PPD

JULY 29, 2025

For sponsors, the imperative to streamline development processes and improve clinical development speed and efficiency has never been more critical. With more than 30 years of support for clinical and marketed products, we know what it takes to solve your specific challenges. For more information, visit our website.

Clinical Trials

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. Be prepared to share necessary information about your study with the CRO,” says Chad.

Drug Development

Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Bioanalysis to support drug development requires meticulous attention to detail across many clinic and laboratory disciplines.

Clinical Trials

PPD

JULY 8, 2025

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. One major concern is its tendency to hallucinate, confidently producing factually incorrect information.

Clinical Research

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines. One of the most significant challenges in drug development is global regulatory variability.

Drug Development

Drug Target Review

AUGUST 8, 2025

To help address this, TCE developers can implement structured, platform-based approaches that prioritise rational design and early risk assessment. These platforms can be engineered to evaluate multiple constructs in parallel, enabling informed lead selection without delaying development timelines.

Engineering

The Pharma Data

JUNE 26, 2025

BeOne Medicines’ rise has been fueled by a strategic commitment to innovation at every level of the drug development continuum. Its end-to-end R&D model integrates in-house discovery, development, and manufacturing capabilities—enabling rapid iteration, lower development costs, and sustained pipeline productivity.

Research

Drug Target Review

JULY 29, 2025

Kyle notes that “clinical trials face costly delays, inefficient resource allocation, and even standstill or stalling of trials, ultimately resulting in the failure to bring crucial treatments to market.” With limited resources and growing demands, it becomes even more critical to find a way to streamline financial operations.

Clinical Trials

Conversations in Drug Development Trends

JULY 3, 2025

This natural evolution in regulatory guidance acknowledges that while safety remains paramount, it is equally essential to ensure that therapies are accessible to those in need within the framework of informed medical oversight. This shift may occur through enhanced enrollment by expanding trial accessibility to a broader range of sites.

Therapies

Alta Sciences

JULY 7, 2025

Nonclinical safety assessment serves as a cornerstone in drug development, providing essential data to identify early signs of potential toxicity and inform subsequent clinical trial design. One important aspect of toxicity studies is determining whether the drug produces undesired immune effects.

Immune Response

Alta Sciences

JULY 7, 2025

Nonclinical safety assessment serves as a cornerstone in drug development, providing essential data to identify early signs of potential toxicity and inform subsequent clinical trial design. One important aspect of toxicity studies is determining whether the drug produces undesired immune effects.

Immune Response

DrugBank

JULY 14, 2025

The complexity of pharmacokinetics and pharmacodynamics, coupled with the variability in patient populations, makes predicting and managing DDI a particularly challenging aspect of drug development.  These models simulate drug interactions based on their molecular properties, metabolic pathways, and transport mechanisms.

Clinical Development

BioPharma Drive: Drug Pricing

JUNE 11, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. The FDA’s prescribing information includes warnings and precautions for an effect on heart rhythms, liver toxicity, lung inflammation and other potential health issues.

FDA

BioPharma Drive: Drug Pricing

JULY 10, 2025

Skip to main content CONTINUE TO SITE ➞ Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Until Vykat came along, though, no drug therapies were specifically approved to curb the all-consuming hunger that hallmarks the condition. All copyright resides with them.

Drugs

PPD

APRIL 14, 2025

Ideally, the dietitian and dietary information/tools are centralized to ensure all stakeholders patients and site personnel alike receive consistent counseling across all sites. It is vitally important, however, that diet and exercise information be attuned to the cultural and economic makeup of patients.

Clinical Trials

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. Section #1: FDA Interactions Given the wide range of sponsors (i.e.,

Therapies

Conversations in Drug Development Trends

MAY 15, 2025

The Investigational New Drug (IND) application is a pivotal step in the drug development journey, offering a multitude of strategic advantages and enhanced opportunities. Have you considered the multiple associated benefits and implications in the context of your novel drug development plan?

Clinical Trials

PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

Clinical Development

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 can expect transparency.

Clinical Development

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

Drug Development

DrugBank

JUNE 6, 2024

In the rapidly evolving landscape of oncology drug development, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.   What sets RADR ® apart is its robust data-driven approach.

Drug Development

The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. Drug substance content in Module 3.2.S

Clinical Development

Alta Sciences

MAY 29, 2024

How to Optimize Your Early-Phase Drug Development Program pmjackson Wed, 05/29/2024 - 20:32 The Challenges With Outsourcing Drug Development In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.

Drug Development

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.

Clinical Development

PPD

NOVEMBER 21, 2023

The drug development industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drug development industry experienced setbacks during the COVID-19 pandemic, the field  is again gaining momentum reminiscent of its pre-pandemic pace.

Clinical Development

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

Clinical Pharmacology

The Pharma Data

JULY 8, 2021

The update clarifies the indication by emphasizing information about the disease stages studied in the ADUHELM clinical trials. Information about the population studied has been previously communicated by Biogen and Eisai, including in the companies’ statement of June 23, 2021. Please see the full Prescribing Information.

Clinical Trials

Conversations in Drug Development Trends

AUGUST 23, 2023

Patients are the backbone of clinical trials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA. Our mission is a lofty one.

FDA

PPD

OCTOBER 16, 2023

Consent development: Informed consent is the most important step in the tokenization process. This enables deeper and more meaningful real-world insights on clinical study data. Tokenization can accelerate innovation in clinical trials and drug development.

Clinical Trials

BioPharma Drive: Drug Pricing

JUNE 23, 2025

Skip to main content Dont miss tomorrows biopharma industry news Let BioPharma Dives free newsletter keep you informed, straight from your inbox. Cookie Preferences / Do Not Sell This website is owned and operated by Informa TechTarget, part of a global network that informs, influences and connects the worlds technology buyers and sellers.

Treatment

Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions.

Clinical Research

Alta Sciences

JULY 22, 2024

Recently, we have seen increasing numbers of complex FIH studies in CNS-active drugs to gather comprehensive data with a wider range of doses as early as possible. jpg Tags Clinical Trials Weight 1

Trials

PPD

JULY 18, 2023

Nearly two-thirds of drug developers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinical research business of Thermo Fisher Scientific. Regular review and management of KPIs and budget. Escalations and risk mitigation.

Clinical Development

NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

For those drug candidates that are ultimately doomed, “failing early” is key to reducing drug development costs. The ultimate goal is to accelerate the translation of basic discoveries into clinical breakthroughs. For more information about tissue chips, take a look at NIH’s Tissue Chip for Drug Screening program.

Drugs

Conversations in Drug Development Trends

JANUARY 24, 2024

However, they lack awareness of specific clinical trials that may be relevant to their patients, and they don’t always feel they have the knowledge to explain certain aspects of clinical trials confidently to patients and their family members. These datasets can help find providers and patients based on genetic information.

Trials

The Pharma Data

DECEMBER 10, 2020

executive vice president of research and development. “We We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. For additional information, please visit www.lexpharma.com. Safe Harbor Statement.

FDA

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects. View the Driving Simulation Fact Sheet for more information.

Clinical Trials