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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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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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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Vial

MARCH 1, 2024

By type of service, clinical research services accounted for the lion’s share of the North American CRO services market, followed by early-phase development services, laboratory services, and consulting services. This acquisition has allowed the company to position itself as a global leader in clinical research services.

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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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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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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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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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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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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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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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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

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

SEPTEMBER 11, 2020

“The ability to deliver remdesivir via a long-acting, subcutaneous injection has the potential to expand its application in countries with less developed healthcare systems and help improve patient convenience,” Fairley added. Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease.

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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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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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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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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

NOVEMBER 1, 2020

Clinical Data Expected by End of Year. Tiziana Life Sciences plc. (“Tiziana” or the “Company”). 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.

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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 19, 2020

The appointments of Maarten and Teun come at an essential time for AM-Pharma as we finalize all preparations to move into the last stage of clinical development for our lead program,” said Erik van den Berg , Chief Executive Officer at AM-Pharma. UTRECHT, The Netherlands–( BUSINESS WIRE )– AM-Pharma B.V. ,

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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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Advarra

AUGUST 10, 2023

This will aid clinical development and preparation for investigational new drug (IND) and biologics license application (BLA) submissions. The project should also help clinical research sponsors take advantage of various FDA pathways for accelerated review and approval.

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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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The Pharma Data

DECEMBER 15, 2020

It is funded by the world’s leading charities dedicated to diabetes research, JDRF, and Diabetes UK, guided by both organizations’ strong commitment to facilitate deep interrogation of consolidated community-wide trial data as a means to accelerate clinical research and therapeutic development for T1D.

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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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