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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Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

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. Data from these studies can accelerate research timelines and improve trial planning throughout the product life cycle.

Drug Development 52

Drug Development Clinical Trials Disease Trials 52

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.

Clinical Development 52

Clinical Development Drug Development Clinical Research Treatment 52

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.

Clinical Development 52

Clinical Development Clinical Trials Trials Clinical Research 52

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.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

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.

Trials 98

Trials Clinical Trials Clinical Development Clinical Research 98

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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Therapies Clinical Trials Clinical Research Trials 97

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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Drug Development Clinical Trials Drugs Clinical Research 98

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.

Clinical Development 52

Clinical Development Trials Clinical Research Treatment 52

Conversations in Drug Development Trends

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Pharmaceutical Companies 52

PPD

JUNE 13, 2023

It is imperative that the right vaccine development partner demonstrates expertise from early clinical development to study design, execution, regulatory submission and commercialization. Working with a vertically integrated organization can further accelerate market entry.

Vaccine 52

Vaccine Clinical Trials Clinical Research Trials 52

Conversations in Drug Development Trends

AUGUST 23, 2023

Her fellow panelists represented a diverse group of stakeholders across clinical research, including patient advocates, sponsors, sites, and the FDA itself. We focus on patients as equal stakeholders who need to be involved in discussions early on in the development process to develop a path forward together,” McNary says.

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FDA Trials Clinical Trials Disease 96

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

Clinical Trials 52

Clinical Trials Clinical Development Clinical Research Trials 52

PPD

SEPTEMBER 6, 2023

Benefits of Rebadging Under an FSP Model in Clinical Research A functional service partnership (FSP) model in clinical research can help sponsors navigate unforeseen staffing challenges. Rebadge staffing is a critical part of an FSP model in clinical research. What is rebadging in an FSP model?

Clinical Research 59

Clinical Research Regulations Packaging Drug Development 59

Advarra

OCTOBER 15, 2024

The International Council for Harmonisation (ICH) good clinical practice (GCP) guidelines are critical in ensuring the safety and rights of clinical trial participants. Sponsors should ensure a diverse multidisciplinary team of stakeholders supports the design of the study and the clinical development plan.

Clinical Trials 52

Clinical Trials Trials Clinical Research International 52

PPD

OCTOBER 31, 2023

If recruitment moves slowly or individuals with the wrong skills are selected, the clinical research process stalls, costing sponsors valuable time, money and resources. Selecting the Right Partnership Model Clinical research outsourcing models have changed over time to accommodate the industry’s evolving needs.

International 52

International Clinical Research Clinical Development Research 52

Vial

FEBRUARY 29, 2024

From the pre-clinical testing and lead discovery, to human testing and post-marketing surveillance, CROs offer a comprehensive array of services that sponsors now commonly seek out. There’s no doubt the market value for CROs is trending upwards; in 2022 alone, the CRO market was estimated to be worth US$56.7

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

Laboratories 45

Laboratories Clinical Trials Clinical Research Compliance 45

PPD

JUNE 22, 2023

If your company is struggling to hire qualified clinical research associates (CRAs), you’re not alone. A decade-long CRA talent shortage intensified as the COVID-19 pandemic increased strain on the clinical research industry at large.

Clinical Research 52

Clinical Research Clinical Trials Trials Drug Development 52

Conversations in Drug Development Trends

JUNE 13, 2024

However, Project Optimus emphasizes the importance of dose-finding studies in early clinical development. By comparing the minimum biologically active dose with the highest tolerable dose, researchers can maximize the efficacy of the drug while minimizing its toxicity. How Does Project Optimus Impact Your Study’s Operations?

Trials 52

Trials Clinical Trials Drug Development Clinical Development 52

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

Laboratories 52

Laboratories Clinical Development FDA Regulations 52

PPD

DECEMBER 5, 2023

Non-footprint countries are regions where drug developers lack a physical presence, often in emerging markets or remote areas. These countries offer new opportunities for drug developers to access additional resources, ensure project continuity and rely on localized expertise for recruitment, regulatory insights and more.

Clinical Development 52

Clinical Development Clinical Research Drug Development International 52

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. Our core areas of research are: Immunology.

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Clinical Trials Trials Clinical Development Clinical Research 40

The Pharma Data

AUGUST 31, 2021

This label update follows the FDA’s Oncologic Drugs Advisory Committee (ODAC) meetings held earlier this year as part of an industry-wide evaluation of indications based on accelerated approvals that have not met their post-marketing requirements.

FDA Approval 52

FDA Approval Treatment FDA Research Laboratories 52

The Pharma Data

SEPTEMBER 15, 2020

During her medical practice, Seredina worked in clinical research as an investigator. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric. The webinar will take place at: .

Clinical Supply 52

Clinical Supply Clinical Trials Doctors Clinical Development 52

Precision for Medicine

MAY 24, 2023

CRO Leadership Awards recognize companies judged by customers as exceeding expectations BETHESDA, MD, May 25, 2023 – Precision for Medicine, the first biomarker-driven clinical research organization (CRO), announces its wide recognition in the 2023 CRO Leadership Awards. For more information, visit PrecisionForMedicine.com.

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Clinical Trials Clinical Research Science Trials 40

The Pharma Data

MAY 2, 2023

Mr. Bonello has more than 30 years of financial leadership experience, including 15 years in the clinical research industry. a clinical trial data collection company, since 2021. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Clinical Trials 40

Clinical Trials Clinical Research Science Clinical Development 40

PPD

JUNE 17, 2024

For a developer using an FSO model but looking to evolve the way they undertake clinical trials, a bespoke FSP/FSO hybrid solution can provide a smooth transition to FSP outsourcing. This approach enables unbroken continuity of support and resources across clinical trial operations.

Clinical Trials 52

Clinical Trials Clinical Development Trials International 52

Precision for Medicine

JUNE 26, 2023

Baseline Control’s expertise will become part of Project Farma, Precision for Medicine’s existing biomanufacturing strategy and execution group, expanding the scope of its manufacturing solutions for life science companies and driving greater speed and efficiency in bringing new drugs to market. Bethesda, Md.,

Science 40

Science Small Molecule Clinical Research Engineering 40

PPD

DECEMBER 12, 2023

A follow-the-sun model offers several advantages, but it takes specialized expertise to implement and operationalize for clinical development and post-marketing surveillance. Clinical research and post-marketing surveillance involves ongoing data analysis and interpretation.

Compliance 52

Compliance Clinical Research Trials Clinical Trials 52

Conversations in Drug Development Trends

MARCH 7, 2024

Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Clinical Trials 52

Clinical Trials Trials FDA Drug Development 52

The Pharma Data

NOVEMBER 9, 2020

Merck and Eisai intend to discuss their new data with global regulatory authorities, with the intent to submit marketing authorization applications based on these results. It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity.

Research Laboratories 52

Research Laboratories Laboratories Treatment Therapies 52

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. Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role.

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Drugs FDA Disease Animal Testing 111

The Pharma Data

DECEMBER 14, 2020

Attention: Equity Capital Markets, 55 East 52nd Street, 37th Floor, New York, NY 10055, by telephone at (888) 474-0200, or email: ecm.prospectus@evercore.com ; and Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by email: prospectus@cantor.com.

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Clinical Trials Clinical Development Production Trials 40

The Pharma Data

JANUARY 7, 2021

As CEO of Freeline, a liver-directed gene therapy company, she scaled the company from preclinical stage to a fully integrated biotechnology organization, which included a broad, internally developed pipeline, two programs in clinical development and a commercial-scale, high-quality CMC and manufacturing platform.

Small Molecule 40

Small Molecule Clinical Development Production Science 40

Molecule Blog

MARCH 17, 2023

Moving research from concept to market is like conducting a symphony — there are numerous players and stakeholders, each bringing their unique expertise to work in harmony and advance a project. If approved, the company can then market and distribute the therapeutic.

Engineering 52

Engineering Research Clinical Trials Government 52

The Pharma Data

NOVEMBER 19, 2020

He focused on corporate and business unit strategies, organizational transformations, product launches, growth strategies and new market entries. Previously, Baffa was Therapeutic Area Head of Oncology, Global Clinical Development for Shire. Baffa joins the company from Medisix, where he held the role of Head of R&D and CMO.

Laboratories 52

Laboratories Research Laboratories Science Organic Chemistry 52