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EDITORIAL ADVISORY BOARD
Michael J. Beier,
Senior Vice President of Operations
TITAN PHARMACEUTICALS, INC.
Dr. James V. Blackwell, PhD, Consultant
BIOPROCESS TECHNOLOGY CONSULTANTS, INC.
Ronald C. Branning,
Vice President Global Quality
Robert F. Dream, Vice President
H.D.R. COMPANY LTD.
Johanna Carmel Egan,
VGP Project Management
Girish Malhotra, President
Allan F. Pfitzenmaier, President
VECTECH PHARMA CONSULTANTS INC.
Susan Polizzotto, Manager,
R&D QA GMP Compliance
US SANOFI PASTEUR
Carlos Villalobos, Sr. Dir. Global Engineering
Richard G. Whitfield, Senior Director
Patrick Wong, Director of Global Engineering
BRISTOL-MYERS SQUIBB (BMS)
Here are ten issues to look for in the coming year. I’ve probably missed some that are just as critical, so if you see something missing, email me at the address below. 1. Costs/Manufacturing Efficiencies As long as drug prices were high and new products were in the pipe- line, manufacturers could tolerate inefficient manufacturing processes.
Manufacturing is now under scrutiny to reduce costs and increase efficiencies.
A lack of potential blockbusters in the pipeline and the incredibly high
cost of identifying, developing and marketing new drugs has put a strain on
financials for big pharma.
Increased pressure from generic manufacturers has put yet another dent in big pharma’s wallet.
Small companies are taking advantage of new technology to cost-effectively
manufacture drugs for smaller patient populations and still make a profit.
5. Contract Manufacturing/Contract Services
Big pharma does not have the facilities and staff they used to rely on. They are
now turning to CMOs/CSOs to do the work that used to be done in house.
6 Counterfeiting/Drug Diversion
Two topics that can erode a company’s bottom line and ruin their reputation.
7. Supply Chain
As pharma companies become more global and their product lines become
more diversified, a robust supply chain is essential.
8. Networked Enterprise
Pharma companies need to manage a complex array of capabilities on a global
scale. A robust networked enterprise is essential.
The FDA has been forced to implement industry programs to bolster the public’s
confidence in the nation’s drug supply.
10. Emerging Markets
Demand for medicines in many emerging markets such as India, China and
South America have forced major pharma companies to set up operations in these
2015 Critical Issues
Have a comment or question about Pharmaceutical Processing?
My E-mail is: firstname.lastname@example.org
A lack of blockbusters in the pipeline and the
incredibly high cost of identifying, developing
and marketing new drugs has put a strain on
financials for big pharma.…
■ Michael Auerbach, Editor in Chief