Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. 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

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

The Pharma Data

JANUARY 27, 2021

“Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular. “Our commitment to supporting clinical research sites with strategic flexible resources has been increasingly important over the past 12 months in particular.

Clinical Research 40

Clinical Research Clinical Trials International Clinical Development 40

The Pharma Data

JANUARY 4, 2021

From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinical research, development, and lifecycle management of all promising oncology products. program and Institute for Immunity, Transplantation and Infection.

Pharma Companies 52

Pharma Companies Clinical Development Clinical Research International 52

PPD

JULY 18, 2023

Nearly two-thirds of drug developers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinical research business of Thermo Fisher Scientific. Performance management.

Clinical Development 52

Clinical Development Drug Development International Clinical Research 52

The Pharma Data

JANUARY 6, 2021

“Further, PDE4-inhibition is a well-documented pharmacological target for a number of other inflammatory indications, and we look forward to advancing our clinical research to realize the full potential of orismilast for the benefit of the millions of patients living with inflammatory conditions globally,” adds Professor Sommer.

FDA Approval 52

FDA Approval FDA Clinical Development Clinical Research 52

PPD

DECEMBER 5, 2023

By doing so, companies can augment their ongoing clinical research and sidestep the challenges of global extension, such as language barriers and compliance concerns, without the need to manage the in-country presence themselves. This facilitates smooth, on-schedule operations, de-risking the pipeline.

Clinical Development 52

Clinical Development Clinical Research Drug Development International 52

Vial

APRIL 10, 2024

The strong commitment to innovation allows IQVIA to provide advanced analytics, technology solutions, and industry-specific expertise in the health information technologies and clinical research domains. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. 2) An established FSO arrangement is to be replaced, and the developer needs to transition to FSP without disrupting momentum.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 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.

Clinical Trials 52

Clinical Trials Trials Clinical Development Clinical Research 52

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Our core areas of research are: Immunology.

Clinical Trials 40

Clinical Trials Trials Clinical Development Clinical Research 40

Vial

MARCH 27, 2024

Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials. Lastly, global trials will also require additional expenses for international site management, translation services, and regulatory consultants to ensure proper compliance in each participating country.

Clinical Trials 52

Clinical Trials Trials International Compliance 52

The Pharma Data

OCTOBER 29, 2020

on clinical trial costs, throughout all study phases, across both regions. “We We are very excited about this model that seamlessly incorporates two of the most compelling and complementary international clinical research hubs for our biotech clients from early to late phase studies,” said Yvonne Lungershausen, CEO of Avance Clinical.

Clinical Trials 40

Clinical Trials Trials International Biosimilars 40

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

Small Molecule 40

Small Molecule Clinical Development Production Science 40

PPD

DECEMBER 12, 2023

A follow-the-sun model offers several advantages, but it takes specialized expertise to implement and operationalize for clinical development and post-marketing surveillance. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation.

Compliance 52

Compliance Clinical Research Trials Clinical Trials 52

Drug Target Review

SEPTEMBER 26, 2023

1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. 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. International Union of Pharmacology.

Drugs 111

Drugs FDA Disease Animal Testing 111

The Pharma Data

DECEMBER 17, 2020

Cadavid will be responsible for the strategy, direction and execution of the company’s clinical development programs. Prior to Fulcrum, Cadavid held several leadership positions at Biogen, including Senior Medical Director of the multiple sclerosis clinical development group. Sinai Health Network.

Small Molecule 52

Small Molecule Engineering Clinical Development Pharmaceuticals 52

The Pharma Data

DECEMBER 14, 2020

Both ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis.

Clinical Trials 40

Clinical Trials Clinical Development Production Trials 40

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. All clinical development plans are subject to additional funding. ” “I am excited about the potential of NVG-291,” stated Dr. .”

Disease 40

Disease Clinical Development Molecular Biology Treatment 40

Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7 This means study startup times can vary greatly.

Trials 52

Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

NOVEMBER 19, 2020

Hyman currently serves as director of the Stanley Center for Psychiatric Research at the Broad Institute of MIT and Harvard and is the Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology. Previously, Baffa was Therapeutic Area Head of Oncology, Global Clinical Development for Shire.

Laboratories 52

Laboratories Research Laboratories Science Organic Chemistry 52

Drug Target Review

DECEMBER 13, 2024

7,8 The discovery of these biomarkers provides valuable insights into prognosis and disease progression, while also guiding the clinical development of new targeted immunotherapies. Antibody-drug conjugates treatment of small cell lung cancer: advances in clinical research. Discov Oncol. 2024;15(1):327. 2022;39(1):89-103.

Therapies 52

Therapies Treatment Clinical Trials Drugs 52

The Pharma Data

JANUARY 14, 2021

Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 2063209.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

APRIL 22, 2023

. “We have reached an important milestone with the dosing of the second participant in our clinical trial evaluating a potentially groundbreaking CAR T-cell therapy to cure HIV,” said Mehrdad Abedi, professor of internal medicine, hematology and oncology and co-investigator of the study.

Clinical Trials 40

Clinical Trials Trials Therapies Treatment 40

Molecule Blog

MARCH 17, 2023

This phase is typically executed by private biotech labs and/or contract research organizations, funded by venture capital and/or pharma balance sheets. Once an experimental medicine has undergone all clinical development phases, the company files a new drug application ( NDA  — or MAA ), which can be approved or denied by the FDA (or EMA).

Engineering 52

Engineering Research Clinical Trials Government 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 Trials Vaccine 40

The Pharma Data

NOVEMBER 10, 2020

About Tiziana Life Sciences Tiziana Life Sciences plc is a UK biotechnology company that focuses on the discovery and development of novel molecules to treat human disease in oncology and immunology. In addition to Milciclib, the Company is also developing Foralumab for liver diseases. NEW YORK and LONDON, Nov.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

The Pharma Data

NOVEMBER 1, 2020

This clinical trial will be coordinated by the team at the INTRIALS, a leading, full-service Latin America Clinical Research Organization (CRO), based in Sao Paulo City, Brazil. The clinical data from this trial is expected to available by the end of this year. Brazil has reported almost 5.5M

Clinical Trials 40

Clinical Trials Trials Medical Schools Hospitals 40

The Pharma Data

JULY 29, 2021

Gilead presented additional lenacapavir clinical development program data at the International AIDS Society (“IAS”) 2021 Conference on HIV Science. Gilead announced interim results from the Phase 3 study (MYR301) of bulevirtide for the treatment of HDV at the International Liver Congress (“ILC”) 2021 annual meeting.

Science 52

Science Production Treatment FDA 52

Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

FDA 40

FDA Production Regulations Vaccine 40

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 Clinical Trials Research 69

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

Science 40

Science FDA Production Trials 40

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. This convergence of trials, labs and data sciences is driving faster clinical development and approval.

Clinical Research 40

Clinical Research Research Engineering Clinical Development 40

The Pharma Data

JULY 15, 2021

“These highly anticipated event-free survival results in this TNBC population build upon earlier findings from the KEYNOTE-522 trial and further support the potential use of KEYTRUDA in these patients,” said Dr. Vicki Goodman, vice president, clinical research, Merck Research Laboratories.

Therapies 52

Therapies Treatment Trials FDA 52

The Pharma Data

MARCH 17, 2022

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. Key studies in earlier stages of NSCLC include KEYNOTE-091, KEYNOTE-671, KEYNOTE-867 and KEYLYNK-012. About ETOP.

Therapies 52

Therapies Clinical Trials Disease Treatment 52

The Pharma Data

DECEMBER 13, 2020

Harrison, MD, Director, Summit Clinical Research. The worldwide impact of COVID-19 may notably affect the Company’s internal organization and efficiency, particularly in countries where it operates and where confinement measures are implemented by the authorities.

Trials 40

Trials Disease Treatment Pharmacokinetics 40