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. Download your copy today. In this complimentary webinar , Mel B. Watch the webinar.

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LifeSciVC

FEBRUARY 27, 2024

By Ivana Magovčević-Liebisch, CEO of Vigil Neuroscience, as part of the From The Trenches feature of LifeSciVC Patients and their care partners are at the center of our work in the life sciences industry – but at what point during the drug development process should companies start to engage these key stakeholders?

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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. Panelists will answer questions such as: What are the greatest challenges holding patients back from enrolling in trials?

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Alta Sciences

JANUARY 22, 2024

Get a Head Start On Your 2024 Preclinical Drug Development Program blussier Mon, 01/22/2024 - 15:18 HTML EXPERTISE Matters. With four strategically placed preclinical research facilities throughout North America, Altasciences can get your CTA/IND-enabling studies underway in just 8 weeks!

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Conversations in Drug Development Trends

AUGUST 10, 2023

The event provided a unique opportunity to interact with a large and diverse group of fellow stakeholders, expanding my perspective on the impact of psychedelic clinical trials. Psychedelic Research at Worldwide Since 2017, Worldwide Clinical Trials have supported a myriad of sponsors leading the way in psychedelic research programs.

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Fierce BioTech

JULY 17, 2023

Best practices for capturing reproducible and accurate in vivo data to reduce failure in clinical trials – the most expensive phase of drug development. Discussion will include: Current in vivo study management practices and processes. How did we get here?

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Cytel

APRIL 3, 2024

Thank you to Charlotta Gauffin, Chief Scientific Officer at Dicot, for joining us for our recent webinar, “The Road to First-in-Human Trials: Insights from a Real-World Example.” Thoughtfully and carefully planned nonclinical studies help pave a smooth path toward first-in-human Phase 1 clinical trials.

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Alta Sciences

MARCH 21, 2024

Top 5 Scientific Resources in CNS Clinical Trials blussier Thu, 03/21/2024 - 18:09 HTML CNS Center of Excellence Resource Library Altasciences has an extensive understanding of psychiatric and neurologic disorders, stemming from our decades of conducting complex studies in various therapeutic indications impacting the central nervous system.

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Conversations in Drug Development Trends

NOVEMBER 14, 2022

But in a clinical trial setting, what role does a therapist play and how do they affect the clinical trial data? We connected with her to answer a few questions about how these roles function: When should a psychedelic trial utilize a therapist? This is called “psychedelic-assisted psychotherapy” (PAP).

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PPD

OCTOBER 16, 2023

” By tokenizing participants in a clinical trial, researchers gain the ability to link RWD from trial participants’ medical data to their clinical trial data. Tokenization can accelerate innovation in clinical trials and drug development. Here are five things you need to know about tokenization.

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Fierce BioTech

MARCH 12, 2024

For biopharma and biotech companies, FSP partnerships have emerged as a pivotal strategy for accessing the complementary expertise and resource flexibility they need to meet their timelines, and innovative providers are implementing new, globalized FSP strategies to keep their clients ahead of the curve.

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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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Conversations in Drug Development Trends

FEBRUARY 28, 2023

Rob found out that in 1980, a researcher in Birmingham, England first synthesized a very niche cancer drug in a small lab. Over the next few decades, that drug made its way through clinical trials, securing approval in 2007—just 36 months before Rob was diagnosed in 2010. But what was truly remarkable?

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Clinical Trials Disease Trials Research 52

Alta Sciences

AUGUST 7, 2024

blussier Wed, 08/07/2024 - 19:51 HTML Timing is Everything Early collaboration with an experienced CDMO is crucial in drug development to mitigate manufacturing risks and ensure the efficient formulation of your API for preclinical and clinical testing. Contact us today to discuss the next stage of your drug development journey.

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Alta Sciences

JANUARY 24, 2024

Discover the Power of Driving Simulations for CNS Side-Effect Analysis blussier Wed, 01/24/2024 - 18:25 HTML Start Your Driving Trial Quickly—Simulators On-Site Driving simulator studies are a safe, efficient, and effective alternative to on-the-road driving trials for CNS-active drugs. jpg Tags Clinical Trials Weight 1

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Conversations in Drug Development Trends

JUNE 21, 2024

Worldwide Clinical Trials attends each year to hear from the research community, connect with our sponsors and sites, and explore potential partnerships to drive forward novel treatments. Check out this webinar on navigating the landscape of oncology clinical trials. Interested in hearing more insights from Matt?

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Agency IQ

JULY 8, 2024

Several webinars and training sessions are geared towards ISO identification of medicinal products (IDMP) standards which is referred to as Substance, Product, Organization, Referentials (SPOR) data management services. ’s Medicines and Healthcare products Regulatory Agency (MHRA).

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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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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. The large number of ongoing clinical trials of recombinant AAV (rAAV)-based therapies highlights their promise for addressing a wide variety of human genetic disorders.

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Agency IQ

AUGUST 23, 2024

The rule has significant implications for the way that LDTs are regulated in general, but also has additional impact on the use of LDTs in the context of drug development (i.e., There are several high-level takeaways from these updates for drug developers.

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Agency IQ

AUGUST 2, 2024

September 30, 2024 Upcoming (or overdue) legislative requirements due as of August and September Congress often asks the FDA to release or hold guidance documents, regulation, reports, meetings, hearings or pilot programs as of specific dates.

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Agency IQ

APRIL 12, 2024

In drug development, biochemical assays might be used to determine a product’s binding affinity to a target receptor of interest, along with the strength, stability and duration of the target-ligand complex after the product binds to the receptor. What does progressive implementation of a potency assurance strategy mean?

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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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Agency IQ

JUNE 29, 2023

.; Request To Revoke Color Additive Listing for Use of Titanium Dioxide in Food Proposed Rule July 3 Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket Request for Comments July 3 Methodological Challenges Related to Patient Experience Data; Request for Information (..)

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Agency IQ

NOVEMBER 3, 2023

A trial run: The Covid-19 EUA transition. That transition could potentially serve as a trial run to the phased-in system under the proposed LDT rule in which a high volume of products would have a time-limited window to submit regulatory applications to the FDA. See AgencyIQ’s full discussion on this issue here.]

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Agency IQ

OCTOBER 27, 2023

Start Date End Date Event Event Type Center 10/30/2023 10/30/2023 Defining ‘Candy-Like’ Nonprescription Drug Products Workshop CDER 10/31/2023 10/31/2023 Cellular, Tissue, and Gene Therapies Advisory Committee Advisory Committee Meeting CBER 10/31/2023 10/31/2023 Webinar – Proposed Rule: Medical Devices; Laboratory Developed Tests (..)

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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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Conversations in Drug Development Trends

FEBRUARY 26, 2024

With the necessary prioritization of various factors when designing your clinical trial, the patient experience can be overlooked or improperly addressed in study design. However, incorporating the patient experience into your design is one of the best ways to ensure your drug development program is a commercial success.

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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. Each nation has varying definitions of what qualifies as a pivotal study.

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Alta Sciences

JULY 25, 2024

Discover some of the nonclinical requirements for moving dermal studies into Phase I clinical trials, including formulation considerations, species selection, and ideal candidates for transdermal drug delivery systems (TDDS). Watch the webinar. Watch the webinar. Catch up on what you might have missed below!

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The Pharma Data

DECEMBER 15, 2020

Company plans to meet with regulatory authorities as it evaluates next development steps. Company to host Key Opinion Leader (KOL) webinar to discuss these results today, December 16, at 8:00 am EST; registration link below. months that we observed in this trial. TEL AVIV, Israel , Dec.

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Agency IQ

MARCH 1, 2024

District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing.

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Alta Sciences

SEPTEMBER 29, 2023

If you have yet to visit our Montréal clinical facility to learn about the advantages of conducting trials in Canada or had the pleasure of meeting the friendly, uniquely talented, and experienced team working on your studies, you will want to watch our latest video.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. Prohaska, Kavita C. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

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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. There are several reasons why choosing Canada for your clinical trials can be beneficial. Read or listen.

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Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

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Agency IQ

FEBRUARY 2, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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