Advarra

OCTOBER 4, 2023

When it comes to clinical development, precision, compliance, and quality assurance are paramount. For clinical development organizations, an effective CAPA serves as an essential compass, directing a path towards continuous improvement while maintaining steadfast regulatory compliance.

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Clinical Development Compliance Clinical Trials Trials 52

Drug Hunter

JUNE 5, 2023

While most biologically active macrocycles are peptides or natural product-derived , ring-closing metathesis (RCM) reactions have contributed to greater accessibility of unnatural macrocycles in medicinal chemistry. RCM is now used in over half of macrocyclic kinase inhibitor syntheses , for example. M) at 40 °C.

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Process Chemistry Drugs Production Clinical Development 206

PPD

NOVEMBER 9, 2023

Our dedicated, global and highly experienced cross-functional early development team is ready to support you through this journey. The partner you select for your early phase studies is critical in enabling you to achieve your overall development timeline efficiently and within budget.

Clinical Development 52

Clinical Development Drug Development Clinical Research Treatment 52

DS in Pharmatics

JANUARY 7, 2023

In the last decade, approval of cell and gene therapy (CGT) products has increased significantly. Multiple other products are in clinical development for solid tumors, genetic deficiencies, and infections that promise more effective […]

Production 52

Production Therapies Clinical Development 52

The Premier Consulting Blog

MARCH 7, 2024

The analytical package, consisting of release, stability, and characterization tests, includes data generated throughout the product development and manufacturing process. For gene therapy vectors, this testing encompasses production cell lines, master and working cell banks (MCB, WCB), and virus banks.

Production 52

Production Therapies DNA Virus 52

The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. You should not place undue reliance on these statements.

Biosimilars 52

Biosimilars Clinical Development Production Government 52

Cytel

MAY 7, 2024

In 2000, the EU established its Orphan Drug Regulation, offering a ten-year market exclusivity from similar products within the same indication, to encourage the development of drugs for conditions affecting not more than five in 10,000 citizens.

Marketing 59

Marketing Production Drugs Disease 59

Drug Target Review

JUNE 9, 2023

This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinical development, offering promising advancements in innovative cancer treatments.

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Treatment Packaging Clinical Research Therapies 105

PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

Trials 95

Trials Clinical Trials Clinical Development Clinical Research 95

The Pharma Data

SEPTEMBER 29, 2021

Healthy kidneys act as the body’s filter, removing waste products from the blood. The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. In the U.S., 1 in 3 adults is at risk for the disease.

Clinical Development 52

Clinical Development Disease Clinical Trials Trials 52

Cytel

MAY 28, 2024

Written by Susannah Sadler and Stacy Grieve Launching a treatment for inflammatory diseases can be a make-or-break endeavor. A robust evidence base and a compelling value story are crucial to success, but current challenges and unexpected bumps in the road will require creative solutions.

Disease 64

Disease Production Treatment Clinical Development 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 95

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 95

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 Clinical Trials 145

Cytel

MARCH 11, 2024

In 2023, rare diseases accounted for 30% of product pipeline under development, about half of which comprising non-oncology rare diseases. Clinical development in rare diseases has specific challenges. Effective clinical development strategy for rare diseases requires agility to adapt to accumulating learning.

Clinical Trials 59

Clinical Trials Trials Disease Clinical Development 59

The Pharma Data

FEBRUARY 24, 2022

The cardiology franchise at Bayer already includes a number of products and several other compounds in various stages of preclinical and clinical development. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition.

Clinical Development 52

Clinical Development Therapies Disease Treatment 52

Drug Target Review

SEPTEMBER 5, 2024

Later, heading up early gastrointestinal projects as Global Product Director, it was exciting to reach Proof of Concept, however I was seen not experienced enough to bring this project forward in development. Already, three candidates are in clinical development and the lead candidate is ready to enter Phase III.

Pharma Companies 111

Pharma Companies Licensing Licensing Disease 111

Agency IQ

FEBRUARY 2, 2024

In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The revisions flesh out considerations for use of biomarkers at all stages of product development and add new content on rare cancers and platform trial designs.

Clinical Development 59

Clinical Development Trials Production 59

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.”. We also market or plan to market in China additional oncology products licensed from Amgen Inc.,

Production 52

Production Trials Clinical Trials Treatment 52

Drug Target Review

AUGUST 28, 2024

The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.

Therapies 116

Therapies Disease Engineering Medical Schools 116

FDA Law Blog: Biosimilars

AUGUST 8, 2023

Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs that may be nitrosamines, even having a deviation in pH of an Active Pharmaceutical Ingredient that might conceivably contribute to the formation of nitrosamines in a finished drug product.

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FDA Organic Chemistry Drugs Production 74

PPD

JULY 6, 2023

As a result, sponsors must decide whether to leverage a CRO partner even earlier in their drug development timelines to ensure proper planning for these constraints. How a CRO Accelerates Clinical Development Clinical trials are becoming increasingly complex as the industry evolves.

Clinical Trials 98

Clinical Trials Trials Drug Development Testimonials 98

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

Cytel

MAY 5, 2023

As clinical trials become more complex, simulation-guided design approaches are crucial.

Clinical Trials 52

Clinical Trials Trials Clinical Development Production 52

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. How does “potency” apply to cell and gene therapy (CGT) products?

Production 40

Production FDA Therapies Biochemical Assays 40

DrugBank

SEPTEMBER 26, 2024

This reduction in cost does not equate to a compromise in quality or efficacy, as biosimilars undergo rigorous analytical and functional characterization to demonstrate biosimilarity to the reference product. biosimilars are often priced slightly lower than their reference products, limiting their potential for cost savings.

Biosimilars 86

Biosimilars Clinical Trials Production FDA 86

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

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 67

International Clinical Development Clinical Trials Clinical Research 67

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.

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Therapies Clinical Trials Clinical Research Trials 88

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

Drug Target Review

OCTOBER 11, 2023

In those with CMT1A, over-production of a protein called PMP22 damages the nerves that supply the arms, hands, legs and feet, leading to muscle weakness or paralysis, problems with balance and loss of sensation. He started his career at AstraZeneca leading medicinal chemistry teams in the respiratory and inflammation disease areas.

Disease 113

Disease Treatment Small Molecule Therapies 113

Drug Target Review

JULY 17, 2024

The final product contains thousands of antibodies, is typically thousands of times more potent than similar plasma-derived therapies, can be produced from a single cell bank in a single manufacturing run and can be purified using similar methods to monoclonal antibodies (mAbs).

Immune Response 59

Immune Response Therapies Laboratories Vaccine 59

Drug Target Review

JANUARY 15, 2024

This approach has produced a broad range of approved and investigational products. Some examples of new products incorporating TCR and TCR-like technologies are below. Notable recent examples include CD19‑directed chimeric antigen receptor (CAR) T cells. References Robinson R, McMurran C, McCully M, Cole D.

Engineering 110

Engineering DNA Virus Immune Response 110

The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. SHANGHAI , Jan. ” About SPR206.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 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

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

The Pharma Data

JANUARY 10, 2021

Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In July 2020, the U.S. subsidiary MorphoSys US Inc.,

Clinical Trials 52

Clinical Trials Clinical Development Clinical Supply Trials 52

Cytel

APRIL 5, 2024

Written by Sydney Ringold, Customer Success Manager, and Kevin Trimm, Chief Product Officer In an ever-changing clinical development environment, sponsors face many challenges when designing clinical trials.

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Clinical Trials Trials Clinical Development Regulations 45