Alta Sciences

MAY 28, 2024

Altasciences Receives 2024 CRO Leadership Award for Capabilities aasimakopoulos Wed, 05/29/2024 - 17:54 Laval, Québec, May 29, 2024 – Altasciences announced today that it has been recognized for excellence in contract research with a 2024 CRO Leadership Award for Capabilities.

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Drug Discovery World

JUNE 20, 2024

A single phase III clinical trial can rack up to 3.56 With nearly 479,000 trials 6 registered globally as of early 2024, we are facing an outright data avalanche. Now, you might wonder: how exactly can these advanced artificial intelligence models propel clinical research forward? million data points 5.

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Perficient: Drug Development

FEBRUARY 1, 2024

The conference will take place on February 11-14, 2024, in Orlando, Florida. The SCOPE (Summit for Clinical Ops Executives) conference is a premier event in the field of clinical operations, providing a comprehensive platform for professionals to explore the latest trends and innovations in clinical research.

Science 59

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PPD

MARCH 28, 2024

Through the first few months of 2024, the economic landscape is showing signs of returning to a semblance of normalcy, mirroring the pre-COVID era. According to Jeffries Equity Research, funding totals exceeded $15 billion in January and February, marking the best monthly tallies in over a year.

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Drug Discovery World

AUGUST 18, 2023

CorEvitas expands our clinical research business with highly complementary real-world evidence solutions, which is an increasingly important area and will help to enhance decision-making as well as the time and cost of drug development.” of adjusted earnings per share in 2024.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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Alta Sciences

JUNE 21, 2024

Simpler Clinical Development From Day Dot blussier Fri, 06/21/2024 - 19:10 HTML Connecting the Dots With Comprehensive CRO Solutions When you CONNECT THE DOTS, you open a world of possibilities. Ready for a simpler drug development journey? At Altasciences, we connect the dots, so you don’t have to.

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Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Interested in hearing more insights from Matt?

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Drug Discovery World

DECEMBER 26, 2023

Atropos Health and SEQSTER Real-world data company Atropos Health and SEQSTER, a provider of patient-centric healthcare data technology, have partnered to accelerate patient registries in clinical research. The collaboration will advance the speed-to-insight for many underrepresented populations served by registry-based research.

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. How do CROs solve the challenges of managing clinical trials?

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Alta Sciences

JANUARY 23, 2024

Altasciences Appoints New General Manager, Clinical Operations pmjackson Tue, 01/23/2024 - 19:52 Laval, Québec, Monday, January 29, 2024 — Altasciences announced the appointment of James Brazeal as General Manager, Clinical Operations, at its clinical facility in Kansas City.

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Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). from 2024 to reach US$129.8 ’s services include supporting life sciences research, analytical solutions, and diagnostics or developing and manufacturing therapeutic interventions.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs? To learn more about our end-to-end services, contact us today.

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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. WHAT IS THE ALTASCIENTIST ?

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PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

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Drug Discovery World

APRIL 11, 2024

On the final day of AACR, the plenary session of the Annual Meeting put artificial intelligence at the forefront and featured a stellar lineup of AI and data science experts who discussed AI and topics such as imaging, precision medicine, and drug development. And thanks to the city of San Diego for its hospitality.”

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LifeSciVC

JULY 11, 2023

The meeting brings together tens of thousands of physicians, scientists, patients, advocates, innovators, and those involved in oncology drug development from around the world in order to explore the latest advances in cancer treatment, clinical trials, and translational and clinical research.

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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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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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Conversations in Drug Development Trends

NOVEMBER 27, 2023

In addition to sickle cell disease, exa-cel has also been developed for the treatment of transfusion-dependent b-thalassemia (TDT), and its Standard Review has a PDUFA target action date of March 30, 2024. What Does the Future of Gene Editing Hold?

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The Pharma Data

MARCH 23, 2023

The broader Sanofi and Regeneron COPD clinical research program includes Phase 3 trials with itepekimab, a fully human monoclonal antibody that binds to and inhibits interleukin-33 (IL-33). AEs leading to deaths were balanced between the two arms (1.7% placebo, 1.5% Itepekimab received Fast Track Designation from the U.S.

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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. Researchers established efficacy of edaravone in a 24 week, randomized, placebo-controlled double-blind study in 137 Japanese patients.

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Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. from 2023 to 2030.

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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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Alta Sciences

AUGUST 28, 2023

We wish the team at Ischemix continued success on the next Phase of clinical research.” Additionally, Co-chief Operating Officer, Marie-Hélène Raigneau, said of the study: “Our goal at Altasciences is to help companies like Ischemix expedite the drug development process without compromising on quality or safety.

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Drug Discovery World

FEBRUARY 26, 2024

And it’s not just bit.bio – there are many other companies exploring different cell types within clinical research. Moreso, research using natural killer cells blossomed in 2023 with a number of companies targeting use-cases in Alzheimer’s oncology, and even diabetes. I think for us, it’s limitless.” J Clin Oncol.

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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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Agency IQ

FEBRUARY 2, 2024

The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs. BY KIRSTEN MESSMER, PHD, RAC, KARI OAKES | JAN 31, 2024 9:01 PM CST Regulatory Background Cancer is the second leading cause of death in the E.U. were from cancer.

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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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. A number of E&C Committee members remain concerned about the U.S.

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Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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