Conversations in Drug Development Trends

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection.

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Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. By geographical region, the global CRO services market in 2023 was dominated by North America.

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. The government has also enacted strict trade compliance policies that limit genetic materials, such as patient cells, leaving and entering China.

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Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. The first guidelines published in 1996 and known as ICH GCP E6 provided guidance on the design, conduct, and reporting of clinical trials.

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The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

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Metabolite Tales Blog

DECEMBER 19, 2023

Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.

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Conversations in Drug Development Trends

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You have the oversight you need.

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Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

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Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Whether you’re considering a new study or need support with an ongoing trial, we’re here to partner with you.

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Precision for Medicine

DECEMBER 1, 2023

This laboratory is one of Precision’s 7 global labs – 2 of which have previously been awarded CAP accreditation – indicative of Precision’s ongoing commitment to compliance and quality. This convergence is driving faster clinical development and approval.

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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 trials often engage patients located in different global regions. This enhances patient safety and trial effectiveness.

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The Premier Consulting Blog

NOVEMBER 20, 2023

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. billion each year.

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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey. Let the CRO know any key outcomes from each.

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Drug Target Review

JULY 1, 2024

Overall, SRP-001’s modulation of pain signalling genes and pathways through endocannabinoid enhancement and FAAH inhibition supports its potential as an effective non-opioid pain therapeutic, validating the planned clinical trials. Figures Figure by South Rampart Pharma, illustrating the properties of SRP-001.

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PPD

DECEMBER 5, 2023

By doing so, companies can augment their ongoing clinical research and sidestep the challenges of global extension, such as language barriers and compliance concerns, without the need to manage the in-country presence themselves. This facilitates smooth, on-schedule operations, de-risking the pipeline.

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The Pharma Data

APRIL 19, 2022

The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

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The Pharma Data

NOVEMBER 10, 2020

This clinical study will evaluate the safety, tolerability, and clinical activity of escalating doses of orally administered capsules of Foralumab. The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. In addition to Milciclib, the Company is also developing Foralumab for liver diseases.

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Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. Improving Communication Between FDA and Sponsors.

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The Pharma Data

MARCH 17, 2021

The data builds on the primary outcome analysis of the positive Phase 3 monarchE trial that previously showed Verzenio, in combination with ET, decreased the risk of breast cancer recurrence by 28.7 Overall, patient compliance for PROs was greater than 90 percent. Across clinical trials (MONARCH 1, MONARCH 2, MONARCH 3), 3.3%

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Advarra

JUNE 6, 2022

A: If the GCLP term referenced is interpreted as a combination of good laboratory practice (GLP) and good clinical practice (GCP), then the roadmap needs to include processes covering pre-clinical and clinical development stages. However, this is not a requirement, and it may not deliver an enhanced level of compliance.

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The Pharma Data

DECEMBER 27, 2020

The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules). and Versant Ventures. Cowen served as the sole placement agent for each of the PIPE financings.

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Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials.

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PerkinElmer

JANUARY 25, 2023

These same challenges and needs also extend from research and discovery to clinical development. Here too cloud-native software solutions can facilitate the scientific process by enabling stronger trial data centralization, collaboration, reproducibility of results and workflows.

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Molecule Blog

MARCH 17, 2023

Clinical development kicks off when the company files an IND with the FDA , progressing through Phase I for safety, Phase II for early signs of efficacy, and Phase III for determining full approval. Data federation has compelling benefits, especially in areas like clinical trial recruitment.

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The Pharma Data

SEPTEMBER 16, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor The Phase 2 CRC trial is expected to have a data readout in early 2021. Additional information about CodeBreaK clinical trials can be found at [link].

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The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. Before joining Acorda, Ms. Shah also serves on the boards of several civic organizations and initiatives.

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The Pharma Data

JANUARY 3, 2021

and in Asia and for our R&D pipeline, including the Phase 1 trial of EYP-1901 in wet age-related macular degeneration that is expected to commence in the coming months.”. “We We are excited about the significant potential of these products in both the U.S.

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The Pharma Data

SEPTEMBER 20, 2020

Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor The Phase 2 CRC trial is expected to have a data readout in 2021. Additional information about CodeBreaK clinical trials can be found at [link].

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Agency IQ

JUNE 9, 2023

However, nonclinical studies are not conducted exclusively before human trials begin; they usually continue throughout the early phases of clinical trials to further assess a product’s performance on different metabolic pathways and at different doses. Pivotal (i.e.,

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Agency IQ

APRIL 8, 2024

This week, the FDA announced it is finally ready to start accepting adverse event submissions in ICH E2B(R3) format and that the countdown to mandatory compliance with these requirements has begun. Sponsors will have 24 months to get comfortable submitting IND safety reports in E2B(R3) format before compliance becomes mandatory in April 2026.

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Agency IQ

JANUARY 4, 2024

For example, while federal law might require a company to submit substantial evidence of effectiveness to the FDA to obtain approval, the FDA could then issue a guidance document on how it interprets the phrase “substantial” in terms of the number of trials, the types of enrollees, and the design of the studies for a specific disease.

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Agency IQ

AUGUST 18, 2023

Additionally, the regulations outlined requirements not only for manufacturers and distributors of medical devices in general but for particular roles, such as the newly created role of Person Responsible for Regulatory Compliance (PRRC), required by both manufacturers and authorized representatives (MDR and IVDR Article 15).

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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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The Pharma Data

OCTOBER 25, 2020

In a sample of charts from 56 patients with SCD, voxelotor increased hemoglobin by more than 1 g/dL on average and decreased hemolysis markers to a degree consistent with the randomized controlled HOPE trial results. .

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The Pharma Data

JULY 21, 2021

In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever 3 (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

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The Pharma Data

FEBRUARY 22, 2021

The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

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The Pharma Data

MAY 7, 2021

The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The EMA will assess the medicine’s compliance with the usual standards for efficacy, safety and quality. About the Sotrovimab Clinical Development Program. About the COMET-ICE Study Design.

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