The Pharma Data

MARCH 9, 2021

New data from 10 studies will be presented by Eli Lilly and Company (NYSE: LLY) at the upcoming virtual International Conference on Alzheimer’s & Parkinson Diseases 2021 (AD/PD 2021), March 9-14, 2021.

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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. 2) An established FSO arrangement is to be replaced, and the developer needs to transition to FSP without disrupting momentum.

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Drug Target Review

APRIL 9, 2024

Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy. These compounds were later licensed to the pharmaceutical industry for clinical development. Oscar’s scientific career has been recognised by multiple awards and recognitions, national and internationally.

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PPD

OCTOBER 2, 2024

For our clients, the ability to outsource these capabilities is a marked improvement compared to hiring, training and maintaining a large workforce to fulfill every aspect of clinical operations — a feat made even more complicated by workloads that can fluctuate widely depending on the number of products under development.

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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. External recruitment: Meeting the client’s additional needs, particularly for roles that require experience and competencies not currently provided by internal employees.

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PPD

SEPTEMBER 6, 2023

The PPD expert talent pool delivers customers the highest-quality expertise, with the knowledge and experience of working within various models and integrating as extensions of internal teams.

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Drug Target Review

SEPTEMBER 5, 2024

Already, three candidates are in clinical development and the lead candidate is ready to enter Phase III. She has extensive experience in executive management, drug development, regulatory affairs and licensing with major international pharmaceutical companies, including in the field of neurodegenerative diseases.

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PPD

JULY 18, 2023

By outsourcing individual functional services, companies gain flexibility and financial efficiencies that complement their internal expertise and resources to proactively drive on-time, on-budget performance for their projects. Performance management.

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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. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

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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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The Pharma Data

JANUARY 4, 2021

During his time in this role, he oversaw the development and regulatory approval of 11 different oncology assets, including the combination of Xalkori and Lobrena for ALK+ non-small cell lung cancer (NSCLC); Xalkori for ROS1 positive NSCLC; kidney cancer drug Inlyta; Ibrance for HR+ breast cancer; Besponsa for acute lymphoblastic leukemia; and more.

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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). Studies in non-clinical species raised no obvious red flags of this clinical outcome.

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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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Drug Target Review

DECEMBER 28, 2023

His research unveiled the critical role of Fc receptors and the tumour microenvironment in the mechanism of action of anti CTLA-4 antibodies, and he is an inventor of several key patents supporting the clinical development of antibodies targeting immune checkpoints.

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The Pharma Data

DECEMBER 8, 2020

9, 2020 /PRNewswire/ — The members of the Nomination Committee for BioInvent International AB :s (publ) (“BioInvent) Annual General Meeting in 2021 have now been appointed. Proposals to the Nomination Committee can be sent to Stefan Ericsson , by mail: BioInvent International AB (publ).), BioInvent International AB (publ).

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The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. BioInvent International AB (publ).

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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 demands synchronization between sponsor training protocols and internal resource management. Here’s how we do it.

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The Pharma Data

APRIL 27, 2022

“We plan to discuss these data with health authorities, and we will continue to expand our tislelizumab clinical development program in pursuit of novel, synergistic combinations with the ultimate goal of extending survival for more patients.”.

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The Pharma Data

OCTOBER 26, 2020

The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. During the conference call, the Company will review its financial results and provide a corporate update. The conference ID number for the call is 8557525.

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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. Discov Oncol. 2024;15(1):327. 2022;39(1):89-103.

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The Pharma Data

JANUARY 20, 2021

Dr. Rouleau has an international reputation in cardiovascular research, particularly in the field of both basic mechanisms and improving the clinical care of patients with heart failure. This patient population is at significant risk of developing cardiovascular complications, which are frequently fatal, during their illness.

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PPD

DECEMBER 5, 2023

Clients benefit greatly from strategic partnerships with FSP providers that have the expertise, adaptability and precise operational requirements that deliver clinical development programs on time in non-footprint countries.

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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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The Pharma Data

JANUARY 14, 2021

PRA Health Sciences is one of the world’s leading global contract research organizations by revenue, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries. Since 2000, PRA has participated in approximately 4,000 clinical trials worldwide.

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The Pharma Data

DECEMBER 28, 2020

Her international experience in leading clinical development and in building development organizations will significantly strengthen our clinical capacity. This is crucial in the phase we are in now, with two products on the way to Phase II and another product in clinical Phase I.

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The Pharma Data

SEPTEMBER 6, 2021

Given the high unmet medical need, we are very encouraged with the positive outcome of eliapixant in the chronic cough indication regarding efficacy and safety,” said Christian Rommel, Member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development. About the Phase IIb Study.

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The Pharma Data

OCTOBER 18, 2020

Dr. Berk, commented “I am excited to join the Board of Inflection Biosciences as it advances its novel PIM/PI3K inhibitor, IBL-202, towards clinical development for unmet needs in B-cell malignancies and other cancers.”. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies.

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Vial

MARCH 27, 2024

Personnel salaries, site rentals, and equipment maintenance are other necessary expenses associated with clinical trials. Lastly, global trials will also require additional expenses for international site management, translation services, and regulatory consultants to ensure proper compliance in each participating country.

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PPD

MAY 7, 2024

This is due to concurrent processes with the European Medicines Agency (EMA) and national pricing and reimbursement procedures, leading to competition for internal resources within pharmaceutical companies. Early scientific advice, either formal or informal, can shape pivotal study design early in the development process.

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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.

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The Pharma Data

JANUARY 6, 2021

He continues: “With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. UNION is headquartered in Hellerup ( Denmark ) and is managed by an experienced international team.

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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. ” About CROMSOURCE. CROMSOURCE operates offices across all regions of Europe and North America and conducts projects globally.

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Drug Target Review

JULY 26, 2024

However, we see applications across the entire drug development life cycle, from target discovery and biomarker development to clinical development programmes and finding patients for clinical trials based upon both genotypic and phenotypic criteria. The second category would be our internal team of researchers.

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The Pharma Data

JANUARY 7, 2021

This platform has enabled Apexigen and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. For more information, please visit www.apexigen.com.

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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.

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Drug Target Review

FEBRUARY 10, 2025

My focus has always been on advancing novel medicines from research to clinical development. We believed the missing piece was essentially an internal biotech at MD Anderson – one that could collaborate with researchers to industrialise their processes for cell therapies.

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The Pharma Data

JANUARY 17, 2021

“Our internal cell therapy process expertise combined with Lonza’s cell processing know-how provide the perfect combination to manufacture ARU-1801 for our pivotal study. As we advance our gene therapy through clinical trials, this partnership signifies a critical milestone in the development pathway.”

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