Clinical Research and Workshop - Drug Discovery Digest

Top Clinical Research Conferences of 2024

Vial

MARCH 6, 2024

The field of clinical research is a dynamic and rapidly evolving one. One way to ensure that you are at the forefront of these developments is by attending clinical research conferences. AACR, founded in 1907, is the world’s oldest and largest professional organization dedicated to advancing cancer research.

Clinical Research

Clinical Research Research Clinical Trials Trials

FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

DECEMBER 11, 2023

At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. Fill out the form to read the full article.

Research

Research Clinical Research FDA Regulations

Improving Diversity: Increased Patient Access to Clinical Trials

Vial

JUNE 18, 2024

Black/African American and Hispanic/Latino adults in terms of prevalence, incidence, and outcomes, these populations are underrepresented in AD clinical research. held an international workshop to develop recommendations regarding diversity and inclusivity of participants of clinical trials. Specifically, U.S.

Clinical Trials

Clinical Trials Trials Clinical Research Research

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. FDORA also directed the FDA to convene a meeting.

FDA

FDA Research Clinical Trials Trials

Article EMA Thank You What we expect European regulators to do in March 2024

Agency IQ

MARCH 1, 2024

9 – Advertising for medical devices and in vitro diagnostic medical devices Webinar/ Seminar ( OPEN ) Czech State Institute for Drug Control (NISZP) 3/25/2024 3/25/2024 Clinical Trials Information System Webinar: Last Year of Transition Webinar/ Seminar ( OPEN ) EMA 3/25/2024 3/25/2024 Next steps for clinical research in the U.K.

Regulations

Regulations Biosimilars Clinical Trials Production

Regulatory Trends in Cell and Gene Therapies

Advarra

NOVEMBER 29, 2022

The BGTC will act as a traffic light for these therapies, providing information on basic and clinical research, manufacturing, production, and regulatory requirements. OTAT recently announced its plans to provide increased guidance for sponsors, facilitating a variety of workshops and webinars.

Therapies

Therapies Clinical Trials FDA Production

More than Just Words: Prioritizing Patient-Centered Drug Development

LifeSciVC

FEBRUARY 27, 2024

As we continuously deepen our scientific expertise in ALSP through clinical research, we are also broadening our understanding of the day-to-day by listening to the one living with the disease – patients, care partners, and family members.

Drug Development

Drug Development Disease Drugs Treatment

Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Agency IQ

APRIL 12, 2024

In 2019, ICH announced a final concept paper proposing “a full rewrite and reorganization” of its E6(R3) Guideline on Good Clinical Practice, noting at the time that the intent of the update would include a focus on “increasingly diverse trial types” including DCTs [ Read AgencyIQ’s analysis of the Public Workshop on the ICH E6 renovation here ].

Regulations

Regulations Trials Clinical Trials Science

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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 (..)

FDA

FDA Science Regulations Production

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Read AgencyIQ analysis here for a detailed discussion of these issues. ]. See AgencyIQ’s analysis of the draft guidance here. ]. and in Europe.

FDA

FDA Trials Therapies Regulations

Raising Welfare for Lab Rodents

Codon

JULY 21, 2024

Rex Burch and William Russell at Sheringham Town Hall for the Sheringham Workshop, 31 May, 1995. Organoids and similar systems are incomplete models, which means they lack immune systems—often an essential part of what is being researched in biomedicine as pain and the immune system modulate each other in important ways.

Research

Research Engineering Disease Science

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

See AgencyIQs analysis of a workshop on novel methodology qualification.] This collaboration examining trial formats involved “numerous discussions with regulators, including the US FDA and the EMA Innovation Task Force,” as well as workshops.

Clinical Trials

Clinical Trials Trials Treatment Disease

Article EMA Thank You EMA’s psychedelic workshop leaves stakeholders with as many questions as answers

Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. EMA has now published a report on the workshop; read on for AgencyIQ’s analysis.

Clinical Trials

Clinical Trials Regulations Trials FDA

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

A description of the project and summary of outcomes will be posted on the FDA website. primary and secondary).

FDA

FDA Science Clinical Trials Regulations

Drug Discovery Digest

Top Clinical Research Conferences of 2024

FDA offers a status check on its diversity in research provisions, one year post-FDORA

Webinars

Trending Sources

Improving Diversity: Increased Patient Access to Clinical Trials

Webinars

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Article EMA Thank You What we expect European regulators to do in March 2024

Regulatory Trends in Cell and Gene Therapies

More than Just Words: Prioritizing Patient-Centered Drug Development

Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Raising Welfare for Lab Rodents

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Article EMA Thank You EMA’s psychedelic workshop leaves stakeholders with as many questions as answers

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

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