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In this issue: News, interviews, and articles on advances in pharmaceutical ingredients manufacturing, outsourcing trends, and maintaining effective supply chains.

Outsourcing
Are CMOs Out of Synch With Market Realities?
By Jim Miller
Why can’t the CMO industry break through to manufacture a greater share of drugs?
>> Read More

Key Considerations for Quality-Technical Agreements
By Siegfried Schmitt
A drug sponsor’s responsibility does not end when a task is outsourced.
>> Read More

API Synthesis & Manufacturing
HPAPIs: Fast-growing Segment Presents Challenges and Opportunities
By Cynthia Challener, PhD
Appropriate process design and engineering are critical for the production of small-molecule and biologic HPAPIs.
>> Read More

Cocrystals: Industry Takes a Wait-and-See Approach
By Cynthia Challener, PhD
The perceived risks associated with cocrystals may be slowing progress of their industrial application.
>> Read More

Supply Chain
Defining Quality Metrics to Ease Drug Shortages
By Susan J. Schniepp
Industry players and FDA evaluation possible quality metrics to improve manufacturing efficiencies and avoid drug shortages.
>> Read More

BPTF Warns FDA on Reduced API Manufacturer Inspections
The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.
>> Read More

EMA and European Chemicals Agency Strengthen Collaboration
EMA and ECHA sign agreement to share information and work together on risk assessments.
>> Read More

DCAT Sharp Sourcing Addresses Procurement Topics
DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.
>> Read More

Business Development News
FDA Expands CERSI Network
By Melanie Sena
John Hopkins and UCSF-Stanford join FDA’s Centers of Excellence in Regulatory Science and Innovation.
>> Read More

India Offers Biopharma Opportunities and Challenges
By Jill E. Sackman and Michael Kuchenreuther
An established drug-manufacturing base with quality and safety issues, and patent protection and price capping concerns complicate efforts to do business in India.
>> Read More

Turkish Pharma Manufacturers Look to New Markets
The CPhI report warns that Turkey's dynamism is being restricted by the current government reimbursement model.
>> Read More

Contract Services Roundup

SAFC Installs Continuous-Flow Reactor

SGS Announces Appointments at New Facility in California

Novasep Commissions Plant Extension for Highly Potent APIs

Pharma Company Social Responsibility News

Pfizer and Avon Announce Metastatic Breast Cancer Program

GSK Announces Vaccine Price Freeze in Support of GAVI Alliance

Lilly Oncology On Canvas Celebrates 10 Years of Cancer Journeys

Industry Supplier Updates

BioPlan Associates Releases 11th Annual Global Biomanufacturing Study

EquipNet Celebrates 15 Years of Asset Management

DPx Holdings B.V. Donates to Hospitals and Organizations

Brookfield Marks 80 Years of Laboratory Technology

Webcasts

Delivering Biologics with a Difference
Thursday June 5, 2014 at 11:00 AM EDT
Sponsored by Baxter BioPharma Solutions

Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
Wednesday, June 11, 2014 at 11:00 AM EDT
Sponsored by Patheon