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.

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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.

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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.

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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.

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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.

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Clinical Trials Trials Clinical Research Research 52

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.

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Clinical Trials Trials Clinical Research 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%

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Clinical Trials Trials Clinical Research Compliance 52

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.

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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.

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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.

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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.,

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Laboratories Clinical Trials Clinical Research Compliance 45

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 59

Disease Clinical Trials Clinical Pharmacology Trials 59

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.

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Clinical Development Drug Development International 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.

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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].

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

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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.

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Laboratories FDA Clinical Development Regulations 52

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.

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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.

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Clinical Supply Clinical Trials Doctors Clinical Development 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

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.

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Clinical Trials Clinical Research Science Trials 40

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.

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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.

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Vaccine Clinical Trials Long-Term Care Facilities Trials 52

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.

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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.

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The Pharma Data

JANUARY 10, 2021

Editas Medicine is preparing to initiate the RUBY clinical trial, a Phase 1/2 trial designed to assess the safety and efficacy of EDIT-301 for the treatment of sickle cell disease. The Company has identified a lead principal investigator and engaged a Clinical Research Organization (CRO). Source link.

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Clinical Trials Disease FDA Trials 52

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.

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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 40

Disease Clinical Development Molecular Biology Treatment 40

PPD

OCTOBER 24, 2024

Coordinated efforts are needed to combat this disease and improve the clinical status of persons with HBV infection. Currently there is no cure for hepatitis B, however there are several drugs in clinical development to improve the lives and clinical outcomes for persons with chronic HBV infection, including functional cure strategies.

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Vaccine Virus Treatment Disease 52

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.

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Trials Clinical Trials FDA Approval Therapies 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. Five Prime Webcast /Conference Call Information. This vision is what defines us and guides our research, clinical development and partnerships.

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The Pharma Data

APRIL 12, 2022

vice president and global head of oncology clinical development at AbbVie. “Data obtained from this exploratory analysis holds promise for potential future clinical research,” said Jacqueline S. More information can be found on www.clinicaltrials.gov (NCT03222609). Garcia, M.D.,

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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.

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Immune Response Clinical Trials Therapies Cell Biology 40

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 52

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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.

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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. Curr Probl Cancer. 2024;49:101075. Discov Oncol.

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