Leadership

Laurie Smaldone Alsup, MD

Dr. Laurie Smaldone Alsup, COO/CSO, has 25 years of executive leadership experience in drug development, regulatory strategy, and regulatory approvals across all major therapeutic areas and product technologies.

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Marianne Mann, MD

Dr. Marianne Mann is an independent regulatory consultant who works with PharmApprove on specifically requested projects. She is a pulmonologist and intensivist who trained at the University of Connecticut Health Center.

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Carol Maskin, MD

Carol is an independent medical and regulatory consultant who provides strategic advice and guidance regarding new drug development and high stakes regulatory meetings, including FDA Advisory Committee meetings, in a broad range of therapeutic areas.

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Martha Arnold

Principal Martha Arnold brings extensive experience in cross-functional development team activities, working closely with clinical, regulatory and scientific experts to move candidates through all stages of the product lifecycle.

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Elaine Klein

Principal Elaine Klein has led over 20 Advisory Committee preparation projects for drugs and devices in a number of therapeutic areas since joining PharmApprove in 2008.

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Kaia Agarwal, MSc

Kaia Agarwal is an independent regulatory consultant who works with PharmApprove. Kaia has over 25 years of global leadership experience in the pharmaceutical and biotechnology industry, and strategic regulatory expertise across CMC and Clinical Development.

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Neelu Agrawal

Principal Neelu Agrawal has over 20 years of strategic communication, cross-functional leadership and management consulting experience.

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Len Baum, RPh

Principal Leonard (Len) Baum RPh, has over 36 years of leadership experience in global product development and regulatory science covering a broad range of prescription and over-the counter (OTC) therapeutic and diagnostic imaging drugs, nutritionals and biologics.

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Alison McGregor

Alison McGregor is originally from the UK. She has over 20 years regulatory experience across therapy areas and is used to working with teams globally across sites and regions.

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Mary Martinson

Bio coming soon…

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Liz Yamashita

Liz Yamashita has over 35 years of experience in the pharmaceutical industry, spanning small molecule and biotechnology CMC, clinical and nonclinical development, as well as marketing, and business development.

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Lisa Peluso

Lisa Peluso, Director of Coaching and Client Engagement, has coached individuals, provided presentation training and facilitated workshops with numerous global teams in pharma and biotech.

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