I helped those who didn’t speak English get the diapers and food they could no longer buy at the corner store because it burned down. After the murder of George Floyd, I protested, and with my broom and trash bags in hand I helped clean up the ashes of grief sprayed out on the streets for miles. “I’ve always been in tune with injustice. Even then, I could imagine the seismic surge of energy, shaking the depths of the world as we knew it.”
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“I remember in 5th grade when we had this creative writing assignment, ‘If you could go back in time, where would you go?’ I always felt a deep connection to the Civil Rights Movement, so I chose the March on Washington during Martin Luther King, Jr.’s ‘I have a Dream’ speech. Especially this past year, I’ve learned a lot about race, policy, local systems of oppression, and the ways that some have felt motivated to take action, where others need space to process and heal.” “This moment has brought up more questions than answers. She joined the team in March of this year, which was motivated upon experiencing unique concern and activation in the wake of the murder of George Floyd. To consider new ways of connecting the threads between the needs of our entrepreneurs and under-represented communities, and the opportunities they so squarely deserve.”īorn and raised in Minneapolis, Janie felt called to commit her talent and passion to Rising Tide’s mission. “It’s so important to have artists at the table, to think about challenges differently. “I feel a deep sense of purpose being in Jersey City and working with Rising Tide by leveraging my specific skills and to celebrate beauty and opportunity, while addressing the tears and holes within society’s fabric,” Janie shared.
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“So this is just some really important grounding that we try to continue to remind, especially sponsors who are selecting digital tools for use primarily as exploratory endpoints, but their goal really is a digital endpoint in a trial,” Stephenson said.It’s no accident that an artist like Janie Arguedas finds herself at Rising Tide Capital: with fabric as her primary medium, Janie hand-deconstructs and recontextualizes knit fabric, celebrating the fundamental ways in which it exists, valuing each thread, tending to areas that need mending and creating greater coherence through a diversity of contributions to the whole.
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“As we’ve heard today many times that definitions of how to define what would be achieved with an endpoint are quite unique,” she noted, while pointing to the FDA’s formal qualification process for drug development tools. “I’ve been told many times that people think that if you use an FDA cleared device or an approved device – 510(k) cleared device - then that automatically means that that device will be accepted as an endpoint, a digital endpoint in a trial, so that’s incorrect,” she said.
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The collaboration between the companies is a bit of an exploratory mission too as the FDA has never authorized or approved any new medical products on the basis of these digital endpoints, which are defined as endpoints that use sensors to capture existing measures in a new way, according to an op-ed by Jen Goldsack, CEO of the Digital Medicine Society.ĭiMe is helping these five biopharma companies in their collaboration and believes that digital endpoints present an opportunity to provide “a more meaningful and complete understanding” of patients’ conditions and responses, and potentially reduce the time and cost of bringing new therapies to market.īut for the FDA, which doesn’t use the term “digital endpoint,” the challenges of capturing patient-reported outcomes are numerous, and can include everything from the instrument used appropriately in the trial, to how the sponsor adequately measured the results, which are often conveyed in a “score,” and may be difficult to understand the magnitude of the benefit, particularly in relation to safety risks, according to an FDA presentation.ĭiane Stephenson, executive director of the Critical Path for Parkinson’s, also explained some of the confusion around digital endpoints at a patient-focused drug development workshop in 2019 at FDA. Pfizer faces an increasingly crowded atopic dermatitis space as AbbVie’s blockbuster Rinvoq is currently under FDA review for the indication, and according to SVB Leerink biotech analyst Geoffrey Porges, “looks spectacularly effective at its highest dose.” But he said Pfizer’s abrocitinib, its next-gen follow-up on Xeljanz, “continues to look meh.”