Sandra L “Sandi” Bihary Waltz is a Global Pharma Industry executive with 25 years of experience in Pharma Regulatory, Ally Development, Clinical Trials/Drug Development and Public Affairs.
Engaged in a longer-term assignment now as a consultant to the Federal Government on Pharma Strategies for Bioterrorism, Anthrax, Global Plagues and similar issues, she also provides strategic consulting services via SW&A.
Working in larger multi-disciplinary teams, she works in a capacity drawing on the depth and breadth of her experience to provide resources, perspective and strategy to the team. In smaller environments, e.g., early-stage companies, Sandi is very comfortable providing hands-on leadership and advocacy as a team leader, including managing US FDA and other Regulatory relationships.
She’s worked across many, if not most disease states, but her background is particularly deep in CardioVascular and Oncology issues. With a Clinical Professional background, early in her career she created and managed a Coronary Intensive Care Unit (ICU).
A Doctor of Business Administration (DBA) degree candidate presently at Wilmington University, she holds BSN degree (1980 with Honors) from Carlow University (Pittsburgh) and an MSN degree (1988) from Widener University (Philadephia region), with additional graduate work in healthcare, healthcare administration, cardiology and business, some of it at the University of Delaware.
Provide strategic counseling, leadership and advice to businesses and organizations on the issues of regulatory affairs and drug development, development and management of relationships with patient and professional organizations. Provide individual instruction on drug development and the pharmaceutical industry to select clients. Manage outreach to prospective allies, matching customer needs with the expertise and areas of influence of patient and professional organizations.
An executive with AstraZeneca and its predecessor companies, ICI Americas and Zeneca Inc., from 1988-2005, Sandi moved through progressively senior assignments to Executive Director, with work in Ally Development and External Relations, She also provided leadership to the US Regulatory Operations Group, ensuring appropriate submission management, global submissions management and integration of business systems from Astra and Zeneca. Led activities and structure to ensure compliance with eCTD for US submissions.
Sandi headed the US Regulatory team for AZ’s Oncology portfolio, providing expert therapeutic knowledge in all aspects of US Regulatory Affairs, including Subpart H and accelerated development/fast track. She built a proven track record with approvals with FDA and extensive negotiation experience with FDA and other organizations to ensure support for submissions. Significant interaction with multiple divisions within FDA, including Office of the Commissioner, DDMAC. Direct management of leadership team of 5 Directors, and all activities within their respective organizations.
Early in her career, she worked for Christiana Care, then called the Medical Center of Delaware, with assignments both in Coronary and Oncology practice. She started her career with Montefiore Hospital in Pittsburgh.
She’s volunteered extensively in both HealthCare Industry and Civic Leadership roles, serving a decade on the National Board of Directors for The Wellness Community, where she was Treasurer. She’s also been actively involved with the American Cancer Society, co-chaired the American Heart Association Heart Ball twice, and serves on the Advisory Council to the Girl Scouts Chesapeake Bay Council.
Among her Professional Presentations, some examples:
Industry Perspective of Drug Development and Interaction Between the Pharmaceutical Industry and the FDA, FDA New Reviewer’s Workshop, Washington, DC (June 1996)
Annual Reports and Supplemental Applications for Approved NDA’s, PERI Presentation, Arlington, VA (20 April 1999)
FDA Drug Approval Process, Barnett, Philadelphia, PA (November 2000)
Drug Development Process, Prostate Cancer Coalition (June & August 2002)
Drug Development and the Role of Patient Advocacy Organizations, The Wellness Community, Delaware Stroke Initiative, Wilmington, DE (November 2002, April 2003)
Drug Development and the Role of Multicultural Organizations in the Process, National Black Nurses Association Annual Conference, San Francisco, CA (5 August 2004)
Drug Development and the Role of Nurse Practitioners, National Nurse Practitioners Association, Annual Conference, Philadelphia, PA (27 October 2004)
Drug Development: Safety, Efficacy and Dosage: Conundrums in Today’s Regulatory Environment, Keynote Speaker, University of Pittsburgh, Pharmacology Update Annual Conference, Pittsburgh, PA (26August2005)