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

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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Precision for Medicine

APRIL 7, 2023

Our new state-of-the-art laboratory, combined with the deep knowledge of our scientists, gives an advantage to clients developing novel therapeutics and diagnostic products in oncology, liver disease, and skin diseases. This service accelerates the validation of these products and helps shorten the time for regulatory approvals.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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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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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 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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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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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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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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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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Vial

APRIL 24, 2024

The Vial Dermatology CRO Phase I unit provides a unified full-service solution to early clinical development. Syneos Health has completed more than 200 dermatology trials for indications that include psoriasis , atopic dermatitis, skin cancer , rare skin disorders, and skincare and medical aesthetic products.

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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

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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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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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

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

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The Pharma Data

SEPTEMBER 28, 2021

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. Merck has the industry’s largest immuno-oncology clinical research program.

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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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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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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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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

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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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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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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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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The Pharma Data

JANUARY 3, 2021

. Weber is a renowned melanoma specialist and leading immunotherapy translational and clinical scientist. Both will help NexImmune advance current early-stage clinical trials and will guide Company’s translational efforts to develop new immunotherapy products. GAITHERSBURG, Md.,

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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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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to treat a variety of acute and chronic diseases.

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Vial

MARCH 27, 2024

Ultimately, conducting an informed review of these cost factors will ensure companies make the best decision for their clinical development and operational needs. However, this will depend heavily on the specific circumstances of the trial.

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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7

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The Pharma Data

JUNE 25, 2021

Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinical development program, which includes over 20 clinical studies and more than 4,000 patients.

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The Pharma Data

APRIL 12, 2022

vice president and global head of oncology clinical development at AbbVie. “Data obtained from this exploratory analysis holds promise for potential future clinical research,” said Jacqueline S. The most common SAEs were pneumonia (n= 4, 12%) and splenic infarction (n= 2, 6%).2 Garcia, M.D.,

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The Pharma Data

OCTOBER 29, 2020

on clinical trial costs, throughout all study phases, across both regions. “We We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical.

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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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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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