FDA Law Blog: Biosimilars

MARCH 29, 2024

According to GAO, FDA is facing challenges with clinical research inspections to ensure that the sites that oversee the research that lead to drug approvals meet the necessary standards. Complete numbers for 2023 and 2024 are not available, but it appears that FDA was only able to complete 537 BIMO inspections in 2022.

Clinical Research 59

Clinical Research FDA Research Clinical Trials 59

Drug Patent Watch

DECEMBER 11, 2024

It is crucial to determine whether you will be working with a CDMO for discovery and drug development all the way through approvals and commercialization or if your work with a CDMO will begin with preclinical development or clinical research. 2024, March 13). References Ajinomoto Bio-Pharma Services. 2019, March 6).

Pharmaceutical Companies 98

Pharmaceutical Companies Compliance Pharmaceuticals Drug Development 98

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. between 2024 and 2030. billion in 2023 and is expected to grow at a CAGR of 7.0%

Clinical Research 52

Clinical Research Clinical Trials Research Trials 52

Fierce BioTech

MARCH 12, 2024

Listing Image PPD-TF-logo.png Listing Introduction Get the latest FSP trends, strategies, and projections for biopharma and biotech companies as Lori Boyce, Vice President, PPD FSP Solutions, and Mike Lydon, Director, PPD FSP Solutions, share findings from The 2024 FSP Trends Report. On Demand Start Date Thu, 04/11/2024 - 12:00

Clinical Research 52

Clinical Research Drug Development Trials Research 52

Crucial Data Solutions

DECEMBER 21, 2023

Over the past year, all of us working in clinical research have seen a significant increase in the number of. The post The Year Ahead: What Does EDC Look Like In 2024 and Beyond? appeared first on Crucial Data Solutions.

Clinical Research 59

Clinical Research Research 59

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

Science Clinical Research Clinical Trials Trials 59

PPD

OCTOBER 31, 2024

In response, the PPD clinical research business of Thermo Fisher Scientific conducted its third global survey of 150 drug developers to capture a comprehensive view of these evolving trends. This aims to ensure that treatments are effective across varied demographics and to address historical gaps in clinical research.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

Conversations in Drug Development Trends

JULY 9, 2024

Due to this meaningful change, the first-ever GLP-1-Based Therapeutics Summit took place in Philadelphia on May 15-16th, 2024, serving as a platform for industry decision-makers to provide invaluable insights for therapeutic strategies.

Clinical Research 52

Clinical Research Treatment Research Clinical Trials 52

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.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

Broad Institute

FEBRUARY 19, 2024

Now, a team of researchers at the Broad Institute of MIT and Harvard, in collaboration with 10 academic medical centers across the US, has implemented 10 such tests for use in clinical research. Online February 19, 2024. DOI: 10.1038/s41591-024-02796-z Tags: Broad Clinical Labs Using genomics to predict disease risk

Disease 124

Disease Clinical Research Research Treatment 124

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.

Trials 52

Trials Clinical Trials Drug Development Clinical Research 52

Vial

DECEMBER 8, 2023

As we look forward to 2024, several groundbreaking therapies are poised to radically change the landscape of ophthalmology, providing hope and improved treatment options for patients with ocular conditions. The intention is to recruit 18 participants for the trial, with results expected to be announced in 2024 or 2025.

Therapies 52

Therapies Clinical Trials Trials Treatment 52

SCIENMAG: Medicine & Health

FEBRUARY 19, 2024

February 19, 2024, Cleveland: Cleveland Clinic researchers have identified a new pathway that contributes to cardiovascular disease associated with high levels of niacin, a common B vitamin previously recommended to lower cholesterol.

Disease 71

Disease Clinical Research Research 71

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

Clinical Development 69

Clinical Development Production Clinical Trials Treatment 69

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.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Research 40

On Medicine

FEBRUARY 8, 2024

As noted, older people are under-served by clinical research and CHARMER has made a concerted effort to involve public and patient representatives in all CHARMER study activities, including as co-applicants. This is reflective of the collaborative approach the CHARMER programme has adopted since its inception.

Hospitals 109

Hospitals Trials Doctors Clinical Research 109

keypoint

DECEMBER 4, 2023

AI and Machine learning are transforming biomedical research at an astounding pace, enabling transformative insights into disease pathology and etiology, as well as diagnostics, treatment and personalized medicine.

Clinical Research 68

Clinical Research Treatment Disease Research 68

Fierce BioTech

JUNE 14, 2024

How AI Accelerates Clinical & Drug Development Timelines pesurya Fri, 06/14/2024 - 10:59 Wed, 09/11/2024 - 14:00 Resource Type Webinar Viswa Colluru, Ph.D. Embrace this opportunity to stay ahead and lead in a rapidly evolving field by registering for this exclusive webinar sponsored by Dr. Vince Clinical Research.

Drug Development 52

Drug Development Clinical Research Drugs Research 52

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?

Clinical Trials 64

Clinical Trials Therapies Clinical Research Immune Response 64

Broad Institute

NOVEMBER 25, 2024

Ladders to Cures (L2C) Accelerator By Maria Nemchuk November 25, 2024 Breadcrumb Home Ladders to Cures (L2C) Accelerator The Ladders to Cures (L2C) Accelerator aims to catalyze progress across the research ecosystem and accelerates advances leading to treatments and cures for patients with rare genetic diseases.

Clinical Trials 52

Clinical Trials Disease Trials Therapies 52

PPD

DECEMBER 16, 2024

The drug development industry faces rising costs and increasingly complex protocols as top challenges, with 49% of developers citing costs as their primary concern and 39% pointing to protocol complexity as a key hurdle, according to a recent survey of 150 drug developers worldwide by the PPD clinical research business of Thermo Fisher Scientific.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Alta Sciences

NOVEMBER 18, 2024

Strategic Site Identification for Clinical Trials blussier Mon, 11/18/2024 - 21:10 HTML Start Your Study Faster Watch our latest podcast to discover Altasciences' unique process for identifying and selecting the right clinical sites for your unique project. WATCH NOW Book a visit ; we’d love to host you!

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Broad Institute

DECEMBER 11, 2024

#WhyIScience Q&A: A computational biologists world travels have shaped her approach to research By Corie Lok December 11, 2024 Breadcrumb Home #WhyIScience Q&A: A computational biologists world travels have shaped her approach to research Wolu Chukwu talks about how she brings a community-first focus to her work in cancer genetics.

Research 105

Research DNA Clinical Research Science 105

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. At Altasciences, we connect the dots, so you don’t have to. All you have to do is reach out and get the conversation started. WATCH THE VIDEO.

Clinical Development 52

Clinical Development Clinical Trials Clinical Research Drug Development 52

Alta Sciences

JULY 22, 2024

WATCH THE VIDEO You may also be interested in these resources: Webpage: CNS Drug Development Solutions Webinars: Inside the Pharmacodynamic Toolbox A Review of the FDA's Psychedelic Clinical Research Guidances Image Social_Media_Webinar_CNS_Active_Compounds_v2_04.jpg jpg Tags Clinical Trials Weight 1

Trials 52

Trials Clinical Trials Clinical Development Clinical Research 52

Vial

MARCH 1, 2024

from 2024 to reach US$129.8 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. launched a PV platform for clinical research registries.

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

Vial

FEBRUARY 8, 2024

In recent years, however, clinical trials have become increasingly complex, adding burden to research teams and clinical research sites. Starting with describing challenges faced in managing clinical trials, we explore how CROs address challenges and how sponsors benefit from partnering with CROs. billion in 2030.

Clinical Trials 52

Clinical Trials Trials Clinical Research Research 52

Conversations in Drug Development Trends

DECEMBER 7, 2023

Other drawbacks reported from working with these large CROs were: These performance disruptions and drawbacks have resulted in an environment of uncertainty among this CRO service provider segment in 2023, with likely ramifications extending into 2024 and beyond.

Clinical Trials 136

Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

Fierce BioTech

DECEMBER 23, 2024

Pharmacy Considerations for Early Phase Trials dwunderlin Mon, 12/23/2024 - 15:20 Wed, 02/12/2025 - 14:00 Resource Type Webinar Todd Janssen, RPh Donnie Keeney, PharmD Sheri Sander Duration 60 Minutes From sterile compounding to handling controlled substances, a crucial aspect of conducting successful early phase trials is the careful preparation of (..)

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Development 52

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.

Disease 52

Disease Trials Clinical Trials Clinical Research 52

Alta Sciences

OCTOBER 15, 2024

Up Close and Personal with Jason Boehme, Associate Director, Program Management nbartlett Tue, 10/15/2024 - 09:00 Jason Boehme joined Altasciences in 2018 as Senior Project Manager. As my experience in preclinical research grew, so did my curiosity in the overall drug development process; I wanted to expand into clinical research.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Science 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

thought leadership

SEPTEMBER 26, 2024

On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for the enforcement discretion approach that FDA has previously exercised for LDTs.

FDA 58

FDA Laboratories Regulations Drugs 58

PPD

OCTOBER 24, 2024

Currently there is no cure for hepatitis B, however there are several drugs in clinical development to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies. The economic burden includes health care costs, loss of productivity and social stigma associated with the disease.

Vaccine 52

Vaccine Virus Treatment Disease 52

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.

Clinical Pharmacology 40

Clinical Pharmacology Clinical Trials Drug Development Clinical Research 40

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.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

Alta Sciences

FEBRUARY 14, 2024

Healing Hearts: A Journey of Compassion and Commitment aasimakopoulos Wed, 02/14/2024 - 23:35 GETTING TO THE HEART OF SCIENCE WITH MARTA RODRIGUEZ Marta Rodriguez, Altasciences At the heart of science are stories—stories of experiences, challenges, impacts, lessons, and more. Q: How did you transition to working in clinical research?

Clinical Trials 52

Clinical Trials Science Trials Clinical Research 52