Conversations in Drug Development Trends

DECEMBER 7, 2023

Other drawbacks reported from working with these large CROs were: These performance disruptions and drawbacks have resulted in an environment of uncertainty among this CRO service provider segment in 2023, with likely ramifications extending into 2024 and beyond.

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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.

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Drug Discovery World

AUGUST 22, 2024

Prolonging health span with drug development Life Biosciences aims to restore and prolong a patient’s health span by targeting the underlying biology of ageing and increasing the quality of years one spends in good health compared with just increasing the total number of years one lives.

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Drug Target Review

AUGUST 28, 2024

Resolution has recently been granted clinical trial authorisation (CTA) approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for our EMERALD Phase I/II study which will begin in Q3 2024. J Hep, 2024 (EASL ILC 2024 Abstract #LBP-007). Reference 1 Brennan P et al.,

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Drug Discovery World

JULY 15, 2024

From 5-10 April 2024 in San Diego, the cancer research community gathered for the annual meeting of the American Association for Cancer Research (AACR). The AACR has more than 58,000 members residing in 141 countries and territories, and the 2024 conference attracted over 22,000 attendees.

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Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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Fierce BioTech

APRIL 10, 2024

Redefining Antibody Specificity Profiling for IND swheeler Wed, 04/10/2024 - 17:56 Thu, 06/06/2024 - 11:00 Resource Type Webinar Kris Raghavan, PhD Fernanda I. Staquicini, PhD Duration 60 minutes Assessment of antibody off-target reactivity is a regulatory requirement for clinical development.

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Drug Discovery World

MAY 3, 2023

Adcendo intends to use the proceeds from the financing to initiate a broad clinical development programme for uPARAP ADC in sarcoma and is also planning to advance the development of its 2nd ADC pipeline asset with Development Candidate Nomination (DCN) planned in the first half of 2024. Michael Pehl, Chief Executive Officer of Adcendo, said: “2022 (..)

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Drug Discovery World

MAY 6, 2024

Even before this, however, Amsterdam was established as an important centre for drug development. Under the partnership, KWF will provide funding to enable the development of select early phase clinical programmes through Cancer Research UK’s Centre for Drug Development (CDD).

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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Alta Sciences

MARCH 21, 2024

Top 5 Scientific Resources in CNS Clinical Trials blussier Thu, 03/21/2024 - 18:09 HTML CNS Center of Excellence Resource Library Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

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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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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.

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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. His remarks are worth reading in their entirety.

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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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Drug Discovery World

FEBRUARY 26, 2024

DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. As a result, this will mean fewer clinical studies will be run until investors start to increase investment back to clinical development.

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LifeSciVC

OCTOBER 18, 2023

As we think about our own future with our Phase 2 ready program, we discuss internally how well we fit venture funds’ criteria today and just what is an ’ideal‘ investment profile in 2023 going into 2024? In a market like today, later stage, clinically validated targets are a potentially ‘safer’ place to balance portfolios.

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Alta Sciences

MAY 29, 2024

How to Optimize Your Early-Phase Drug Development Program pmjackson Wed, 05/29/2024 - 20:32 The Challenges With Outsourcing Drug Development In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024.

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Vial

MARCH 27, 2024

from 2024 to 2030. The type of sponsorship must also be accounted for because academic institutions sponsoring clinical trials often have access to fewer financial resources compared with commercial sponsors, which typically have larger budgets for their drug development programs.

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LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. For others this may serve as a reminder of some of the pitfalls that can befall biotech companies this time of year and what the key questions are to ask yourself and the team to manage through the madness and finish strong in 2024. Don’t get me wrong.

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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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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.

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Drug Discovery World

MAY 23, 2024

This approach is particularly effective against diseases, such as cancer, in which attacking the disease from multiple therapeutic angles can prevent resistance development. DDW Volume 25 – Issue 2, Spring 2024 Biography Sam Deutsch is Chief Scientific Officer at Nutcracker Therapeutics, leading biological R&D.

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The Pharma Data

MARCH 23, 2023

Head of Global R&D ad interim and Chief Medical Officer at Sanofi “Change cannot come quick enough for people living with uncontrolled COPD but , unfortunately , many investigational treatments have failed to demonstrate significant clinical outcomes leaving these vulnerable patients with limited treatment options.

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Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” The new draft guidance can be broken into three main parts.

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Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

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PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

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Agency IQ

AUGUST 2, 2024

By Laura DiAngelo, MPH | Jul 29, 2024 9:52 PM CDT First up: HHS has a new digital technology office In July 2024, the Department of Health and Human Services (HHS) announced a reorganization of its digital health functions. We will further explore the potential of LLMs in a follow-up project in 2024,” the report concludes.

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Advarra

APRIL 4, 2024

As the board becomes familiar with the company’s protocols and reporting mechanisms, discussions can be more focused, potentially accelerating the pace of clinical development. Recent FDA Draft Guidance The importance of continuity in data monitoring is underscored by the 2024 FDA draft guidance on DMCs.

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LifeSciVC

MARCH 8, 2024

By Robert Clarke, CEO of Kinaset, as part of the From The Trenches feature of LifeSciVC As I write, I am on the train back from New York after watching my son’s NYU basketball team play in the 2024 D3 Men’s Basketball Tournament. Alas, NYU ran into a tough Tufts team in the second round and lost a tight one 65-62.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name.

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Agency IQ

AUGUST 16, 2024

By Rachel Coe, MSC | Aug 12, 2024 6:15 PM CDT Background For decades, sponsors have turned to maximum tolerated dose (MTD) as the primary method for dose selection in oncology. In early-stage development of traditional cytotoxic oncology drugs (i.e., To be [administered with] food or not to be?

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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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Drug Discovery World

JULY 3, 2024

Protocol AI, which was created by Risklick, a spin-off from the University of Bern, uses artificial intelligence to enable faster drafting of clinical trial protocols with the aim of accelerating drug development, reducing costs and improving safety standards. Meanwhile, Lugano-based Anthropos raised $2.7m

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Agency IQ

DECEMBER 11, 2023

What to look for in 2024: This year, OCE amassed a significant volume of feedback from its advisory committee members and from stakeholders via the rulemaking process on trial design. What to expect in 2024? As AgencyIQ stated previously , this point is well-aligned with the goal of OCE’s Project FrontRunner.

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Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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