Articles in this Issue

• Alliance Management and Project Management – Working Together as a Team

  Kendra B. Eager, Ph.D.
  With companies being driven by innovation to maintain or enhance their industry position, many have searched outside their own organizations for productive collaborations.

• A Silent Epidemic: Protecting the Safety and Security of Drugs

  David Howard
  Millions of people regularly buy medicines over the internet but how many of these transactions are genuine and how many consumers end up with counterfeit or substandard products? Research carried out recently suggests that as many as 60 percent of online products could be counterfeit or substandard.

• Where Do Consultants Fit in to the Early Development API Supply Chain?

  Alan Harris
  Pfizer, GSK, Lilly, AstraZeneca and others have all recently announced reductions in the size of their internal R&D organizations[1].

• Monoclonal Antibody Manufacturing Strategies for the 21st Century

  James Blackwell, Ph.D., MBA, Thomas Ransohoff, Howard L. Levine, Ph.D.
  One of the greatest challenges facing biopharmaceutical companies is ensuring adequate manufacturing capacity for products that are under development and potentially years away from commercialization. Companies without existing manufacturing capacity must decide among several alternatives, including building internal manufacturing capability, acquiring existing manufacturing facilities, outsourcing production to a contract manufacturing organization (CMO), or combinations of these.

• Common Practices for Analytical Methods Transfer

  Roberto Rodriguez-Diaz, Kevin Bullock, Ph.D., Steve Durban, Tim Sullivan, Ph.D.
  For most products, and especially for a successful one, the transfer of analytical methods during development is inevitable.

• Unique Challenges and Opportunities for Enabling and Supporting Preclinical and Translational...

  Ashwin Datt, Sara Kenkare-Mitra, Ph.D.
  Much has been written and said about the challenges facing the Biotech/Pharma industry. How and where will innovation come from? How do you control the increasing cost of drug development? The impact of healthcare reform? What is the value and impact of globalization on R&D efforts? Consolidation within Biotech/Pharma and CROs.

• Cold Chain Management – A Strategic Quality Approach

  Arminda Montero
  In order to maintain product quality, safety and efficacy during distribution, Good Distribution Practices (GDPs) specify that temperature-sensitive products are to be distributed (stored, handled and transported) throughout the distribution network (manufacturer, service providers and customers) as per specified temperature conditions.