This site uses cookies to improve your experience. By viewing our content, you are accepting the use of cookies. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country we will assume you are from the United States. View our privacy policy and terms of use.
2023 Clinical Development Drug Development 
PPD
NOVEMBER 11, 2024
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drug development. billion in 2023 to 1.2 billion in 2023 to 1.2 billion in 2035. billion in 2035.
PPD
NOVEMBER 21, 2023
The drug development industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drug development industry experienced setbacks during the COVID-19 pandemic, the field is again gaining momentum reminiscent of its pre-pandemic pace.
KIF1A
SEPTEMBER 30, 2023
Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drug development, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.
111 
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. Speak with an expert today to discuss your next clinical program. Watch the webinar.
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. Asia, and Europe.
Conversations in Drug Development Trends
DECEMBER 7, 2023
However, despite their greater service capabilities, large CROs have hit an inflection point in the clinical landscape, leading to unexpected industry dynamics characterized by a rise in CROs that take a more personalized approach.
136 
Alta Sciences
AUGUST 18, 2023
Don’t miss out: [link] Event End Date Thu, 10/26/2023 - 12:00 Event Start Date Thu, 10/26/2023 - 12:00 Weight 1
Conversations in Drug Development Trends
DECEMBER 5, 2023
Vendors that seamlessly integrate with CROs, delivering services in a timely manner, regardless of which phase the clinical trial is in, can significantly help maintain drug development timelines.
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. We owe it to our patients to step firmly on the scientific accelerator.”
67 
The Premier Consulting Blog
JUNE 18, 2023
This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
Advarra
AUGUST 10, 2023
Given the relatively small populations affected by any one rare disease or condition, a pharmaceutical company developing an orphan drug may reasonably expect the final approved drug to generate relatively small sales (when compared with the drug development costs) and consequently incur a financial loss.
Cytel
OCTOBER 27, 2023
Since its launch in 2021, Project Optimus has been reforming the dose optimization and dose selection paradigm in oncology drug development. To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus. With consensus of multiple stakeholders on “why” the change is needed, the speakers focused on “how.”
Broad Institute
NOVEMBER 2, 2023
Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.
105 
PPD
JUNE 17, 2024
One interesting trend emerging from the 2023 Pulse Report is the rise of hybrid functional service provider (FSP)/full-service outsourcing (FSO) arrangements. Partner with an FSP provider that delivers results across every use case Drug developers count on strategic collaborations for success, and those collaborations come in many forms.
Metabolite Tales Blog
DECEMBER 19, 2023
Metabolite Bioanalysis in Drug Development: Recommendations from the IQ Consortium Metabolite Bioanalysis Working Group A Metabolite Bioanalysis Working Group comprised of experts from 14 different pharma companies have proposed recommendations around best practice in metabolite bioanalysis during drug development.
Drug Target Review
FEBRUARY 1, 2024
But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. In other cases, well-established biomarker profiles enable patient enrichment strategies in early-stage clinical development.
104 
Agency IQ
DECEMBER 11, 2023
The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings.
40 
Conversations in Drug Development Trends
FEBRUARY 22, 2023
What will have the greatest impact on rare disease patients in 2023? Katie Nichols, senior project manager at Worldwide Clinical Trials, has been dedicated to rare disease research for seven years, seeing the impact firsthand that the progression of rare disease research has on rare disease communities. So, I decided to pivot.
52 
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.
PPD
NOVEMBER 30, 2023
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.
Labcorp Drug Development
FEBRUARY 3, 2023
Welcome to the February 2023 Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. With Rare Disease Day coming soon on February 28, we are going to focus on how patients, sites and investigators can benefit by improving the design and execution of rare disease trials. What is Rare Disease Day?
52 
Vial
MARCH 1, 2024
Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). By geographical region, the global CRO services market in 2023 was dominated by North America. billion in 2023 attributable to its laboratory products and biopharma services segment (53.8% of total revenue).
Conversations in Drug Development Trends
JANUARY 24, 2024
However, they lack awareness of specific clinical trials that may be relevant to their patients, and they don’t always feel they have the knowledge to explain certain aspects of clinical trials confidently to patients and their family members. Enrolling adequate populations will be required to advance these programs.
75 
Vial
APRIL 10, 2024
The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2%
PPD
NOVEMBER 14, 2023
In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinical development. This comes as the demand for qualified clinical research associates (CRAs) is expected to increase by more than 36% in the next decade.
Vial
FEBRUARY 29, 2024
Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. between 2023 and 2032. By 2032, this value is expected to reach US$108 billion.
LifeSciVC
JANUARY 16, 2024
By Aimee Raleigh, Principal at Atlas Venture, as part of the From The Trenches feature of LifeSciVC Just in time for new years’ reflections and resolutions, this year’s JPM felt like a refreshing burst of enthusiasm for a sector that has seen its challenges in 2022 and 2023 but also some green shoots.
139 
LifeSciVC
OCTOBER 18, 2023
By Bob Clarke, CEO of Kinaset Therapeutics, as part of the From The Trenches feature of LifeSciVC As we enter the final leg of 2023, navigating the investment market in biotech continues to be fraught with twists and turns. So, what are investors looking for? I mean it’s easy, right? Where are investments going in the current market?
Drug Target Review
OCTOBER 3, 2024
In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. Crescioli S, Kaplon H, Chenoweth A, et al. www.science.org.
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.
PPD
JUNE 22, 2023
Sponsors and clinical research organizations (CROs) alike are facing competitive recruiting from limited talent pools. These challenges were echoed in a 2022 industry survey conducted by the PPD clinical research business of Thermo Fisher Scientific. We are committed to operational excellence across drug development.
PPD
JUNE 20, 2023
As some drug development organizations right-size their workforces , a strong CRO partner will rehire your talent — avoiding destabilization of your clinical research — via rebadging through functional service provider (FSP) engagements. The drug development industry is undoubtedly in a season of change.
FDA Law Blog: Drug Discovery
JANUARY 4, 2023
The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Other Questions.
59 
Conversations in Drug Development Trends
DECEMBER 20, 2023
In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.”
PPD
OCTOBER 31, 2023
Our 2023 industry trends report found that an increasing number of sponsors have begun to gravitate toward the FSP model, with respondents now saying FSP engagements represent 26% of their clinical work on average. Moreover, FSP models allow drug developers to outsource individual functional services to gain efficiency and flexibility.
FDA Law Blog: Drug Discovery
OCTOBER 2, 2023
Two weeks ago, FDA published a draft of its latest drug development guidance explaining how drug and biological product developers can use this pathway to meet the statutory standard for efficacy. In the December 2019 Guidance, FDA writes that the clinical context for a disease (i.e.,
64 
Agency IQ
JULY 21, 2023
The paper recommends a risk-based approach that weighs patient safety and integrity of development data. BY KIRSTEN MESSMER, PHD, RAC JUL 18, 2023 11:07 PM CDT Regulatory background In April 2021, the E.U. An earlier report highlighted three key areas for international regulatory consideration when employing AI in drug development.
40 
Drug Target Review
SEPTEMBER 26, 2023
CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinical development, a phase where consequences are high in terms of resources and patient impact.
111 
Vial
MARCH 27, 2024
Increasing Demand for Contract Research Organization (CRO) Support CROs are pivotal to the successful execution of clinical trials, offering a tailored resource of expertise, services, and logistical support that can significantly streamline the process for sponsors. from 2024 to 2030.
Broad Institute
OCTOBER 11, 2023
By Allessandra DiCorato October 11, 2023 In 2011, Robert Manguso was working in a cell biology lab when his mother was diagnosed with Merkel cell carcinoma, a rare and aggressive skin cancer. Along the way, TIDE is showing how careful, systematic science at scale can quickly home in on promising drug targets.
137 
Agency IQ
FEBRUARY 12, 2024
Furthermore, the Consortium would also work to develop standardized approaches to nonclinical testing as well as a set of standardized analytical methods, which could be used to assess product quality and manufacturing processes and controls.
40 
FDA Law Blog: Drug Discovery
NOVEMBER 2, 2023
Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.
59 
Agency IQ
SEPTEMBER 22, 2023
BY AMANDA CONTI, ALEXANDER GAFFNEY, MS, RAC SEP 18, 2023 9:24 PM CDT Background: FDA’s standards for evidence When seeking approval from the FDA, companies are required to demonstrate that their product is safe and effective when used as intended. FDA will accept comments on the draft guidance until December 18, 2023. What’s next?
40 
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.
Expert insights. Personalized for you.
We have resent the email to
Are you sure you want to cancel your subscriptions?
Let's personalize your content