Articles in this Issue

• Digital Automation in Clinical Trials: The Promise And Potential

  Zaher El-Assi
  The use of mobile technologies and basic clinical electronic data capture (EDC) systems, both of which are encouraged by the Food and Drug Administration (FDA), is helping to streamline the clinical trial process and reduce costs.

• Risk Minimization Through Careful Cdmo Selection

  Greg Flyte
  Due to the rapidly changing pharmaceutical industry landscape, both the branded biologics and biosimilars markets are predicted to continue on a rapid growth trajectory.

• Choosing the Optimal Drug Delivery System to Meet Patient Needs

  Kevin Haehl
  For the last three decades, the challenge of poor medication adherence has been discussed by the healthcare industry, while the rates and associated costs of non-adherence continue to rise. Medication non-adherence is a significant risk to patient safety and substantially elevates the cost of care. Children, seniors, and many chronically ill patients are more prone than others to use medications incorrectly. The healthcare industry continues efforts to improve medication use, developing innovative drug delivery systems and packaging to ensure that patients take the right dose at the right time.

• Bolstering Capabilities for Parenteral Drug Development and Manufacturing

  Syed T. Husain
  As the pharmaceutical and biotechnology markets undergo significant changes, companies are relying more heavily on CROs and CMOs to provide the needed services, expertise, and technologies to help them favorably compete in a challenging marketplace. Contract service providers, in turn, are strengthening their capabilities to satisfy current demands, in some cases by coming together.

• Innovative Strategies to Meet Today’s Changing Equipment Needs

  Larry Kadis
  Dramatic changes in the pharmaceutical industry are driving pressures to lower the time and costs of drug development, manufacturing, and packaging. Manufacturers and their contract service providers are looking to improve efficiency, eliminate redundancies, and rapidly increase pipelines. Significant company consolidation is resulting in considerable surplus equipment, driving growth for the used -equipment market.

• Ensuring the Integrity of Temperaturesensitive Drugs Along the Cold Chain

  Jay Mcharg
  Dramatic changes in the pharmaceutical industry are forcing manufacturers to find better solutions to ensure the integrity of temperature-sensitive products along the cold chain. From shipments of active ingredients to clinical trial materials and finished products, even a minor temperature excursion during transit can have dire consequences for drug sponsors, patients and other stakeholders. An excursion outside the acceptable temperature range can compromise product efficacy and patient safety, lead to product loss or costly quarantine for analysis, and damage company reputation.

• What Does It Mean to Be A Full-service Cdmo?

  Stephen A. Munk
  Numerous trends in the pharmaceutical industry are driving drug manufacturers to outsourcing more activities, from discovery through commercial production and even life cycle management. In many cases they are looking for a combination of specialized expertise and integrated project management combined with cost-effective services.

• Cultural Competence In Pharma

  Rhea Kim, Ph.D.
  The healthcare industry is in the midst of a turbulent global transformation, and with the advent of technology and the ability to reach consumers across country boundaries, cultural-value-based strategy and messaging is more important than ever before. Multicultural influence will be driving trends in the pharmaceutical industry and personalized medicine. CMOs will have to stay ahead of these trends and adapt to these influences, culture shifts, and demands on medicine.

• In-depth Process and Product Expertise

  Kristine K. Senft
  As older blockbuster drugs lose patent protection and generic competition increases, many pharmaceutical companies are focusing discovery efforts on therapies with the potential to treat multiple niche populations. Increasingly, innovative small and emerging pharma firms are developing new drug candidates with orphan or breakthrough therapy status that are ultimately licensed or sold to large brand manufacturers.

• Outsourcing Provides Advantages to Sponsor Companies

  The pharmaceutical contract manufacturing industry is undergoing some important changes that reflect the current evolution of the pharmaceutical industry. An emphasis on cost control, a shift in growth from mature to emerging markets, the rising importance of generics and other low-cost drugs, the switch from large-volume blockbusters to small-volume targeted therapies, and the increasing potency of many new candidates are all driving the use of contract development and manufacturing services. At the same time, and not surprisingly, pharmaceutical and biotech companies are increasingly more selective when choosing service partners, and this is even more pronounced with new chemical entities (NCEs).

• Special Focus–Achieving Strong Customer Perception

  Guy Tiene, MA
  The Nice Insight Pharmaceutical and Biotechnology Survey is deployed to outsourcing-facing pharmaceutical and biotechnology executives each year. Customer Perception (CP) of CRO/CMO/CDMOs is a major focus of the survey. Based on consistently high survey results, Capsugel Dosage Form Solutions is featured in this article to help readers learn more about creating an exceptional customer experience.

• Be Innovative! Maneuvering the Global Pharmaceutical Market

  Nigel Walker
  The recent spike of patent cliffs has made a huge dent in pharma sales revenue. To recoup the loss and sustain market position, pharma companies are in the race for new drugs. The hunt for the next blockbuster has shifted away from small molecules towards biologics. Biotech companies are leading the drug discovery efforts, especially the early stage. Faced with stagnating growth in the developed market, pharma companies have increasingly turned to emerging markets for new growth and profit opportunities.