Episode Details

Michael D Levin is our guest on KISC My Health Radio show with Peter Mingils and the King of Cranberries Stephen Lukawski.

This week on KISC My Health Radio, Captain Cran Man Stephen Lukawski and Peter Mingils have the privilege of interviewing Michael D Levin.

Summary: Healthcare executive with successful experience spanning 29 years
Natural Medicine after 23 years in pharma, including generic pharmaceuticals,
wholesale distribution, bids and contracts, chargeback accounting systems,
compliance, performance audits, and managed care contracting for pharmaceuticals
and pharmacy services. Work environment included start-ups, turnarounds,
Fortune 50s, and privately owned firms. An articulate, seasoned, compassionate
and decisive visionary possessing extensive medical, operations, regulatory,
technical, and business development acumen.
Systems, IP, expert witness, contract law, and technology literate. Extensive clinical
and regulatory compliance experience with drugs, IV compounding, and natural
products. USP and NSF cGMP standards development. Congenial, ethical, and
biased towards action. Lives near Portland, OR.

2004 to Current
HEALTH BUSINESS STRATEGIES, LLC, Clackamas, OR
Founder
Led business development, R&D, QA, and regulatory compliance functions for
divisions at Cancer Treatment Centers of America. Additional client projects
included: Medical Foods, Foods for Special Dietary Use, cGMP compliance, labels,
labeling, substantiation, compounding pharmacy advocacy, and strategy.

• Implemented quality improvement and regulatory compliance systems
• Developed and implemented the nation's first hospital-based Dietary Supplement
  Formulary Committee
• Championed nutritional interventions as a strategy to reduce healthcare costs
  and improve outcomes
• Led Award Winning International Initiative to Stop Resale of Adulterated
  Products (Botanical Adulterants Prevention Program)
• Serves as expert witness in criminal dietary supplement cases (food law)
• Advocated to FDA on behalf of medical and compounding pharmacy stakeholders.
• cGMP Compliance Audits, Contract Audits, Product/Service Development
  2001 – 2004
  CARDINAL ASSOCIATES, INC. Vancouver, WA
  President, Chief Operating Officer
  Provided strategic vision and operating leadership to this quality-driven, highly
  respected, dietary ingredient manufacturer that services global markets.
  Responsibilities include P&L, contracting regulatory compliance, continuous quality
  improvement and daily operations. Initiated GRAS prosecution, IP defense,
  conceived/directed/approved a double blind, placebo controlled human clinical trial
  on a dietary supplement later published in a peer-reviewed medical journal.
  
  1996 – 2000
  TYLER ENCAPSULATIONS, Gresham, OR
  Vice President, Chief Operating Officer
  Provided strategic direction and operating leadership to this privately held dietary supplements company serving healthcare practitioners and distributors.
  Responsible for operations, sourcing, business development, pricing/contracting,
  regulatory compliance, and strategic management. Accomplished shareholder
  financial objectives through industry consolidation. Sold Co. in March 2000
  o Secured first national GPO contract for dietary supplements (AmeriNet)
  o Reorganized and recruited effective senior management team
  o Conceived, developed, and deployed the first supplements/drug interactions
  dispensing solution for in-office physician us