Conversations in Drug Development Trends

MARCH 1, 2024

Master protocols allow a trial to perform multiple tests on diverse patient populations or diseases under a unified design. Umbrella Studies Umbrella studies evaluate multiple investigational products (IPs) within a single disease. But how do they work, and when are they appropriate? What Are Master Protocols? Contact us.

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Conversations in Drug Development Trends

AUGUST 14, 2024

Heterogeneity in Hematological Cancers Due to their disease heterogeneity, hematological cancers are well-suited for personalized approaches. Molecular Biomarkers : Encompass various molecules, such as RNA and metabolites, to reflect the physiological state of the cells and their disease pathways.

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The Pharma Data

MARCH 31, 2022

. ™, Janssen seeks to elevate PAD research, collaboration, education and screening for communities placed at increased risk of cardiovascular disease. Cardiovascular disease – also known as heart disease – is the leading cause of death in the U.S.2 At Janssen, we’re creating a future where disease is a thing of the past.

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EG Life Sciences

FEBRUARY 15, 2023

To perform this, CDER is required to understand the science used to create new products, testing and manufacturing procedures, and the diseases and conditions that new products are designed to treat. The US Food and Drug Administration (FDA) approved around 26 novel drugs in 2022.

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The Pharma Data

SEPTEMBER 11, 2020

While stories from news outlets indicate the peak of the infection has passed in most European countries, cases of the disease continue to rise in other parts of the world, especially Latin America and Africa. Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease.

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Conversations in Drug Development Trends

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. For example, Azathioprine, an autoimmune disease and organ transplantation treatment, was linked to severe myelosuppression for patients with specific genetic variants, such as the TPMT and NUDT15 genes.

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PPD

OCTOBER 12, 2023

Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes. The post Informed Design of Bioanalytical PCR Assay Testing Parameters appeared first on PPD Inc.

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PerkinElmer

FEBRUARY 18, 2021

A PerkinElmer White Paper offers a detailed look at the findings. The hope is that complex models, which offer a more accurate reflection of disease biology, will provide better predictive data on the likelihood for later success. Top 10 trends in pre-clinical drug discovery at top 20 Pharma 1. Full decks up to 1.4M

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Conversations in Drug Development Trends

JULY 29, 2024

Evolving sentiments recognize obesity as a medical condition and lifestyle choice as well as a chronic disease with genetic, psychological, cultural, and environmental causes (Figure 1). They should include a comprehensive set of outcomes and endpoints to capture multiple areas of potential improvement within obesity as a disease.

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The Pharma Data

AUGUST 7, 2020

The ARM report also showcased robust pipelines of therapies targeting indications in cancers, infectious diseases and inherited disorders. For more pivotal trends from regulatory bodies, download MasterControl’s white paper to find out how the FDA is modernizing its plans to change the regulatory landscape to improve public health.

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PPD

MARCH 21, 2024

Our Rare Disease and Pediatric Center of Excellence provides deep pediatric knowledge and experience to drug developers across all therapeutic areas. DOWNLOAD OUR LATEST WHITE PAPER The post Five Strategies to Tailor Your Pediatric Clinical Trials to the Child’s Needs appeared first on PPD Inc.

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The Pharma Data

JANUARY 5, 2021

Geriatric, pediatric, and patients suffering from gastroesophageal reflux disease are often administered pharmaceuticals mixed with food or liquids due to difficulty swallowing tablets or capsules. Alternate methods of administering solid oral formulations are necessary to meet the needs of all patients.

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The Pharma Data

DECEMBER 28, 2020

Mr. Weild authored and co-authored a number of definitive white papers that were key catalysts for new legislation and regulatory reforms, including the JOBS Act. The company is also developing additional new chemical entities to treat other serious diseases with significant unmet medical needs, including systemic sclerosis.

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Agency IQ

JULY 21, 2023

That’s why, according to FDA’s Oncology Center of Excellence, the determination of an appropriate endpoint in oncology is based on the specific disease and is highly dependent upon numerous factors. But unlike ORR, PFS is considered by FDA to be a more appropriate measure of stable disease and is thought to be correlated to overall survival.

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FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development.

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The Pharma Data

DECEMBER 7, 2020

Download Pharma IQ ’s short guide to receive four key takeaways to support supply chain frameworks in a state of emergency – from disease outbreaks, such as the Covid-19 pandemic, to natural disasters. Enforce strong supplier relationships from the very beginning and diversify your supply base.

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The Pharma Data

NOVEMBER 26, 2020

In doing so, the industry has deepened its focus on patient-centricity and has expanded treatment options available for unknown diseases. . The uncertainty raised by the Covid-19 pandemic has forced the pharma industry to turn its resources toward strengthening clinical trial supply chains and improving patient access to care.

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Codon

APRIL 30, 2023

If these printers were set up in resource-starved countries, where malaria and other diseases are endemic, they could make a world of difference. If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans.

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Codon

APRIL 30, 2023

If these printers were set up in resource-starved countries, where malaria and other diseases are endemic, they could make a world of difference. If approved, these wouldn’t be the first gene therapies on the market, but they would be the first gene therapies for a disease that affects something like 100,000 Americans.

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The Pharma Data

MARCH 20, 2021

Accurate and timely laboratory diagnosis of COVID-19 is one of the most pivotal requirements for optimal disease management and contact tracing.

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Agency IQ

FEBRUARY 21, 2024

As described in its white paper , the platform developed by Accumulus is also envisioned to provide a “shared space where a sponsor and health regulators can communicate, and there will be a regulatory-only space where regulators can review the data, can interpret the data, can speak and exchange information amongst themselves.”

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Drug Channels

FEBRUARY 7, 2025

Richard outlines the key factors for commercialization success when a manufacturer launches treatments for rare and orphan diseases. To learn more, download PANTHERxs latest white paper and SP decision-support resource: Selecting the Right Specialty Pharmacy Partner for a Successful Launch.

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LifeSciVC

MARCH 12, 2025

He proposed that it may be possible to kill disease causing agents without harming the host, what he referred to as a magic bullet. Companies developing ADCs for cancer treatment have begun to shift their focus to addressing the unmet needs in autoimmune and inflammatory diseases (I&I). ADCs are here to stay. Butheres the problem.

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