Alta Sciences

MAY 29, 2024

How to Optimize Your Early-Phase Drug Development Program pmjackson Wed, 05/29/2024 - 20:32 The Challenges With Outsourcing Drug Development In a Biopharma Dive survey, 45% of the over 143 biopharmaceutical executives surveyed cited the inability to adhere to tight deadlines as a common challenge in preclinical and Phase I clinical development.

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Drug Target Review

JULY 18, 2024

Why is detecting cancers via liquid biopsy before they become visible on imaging important for drug development, not just diagnostics? We believe liquid biopsy is very helpful for oncology drug development because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.

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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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Alta Sciences

NOVEMBER 15, 2024

4 Essential Topics to Cover in Your First CRO Meeting pmjackson Fri, 11/15/2024 - 19:22 Starting a partnership with a contract research organization (CRO) is a sometimes intimidating—yet exciting—first step in your drug development journey.

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Alta Sciences

JULY 22, 2024

Insights in FIH studies provide valuable information on potential dosing, efficacy, and safety, and serve as a good guide for the regulatory requirements needed throughout clinical development. jpg Tags Clinical Trials Weight 1

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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.

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Fierce BioTech

DECEMBER 23, 2024

First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), 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.

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Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

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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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LifeSciVC

JULY 11, 2023

Redig, SVP and Head of Clinical Development at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J. His remarks are worth reading in their entirety.

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Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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Advarra

APRIL 4, 2024

As the board becomes familiar with the company’s protocols and reporting mechanisms, discussions can be more focused, potentially accelerating the pace of clinical development. Recent FDA Draft Guidance The importance of continuity in data monitoring is underscored by the 2024 FDA draft guidance on DMCs.

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The Pharma Data

MARCH 28, 2022

Dupixent peak sales ambition raised to more than €13 billion Chronic obstructive pulmonary disease 2023 pivotal readouts provide potential for additional Dupixent sales ambition upgrade 13 potential new medicines currently in the clinic to treat chronic inflammatory diseases, with 17 readouts expected by the end of 2024.

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Small Molecule Clinical Development Disease Science 52

LifeSciVC

OCTOBER 18, 2023

As we think about our own future with our Phase 2 ready program, we discuss internally how well we fit venture funds’ criteria today and just what is an ’ideal‘ investment profile in 2023 going into 2024? In a market like today, later stage, clinically validated targets are a potentially ‘safer’ place to balance portfolios.

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Drug Target Review

OCTOBER 3, 2024

Since the 1970s, when hybridoma technology enabling the generation of monoclonal antibodies (mAbs) was first developed, 1 antibody-based therapeutics have become one of the most rapidly growing drug categories, with applications across cancer indications, immune disorders and infections. Antibodies to watch in 2024.

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Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

Vial

MARCH 1, 2024

Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drug development and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards. billion by 2029.

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Drug Target Review

SEPTEMBER 19, 2024

Could you give us an overview of IRLAB’s current drug development pipeline? IRL1117 is expected to be ready to move into clinical development at the end of 2024/first half 2025.

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Disease Drugs Treatment Drug Development 52

Vial

MARCH 27, 2024

from 2024 to 2030. The type of sponsorship must also be accounted for because academic institutions sponsoring clinical trials often have access to fewer financial resources compared with commercial sponsors, which typically have larger budgets for their drug development programs.

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LifeSciVC

AUGUST 21, 2024

Drug development is a long process, and patients are waiting. For others this may serve as a reminder of some of the pitfalls that can befall biotech companies this time of year and what the key questions are to ask yourself and the team to manage through the madness and finish strong in 2024. Don’t get me wrong.

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LifeSciVC

MARCH 8, 2024

By Robert Clarke, CEO of Kinaset, as part of the From The Trenches feature of LifeSciVC As I write, I am on the train back from New York after watching my son’s NYU basketball team play in the 2024 D3 Men’s Basketball Tournament. Alas, NYU ran into a tough Tufts team in the second round and lost a tight one 65-62.

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Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

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Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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Agency IQ

APRIL 12, 2024

BY RACHEL COE, MSC | APR 11, 2024 1:06 PM CDT Regulatory background: Product potency and assays As defined in statute , the FDA uses the term “potency” to refer to the “specific ability or capability” of a product to “effect a given result.” The new draft guidance can be broken into three main parts.

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Agency IQ

DECEMBER 11, 2023

What to look for in 2024: This year, OCE amassed a significant volume of feedback from its advisory committee members and from stakeholders via the rulemaking process on trial design. What to expect in 2024? As AgencyIQ stated previously , this point is well-aligned with the goal of OCE’s Project FrontRunner.

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Drug Target Review

AUGUST 28, 2024

Resolution has recently been granted clinical trial authorisation (CTA) approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for our EMERALD Phase I/II study which will begin in Q3 2024. J Hep, 2024 (EASL ILC 2024 Abstract #LBP-007). Reference 1 Brennan P et al.,

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PPD

NOVEMBER 8, 2022

As 2022 comes to a close, we’re reflecting on the past 12 months as a transformative year for the drug development industry — one that foreshadows both change and opportunity in biopharma and biotech clinical trials in 2023. Six Predictions for the Drug Development Industry in 2023 1.

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Conversations in Drug Development Trends

MAY 30, 2024

This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. The shared placebo design is another approach to accelerating drug development in ALS research.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

FDA issued its draft guidance titled “ Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies ,” (the “Draft Guidance”) which replaces the previous pre-FDORA April 2022 draft guidance of the same name.

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Agency IQ

AUGUST 16, 2024

By Rachel Coe, MSC | Aug 12, 2024 6:15 PM CDT Background For decades, sponsors have turned to maximum tolerated dose (MTD) as the primary method for dose selection in oncology. In early-stage development of traditional cytotoxic oncology drugs (i.e., To be [administered with] food or not to be?

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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Agency IQ

AUGUST 2, 2024

By Laura DiAngelo, MPH | Jul 29, 2024 9:52 PM CDT First up: HHS has a new digital technology office In July 2024, the Department of Health and Human Services (HHS) announced a reorganization of its digital health functions. We will further explore the potential of LLMs in a follow-up project in 2024,” the report concludes.

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Drug Target Review

FEBRUARY 11, 2025

Drug development: addressing complexity and success rates Drug development is a complex and expensive process, requiring multidisciplinary expertise and high-risk financial investments. The financial burden of drug development is substantial, often exceeding $2 billion per drug.

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PPD

JANUARY 21, 2025

However, amid this progress, the complexities of drug development have never been more apparent. In 2024, the U.S. Food and Drug Administration (FDA) approved 38 new molecular entities for therapeutic use, a decline from 47 in the previous year. This focus on efficiency is especially vital as trial costs continue to rise.

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PPD

FEBRUARY 3, 2025

However, achieving this requires drug developers to navigate a highly complex and competitive environment. Delays in clinical trials can have significant financial consequences for sponsors. Recognized as the 2024 No. 1 provider of clinical research solutions , our teams deliver 1.5x

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FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. On the other hand, CBER provided no additional guidance as to when a clinical endpoint would be appropriate as an intermediate clinical endpoint to support accelerated approval.

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Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

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