Knowledge Base

OrthoTrophix' Intra-Patient Randomization Design Supported by Advanced Cold-Chain Packaging April 9, 2018 in Research Papers,

Discussion regarding how OrthoTrophix and Sherpa worked through the clinical supply challenges presented by a frozen drug. Read More

Clinical Endpoints: What Do Payers and Regulators Want? April 5, 2018 in White Papers,

The requirement that new drugs show effectiveness is based on a 1962 amendment to the Federal Food, Drug, and Cosmetic Act. This law requires substantial evidence of effectiveness and specifies that t Read More

Not Just Tiny Humans: Considerations for Conducting Pediatric Clinical Trials April 3, 2018 in White Papers,

When it comes to the conduct of pediatric clinical trials, there are number of things you need to consider in order to ensure the successful conduct of a study. While we can’t predict the outcome, pla Read More

Cytokines emerge as 2018's immuno-oncology stars EvaluatePharma USA, Inc. March 28, 2018 in White Papers,

No sooner had cytokine therapies been labelled an area to watch in 2018 than Bristol-Myers Squibb paid a massive $1.85bn for rights to Nektar’s NKTR-214, and interest in IL-2 is not about to abate. Read More

Implementing Patient-Centric Principles in Asthma Research March 28, 2018 in White Papers,

The term patient centricity is fraught with uncertainty for many. This term carries the nuances of widely varying practical application methods as well as theoretical disagreements from stakeholders Read More

6 Strategies to Stretch your Limited Drug Supply for Clinical Studies March 7, 2018 in White Papers

Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. Read More

What your Clinical Study Design Reveals About your Clinical Packaging Needs March 7, 2018 in White Papers

As the cost and complexities of drug development increase, so do the challenges of global clinical trials. Read More

Stark Laws and False Claims Poretta & Orr, Inc. March 6, 2018 in White Papers

“Why should someone in healthcare meetings and events care about Stark or Anti-Kickback Laws?” To put it simply, because we often work with physicians and the entities they conduct business with, so Read More

MedTech Europe Code - Poretta & Orr, Inc. March 6, 2018 in White Papers

You are probably asking yourself, why would a member of MassBio want to know about the MedTech Europe Code of Ethical Business Practices? Great question and I hope to answer that question with the hig Read More