Industry Insights

  1. Six Principles For Developing A Robust Training Program 7/23/2018

    Well-designed training maximizes learner retention and understanding, and focuses on the information needed for safe and successful use. It also is important to understand that training for purposes of risk management cannot prop up a poorly designed device.

  2. Fundamentals Of Viral Clearance Studies Part 2: How To Design Pre-Study Experiments For Viral Clearance Studies 4/29/2013

    Careful design of viral clearance studies is critical, and knowledge of the basic principles behind the procedures and assays used in a viral clearance study will make the development of a successful study much easier. By Kathryn Martin Remington, Ph.D., Principal Scientist for Clearance Services, BioReliance

  3. Shall We (Patent) Dance? — Key Considerations For Biosimilar Applicants 2/27/2018

    The Biologics Price Competition and Innovation Act of 2009 (BPCIA), enacted in March 2010, provides for an elaborate process of information exchange — known as the “patent dance” — between a biosimilar applicant and a reference product sponsor (RPS) intended to resolve potential patent disputes in an orderly and expeditious fashion. 

  4. What’s The Right Pricing Strategy For Cell And Gene Therapies? 5/15/2018

    This article highlights the diverse interests and range of opinions about pricing innovative and often high-cost therapies, but also demonstrates that most players in the sector see an urgent need for new pricing models to accommodate cell and gene therapy products.

  5. Innovation Stimulates Growth In The U.S. Gastrointestinal Endoscopic Device Market 6/3/2019

    The U.S. gastrointestinal (GI) endoscopic device market is increasingly focusing on specialized procedures, propelling the launch of innovative devices that address unmet medical needs and drive overall market growth.

  6. FDA's Quality Metrics Guidance: Reading Between The Lines 4/14/2017

    Lou Angelucci, currently a project management consultant to Johnson & Johnson focuses more on what the FDA's Revised Quality Metrics Guidance document fails to say and do.

  7. Hybrid Decentralized Trials: Using Technology To Create More Patient-Centric Studies 11/5/2019

    While it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.

  8. Online HCP Communities Provide Rapid Advice To Support Clinical Development - Part 1 5/2/2012

    The pharmaceutical and biotech industries continue to invest in specialty products and explore expanding indications for existing brands. In a competitive environment, rapid communication is necessary to support critical decision-making and impact a product’s success. By Lance Hill and Joan Bradley, PharmD

  9. HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope? 4/30/2019

    On Feb. 6, 2019 the Department of Health and Human Services (HHS) officially proposed the rebate rule known as the “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”

  10. How An Emerging Biopharma Changed Its Supply Chain Methodology — And What It Learned 3/14/2018

    When Trevena, Inc. needed to establish a supply chain for its lead compound, oliceridine fumarate — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework.