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. You can expect transparency.

Clinical Development

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. As we look towards future developments in oncology and beyond, the importance of strategic regulatory planning and execution cannot be overstated.

Clinical Research

PPD

NOVEMBER 9, 2023

The possibility for change needs to be ethically sound and clear to all involved, including investigators, site staff and cross-functional team members, like clinical monitors, statisticians, data managers and vendors. Each step of the process is conducted with an eye toward supporting later-phase programs and regulatory submissions.

Clinical Development

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.

Clinical Development

PPD

SEPTEMBER 6, 2023

Examples of Hybrid Outsourcing Strategies for Clinical Trials For biotech and biopharmaceutical organizations, a strong CRO partner with broad experience in both FSO and FSP engagements is necessary to guide the right mix of service models to use.

Drug Development

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

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

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

Trials

PPD

OCTOBER 16, 2023

Consent development: Informed consent is the most important step in the tokenization process. Part of the operational model includes selection of the tokenization vendor and determining what technology and data sources are required. If you don’t tokenize today, you may miss an opportunity to do so tomorrow.

Clinical Trials

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

Clinical Trials

Conversations in Drug Development Trends

AUGUST 23, 2023

Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself. Canary Advisors recommends including patient advisory boards, which a sponsor, CRO, or patient advocacy organization can create in the early stages of clinical development.

FDA

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

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. Risks to CtQs factors should be proactively managed and risk language/monitoring adjusted according to new and changing information during the clinical trial.

Clinical Trials

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

Drug Target Review

JUNE 6, 2023

Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy. Our deep interest in the interplay between immune cells, cytokines, and the tumour microenvironment has informed our clinical research to date as well as our IO pipeline program.

Engineering

The Pharma Data

JANUARY 4, 2021

Rothenberg did not provide any information as to what his next role may be – whether he will take over the helm of a pharma company or assume a role on one or more boards of directors. “Aida is an extremely accomplished physician-scientist as well as an inspirational leader.

Pharma Companies

Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

Laboratories

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. Regular review and management of KPIs and budget. Performance management.

Clinical Development

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

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. For more information, visit www.cromsource.com. VERONA, Italy , Jan. ” About CROMSOURCE. Logo – [link].

Clinical Research

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

Laboratories

Drug Target Review

MAY 7, 2024

For instance, AI algorithms could facilitate patient-trial matching, encompassing medical records, genetic information, demographics, and personal preferences. At Debiopharm, he has overseen both preclinical and clinical pharmacology of assets from phase I to III.

Disease

Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline. Improving Communication Between FDA and Sponsors.

Therapies

The Pharma Data

SEPTEMBER 15, 2020

Join best-in-class experts from S-Clinica to discuss how IRT and supply forecasting grants sponsors the flexibility to utilize information consistently and accurately, while helping to reduce supply drug waste and efficiently manage study and potential and existing inventory changes. The webinar will take place at: . 7am PDT.

Clinical Supply

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

Precision for Medicine

MAY 24, 2023

CRO Leadership Awards recognize companies judged by customers as exceeding expectations BETHESDA, MD, May 25, 2023 – Precision for Medicine, the first biomarker-driven clinical research organization (CRO), announces its wide recognition in the 2023 CRO Leadership Awards. For more information, visit PrecisionForMedicine.com.

Clinical Trials

Precision for Medicine

JUNE 26, 2023

About Precision for Medicine Precision for Medicine is the first biomarker-driven clinical research and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. For more information, visit PrecisionForMedicine.com.

Science

PPD

MAY 11, 2023

From study participants’ consent, to minimizing the patient and caregiver burden, to planning for different needs at different stages of the pediatric immune system, there are many factors to consider when conducting clinical research with this specific population.

Vaccine

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. You can expect transparency.

Clinical Development

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

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. For further information, please contact: Huitt Tracey, Corporate Communications htracey@nervgen.com c: 604.537.2094. Corey Davis Ph.D.,

Disease

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. Rigorous data security measures are essential.

Compliance

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 It can also potentially drive up net costs of the research.

Trials

The Pharma Data

JANUARY 3, 2021

We are very honored to have someone of Dr. Zeldis’ caliber lead our scientific research and clinical development teams. Later as CMO and President of Clinical Research, Medical Affairs, Drug Safety, Quality, and Regulatory at Sorrento Therapeutics, Inc, he helped to advance its unique immuno-oncology programs.

Immune Response

The Pharma Data

OCTOBER 1, 2021

The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.

Disease

The Pharma Data

OCTOBER 22, 2020

The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem, and for working capital and general corporate purposes.

Clinical Trials

Vial

MARCH 27, 2024

Ultimately, conducting an informed review of these cost factors will ensure companies make the best decision for their clinical development and operational needs. Given the steadily growing popularity of outsourcing, hiring a CRO may end up being the more cost-effective solution in many case.

Clinical Trials