Cytel

JANUARY 23, 2023

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture.

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Drug Discovery World

FEBRUARY 12, 2024

“In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. In 2024, we can expect another wave of innovative new drugs to be developed using the technology, given that the AI-fuelled small molecule discovery pipeline is growing by almost 40% annually.”

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Conversations in Drug Development Trends

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.

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Drug Discovery World

FEBRUARY 10, 2023

Three of the top five most-studied disease areas fell within oncology, with prostate cancer the third most-studied disease, solid tumours fourth, and stroke fifth. “Oncology remains an area of high investment in clinical development, however, 2022 has seen a widespread scale back of overall activity.

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The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. About Chronic Kidney Disease CKD is a common and potentially deadly condition that is widely underrecognized.

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Vial

MARCH 1, 2024

By geographical region, the global CRO services market in 2023 was dominated by North America. 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.

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. 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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PPD

JUNE 13, 2023

It is imperative that the right vaccine development partner demonstrates expertise from early clinical development to study design, execution, regulatory submission and commercialization. Working with a vertically integrated organization can further accelerate market entry.

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Vial

FEBRUARY 29, 2024

From the pre-clinical testing and lead discovery, to human testing and post-marketing surveillance, CROs offer a comprehensive array of services that sponsors now commonly seek out. There’s no doubt the market value for CROs is trending upwards; in 2022 alone, the CRO market was estimated to be worth US$56.7

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Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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PPD

OCTOBER 31, 2023

If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinical research outsourcing models have changed over time to accommodate the industry’s evolving needs.

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PPD

SEPTEMBER 6, 2023

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. Rebadge staffing is a critical part of an FSP model in clinical research. What is rebadging in an FSP model?

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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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Laboratories FDA Clinical Development Regulations 52

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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Precision for Medicine

MAY 24, 2023

CRO Leadership Awards recognize companies judged by customers as exceeding expectations BETHESDA, MD, May 25, 2023 – Precision for Medicine, the first biomarker-driven clinical research organization (CRO), announces its wide recognition in the 2023 CRO Leadership Awards. For more information, visit PrecisionForMedicine.com.

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The Pharma Data

MAY 2, 2023

Mr. Bonello has more than 30 years of financial leadership experience, including 15 years in the clinical research industry. a clinical trial data collection company, since 2021. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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Precision for Medicine

JUNE 26, 2023

Baseline Control’s expertise will become part of Project Farma, Precision for Medicine’s existing biomanufacturing strategy and execution group, expanding the scope of its manufacturing solutions for life science companies and driving greater speed and efficiency in bringing new drugs to market. Bethesda, Md.,

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Drug Discovery World

OCTOBER 16, 2023

The country’s pioneering genomics research, crucial for future drug discovery, is demonstrated by institutes like the Wellcome Sanger Institute and projects like the 100,000 Genomes Project. The UK is additionally able to serve the US market with excellent international cultural and linguistic links.

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Conversations in Drug Development Trends

MARCH 7, 2024

Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

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Vial

APRIL 24, 2024

The Vial Oncology CRO offers sponsors solutions to support their research, including optimized study design, innovative patient recruitment strategies, and advanced data analytics. By partnering with Vial, sponsors conducting oncology clinical trials can accelerate getting innovative therapies to market.

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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.

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The Pharma Data

SEPTEMBER 28, 2021

The CHMP’s recommendation will now be reviewed by the ecu Commission for marketing authorization within the European Union. Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories.

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PPD

JULY 6, 2023

How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves. Our recent survey on industry trends found that 51% of drug developers denote the increasing complexity of clinical trials as a top challenge, along with patient recruitment (55%) and regulatory hurdles (46%).

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The Pharma Data

AUGUST 31, 2021

This label update follows the FDA’s Oncologic Drugs Advisory Committee (ODAC) meetings held earlier this year as part of an industry-wide evaluation of indications based on accelerated approvals that have not met their post-marketing requirements.

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The Pharma Data

SEPTEMBER 11, 2020

“The ability to deliver remdesivir via a long-acting, subcutaneous injection has the potential to expand its application in countries with less developed healthcare systems and help improve patient convenience,” Fairley added. Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease.

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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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The Pharma Data

DECEMBER 14, 2020

Attention: Equity Capital Markets, 55 East 52nd Street, 37th Floor, New York, NY 10055, by telephone at (888) 474-0200, or email: ecm.prospectus@evercore.com ; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by email: prospectus@cantor.com.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. The global esophageal cancer drugs market is estimated to grow by USD $1.5

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FDA Drugs Clinical Development Pharmaceutical Companies 52

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. Searching for overlap might allow the investigational product to have a more rapid marketing authorization in multiple regions. Japan, and China.

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The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

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The Pharma Data

NOVEMBER 9, 2020

Merck and Eisai intend to discuss their new data with global regulatory authorities, with the intent to submit marketing authorization applications based on these results. It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity.

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Research Laboratories Laboratories Treatment Therapies 52

Vial

MARCH 27, 2024

Increasing Demand for Contract Research Organization (CRO) Support CROs are pivotal to the successful execution of clinical trials, offering a tailored resource of expertise, services, and logistical support that can significantly streamline the process for sponsors. from 2024 to 2030.

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PPD

NOVEMBER 9, 2023

Decreased timelines A flexible and adaptive protocol provides the potential to expedite drug development timelines by decreasing the overall duration of the early development/Phase I stage. Expediting time to market in this way is extremely valuable for those who ultimately benefit from improved therapeutic care.

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The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. All clinical development plans are subject to additional funding. ” “I am excited about the potential of NVG-291,” stated Dr. .”

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The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

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The Pharma Data

NOVEMBER 10, 2020

Crohn’s Disease Therapeutics Market Size $4.7 Phase1b/2 clinical study to be conducted in the United States and several European countries. The CD therapeutic market size will be worth $4.7 billion by 2025, according to Grand View Research 1. Billion by 2025. NEW YORK and LONDON, Nov.

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