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.

Therapies 64

Therapies Treatment Engineering Clinical Trials 64

PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

Drug Target Review

JUNE 11, 2025

Internally, the models learn to associate concepts, find patterns and relate text and images (or other modalities) so that they can be analysed in the same way. Using clinical genomics and AI in drug development to elevate success. Early evidence and emerging trends: How AI is shaping drug discovery and clinical development.

Drugs 59

Drugs Clinical Trials Drug Development Pharmaceuticals 59

Metabolite Tales Blog

DECEMBER 12, 2024

Predictability of in vitro to in vivo metabolism Predictivity varies but the top line from the responses is that the probability of discovering a major metabolite during later stages of clinical development are low, as is complete discordance of in vitro to in vivo metabolism.

Science 52

Science Pharma Companies Clinical Trials Clinical Development 52

The Pharma Data

JUNE 6, 2025

Designed to serve a diverse international audience—including patients, healthcare providers, business partners, and investors—the site embodies the company’s twin commitments to scientific rigor and human empathy. Importantly, JCR’s approach to innovation is deeply rooted in collaboration. JCR Pharmaceuticals Co.,

Pharmaceuticals 40

Pharmaceuticals Science Disease International 40

The Pharma Data

JUNE 6, 2025

Sanofi Highlights Robust Pipeline of Innovations in Rare Blood Disorders at ISTH 2025 Sanofi is poised to take center stage at the 33rd Congress of the International Society on Thrombosis and Haemostasis (ISTH), set to be held in Washington, D.C., from June 21 to 25, 2025.

Disease 40

Disease Therapies Treatment International 40

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 81

Science Small Molecule International Clinical Development 81

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. For example, there are accelerated pathways for oncology drug approval in the U.S., Japan, and China. and the U.S.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

New Drug Approvals

MAY 15, 2025

A final lipophilicity adjustment led to the discovery of CDZ173 (leniolisib), a potent PI3K selective inhibitor with suitable properties and efficacy for clinical development as an anti-inflammatory therapeutic. Jump up to: a b c d e f “Joenja- leniolisib tablet, film coated” DailyMed. 29 March 2023. Retrieved 20 June 2023.

FDA Approval 62

FDA Approval FDA Treatment International 62

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.

Disease 40

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

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.

Clinical Trials 52

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.

International 52

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.

Drug Development 98

Drug Development Clinical Trials Drugs Clinical Research 98

Conversations in Drug Development Trends

MAY 15, 2025

Engaging with regulatory agencies and industry peers allows sponsors to share resources, knowledge, and expertise, collectively leading to more efficient and effective drug development.

Clinical Trials 52

Clinical Trials Drug Development FDA Trials 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.

RNA 64

RNA Cell Biology Clinical Development Disease 64

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.

Clinical Development 52

Clinical Development Drug Development International Clinical Research 52

Drug Target Review

MARCH 17, 2025

He is the inventor of more than 130 granted US patents and has overseen the discovery, IND filing and clinical development of over 12 clinical candidates in pain, cognition, depression and a range of ophthalmic and dermatologic diseases.

Treatment 52

Treatment Licensing Licensing Science 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

Conversations in Drug Development Trends

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. The goal is to deliver a precise radiation dose to the diseased tissues while minimizing damage to surrounding healthy tissue.

Clinical Trials 52

Clinical Trials Therapies Regulations Clinical Development 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.

Pharma Companies 52

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.

International 52

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.

Biosimilars 52

Biosimilars Clinical Trials International Clinical Development 52

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).

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

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

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.

Clinical Trials 52

Clinical Trials Clinical Development Trials Engineering 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 addition, these products have established a clinical development path that supported a drug approval that is applicable to our program.

Clinical Development 74

Clinical Development Marketing Clinical Trials Production 74

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.

Small Molecule 52

Small Molecule DNA Drugs 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.

Clinical Development 40

Clinical Development Drug Development Doctors International 40

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.

Trials 52

Trials Clinical Trials Treatment International 52

Drug Patent Watch

JANUARY 8, 2025

Here are some key strategies: File early and often Pursue multiple patent types Consider international patent protection Continuously innovate and file improvement patents By implementing these strategies, you can create a web of protection that’s difficult for competitors to navigate around.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Licensing Licensing 52

Conversations in Drug Development Trends

JANUARY 24, 2024

Fortunately, today, various genetic testing laboratories have significant amounts of genetic and genomic data that can support life cycle management, clinical development plans, and country/site selection. Enrolling adequate populations will be required to advance these programs.

Trials 75

Trials Disease Clinical Trials Clinical Research 75

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.

Small Molecule 40

Small Molecule Clinical Development Clinical Trials Licensing 40

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.

International 52

International Pharmaceuticals Drug Development Marketing 52