Hardware Podcasts

063 - Combination Products Regulatory, Going Wide, and Patient Impact with Niedre Heckman

Let's Combinate · 14 Dec 2022 · 48m

What this episode covers

Niedre Heckman, Director of Regulatory Affairs Strategy at Takeda, discusses the complexities of global regulatory strategies for combination products, highlighting the challenge of harmonizing US definitions with international frameworks where devices and drugs are often regulated separately. She explains how these regulatory differences directly impact patient adoption and product design, such as the choice between home self-administration and clinical infusion settings based on psychosocial factors. Heckman also details her career path of 'going wide' across drugs, biologics, and devices, and shares her unique approach to 'reading the room' in corporate settings, influenced by her albinism and public health background.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Takeda, Baxter International Inc., Shire, Baxalta, 3M, GSK
Products
Thinking in Pictures
Also
FDA, RAPS, ASQ, EUMDR, Temple Grandin

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