Drug Discovery World

JUNE 29, 2023

Join DDW for this exclusive free event , A Comprehensive Guide to Using Adeno-Associated Virus (AAV) Vectors in Gene Therapy, which is supported by Azenta Life Sciences. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

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Drug Discovery World

JUNE 22, 2023

Join DDW for this exclusive free event , A Comprehensive Guide to Using Adeno-Associated Virus (AAV) Vectors in Gene Therapy, which is supported by Azenta Life Sciences. AAV is optimal for gene therapy due to its efficiency and safety in humans; however, AAV processes can present obstacles for researchers.

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Drug Discovery World

JANUARY 25, 2023

Cell and gene therapies (CGT) are transforming the way diseases are treated. As research progresses it is hoped that cell and gene therapies will offer innovation for the future. autologous therapies/solid tumours/ indications outside of oncology?)     The webinar will take place on February 17, 2023 4PM GMT. 

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Fierce BioTech

APRIL 3, 2024

Mini-Organs, Major Breakthroughs: How Hub Organoids Are Accelerating Oncology Drug Development dwunderlin Wed, 04/03/2024 - 17:28 Tue, 05/14/2024 - 09:30 Resource Type Webinar Dr. Sylvia F. Boj Duration 60 Minutes Patient-derived organoids are viewed as the gold standard in bridging the gap between the lab and the clinic.

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Drug Discovery World

JUNE 12, 2024

This unique combination bridges the gap between the lab and the clinic, enabling the development of more effective therapies. The webinar will feature Dr Sylvia F Boj, Chief Scientific Officer of HUB Organoids.

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Drug Discovery World

MAY 22, 2024

This unique combination bridges the gap between the lab and the clinic, enabling the development of more effective therapies. The webinar will feature Dr Sylvia F Boj, Chief Scientific Officer of HUB Organoids.

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Drug Discovery World

JUNE 5, 2024

This unique combination bridges the gap between the lab and the clinic, enabling the development of more effective therapies. The webinar will feature Dr Sylvia F Boj, Chief Scientific Officer of HUB Organoids.

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Laboratories Disease Regulations Drug Development 130

Drug Discovery World

MAY 29, 2024

This unique combination bridges the gap between the lab and the clinic, enabling the development of more effective therapies. The webinar will feature Dr Sylvia F Boj, Chief Scientific Officer of HUB Organoids.

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Drug Discovery World

APRIL 3, 2023

Hosted by DDW and supported by Tecan, “How next-generation sequencing is informing oncology drug discovery” will be free to attend on April 24 at 7AM PST / 10AM EST / 3PM BST / 4PM CET. Join this free webinar to learn about the biggest challenges and opportunities facing the NGS oncology space. You will hear from Darrell Green, a lecturer in (..)

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Drug Discovery World

APRIL 18, 2023

Join this free webinar to learn about the biggest challenges and opportunities facing the next-generation sequencing (NGS) oncology space. The post Register now to learn how NGS is informing oncology drug discovery appeared first on Drug Discovery World (DDW). Register now.

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Drug Discovery World

JUNE 23, 2023

Advanced Therapy Medicinal Products (ATMPs) have been making the news this week. FDA approves first gene therapy for Duchenne muscular dystrophy Sarepta Therapeutics’ Elevidys has become the first gene therapy for Duchenne muscular dystrophy (DMD) to gain marketing authorisation in the US.

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Drug Discovery World

MAY 5, 2023

My five stand-out news headlines this week all relate to immunotherapy or immunomodulatory therapies for cancer, particularly advances in our understanding of how other factors in the body, i.e., vitamin D levels and the gut microbiome, can impact the patient’s response to treatment. will be free to attend on May 10.

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Drug Discovery World

APRIL 4, 2023

The post Next-generation sequencing and oncology drug discovery appeared first on Drug Discovery World (DDW). Register now.

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Conversations in Drug Development Trends

FEBRUARY 22, 2023

Our rare disease team at Worldwide will be hosting a panel discussion webinar with patient advocates active in Rare Disease Day events to synthesize the most salient conversations taking place. See their conversation below and register for the webinar to hear more from these advocates!

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Drug Discovery World

OCTOBER 17, 2023

The presentation will address important issues in antibody drug development, including choosing the right biomarker, drug formulation and manufacturing. Muaiad Kittaneh Dreps and Kittaneh will also explore the importance of collaboration and data sharing in antibody drug development.

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Conversations in Drug Development Trends

JUNE 21, 2024

Antibody-Drug Conjugates: Advancing Precision Therapy ADCs represent a compelling combination of targeted antibody therapy and potent chemotherapy, aiming to enhance treatment efficacy while minimizing systemic toxicity. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

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Conversations in Drug Development Trends

OCTOBER 26, 2022

Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now. Check out the full webinar !

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PPD

OCTOBER 16, 2023

There has been continuous growth in the variety and volume of available health care data, and newer applications for use of real-world data (RWD) and real-world evidence (RWE) to enhance the speed of patient access to new therapies. Tokenization can accelerate innovation in clinical trials and drug development.

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Drug Discovery World

JUNE 7, 2023

What can we expect from the cell & gene therapy market? Is it true that the next era will belong to antibody drug conjugates? Will AI be key to expediting the drug discovery process and what role will data science have? Panellists will discuss the following questions: Where will the opportunities be in 2024?

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Drug Discovery World

MARCH 29, 2023

According to the Wellcome Trust 5 , it can take between 10 and 15 years and over $1billion to develop a new antibiotic, so systems such as this aim to provide incentive to drug developers. In the same webinar, Emer Cooke, EMA Executive Director, countered, in relation to regional drug approvals, “Faster isn’t necessarily better.

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Drug Discovery World

FEBRUARY 9, 2024

DDW recently hosted a webinar ‘Discover how iPSC derived cells can be used to support the development of drug and gene therapies’, supported by DefiniGEN. Chris explained that DefiniGEN is a liver cell company focussed on hepatocytes, particularly supporting the drug development industry in producing liver therapies.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Conversations in Drug Development Trends

NOVEMBER 14, 2022

So, it should come as no surprise that as the field explores the use of psychedelics as treatment options for mental illnesses, they are studying the use of psychological therapy alongside them. As with any successful therapy session, a patient should feel trusting towards and comfortable with the therapist supporting them.

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Drug Discovery World

SEPTEMBER 26, 2023

In this webinar you will discover how iPSC derived cells can be used to advance the efficiency and efficacy of disease modelling. ‘ Discover how iPSC derived cells can be used to support the development of drug and gene therapies’ will take place on 28 September 4PM BST, 5PM CEST, EDT 11AM, PDT 8AM.

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Drug Discovery World

SEPTEMBER 5, 2023

In this webinar you will discover how iPSC derived cells can be used to advance the efficiency and efficacy of disease modelling. ‘ Discover how iPSC derived cells can be used to support the development of drug and gene therapies’ will take place on 28 September 4PM BST, 5PM CEST, EDT 11AM, PDT 8AM.

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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?

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Production FDA Therapies Biochemical Assays 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.

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Alta Sciences

JULY 18, 2023

Webinar: Gene and Cell Therapy: Enhanced CNS and Ocular Delivery in Nonhuman Primates With the new modalities, early drug discovery may require more specialized and focused delivery options for animal disease models. Discover the unique advantages of this large animal model alternative. Read or listen.

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Agency IQ

MARCH 1, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes Request for Information February 29 (Extended) Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments Draft Guidance March 11 Advanced Manufacturing Technologies Designation Program Draft Guidance March (..)

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Drug Discovery World

JANUARY 19, 2023

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). Figure 1: The integrated development pathway for cell and gene therapies.

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Conversations in Drug Development Trends

FEBRUARY 28, 2023

If we don’t fund this research, we never have the chance for treatments, cures, or innovative therapies. To hear more about Rob and the work they are doing at Uplifting Athletes, register for Worldwide’s upcoming webinar featuring Rob, Rare Disease Day 2023 Wrapped: What You Need To Takeaway. And that’s exactly where UA starts.

Clinical Trials 52

Clinical Trials Disease Trials Research 52

Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

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Agency IQ

JUNE 2, 2023

Title Type Comments Close Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the Federal Food, Drug, and Cosmetic Act Guidance June 5 Patient Preference Information—Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in (..)

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Drug Discovery World

FEBRUARY 6, 2023

Johannes Goll, Global Head of Emmes’ Biomedical Data Science and Bioinformatics department, explains how big data analytics can deliver improved therapies and bring clinical research one step close to realising the potential of personalised care.

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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. Yet, it becomes a manageable aspect of drug development with careful planning, strategic engagement, and flexible problem-solving.

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Agency IQ

OCTOBER 27, 2023

Title Type Comments Close Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief Guidance November 1 Post-Warning Letter Meetings Under GDUFA Guidance November 6 In-Home (..)

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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