PPD

AUGUST 14, 2024

Clinical trials have significantly increased in complexity over the last 20 years, creating new challenges. One of the top reported challenges facing drug developers today is recruiting, enrolling and retaining the right patients for studies. The increase in complexity isn’t just creating challenges for patients.

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Conversations in Drug Development Trends

APRIL 4, 2024

Global Impact of ICH M10 Validation Guidelines Harmonization of bioanalytical validation methods is crucial in a world where pharmaceuticals are developed and approved across different regions. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

Drug Patent Watch

DECEMBER 9, 2024

Ancient civilizations in China, Egypt, and India documented the use of herbs for healing. This approach has led to the discovery of numerous potential drug candidates. From Lab to Market: The Long Road of Drug Development Once a promising compound is identified, it enters the long and costly process of drug development.

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Drugs Drug Development Production Pharmaceuticals 87

Labcorp Drug Development

APRIL 17, 2023

The association between excessive alcohol consumption and liver disease is well documented. In fact, the effect on alcohol consumption levels during the COVID-19 pandemic has more recently been investigated.

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Clinical Trials Disease Trials Research 52

PPD

NOVEMBER 7, 2023

Food and Drug Administration (FDA) draft guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” ” Adding to this momentum, in December 2022 the U.S.

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Clinical Trials Trials Clinical Research Disease 59

Quanticate

SEPTEMBER 2, 2024

As a result, clinical trials must be performed to the highest degree of scientific and ethical standards, for results to be recognised as credible and the trial deemed as successful.

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Clinical Trials Trials Clinical Research Production 52

PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions. With FSO, all tasks for a clinical trial are outsourced.

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International Clinical Development Clinical Trials Clinical Research 87

Alta Sciences

OCTOBER 9, 2024

This document examines various analytical techniques that support pharmaceutical product development, with a focus on bioavailability. We take pride in developing, qualifying, and validating robust and rugged analytical procedures to ensure the quality of your products and meet the requirements of regulatory agencies worldwide.

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Clinical Trials Drug Development Pharmaceuticals Trials 52

Conversations in Drug Development Trends

APRIL 8, 2024

By Rolana Avrumson, MS, Vice President of Clinical Projects, Clinical Assessment Technologies In the intricate world of clinical trials, the precision and reliability of clinical assessments stand as pivotal factors in determining a trial’s success.

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Clinical Trials Clinical Research Trials Compliance 75

Agency IQ

JULY 22, 2024

Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024 In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products. Most NMEs approved so far this year relied on one pivotal trial.

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Clinical Trials Trials Science FDA 52

Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

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Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

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FDA Approval FDA Clinical Trials Drug Development 52

Conversations in Drug Development Trends

NOVEMBER 12, 2024

Despite their exciting potential, the smooth operation of cell therapy development trials requires extraordinary orchestration, perfectly aligning the product and patient journeys. While clinical supply is essential to any successful trial, autologous cell therapy trials occupy the far end of the spectrum regarding risk tolerance.

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Therapies Clinical Supply Clinical Trials Molecular Biology 72

Perficient: Drug Development

AUGUST 14, 2023

Document all actions taken in Google Optimize. Documentation Checklist should include: A/B testing results Personalization campaigns Goals and Metrics setup Google Analytics audience setup Development workflows and troubleshooting documentation 2. Remember, the best tool for you depends on your specific needs and context.

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Packaging Marketing Trials Production 98

FDA Law Blog: Drug Discovery

APRIL 23, 2023

This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources. For example, objective response rate is often used as a single-arm trial endpoint in oncology given the established understanding that tumor shrinkage rarely occurs without an intervention.”

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Trials Clinical Trials FDA Treatment 49

Advarra

DECEMBER 14, 2023

Sponsor study team members and research sites each play a critical role in clinical trial executions. Sites working with an investigational new drug (IND) are often subject to an FDA site inspection. Despite the consequences, the FDA has reported a failure rate of 36% in clinical trial site inspections over the past five years.

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Compliance FDA Clinical Trials Trials 52

FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. the single trial) is and (2) how robust and convincing the confirmatory evidence is.

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DrugBank

JUNE 27, 2024

  The benefits of drug repurposing are clear: development times and costs are significantly reduced due to existing knowledge about the drug's properties. These include matching molecular signatures, virtual screening, and analyzing large datasets from health records and clinical trials.

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Drugs Pharma Companies Clinical Trials Computational Chemistry 72

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

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Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website.

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Production Clinical Trials FDA Drugs 52

The Premier Consulting Blog

JUNE 26, 2023

1 With their poorly understood natural histories, phenotypic heterogeneity, and diverse clinical manifestations, rare cancers pose challenges to drug development and represent a significant unmet need in oncology. Rare cancers account for 25-30 percent of all new cancer diagnoses and 25 percent of cancer deaths.

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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. IND, CTA, NDA, BLA). “If

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Drug Development Clinical Trials Trials Compliance 52

FDA Law Blog: Drug Discovery

FEBRUARY 28, 2024

As the approval was granted using the accelerated approval pathway, the approval was subject to a postmarketing requirement to verify and describe the clinical benefit of the drug in a Phase 3 trial. On August 4, 2023, Oncopeptides submitted its appeal. On September 8, 2023, CDER submitted its response.

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FDA Trials Therapies Drugs 59

The Pharma Data

MAY 7, 2021

The US Food and Drug Administration (FDA) announced the awarding of two grants under its Clinical Outcome Assessments (COAs) program to inform the selection of clinical trial endpoints for drugs to treat neurodevelopmental disorders (NDDs) and nephrotic syndrome. .

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FDA Clinical Trials Drug Development Trials 52

Alta Sciences

OCTOBER 7, 2024

During the early stages of drug development, fully characterizing the active pharmaceutical ingredients (APIs) is crucial for optimizing the drug product formulation. There are many important considerations to make during drug product formulation development. WHAT IS THE ALTASCIENTIST?

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Clinical Trials Drug Development Production Pharmaceuticals 52

PPD

NOVEMBER 9, 2023

However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.

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Clinical Development Drug Development Clinical Research Treatment 52

Vial

DECEMBER 11, 2023

According to a study by the Tufts Center for the Study of Drug Development, the average time from site identification to study start-up completion is approximately 31.4 Overview of key clinical trial milestones during start-up. Examples of delays that contribute to longer clinical trial start-up times.

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Clinical Trials Clinical Research Trials Research 52

Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. Read Agency IQ’s complete breakdown of the FDA’s PHE guidance documents here.]

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FDA Clinical Trials Vaccine Trials 40

The Premier Consulting Blog

NOVEMBER 12, 2023

There have been multiple guidance documents aimed at providing industry oversight of regulatory activities related to AI/ML-enabled devices since the release of these action plan. The number of drug submissions involving AI/ML has also increased.

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FDA Drug Development Regulations FDA Approval 52

The Premier Consulting Blog

APRIL 15, 2024

However, when it comes to an IND and supporting a clinical trial, FDA’s primary focus is on healthy volunteer and patient safety. It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies.

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FDA Pharmacokinetics Laboratories FDA Approval 52

LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. Clinical Trials Are your clinical trials on track? What has the impact of summer been on recruiting efforts and the ability to manage clinical trial participants? Have you identified and reached out to the PIs and potential clinical trial sites?

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Clinical Trials Trials Disease Treatment 61

LifeSciVC

JANUARY 25, 2024

This rough patch has been well documented in this space and particularly tough. Testing drugs that make it into clinical trials has its own specific challenges. Designing trials to show safety and efficacy in people and doing it in a way that complies with all the regulatory and ethical guidelines is where many drugs fail.

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Science Clinical Trials Trials Medical Schools 67

The Pharma Data

OCTOBER 25, 2020

Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. The Company plans to initiate a Phase 2 trial within the next several months. “We In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”.

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Treatment Trials FDA Hospitals 40

Vial

APRIL 18, 2024

Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. Specifically, the global ophthalmic clinical trials market, valued at USD 1.5 from 2023 to 2030.

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Clinical Trials Trials Treatment Clinical Research 52

Altus Drug Development

MAY 31, 2022

From natural health products to life-saving medicines, all pharmaceutical products must undergo an analytical method development process. Through analytical method development, validation, and transfer, drug development and manufacturing are kept safe, efficient, and compliant with the law.

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Pharmaceuticals Production Clinical Trials Drug Development 52

Vial

DECEMBER 13, 2023

Clinical sites have endured a particularly challenging period in recent years, from adopting new operating models and technologies supporting decentralized clinical trials (DCTs) to mitigating financial repercussions of inflation, greater protocol complexity, and managing increased responsibilities despite staff shortages.

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Clinical Trials Trials Clinical Research Research 52

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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