Fierce BioTech

JUNE 18, 2024

Experts recommend that CGT manufacturers proactively design a comprehensive market access strategy early in clinical development and commercial planning timelines, ideally more than three years pri | CGT companies should consider developing a market access strategy early in clinical development, ideally more than three years prior to launch.

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Cytel

JANUARY 15, 2024

After explosive and frenetic activity in the clinical trial industry during the COVID era, the past two years have seen challenging market dynamics and a drop-off in activity. Every one of us working in clinical development has felt this slowdown, but as we begin 2024, there is reason for optimism.

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Cytel

JANUARY 10, 2024

A clinical development strategy is a comprehensive plan designed to establish the safety and efficacy of new therapeutics. Developing an effective plan requires multidisciplinary expertise and adapting to accumulating learning and changes in clinical practice and the market environment.

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PPD

JANUARY 15, 2025

Click to enlarge Six AI and machine learning considerations for effective clinical trial management 1. Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time.

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The Premier Consulting Blog

AUGUST 21, 2024

As clinical development of an investigational product proceeds, Sponsors often conduct global clinical trials which require preparation of content to support dossiers in multiple geographies, meeting the regulatory requirements of each region. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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PPD

NOVEMBER 11, 2024

As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients. According to the United Nation’s 2024 World Population Prospects data, the global population of those 65 years old and over will grow from 0.8

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Conversations in Drug Development Trends

DECEMBER 7, 2023

These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinical development goals and corporate culture.

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PPD

NOVEMBER 9, 2023

Decreased timelines A flexible and adaptive protocol provides the potential to expedite drug development timelines by decreasing the overall duration of the early development/Phase I stage. Expediting time to market in this way is extremely valuable for those who ultimately benefit from improved therapeutic care.

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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.

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Drug Target Review

APRIL 30, 2025

Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. Faster time-to-market and reduced costs. The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT. The result?

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Cytel

MAY 7, 2024

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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The Pharma Data

MAY 8, 2021

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1.

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The Pharma Data

OCTOBER 21, 2020

and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinical development programme.

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PPD

OCTOBER 8, 2024

The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinical development activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinical development functions.

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The Pharma Data

NOVEMBER 29, 2020

Prior to joining Gannex, Dr. Palmer was Head of Liver Disease Clinical Development at Takeda Pharmaceuticals. She has also held senior leadership positions at Shire Pharmaceuticals and Kadmon Corporation, where she was in charge of the global development of NASH and other liver disease programs. . ” About Ascletis.

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PPD

MARCH 11, 2025

Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development. Challenge #4: Regulatory and market access hurdles The regulatory and health technology assessment (HTA) pathways for rare disease therapies are complex and vary by region.

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PPD

MARCH 26, 2024

A large majority of drug developers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinical development outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.

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The Pharma Data

MAY 2, 2021

With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.

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DrugBank

SEPTEMBER 26, 2024

Due to the less extensive clinical trial requirements and the competitive nature of the biosimilar market, these biologics can be produced and marketed at significantly lower prices than their reference counterparts. Still, significant differences exist between these two major markets.

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Drug Target Review

FEBRUARY 10, 2025

My focus has always been on advancing novel medicines from research to clinical development. His experience has played a key role in shaping a more capital-efficient model for bringing cell therapies to market. Over the years, Ive had the privilege of working on more than 25 different products, Bock shared.

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Cytel

JANUARY 23, 2023

Ever since the first immune checkpoint inhibitor was approved for market nearly twelve years ago, the industry has witnessed a steady rise in the search for new immunotherapies. This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology.

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The Pharma Data

JANUARY 24, 2021

. (“Citius” or the “Company”) (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $20.0

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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. Where are investments going in the current market? This type of approach can certainly yield winners.

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PPD

SEPTEMBER 6, 2023

Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. Growth of the FSP market is steadily increasing.

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Conversations in Drug Development Trends

MAY 15, 2025

Have you considered the multiple associated benefits and implications in the context of your novel drug development plan? This blog highlights some of the key themes discussed in our white paper on the application process, From Concept to Market: The Strategic Role of an IND in Drug DevelopmentMoving Beyond “May Proceed.”

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Drug Target Review

JULY 18, 2023

AI is being used to find the targets themselves, design the drugs to manipulate that biology, and thirdly, AI is being used to support validation of those targets and drugs as part of pre-clinical development. Cavlan explains that “they are brilliant at developing and bringing new drugs to market.”

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Cytel

JUNE 20, 2023

How might this affect pediatric drug development? Legislation on pediatric studies has existed for more than 20 years in the US, yet additional guidance from the FDA has been relatively scarce.

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ProRelix Research

APRIL 29, 2025

Gain insights into key strategies for clinical validation in the probiotics industry that uphold scientific rigor while driving market growth and consumer confidence.

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Conversations in Drug Development Trends

AUGUST 23, 2023

How the Patient’s Role in FDA Engagement Benefits Sponsors When the FDA, patient community, and sponsors can successfully collaborate, an investigational product’s chances of receiving regulatory approval and gaining market acceptance may improve. “We

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LifeSciVC

JANUARY 16, 2024

These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline. Figure 2 shows pipelines across modalities for some of the competitive targets today.

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Alta Sciences

NOVEMBER 15, 2024

As the CRO, our role is to provide a broader perspective and identify additional areas where our expertise can support their development program,” explains Lisa. For example, at Altasciences, we can discuss clinical development strategies that include adding study arms such as ethnobridging , or early precision QT analysis assessments.

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The Pharma Data

JUNE 6, 2025

Rilzabrutinib is currently under regulatory review in major markets including the United States, European Union, and China for the treatment of ITP. In the U.S., the therapy has been granted Fast Track Designation , and the Food and Drug Administration (FDA) is expected to make a regulatory decision by August 29, 2025.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

In some cases, the FDA has had to remove approvals of oncology drugs based on single-arm trials after they came to market because confirmatory studies had found that the safety/tolerability profile was less acceptable in the wider population.

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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. Japan, and China.

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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.

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Conversations in Drug Development Trends

APRIL 15, 2024

The Advantages of Midsize CROs In contrast to large CROs, midsize CROs like Worldwide Clinical Trials offer a unique value proposition to the market. To gain deeper insights into this pivotal shift and how it can benefit your clinical development strategy, we invite you to download our full industry survey report.

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