@CagedLionPhilos - The Philosophy of a Caged Lion
BILL GATES' HONEYPOT
💸🩸🧬⚗️🧪🧫💉☠️💸
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
In other words, they want to harmonize you to their agenda, which is death.
✅Murray Lumpkin - FDA Center for Drug Evaluation and Research (CDER), Bill & Melinda Gates Foundation
Studied Medical Parasitology & Tropical Medicine
✅Ms. Yoongthong - FDA/WHO/ASEAN
Master of Science in Epidemiology from Harvard
✅Dr. Axelrod 🇮🇱- Immunological research in Israel and the US
✅Ms. Flavia Firmino - Pfizer Director of CMC (Chemistry, Manufacturing & Controls)
The ICH is made up of members from:
The Bill & Melinda Gates Foundation, Health Canada, European Commission (Unit B5), European Medicines Agency, Vaccines Europe, Japan Pharmaceutical Manufacturers Association, Pan American Health Organization, WHO, (global) Food and Drug Administrations, Office of Surveillance and Epidemiology, Pharmaceutical Research and Manufacturers of America (PhRMA), Christ AG (water purification systems).
GlaxoSmithKline, Pfizer, CSL Vifor, Krka, Eisai, Genentech Roche, F. Hoffmann-La Roche AG, TransCelerate Biopharma, Accumulus Synergy, Novartis and Zentiva Pharmaceuticals.
Red Cross, Octapharma, Biovitrum, Pharmacia Plasma Products, American Association of Blood Banks, International Society of Blood Transfusion, International Haemovigilance Network.
UNICEF, United Nations High Commissioner for Refugees (UNHCR), ISB-Kellogg, BIO, BioGen, National Human Genome Research Institute, NIH, American Heart Association, American Society of Human Genetics, Carnegie Mellon University, Princeton, Harvard, Cornell, Bloomberg School of Public Health of the Johns Hopkins University.
...with representatives from almost every Nation.
Observers 🧐
https://ich.org/page/observers
Full Member List
https://ich.org/page/members
James Lind Institute - Switzerland 🇨🇭
https://jliedu.com/blog/ich-is-now-international-council-on-harmonisation-a-legal-swiss-entity/
Biotechnology Innovation Organization
https://bio.org
BioGen
https://investors.biogen.com/news-releases/news-release-details/biogen-and-therapanacea-announce-new-collaboration-potential
@CagedLionPhilos - The Philosophy of a Caged Lion
✅️Dr. Theresa Mullin - SES [Keystone] Award, Patient-Focused Drug Development, FDA Reauthorization Act, 21st Century Cures Act
✅️Dr. Barbee Whitaker - Lead Scientist at Office of Biostatistics and Epidemiology 🩸🩸🩸
✅️Pär Tellner - The Vampire of the Ghettos 🩸🩸🩸
✅️Dr. Bruno Sepodes - Chair of the Committee of Orphan Medicinal Products. Was awarded the “EURORDIS Leadership Black Pearl Award” on Rare Diseases
PRIONS???
Questionabe areas of research....
Chimeric Antigens:
Chimeric antigen receptors (CARs) are engineered receptor proteins that enable T cells to target specific antigens on cancer cells. CAR T-cell therapy involves modifying a patient's T cells to express these receptors, allowing them to recognize and destroy cancer cells. This therapy has shown promise in treating certain leukemias, lymphomas, and myelomas by targeting antigens like CD19 on tumor cells. The process includes collecting T cells from the patient, genetically engineering them, expanding their numbers, and then infusing them back into the patient to attack the cancer.
Epithelial Tight Junction Biology:
Tight junctions (TJs) are specialized structures found in epithelial and endothelial cells, forming a barrier that regulates the passage of molecules between cells. They are composed of multiprotein complexes, including claudins, occludins, and junctional adhesion molecules, which interact with cytoskeletal and signaling proteins to maintain cell polarity and tissue homeostasis.
TJs play crucial roles in various physiological processes, including maintaining the Blood-Brain Barrier, preventing leakage in the mammary gland during lactation, and regulating intestinal permeability. Disruption of TJs can lead to diseases such as cancer, diabetes, and inflammatory conditions.
Chimeric Antigen Receptor T-Cell Therapy - StatPearls - NCBI https://www.ncbi.nlm.nih.gov/books/NBK537294/
Chimeric Antigen Receptor (CAR) T-Cell Therapy https://www.lls.org/treatment/types-treatment/immunotherapy/chimeric-antigen-receptor-car-t-cell-therapy
CAR T Cells: Engineering Immune Cells to Treat Cancer - NCI https://www.cancer.gov/about-cancer/treatment/research/car-t-cells
The Organization of Tight Junctions in Epithelia: Implications ... - NCBI https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2933220/
Tight Junctions - Epithelial Cells - Biology - Davidson College https://www.bio.davidson.edu/bernd/Lab/EpithelialInfoWeb/Tight%20Junctions.html
A short guide to the tight junction | Journal of Cell Science https://journals.biologists.com/jcs/article/137/9/jcs261776/347159/A-short-guide-to-the-tight-junction
@CagedLionPhilos - The Philosophy of a Caged Lion
How to hide Crimes Against Humanity data?
CONTROL EVENT MONITORING AND SURVEILLANCE
Data Mining and Social Media Analysis
Recommendations for the Use of Social Media in Pharmacovigilance https://pubmed.ncbi.nlm.nih.gov/31446567/
ARISg and Argus are both prominent pharmacovigilance databases used in the pharmaceutical industry for managing safety data.
Oracle Argus:
- A leading pharmacovigilance database offering global case processing, signal detection, detailed analytics, and electronic reporting in E2B(R2) and E2B(R3) formats.
- Features include risk management, periodic reporting, and the capacity to handle large volumes of cases, making it suitable for large pharmaceutical companies.
ArisGlobal ARISg/LifeSphere Safety:
- Another market-leading pharmacovigilance database with a comprehensive suite of functionalities.
- Covers various aspects of pharmacovigilance, regulatory, medical affairs, and clinical solutions.
- Known for its established popularity and options for configuration and integration with other modules and systems.
IMI WEB-RADR
The IMI WEB-RADR (Recognising Adverse Drug Reactions) project was launched in September 2014 as part of the European Union's Innovative Medicines Initiative. Its primary goal was to leverage social media and new technologies for pharmacovigilance purposes.
Key aspects of the WEB-RADR project include:
1. Development of mobile applications for patients, caregivers, and healthcare professionals to report adverse drug reactions (ADRs) and receive safety information.
2. Exploration of social media data for identifying adverse events and safety signal detection.
3. Creation of a collaborative workspace for visualizing and analyzing social media data related to medicinal products.
4. Development of novel text and data mining methods for social media analysis.
The project resulted in several outcomes:
- Country-specific mobile apps launched in the UK, Netherlands, and Croatia.
- A generic multi-country version called the Med Safety app, adopted in several African countries[2].
- Recommendations for using social media in pharmacovigilance.
- Guidelines for developing and implementing mobile apps for pharmacovigilance.
WEB-RADR involved collaboration between various partners, including pharmaceutical companies, regulatory agencies, academic institutions, and patient organizations. The project was supported by the Innovative Medicines Initiative Joint Undertaking under grant agreement n° 115632.
PV SOFTWARES - Fineness Institute Of Clinical Research https://www.finenessinstitute.com/pv-softwares/
Pharmacovigilance Safety Database - Quanticate https://www.quanticate.com/pharmacovigilance-safety-database
ArisGlobal Enables Biotechnology Firm to Triage Inbound Adverse ... https://www.arisglobal.com/safety-case-study/arisglobal-enables-mid-tier-biotechnology-company-triage-inbound-adverse-event-reports/
Argus | Oracle https://www.oracle.com/life-sciences/pharmacovigilance/argus-safety-case-management/
Oracle Data Migration - Valiance Partners https://www.valiancepartners.com/gxp-systems/oracle-argus-safety-data-migration/
WEB-RADR 1 https://web-radr.eu/web-radr-1/
WEB-RADR https://web-radr.eu
Lessons from IMI WEB-RADR - PubMed https://pubmed.ncbi.nlm.nih.gov/30911975/
WEB-RADR | IMI Innovative Medicines Initiative - European Union imi.europa.eu/projects-resul…
