Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. This suppressive mechanism involves a negative regulator – a protein called IL-18BP or IL-18 binding protein, that works as a “decoy receptor” by binding to IL-18 and preventing it from binding to its functional receptor.

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The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

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Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Maintaining open lines of communication helps address issues as they arise, allowing for real-time clarification and adjustments.

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The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. Immune Regulation – U.K.-based

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The Pharma Data

APRIL 12, 2022

vice president and global head of oncology clinical development at AbbVie. “Data obtained from this exploratory analysis holds promise for potential future clinical research,” said Jacqueline S. The BCL-2 family of proteins are known regulators of the apoptosis pathway.3 Garcia, M.D.,

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Persons”, as such term is defined in Regulations under the U.S.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. All clinical development plans are subject to additional funding. ” “I am excited about the potential of NVG-291,” stated Dr. .”

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity. At Canary Advisors , we concentrate on patient-focused drug development, making sure sponsors, regulators, and other key stakeholders can better align with what’s most meaningful to patients.

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Disease Clinical Trials Trials Treatment 52

The Pharma Data

NOVEMBER 10, 2020

We believe switching to oral, nasal and inhalational administration of mAbs from the traditional intravenous administration could potentially be transformational for the future development of immunotherapies.”. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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The Pharma Data

DECEMBER 15, 2020

It is funded by the world’s leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations’ strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D.

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The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. About PXL770.

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Conversations in Drug Development Trends

AUGUST 23, 2023

To spur more frequent engagement between patients, sponsors, and regulators, Richie Kahn and Jenn McNary co-founded Canary Advisors , a patient engagement consultancy that works to better align development programs with patient needs.

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PPD

DECEMBER 12, 2023

A follow-the-sun model offers several advantages, but it takes specialized expertise to implement and operationalize for clinical development and post-marketing surveillance. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation. Rigorous data security measures are essential.

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PPD

JUNE 20, 2023

As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. Does your CRO look after your most valuable resources?

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The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Our core areas of research are: Immunology.

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Clinical Trials Trials Compliance Clinical Development 40

Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. Ther Innov Regul Sci. Rockley KL.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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Advarra

AUGUST 10, 2023

“I am very excited for the field because I feel like we’re beginning to get to a critical mass, where a single method or product can be deemed safe and then adapted for many uses,” said Dr. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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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. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

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Science FDA Production Trials 40

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

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD.

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FDA Clinical Trials Disease Trials 59

The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.

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Trials Clinical Trials International Production 52

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. at a Friends of Cancer Research event in February 2024. ANNA ESHOO (D-Calif.)

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