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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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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Steven Linberg, PhD

Principal Steven Linberg has over 35 years in the regulatory industry with emphasis on drug and biologics development, clinical trial design, and interactions with the FDA.

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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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Pete Taft

Pete Taft, Executive Communications Strategist, founded PharmApprove in 1999 when pharmaceutical clients began asking him to prepare global teams for critical regulatory presentations in both the US and Europe.

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Lisa Peluso

Lisa Peluso, Director, Coaching and Client Engagement

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