Conversations in Drug Development Trends

AUGUST 15, 2023

Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations.

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Cytel

AUGUST 28, 2023

A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drug development and helps ensure that new therapies are safe, effective, and of high quality.

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Fierce BioTech

JULY 19, 2023

Don't miss this opportunity to gain valuable insights and explore the future of clinical development. png Listing Introduction Join us for an engaging webinar that explores how innovative automation capabilities are transforming the landscape of clinical development in the life sciences industry. Click here to login.

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Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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PPD

NOVEMBER 9, 2023

Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey. The partner you select for your early phase studies is critical in enabling you to achieve your overall development timeline efficiently and within budget.

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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.

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Cytel

FEBRUARY 3, 2023

For clinical development and research and development teams, the Pareto Frontier can perform two functions. Let’s take a closer look:

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Cytel

JANUARY 13, 2023

Bayesian methods, with their ability to facilitate flexibility and learning, are often associated with early-phase clinical trials. Yet there are also many strategic uses of Bayesian methods in late-phase clinical trial design, which can help generate more effective, efficient, and ethical clinical trials.

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Cytel

JANUARY 17, 2024

Despite accumulating learnings from early phases, several uncertainties remain to be addressed when designing pivotal trials. Adaptive trials can help mitigate uncertainties; however, the trade-offs and their impact differ in the confirmatory setting.

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The Pharma Data

DECEMBER 14, 2020

AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. About AlgoTherapeutix AlgoTx was founded in 2018 by Stéphane Thiroloix and Olivier Bohuon to develop topical treatments for complex pain and was incubated by Paris Biotech Santé. Source link.

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The Pharma Data

MARCH 23, 2022

Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July. He also led the expansion of Merck’s research and development in China and Japan. “It Baynes will be succeeded by Dr. Eliav Barr, senior vice president, Global Clinical Development.

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Drug Discovery World

JANUARY 15, 2024

This agreement reflects the creativity and commitment of scientists and clinical development teams at Harpoon. We look forward to further evaluating HPN328 in innovative combinations with other pipeline candidates.”

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. GAITHERSBURG, Md., 30, 2020 (GLOBE NEWSWIRE) — Novavax, Inc.

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Drug Discovery World

MARCH 10, 2023

Cancer Research UK and UCB have agreed a clinical development collaboration to advance two of UCB’s investigational oncology antibody candidates through clinical trials.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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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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Drug Discovery World

JANUARY 11, 2024

Vice President, Clinical Development, Infectious Diseases at Moderna examines the data on cytomegalovirus (CMV), why attempts at vaccines for CMV have so far proved elusive and the emerging options to address this unmet need. In the first article, Allison August, M.D.,

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Drug Discovery World

APRIL 18, 2023

AVA3996 is in pre-clinical development with the aim of submitting an Investigational New Drug (IND) application to allow clinical development to begin during 2024. “We are focused on accelerating AVA3996 through to IND filing as soon as possible so that it can follow AVA6000 into the clinic next year.”

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The Pharma Data

SEPTEMBER 29, 2021

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development.

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Clinical Development Disease Clinical Trials Trials 52

Drug Discovery World

DECEMBER 22, 2023

The trial met all pharmacokinetic objectives, so the company plans to progress the candidate into further clinical development and will meet with the US Food and Drug Administration (FDA) at a Pre-IND meeting in the first half of 2024. We now look forward to the next stage of clinical development.”

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Drug Discovery World

SEPTEMBER 28, 2023

Can a manufacturer of a cell or gene therapy switch suppliers midstream in clinical development? What are the costs and time delays of switching suppliers later in clinical development? How will not having a GMP supplier impact the speed a therapy gets to market?

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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.

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Drug Discovery World

DECEMBER 5, 2023

The agreement will enable the parties to discuss opportunities for collaboration to support the charity’s research and clinical development activities, focusing primarily on its clinical trials run by its Centre for Drug Development.

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Drug Discovery World

MARCH 15, 2024

“We are excited to begin the next phase of development with the initiation of two 28-day patient studies, the first studies of ALX-001 in people living with Alzheimer’s and Parkinson’s disease,” commented Tim Siegert, Chief Operating Officer and Co-Founder of Allyx Therapeutics. “We

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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 27, 2024

The results support the continued clinical development of VXX-401 as a candidate for the treatment of hypercholesterolemia and prevention of atherosclerotic cardiovascular disease. New studies have demonstrated that Vaxxinity’s vaccine VXX-401 reproducibly lowers low-density lipoprotein cholesterol (LDL-C) in non-human primates.

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The Pharma Data

MAY 2, 2021

Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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Cytel

MARCH 11, 2024

In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising non-oncology rare diseases. Clinical development in rare diseases has specific challenges. Effective clinical development strategy for rare diseases requires agility to adapt to accumulating learning.

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Drug Discovery World

JANUARY 23, 2024

These high levels of attrition at Phase II may slow the rate at which new therapies reach market and are likely to have an ongoing effect on the clinical development industry, adding to rising costs.

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The Pharma Data

FEBRUARY 24, 2022

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition.

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Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

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Cytel

NOVEMBER 8, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development, and Ari Brettman, Senior Managing Director, Blackstone Life Sciences When working with investors, it’s critical that drug and device developers consider how their clinical trial design aligns with investment priorities. Let’s take a closer look:

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The Pharma Data

JULY 28, 2021

– If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1. today announced that the U.S.

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Drug Discovery World

MAY 11, 2023

Under the terms of the agreement, Bicycle will utilise its proprietary phage platform to discover and develop bicyclic peptides and Bayer will be responsible for, and fully fund, all further preclinical and clinical development, manufacturing, and commercialisation activities. billion.

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Drug Discovery World

APRIL 17, 2024

Under the terms of the transaction agreements, Novartis will be responsible for worldwide clinical development and commercialisation of ARV-766 and will have all research, development, manufacturing, and commercialisation rights with respect to the preclinical AR-V7 programme.

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Drug Discovery World

MARCH 15, 2024

Using Exploristics’ study simulation software platform, KerusCloud, the companies established a more efficient, data-driven approach to study design and protocol development within Exonate’s clinical development programmes in retinal vascular diseases.

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Drug Discovery World

APRIL 24, 2024

Evotec will identify best-in-class small molecules targeting a key fibrotic pathway with strong genetic support identified by Variant Bio and progress the programme towards the selection of a clinical development candidate(s) using its R&D platform.

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