different types
of aggregates on immune activation. These observations may inform the
monitoring approaches of these aggregates during process development.
5:30 Immunogenicity of Sub-Visible Particles:
Are We Barking Up the WrongTree?
Atanas Koulov, Ph.D., Group Head, Pharma Technical Development Europe
(Biologics), Analytics, F. Hoffmann-La Roche Ltd.
This presentation will discuss our recent findings using an IgG1 transgenic
mouse model and newly developed methods for particle fractionation and
selective particle modification. Using chemically characterized and well-defined
size-fractions of subvisible particles afforded interrogation of the factors
governing potential break of immune tolerance. Our findings demonstrate
that only particles that are heavily modified chemically (oxidized) can break
immune tolerance in this transgenic mouse model, whereas unmodified
particles cannot.
6:00 End of Day One of Immunogenicity Prediction Mitigation
6:00 Dinner Short Course Registration
6:30 – 9:30 Dinner Short Courses*
SC3: Immunogenicity Risk Assessment and Regulatory
Strategy
SC4: Strategic Bioassay Design and Analysis
*Separate registration required. See page 3 for details.
THURSDAY, NOVEMBER 19
TOLERANCE INDUCTION
7:30 am Registration and Morning Coffee
8:00 am Chairperson’s Remarks
Marisa Joubert, Ph.D., Senior Scientist, Process Development, Amgen, Inc.
8:05 Anti-Drug Antibody – A Challenge in the Field ofTherapeutic
Proteins, Lessons Learned from Pompe Disease; Immune
Tolerance Induction in ERT
Zoheb Kazi, MBBS, Postdoctoral Research Associate, Pediatrics/Medical
Genetics, Duke University Medical Center
Cross-Reactive Immunological Material (CRIM) -negative (CN) and a subset of
CRIM-positive (CP) Infantile Pompe disease (IPD) mount an immune response
against enzyme replacement therapy (ERT) resulting in clinical decline.
Prophylactic immune tolerance induction (ITI) protocol has prevented immune
responses in CN patients treated with ERT. We will present data on the safety
and efficacy of ITI approaches for CP and CN IPD receiving ERT.
KEYNOTE PRESENTATION:
8:35 Addressing Immunologic Sabotage of Dystrophin
ReplacementTherapies in Duchenne Muscular Dystrophy
Amy S. Rosenberg, M.D., Division Director, Office of
Biotechnology Products, FDA
Clinical investigation for more definitive treatment of
Duchenne Muscular Dystrophy (DMD), will only meet with
success by addressing key immunologic features of the
disease: the profound inflammatory response in DMD muscle mediated
by innate immune system elements and the preexisting or potential
cellular immune response to dystrophin, mediated by CD8+ and CD4+ T
cells. Thus, taming inflammation is essential not only to reducing muscle
cell loss and fibrosis per se, but as well to facilitate induction of immune
tolerance to dystrophin by facilitating the conversion to, recruitment of, and
function of regulatory T cells (Tregs).
November 18-19, 2015
7. ImmunogenicitySummit.com | 7
Immunogenicity Prediction Mitigation
Identification of Risk Factors and Tolerogenic Approaches
9:05 Tools andTechnologies for Comprehensive Sponsored by
Immunogenicity Risk Management
Emilee Knowlton, D.Phil., Immunology Sales Specialist, ProImmune
Immunogenicity is a very complex issue to address in drug design and
development. An overview of the best tools for immunogenicity risk mitigation
will be provided, including Mass Spectrometry antigen presentation assays, DC-T
cell assays to measure responses to fully formulated biologics, HLA-peptide
Binding Assays, and naïveT cell Proliferation Assays to characterize individual
epitopes. How the potential risk of first infusion reactions can be mitigated using
whole-blood cytokine release assays will also be described.
9:35 Problem Solving Roundtable Discussions
Table 1: Potential Immunogenic Risk of Drug Product Formulations
Moderator: Marisa Joubert, Ph.D., Senior Scientist, Process Development,
Amgen, Inc.
Table 2: Current and EmergingTools: Selecting Candidates and
Predicting Clinical Outcome
Moderator: Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics,
Dynamics and Metabolism, Pfizer, Inc.
Table 3: Protein DesignTools for Biotherapeutic Deimmunization
Moderator: Karl Griswold, Ph.D., Associate Professor, Thayer School of
Engineering, Dartmouth
Table 4: Progress towards Inducing ImmunologicalTolerance to
Biotherapeutics
Moderator: Stephan Kontos, Ph.D., Co-Founder, Director, Research, Anokion
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
ROLE OF B ANDT CELL EPITOPES
11:15 Decreasing Immunogenicity of Recombinant Immunotoxins
by Identifying and Modifying B andT Cell Epitopes
Ira Pastan, M.D., Co-Chief, Molecular Biology, National Cancer Institute,
National Institutes of Health
Recombinant Immunotoxins are chimeric proteins designed to kill cancer
cells. They consist of an Fv or Fab that binds to the cancer cell and a portion
of pseudomonas exotoxin A that kills the cell. RITs have shown anti-tumor
activity in some leukemias and in mesothelioma, but antibody formation limits
the amount that can be given. We have developed experimental approaches
to identify and remove T and B cells while maintaining high cytotoxic activity.
Clinical trials with one of these have recently opened.
11:45 Design and Development of Deimmunized Lysostaphin for
Treatment of Drug-Resistant Staphylococcus aureus Infections
Karl Griswold, Ph.D., Associate Professor,Thayer School of Engineering, Dartmouth
Using advanced protein design algorithms, predicted T cell epitopes were
depleted from lysostaphin, a potent antibacterial drug candidate that
exhibits undesirable immunogenicity. Aggressively deimmunized variants
rescued humanized mice from recurrent infection by methicillin-resistant
Staphylococcus aureus, whereas wild type lysostaphin failed due to high
anti-drug antibody titers. These controlled experiments in a clinically relevant,
immunocompetent disease model demonstrate for the first time that T cell
epitope depletion enhances therapeutic efficacy.
12:15 pm DesigningTherapeutic Drugs with Reduced
Immunogenicity
Mark Fogg, Ph.D., Group Leader, Immunology, Abzena
The importance of T cell help has been widely accepted as a significant risk
factor in the development of anti-drug antibodies (immunogenicity). Case
study data will be presented on the deimmunisation of naturally immunogenic
non-human protein therapeutics.
12:45 Luncheon Presentation (Sponsorship Opportunity Available)
or Lunch onYour Own
1:15 Cupcakes and Coffee in the Exhibit Hall with Poster Viewing
DEIMMUNIZATION ANDTOLERANCE MECHANISMS
2:00 Chairperson’s Remarks
Tim Hickling, Ph.D., Associate Research Fellow, Pharmacokinetics, Dynamics
and Metabolism, Pfizer, Inc.
2:05 Controlling Antibody Responses by Engaging CD22
Matthew Macauley, Ph.D., Assistant Professor, Chemical Physiology, Scripps
Research Institute
CD22 is an inhibitory B-cell co-receptor that recognizes glycans. We have
shown that co-engaging it with the B-cell receptor (BCR) induces antigen-
specific B-cell tolerance. This was first demonstrated using liposomes that co-
present a high affinity CD22 and antigen. More recently, we have developed a
cell-based platform that takes advantage of these same principles.
2:35 Creating Biologics Drugs with Improved Efficacy and Safety
Profiles by Preventing Anti-Drug Antibodies withTolerogenic
Nanoparticles
Kei Kishimoto, Ph.D., CSO, Selecta Biosciences
Anti-drug antibodies (ADAs) can adversely affect the safety and efficacy
of biologic drugs. We will describe the development of Synthetic Vaccine
Particles (SVPs) for the induction of antigen-specific tolerance to prevent
ADAs, using coagulation Factor VIII for the treatment of haemophilia A and
pegylated uricase for the treatment of refractory gout as case examples.
3:05 Induction ofTolerance Using Engineered RegulatoryT and
CytotoxicT Cells with Chimeric Antigen Receptors
David W. Scott, Ph.D., Professor and Vice Chair for Research, Department of
Medicine (MED), Uniformed Services University of Health Sciences
Human T cells engineered to express chimeric antigen receptors (CARs)
have been utilized to successfully target cancer cells. We have adapted
this approach to create specific T regulatory cells using both CARs and
chimeric T-cell receptors from patients in two disease models. Application
of engineered T cells to modulate adverse antibody responses in hemophilia
and pathogenic responses to CNS proteins will be presented. Prospects with
engineered cytotoxic cells will be discussed.
3:35 Inducing ImmuneTolerance to Highly ForeignTherapeutics
by Engineering for Erythrocyte Binding
Stephan Kontos, Ph.D., Co-Founder, Director, Research, Anokion
We sought to develop a recombinant, translational approach that exploits
the tolerogenic potential of apoptotic cells without the need to manipulate
cells themselves, with the goal of inducing antigen-specific tolerance to
immunogenic therapeutics. In engineering erythrocyte-binding domains into
the chemotherapeutic E. coli enzyme asparaginase, we show that in addition
to greatly enhancing PK and PD profiles, erythrocyte-binding drives potent,
long-lived antigen-specific humoral immune tolerance towards the therapeutic.
4:05 Close of Conference
November 18-19, 2015
High level presentations and well
organized: a perfect combination
to bring people together.
- Chloe A, ImmunXperts
8. 8 | ImmunogenicitySummit.com
Optimizing Bioassaysfor Biologics
Merging Biology and Statistics for Successful Biological Assay Development
WEDNESDAY, NOVEMBER 18
ADVANCES IN BIOASSAYTECHNOLOGIES
2:00 pm Chairperson’s Opening Remarks
Max L. Tejada, Ph.D., Senior Research Scientist II, Analytical Operations,
Gilead Sciences
2:05 Back to the Future, Envisioning the Next Generation
Bioassay Development
Ray Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb
Bioassay development requires a unique combination of techniques, from cell
line selection and generation, to assay design, validation and final testing. An
ideal bioassay needs to reflect true MOA, robust, sensitive and reproducible.
Our thoughts on a bioassay development incorporating advance technologies
from in house and vendors will be presented. Our ultimate goal is to develop a
system that will have broad and long lasting applications.
2:35 Development of Luminex as a Platform for the Detection of
Anti-Drug Antibody IgE Isotypes in Human Serum
LiNa Loo, Ph.D., Senior Scientist, Bioanalytical Development, Merck
Since biotherapeutic drugs such as monoclonal antibodies (mAbs) have the
potential to induce immunogenicity, it is critical to perform an immunogenicity
assessment to ensure drug efficacy and patient safety. Here, Luminex and
Mesoscale were evaluated as platforms for detection of anti-drug antibody
IgE isotype in human serum. By using a mouse-human chimeric drug-specific
monoclonal IgE antibody as the positive control, the assay characteristics
were compared for the two platforms.
3:05 Reporter Assays to Assess Effector Function
Shihua Lin, Ph.D., Analytical Biotechnology Development, MedImmune LLC
3:35 Sponsored Presentation (Opportunity Available)
3:50 Refreshment Break with Exhibit and Poster Viewing
POTENCYTESTING FOR GENE AND CELLTHERAPIES
4:30 Challenges in Potency Assay Development for a Non-
Replicating Lentiviral Vector
Brenna Kelley-Clarke, Ph.D., Scientist II, Assay Development, Immune Design
Immune Design has developed an HIV-1-based integration-deficient lentiviral
vector currently being evaluated in cancer immunotherapy (LV305). LV305 is
designed to transduce human dendritic cells, triggering presentation of an
encoded antigen via the MHC Class I pathway; this is proposed to elicit an
effective CD8-T lymphocyte response towards malignancies that over-express
that antigen. The biological complexity of LV305 and its proposed MOA pose
unique challenges in developing a potency assay matrix.
KEYNOTE PRESENTATION
5:00 A Regulatory Perspective for Development of Potency
Assay for Cellular and GeneTherapy Products: A Product
Lifecycle Approach
Xiaobin (Victor) Lu, Ph.D., CMC Reviewer, Division of Cellular
Gene Therapies, OCTGT, CBER, FDA
The challenges of developing a potency assay for a CGT are
multi-factorial including complexity of assay procedures,
inherent variability due to use of living cells, tissues or live
organisms, and variable reagents. Furthermore, a bioassay based potency
assay can be impacted by changes made in the product manufacturing
processes. This presentation will outline a product life-cycle approach
for developing potency assays for a CGT product from preclinical studies
to the Biological License Application. It will conclude with general
recommendations for addressing some of the challenges in potency assay
development and implementation for CGT during product and clinical
development programs.
ASSAY ACCEPTANCE CRITERIA
5:30 Assay Acceptance Criteria for Multiwell-Plate–Based
Biological Potency Assays
C. Jane Robinson, Scientific Liaison, Biopharmaceutical Emerging Best
Practices Association (BEBPA)
Following preliminary consultation, a draft white paper “Assay Acceptance
Criteria for Multiwell-Plate–Based Biological Potency Assays” was published
in 2014. In the subsequent extensive consultation process, a variety of issues
were raised and discussed, including a range of current practices. Some of
these issues and the recommendations of the white paper, including the two-
level sequential assessment of acceptance criteria and use of an assay control
sample, will be presented.
6:00 End of Day One of Optimizing Bioassays for Biologics
6:00 Dinner Short Course Registration*
6:30-9:30 SHORT COURSE:
Strategic Bioassay Development and Design
Instructor: Liming Shi, MS, MA, Senior Research Scientist, Bioassay
Development, Eli Lilly and Company
*Separate registration required. See page 3 for details.
THURSDAY, NOVEMBER 19
DEVELOPING ASSAYS FOR MULTIPLE
MODES OF ACTION
7:30 am Registration and Morning Coffee
8:00 am Chairperson’s Remarks
Liming Shi, MS, MA, Senior Research Scientist, Bioassay Development, Eli
Lilly and Company
8:05 Bioassay Development for Bispecific Antibodies: A Different
Ball Game
Piyush M. Vyas, Ph.D., Research Scientist, Bioassay Development, Eli Lilly and
Company
Bispecific Antibodies are evolving rapidly and are already in stages for
clinical trials. Some of these Bispecific Antibodies have shown synergy in
their biological activity as compared to the combination of their individual
counterparts. Bioassay development and Data analyses for such Bispecific
Antibodies to show the synergy, is a complex process. Traditional data
analyses approaches might not be suitable enough in order to analyze such
data. Data analyses of such Bispecific Antibodies need to be approached in a
different way.
8:35 Regulated ADC Bioanalysis Using Ligand Binding Assays:
Challenges and Strategies
Seema Kumar, Ph.D., Principal Scientist, Pfizer, Inc.
The complex multi-component structure in combination with heterogeneous
and dynamically evolving behavior presents unique challenges in ADC
bioanalysis. The challenges may vary depending on the objective of ADC
bioanalysis. The case studies showcasing various bioanalytical strategies that
could be employed in developing and validating successful ligand binding
assays for ADC characterization will be presented.
9:05 Critical Success Factors for Cell-Based
Assay Development andTransfer
Sponsored by
John Kamerud, Ph.D., Scientific Director, Eurofins
Method development or transfer must occur before a CRO validates an assay.
The development / transfer of complex methods that involve the use of cell
lines require specific criteria to be evaluated to ensure the success of the assay.
In particular, the growth characteristics of the cell line, culture conditions, cell
banking requirements, assay format, readout, reagents and data interpretation
should be evaluated and controlled to ensure a robust path to validation.
November 18-19, 2015
9. ImmunogenicitySummit.com | 9
Optimizing Bioassaysfor Biologics
Merging Biology and Statistics for Successful Biological Assay Development
9:35 Problem Solving Roundtable Discussions
Table 5: Incorporating NewTechnologies into Bioassay
Development
Moderator: Ray Zhang, Ph.D., Research Investigator, Bristol-Meyers Squibb
Table 6: Challenges in Assay Bridging
Moderator: Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics
Biotechnology, United States Pharmacopeia
Table 7: MethodTransfers
Moderator: Max L. Tejada, Ph.D., Senior Research Scientist II, Analytical
Operations, Gilead Sciences
10:35 Coffee Break with Poster Viewing
PROCESS COMPARABILITY AND CHARACTERIZATION
11:15 Use of aTiered Approach to Develop Robust Potency
Assays in Support of Monoclonal Antibody Product Development
Laura Geagan, Principal Research Associate, Bioanalytical Development, Genzyme
Cell-based assays are often used for evaluating the potency of biological
therapeutics during product development. The development of cell-based methods
frequently coincides with the stage of development of the product they support.
Early stage assays are often required to provide meaningful data to support
process, purification and formulation development at a time when optimization of
the method is not complete. As the drug progresses through the development
paradigm, the performance of the cell-based potency assay improves as well. In
this presentation we describe a tiered approach to develop a robust cell-based
potency assay to support pre-clinical product development. The analysis paradigm
was updated as the drug progressed into Phase I for consistency with guidance
provided in USP chapters 1032-1034.The use of the assay to support process
development will be discussed.
11:45 Late Breaking Presentation
12:15 pm Sponsored Presentations (Opportunities Available)
12:45 Luncheon Presentation (Sponsorship Opportunity Available)
or Lunch onYour Own
1:15 Cupcakes and Coffee in the Exhibit Hall with Poster Viewing
BRIDGING STUDIES AND ASSAYTRANSFER
2:00 Chairperson’s Remarks
2:05Transfer and Validation of a Cell-Based Neutralizing Antibody
(NAb) Assay to a CRO
Florence Guilhot, Ph.D., Head,Translational Pharmacology Lab, NovImmune SA
Biotherapeutics can lead to the production of anti-drug antibodies (ADA) in treated
subjects which may result in loss of efficacy or elicit adverse events. Standard
immunoassays can detect ADA, but cannot differentiate between neutralizing and
non-neutralizing ADA. Development of a neutralizing antibody (NAb) assay is a key
step to support clinical trials.This presentation will provide an overview of (i) assay
characteristics of the functional reporter NAb cell-based assay (ii) challenges for
the transfer and validation of a NAb assay to support the clinical trial.
2:35 Leveraging Automated Liquid Handlers, High-Density Plates,
and Multi-Dimensional Assay Optimization to Accelerate the
Delivery of Neutralizing Antibody Bioassay
John M. Lehrach, Research Scientist II, Bristol-Meyers Squibb
BMS Core BioAssay Group (CBG) leveraged the cellular assay repertoire,
cell inventory, and the detection technology platforms in Leads Discovery
and Optimization (LDO) Department to perform automation assisted multi-
dimentional optimization for the development of a Nab Bioassay. BMS
informatics tools enabled automated data analysis. The technology platform
selected was a homogenous cAMP HTRF assay. CBG delivered a 96-well
format Nab assay with excellent Nab sensitivity, assay reproducibility, and
serum tolerance utilizing assay-ready cryo cells.
KEYNOTE PRESENTATION
3:05 Compendial Potency Assays and Associated Biological
Reference Materials – Challenges in Assay Bridging
Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics
Biotechnology, United States Pharmacopeia
USP, regulators, and manufacturers share a common goal
of reducing in vivo testing, yet replacing animal assays with
suitable in vitro assays may be challenging. This presentation
will highlight USP’s current efforts to include modern bioassays in the USP-
NF as well as bridging expectations for revision sponsors who would like to
propose a modern assay for the compendium.
3:35 Global BioassayTransfers
Camille Dycke, Ph.D., F. Hoffmann-La Roche Ltd. / Genentech; Associate
Director, Method Management andTechnologies, Bioassay, Global Biologics QC
To support global product release, the bioassay used in the commercial
control system of the product is transferred to multiple QC testing laboratories
around the globe. In order to facilitate these global method transfers, the
implementation of global processes, a global training plan and a solid method
life cycle management program, are key elements to ensure success. A few
case studies will be presented, illustrating product globalization.
4:05 Close of Conference
November 18-19, 2015
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