Life Cycle Management Strategies More Crucial than Ever for Pharmaceutical Success August 26, 2015

CLINICAL TRIALS - New Technology & the Global COVID Pandemic Drive the Need for More Decentralized Trials March 1, 2023

Suhas Gudihal, MS, MBA, explains how the COVID-19 pandemic has accelerated the ongoing shift to remote clinical trial monitoring, and remote site access and monitoring platforms are now an essential element of the clinical trial process and a vital connection between the sponsor, CRO, and research site.

DRUG DEVELOPMENT STRATEGIES - Marrying Target Product Profile, Regulatory & Partnering Strategies for Long-Term Product Success August 31, 2022

Chris Rojewski believes given the costs, time, and risks associated with contemporary drug development, it’s time this fundamental aspect of successful development be brought as close to the program as possible — the CDMO tasked with executing drug strategy in the first place.

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022

Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.

SUPPLY CHAIN MANAGEMENT- Are Supply Chains Up for the Post-Pandemic Challenge? April 4, 2022

John Swift believes each medical device manufacturer will discover different patterns of risk as a result of COVID-19. It is therefore imperative that businesses carry out an in-depth and urgent re-appraisal of their supply chain, as failing to do so may cause commercial damage.

DATA STRATEGIES - As We Shift Toward Biologics, We Also Need to Shift Toward Smarter Data Management March 1, 2022

Christian Marcazzo explains how adopting a new kind of data strategy might be disruptive to the expectation of how biologics development is carried out — but it may also be transformational.

Scientific Management of Pharmaceutical Container Closure & Delivery Device Compatibility October 13, 2020

Diane Paskiet says the relationship between pharmaceutical products and CC/DD is best managed through a rich science-based approach that factors in potential risk and is adapted early in the development process.

2019 Respiratory Drug Development eBook - Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal June 26, 2019

This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.

Creative & Integrated Pharmaceutical Lifecycle Management Strategies Remain Vital in Tough Market Environment April 27, 2017

SPECIAL FEATURE - Formulation Development & Manufacturing - CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs April 4, 2017

Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

MANAGEMENT INSIGHT - Forging a Blue Ocean Strategy to Work in a Red Pharma Ocean January 7, 2016

REGULATORY MANAGEMENT - Renewed Focus on Reg IM as Commercial Takes Center Stage June 3, 2014

Joel Finkle emphasizes that as companies start to shift their thinking toward their commercial needs, they’re coming to realize that the regulatory function plays a crucial role in securing and maintaining market access and that Reg IM is more than simply a useful submission tool – that it is essential to managing the big picture.

SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest February 29, 2024

Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.

EXECUTIVE INTERVIEW - Samsung Biologics: Exploring The Evolving Biopharma Landscape January 26, 2024

Kevin Sharp, Senior VP & Head of Sales for Samsung Biologics, discusses the evolving biopharma space, exploring current challenges, and the demand for sustainable solutions.

Zevra Therapeutics Completes Acquisition of Acer Therapeutics in its Journey to Become a Leading Rare Disease Company November 20, 2023

Zevra Therapeutics, Inc. recently announced the completion of its acquisition of Acer Therapeutics Inc., which marks a significant step forward in executing Zevra’s strategy to become….

EXECUTIVE INTERVIEW - HERMES PHARMA: Reducing Risk, Speeding Development - A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies September 29, 2023

Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.

The Evolving Role of a Contract Development & Manufacturing Organization September 7, 2023

The meaning of a Contract Development and Manufacturing Organization (CDMO) is not the same as it was a decade ago. Customers today are seeking….

SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance September 5, 2023

Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.

Zevra Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio & Adding Commercial Product August 31, 2023

Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra’s purchase of Acer’s secured debt in capital efficient structure….

SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First June 5, 2023

Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.

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