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Karen Smith

Karen Smith, MD, PhD, MBA, LLM

Principal, Biotech CEO/CMO/CSO

Dr. Karen Smith is an accomplished Biotech/Pharmaceutical Executive, Board Director, and Clinical/Scientific Advisor, boasting an extensive portfolio of achievements. With a wealth of experience, she has overseen 100+ clinical trials and secured 20+ regulatory approvals across various global jurisdictions, including the FDA (USA), EMA (Europe), TGA (Australia), ANVISA (Brazil), and PMDA (Japan). Her leadership has consistently led to successful product launches spanning diverse therapeutic areas such as oncology (Herceptin, Vyxeos), rare diseases (Defitelio), cardiology (Irbesartan), dermatology (Voluma, Botox, Aczone), neuroscience (Abilify, Solriamfetol), and anti-infectives (Teflaro).

Dr. Smith has a proven track record in business development, marked by successful acquisitions, divestitures, and partnership deals. Over the past two decades, she has held various clinical and business roles, including President, CEO, Global Head R&D, and Chief Medical Officer. Notably, she has founded companies from the ground up, demonstrating a remarkable ability to drive growth and create robust R&D pipelines.

Dr. Smith’s commitment extends beyond professional accomplishments; she is a staunch advocate for women in science and a dedicated proponent of diversity in the boardroom. Her transformative leadership has left an indelible mark on organizations, shaping inclusive corporate cultures.

Earlier in her illustrious career, Dr. Smith held senior leadership roles at Merck, Allergan, AstraZeneca, and Bristol Myers Squibb before transitioning into executive roles within several biotech and startup companies.

Currently serving on the boards of Sangamo Tx (SGMO), Aurinia Pharma (AUPH), and Capstan Tx, Dr. Smith’s strategic acumen has contributed to the success of these organizations. Notably, her past board involvements with Forward Pharma A/S (FWD), Sucampo (SCMP), Acceleron (XLRN), Antares Pharma (ATRS), and Talaris Therapeutics (TALS) all culminated in acquisitions or other favorable exits.

Dr. Smith’s academic prowess is equally impressive, holding several degrees, including an MD from the University of Warwick (UK), a PhD in Oncology from UCLA (USA)/UWA (Australia), an MBA from the University of New England (Aust), and an LLM (Masters in Law) from the University of Salford (UK). This multidisciplinary background underscores her holistic approach to the biotech and pharmaceutical landscape.


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