Internal articles for Aimmune Therapeutics website
ARSCI Made Easy
On October 1st we launched ARSCI in every area of the company. Anyone who has used it will tell you - it's in the act of using it that you learn its value. In this article we focus on some examples from people who have used it successfully and and as a result, continue to use it.
First Example — Cross Functional Teams
The process of manufacturing and delivering Palforzia is a very cross-functional process. It is the Responsibility of the Commercial Supply Chain.
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REMS and ARSCI
On September 6, 2019, a week before the APAC for AR101 was held, the FDA notified Aimmune that a Risk Evaluation and Mitigation Strategy (REMS) program would need to be put in place for AR101 as an approval requirement. A REMS program is meant to provide risk mitigation strategies to ensure the benefits of the treatment outweigh the risks. These mitigation strategies require tracking, monitoring and reporting to the FDA.
In the case of AR101, participants in the REMS program include patients, health care facilities and specialty pharmacies.
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Town Hall Launches AIMMUNE into Exciting Year
Jayson Dallas began a celebratory meeting that hit several high points for the coming months of 2019. Besides announcing the tremendous achievement of the BLA acceptance last month, he highlighted the onboarding of our Chief Commercial Officer, Andrew Oxtoby, the securing of financing to complete the initial launch of AR101, and the positive results of the ARTEMIS Phase 3 Data as just the beginning of an exciting year for Aimmune.
He then passed the mike to Dan Adelman to lead the champagne toast for a successful BLA and completion of the ARTEMIS study for Europe.
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Town Hall: an ARC-mazing year
It was a Global Town Hall - 8am in Brisbane, 11am in North Carolina and 4pm in London on Tuesday, June 25 when Jayson opened the meeting, looking back and recapping Aimmune's accomplishments in the last year, as well as reflecting on his first year as CEO, which began in June 2018. He was assisted by reports from Andrew Oxtoby, Eric Bjerkholt, Dan Adelman, Louise Peacock (from London), Richard Smith, Doug Sheehy, and Fabiana Lacerca-Allen. There was, in fact, so much news to report that the newest featured presentation, on the AR101 Commercial Strategy, which was to be presented by Gina Squara, Sr. Director of Consumer Marketing, had to be tabled for another time – to be announced.
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Lunch ‘n Learn – A New Name for AR101
On August 26 in Brisbane, it was Launch & Learn as local Aimmune staff gathered to learn about Launch readiness for AR101. Watch the video below for more information, including the speakers' recorded commentary and accompanying slides. Presenters were Andrew Oxtoby, Jason Zwerner, and Gina Squara from Commercial, and Paul James from Medical Affairs. Their update covered Planning and Market Preparation to Marketing and Consumer Strategy messaging.