Fierce BioTech

MAY 29, 2024

Redefining Antibody Specificity Profiling for IND Assessment of antibody off-target reactivity is a regulatory requirement for clinical development, but conventional methods are often ineffective, and their predictive value for in vivo safety and toxicity is poor.

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Fierce BioTech

DECEMBER 23, 2024

and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development. First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.),

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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! So, I decided to pivot.

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Fierce BioTech

JANUARY 10, 2025

New Single Cell Foundational Model Use Case pesurya Fri, 01/10/2025 - 13:22 Wed, 02/26/2025 - 12:00 Resource Type Webinar Promotion End Wed, 02/26/2025 - 11:17 Duration 60 Minutes In todays world, life sciences and healthcare companies face major challenges managing complex datasets, accelerating drug discovery, and advancing precision research.

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Fierce BioTech

SEPTEMBER 10, 2024

Women’s Health: Experts Talk Economics, Education & Equality dwunderlin Tue, 09/10/2024 - 12:32 Wed, 10/16/2024 - 11:00 Resource Type Webinar Dorothy Gemmell Aditi Goenka Promotion Start Wed, 09/18/2024 - 13:45 Duration 60 Minutes While just over 50% of people living in the U.S. Click here to login.

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Conversations in Drug Development Trends

JUNE 13, 2024

At Worldwide, Matt Cooper and Jim Eamma , our Executive Directors, Therapeutic Strategy Leads in Oncology, shed light on the intricacies of modern oncology trials in their recent webinar, “ Navigating the Landscape of Complex & Adaptive Oncology Trials.” How Does Project Optimus Impact Your Study’s Operations?

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Fierce BioTech

APRIL 10, 2024

Redefining Antibody Specificity Profiling for IND swheeler Wed, 04/10/2024 - 17:56 Thu, 06/06/2024 - 11:00 Resource Type Webinar Kris Raghavan, PhD Fernanda I. Staquicini, PhD Duration 60 minutes Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. So, what are the alternatives?

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Fierce BioTech

AUGUST 25, 2023

Your Comprehensive Guide to Analytical Testing, From Clinical to Commercial pesurya Fri, 08/25/2023 - 10:45 Tue, 10/03/2023 - 11:00 Resource Type Webinar Katie Schlipp Elliott Franco, Ph.D. Today there are many CDMOs who offer services in various domain of analytical testing. How can you be sure that you have chosen an ideal partner?

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Conversations in Drug Development Trends

MAY 1, 2024

The clinical trials sector prompted a recent modernization of ICH E8 and a subsequent renovation of ICH E6 to provide updated guidance that is appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources employed to support regulatory and other health policy decisions.

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Fierce BioTech

MAY 15, 2024

Life Sciences Industry Roundtable: How Data & AI Pave the Way for Innovation dwunderlin Wed, 05/15/2024 - 16:19 Tue, 06/25/2024 - 13:00 Resource Type Webinar Chaitanya Geddam Avishek Roy Rohit Verma Lisa Arbogast Harini Gopalakrishnan Promotion Start Tue, 05/21/2024 - 12:50 Promotion End Thu, 11/21/2024 - 12:50 Duration 60 Minutes Data and AI are (..)

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PPD

OCTOBER 16, 2023

Following tokenized study participants in the real world and in real time across a broad data ecosystem extends the ability to answer more research questions through continuous evidence generation across a variety of use cases and therapy areas throughout the development life cycle.

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Alta Sciences

JUNE 9, 2023

Download your copy today. In this complimentary webinar , Mel B. Affrime , PharmD, Executive Vice President, Translational Medicine, discusses how ethnic differences can impact the bioavailability of your drug candidate and how to design a multiregional clinical development program to hasten worldwide regulatory approval safely.

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Fierce BioTech

AUGUST 14, 2023

The democratization of data, large language models and natural language processing (NLP) among other tools offer unprecedented access and empowerment for clinical development teams to enhance the value of their programs.

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Cytel

JANUARY 25, 2023

And it is this adaptive thinking that can be so useful in clinical trials, for example, in oncology trials where the standard of care might evolve during the course of the trial. In his recent webinar, “Novel Methods of Trial Design,” Prof. Let’s take a closer look.

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Cytel

JANUARY 23, 2023

This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:

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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

Watch Now The Altascientist: Central Nervous System Early-phase development of CNS-acting drugs is a complex, challenging undertaking.

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Alta Sciences

APRIL 17, 2024

With industry-leading solutions in the field of psychedelic drug development, and CNS drugs in general, our CNS Center of Excellence has supported numerous CNS drug development programs and is on the leading edge of the latest scientific knowledge in the field. Asia, and Europe.

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Advarra

NOVEMBER 29, 2022

Bottlenecks in the manufacturing process, supply chain issues such as accessibility of good manufacturing practice (GMP)-grade reagents, and shortages of qualified scientists and engineers have caused many therapies to fail at critical stages of the clinical development pipeline.

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The Pharma Data

JANUARY 27, 2021

The Company is in late-stage clinical development and has been working toward establishing commercial readiness. This webinar will give current and prospective investors a clear vision of the Company’s goals for 2021 and beyond. About MultiStem ®.

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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. Interested parties can register for the webinar here. Kenilworth, N.J. ,

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Advarra

JUNE 6, 2022

Advarra expert Steffen Engel answers questions from the recent webinar, Stepwise Implementation of a Clinical Quality Management System. A: The webinar discussed the following factors: Conduct a thorough assessment of each site’s QMS. A: That is a tough one. First, congratulations on realizing such a mindset may exist.

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The Pharma Data

DECEMBER 12, 2020

AstraZeneca , with Alexion ‘s R&D team, will work to build on Alexion ‘s pipeline of 11 molecules across more than 20 clinical-development programmes across the spectrum of indications, in rare diseases and beyond. Webinar and conference call. Webinar ID: 995 4603 8702. UK : +44 203 481 5237.

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Agency IQ

AUGUST 9, 2024

Following a recent AgencyIQ webinar, we collected dozens of questions from our subscribers and webinar attendees to put together this list of commonly-asked questions, as well as our attempts to answer them using available information. We’ve also collected additional questions that we have about the guidance.

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Agency IQ

APRIL 12, 2024

In an effort to further explain its current views on potency assurance, the FDA also recorded a webinar to accompany the new draft. The FDA’s revamp of the potency assay guidance extends these same principles to this other important aspect of product development, he emphasized.

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Agency IQ

AUGUST 18, 2023

Expert panels have two main tasks under the MDR and IVDR, which is to provide opinions and view as part of the clinical and performance evaluation consultation procedures (MDR Article 54 / IVDR Article 48). The second is ad hoc advice on clinical development plans and clinical investigation proposals.

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PPD

APRIL 14, 2025

Expertise that accelerates your clinical development success The PPD clinical research business of Thermo Fisher Scientific has significant experience in customized Phase I-IV metabolic clinical trials. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.

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SCIENMAG: Medicine & Health

FEBRUARY 6, 2024

The Brain & Behavior Research Foundation (BBRF) is hosting a free webinar, “Developing Biological Markers to Improve Clinical Care in Autism” on Tuesday, February 13, 2024, at 2:00 pm ET. The presenter will be James McPartland, Ph.D.,

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Agency IQ

DECEMBER 1, 2023

Start Date End Date Event Event Type Organization 12/01/2023 12/01/2023 BIVDA Environmental Working Party Webinar/Seminar ( CLOSED ) British In Vitro Diagnostics Association (BIVDA) 12/04/2023 12/04/2023 HMA/EMA Big Data Stakeholder Forum 2023 Webinar/Seminar ( OPEN ) European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) 12/04/2023 12/04/2023 (..)

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Agency IQ

AUGUST 2, 2024

While ASTP/ONC’s work is likely to be higher-level than FDA’s, the strategic plan on AI could, depending on its development, roll down to FDA policy. The HHS announcement also comes with a note that the Department will be hosting a webinar about federal workforce opportunities in this area.

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