PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Yet, today’s clinical research sponsors face significant challenges. These delays financially disrupt the potential of both current and future clinical research. With a median delay of 12.2

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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. Optimizing and Accelerating Drug Discovery How can AI be utilized to obtain new biological insights and optimize chemical processes? Tony Cardozo Todd Rudo, M.D.

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PPD

JUNE 10, 2024

We are thrilled to announce that the PPD clinical research business of Thermo Fisher Scientific is getting a brand refresh! Our new visual identity will align more closely with Thermo Fisher’s style, while still retaining elements unique to our PPD clinical research business. Ready to unlock efficiencies?

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Drug Target Review

SEPTEMBER 22, 2023

Organoid technologies are becoming an invaluable solution for preclinical research, with the ability to augment the development of personalised medicine, drug discovery and gene therapies. 5 Organoids are recognised as New Alternative Methods (NAMs) in drug development. billion by 2030.

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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. What is a Pre-Clinical CRO? over this period.

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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.

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Conversations in Drug Development Trends

JULY 29, 2024

Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research. DEXA (Dual-Energy X-ray Absorptiometry) is the optimal method for accurately measuring body composition in clinical research.

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FDA Law Blog: Drug Discovery

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Valentine, HPM Director.

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Advarra

JUNE 27, 2023

The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs. A clinical trial investigating a drug or therapy is typically divided into four phases: Phase I, Phase II, Phase III, and Phase IV.

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PPD

DECEMBER 19, 2022

PPD, Thermo Fisher Scientific ’s clinical research business, surveyed more than 150 decision-making leaders at pharmaceutical and biotech companies around the globe to collect key insights on the state of the evolving drug development industry. The opportunity to leverage new technologies in drug development (e.g.,

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Alta Sciences

JULY 5, 2023

How to Facilitate Your Ophthalmic Drug Development tchichekian Thu, 07/06/2023 - 01:11 HTML From Discovery to Market, We’ve Got You Covered. As a leading partner in ophthalmic drug development , Altasciences has an outstanding track record formulating, testing, and manufacturing ophthalmic products.

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Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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LifeSciVC

FEBRUARY 27, 2024

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC Patients and their care partners are at the center of our work in the life sciences industry – but at what point during the drug development process should companies start to engage these key stakeholders?

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Quanticate

JULY 5, 2024

It’s essential for maintaining ethical standards, high-quality outcomes and facilitating global standardisation, enabling multi-center and multinational studies, thereby streamlining the development and approval process for new medical treatments, and maintaining public trust in clinical research.

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BioPharma Drive: Drug Pricing

AUGUST 14, 2023

Stephen Apps discusses how technology can help improve the speed and quality of clinical research and why a dedicated, cross-functional approach is needed to maximize its value for smaller biotechs.

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LifeSciVC

JULY 17, 2024

By Mike Cloonan, Chief Executive Officer of Sionna Therapeutics, as part of the From The Trenches feature of LifeSciVC The drug development process in rare diseases is rife with challenges especially when companies target significant differentiation or first-in-class targets.

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Conversations in Drug Development Trends

JULY 9, 2024

These strategies are critical for enhancing the overall success of GLP-1 therapies in clinical practice. GLP-1 Drug Class: Market Overview The market for GLP-1 medications is expanding, with several establishing options and numerous promising therapies on the horizon.

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Advarra

AUGUST 10, 2023

Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases.

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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.

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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.

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PPD

OCTOBER 17, 2024

This expansion represents a significant opportunity for both drug developers and patients, while also presenting a new and diverse set of challenges for drug developers, particularly in clinical trial execution.

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FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. 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.

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Conversations in Drug Development Trends

NOVEMBER 5, 2024

In preparation for World Orphan Drug Congress Europe, we interviewed Nathan Chadwick, Senior Director, Therapeutic Strategy Lead, Rare Disease, and Derek Ansel, MS, LCGC, Vice President, Therapeutic Strategy Lead, Rare Disease, to hear their insights into the current progress in rare disease research and their hopes for 2025.

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PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. Whichever route a company takes, deliberate decision-making around the nature and timing of early phase studies is important to manage risks in the clinical development process.

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Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88 In Britain, 2.88

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Alta Sciences

OCTOBER 15, 2024

He was promoted to Associate Director, Program Management , in 2022, and now oversees a team of program managers who guide end-to-end solutions, including preclinical , clinical , CDMO , regulatory , and bioanalytical solutions. Keep your curiosity about life sciences fresh and keep learning about the drug development process!

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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

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Conversations in Drug Development Trends

JANUARY 24, 2024

Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. In my capstone, I focused on how, if, and when genetic counselors discuss clinical trials with their patients in the context of a counseling session.

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Alta Sciences

JUNE 21, 2024

With you in mind, we establish a clear and consistent path from drug discovery to delivery—one solution seamlessly connecting to the next. Ready for a simpler drug development journey? All you have to do is reach out and get the conversation started. WATCH THE VIDEO. Contact us today.

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PPD

SEPTEMBER 7, 2023

For more than 40 years, drug developers have been dedicated to advancing HIV clinical research in the quest for treatments and, ultimately, a cure. With continued evolution and access to treatment, the HIV drug development landscape is ripe with opportunity. million new infections in 2022. Since the U.S.

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Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Fierce BioTech

MARCH 12, 2024

For biopharma and biotech companies, FSP partnerships have emerged as a pivotal strategy for accessing the complementary expertise and resource flexibility they need to meet their timelines, and innovative providers are implementing new, globalized FSP strategies to keep their clients ahead of the curve.

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PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. In many cases, higher levels of sponsor oversight are even required by regulation.

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PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

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Conversations in Drug Development Trends

JUNE 13, 2024

Their webinar highlighted key initiatives like Project Optimus, recent study design trends, and the benefit a Bayesian model can have on your drug development program. However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development.

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