Clinical Research Informer

Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Rethinking Clinical Trials

NOVEMBER 1, 2022

Department of Population Health Sciences. The HERO TOGETHER study leveraged the HERO Registry to estimate real-world incidence of safety events among vaccinated individuals. ? ? ? ? ? ?. Speakers. Emily O’Brien, PhD, FAHA. Associate Professor. Duke Clinical Research Institute. Duke University School of Medicine.

Trials

Trials Clinical Research Vaccination Vaccine

Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

Rethinking Clinical Trials

NOVEMBER 16, 2022

Associate Director, Center for Bioethics & Social Sciences in Medicine. clinicians, health systems), data may have been collective for administrative/clinical purposes, data may be more representative of “real world” conditions, and data may be controlled by a third party (e.g. Kayte Spector-Bagdady, JD, MBioethics.

Clinical Trials

Clinical Trials Clinical Trials Trials Research

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Rethinking Clinical Trials

AUGUST 28, 2023

The rapidly evolving ecosystem now relies on real-world data, which is becoming increasingly more advanced, and clinical trial design is becoming more complex and innovative. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Rethinking Clinical Trials

AUGUST 28, 2023

The rapidly evolving ecosystem now relies on real-world data, which is becoming increasingly more advanced, and clinical trial design is becoming more complex and innovative. Annex-2 of E6(R3) will include additional considerations of GCP principles focused on decentralized elements, pragmatic elements and real-world data sources.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)

Rethinking Clinical Trials

MARCH 28, 2023

It has grown to be a major force for supporting pragmatic research, both real-world evidence research and supporting observational research and pragmatic clinical trials. It is an independent, nonprofit, research institute and leading funder of patient-centered comparative clinical effectiveness research (CER).

Clinical Trials

Clinical Trials Clinical Trials Trials Research

What can pharma marketing learn from other regulated industries?

pharmaphorum

AUGUST 17, 2020

The financial world, like the pharmaceutical industry, must operate within a tightly-defined regulatory environment, and in doing so has proved adept at connecting with its customers. Joanna Carlish, managing director, financial services, Tag Americas. Joanna began her career at Tag as an Account Manager with Banco Santander in London.

Regulation

Regulation Marketing Sales Branding

New to ELRIG Drug Discovery 2022: Tech Theatre supported by DDW

Drug Discovery World

OCTOBER 3, 2022

Dr Yahya Anvar, Head of Data Science, OKRA.ai She also works on her own research following her PhD in the digitisation of scientific research, smart labs and the lab of the future, and semantic tagging of scientific data, which she has continued as part of the Physical Sciences Data Infrastructure (PSDI) Project.

Drugs

Drugs Scientist Bioinformatics Medicine

Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

OCTOBER 9, 2021

This designation is predicated on data showing that gantenerumab significantly reduced brain amyloid pillar, a pathological hallmark of Notice, in the ongoing SCarlet RoAD and Marguerite RoAD open- tag extension trials, as well as other studies.

Antibody

Antibody In-Vitro Trials Development

A history of Pfizer

pharmaphorum

DECEMBER 2, 2020

Here we take a look at the colourful history of one of the biggest drugmakers in the world. In 1919 their scientists pioneered mould fermentation production of citric acid from molasses, freeing their citric acid business from European citrus fruit supplies, which had been disrupted by the First World War.

Sales

Sales Production Drugs Marketing

Owkin taps Linux Foundation to open-source its AI learning software

pharmaphorum

NOVEMBER 28, 2022

Owkin is simultaneously releasing two other open-source projects: FLamby, a federated learning model-ready dataset that researchers can use to develop models before training them on other data sets, and SecureFedYJ, a tool for normalising real-world healthcare data while maintaining data privacy.

Pharma Companies

Pharma Companies Life Science Research Development

Sanofi offers refunds for Cablivi in novel model for rebates

Pharmaceutical Technology

JANUARY 27, 2023

Dr. James George, a research professor at the University of Oklahoma Health Sciences Center, said Cablivi “adds a new aspect to treatment, the prompt recovery of platelets and prompt resolution of transient neurologic symptoms”. The disorder has a reported annual incidence between 1.5 cases per million in Europe.

Manufacturing

Manufacturing Drugs Research Analyst FDA Approval

PentagonFit Fitness Tracker

The Pharma Data

MAY 15, 2021

Whatever you do, if you care about your health and freedom, don’t miss out on this opportunity to discover what might be the best weight loss and longevity solution in world history. I have spent over 7 years in the medical and biological sciences. We all know that real and lasting fat loss is so much more than just reducing calories.

Production

Production Containment Medicine Vaccination

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

MAY 4, 2021

In addition, we have achieved important clinical, regulatory and commercial milestones across our pipeline and portfolio while also continuing to increase our capacity to supply urgently-needed doses of BNT162b2 to the world. Hospital products, which grew 10% operationally to $2.3 down 7%, which reflects relatively stable U.S.

Vaccination

Vaccination Vaccine Production Sales

Clinical Research Informer

Grand Rounds October 28, 2022: The HERO (Healthcare Worker Exposure Response & Outcomes) Program: An Online Community to Support Observational Studies, Randomized Trials, and Long-Term Safety Surveillance (Emily O’Brien, PhD, FAHA; Russell Rothman, MD, MPP)

Grand Rounds Ethics and Regulatory Series November 11, 2022: Data Sharing and Pragmatic Clinical Trials: Law & Ethics Amidst a Changing Policy Landscape (Stephanie Morain, PhD, MPH; Kayte Spector-Bagdady, JD, MBioethics)

Trending Sources

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH)

Grand Rounds August 18, 2023: Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6R3) (Prof Sir Martin Landray, FMedSci; M. Khair ElZarrad, PhD, MPH; Adrian F. Hernandez, MD, MHS)

Grand Rounds March 24, 2023: From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet® (Erin Holve, PhD, MPH, MPP; Russell Rothman, MD, MPP; Schuyler Jones, MD; Neha Pagidipati, MD, MPH)

What can pharma marketing learn from other regulated industries?

New to ELRIG Drug Discovery 2022: Tech Theatre supported by DDW

Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

A history of Pfizer

Owkin taps Linux Foundation to open-source its AI learning software

Sanofi offers refunds for Cablivi in novel model for rebates

PentagonFit Fitness Tracker

PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

Stay Connected