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Whodini augments LinkedIn profiles instantly with detailed drug and company information.

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Pharma companies and drugs are automatically highlighted.
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Insights panel helps recruiters screen candidates faster.
Works seamlessly with LinkedIn and LinkedIn Recruiter.

linkedin.com/in/jane-smith

Jane Smith, PhD, RACVP, Head of Global Regulatory Affairs at Day One Biopharmaceuticals

Experience

VP, Head of Global Regulatory Affairs

Day One Biopharmaceuticals

Oct 2022 - Present · 2 yrs 5 mos

Executive Director, Head of Regulatory Affairs

Elucida Oncology

Jan 2020 - Sept 2022 · 2 yrs 9 mos

Architected and executed the regulatory strategy for ELU001, culminating in its successful IND clearance and September 2021 Phase 1 clinical trial initiation.

Executive Director, Regulatory Affairs

Daiichi Sankyo

May 2017 - Dec 2020 · 3 yrs 8 mos

Led global strategy for fam-trastuzumab deruxtecan-nxki to ensure accelerated timelines.

Senior Director, US Regulatory Affairs

Novartis

Nov 2014 - Apr 2017 · 2 yrs 6 mos

Managed the historic FDA submission and advisory committee prep for Kymriah.

Director, Regulatory Affairs

Merck

Feb 2008 - Oct 2014 · 6 yrs 9 mos

Oversaw the pivotal regulatory filings and clinical data integration for MK-3475.

ENHERTU

(trastuzumab deruxtecan) DS-8201

ENHERTU (fam-trastuzumab deruxtecan-nxki) is a mega-blockbuster ($5B+ in 2025 sales) antibody-drug conjugate (ADC) targeting HER2, a receptor whose overexpression or mutation drives tumor proliferation. A trastuzumab-based mAb delivers a cleavable DXd topoisomerase I inhibitor payload, producing potent cell kill and a "bystander" effect. First FDA approval was on 12/20/2019 for unresectable or metastatic HER2+ breast cancer (mBC). Key expansions: HER2+ gastric/GEJ cancer on 01/15/2021, HER2-low mBC on 08/05/2022 (first approved therapy for HER2-low), HER2-mutant NSCLC (non-small cell lung cancer) on 08/11/2022, and a tumor-agnostic HER2+ solid tumor indication on 04/05/2024. It is an oncology drug for solid tumors. Discovered by Daiichi Sankyo (DXd platform) and co-developed with AZ under a March 2019 global collaboration: $1.35B upfront, up to $5.55B in milestones (total up to $6.9B), and 50:50 profit share worldwide except Japan. In the US, AZ and Daiichi co-commercialize; they co-commercialize globally ex-Japan, while Daiichi markets in Japan. Estimated 2026 sales of $6.5B with peak sales as high as $15B by 2031. Competitors in HER2+ / HER2-low mBC include Roche/Genentech's KADCYLA (ado-trastuzumab emtansine), HERCEPTIN (trastuzumab) with PERJETA (pertuzumab), Pfizer's TUKYSA (tucatinib), and Puma's NERLYNX (neratinib). In gastric cancer it competes against trastuzumab-based regimens.

Current FDA holderDaiichi Sankyo Co., Ltd.

Approved indications:9

12/20/19First approval

HER2-Positive Breast Cancer

Orphan

Therapeutic areasOncology

ModalityAntibody drug conjugate

Drug classHER2-directed antibody and topoisomerase inhibitor conjugate

Target

Receptor tyrosine-protein kinase erbB-2

DNA topoisomerase 1

HER2/Neu/cerbB2 Antagonists

Dosage formfor injection

Routeintravenous

Clinical trials:59

Phase 3 - Recruiting

Bronchial Neoplasms, Carcinoma, Bronchogenic, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Lung Neoplasms, Neoplasms, Neoplasms by Site, Respiratory Tract Diseases, Respiratory Tract Neoplasms, Thoracic Neoplasms

CollaboratorsMerck & Co., Inc.

Start date10/24/2025

Completion date07/05/2032

More information

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