Issue The Final Frontier: Total Data Integration

Current Issue: Q4 2018

The Innovation Issue

The Final Frontier: Total Data Integration

Our fourth quarter edition features leading insights from key opinion leaders with findings specific to data integration and the industry today

Also In This Issue

Acquisition

The Value of Complementary Specialized Capabilities

As APIs and drug formulations become more sophisticated, pharma companies are relying heavily on contract service providers with specialized capabilities. Two such specialized service areas of growing importance in the industry are aseptic processing and high containment. In order to create value for our customers and accelerate drug development, Avara Pharmaceutical Services has strategically applied […]

Big Data

The Evolution of Pharma Depends on Data Integration and Application

NICE INSIGHT OVERVIEW: The Cloud The pharmaceutical industry must respond to increasing pressure to rapidly develop cost-effective, fairly priced medicines. New business models must be adopted to leverage the massive amounts of data generated across the pharma/healthcare continuum. Pharma companies must also pursue new collaborations to enable optimal digital workflows that provide maximum efficiency and […]

Formulation

The Coming of Age of Amorphous Solid Dispersions

Although the majority of new drug candidates suffer from poor solubility and bioavailability, oral solid dosage forms remain the preferred route of administration due to their ease of use and convenience for patients and caregivers. In recent years, numerous drugs formulated as amorphous solid dispersions (ASDs) have been successfully commercialized, confirming the effectiveness of these […]

Viral Vector Manufacturing

From Proof of Concept to Commercialization

Nice Insight sat down with Brammer Bio’s cofounders Mark Bamforth, Chief Executive Officer, and Richard Snyder, Chief Scientific Officer, to discuss the evolution of the viral vector marketplace and how Brammer Bio is investing to support the commercial development of the next generation of gene and cell therapies. What have been the most significant changes […]

Tech Transfer

Knowledge and Experience Equal Successful Technology Transfer

Pharmaceutical technology transfer is part of the commercial project life cycle. It is a multi-faceted, multi-stage process that requires excellent project management capabilities as well as broad technical expertise. CDMOs that have experienced, multidisciplinary tech transfer teams with a demonstrated ability to work collaboratively — both internally and with clients — to develop effective tech […]

Equipment

A Turnkey Solution: Sourcing Equipment and Empowering Operators

At Federal Equipment Company, we understand the dilemma that organizations face when selecting an equipment supplier. After over 60 years supplying not just the pharmaceutical, but also the chemical, plastics, packaging, utility and food processing industries with equipment, we have added services and partnerships to enhance our offerings and capabilities. Clients that partner with us […]

Oligonucleotides

Designing Effective Facilities to Meet the Growing Demand for Oligonucleotide Drugs

Oligonucleotide drugs have been in development for over 30 years. There has been considerable progress in overcoming the challenges related to their administration, biodistribution, cellular uptake and undesired side effects, and several drugs have received regulatory approval. Many more drug products are currently in late-stage clinical trials and moving toward commercialization, which creates the next […]

Serialization

Regulatory Spotlight: FDA Delays Enforcement of Serialization Mandate

In late September, the U.S. Food and Drug Administration (FDA) issued a pair of draft guidances related to the implementation of product identifiers as mandated by the Drug Supply Chain Security Act (DSCSA).1,2 These new guidances come in response to continuing indications across the industry that the start date of November 27, 2017 was not […]

Past Issues

View all Past Issues

The Innovation Issue

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Issue #4 | Volume #6 | Q4 2020

The Advanced Therapeutics Issue

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Issue #2 | Volume #5 | Q2 2019

Market Landscape

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Issue #1 | Volume #3 | Q1 2017

The Outsourcing Issue

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Issue #3 | Volume #6 | Q3 2020