LifeSciVC

APRIL 2, 2024

And the experience of those around you, including Board members and internal investors. Our Board and internal investors help strengthen our narrative and the corporate strategy to ensure our science and strategy will resonate with new investors. The science presents an opportunity and a challenge for us at Sionna.

Science 67

Science Small Molecule International Clinical Development 67

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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Disease International Research Therapies 40

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.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

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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RNA Cell Biology Clinical Development DNA 65

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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Clinical Trials Clinical Development Clinical Research Trials 52

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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International Clinical Research Clinical Development Research 52

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 Development Clinical Trials Drugs Clinical Research 98

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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Clinical Development Drug Development International Clinical Research 52

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.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

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.

Clinical Development 52

Clinical Development Clinical Trials International Trials 52

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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Pharma Companies Clinical Development Clinical Research International 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). Studies in non-clinical species raised no obvious red flags of this clinical outcome.

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International Licensing Licensing Treatment 52

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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Biosimilars Clinical Trials International Clinical Development 52

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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Bioinformatics Immune Response DNA Vaccine 105

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).

Clinical Trials 52

Clinical Trials Licensing Licensing International 52

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.

Clinical Research 52

Clinical Research Clinical Development International Engineering 52

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.”.

Treatment 52

Treatment Clinical Development Therapies Clinical Trials 52

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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Clinical Trials Clinical Development Trials Engineering 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. 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.

Hospitals 52

Hospitals Trials International Clinical Trials 52

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.

Clinical Development 52

Clinical Development Clinical Research Drug Development International 52

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

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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Science Treatment Clinical Trials Clinical Development 52

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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Trials Clinical Trials Treatment International 52

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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Small Molecule Clinical Development Clinical Trials Licensing 40

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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Clinical Trials Trials International Compliance 52

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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Regulations Pharmaceutical Companies International Pharmaceuticals 52

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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International Pharmaceuticals Drug Development Marketing 52

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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FDA Approval FDA Clinical Development Clinical Research 52

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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Clinical Trials Science Trials International 73

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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Clinical Research Clinical Trials International Clinical Development 40

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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Clinical Development International Production Drugs 40

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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Clinical Trials Trials Clinical Development Clinical Research 52

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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