Conversations in Drug Development Trends

JANUARY 24, 2024

Written By: Derek Ansel, MS, CCRA, Executive Director, Therapeutic Strategy Lead, Rare Disease Given that 80% of rare diseases have a genetic etiology, genetic implications should be addressed at the onset of a clinical program to support trial enrollment. One diagnostic example that I discussed in my presentation is autism.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

Trials 80

Trials Clinical Trials Regulations FDA 80

Drug Discovery World

NOVEMBER 6, 2023

Under the partnership, KWF intends to provide funding to enable the development of select early phase clinical programmes through Cancer Research UK’s Centre for Drug Development (CDD). The CDD will sponsor and manage KWF-supported trials. Collaboration with like-minded organisations is essential to what we do.

Research 130

Research Clinical Trials Clinical Development International 130

PPD

JUNE 7, 2023

Food and Drug Administration (FDA) for approval , much work remains for drug developers aiming to advance treatments for pediatric populations. Reflecting Patient Diversity in NASH Trials Data from NASH clinical trials within adult populations may support clinical research into treatment for pediatric populations.

Trials 98

Trials Clinical Trials Clinical Research Disease 98

Conversations in Drug Development Trends

APRIL 3, 2024

As with other targeted therapies, radiopharmaceutical development requires unique and specialized strategies to ensure successful execution. Are you aware of the challenges you must address for a successful radiopharmaceutical trial? These include ensuring informed consent, particularly around the risks and benefits of participation.

Trials 81

Trials Clinical Trials Compliance Treatment 81

H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. A recent McKinsey analysis of drugs and vaccines developed since 2000 shows that it takes nearly ten years to go from clinical testing to approval.

Trials 59

Trials Clinical Trials International Regulations 59

Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

Clinical Trials 130

Clinical Trials Drugs Trials Therapies 130

Vial

MARCH 25, 2024

Introduction Worldwide Clinical Trials vs. Vial. Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

Drug Discovery World

MARCH 20, 2024

Cancer Research UK and the Norwegian Cancer Society (NCS) have announced a new multi-project strategic partnership to maximise the unique drug development capabilities of both countries. Suitable projects will then be brought into the CDD post-approval for its experienced team to plan, sponsor and run an early-phase clinical trial.

Drugs 130

Drugs Clinical Trials Licensing Licensing 130

Drug Discovery World

DECEMBER 9, 2022

The benefits of collaboration have also been seen in the announcement of positive trial data for Jardiance, a type 2 diabetes treatment created by an alliance between Boehringer Ingelheim and Eli Lilly, while various research groups team up to bring us closer to a HIV vaccine. . Partnership hopes to advance precision drug development .

Vaccine 130

Vaccine Drugs Clinical Trials Disease 130

Drug Discovery World

MAY 6, 2024

billion on R&D during 2021, with Germany and Switzerland being the biggest contributors, and around one fourth of clinical trials worldwide were performed in Europe 1. Even before this, however, Amsterdam was established as an important centre for drug development. The CDD will sponsor and manage KWF-supported trials.

Drugs 147

Drugs Science Molecular Biology International 147

Drug Discovery World

SEPTEMBER 7, 2023

However, despite the fact that children’s response to adult cancer drugs is often poor, due to the challenges of developing medicines for this population, only six drugs are made specifically for childhood cancer. This could have profound impacts on end-stage patients who have previously had little or no treatment options.

Clinical Trials 147

Clinical Trials Trials Drugs DNA 147

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

H1 Blog

JULY 19, 2023

Streamlining recruitment and reporting to support advanced oncology drug development In March of 2023, the U.S. In order to qualify for accelerated approval, drug manufacturers must demonstrate that the medication provides meaningful clinical benefit to patients with life-threatening illnesses during their clinical trials.

Clinical Trials 52

Clinical Trials Trials FDA Treatment 52

Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). In particular, regulations in both the U.S.

Clinical Trials 40

Clinical Trials Trials Science FDA 40

Drug Discovery World

JANUARY 24, 2023

DDW Multimedia Editor Megan Thomas observes the 2023 drug discovery landscape, speaking to industry experts and looking at the foundations of 2022 on which next year will lean. Virtual clinical trials ‘Virtual’ and ‘technology’ are concepts which are readily exchanged in this industry, but these are more than just buzzwords.

Clinical Trials 242

Clinical Trials Trials Drugs Treatment 242

Drug Discovery World

FEBRUARY 7, 2023

Orbit Discovery has entered a partnership with Endevica Bio following the release of data proving that the company’s lead compound is safe and well-tolerated in Phase I trials.

Cell Based Assays 130

Cell Based Assays International Drug Development Trials 130

Drug Discovery World

FEBRUARY 29, 2024

Dr Alexander Shneider, the primary author of the paper and CureLab’s founder, argues the results prove the deficiencies in mechanism-based drug development. He said: “After five decades and hundreds of billions spent, relatively few drugs have made it to medical practice using the mechanism-based approach.

DNA 130

DNA Drug Development Vaccine International 130

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.

52

52

Drug Discovery World

JUNE 6, 2023

The international RAMP-201 study, led by researchers from The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK, and sponsored by Verastem Oncology, tested avutometinib alone and in combination with defactinib in 29 patients with LGSOC.

Drugs 130

Drugs Treatment Clinical Trials Trials 130

Drug Target Review

AUGUST 28, 2024

The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.

Therapies 114

Therapies Disease Engineering Medical Schools 114

Drug Discovery World

MARCH 16, 2023

International Journal of Molecular Science, 21(4): 1537. Therapeutic targeting of FLT3 and associated drug resistance in acute myeloid leukemia. Around one third of patients with AML are diagnosed with FLT3-mutations, which are associated with a higher risk of relapse and poor clinical outcome. and Leung, A. and Wang, H-G.

Treatment 130

Treatment FDA FDA Approval Drug Development 130

PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Despite advances in technology and innovation, pharmaceutical leaders say that trials are increasingly complex, particularly when it comes to patient recruitment and site engagement. With a median delay of 12.2

Clinical Research 52

Clinical Research Research Pharmaceuticals Clinical Trials 52

Drug Discovery World

OCTOBER 20, 2022

DDW Multimedia Editor Megan Thomas takes a broad look at the drug discovery and development landscape in Japan and highlights how it is bolstered by government policies, investment, collaboration, start-up ecosystems and academic research. . Overview . Start-up ecosystem . Japan is evolving with such ecosystems.

Drugs 130

Drugs International Science Government 130

Drug Discovery World

AUGUST 31, 2022

A new study, published in the Annals of Internal Medicine , shows that higher levels of viral antigen in the blood, which could indicate ongoing SARS-CoV-2 replication, correlated with more severe disease. .

Hospitals 130

Hospitals Trials Virus International 130

Drug Discovery World

MARCH 13, 2024

In terms of drug discovery, every year the agency awards national grants through the Singapore Therapeutics Development Review (STDR), designed to boost the quality and quantity of drug development and biotech pipelines in Singapore 3.

Government 173

Government Science Pharmaceuticals Vaccine 173

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

Pharmaceutical Companies 98

Pharmaceutical Companies Clinical Research Clinical Development Drug Development 98

Vial

MARCH 27, 2024

The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. However, because these trials come with a significant financial burden, sponsor companies are constantly seeking ways to optimize their operations.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

Drug Discovery World

JANUARY 23, 2023

Additionally, the clinical trial period will be considerably shorter than that required for new drug development. In this regard, cladribine could become a standard future treatment for GBM.” Taken together, this study demonstrates that DGKB and DGAT1 are potential therapeutic targets for overcoming GBM radioresistance.

FDA Approval 130

FDA Approval FDA Drugs Pharmacokinetics 130

Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. Deepika Khedekar, Clinical Trial Lead at IQVIA, provides an overview of the pros and cons, and suggests a possible solution.

Clinical Research 147

Clinical Research Research Clinical Trials Trials 147

Drug Discovery World

SEPTEMBER 14, 2023

The collaboration contemplates conducting preclinical studies and a Phase I clinical trial evaluating the safety and efficacy of the combination with the objective of further enhancing IMA203 T cell responses. Evaluating Immatics’ IMA203 TCR-T therapy, targeting PRAME, in combination with Moderna’s PRAME mRNA-based cancer vaccine.

Vaccine 130

Vaccine Bioinformatics Clinical Trials Therapies 130

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Drug Discovery World

JUNE 29, 2023

It’s been another busy month for senior appointments in the drug discovery sector. David Favre, Chief Development Officer, SpliceBio Dr Favre brings more than 25 years of experience in gene therapy, immunology and drug development throughout academia and the biopharma industry.

Drugs 130

Drugs Laboratories Research Laboratories Clinical Trials 130

Drug Discovery World

OCTOBER 16, 2023

From the Beatson Institute for Cancer Research in Glasgow, to Edinburgh Drug Discovery in the University of Edinburgh’s Institute for Genetics and Cancer (IGC). At ELRIG’s Scottish Research and Drug Development Forum meeting, DDW’s Diana Spencer provided a snapshot of drug discovery in Scotland.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

Drug Discovery World

APRIL 29, 2024

Even after high quality research is done, the US Food and Drug Administration (FDA) review of the data from rigorous clinical trials will be needed to ensure that those products are safe and efficacious for the various therapeutic uses for which they are being proposed. Ann Intern Med. 2022;175(8):1143. Epub 2022 Jun 7.

Research 147

Research FDA Drug Development Production 147

Drug Discovery World

OCTOBER 21, 2022

Enanta Pharmaceuticals, a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, has dosed the first subject in its Phase I clinical trial of EDP-323, a novel, oral L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV). .

Small Molecule 130

Small Molecule Virus Drugs Clinical Trials 130

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. Moreover, an extra six months of RDP for drugs with full comparator clinical trials (rather than showing only that a drug is no worse than the standard of care).

Clinical Trials 130

Clinical Trials Pharma Companies Biosimilars Production 130