-----

Welcome to the January 2014 issue of Pharmaceutical Technology Sourcing and Management, an information resource for contract manufacturing, ingredients sourcing, and the supply chain from the editors of Pharmaceutical Technology and Pharmaceutical Technology Europe. In this issue, preview the outlook for CMOs, review an analysis of GDUFA, and read the latest business and corporate social responsibility developments from bio/pharmaceutical companies.

Viewpoints
Viewpoint: GDUFA Off to Good Start, But Storm Clouds on the Horizon
By John DiLoreto, Executive Director of the Bulk Pharmaceuticals Task Force
GDUFA is off to a good start from a facility inspection perspective, but there are storm clouds on the horizon.
>> Read More

Viewpoints
New Dynamics in Drug Pricing and Prescribing
What price can (or will) patients pay for the needed therapy? Changes in prescribing and regulatory practices worldwide continue to shape the financial outlook of biopharmaceutical companies.
>> Read More

Outsourcing
Climate Change Drives New Opportunities in Outsourcing
By Jim Miller
Ongoing changes create new opportunities for CROs and CMOs.
>> Read More

API Sourcing and Manufacturing
Deficiencies Discovered in API Inspections Suggest Strategies for Improvement
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
>> Read More

Corporate Social Responsibility
BMS Grants Support Mental Health Needs of US Military Veterans
The Bristol-Myers Squibb Foundation is awarding 10 grants to fund programs for veterans and their families.
>> Read More

Corporate Social Responsibility
Jimmy Carter and Pfizer Mark 15-Year Effort To Help End Blinding Trachoma
Former US President Jimmy Carter and Pfizer commemorate the 15th anniversary of the International Trachoma Initiative to end blinding trachoma by the year 2020.
>> Read More

Corporate Social Responsibility
Janssen Announces Drug Donation Program for HIV Treatment-Experienced Children
Janssen's donation program will improve access to the company's approved HIV medicines for children and adolescents in sub-Saharan Africa.
>> Read More

Business News Roundup

Pall Corporation to Acquire ATMI's LifeSciences Business for $185 million

Cambrex Completes FDA Inspection

Metrics Appoints New Vice-President

Bridgepoint Development Capital Acquires Quotient Clinical

Events

Quality Audit World:
January 27‑29, 2014, Philadelphia, PA USA

IVT Change Control Conference:
January 29‑31, 2014, Philadelphia, PA USA

Serialization Summit:
February 27‑28, 2014, San Diego, CA USA

DCAT Week 2014:
March 10-13, 2014, New York, NY

Webcasts

Optimizing CMO Selection for High-Potency Pharmaceutical Product Development and Manufacturing
Wednesday, January 15, 2014 at 10:00 AM - 11:00 AM CET
Sponsored by Evonik Industries

Application of Engineering Solutions to Solve Challenges in Pharmaceutical Processing: Case Studies from Development to Production Scale
View On Demand
Sponsored by Patheon

Risk-Mitigation Strategies for API Manufacturing in Emerging Markets
View On Demand
Sponsored by Neuland