Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Watch the video. Listen here.

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Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

Drug Target Review

MARCH 17, 2025

He has contributed to more than 130 granted patents and advanced over 12 clinical drug candidates across various therapeutic areas, including cognition, depression, pain and other disorders. This concept is crucial in early drug discovery because it challenges traditional methods of drug development, where the focus is often on the PK.

Treatment 52

Treatment Licensing Licensing Science 52

KIF1A

SEPTEMBER 30, 2023

Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.

Disease 111

Disease FDA Clinical Trials Therapies 111

Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. In other cases, well-established biomarker profiles enable patient enrichment strategies in early-stage clinical development.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

Drug Target Review

FEBRUARY 29, 2024

From a very young age, I was drawn to science and medicine. This early exposure to bench science had a long-lasting impact. 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.

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Therapies Disease Clinical Trials Science 111

NIH Director's Blog: Drug Development

SEPTEMBER 26, 2019

Science Translational Medicine, 2019 Researchers continue to produce impressive miniature human tissues that resemble the structure of a range of human organs, including the livers, kidneys, hearts, and even the brain. As published in Science Translational Medicine , they more than met the challenge. Credit: McAleer et al.,

Drugs 72

Drugs Science Treatment Clinical Trials 72

The Pharma Data

JANUARY 31, 2021

–( BUSINESS WIRE )– Gilead Sciences, Inc. While HIV treatment has advanced dramatically over the past three decades, people living with HIV still face a lifetime of therapy,” said Diana Brainard, MD, Senior Vice President, Virology Therapeutic Area, Gilead Sciences. About Gilead Sciences. Gilead Sciences, Inc.

Vaccine 52

Vaccine Science Clinical Trials Licensing 52

Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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Clinical Trials Trials Clinical Research Drug Development 98

Drug Target Review

JULY 26, 2024

We have a dual aim: to use the power of sequencing for more personalised patient care; and to be able to leverage those datasets to progress various programmes within drug discovery. That is how we see these datasets working for life sciences companies. That ability to go back to the patient is unique for the HRN.

Clinical Trials 72

Clinical Trials Science Trials International 72

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. In fact, the evidence suggests that such drugs might even offer some protection against heart disease.

Drugs 52

Drugs Disease Drug Development Clinical Trials 52

Cytel

JUNE 5, 2023

Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative, computational, regulatory, and strategic drug development capabilities.

Drug Development 52

Drug Development Science Drugs Clinical Development 52

Cytel

JUNE 5, 2023

Cytel recently announced the launch of its Therapeutics Development Team, bringing together quantitative, computational, regulatory, and strategic drug development capabilities.

Drug Development 52

Drug Development Science Drugs Clinical Development 52

NIH Director's Blog: Drug Development

SEPTEMBER 29, 2015

As described in Proceedings of the National Academy of Sciences [2], this new tool is poised to predict earlier, faster, and less expensively which new or untested compounds—be they drug candidates or even ingredients in cosmetics and pesticides—might harm the brain, particularly at the earliest stages of development.

RNA 52

RNA Science Laboratories Clinical Trials 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.

Vaccine 52

Vaccine Clinical Development RNA Clinical Trials 52

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

Drug Development 64

Drug Development Clinical Supply Production FDA 64

The Pharma Data

DECEMBER 28, 2020

Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc.

Clinical Development 40

Clinical Development Doctors Drug Development International 40

LifeSciVC

OCTOBER 18, 2023

However, the challenge here lies in the finite number of experienced leaders/drug development teams that can operate these companies and are also willing to bet on the future upside. In a market like today, later stage, clinically validated targets are a potentially ‘safer’ place to balance portfolios.

Clinical Development 63

Clinical Development Marketing Clinical Trials Production 63

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

The Pharma Data

JULY 6, 2021

PGRN is a key regulator of immune activity in the brain with genetic links to multiple neurodegenerative disorders, making it one of the most attractive genetically validated targets for the development of new immuno-neurology treatments. billion in clinical development, regulatory and commercial launch-related milestone payments.

Disease 52

Disease Science Treatment Clinical Development 52

The Pharma Data

SEPTEMBER 15, 2020

. Sign up today to understand how to implement an affordable supply-forecasting tool into your clinical supply chain. Irena Seredina holds a Medical Doctor, honors diploma and a Master of Science degree in Health Economics. During her medical practice, Seredina worked in clinical research as an investigator.

Clinical Supply 52

Clinical Supply Clinical Trials Doctors Clinical Development 52

The Pharma Data

FEBRUARY 21, 2022

At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We

Clinical Trials 52

Clinical Trials Small Molecule Clinical Development Disease 52

The Pharma Data

OCTOBER 19, 2020

20, 2020 /PRNewswire/ — Caris Life Sciences® , a leading innovator in molecular science focused on fulfilling the promise of precision medicine, announced today that Winship Cancer Institute of Emory University (Winship) has joined Caris’ Precision Oncology Alliance (The Alliance/POA). . IRVING, Texas and ATLANTA , Oct.

Clinical Trials 52

Clinical Trials RNA DNA Science 52

The Connected Lab

APRIL 8, 2020

How is AI being applied in Drug Discovery efforts? It is reported that every one of the major pharmaceutical companies has announced a partnership with at least one AI-based drug development company, but how is AI being used to facilitate drug development? A Tough Road: Cost To Develop One New Drug Is $2.6

Pharma Companies 52

Pharma Companies Laboratories Drugs FDA Approval 52

The Pharma Data

JANUARY 20, 2021

Franchi is an experienced board member, finance executive and operational leader with more than three decades of experience in the life sciences industry. “I am honored to join the Dynacure Board and am eager to help the team advance its pipeline through development.” Franchi to its Board of Directors. ” Ms.

Treatment 40

Treatment Pharmaceuticals Drug Development Science 40

Precision for Medicine

JANUARY 23, 2023

SolveBio’s intelligent technologies and enterprise data management platform has integrated into QuartzBio’s suite of SaaS solutions, providing a single, scalable solution supporting clinical sample inventory management and biomarker data management for the biotech and pharmaceutical sectors. Canada, Europe and Australia.

Clinical Research 40

Clinical Research Research Clinical Development Engineering 40

Drug Target Review

SEPTEMBER 26, 2023

CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.

Drugs 111

Drugs FDA Disease Animal Testing 111

The Pharma Data

JANUARY 18, 2021

Potential first-in-class disease-modifying biologic in late-stage clinical studies. Experienced executive development team from Gilead Sciences. ” Vera has executive and clinical development teams with deep experience in drug development and commercialization from Gilead Sciences.

Disease 40

Disease Science Clinical Development Treatment 40

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

Vaccine 52

Vaccine Clinical Trials Long-Term Care Facilities Trials 52

The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

Clinical Trials 52

Clinical Trials FDA Trials Production 52

The Pharma Data

DECEMBER 13, 2020

Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. Before that, he was Director of Development at Cobalt Biomedicine leading CAR-T and other cell/gene therapy programs, and R&D Director at OvaScience developing stem cell-based products.

Medical Schools 40

Medical Schools Clinical Development Therapies RNA 40

FDA Law Blog: Drug Discovery

MARCH 7, 2024

Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. It is also reflective of evolving FDA perspectives, in addition to evolving regulatory science.

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Clinical Trials Trials FDA Regulations 105

Agency IQ

JULY 21, 2023

An earlier report highlighted three key areas for international regulatory consideration when employing AI in drug development. EMA notes in the paper that many learnings and best practices from areas such as model informed drug development and biostatistics also can be applied to AI. image refinement).

Science 40

Science Clinical Trials Trials Regulations 40

Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025. How do you envision the future of drug discovery evolving over the next decade? See more information about Kristina here: [link]

Disease 52

Disease Drugs Treatment Drug Development 52

LifeSciVC

JANUARY 16, 2024

The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinically develop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Figure 2 shows pipelines across modalities for some of the competitive targets today.

Small Molecule 140

Small Molecule Trials Therapies Disease 140

The Pharma Data

APRIL 6, 2022

Change in Global Drug Development (GDD) Leadership. as President, Global Drug Development and Chief Medical Officer effective May 16th, 2022. Aradhye has dedicated his entire professional career to improving patient lives, first as an academic clinician and then as a drug developer and business leader.

International 52

International Pharmaceuticals Drug Development Marketing 52

FDA Law Blog: Drug Discovery

OCTOBER 2, 2023

Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e.,

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