Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. These datasets can help find providers and patients based on genetic information.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

PPD

JULY 6, 2023

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints. How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves.

Clinical Trials 98

Clinical Trials Trials Drug Development Testimonials 98

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

Packaging 52

Packaging Laboratories Pharmaceutical Companies Compliance 52

Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. About QuartzBio QuartzBio helps overcome the data chaos inherent in modern drug development.

Clinical Research 40

Clinical Research Research Engineering Clinical Development 40

Vial

MARCH 1, 2024

billion in 2023 attributable to its laboratory products and biopharma services segment (53.8% By type of service, clinical research services accounted for the lion’s share of the North American CRO services market, followed by early-phase development services, laboratory services, and consulting services.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

PPD

DECEMBER 18, 2023

A good central lab will help reduce the costs and accelerate the timeline of a sponsor’s drug development program. A laboratory services partner that provides globally standardized clinical testing, centralized data visibility and a robust drug development database solution will help drive clinical trial success.

Clinical Trials 52

Clinical Trials Laboratories Trials Drug Development 52

Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines.

Therapies 52

Therapies DNA RNA Laboratories 52

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

The Pharma Data

NOVEMBER 1, 2020

Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. Prior to VHsquared, Suhail was Senior Vice President and Head of Development and Medical Affairs for Shionogi in Europe.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

PPD

OCTOBER 4, 2023

Preclarus dashboards deliver unprecedented reporting scope that exceeds functional-based study reporting and integrates data collected from three main areas — the laboratory, the operations team and the clinical trial site.

Clinical Trials 52

Clinical Trials Trials Compliance Laboratories 52

Vial

FEBRUARY 26, 2024

The pharmaceutical and biotechnological landscape is constantly evolving and a key partner within the drug development process is contract research organizations (CROs) , who are at the forefront with sponsors to drive innovation in clinical research.

Clinical Trials 52

Clinical Trials Trials Clinical Research Pharmaceuticals 52

Conversations in Drug Development Trends

NOVEMBER 27, 2023

Casgevy, the commercial product formerly known as exa-cel, is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow. In June 2023, the U.S.

Treatment 75

Treatment FDA Clinical Trials Therapies 75

The Pharma Data

OCTOBER 22, 2020

Conclusive Evidence from Rigorous Clinical Trials Nine months later, results from the randomized, controlled trials of Veklury involving thousands of patients have been published in peer-reviewed journals, conclusively demonstrating the clinical benefits of treatment with Veklury. Adverse reactions.

Science 52

Science Clinical Trials Hospitals Trials 52

Agency IQ

MAY 28, 2024

Representatives on both sides of the aisle took full advantage of their floor time to probe FDA leadership on its spending, performance and specific regulatory policies – including its recent Laboratory Developed Test final rule. If you don’t have the staff to do this, how are you going to have the staff to do that?”

FDA 40

FDA Production Science Clinical Trials 40

The Pharma Data

NOVEMBER 30, 2020

Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution of the COVE study. at large.

Vaccine 52

Vaccine FDA Clinical Trials Disease 52

The Pharma Data

NOVEMBER 16, 2020

Moderna’s partner PPD (Nasdaq: PPD), a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services, has also been essential to the successful execution of the COVE study. at large.

Vaccine 52

Vaccine Clinical Trials FDA Disease 52

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

SEPTEMBER 1, 2023

Interestingly, the agency noted that this is still the case when a sponsor adds “ancillary protocol-specific activities,” such as a questionnaire unique to the study that would not otherwise be captured in the course of medical care or supplementing a registry’s data collection with a specific laboratory test.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

FDA 40

FDA Science Regulations Production 40

PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

Examples of these strategies include: Sustained community engagement; Providing cultural competency and proficiency training for investigators and research staff; Improving study participant awareness and knowledge of the clinical study (e.g., providing language assistance); Reducing participant burden (e.g.,

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

MARCH 1, 2024

Date Group Event Notable FDA Speakers February 28 TransCelerate Rapid RWD Analyses to Support Safety Signal Assessments February 28 White House Rare Disease Forum Julie Tierney March 1 Foundation Fighting Blindness PFDD Meeting on Dry Age-Related Macular Degeneration (Dry AMD) March 4 America’s Blood Centers 2024 Annual Meeting Peter Marks March (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

FDA 40

FDA Science Clinical Trials Production 40