Articles in this Issue

• Identifying Segmentation within the Pharmaceutical Outsourcing Market

  Cliff Echols, MSc
  Understanding segmentation within your market offers a variety of benefits for the forward-thinking company. Market segmentation is defined as the process of defining and subdividing a large homogeneous market into clearly identifiable segments having similar needs, wants, or demand characteristics.

• Supply Chain Guidance and the United States Pharmacopeia Direction

  Mary G. Foster, PharmD
  The ongoing health care crisis around drug safety and reliability has the attention of the global regulatory agencies responsible for providing the public with safe health care products. Regulatory agencies such as the US Food and Drug Administration (FDA) are charged with protecting the public from unsafe pharmaceutical, biologic, medical device, and dietary supplement finished products (FP). These agencies write regulations and guidance to provide business entities direction they can use to create the systems needed to ensure compliance in the production of safe FPs. In addition, these guidances may also apply to raw materials including active pharmaceutical ingredients (APIs) and excipients that are used to manufacture FP.

• HORIZON LINES: A Quarterly Review of NDAs

  Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
  New Drug Application (NDA) approval involves various steps including pre-clinical research, investigational new drug application, clinical studies, and NDA review. NDAs can be obtained for new molecules or for existing drug molecules with a new formulation or for a new indication. This column summarizes NDAs for the second quarter 2014 (April 2014 to June 2014). FDA awarded 23 NDAs in 2Q14. The key indications were in the areas of various types of cancer, cardiovascular diseases, and diabetes.

• Biosimilars Impacting CMO Capacity

  Ronald A. Rader, Eric S. Langer
  Although relatively few biosimilar products have entered major markets, including no approvals yet in the US, this new class of biopharmaceuticals is already having a major impact on many (bio)pharmaceutical contract manufacturing organizations (CMOs). As noted below, US and European biopharmaceutical CMOs are already reporting a 15% increase in business due to biosimilar projects at various development stages. And while 30% of current commercially manufactured biologics are done by CMOs, we expect at least this level of commercial manufacture of biosimilar products by CMOs.

• Utilizing Social Media in Clinical Research: How Understanding the Regulatory Past and Present...

  Molly Salyers
  In the United States, it is impossible to watch television or read a magazine without seeing a pharmaceutical advertisement. Usually, a seemingly healthy person happily plants a garden on a sunny day, with or without a grandchild; meanwhile, a hurried list of expected adverse events and drug contraindications are read in a concerned tone or relegated to the small print on the next page. Since the Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act passed in 1962, these ads have been regulated by the US Food and Drug Administration (FDA) to ensure that their content is true and not misleading to the general patient population.

• An Interview With...Dr. Claus Feussner, Senior Vice President in Vetter Development Service

  As we have seen over the last several years, drug development costs have continued to rise which has consequently led to higher risk, especially for small biotech companies with very limited budgets. Given the cost of bringing a drug through the development phases,even a minor error in their development process can lead to financial catastrophe for the company.

• Training: How Important Is It?

  Scott M. Wheelwright, PhD
  I clearly remember my first job in the industry following graduate school. One of the things that impressed me about my employer (Abbott Laboratories, a large multinational pharmaceutical company) was the broad spectrum of training that they offered to employees. Two things struck me: firstly, they offered us the opportunity to take time from our schedules to attend any of the training that was offered within the company, and secondly, they had a wide variety of training courses available.

• Analytical Methods and Control Strategies: The Forgotten Interface?

  Phil Borman, Matt Popkin, PhD, Nicola Oxby, Marion Chatfield, David Elder, PhD
  There is considerable interest in enhancing approaches for analytical method development, validation, and lifecycle management which are aligned with Quality by Design (QbD) approaches to drug development. These enhanced approaches utilize risk assessments and in-depth systematic evaluations of critical method variables to identify those controls required to ensure that the measurement uncertainty of a reportable result is controlled to a level that ensures that the method is “fit for purpose” (ie, suitable for its intended original use). Predefined criteria can be established in the form of an Analytical Target Profile (ATP), which contains the desired performance criteria for the measurement of the attribute(s), eg, impurities content, dissolution, potency, etc. The ATP defines the appropriate performance criteria for the analytical result and is method-independent.

• Expediency vs. QbD: Resolving the Conflict in Early and Mid-Stage API Development for Virtual...

  Stuart G. Levy, PhD
  The impetus for this article was provided by a panel discussion held at PharmaChemOutsourcing in September 2014, during which a major focus of the discussion was how much effort to invest in developing and understanding the chemical processes used to manufacture active pharmaceutical ingredient (API) at early and middle stages of new chemical entity (NCE) drug development.