This document summarizes the ABIRISK project, which aims to better understand and predict anti-drug antibody (ADA) responses to biopharmaceutical drugs. The project brings together various experts and stakeholders to develop standardized ADA assays, characterize the mechanisms underlying immunogenicity, evaluate predictive tools, and develop models and clinical data integration to predict ADA occurrence and impact. The goal is to provide science-based guidance to reduce immunogenicity testing burden during drug development and improve patient care and outcomes.
We have 13 research and development projects within:
• Research
• Oncology
• Respiratory, Inflammation and Autoimmunity
• Cardiovascular and Metabolic Disease
• Antibody Discovery and Protein Engineering
• Pathology
• Biopharmaceutical Development
• Cell Culture and Fermentation Sciences
• Formulation Sciences
• Analytical Biotechnology Science
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We have 13 research and development projects within:
• Research
• Oncology
• Respiratory, Inflammation and Autoimmunity
• Cardiovascular and Metabolic Disease
• Antibody Discovery and Protein Engineering
• Pathology
• Biopharmaceutical Development
• Cell Culture and Fermentation Sciences
• Formulation Sciences
• Analytical Biotechnology Science
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Shows the latest developments in pharmaceutical biotechnology and provides a broad overview of biotherapeutic & biosimilar regulations globally and in the EU
Cancer immunomodulators market & pipeline insight 2020KuicK Research
"Cancer Immunomodulators Market & Pipeline Insight 2020" Report Highlights:
Introduction & Need of Cancer Immunomodulators
Cancer Immunomodulators Mechanism
Cancer Immunomodulators Clinical Pipeline By Company, Indication & Phase
Cancer Immunomodulators Clinical Pipeline: 747 Cancer Immunomodulators Drugs
Majority Cancer Immunomodulators in Preclinical Phase: 300 Marketed Cancer Immunomodulators Clinical Insight
Marketed Cancer Immunomodulators: 47
Cancer Immunomodulators Drug Patent Analysis
Presentation at Advanced Intelligent Systems for Sustainable Development (AISSD 2021) 20-22 August 2021 organized by the scientific research group in Egypt with Collaboration with Faculty of Computers and AI, Cairo University and the Chinese University in Egypt
Leading Molecules to Market - An overview on licensingBananaIP Counsels
Leading Molecules to Market - An overview on licensing
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
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The difference between medical device product development and pharmaceuticals that are supposed to be launched are based on industry composition where above 80% small and medium-sized companies require medical devices and large multinational organizations seek new medicines. Pepgra gives you the different stages of Medical Device Development and Drug Development, some are:
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International Journal of Engineering and Science Invention (IJESI) is an international journal intended for professionals and researchers in all fields of computer science and electronics. IJESI publishes research articles and reviews within the whole field Engineering Science and Technology, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
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After spending 12 years in Philadelphia World Pharma Congress is moving to Boston, which is buzzing with new findings and technologies that can potentially revolutionize the way in which traditional preclinical drug discovery is done. World Pharma Congress 2014 will provide a forum for scientists and clinicians to meet to exchange ideas and launch collaborations. Coverage includes: Tumor Models for Targeted Therapy, Tumor Models for Cancer Immunotherapy, Imaging in Oncology, In Vitro Tumor Models, Preclinical Drug Safety, Epigenetics Screening, Formulation & Drug Delivery, Process Chemistry and Targeting Pain. For event updates and the full speaking faculty list, visit http://www.worldpharmacongress.com
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Precision medicine is an emerging strategy that considers individual variability in genes, environment, and lifestyle to diagnose, treat, forecast, and prevent disease. As regulatory health authorities begin to develop clearer regulatory pathways in precision medicine, industries must prepare to swiftly adopt to any regulatory changes. This white paper aims to provide a broad overview on the following key topics in precision medicine:
1. Genomics and Pharmacogenetics
2. Precision Medicine vs Personalized Medicine
3. Foundation of Precision Medicine as A Treatment Tool
4. Examples of Precision Medicine as A Treatment, Predictive, and Preventative Tool
5. Precision Medicine and Cancer
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Presentation at Advanced Intelligent Systems for Sustainable Development (AISSD 2021) 20-22 August 2021 organized by the scientific research group in Egypt with Collaboration with Faculty of Computers and AI, Cairo University and the Chinese University in Egypt
Leading Molecules to Market - An overview on licensingBananaIP Counsels
Leading Molecules to Market - An overview on licensing
Contact Us for Intellectual Property Services
BananaIP Counsels
Regd Office
No.40,3rd Main Road,JC Industrial Estate,
Kanakapura Road,Bangalore – 560 062.
Email: contact@bananaip.com
Telephone: +91-80-26860414 /24/34
Personalized medicine involves the prescription of specific therapeutics best suited for an individual based on their genetic or proteomic profile. This talk discusses current approaches in drug discovery/development, the role of genetics in drug metabolism, and lawful/ethical issues surrounding the deployment of new health technology.
Regulatory requirements for drug approval unit3Aman chourasia
New Drug Application (NDA) is an application submitted to the individual regulatory authority for authorization to market a new drug i.e. innovative product. To gain this permission a sponsor submits preclinical and clinical test data for analyzing the drug information, description of manufacturing trials.
Computational Prediction for Antibiotics Resistance Through Machine Learning ...CrimsonpublishersCJMI
Computational Prediction for Antibiotics
Resistance Through Machine Learning and Pk/Pd
Analysis by Hyunjo Kim in Cohesive Journal of Microbiology & Infectious Disease
Different Stages of Medical Device Development and Drug Development: PepgraDi...PEPGRA Healthcare
The difference between medical device product development and pharmaceuticals that are supposed to be launched are based on industry composition where above 80% small and medium-sized companies require medical devices and large multinational organizations seek new medicines. Pepgra gives you the different stages of Medical Device Development and Drug Development, some are:
1. Lead discovery optimization
2. Pre-clinical Research
3.. Clinical Research
4. Post- Market safety monitoring
Continue Reading: https://bit.ly/3ryCQC4
Youtube: https://www.youtube.com/watch?v=cYz_BOArGhA
If you need any further information, then please contact via
Email us: sales.cro@pepgra.com
Whatsapp: +91 9884350006
Clinical Pharmacology in Orphan Drug DevelopmentE. Dennis Bashaw
This is the fourth talk that I gave in Asia back in May. It was presented at the Konect (Korea National Enterprise for Clinical Trials) 3rd symposia that was held in Seoul at Seoul National University.
A provider of contract pharma services in high potent manufacturing, Alkermes Contract Pharma Services, outlines here some of the elements that should be considered by a Sponsor/Donor Pharmaceutical company when outsourcing secondary processing (i.e. dosage form transfer, scale-up and commercial manufacture) of a highly potent product.
In silico Drug Design: Prospective for Drug Lead Discoveryinventionjournals
International Journal of Engineering and Science Invention (IJESI) is an international journal intended for professionals and researchers in all fields of computer science and electronics. IJESI publishes research articles and reviews within the whole field Engineering Science and Technology, new teaching methods, assessment, validation and the impact of new technologies and it will continue to provide information on the latest trends and developments in this ever-expanding subject. The publications of papers are selected through double peer reviewed to ensure originality, relevance, and readability. The articles published in our journal can be accessed online.
13th Annual World Pharma Congress [Full Agenda]Jaime Hodges
After spending 12 years in Philadelphia World Pharma Congress is moving to Boston, which is buzzing with new findings and technologies that can potentially revolutionize the way in which traditional preclinical drug discovery is done. World Pharma Congress 2014 will provide a forum for scientists and clinicians to meet to exchange ideas and launch collaborations. Coverage includes: Tumor Models for Targeted Therapy, Tumor Models for Cancer Immunotherapy, Imaging in Oncology, In Vitro Tumor Models, Preclinical Drug Safety, Epigenetics Screening, Formulation & Drug Delivery, Process Chemistry and Targeting Pain. For event updates and the full speaking faculty list, visit http://www.worldpharmacongress.com
James T. Kenney, RPh, MBA, and Michael B. Atkins, MD, prepared useful Practice Aids pertaining to cancer immunotherapies for this CME/MOC/CE/CPE activity titled "Incorporating Cancer Immunotherapies Into the Oncology Treatment Arsenal in Managed Care Settings: Navigating the Complexities of Value Assessment & Cost Optimization in the Era of Immuno-Oncology." For the full presentation, monograph, complete CME/MOC/CE/CPE information, and to apply for credit, please visit us at http://bit.ly/2Er15gR. CME/MOC/CE/CPE credit will be available until December 23, 2019.
DIA China 2017 Optimizing Clinical Trials with Advanced ToolsE. Dennis Bashaw
This is the companion talk to one I posted yesterday. This is the Third of the talks that I gave in Asia back in May. Both this talk and the "Making Every Patient Count" presentation were part of a larger program at the DIA China Annual meeting.
The report “Chemiluminescence Immunoassay Market, By Product (Consumables, Instruments, Software & Services), By Application (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease, Autoimmune Disease), By End User (Hospitals and Clinics, Medical and Diagnostic Laboratories, Pharmaceutical and Biotechnology Companies, Research Institutes),and By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa) - Trends Analysis and Forecast till 2032 “
Precision medicine is an emerging strategy that considers individual variability in genes, environment, and lifestyle to diagnose, treat, forecast, and prevent disease. As regulatory health authorities begin to develop clearer regulatory pathways in precision medicine, industries must prepare to swiftly adopt to any regulatory changes. This white paper aims to provide a broad overview on the following key topics in precision medicine:
1. Genomics and Pharmacogenetics
2. Precision Medicine vs Personalized Medicine
3. Foundation of Precision Medicine as A Treatment Tool
4. Examples of Precision Medicine as A Treatment, Predictive, and Preventative Tool
5. Precision Medicine and Cancer
6. Challenges, Next Step & Opportunities in Precision Medicine
7. Regulatory insight on Precision medicine
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scientific represents to design genomic drugs. This new outline will drive the medical to discover public data
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Cancer immunomodulators market & pipeline insight 2020KuicK Research
"Cancer Immunomodulators Market & Pipeline Insight 2020" Report Highlights:
Introduction & Need of Cancer Immunomodulators
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Like personalized medicine, personalized vaccinology aims to provide the right vaccine, to the right patient, at the right time, to achieve protection from disease, while being safe (i.e., free from unintended side effects). Starting with these lines, this presentation will provide overall information related to the vaccinomoic along with the suitable examples and thus will be helpful for the students to understand the basics related to the same.
1. ANTI-BIOPHARMACEUTICAL
IMMUNIZATION- THE PROBLEM
A major limitation to the use of biopharmaceuticals
products (BPs) is the development of anti-drug
antibodies (ADA) in a subset of patients. ADA may
decrease the efficacy of BPs by neutralizing them or
modifying their clearance, and they may be associated
with BP-specific hypersensitivity reactions. ADA
may also cross-react with closely related endogenous
counterparts of BPs thereby compromising important
physiological functions.
Given this scenario, the prediction, prevention and
cure of anti-drug (AD) immunogenicity are thus
major goals in biopharmaceutical drug development
and patient safety.
Many factors contribute to the immunogenicity of
BPs. Some are related to the product itself, others to
its mode of administration and still others to the
underlying disease or the characteristics of patients.
Elucidating the significance of these factors and
their specific contribution to immunogenicity requires
a varied approach including: the development,
evaluation and standardization of new tools for
predicting and measuring AD immunization, the
testing of new concepts originating from basic
immunology that have not yet been translated into
clinical practice, the development of synthetic
predictive models condensing in a comprehensive
form all that is known about AD immunization and
their validation in a clinical setting. Improvements in
our understanding of AD immunization should also
lead to the production of guidelines for drug
development and the clinical care of patients.
ABIRISK FOCUS AND OUTCOME
ABIRISK Project aims to provide an integrated approach
to AD immunization, bringing together, in an
extensive and coordinated manner, a large network of
clinicians from various specialties with broad
experience in the care of patients treated with various
type of BPs and developing ADA, biologists familiar
with the immune monitoring of patients, scientists
specialized in the mechanisms of immunogenicity,
methodologists and biostatisticians. In addition the
collaboration with a large network of private
pharmaceutical industries under European Federation
of Pharmaceutical Industries and Associations (EFPIA),
will ensure direct transfer of the experimental findings
into BP development and patient management.
Collectively, this group will critically evaluate the
immunogenicity of existing BPs for Hemophilia A,
Multiple Sclerosis, and Inflammatory Diseases, and
develop standardized ADA assays, including
Neutralizing Antibody (NAb) Assays, for each BP.
Novel integrated approaches to characterize AD
lymphocyte responses will be used to provide
insight into the basic mechanisms by which BPs drive
immune cell activation. The predictive value of
existing as well as new tools used for prediction of
protein drug immunogenicity will be explored and
evaluated, including T cell assays, in silico prediction,
in vitro generated BP-derived agretopes generated
by processing in human dendritic cells, measurement
of peptide affinity for HLA class II molecules, modulation
of dendritic cell function and activation by BPs,
human in vitro mononuclear leukocytes assays, use of
artificial lymph nodes, animal models, and generation
of post-translational modifications and aggregates
and characterizing them in various models.
Collection and integration of immunogenicity-related
data and clinical relevance will be assembled into a
single immunogenicity databank that will be used to
The research leading to these results has received support
from the Innovative Medicines Initiative Joint Undertaking
under grant agreement n° [115303], resources of which are
composed of financial contribution from the European
Union's Seventh Framework Programme (FP7/2007-2013)
and EFPIA companies’in kind contribution.’
www.imi.europa.eu
ABIRISK ALLIANCE
The ABIRISK project consortium is presently made
up of thirty-eight partners, twenty-six of which are
academic institutions, nine are EFPIA member
companies and three are small and medium
enterprises (SMEs).
Thirteen countries are represented: The United
Kingdom, France, Italy, Germany, Switzerland,
Denmark, Belgium, the Netherlands, Spain, Sweden,
Austria, Israel and Czech Republic.
describe the natural history of the occurrence of ADA,
identify common and disease-specific/drug-specific
variables associated with immunogenicity/outcomes,
develop models that will predict occurrence of ADA,
presence or absence of subsequent clinical outcomes,
derivepredictivesignaturesforimmunogenicityphenotypes
(ADA or NAb) and immunogenicity-related-events,
and evaluate the operating characteristics of the
predictive signatures.
ABIRISK Project will investigate the correlation
between patient and clinical factors and the incidence
of immunogenicity. A major goal is to further
elucidate the underlying mechanisms of immunogenicity
and this may result in more science-based regulatory
guidelines, which may reduce the regulatory burden
for immunogenicity testing and save time and resources
in the BP drug development process.
PROJECT ORGANIZATION
2. EUROPEAN
COMMISSION
Total cost:
€34.9 million
IMI funding:
€18.2 million
EFPIA in kind contribution
€9.6 million
Anti-Biopharmaceutical
Immunization:
Prediction and Analysis
of Clinical Relevance
to Minimize
the Risk
EFPIA MEMBER COMPANIES
SMEs
ACADEMIC INSTITUTES
GlaxoSmithKline Research & Development Limited
United Kingdom
www.gsk.com
Johann Wolfgang Goethe Universität - Klinikum und
Fachbereich Medizin - Germany
www.kgu.de
Rambam Medical Center
Israel
www.rambam.org.il
Università di Firenze
Italy
www.unifi.it
Universitätsklinikum Düsseldorf
Germany
www.uniklinik-duesseldorf.de
University Hospital Basel
Switzerland
www.unispital-basel.ch
Paul-Ehrlich-Institut, Bundesinstitut für Impfstoffe
und biomedizinische Arzneimittel - Germany
www.pei.de
Klinikum rechts der Isar der Technischen
Universitaet Muenchen - Germany
www.med.tum.de
Karolinska Institutet
Sweden
ki.se
Medizinische Universität Innsbruck
Austria
www.i-med.ac.at
Queen Mary and Westfield - University of London
United Kingdom
www.qmul.ac.uk
Region Hovedstaden
Denmark
www.regionh.dk
Universitaetsklinikum Bonn
Germany
www.ukb.uni-bonn.de
University College London
United Kingdom
www.ucl.ac.uk
Univerzita Karlova v Praze
Czech Republic
www.cuni.cz
ALTA Ricerca e Sviluppo in Biotecnologie S.r.l.u
Italy
www.altaweb.eu
Biomonitor A/S
Denmark
www.biomonitor.dk
Bayer Pharma AG
Germany
www.bayer.com
IPSEN Innovation S.A.S
France
www.ipsen.com
Merck KGaA
Germany
www.merckserono.com
Novartis Pharma AG
Switzerland
www.novartis.com
Novo Nordisk A/S
Denmark
www.novonordisk.com
Pfizer Limited
United States
www.pfizer.com
Sanofi-Aventis Research and Development
France
en.sanofi.com
UCB Pharma S.A.
Belgium
www.ucb.com
Leids Universitair Medisch Centrum
the Netherlands
www.lumc.nl
Academisch Medisch Centrum
the Netherlands
www.amc.nl
Centre National de la Recherche Scientifique
France
www.cnrs.fr
DRK-Blutspendedienst Baden-Württemberg – Hessen
gemeinnützige GmbH - Germany
www.blutspende.de
Fondazione per l‘Istituto di Ricerca in Biomedicina
Switzerland
www.blutspende.de
Fundació Institut de Recerca de L'hospital Universitari
Vall D'hebron - Spain
www.vhir.org
Groupe d‘EtudesTherapeutiques des Affections
Inflammatoires duTube Digestif - France
www.getaid.org
Commissariat a L‘Energie Atomique et aux Energies
Alternatives- France
www.cea.fr
InstitutNationaldelaSantéetdelaRechercheMédicale
France
www.inserm.fr
Project Coordinator
Sebastian Spindeldreher
Novartis Institutes for BioMedical Research (NIBR)
Novartis Pharma AG
4002 Basel
Switzerland
sebastian.spindeldreher@novartis.com
Managing Entity for EU funds
Marc Pallardy
InstitutNationaldelaSantéetdelaRechercheMédicale
UMR 996, University Paris-Sud
32 rue des Carnets
92140 Clamart
France
marc.pallardy@u-psud.fr
www.abirisk.eu
EUROPEAN
COMMISSION
SciCross AB
Sweden
www.scicross.com
Chaim Sheba Medical Center
Israel
www.eng.sheba.co.il
Istituto Giannina Gaslini
Italy
www.gaslini.org
Assistance Publique-Hôpitaux de Paris
France
www.aphp.fr