Articles in this Issue

• Editor's Message: Remote Control

  If you grew up in the 70’s like I did, and, if you had a mother like I did – someone who was pretty fastidious regarding her children’s health – you probably remember going to the dentist. Going to the dentist is usually not a fun... read more

• Sparking Continued Interest in Science, Post-Pandemic, Requires Raising the Next Generation...

  Derek Richards
  COVID-19 continues to cause massive disruption to the supply chain and has exposed our vulnerabilities in relying on off-shore suppliers. The situation has caused both private and government sectors to question the validity of ... read more

• Strengthening Biopharma’s Resilience

  Francis Van Parys
  At a time when a robust global biopharma industry is critical, the global pandemic has exposed some of its weaknesses, as well as its strengths. New industry research shows that in our interconnected and global world there are ... read more

• Utilization of Physiologically Based Pharmacokinetics Modeling in the Development of Orally...

  An oral physiologically-based pharmacokinetics (PBPK) in silico model focuses on the link between a molecule’s physiochemical properties, formulation parameters and plasma exposure (including Cmax, Tmax, T1/2 and area under the ... read more

• Maximizing Cloud Value in Life Sciences

  Most life sciences executives recognize the cloud is one of the most value-creating technologies of our time. They understand it is the foundation for the digital transformation that is driving profound changes in how businesses ... read more

• Transforming to Decentralized Trials

  The transition of clinical trials away from investigator sites and into volunteer homes offer a more patient-centric approach and reduces the burden on caregivers. It also offers up great opportunities for the industry to capture ... read more

• Adding State Licensing to Your Cell and Gene Launch Strategy

  We know that the cell and gene therapy market is growing. In Q1 of this year, a report was released stating that the market is projected to reach $25 billion by 2027 and acknowledging that with more than 1,000 clinical trials ... read more

• Building Outsourcing Strategies That Reduce Risk and Promote Flexible, Patient-Centric and...

  Small, emerging biotechnology companies are at the frontier of a revolution in human healthcare. They are also operating in an era where traditional clinical trial models are being surpassed by demand for flexible, patient-centric... read more

• Up for Debate. Interchangeable Data/Document Management: The Key to Transforming Life Sciences...

  Compared to other industries, the life sciences industry has been slow to appreciate the benefits of information management fluidity. But that’s all beginning to change. In this roundtable discussion, Steve Gens of Gens & ... read more

• Data Capture in the Age of Decentralized Trials: Why “Electronic” Is Not Enough

  The clinical research industry has made gradual, steady progress toward incorporating remote monitoring and virtual clinic visits as well as virtual enrollment, electronic informed consent (eConsent), and electronic patient-... read more

• Outsourcing Clinical Research Support – Time to Put Safety First

  For many clinical research organizations (CROs), offering full-service outsourcing, safety is too often an add-on. The risk of this approach is the safety team is not sufficiently knowledgeable to ensure full compliance or to ... read more

• Specialty Pharmacy Benefit Management Mitigates High Cost of Gene Therapies for Rare and Orphan...

  Specialty pharmaceuticals represent the fastest-growing segment of the pharmaceutical industry, dominating new drug development while capturing the attention of payers, providers and consumers seeking effective treatment options ... read more

• How Real World Data, Decentralized Trials, and Diversity Will Put the Patient First

  It has been nearly a year since the U.S. government introduced Operation Warp Speed (OWS). The public-private partnership has surely been imperfect during the quest to develop, manufacture, and distribute COVID-19 vaccines. But ... read more

• Achieving Clinical Trial Diversity Through Actionable Steps

  The medical community and cultural opinion agree: clinical trials need diversity. It’s our job to serve affected populations, but we cannot do that if we don’t have an appropriate representation of these populations in our ... read more

• Light at the End of the Tunnel: Serialization of Pharmaceutical Products Nearly Complete

  There is reassuring news about the healthcare industry’s ability to meet increasingly difficult supply chain challenges: U.S. pharmaceutical manufacturers have now almost universally adopted product identification standards that ... read more

• HORIZON LINES: A Quarterly Review of New Drug Applications – January-March 2021

  This quarterly review on New Drug Applications (NDAs) contains data for applications approved for the first time during the first quarter of 2021, which includes New Molecular Entities (NMEs) and new biologics. A total of 26 ... read more