Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. These datasets can help find providers and patients based on genetic information.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

PPD

OCTOBER 31, 2023

If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinical research outsourcing models have changed over time to accommodate the industry’s evolving needs.

International 52

International Clinical Research Clinical Development Research 52

Drug Target Review

SEPTEMBER 5, 2024

However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

Drug Discovery World

APRIL 29, 2024

It has encouraged cannabis-derived and cannabis-related drug teams to contact the relevant Center for Drug Evaluation and Research (CDER) review division and CDER’s Botanical Review Team (BRT) to answer questions related to their specific drug development programme. Ann Intern Med. 2022;175(8):1143.

Research 147

Research FDA Production Drug Development 147

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

PPD

NOVEMBER 14, 2023

Clinical research requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

Drug Discovery World

DECEMBER 26, 2023

Atropos Health and SEQSTER Real-world data company Atropos Health and SEQSTER, a provider of patient-centric healthcare data technology, have partnered to accelerate patient registries in clinical research. The collaboration will advance the speed-to-insight for many underrepresented populations served by registry-based research.

Small Molecule 130

Small Molecule Drugs Molecular Biology Bioinformatics 130

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

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

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 adopts a fixed-fee pricing model devoid of change orders to streamline cost-effectiveness in drug development.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

Alta Sciences

SEPTEMBER 13, 2023

Pain models can be important clinical tools to characterize a novel analgesic, and determine its potential effectiveness in models simulating varying pain stimuli. Here are four main pain models we use to assess treatments in clinical trials: 1. WHY IS PAIN RESEARCH SO IMPORTANT?

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

Vial

MARCH 25, 2024

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. According to Hardman et al.,

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

Drug Development 40

Drug Development Clinical Trials Vaccine Trials 40

Conversations in Drug Development Trends

AUGUST 9, 2024

However, implementing adaptive trial designs within MRCTs requires careful consideration of international regulatory standards to optimize patient outcomes and resource efficiency. The International Council for Harmonisation of Technical Pharmaceuticals for Human Use provides guidelines, but local adaptations and interpretations still vary.

Trials 80

Trials Clinical Trials Regulations FDA 80

Vial

FEBRUARY 15, 2024

Sponsors often contract a CRO to delegate specific day-to-day tasks, streamlining their research processes and enhancing efficiency. Patient recruitment and retention : Recruiting and retaining a sufficient number of eligible participants is one of the major challenges in conducting clinical trials.

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

Drug Discovery World

JULY 5, 2023

MG: I meet regularly with the brilliant European scientists driving cutting edge global cancer research. Europe is a hub for comprehensive cancer centres where basic research, clinical research and clinical care are centralised within one institute. RA: What’s next for cancer research/the industry?

Research 246

Research Immune Response Pharmaceutical Companies Treatment 246

Vial

MARCH 27, 2024

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.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

Drug Discovery World

JANUARY 24, 2023

In early November 2022, two Alzheimer’s drugs were tested head-to-head in a first-ever virtual clinical trial 3. ” 4,5,6 Asking the right questions Norstella is a newly formed company that aims to guide life sciences companies through drug development so patients can access therapies quicker. The Lancet Oncology.

Clinical Trials 242

Clinical Trials Trials Drugs Treatment 242

PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

Conversations in Drug Development Trends

NOVEMBER 3, 2022

BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. enrollment by diversifying U.S. altogether.”.

Disease 52

Disease Clinical Trials Trials International 52

The Pharma Data

NOVEMBER 1, 2020

Dr Nurbhai has more than 25 years of experience and a strong track record in the strategic and operational leadership of all phases of clinical research and development at companies across Europe and the US. Prior to VHsquared, Suhail was Senior Vice President and Head of Development and Medical Affairs for Shionogi in Europe.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

Drug Discovery World

AUGUST 3, 2023

Dr Sodergren told DDW in an exclusive comment: “I am hopeful that over the next few years we will see further investments by governments and funding bodies to accelerate pre-clinical and clinical research programmes. Examples of people on the Power List include Susan Audino in the Analytical Heroes category. deletion syndrome.

Clinical Trials 130

Clinical Trials Regulations Production FDA 130

PerkinElmer

FEBRUARY 18, 2021

Which high throughput screening (HTS) approach is the most productive in finding hits for drug development: target-based or phenotypic? These simple, stable compounds, used to treat various conditions, are the focus for 78% of preclinical research. Outsourcing is filling internal gaps when it comes to screening.

Biochemical Assays 52

Biochemical Assays Drugs Small Molecule Pharma Companies 52

Conversations in Drug Development Trends

APRIL 3, 2024

Our experience also shows that providing adequate continuing education materials to internal site-level committees is particularly important; doing so ensures that each site is always in compliance and provides a smoother study process.

Trials 81

Trials Clinical Trials Compliance Treatment 81

Conversations in Drug Development Trends

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.

Clinical Research 69

Clinical Research Trials Research Clinical Trials 69

Drug Discovery World

SEPTEMBER 28, 2022

This means that the technique can be applied without the need for any data to be released to third party companies or to be sent between hospitals or across international borders.’. NEC, the Japanese IT and electronics corporation, has pivoted towards drug discovery with a focus on personalised medicines.

Pharma Companies 130

Pharma Companies Hospitals Clinical Trials Drugs 130

The Pharma Data

DECEMBER 15, 2020

At present, the company has developed a number of original new drug product lines for oncology, metabolic diseases, autoimmune diseases, central nervous diseases, and antiviral diseases. View original content: [link].

Pharmaceuticals 40

Pharmaceuticals Small Molecule Clinical Trials Production 40

Drug Discovery World

JANUARY 12, 2023

Here, Thomas reflects specifically on Anita Cooper’s prediction relating to the importance of clinical trials. . DDW shared a global data analysis from Phesi, which showed the extent of the impact from the war in Ukraine on clinical development.

Clinical Trials 243

Clinical Trials Drugs Trials Pharmaceutical Companies 243

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. He currently serves as chair of the medical and scientific advisory group and as a member of the Board of Directors of the Alzheimer’s Association.

Disease 40

Disease Clinical Development Molecular Biology Treatment 40

Drug Target Review

JULY 6, 2023

Animal testing plays a significant role in pre-clinical research and therefore requires the use of millions of animals. 1 Over a quarter of those were for basic research purposes, with most common areas focused on the immune system, the nervous system and oncology. In Britain, 2.88 2020 [cited 2023Feb24]. 2022;12(7):3049–62.

Animal Testing 105

Animal Testing Drugs Clinical Trials Clinical Research 105

Precision for Medicine

JANUARY 23, 2023

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. About QuartzBio QuartzBio helps overcome the data chaos inherent in modern drug development.

Clinical Research 40

Clinical Research Research Engineering Clinical Development 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

FDA 40

FDA Trials Regulations Therapies 40

PPD

DECEMBER 5, 2023

Non-footprint countries are regions where drug developers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drug developers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.

Clinical Development 52

Clinical Development Clinical Research International Drug Development 52

Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

OCTOBER 22, 2020

In parallel with the clinical trials of Veklury, we worked to rapidly expand drug supply, knowing that if proven effective, there would be significant patient need for Veklury. In clinical research, the gold standard for demonstrating the efficacy and safety of a drug is the randomized, double-blind, placebo-controlled trial.

Science 52

Science Clinical Trials Hospitals FDA Approval 52

PPD

MARCH 13, 2024

The role of the clinical logistics monitor (CLM) is a focal point of contact and an escalation point to the internal and external teams. As a conduit, their role is to assess the timelines together, being the liaison with the manufacturing organization and implementing risk management and mitigation.

Clinical Development 98

Clinical Development Clinical Trials Therapies Laboratories 98

Agency IQ

MARCH 1, 2024

Start Date End Date Event Event Type Center 02/26/2024 02/26/2024 FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop Public CDER 02/27/2024 02/27/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer, Black History Month Program: “Real Talk: Our Stories as Black Oncologists at the FDA” Webcast (..)

FDA 40

FDA Science Clinical Trials Regulations 40