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

Vial

MARCH 1, 2024

Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market. billion in 2023 attributable to its laboratory products and biopharma services segment (53.8%

Clinical Trials 52

Clinical Trials Clinical Research Trials Laboratories 52

PPD

JULY 6, 2023

How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves. Our recent survey on industry trends found that 51% of drug developers denote the increasing complexity of clinical trials as a top challenge, along with patient recruitment (55%) and regulatory hurdles (46%).

Clinical Trials 98

Clinical Trials Trials Drug Development Testimonials 98

The Pharma Data

NOVEMBER 9, 2020

It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.”. “We

Research Laboratories 52

Research Laboratories Laboratories Treatment Therapies 52

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

SEPTEMBER 28, 2021

“Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. Merck has the industry’s largest immuno-oncology clinical research program.

Research Laboratories 52

Research Laboratories Clinical Research Treatment Disease 52

The Pharma Data

AUGUST 31, 2021

“While the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “We

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 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.

Clinical Trials 40

Clinical Trials Clinical Research Science Trials 40

PerkinElmer

JANUARY 25, 2023

Laboratory professionals in all areas of science have experienced significant changes in recent years, and 2022 was no exception. Experts in the diagnostics and life sciences industry look back on 2022 and lend their insights on the major trends and technologies shaping laboratories in 2023.

Science 52

Science Laboratories Immune Response Disease 52

The Pharma Data

NOVEMBER 19, 2020

Evenstad served as chief executive officer of Upsher-Smith Laboratories. ZIOPHARM – Mary Thistle, special adviser for the Bill & Melinda Gates Medical Research Institute, was appointed to the board of directors of Ziopharm Oncology. Previously, Baffa was Therapeutic Area Head of Oncology, Global Clinical Development for Shire.

Laboratories 52

Laboratories Research Laboratories Science Organic Chemistry 52

Vial

FEBRUARY 29, 2024

However, despite their increasingly ubiquitous role in the clinical research industry, the question remains as to the extent of their participation. That is, how many clinical trials are actually managed by these organizations? Understanding the Numbers: How Many Clinical Trials Utilize CROs? between 2023 and 2032.

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

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

Disease Laboratories Clinical Pharmacology Treatment 52

The Pharma Data

AUGUST 10, 2021

“The FDA’s acceptance of our application adds to our momentum of advancing new treatment options to address the most challenging cancers facing women,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. Merck has the industry’s largest immuno-oncology clinical research program.

FDA 52

FDA Therapies Treatment Clinical Research 52

The Pharma Data

APRIL 8, 2021

“Since its first approval in renal cell carcinoma nearly two years ago, KEYTRUDA has become an important first-line treatment option in combination with axitinib for patients with advanced renal cell carcinoma,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories.

Therapies 52

Therapies Disease Treatment Research Laboratories 52

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. He spent 27 years at Merck & Co.

Small Molecule 52

Small Molecule Engineering Clinical Development Pharmaceuticals 52

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. Bethesda, Md.,

Science 40

Science Small Molecule Clinical Research Engineering 40

The Pharma Data

JUNE 25, 2021

Merck is continuing to study KEYTRUDA, in combination or as monotherapy, as well as other investigational products across multiple settings and stages of RCC including adjuvant and advanced or metastatic disease through our broad clinical development program, which includes over 20 clinical studies and more than 4,000 patients.

Disease 52

Disease Therapies Treatment Medical Schools 52

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.

Vaccine 52

Vaccine Virus Treatment Disease 52

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

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

NOVEMBER 10, 2020

This potentially ground-breaking approach for immunotherapies originated in my laboratory and was subsequently reported by other researchers in the field.”. 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 30, 2020

“I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. on October 22, including those at high risk of severe complications of COVID-19 disease. at large.

Vaccine 52

Vaccine FDA Clinical Trials Disease 52

The Pharma Data

JUNE 26, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring.

Doctors 52

Doctors Treatment Hospitals Clinical Trials 52

The Pharma Data

MARCH 23, 2021

“There have been few advances in improving survival outcomes in the first-line treatment setting for esophageal cancer over the last three decades,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We

Treatment 52

Treatment FDA Approval FDA Therapies 52

The Pharma Data

APRIL 4, 2023

Merck has the industry’s largest immuno-oncology clinical research program. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Treatment 40

Treatment FDA Approval FDA Therapies 40

Precision for Medicine

MAY 14, 2024

Now with 125,000 square feet of state-of-the-art capability, the facility offers significantly increased capacity and scale across both biorepository and laboratory services, with particular focus on cell and gene therapy, oncology and viral research. This convergence is driving faster clinical development and approval.

Laboratories 49

Laboratories Research Clinical Research Clinical Trials 49

PPD

NOVEMBER 8, 2022

PPD, Thermo Fisher Scientific’s clinical research business, surveyed more than 150 biotech and biopharma leaders this year to assess trends in the drug development industry, yielding data we’ll cite throughout this blog.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

The Pharma Data

NOVEMBER 22, 2020

Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Islatravir is a promising antiviral candidate with evidence from ongoing clinical trials to support its development as a once-monthly oral PrEP agent.

Trials 52

Trials Clinical Trials International Production 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

For drugs, the rationale should describe data and information, if any, that suggest the potential for differential safety and effectiveness across the clinically relevant population, such as possible differences in PK or PD. providing language assistance); Reducing participant burden (e.g.,

FDA 59

FDA Clinical Trials Disease Trials 59

Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. 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.] representative population.

FDA 40

FDA Science Clinical Trials Production 40