PPD

JUNE 17, 2024

When outsourcing some or all key functions to an FSP provider, a drug developer gains access to a wider pool of talent, including specialized functional, scientific and technical experts. This approach enables unbroken continuity of support and resources across clinical trial operations.

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Clinical Trials Clinical Development Trials International 52

Drug Target Review

APRIL 9, 2024

Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drug development projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.

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PPD

OCTOBER 31, 2023

FSOs offer the complete outsourcing of most — if not all — tasks for a clinical development project, reducing the client’s management burden. Moreover, FSP models allow drug developers to outsource individual functional services to gain efficiency and flexibility.

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The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.

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PPD

DECEMBER 5, 2023

Non-footprint countries are regions where drug developers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drug developers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.

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Clinical Development Clinical Research Drug Development International 52

NIH Director's Blog: Drug Development

JUNE 14, 2016

Several years ago, the Food and Drug Administration (FDA) recommended that drug developers take special care to show that potential drugs to treat diabetes don’t adversely affect the cardiovascular system [1]. 5] Clinical development success rates for investigational drugs. Novo Nordisk.

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PPD

NOVEMBER 14, 2023

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. This comes as the demand for qualified clinical research associates (CRAs) is expected to increase by more than 36% in the next decade.

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Clinical Research Clinical Development International Engineering 52

Vial

MARCH 25, 2024

Worldwide Clinical Trials is a mid-size, full-service global contract research organization (CRO) that works with biotech and pharma to advance new medications. With an international presence in nearly 60 countries, Worldwide is supported by over 3,400 team members. According to Hardman et al.,

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Clinical Trials Trials Clinical Development Clinical Research 52

Metabolite Tales Blog

NOVEMBER 17, 2022

Due to internal hydrogen bonding, DELAQ is a linear, nonionized metabolite with a LogP of roughly 7. Figure 2: Internal hydrogen bonding of DELAQ In contrast to laquinimod, DELAQ is a very potent activator of the aryl hydrocarbon receptor (AhR). and a topological polar surface area (TPSA) of 61 Å 2.

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The Pharma Data

APRIL 6, 2022

Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus – Innovative Medicines US and Innovative Medicines International. Change in Global Drug Development (GDD) Leadership. Novartis has appointed Shreeram Aradhye, M.D.,

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International Pharmaceuticals Drug Development Marketing 52

Drug Target Review

JULY 26, 2024

We have a dual aim: to use the power of sequencing for more personalised patient care; and to be able to leverage those datasets to progress various programmes within drug discovery. The second category would be our internal team of researchers. When we think of researchers, we think of at least three different categories.

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The Pharma Data

DECEMBER 28, 2020

Dr Reimer will replace Dr Charlotte Russel and be overall medically responsible for Alligator’s drug development candidates, with an emphasis on bringing mitazalimab and ATOR-1017 into Phase II efficacy studies. Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc.

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Importantly, unlike IQVIA, Vial’s EDC is entirely developed by an internal software engineering team, reducing vendor dependencies.

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PPD

DECEMBER 14, 2023

In an increasingly competitive clinical trial and post-marketing surveillance sphere, many companies have turned to outsourcing models to rapidly expand their capabilities, more efficiently leverage internal resources and reach a broader population of trial participants and research personnel.

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Clinical Development Clinical Trials International Trials 52

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. Fcgamma Receptor-Dependent Internalization and Off-Target Cytotoxicity of Antibody-Drug Conjugate Aggregates. 2022;39(1):89-103.

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The Pharma Data

OCTOBER 18, 2020

DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S. Berk, MD, to its Board of Directors.

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Small Molecule Clinical Development Clinical Trials Licensing 40

The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax.

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Virus Clinical Development Engineering International 40

The Premier Consulting Blog

JULY 9, 2023

Food and Drug Administration (FDA), expect identification, reporting, and qualification of these compounds according to three key guidance documents established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Global regulatory agencies, including the U.S.

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Small Molecule DNA Drugs Clinical Development 52

Vial

MARCH 27, 2024

The type of sponsorship must also be accounted for because academic institutions sponsoring clinical trials often have access to fewer financial resources compared with commercial sponsors, which typically have larger budgets for their drug development programs.

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Clinical Trials Trials International Compliance 52

LifeSciVC

OCTOBER 18, 2023

As we think about our own future with our Phase 2 ready program, we discuss internally how well we fit venture funds’ criteria today and just what is an ’ideal‘ investment profile in 2023 going into 2024? In a market like today, later stage, clinically validated targets are a potentially ‘safer’ place to balance portfolios.

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LifeSciVC

JANUARY 16, 2024

The expectation that Pharma will continue buy-ups here is helping to fuel conviction for another strong year ahead for M&A, especially for those acquirers who will rely on inorganic acquisition to build in areas under-represented by internal R&D (e.g.,

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Drug Target Review

SEPTEMBER 26, 2023

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. 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.

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The Pharma Data

DECEMBER 13, 2020

CEO of EdiGene, “Translating cutting-edge gene editing technologies into innovative solutions for patients requires deep internal R&D expertise as well as strong external partnerships. Dr. Zhang has around 20 years of experience in research and drug development in both industry and academia in the US. He received his B.S.

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Medical Schools Clinical Development Therapies RNA 40

The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. Subjects who show clinical benefit at week 6 continue onto maintenance therapy and receive BI-1206 and rituximab once every 8 weeks for up to 6 maintenance cycles, or up to 1 year from first dose of BI-1206. (Nasdaq: CASI), a U.S.

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The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. and international companies.

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Treatment Pharmaceuticals Drug Development Science 40

The Pharma Data

JULY 29, 2021

Eisai and Biogen Present Preliminary Assessment of the Clinical Effects of Lecanemab Following 18 Months of Treatment in the Open-Label Extension of the Phase 2 Proof of Concept Study at 2021 Alzheimer’s Association International Conference (AAIC) . BioArctic has no development costs for lecanemab in AD. About Eisai Co.,

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025.

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Disease Drugs Treatment Drug Development 52

PPD

DECEMBER 12, 2023

Drug developers using functional service partnerships (FSPs) are taking an increasing interest in the follow-the-sun business model to optimize operations, transitioning work across global locations as the sun rises and sets.

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Compliance Clinical Research Trials Clinical Trials 52

The Pharma Data

JANUARY 13, 2021

This is our sixth global approval for an internally-developed product, and our first approval for tislelizumab in a lung cancer indication, an area where we believe tislelizumab can have a large impact for patients.”. General Manager of China and President of BeiGene. Chief Medical Officer, Immuno-Oncology at BeiGene.

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Production Trials Clinical Trials Treatment 52

The Pharma Data

NOVEMBER 3, 2020

According to the FDA, the purpose of Fast Track designation is to get important new drugs to patients earlier by facilitating the development, and expediting the review, of drugs to treat serious conditions and fill an unmet medical need. Commenting on the announcement, Daniel Gruskin, M.D., About LogicBio Therapeutics.

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The Pharma Data

JANUARY 25, 2021

“The technology has a unique pharmacological profile, which is very different from other products in preclinical and clinical development in that it focuses on restoring function. All clinical development plans are subject to additional funding.

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Disease Clinical Development Molecular Biology Treatment 40

The Pharma Data

NOVEMBER 10, 2020

. Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. TYVYT® (sintilimab injection) has been the only PD-1 inhibitor included in the NRDL since 2019.

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Clinical Trials Treatment Trials Disease 52

The Pharma Data

DECEMBER 8, 2020

AbCellera’s AI-powered antibody discovery platform speeds the otherwise lengthy and grueling process by analyzing the database of natural immune systems to find antibodies that can be developed into drugs. Tackle the toughest problems in drug development.” The promise to partners is to “move quickly. Reduce cost.

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FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Existing published VCS may be identified internally by FDA or externally by stakeholders. These meetings have a question-and-answer format to provide clarity to sponsors about the particular topics at hand.

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The Pharma Data

OCTOBER 19, 2020

Caris Precision Oncology Alliance members also have access to the Caris Pharmatech oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinical development. Europe , Asia and other international markets.

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Clinical Trials RNA DNA Science 52

LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. As the CEO of Lifordi Immunotherapeutics, an ADC company developing treatments for autoimmune and inflammatory diseases, there are three components to manufacture, multiple international CDMOs to manage, and complex supply chains to navigate.

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Clinical Trials Trials Disease Treatment 70

The Pharma Data

JANUARY 31, 2021

This, along with our other partnerships and internal programs, reflects Gilead’s commitment to continuing innovation to discover a cure for HIV and bring about an end to the HIV epidemic.”. “We

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