PPD

DECEMBER 16, 2024

Our annual look at the state of the drug development industry highlights a dual set of challenges complicating progress. Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Drug Patent Watch

DECEMBER 12, 2024

This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceutical companies. In this comprehensive guide, we’ll explore the intricacies of identifying such drugs and leveraging them for successful in-licensing opportunities.

Licensing 92

Licensing Licensing Drugs Biosimilars 92

ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. ” Scientific Research Publishing , 2024. ” U.S.

Drug Development 52

Drug Development Compliance Drugs Regulations 52

Drug Patent Watch

JANUARY 9, 2025

Navigating the complex landscape of drug development and manufacturing can be a daunting task. Enter the Contract Development and Manufacturing Organization (CDMO) a lifeline for many startups looking to bring their innovative therapies to market. How can you ensure your CDMO is up to scratch?

Compliance 52

Compliance Drug Development Pharma Companies Therapies 52

DS in Pharmatics

JUNE 12, 2024

Date: June 12, 2024 Location: San Diego, CA ProductLife Group (PLG), a leading provider of product development and compliance services in the pharmaceutical and biotechnological sectors, is excited to announce a comprehensive solution aimed at transforming the landscape of drug development, underscoring PLG's commitment to advancing healthcare through (..)

Production 52

Production Pharmaceuticals Compliance Drug Development 52

Advarra

DECEMBER 14, 2023

Provide Visit Guidance and Calculators to Sites A Tufts Center for the Study of Drug Development (CSDD) study found the mean number of deviations and substantial protocol amendments has increased across all trial phases. The post How Sponsors and Sites Work Together to Improve Protocol Compliance appeared first on Advarra.

Compliance 52

Compliance FDA Clinical Trials Trials 52

Perficient: Drug Development

APRIL 17, 2025

O ur life sciences team is d e dicate d to supporting clients in the pharmaceutical, biotechnology, medical technology , and contract research organization sectors. As a result, we have d riv e n innovative growth for 14 of the 20 largest pharmaceutical and biotechnology companies , as well as 14 of the 20 largest medical device firms.

Science 59

Science Compliance Production Pharmaceuticals 59

Conversations in Drug Development Trends

APRIL 4, 2024

Developing pharmaceuticals is a complex process, requiring stringent bioanalytical method validation guidelines to ensure drug safety and efficacy. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

The Pharma Data

NOVEMBER 24, 2020

Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to. There’s absolutely no risk to you.

FDA 52

FDA Drug Development Compliance Drugs 52

DS in Pharmatics

OCTOBER 17, 2024

Improve your pharmaceutical product’s chances of success by engaging a biopharmaceutical consultant. These specialists offer essential expertise in drug development, clinical trial design, regulatory compliance, and market strategy.

Clinical Trials 52

Clinical Trials Compliance Drug Development Pharmaceuticals 52

thought leadership

AUGUST 19, 2024

Importance of Quality Assurance in Clinical-Phase Drug Manufacturing Quality Assurance (QA) is a critical function in the pharmaceutical industry , ensuring that every aspect of drug manufacturing meets predefined standards of quality.

Compliance 52

Compliance Clinical Trials Drugs Drug Development 52

FDA Law Blog: Drug Discovery

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

FDA 59

FDA Compliance Pharmaceuticals Pharmaceutical Companies 59

H1 Blog

JULY 30, 2024

This effort seeks to provide the pharmaceutical industry with more accurate representation of patient populations, thereby enhancing the safety and efficacy for prescription drugs and medical devices. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements.

FDA 59

FDA Clinical Trials Compliance Pharma Companies 59

DrugBank

MAY 15, 2024

Its structure makes it incredibly difficult for drugs to bind effectively, which has stymied drug development for decades. The binding pockets on KRAS are shallow and polar , not ideal for the kinds of interactions needed for strong, effective drug binding.

Small Molecule 98

Small Molecule Molecular Biology Drugs Disease 98

Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. For small- and medium-sized pharmaceutical companies, outsourcing represents a strategic leap forward, offering a gateway to unparalleled expertise and cutting-edge analytical technologies.

International 52

International Laboratories Drugs Pharmacokinetics 52

Drug Target Review

AUGUST 9, 2024

What is drug formulation? Drug formulation is the process of designing and producing a final medicinal product from an active pharmaceutical ingredient (API). 1 The goal is to create a dosage form that delivers the drug effectively to the intended site of action with optimal patient benefit and a good commercial value.

Science 59

Science Drugs Compliance Drug Development 59

PPD

OCTOBER 18, 2023

There has been an unprecedented expansion of different types of pharmaceutical therapies, as well as a change in the overall approach to health care. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

Laboratories 52

Laboratories Assay Development Small Molecule Drug Development 52

Pharmaceutical Development Group

FEBRUARY 1, 2022

Effective and consistent compilation of NME & NCE Product and Process Development for inclusion in the electronic submission can reduce costs and timelines. Spanogle, Ph.D. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA, EU-MDR, QMS, PMS, CSV/CSA, and R&D experience.

FDA 52

FDA Drug Development Science Pharmaceuticals 52

ACTO

DECEMBER 17, 2024

The stakes for AI adoption in the pharmaceutical industry have never been higher. Yet, the critical question remains: How can pharmaceutical companies ensure responsible and compliant AI implementation while maximizing its potential for field teams? This approach provides better control over data access and security.

Government 52

Government Compliance Pharmaceutical Companies Pharmaceuticals 52

PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

Packaging 52

Packaging Laboratories Pharmaceutical Companies Compliance 52

Alta Sciences

OCTOBER 5, 2023

He brings to Altasciences over a decade of experience in management and supervisory roles for manufacturing operations and supply chains, having demonstrated an impeccable standard in ensuring adherence to compliance and cGMP policies.

Clinical Pharmacology 52

Clinical Pharmacology Compliance Drug Development Pharmaceuticals 52

Advarra

AUGUST 21, 2024

Nowhere is this more painful than in clinical trials, the backbone of drug development. These complex studies typically generate hundreds or thousands of documents to share across clinical trial sites, pharmaceutical sponsors, physicians, patients, and regulators. However, it is often unengaging, cumbersome, and manual.

Clinical Trials 52

Clinical Trials Trials Compliance Clinical Research 52

The Connected Lab

MAY 31, 2022

Digital transformation is revolutionizing pharmaceutical research and manufacturing. Now, pharmaceutical industry stakeholders, including technology vendors, are taking the lead to facilitate change. The vast majority of pharmaceutical workflows utilize instruments and digital technologies from multiple vendors.

Laboratory Informatics 52

Laboratory Informatics Laboratories Compliance Pharmaceuticals 52

Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. The seamless use of Data Standards also require compliance with Data Integrity Standards. Spanogle, Ph.D.

FDA 52

FDA FDA Approval Biosimilars Regulations 52

Fierce BioTech

JANUARY 12, 2024

Developing and Manufacturing Minitablets to Extend Drug Lifecycle pesurya Fri, 01/12/2024 - 12:38 Wed, 02/28/2024 - 11:00 Resource Type Webinar Robert Strickley, PhD Valjon Demiri, MSc Duration 60 Minutes Oral minitablets can offer several advantages in pharmaceutical applications, making them a valuable option in drug delivery.

Drugs 52

Drugs Packaging Compliance Drug Development 52

Vial

FEBRUARY 15, 2024

Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. Rising costs : The rising costs of clinical trials, including expenses associated with recruiting participants, trial infrastructure, data management, and regulatory compliance, is a critical issue4,5.

Pharma Companies 52

Pharma Companies Clinical Trials Compliance Trials 52

Fierce BioTech

JULY 27, 2023

Process Chemistry Unleashed: A 'Fit-for-Purpose' Approach to Accelerate IND Filing pesurya Thu, 07/27/2023 - 11:27 Tue, 09/05/2023 - 10:00 Resource Type Webinar Qixuan Lu Duration 60 Minutes Process chemistry plays a pivotal role in various stages of the pharmaceutical R&D cycle.

Process Chemistry 52

Process Chemistry Compliance FDA Drug Development 52

Alta Sciences

DECEMBER 13, 2023

Get Improved Bioavailability and Stability With This Dosage Form blussier Wed, 12/13/2023 - 22:36 HTML The choice of dosage form in drug development depends on various factors, such as the properties of the API, the therapeutic goals, and regulatory considerations.

Clinical Trials 40

Clinical Trials Compliance Drug Development Trials 40

Advarra

APRIL 4, 2024

In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is paramount. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial. Cost Savings Forming a new DSMB for each individual trial demands time and resources.

Clinical Trials 52

Clinical Trials Pharmaceutical Companies Trials FDA 52

Conversations in Drug Development Trends

MAY 1, 2024

This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinical trials. Yet, it becomes a manageable aspect of drug development with careful planning, strategic engagement, and flexible problem-solving.

Clinical Research 69

Clinical Research Trials Clinical Trials Research 69

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

Clinical Trials 59

Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

PPD

JUNE 29, 2023

Although several corticosteroid treatments are available as first-line treatments, drug developers continue to seek more effective therapies to improve the wellbeing of those diagnosed with atopic dermatitis. But developing treatments for atopic dermatitis is complex and competitive.

Clinical Trials 52

Clinical Trials Trials Drug Development Clinical Research 52

Altus Drug Development

MAY 31, 2022

From natural health products to life-saving medicines, all pharmaceutical products must undergo an analytical method development process. Through analytical method development, validation, and transfer, drug development and manufacturing are kept safe, efficient, and compliant with the law.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Production Drug Development 52

The Pharma Data

APRIL 6, 2022

” Integrating Pharmaceuticals and Oncology business units. Novartis will integrate the Pharmaceuticals and Oncology business units and create two separate commercial organizations with a stronger geographic focus – Innovative Medicines US and Innovative Medicines International.

International 52

International Pharmaceuticals Drug Development Marketing 52

Pharmaceutical Development Group

JANUARY 5, 2022

In December 2021, the FDA issued new guidance for Inspection of Injectable Products for Visible Particulates to improve Pharmaceutical Quality and for inclusion in the CMC. Compliance with these new focus points hinge upon proactive utilization Drug Development Services , effective FDA Pre-Submission, and comprehensive Regulatory Consulting.

Production 40

Production FDA Regulations Science 40

H1 Blog

DECEMBER 11, 2024

Drug Pricing, Global Diversity Strategies, & Emerging AI Applications Each year, we compile our predictions to provide life sciences, pharmaceutical, and healthcare organizations with a comprehensive look at emerging industry trends and dynamics to help them prepare for the year ahead.

Clinical Trials 52

Clinical Trials Trials Pharma Companies Treatment 52