The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. ” About Ascletis.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme. Related Articles: Cabenuva (cabotegravir and rilpivirine) FDA Approval History. Source: GSK .

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Cytel

DECEMBER 29, 2023

Perspectives has explored a myriad of topics this year within clinical development — from adaptive trial design to advice on regulatory submission to clinical data best practices, and so much more — all written by our many expert authors. As we approach the end of the year, take a look at our most-read articles of 2023:

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,

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Agency IQ

FEBRUARY 2, 2024

In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs.

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Conversations in Drug Development Trends

OCTOBER 31, 2023

Last year, we witnessed a significant milestone in oncology clinical development, with almost 50% of all development programs focused on oncology assets. To encourage further expansion and innovation in cancer studies, it’s critical to consider what contributes to success in an oncology trial.

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Drug Target Review

AUGUST 28, 2024

Available from: [link] About the author Cliff Brass, MD PhD FAASLD, Chief Medical Officer at Resolution Therapeutics Cliff Brass is an expert in clinical development with special expertise in liver disease and over 25 years of experience in pharma. He is named on 15 patents relating to drug development in liver disease.

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Drug Target Review

DECEMBER 13, 2023

The article mentions that TLR4 antagonists have been identified as potential candidates for repurposing long COVID treatment. 42 genes were found to be potentially tractable for novel drug discovery approaches for long COVID, of these 13 genes have drugs in clinical development pipelines.

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Drug Target Review

JULY 18, 2023

This article is the second part of my interview with Olivia Cavlan, Chief Corporate Development and Strategy Officer at Alchemab Therapeutics Ltd, this time exploring the AI applications in personalised medicine, and the evolving landscape of drug development.

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Plenge Gen

MARCH 10, 2021

As a post-doc and, eventually, head of clinical development at a now defunct Bay Area biotech company in the 1990’s, she did research on genetically engineered T cells and hematopoietic stem cells to redirect the immune system to specifically target and kill cancer and HIV-infected cells.

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New Drug Approvals

APRIL 8, 2025

This article incorporates text from this source, which is in the public domain. “Discovery of vimseltinib (DCC-3014), a highly selective CSF1R switch-control kinase inhibitor, in clinical development for the treatment of Tenosynovial Giant Cell Tumor (TGCT)” Bioorganic & Medicinal Chemistry Letters. 74 : 128928.

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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.

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Conversations in Drug Development Trends

FEBRUARY 6, 2023

For a deep look into the best practices and considerations for including genetic testing in your clinical development strategy, read this article by our Aman Khera, Vice President, Global Head of Regulatory Strategy and Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Diseases. Read the full article!

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The Pharma Data

DECEMBER 29, 2020

The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. Any of these intentions may alter in light of future development. ” About Ascentage Pharma. Forward-Looking Statements.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Alta Sciences

NOVEMBER 15, 2024

As the CRO, our role is to provide a broader perspective and identify additional areas where our expertise can support their development program,” explains Lisa. For example, at Altasciences, we can discuss clinical development strategies that include adding study arms such as ethnobridging , or early precision QT analysis assessments.

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Agency IQ

AUGUST 23, 2024

While the centralized procedure has offered sponsors a simplified process for application preparation, submission and review, the same could not be said for submitting investigational applications earlier in clinical development for the conduct of clinical trials—that is, until recently.

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Drug Target Review

SEPTEMBER 5, 2024

All types of activities encouraging women in STEM is important, like this article. Already, three candidates are in clinical development and the lead candidate is ready to enter Phase III. How do you see the representation of women in STEM changing over the years, and what further progress do you believe is needed?

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Agency IQ

FEBRUARY 12, 2024

Far from just an outline of the work completed by Consortium members to date, the Playbook is a thoughtfully organized “how-to-guide” which walks readers through some of the major milestones of early clinical development in just over one hundred pages.

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Drug Target Review

FEBRUARY 10, 2025

Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies. My focus has always been on advancing novel medicines from research to clinical development. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

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Cytel

MAY 5, 2023

For this edition of the Industry Voices series, Cytel’s Chief Product Officer & General Manager Scott Gaines discusses how simulation-guided design and Cytel’s Solara® clinical strategy platform have evolved clinical development strategy, enabling sponsors to select optimal designs even as clinical trials involve more study objectives and more (..)

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The Pharma Data

JANUARY 12, 2021

Dr Graham is a medicines development expert and Infectious Diseases Epidemiologist with global Biotech and Pharma R&D experience in Phase I-IV therapeutics as well as in-vivo & in-vitro diagnostics, across many modalities. He has in depth Global Development Expertise (e.g. Dr. Graham earned an M.D., About Tiziana Life Sciences.

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Drug Target Review

JULY 11, 2023

In this article, I spoke to Olivia Cavlan, Chief Corporate Development and Strategy Officer at Alchemab Therapeutics Ltd, about how AI is transforming the landscape of disease research, unlocking a treasure trove of knowledge that may hold the key to a healthier future. Cavlan will explore more of these ends in our next article.

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Agency IQ

APRIL 12, 2024

Similarly, ARM suggested that the term “candidate potency-related quality attribute” be used in the early stages of clinical development to discuss product attributes that are thought to be linked to potency, but where the “criticality (mechanistic relationship) of the attributes” to product potency has not yet been established.

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The Pharma Data

NOVEMBER 26, 2020

The EGM resolved on amendment of § 4 (share capital) and § 5 (number of shares) of the Articles of Association for the purpose of enabling the directed issue of shares and warrants, as resolved by the Board of Directors on 27 October 2020 subject to the approval by the EGM. § LUND, Sweden , Nov. LUND, Sweden , Nov. sammanläggning 1:25 ).

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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H1 Blog

JUNE 7, 2023

Performance data on principal investigators and clinical trial sites provides invaluable insights to pharma companies, helping them leverage successful sites and patient populations to maximize their clinical development feasibility and operations. There is a tendency to want to measure everything.”

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Cytel

DECEMBER 16, 2022

Bayesian methods have been playing a key role in transforming clinical research, and Bayesian topics are frequently featured in Cytel’s Perspectives on Enquiry and Evidence. Our new ebook features a set of articles exploring various topics related to Bayesian statistical methods. Topics include:

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Cytel

DECEMBER 27, 2022

Bayesian methods have been playing a key role in transforming clinical research, providing a variety of new opportunities for efficient and flexible clinical trials. Here are some of our most-read articles on Bayesian methods in 2022. Bayesian topics are frequently explored in Perspectives on Enquiry and Evidence.

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Labcorp Drug Development

APRIL 17, 2023

In a 2022 Hepatology article, researchers estimated that the one-year increase in alcohol consumption during the pandemic would result in an … The post Alcohol-related liver disease: Inherent Challenges and Strategies for Successful Clinical Trial Conduct appeared first on Insights From Our Labs to Yours.

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Cytel

DECEMBER 19, 2022

Adaptive clinical trial topics are frequently explored in Perspectives on Enquiry and Evidence. Here are some of our most-read articles on adaptive clinical trials of 2022.

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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: . 7am PDT.

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Vial

APRIL 10, 2024

This article provides a comparative overview of Vial and IQVIA. IQVIA’s core strengths lie in its specialized global IT infrastructure tailored for healthcare, analytics-driven clinical development, a robust ecosystem of real-world solutions, and an expanding suite of proprietary clinical and commercial applications.

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Drug Target Review

MARCH 17, 2025

With over 25 years of experience in the pharmaceutical industry, Donello has been instrumental in drug discovery and development. Donello has led numerous international scientific collaborations, acquisition integrations, and the in-licensing and out-licensing of various drug programmes.

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Alta Sciences

MARCH 21, 2024

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking. In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.

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Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. She holds an MD and PhD and has contributed to understanding mechanisms of resistance in acute leukemias.

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