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AbbVie, Astrazeneca, Eli Lilly, GSK, Merck, Regeneron Pharmaceuticals, plus others have submitted comments to the FDA regarding its plans to research animated spokes-characters in DTC Drug Ads (see Federal Register Docket ID: FDA-2016-N-0538).

Merck was not impressed: “While the proposed collection of information may be interesting to learn, it may not have practical utility for the general public and may be unnecessary for the proper performance of FDA's functions.”

Regeneron expressed a similar concern; i.e., "the results from this study should not be used to guide or influence FDA's current thinking on the use of animation in DTC ads."

But FDA is sticking to its guns.

“On the contrary,” says FDA in response, “this particular study has the potential to directly influence policy in an area that we have no prior research on. Although one research study cannot answer all questions, we believe we have designed the study in such a way that we will be able to provide information on the issue of animation in DTC ads. Because there is no previous research of this kind, this will be an informative study that will help FDA develop guidance and policy in the future, should the research reveal a need to.”

Meanwhile, The Advertising Coalition, representing national trade associations whose members prepare and deliver advertising through television, newspapers, magazines, the Internet, whipped out its 1st Amendment gun: “[T]his study must be viewed through the lens of two Supreme Court rulings that explicitly protect Commercial Speech, including advertising. In particular, the FDA must be mindful of the Supreme Court's ruling in Zauderer v. Office of Disciplinary Counsel, which held a state regulation of an advertising illustration unconstitutional and subject to strict scrutiny.”

But the comments I found most interesting had to do with the "Uncanny Valley” Hypothesis and measuring the “eeriness” of certain animated ads. More...

Celgene is planning to use Apple's ResearchKit framework for an observational study into the burden of chronic anaemia in two blood disorders.

Working on the project with biomedical research organisation Sage Bionetworks, Celgene aims to collect difficult-to-quantify data in myelodysplastic syndromes and beta-thalassemia.

The partners' mobile study will also collect neurological assessments of patients using cognitive testing software from BrainBaseline, technology that allows self-assessment of cognitive performance.

Celgene said its app would additionally support patients living with their disease and allow them to understand their physical functioning and other symptoms of anaemia.

Michael Pehl, president of hematology and oncology for Celgene, said: "We stand at a point where technology is unlocking the ability to capture patient reported outcomes.

"Through our collaboration with Sage Bionetworks and the evolving capability of smartphones and wearables as robust data collection devices, we believe we will be able to provide important new insights for patients with MDS and beta-thalassemia."

Myelodysplastic syndromes and beta-thalassemia typically have clinical endpoints outside traditional measures.

The project will see Celgene and Sage work with patient groups the MDS Foundation and Cooleys Anemia Foundation on defining the right elements for the mobile app to capture in order to ensure it is relevant for patients.