FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.

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Conversations in Drug Development Trends

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

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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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PPD

SEPTEMBER 16, 2024

The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.

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Drug Target Review

FEBRUARY 29, 2024

During my academic career, I had the opportunity to examine the underlying causes of neurodegenerative diseases like Parkinson’s disease and develop novel animal models to investigate potential disease-modifying therapeutics. AskBio) I continue to work to bring innovative gene therapies to patients in need.

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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.

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Advarra

NOVEMBER 29, 2022

The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.

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PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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Drug Target Review

DECEMBER 13, 2024

2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 7 Recent clinical studies highlight promising developments in c-MET-targeting ADCs for NSCLC.

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Drug Target Review

JANUARY 8, 2024

Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a clinical-stage private biopharma company developing therapies for neurological and psychiatric diseases.

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Drug Target Review

MAY 22, 2024

How does Circio’s circVec technology aim to enhance the potency and reduce the cost of current gold-standard gene therapy? There are three major reasons for why Circio has selected AATD as its lead gene therapy program. Firstly, there have been previous AAV gene therapy clinical studies in this indication that have shown promise.

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Drug Target Review

DECEMBER 28, 2023

In most cancers, the tumour evolves by acquiring mutations that confer growth advantages or resistance to therapies. However, if the therapy targets only the subclonal (branch) mutations, this will result in the mere ‘pruning’ of specific branches rather than elimination of the whole cancer.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

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KIF1A

SEPTEMBER 30, 2023

#ScienceSaturday posts share exciting scientific developments and educational resources with the KAND community. Each week, Dr. Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. What’s a pre-print?

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The Pharma Data

JANUARY 12, 2021

Working alongside KSQ will facilitate smart drug discovery and development of what we hope will be transformative new therapies for patients with intractable forms of cancer.”. KSQ and Takeda can collaborate on IND-enabling activities, with clinical development led by Takeda to explore multiple modalities.

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The Pharma Data

AUGUST 24, 2020

The FDA has approved a request from American Gene Technologies to begin a clinical study into its HIV gene therapy. The treatment is being researched by scientists collaborating from American Gene Technologies, the Laboratory of Immunoregulation and the National Institute of Allergy and Infectious Diseases. Conor Kavanagh.

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The Pharma Data

MARCH 27, 2021

(Nasdaq: GILD) today announced that Flavius Martin, MD will join the company as Executive Vice President, Research, and will become a member of the company’s senior leadership team, reporting to Chairman and Chief Executive Officer Daniel O’Day. Dr. Martin will assume responsibility for Gilead’s research organization effective April 12, 2021.

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Conversations in Drug Development Trends

JULY 29, 2024

Clinical development programs must acknowledge the complexity and variability of obesity as a condition. Partnering with a CRO that emphasizes the complexity of the patient’s voice and harnesses the nuances of clinical trial design is crucial for executing successful clinical research.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. CARLSBAD, Calif. ,

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The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. In July, finerenone was approved under the name Kerendia® by the us (U.S.)

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The Premier Consulting Blog

MARCH 7, 2024

The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.

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Drug Target Review

JUNE 6, 2023

We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. Difficult-to-treat and rare, complicated cancers remain a perplexing challenge for IO researchers. Clinical development of IL-18 therapies has been curtailed, however, by the protein’s lack of efficacy.

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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).

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PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8

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The Pharma Data

MARCH 29, 2022

Boehringer Ingelheim and Veeva Systems (NYSE: VEEV) today announce Boehringer Ingelheim’s selection of Veeva Development Cloud to drive end-to-end processes and seamless information sharing enterprise wide for greater speed in the delivery of innovative therapies. About Boehringer Ingelheim.

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PPD

OCTOBER 16, 2023

The ability to leverage health care data for real-world research has historically been challenging due to patient privacy and data integration concerns. ” By tokenizing participants in a clinical trial, researchers gain the ability to link RWD from trial participants’ medical data to their clinical trial data.

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Conversations in Drug Development Trends

JANUARY 24, 2024

However, clinical research around Fragile X is considerably robust, making the possibility of clinical trial participation a potential motivation for parents to choose to undergo genetic testing for their children. As of July 2023, the American Society of Cell + Gene Therapy stated there were 3,905 therapies in development.

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Drug Target Review

APRIL 3, 2024

Could you share an example of a specific project or research that you have worked on and the impact it has had in your field? I am currently working as Chief Scientific Officer at CatalYm, where we translate the latest scientific findings into clinical applications.

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The Pharma Data

JANUARY 12, 2021

Additionally, Boehringer has been granted the responsibility for all non-clinical as well as clinical development. In spite of this responsibility, Enara will retain the rights to use any antigens discovered in the collaboration program for use in cell therapy products. Source link.

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The Pharma Data

JUNE 2, 2022

New multi-program collaboration to develop allogeneic TCR-T/CAR-T programs brings together Immatics’ allogeneic gamma delta T cell therapy platform ACTallo ® with Bristol Myers Squibb’s technologies and oncology drug development expertise. Executive Vice President, Research & Early Development, Bristol Myers Squibb. “We

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Drug Target Review

OCTOBER 11, 2023

1,2 Many, however, do have dysfunctional proteins at their core, and for these diseases, a new option is being explored: autophagy-boosting therapies. Gene therapy, of course, also holds great promise. Most of these conditions are genetic in origin and the majority have no effective treatment.

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The Pharma Data

JUNE 2, 2022

Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.

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Creative Biolabs

MAY 25, 2022

It combines the advantages of high specific targeting ability and strong killing effect to achieve accurate and efficient clearance of cancer cells, and has become one of the hotspots in the research and development of anticancer drugs. The overview of the mechanisms of ADC for killing cancer cells via different approaches. (Fu,

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Drug Target Review

AUGUST 24, 2023

Neutralising GDF-15 with CatalYm’s anti-GDF-15 antibody visugromab was shown to reverse its inhibitory effects and to re-sensitise tumours to anti-PD-1 treatment, achieving commensurate survival benefit of anti-GDF-15-anti-PD-1 combination therapy in vivo. in North America) in late 2017.

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The Pharma Data

DECEMBER 10, 2020

Spending several years with Sanofi in Paris, France as a Global safety officer, he then relocated to New Jersey, USA to work in Early and Late Stage Clinical Development in Immunology, when he became the Global Project Head of Dupixent, a medicine that has revolutionized the field of allergic and atopic diseases.

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Drug Target Review

DECEMBER 13, 2023

These disease signatures capture both the linear and non-linear effects of genetic and molecular interaction networks and enable the identification of associations including those that are only relevant to a subgroup of patients that influence disease risk, prognosis and/or therapy response.

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Drug Target Review

DECEMBER 27, 2023

Aside from CD24, there are several other ‘don’t eat me’ signals that have been characterised, and there are multiple programmes currently in clinical development that target these signals. Previously, he served as Director of Translational Research at Forty Seven Inc.,

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