PPD

MARCH 13, 2024

This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy.

Clinical Development 98

Clinical Development Clinical Trials Therapies Trials 98

Drug Target Review

JUNE 6, 2025

Image credit: Crystal Eye Media / Shutterstock The role of SPICA and manufacturing capabilities Drug development in the radiopharmaceutical space is particularly resource intensive. These measures ensure both the efficacy and safety of the final product.

Therapies 100

Therapies Treatment Drug Development Clinical Development 100

The Pharma Data

JUNE 24, 2025

Unlike traditional royalty deals, where investors purchase rights to a portion of revenue from marketed products, this synthetic royalty structure allows Royalty Pharma to provide upfront capital in exchange for a defined share of future revenue, subject to agreed terms and caps.

Drug Development 40

Drug Development Clinical Trials Therapies Drugs 40

PPD

JUNE 17, 2025

Biopharmaceutical and biotech drug developers have faced increasing challenges in recent years. In the past decade alone, the time needed to complete a clinical trial has increased by 20–30%, and the cost to bring a new drug to market has risen to an average of about $2.6

Clinical Development 52

Clinical Development International Drug Development Clinical Research 52

Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Bioanalysis to support drug development requires meticulous attention to detail across many clinic and laboratory disciplines.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

Drug Target Review

APRIL 30, 2025

This not only improved product consistency but also shortened the manufacturing timeline – getting the therapy to patients faster and more reliably. The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT.

Drugs 90

Drugs Therapies Clinical Trials Trials 90

Cytel

AUGUST 28, 2023

A clinical development plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drug development and helps ensure that new therapies are safe, effective, and of high quality.

Clinical Development 52

Clinical Development Drug Development Therapies Production 52

The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. P) is per the specific IMPD guidance.

Clinical Development 52

Clinical Development Pharmaceuticals Clinical Trials Trials 52

Drug Target Review

JUNE 11, 2025

Drug development is plagued by complex challenges, but multimodal AI is unlocking new opportunities. By integrating diverse data sources – from genomics to clinical insights – this approach is accelerating drug discovery, improving patient stratification and boosting success rates. Highlighting data integration.

Drugs 65

Drugs Clinical Trials Drug Development Pharmaceuticals 65

PPD

NOVEMBER 9, 2023

However, over the past decade, a trend toward incorporating multiple study populations into one protocol has slowly gathered momentum among drug developers. Improved prioritization Promising pipeline candidates with a strong early development protocol may see a positive impact to the net present value of an early-stage asset.

Clinical Development 52

Clinical Development Drug Development Clinical Research Treatment 52

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

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. and reduce the overall clinical pharmacology program.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

FDA Law Blog: Drug Discovery

DECEMBER 15, 2024

Valentine We recently published the first part of our review of FDAs draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. If you make a tissue product you may produce one lot per patient where a gene therapy may only need a handful of lots through Phase 3.

Therapies 52

Therapies FDA Clinical Development Production 52

PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. There is a race in the field to overcome these challenges to enable the success of CGT products in Asia-Pacific.

Therapies 97

Therapies Clinical Trials Clinical Research Trials 97

Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

Drug Development 40

Drug Development Clinical Trials Biosimilars Pharmacokinetics 40

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development 52

Drug Development Treatment Drugs FDA Approval 52

Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. About the author Jerry McLaughlin CEO, Life Biosciences, Inc.

Science 145

Science Disease FDA Approval Pharmaceutical Companies 145

Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

PPD

OCTOBER 21, 2024

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions. are outsourced.

International 87

International Clinical Development Clinical Trials Clinical Research 87

The Pharma Data

JUNE 26, 2025

BeOne Medicines’ rise has been fueled by a strategic commitment to innovation at every level of the drug development continuum. Its end-to-end R&D model integrates in-house discovery, development, and manufacturing capabilities—enabling rapid iteration, lower development costs, and sustained pipeline productivity.

Research 40

Research Clinical Development Clinical Trials Engineering 40

Drug Target Review

MAY 23, 2025

Our goals are to progress our pipeline and position each asset for clinical and commercial success. The tight-knit structure of the Poolbeg team allows Tremble to contribute not only to early-stage drug development but also to clinical trial design, patient stratification, and biomarker strategy.

Immune Response 52

Immune Response Therapies Treatment Clinical Trials 52

Conversations in Drug Development Trends

NOVEMBER 21, 2023

As a provider of end-to-end clinical development solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis. At Worldwide, we deliver full-service clinical development to support drug approval and commercialization.

Disease 78

Disease Treatment Clinical Trials Clinical Development 78

Conversations in Drug Development Trends

JULY 3, 2025

Removing the REMS requirements for selected approved products enhances opportunities for studies that use investigational agents in combination with these approved CAR T therapies and ultimately may influence design and operational elements for novel treatment combinations.

Therapies 40

Therapies Regulations Clinical Trials FDA 40

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application.

Therapies 59

Therapies FDA Production Disease 59

Conversations in Drug Development Trends

MAY 15, 2025

The Investigational New Drug (IND) application is a pivotal step in the drug development journey, offering a multitude of strategic advantages and enhanced opportunities. Have you considered the multiple associated benefits and implications in the context of your novel drug development plan?

Clinical Trials 52

Clinical Trials Drug Development FDA Trials 52

Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions. Japan, and China.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

PPD

JULY 8, 2025

Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinical research. Accelerate your clinical research with our drug development digital solutions from Thermo Fisher Scientific.

Clinical Research 52

Clinical Research Research Compliance Government 52

Fierce BioTech

DECEMBER 23, 2024

As Phase 1 clinical trials include several different design types with multiple objectives (e.g. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.),

Pharmacy 52

Pharmacy Trials Clinical Trials Clinical Development 52

LifeSciVC

OCTOBER 18, 2023

However, the challenge here lies in the finite number of experienced leaders/drug development teams that can operate these companies and are also willing to bet on the future upside. In a market like today, later stage, clinically validated targets are a potentially ‘safer’ place to balance portfolios.

Clinical Development 76

Clinical Development Marketing Clinical Trials Production 76

Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

Drug Development 65

Drug Development Clinical Supply Production Protein Expression 65

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Therapies 59

Therapies Engineering Production FDA 59

Cytel

DECEMBER 6, 2023

Chemistry, Manufacturing, and Controls (CMC) is a critical component of drug product development. As a Senior Consultant in Drug Development, I serve as a representative for sponsors with the Contract Development and Manufacturing Organization (CDMO). This is a long-term relationship.

Clinical Trials 64

Clinical Trials Drugs Trials Drug Development 64

BioPharma Drive: Drug Pricing

JUNE 23, 2025

The black and gray market risks Ben warned about the proliferation of counterfeit GLP-1 drugs in unregulated markets, posing significant dangers to patients who might unknowingly use ineffective or harmful products.

Treatment 130

Treatment Drugs Therapies FDA 130

The Pharma Data

JUNE 11, 2025

This mechanism has the potential to partially restore UBE3A protein production in neurons, addressing the root cause of the disorder. Encouraging results from the previously completed Phase 1/2 HALOS study support the continued development of ION582. Source link

Trials 40

Trials Therapies Treatment Disease 40

The Premier Consulting Blog

JULY 9, 2023

During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance, and the drug product (formulated product).

Small Molecule 52

Small Molecule DNA Drugs Clinical Development 52

PPD

JULY 18, 2023

Nearly two-thirds of drug developers’ outsourcing budgets are now allocated to functional service provider (FSP) models or FSP hybrid models, according to research conducted by the PPD clinical research business of Thermo Fisher Scientific. Escalations and risk mitigation. Performance management.

Clinical Development 52

Clinical Development Drug Development International Clinical Research 52

The Pharma Data

JANUARY 13, 2021

14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer. We are excited to attract such top tier talent from the psychedelic drug development community.

Clinical Trials 52

Clinical Trials FDA Trials Production 52