Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. What will have the greatest impact on rare disease patients in 2023?

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PPD

JUNE 22, 2023

If your company is struggling to hire qualified clinical research associates (CRAs), you’re not alone. A decade-long CRA talent shortage intensified as the COVID-19 pandemic increased strain on the clinical research industry at large. Climbing demand is driving the CRA talent gap.

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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. between 2023 and 2032. What is the Role of the Contract Research Organization (CRO)?

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2%

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The Premier Consulting Blog

NOVEMBER 20, 2023

On September 29, 2023, the U.S. Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena.

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Precision for Medicine

APRIL 7, 2023

This provides value to researchers executing clinical trials, particularly those developing novel therapeutics and vaccines, where sample processing requires geographical proximity to the trial site and samples need to be processed within hours of collecting them from patients. Canada, Europe, and Australia.

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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.

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PPD

OCTOBER 31, 2023

Resourcing is one of the most critical services that a contract research organization (CRO) provides to its clients. If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources.

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Drug Discovery World

OCTOBER 16, 2023

Here, DDW’s Megan Thomas highlights the research taking place and where this is happening. This environment of research excellence, in turn, fosters R&D, innovation, spin-offs, start-ups, networking, collaboration and entrepreneurship, which sets a sturdy foundation that attracts funding, and creates an appealing work culture.

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Drug Target Review

JUNE 6, 2023

Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Research has shown that these immune system proteins have the ability to trigger anti-cancer immune pathways. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

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The Pharma Data

MAY 2, 2023

Syneos Health Appoints Michael Bonello as Chief Financial Officer Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, today announced the appointment of Michael Bonello as Chief Financial Officer, effective July 1, 2023. a clinical trial data collection company, since 2021.

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Precision for Medicine

JUNE 26, 2023

About Precision for Medicine Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Bethesda, Md.,

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PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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Vial

MARCH 27, 2024

Traditionally, they can go about this in one of two common approaches: acquire clinical trial services in-house or outsource the study either partially or fully to a contract research organization (CRO). According to a report by Grand View Research, the global CRO services market was valued at approximately US$50.55

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The Pharma Data

APRIL 12, 2022

20% variant allele frequency reduction – At the time of analysis with > 2 year follow up the survival estimate was 100% in patients who had improvements in bone marrow fibrosis or variant allele frequency – Results were presented at the American Association for Cancer Research annual meeting. Garcia, M.D.,

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The Pharma Data

JANUARY 24, 2021

Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. Research and development efforts will be led by Dr. Paul Van Slyke.

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Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

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PerkinElmer

JANUARY 25, 2023

Experts in the diagnostics and life sciences industry look back on 2022 and lend their insights on the major trends and technologies shaping laboratories in 2023. These same challenges and needs also extend from research and discovery to clinical development.

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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. This convergence of trials, labs and data sciences is driving faster clinical development and approval.

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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.

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Drug Discovery World

JANUARY 12, 2023

As we head into 2023, DDW will be publishing a series of reflections on these predictions. Here, Thomas reflects specifically on Anita Cooper’s prediction relating to the importance of clinical trials. . DDW shared a global data analysis from Phesi, which showed the extent of the impact from the war in Ukraine on clinical development.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. Enriching Possibilities for Rare Disease Patients Drug discovery and research starts with in vivo and in vitro models to select drug candidates. Accessed April 4, 2023, at: [link] [2] Russo et al.

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Conversations in Drug Development Trends

MAY 30, 2024

These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography.

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PPD

JUNE 17, 2024

One interesting trend emerging from the 2023 Pulse Report is the rise of hybrid functional service provider (FSP)/full-service outsourcing (FSO) arrangements. With FSO, all clinical trial tasks (study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) are outsourced to the CRO.

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Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. 1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. Cell Stem Cell. 2017 Jul 6;21(1):14–7. 2018;53(4):519–25.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. The pace has since increased: 2022 and 2023 each saw three approvals issued. What is the FDA Proposing to do?

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PPD

JUNE 20, 2023

Biotech and biopharma companies with a dependable contract research organization (CRO) partner will derive strong value across all business cycles — ensuring project delivery excellence and continued speed to market. Check out our industry predictions for 2023 to see our thinking on what’s ahead.

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Drug Discovery World

AUGUST 7, 2023

SD: The level of diversity achieved in clinical trials is the result of competing forces. On one hand, there are relatively deep-rooted fears about participating in clinical trials due to atrocities like the Tuskegee study, in which researchers studied the effects of untreated syphilis in African American men without informed consent.

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: 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.] Read AgencyIQ’s extensive analysis of the draft guidance here.]

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name. providing language assistance); Reducing participant burden (e.g.,

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The Pharma Data

APRIL 4, 2023

Clinically relevant adverse reactions (<20%) include vomiting (19.8%), fever (18%), hypothyroidism (11%), pneumonitis (9%), myositis (3.3%), myasthenia gravis (2.5%), and infusion site extravasation (0.8%). will be diagnosed with bladder cancer in 2023. Merck has the industry’s largest immuno-oncology clinical research program.

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Agency IQ

JUNE 28, 2024

BY LAURA DIANGELO, MPH | JUN 26, 2024 8:17 PM CDT Quick background: FDA’s work to advance clinical trial diversity through prospective planning The FDA has longstanding policy interests focused on research study diversity. See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ].

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