Drug Target Review

JULY 1, 2025

Chief Executive Officer Steve Herne has spent more than 25 years in clinical research, with senior roles at WCG, Bioclinica and Covance. Unlearn’s digital twins are now in use in both early and late-stage clinical trials, with adoption continuing to grow. Unlearn is one of the few companies applying this approach at scale.

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PPD

JUNE 17, 2025

These hubs support a geographically distributed remote workforce that provides greater stability and project continuity while offering the global expertise and capabilities needed to bolster clinical development success.

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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. Additionally, consider the locations of your trial; if it is multiregional, you can start planning for your overall product approval strategy.

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Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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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

NOVEMBER 9, 2023

Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey. The partner you select for your early phase studies is critical in enabling you to achieve your overall development timeline efficiently and within budget.

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PPD

MARCH 11, 2025

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. Developing effective ECs requires more than just matching clinical trial inclusion and exclusion criteria within the RWD source.

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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. There is a race in the field to overcome these challenges to enable the success of CGT products in Asia-Pacific.

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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. are outsourced.

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Drug Target Review

MAY 23, 2025

It takes a family to develop a drug Trembles role at Poolbeg is multifaceted, reflecting the collaborative ethos of the companys scientific team. I take responsibility for identifying pre-clinical research that can support our clinical programs, as well as designing and overseeing its execution, he explains.

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Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. Canada, Europe and Australia. For more information, visit PrecisionForMedicine.com.

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Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), Logos Attribution 0 Attribution 0 Primary Category Biotech On Demand Off Enable Automatic On Demand On Registration Login Link Already registered?

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PPD

SEPTEMBER 6, 2023

Under the stresses of the COVID-19 pandemic, drug development organizations faced difficult decisions about keeping staff employed and productive. Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges.

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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.

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New Drug Approvals

JULY 8, 2025

Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV). It is currently in Phase III clinical development by the German biopharmaceutical company AiCuris Anti-infective Cures AG. Crute, J.J.; Tsurumi, T.; Olivo, P.D.;

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PPD

JUNE 13, 2023

To rise above the competition, sponsors must understand the common pitfalls of vaccine development and have strategies in place to avoid them. It is imperative that the right vaccine development partner demonstrates expertise from early clinical development to study design, execution, regulatory submission and commercialization.

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Advarra

NOVEMBER 29, 2022

Recent Problems in Cell and Gene Therapy Development. Dealing with confusing regulatory guidelines is one of the top obstacles researchers face as they develop CGT products 1. In the last two years, there haven’t been any CGT product approvals, primarily because of the COVID-19 pandemic.

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The Pharma Data

JANUARY 4, 2021

From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products.

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PPD

JUNE 22, 2023

If your company is struggling to hire qualified clinical research associates (CRAs), you’re not alone. A decade-long CRA talent shortage intensified as the COVID-19 pandemic increased strain on the clinical research industry at large.

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PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

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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. Escalations and risk mitigation. Performance management.

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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. The clinical development process.

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The Pharma Data

JANUARY 4, 2021

for expanding activities in the US with its initial focus on facilitating clinical development. Burr Boulevard, Teaneck, NJ 07666 (3) President: Yasushi Miyazawa (4) Scope of business: Clinical research and development (5) Paid in capital: US$100,000. (2) Location: 500 Frank W.

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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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The Pharma Data

SEPTEMBER 15, 2020

During her medical practice, Seredina worked in clinical research as an investigator. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric. The webinar will take place at: .

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PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.

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The Pharma Data

JANUARY 7, 2021

Galecto has an exciting pipeline of product candidates within fibrosis and cancer and a lead candidate in phase 2 for Idiopathic pulmonary fibrosis (IPF). Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta. Dr. Prener holds a Ph.D.

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Vial

FEBRUARY 29, 2024

However, despite their increasingly ubiquitous role in the clinical research industry, the question remains as to the extent of their participation. That is, how many clinical trials are actually managed by these organizations? Understanding the Numbers: How Many Clinical Trials Utilize CROs? between 2023 and 2032.

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The Pharma Data

DECEMBER 14, 2020

The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.

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The Pharma Data

DECEMBER 17, 2020

He previously served as vice president, for drug device industrialization at AbbVie, where he led product scale-up and industrialization projects for drug-device combinations. Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs.

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Conversations in Drug Development Trends

MARCH 7, 2024

Here are a few factors to consider: Key Distinctions Between CTAs and INDs One primary distinction to note between a CTA and an IND submission is that the CTA is protocol-specific, while the IND is product-specific. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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The Pharma Data

NOVEMBER 9, 2020

It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. The product is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight off tumor cells. Source link.

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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. Ready to maximize your operational efficiency?

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Precision for Medicine

JUNE 26, 2023

About Precision for Medicine Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Bethesda, Md.,

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PPD

MAY 11, 2023

From study participants’ consent, to minimizing the patient and caregiver burden, to planning for different needs at different stages of the pediatric immune system, there are many factors to consider when conducting clinical research with this specific population.

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Molecule Blog

MARCH 17, 2023

For instance, many of the top-selling therapeutics available today were originally developed in academia and had to navigate the difficult path of translation. The process of transforming a therapeutic or technology from the research and development stage into a market-ready product or service is intricate and laden with obstacles.

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