Articles in this Issue

• What Could Possibly Go Wrong in API Development?

  Ed Price
  The quality of Active Pharmaceutical Ingredients (APIs) has a significant effect on the efficacy and safety of medications, and as such, poorly manufactured or compromised APIs can result in serious issues, such as illnesses or even death.

• Rolling Feasibility in Competitive Immuno-Oncology Trials

  Jane Fang, MD, MS
  Immuno-oncology (IO) is a fast-growing field at the frontier of cancer therapy. Data from ClinicalTrials.gov indicates a fiercely competitive landscape with over 47,000 oncology trials globally and nearly 1,000 IO studies. Many IO studies are precision medicine driven clinical trials that target narrowly defined patient populations with certain biomarker or genetic profiles. To expedite efficacy and safety evaluation of these new treatments, innovative but more complex trial designs have been introduced - this is especially true for early phase clinical studies.

• Lessons Learned from Continued GDP Inspections in the Netherlands Based on the New EU GDP Guidelines

  Riekert Bruinink, Rafik H. Bishara, PhD
  The new EU GDP Guidelines was published on March 7, 2013 with an implementation period of six months until September 8, 2013. A new version of the Guidelines was published on 23rd November, 2013 for corrections of text and translation errors. More guidance was included for quality management issues, responsible person, procurement/storage, qualification/validation, temperature control including ambient condition, and computerized systems.

• The Right Stuff: Making the Transition from Development to Commercial Manufacturing with Your...

  Bikash Chatterjee
  The emergence of virtual biotech, specialty drug delivery companies and the increase in the number of in-licensed and collaboration development programs has spawned a new generation of Contract Manufacturing Organizations (CMOs) offering services spanning almost every aspect of the drug development lifecycle. Evaluating and selecting a CMO is a seminal decision that affects the overall success of a development program. However, the factors that make a good development partner may not always translate to the ideal commercial partner.

• A Collaborative Approach to Real World Data Collection

  Ginger Spitzer
  The healthcare field is increasingly proactive in its focus on engaging patients in ALL stages of medical care instead of solely as the end-user. This allows patients to not only benefit from medical advancements and care improvements, but to drive them based on real-life experiences, not just theory and lab science. The patient-centric approach is affecting everything from research to clinical care to basic health choices, truly a comprehensive “bench-to-bedside” effect.

• Shining Light on Clinical Trial Recruitment with Social Media

  Chris Iafolla
  Recently, I was speaking with a person working on a clinical trial for a rare brain disorder. The symptoms of this disorder are subtle and they wax and wane, which was making it hard to locate patients eligible for the trial. When I asked how they were identifying potential trial participants, the person described a scene from yesteryear. Essentially, doctors were sifting through binders of patient profiles, evaluating them line-byline, and guessing based on what they read who might be eligible to participate. Not very efficient, right?

• Anticipating New Directions in Contract Clinical Outsourcing

  Kenneth Getz
  Last year - 2017 - nearly 190 merger and acquisition transactions involving contract clinical research service providers were consummated making it one of the most active periods on record. The contract clinical services landscape is undergoing major transformation signaling a profound transition for the global drug development enterprise.

• Engaging the Site as an Active Partner in Patient-Centered Trials

  Abbe Steel
  Customer feedback surveys are nothing new. For the last few decades, companies across many industries have used them as tools for improving both their products and their perception among customers. With the advent of online survey platforms and near universal connectivity, feedback surveys proliferated.

• How Next Generation Data Visualization Tools Enable Real-Time Efficiencies in Clinical Trials

  Miko Pietila
  The ability to manage and analyze the data collected in studies and identify hidden patterns in patient behavior can help sponsors run efficient and successful clinical trials. Visualization tools for the management, reporting and analysis of key trial information can play a crucial role in gaining insights into patient behavior, enabling those running a trial to react in real-time to vital trial information and patient and site data. This in turn enables study teams to discover meaningful insights and drive smarter decisions.

• Lean Principles for Outsourcing Manufacturing: Product Quality and Eliminating Waste

  Paul M. Reece, Leonard B. Antosiak
  Increasing costs are the reality for today’s pharmaceutical manufacturer. Many are addressing increasing costs and a more competitive marketplace by implementing and managing Lean manufacturing practices. Lean requires a culture that believes in continuous improvement through the elimination of waste.

• HORIZON LINES: A Quarterly Review of NDAs October 2017 – December 2017

  Sunny Christian, MS, Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
  This column summarizes newly approved drugs, biologics, new indications and patient populations for already approved drugs from October to December 2017. This includes New Drug Applications (NDAs), Biologics Licensing Applications (BLAs) and Biosimilar applications. FDA granted approvals to 61 applications in these three months.

• Clinical Trial Materials and Manufacturing

  Over the last fi ve years what are some signifi cant advances in technology, supplies, logistics and processes that are helping pharmaceutical companies manage their clinical trials more effectively.