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.

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Also in This Issue

Big Data

The Evolution of Pharma Depends on Data Integration and Application

The potential applications for this vast quantity and variety of data are nearly endless.

Formulation

The Coming of Age of Amorphous Solid Dispersions

Numerous drugs formulated as amorphous solid dispersions have been successfully commercialized.

Viral Vector Manufacturing

From Proof of Concept to Commercialization

Brammer’s vision is to be the leading CDMO for viral vector supply to cell and gene therapy innovators.

Tech Transfer

Knowledge and Experience Equal Successful Technology Transfer

Technology transfer should result in the transfer of product and process knowledge into a new phase of the life cycle.

Equipment

A Turnkey Solution: Sourcing Equipment and Empowering Operators

We offer a turnkey solution by sourcing equipment that meets production line requirements.

Oligonucleotides

Designing Effective Facilities to Meet the Growing Demand for Oligonucleotide Drugs

An oligo drug manufacturing facility incorporates aspects of small-molecule and biologic drug facilities.

Serialization

Regulatory Spotlight: FDA Delays Enforcement of Serialization Mandate

The FDA issued new guidances regarding enforcement of the DSCSA's track and trace mandate.

Big Data

Big Data in Drug Development and Discovery

Companies that apply the data will have a competitive advantage in drug discovery and development.

Big Data

Big Data in Drug Manufacturing

To achieve cohesive data integration in drug manufacturing, systems must be aligned.

Big Data

Big Data in Drug Packaging and Distribution

The emphasis on serialization is a tangible move toward making post-market data mining more robust.

Clinical Trial Logistics

Preparing Clinical Trial Logistics for a No-Deal Brexit

Pharmaceutical companies should prepare for Brexit by mitigating their supply chain risks.

Big Data

Facilitating Drug Repositioning with Artificial Intelligence

Computer-based approaches are essential to enable systematic drug repositioning efforts.

Acquisition

The Value of Complementary Specialized Capabilities

Continued investment in innovations that address the needs of current and next-generation therapies is essential.

Global Network

Risk Minimization with an Integrated Global Network

Collaborating with an embedded organization with an integrated, global network can facilitate access to growing markets.

Design Logic

Preparative Chromatography

Servier’s InnoPreP™ technology offering appeals to mid-size pharmas who need to quickly move their project into clinical studies .

New Drug News

New Drug News: Regulatory Approval Brings siRNA into the Rare Disease Toolbox

siRNA joins the other nucleic acid–based drugs entering the marketplace for the treatment of rare diseases.

Investment

Foreign Investment: Chinese Capital Backs U.S. Biotech

Given the amount of Chinese capital and the growing interest in the segment, the market feels unlimited.

Roundtable

Q: What Innovative Technologies Had the Greatest Impact on your Company this Year? What Were the Impacts?

Industry leaders discuss recent technological innovations.

Roundtable

Q: Looking Forward, What New Technologies/Paradigms Do You Anticipate Having the Greatest Impact Next Year (Digitalization and Industry 4.0, Serialization, etc.)?

Industry leaders discuss forthcoming technological innovations.

Issue Q1 2019

The Business Development Issue

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Issue #1 | Volume #5 | Q1 2019
Issue Q4 2018

The Innovation Issue

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Issue #4 | Volume #4 | Q4 2018
Issue Q3 2018

The Outsourcing Issue

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Issue #3 | Volume #4 | Q3 2018
Issue Q2 2018

The Next-Generation Issue

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Issue #2 | Volume #4 | Q2 2018