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. We are acutely aware that turnover in key project team personnel can lengthen project timelines and inflate clinical trial costs.

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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.

Clinical Research 95

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 95

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.

Trials 95

Trials Clinical Trials Clinical Development Clinical Research 95

PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

Clinical Development 52

Clinical Development Clinical Trials Trials Clinical Research 52

Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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Therapies Clinical Trials FDA Production 52

Drug Target Review

FEBRUARY 29, 2024

Through further research and work as a principal investigator on clinical studies for several central nervous system indications, I laid the groundwork for a career in gene therapy drug development. AskBio) I continue to work to bring innovative gene therapies to patients in need.

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Therapies Disease Clinical Trials Science 111

Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

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Trials Disease Clinical Trials Clinical Research 75

PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8

Drug Development 88

Drug Development Clinical Trials Drugs Small Molecule 88

LifeSciVC

JULY 17, 2024

We already have the first-ever clinical-stage NBD1 stabilizer and a second series of highly potent NBD1 stabilizers that are advancing to Phase 1 this summer. While we are excited by the progress we have made in a short time, we also considered how we could possibly further accelerate and de-risk our development efforts.

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Clinical Research Disease Research Clinical Trials 44

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.”. In July, finerenone was approved under the name Kerendia® by the us (U.S.)

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Clinical Development Disease Clinical Trials Trials 52

Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

Engineering 98

Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

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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Drug Development Clinical Trials Drugs Clinical Research 98

Creative Biolabs

MAY 25, 2022

Fu, 2022) Clinical research progress of ADC After decades of efforts, more than 100 ADCs are currently under clinical development. The overview of the mechanisms of ADC for killing cancer cells via different approaches. (Fu,

Therapies 52

Therapies Drugs DNA Treatment 52

PPD

NOVEMBER 30, 2023

To get a pulse on the changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments. Stakeholders across the drug development sphere will unlock the transformative potential of AI.

Clinical Trials 95

Clinical Trials Trials Clinical Research Drug Development 95

LifeSciVC

JULY 11, 2023

Redig, SVP and Head of Clinical Development at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J.

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Therapies Trials Clinical Development Science 65

Drug Target Review

MAY 7, 2024

Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

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.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

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Clinical Trials Clinical Research Trials Laboratories 52

Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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FDA Therapies Clinical Trials Disease 40

Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

Drug Target Review

OCTOBER 16, 2024

It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinical development process.

Clinical Development 52

Clinical Development Drug Development Therapies Disease 52

Vial

MARCH 25, 2024

With neuroscience experience in Alzheimer’s Disease (AD) and dementia, neurology , pain and addiction, rare and other diseases, and psychiatry, Worldwide has been involved in neuroscience research since the 1970s. With more than 30 years of experience in cardiovascular research, Worldwide has global trial experience in all phases.

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Clinical Trials Trials Clinical Development Clinical Research 52

The Pharma Data

AUGUST 31, 2021

today announced a label update for KEYTRUDA, Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer) in the U.S. Food and Drug Administration (FDA) has converted this indication from an accelerated to a full (regular) approval. Source link: [link].

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FDA Approval Treatment FDA Research Laboratories 52

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.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

PPD

OCTOBER 16, 2023

There has been continuous growth in the variety and volume of available health care data, and newer applications for use of real-world data (RWD) and real-world evidence (RWE) to enhance the speed of patient access to new therapies. If you don’t tokenize today, you may miss an opportunity to do so tomorrow.

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Clinical Trials Trials Research Therapies 80

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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Drug Development Disease Clinical Trials Drugs 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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Clinical Research Clinical Trials Trials Drug Development 52

The Pharma Data

JANUARY 6, 2021

Currently, oral treatment options for plaque psoriasis are limited, and many patients with moderate-to-severe psoriasis are receiving systemic injectable therapies. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

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FDA Approval FDA Clinical Development Clinical Research 52

Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Vial

APRIL 24, 2024

In addition to the areas above (aside from DTx), Syneos Health offers biosimilars , cell and gene therapy , endocrine and metabolic, immunology and inflammation, infectious diseases, pediatrics, respiratory, and women’s health services. Digital therapeutics is not explicitly listed as a therapeutic area of expertise for Syneos Health.

Clinical Trials 52

Clinical Trials Trials Biosimilars Disease 52

PPD

JUNE 17, 2024

For a developer using an FSO model but looking to evolve the way they undertake clinical trials, a bespoke FSP/FSO hybrid solution can provide a smooth transition to FSP outsourcing. This approach enables unbroken continuity of support and resources across clinical trial operations.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

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. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.

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Drug Development Disease Therapies Engineering 52

Precision for Medicine

JUNE 26, 2023

Unraveling the complexity of manufacturing next-gen biologics is critical to the shared mission of accelerating patient access to new therapies,” said Chad Clark, President of Precision for Medicine. This convergence is driving faster clinical development and approval. Bethesda, Md., For more information, visit projectfarma.com.

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Science Small Molecule Clinical Research Engineering 40

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

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group.

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Small Molecule Engineering Clinical Development Pharmaceuticals 52

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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Clinical Trials Clinical Research Science Trials 40

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

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Clinical Trials Trials Clinical Research Research 52