PPD

APRIL 14, 2025

To that end, the PI can ensure patients understand the science of appetite and metabolic regulation, for example, to relieve some of the self-imposed expectations for instant weight loss or other quick signs of success. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

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Fierce BioTech

AUGUST 19, 2024

As advancements in medical science progress, clinical research and development (R&D) are subject to more sophisticated and complex study designs and protocols that require precise global coordi | Market Insights: What’s Driving the Shift Toward FSP Models in Clinical Development?

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Conversations in Drug Development Trends

MAY 1, 2024

By: Sarah Bly and Aman Khera, Regulatory Science and Innovation The journey of bringing a new therapeutic agent from the laboratory to the marketplace is fraught with challenges, not least of which is navigating the complexities of regulatory feedback, which do not always converge but can diverge.

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LifeSciVC

JULY 17, 2024

Specialty companies can play an important role in accelerating clinical development, especially in rare diseases like cystic fibrosis by being strategically opportunistic and moving quickly. The post Looking for Opportunities to Accelerate Clinical Research in Rare Diseases appeared first on LifeSciVC.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture.

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PPD

NOVEMBER 9, 2023

Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey. The partner you select for your early phase studies is critical in enabling you to achieve your overall development timeline efficiently and within budget.

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Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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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.

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Precision for Medicine

JUNE 26, 2023

Baseline Control’s expertise will become part of Project Farma, Precision for Medicine’s existing biomanufacturing strategy and execution group, expanding the scope of its manufacturing solutions for life science companies and driving greater speed and efficiency in bringing new drugs to market. Bethesda, Md.,

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Drug Target Review

FEBRUARY 29, 2024

From a very young age, I was drawn to science and medicine. This early exposure to bench science had a long-lasting impact. Through their own experiences, my mentors have helped me navigate what can be a trying course for women in science. I have had the fortune of strong mentorship from women in STEM.

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PPD

NOVEMBER 30, 2023

To get a pulse on the changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments.

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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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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.

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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.

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The Pharma Data

NOVEMBER 10, 2020

Weiner, chairman of the scientific advisory board of Tiziana Life Sciences, commented: “We understand that this will be the first-ever study with ‘take-home’ capsules of any mAb for immunotherapies for human diseases. Grand View Research August 2018 ( [link] ). Tiziana Life Sciences January 9, 2020 Press Release ( [link] ).

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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. VERONA, Italy , Jan. TalentSource has a long history of providing qualified resources to our clients or directly to investigational sites in locations all over the world.

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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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The Pharma Data

SEPTEMBER 15, 2020

Irena Seredina holds a Medical Doctor, honors diploma and a Master of Science degree in Health Economics. During her medical practice, Seredina worked in clinical research as an investigator. He has worked for a number of partner research organizations in clinical development, including Biotrial, Celerion and Parexel.

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The Pharma Data

MAY 2, 2023

Bonello has more than 30 years of financial leadership experience, including 15 years in the clinical research industry. a clinical trial data collection company, since 2021. From 2008 to 2021, Mr. Bonello held roles of increasing responsibility at Nasdaq-listed PRA Health Sciences, Inc.,

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The Pharma Data

DECEMBER 17, 2020

Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development. Prior to joining Cidara, Kurtz served as head of commercial API manufacturing at Gilead Sciences.

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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.

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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.

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The Pharma Data

JANUARY 7, 2021

Dr. Anne Prener has more than 25 years of leadership experience within life sciences companies, and currently serves as Chief Executive Officer of Imbria Inc. Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta. Dr. Prener holds a Ph.D.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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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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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. Ther Innov Regul Sci. 2018;53(4):519–25.

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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.]

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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. At NexImmune, he will oversee all aspects of research and development. . GAITHERSBURG, Md.,

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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.

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The Pharma Data

NOVEMBER 5, 2020

Taveras will lead all research and non-clinical development functions supporting the company’s pipeline of investigational therapies. Prior to Lonza, she led External Science and Partnering across the globe for Sanofi R&D. Previously, he was an associate director at Navigant Life Science Consulting.

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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).

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

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Richie Kahn: I’m a public health and advocacy guy by training, a clinical researcher by trade, and a patient advocate by necessity. It’s amazing to see the years and years of little actions, relationships built, and the progression of science, all culminate at this point. So, I decided to pivot. This is a huge milestone for us.

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Agency IQ

FEBRUARY 12, 2024

The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinical research to advance gene therapy development for rare diseases.

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The Pharma Data

JULY 29, 2021

Gilead Sciences, Inc. Our flagship HIV therapy, Biktarvy, saw continued growth and gains in market share, despite the ongoing impact of the pandemic,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences. Gilead welcomed William Grossman, MD, PhD, as Senior Vice President, Oncology Clinical Research.

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LifeSciVC

JULY 11, 2023

Redig, SVP and Head of Clinical Development at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J. His remarks are worth reading in their entirety.

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Drug Target Review

OCTOBER 16, 2024

I’ve always been drawn to the early stages of scientific discovery, where hypotheses are formed and developed into something tangible that can benefit patients. Being involved in these formative stages allows you to not only understand the challenges ahead but also shape the science to ensure it addresses patient needs.

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