Articles in this Issue

• Outsourcing Your API Manufacturing to Asia? Key Things to Think About

  Edward S. Price
  Concerned with rising R&D costs, many U.S. bio/pharma companies are considering Asian countries, such as India and China, for the development of their Active Pharmaceutical Ingredients (APIs) and pharma products, in the hope of getting a good deal, thanks to low-cost production facilities and cheap labor.

• A View to Strategic Partnering

  Robert Guzman
  Any human enterprise is subject to challenge from its conceptual stage; from financial hurdles to technology and expertise, they all contribute to the success or failure of our goals. The typical business cycle dictates that we need to define our operating model based on the service or product to be provided, and the market we want to target.

• Anticipating Future Guidelines By Utilizing The Latest Technologies In Particle Characterization

  Nigel Walker
  The presence of particulate matter in pharmaceutical products con-tinues to be one of the top reasons for recall. This year, 11 of the 54 safety alerts issued by the FDA were for the presence of particulates in drug and therapeutic biological products.

• HORIZON LINES: A Quarterly Review of NDAs July-August 2016

  Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
  This column summarizes New Drug Applications (NDAs) approved from July-August 2016. FDA approved 21 NDAs in these two months.

• Contracting – A Key Component of a Strong Vendor Relationship

  Luke van Hengel
  Contracting in any vendor relationship can raise its ugly head when the parties least need or expect it. It is a given in any outsourcing that a contract of some sort needs to be put in place; however, there should be more emphasis on the effort needed to ensure contracting does not become an obstacle. The typical focus of any vendor relationship is on delivery, as this ultimately serves the greater goal of this industry – to bring new treatments to those in need.

• Data Trust and Transparency: New Era of Clinical Outsourcing and Partnerships

  MaryAnne Rizk, PhD
  Demands today and into the next decade for more and better therapies is placing unprecedented pressure on the global pharmaceutical industry, and it is estimated that by 2020, up to three quarters of clinical trials are likely to be performed by CROs.1 Innovative discovery methodology has increased the number of smaller, emerging biopharma organizations who are keen to develop their products to sell, co-license or take to regulatory approval.

• Multi-Site Clinical Partnerships: Bringing Together CROs, Sponsors and Hospitals

  Istvan Udvaros
  As the biopharmaceutical industry is facing a longer, more complex, and more expensive drug development process, all stakeholders must demonstrate flexibility and the ability to innovate and find solutions to overcome challenges. Patient recruitment for clinical trials that are well managed studies, with a high level of consideration towards the subjects, a close follow up, and robust quality of data collection is one of the many challenges within the industry.

• An Interview With... Peter Soelkner, Managing Director, Vetter Pharma International GmbH

  There has always been a variety of challenges affecting the parenteral manufacturing industry and its participants.

• The Dynamics of Outsourcing: A Bibliometric Study

  Yulia Nedelcheva
  The process of globalization expands the focus of outsourcing to all sectors of the economy. The main motive for the implementation of outsourcing strategy is to reduce production costs and to create competitive advantages both to the companies and to the national economy.

• Clinical Trial Contracts: Language and Limitations

  JoAnn P. Pfeiffer
  Contracts provided to study sites by industry sponsors contain legal language that is often confusing and not well understood by the study site representatives. This article reviews risk areas and contract language that sites should be familiar with when reviewing and negotiating a clinical trial agreement. To adequately protect the site, those who review the contract should clearly understand what they are agreeing to before approving a contract.

• An Evolution Is Underway - And Is Here To Stay - In Centralized Monitoring

  Nicole Stansbury
  International Council for Harmonisation Integrated Addendum to ICH E6 R1 - otherwise known as ICH E6 R21 - suggests centralized monitoring be incorporated as an important monitoring methodology in clinical trials. Different companies are taking different approaches to deploy centralized monitoring and these differences will require more detailed discussions when outsourcing clinical trial services.

• The Rising Adoption of Technology in Clinical Trials

  Jennifer Peters
  What’s been proven to reduce data variance, increase patient compliance and decrease site monitoring costs in clinical trials? For certain, it’s not the continued use of paper records. Digitization of clinical trial processes is the driving force behind real ROI and its demonstrated results are increasing the adoption rate among sites and sponsors.