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 use (Allscripts)
  1992 – 1996
  PROVIDER'S CHOICE 2000, INC., Niles, IL
  ALTERNATE SITE INFUSION TECHNOLOGY, INC., Niles, IL
  President (Provider's Choice 2000) and Vice-President (ASIT)
  Organized, staffed, and managed pricing, contracting, and operations of two
  synergistic patient-focused healthcare businesses serving the physician, alternate
  site, and managed care markets (compounding pharmacy, home health care). Built
  custom tri-sectional cleanroom; Joint Commission certified; registered with FDA
  and licensed with DEA. My two partners included the Past-President of the
  American Society of Hospital Pharmacists and the Past-President of the Illinois
  Society of Hospital Pharmacists.
  1987 – 1992
  PSI AND ASSOCIATES, Arlington Heights, IL
  President
  Provided consulting services to generic drug manufacturers, distributors, group purchasing, and service providers. Projects included orphan drug development, competitor intelligence, strategic pricing, the design and development of Rx marketing programs, contract pricing subsystems, operations assessment, market research, strategic and tactical planning.
  1984 – 1987
  ASCOT PHARMACETUICALS/BAXTER HEALTHCARE CORP.
  Deerfield, IL
  Vice President, Materials Management
  Accountable for distribution, pricing, contracting, sourcing, manufacturing,
  purchasing, compliance and information services in the Pharmaceuticals Division (generic drugs, oral and injectables). Achieved shareholder objectives – sold to Baxter in 1986.
  1976 – 1984
  HUMISTON-KEELING, INC, Chicago, IL
  Director, Hospital Services
  Created a $39M specialty hospital sales and services division for this leading
  regional drug wholesaler (now Cardinal Health). Managed contracts and contract pricing. Advanced EDI data requirements to support contract and chargeback accounting systems still used today.
  1973-1976
  WINTHROP LABORATORIES, INC, New York, NY
  Professional Sales Representative and Sales Specialist – Urology
  Trained and promoted to manage a territory of doctors, hospitals, and drug stores in suburban Chicago. Youngest rep hired; youngest rep promoted (1974). Successfully managed one of five regional urology pilot programs in the US. Trained sales representatives.
  Education, Certifications & Training
  Bachelor of Arts, Roosevelt University, Chicago, IL.
  Major: Psychology with emphasis in psychopharmacology
  Post-Graduate training in:
• Professional Medical Selling Techniques, 1973-74
• Asset Management and Demand Forecasting, 1981
• Management Accountability and Strategic Planning, 1984-85
• Quality of Management, 1986
• Management Accountability Process, 1991
• Licensed Pharmacy Technician, Illinois #049-104126. 1996
• FDA Dietary Supplement Training Certificate, 2009
  
• Preventive Controls for Human Food (PCQA) FSPCA Certificate #a9cadb90, 2016
• Foreign Supplier Verification Programs (FSVP), FSPCA Certificate 3cda0f49,
  2021
• Performance Management, 2013
• Champion of Naturopathic Medicine Award, American Association of
  Naturopathic Physicians, 2021
  Invited Speaker (partial list)
  3/99 National Managed Healthcare Congress "NUTRITIONAL INTERVENTIONS:
  AN ECONOMIC IMPERATIVE”
  4/00 Northwest Business Council, Oregon Medical Association, "DIETARY
  SUPPLEMENTS: REGULATORY, CLINICAL, SCIENTIFIC AND ECONOMIC
  CONSIDERATIONS”
  4/02 Collaboration for Healthcare Renewal Foundation, "INTEGRATION OF
  NUTRACEUTICAL INTERVENTIONS: UNTAPPED OPPORTUNITIES”
  7/07 Nutrition Business Journal, Newport Executive Summit "NUTRITIONAL
  INTERVENTIONS: BUSINESS OPPORTUNITY OR ECONOMIC IMPERATIVE?”
  10/07: Cancer Treatment Centers of America: "FDA'S FINAL RULE FOR
  DIETARY SUPPLEMENT GMPS – WORTH THE WAIT?”
  2/08 AND 4/09 Massachusetts College of Pharmacy "DIETARY SUPPLEMENTS: A REGULATORY OVERVIEW FOR PHARMACISTS”
  5/08 CANCER Treatment Centers of America "DIETARY SUPPLEMENT
  CERTIFICATION PROGRAMS: A CRITICAL REVIEW”
  2/09: National College of Naturopathic Medicine: "INEQUALITY: A CRITICAL
  SURVEY OF DIETARY SUPPLEMENT INDUSTRY PRACTICES”
  8/09: Naturopathic Medical Student Association: "INEQUALITY: A CRITICAL
  SURVEY OF DIETARY SUPPLEMENT INDUSTRY PRACTICES”
  11/11: Integrative Medicine Conference – Oklahoma Association of Naturopathic
  Physicians: "SUPPLEMENT QUALITY AND FDA ENFORCEMENT: AN UPDATE
  FOR HEALTHCARE PROFESSIONALS:
  1/12: Cancer Treatment Centers of America: "THE END OF DIETARY
  SUPPLEMENTS? FDAS DRAFT GUIDANCE FOR NEW DIETARY
  INGREDIENTS”
  9/12: Integrative Medicine Conference – Oklahoma Association of Naturopathic Physicians: TRADITIONAL CHINESE MEDICINE: REGULATORY STATUS AND
  QUALITY ISSUES
  5/13: PerkinElmer Inspiring Innovation Tour, Portland, OR REASONABLY
  ANTICIPATED CONTAMINANTS: AVOIDING RECALLS, ASSURING SAFETY
  6/13: PerkinElmer Inspiring Innovation Tour, Los Angeles, CA REASONABLY
  ANTICIPATED CONTAMINANTS: AVOIDING RECALLS, ASSURING SAFETY
  12/13 Cancer Treatment Centers of America, Newnan, GA "SUPPLEMENT
  QUALITY: IMPACT OF LOW-LEVEL CONTAMINANTS ON GENETIC
  EXPRESSION”
  1/14 Midwest Regional Medical Center, ZION, IL "SUPPLEMENT QUALITY: THE
  EFFECTS OF LOW-LEVEL CONTAMINANTS ON GENETIC EXPRESSION”
  5/14 PerkinElmer Analytical Testing of Dietary Supplements Tour, "DIETARY
  SUPPLEMENTS AND REASONABLY ANTICIPATED CONTAMINANTS: A
  REGULATORY REQUIREMENT”
  5/14 PerkinElmer Analytical Testing of Dietary Supplements Tour, "DIETARY
  SUPPLEMENTS AND TESTING: QUALITY AS VIEWED FROM THE
  PERSPECTIVE OF HEALTHCARE PRACTITIONERS”
  6/14 Eastern Regional Medical Center, Philadelphia, PA "SUPPLEMENT
  QUALITY: IMPACT OF LOW-LEVEL CONTAMINANTS ON GENETIC
  EXPRESSION”
  1/15 12th Annual Natural Supplement Conference, Scripps Health, San Diego, CA
  "UNDERSTANDING DIETARY SUPPLEMENT QUALITY VS FDA
  ENFORCEMENT: EVIDENCE-BASED UPDATE FOR PHYSICIANS”
  4/15 3rd Annual Practitioner Channel Forum, Holistic Primary Care, San Diego, CA
  "UNTAPPED OPPORTUNITIES IN MAINSTREAM MEDICINE – AN ECONOMIC
  IMPERATIVE” AND "STRATEGIC PATHWAYS: ADVANCING THE ECONOMIC
  IMPERATIVE”
  1/16: 13th Annual Natural Supplement Conference, Scripps Health, San Diego, CA
  "EVIDENCE BASED QUALITY OF DIETARY SUPPLEMENTS – FOR
  HEALTHCARE PRACTITIONERS”
  10/17 Supplyside West, Las Vegas, NV
  "INTRODUCTION TO INDUSTRY BEST PRACTICES, SOPS AND CONTRACT
  LANGUAGE TO
  ASSURE DESTRUCTION OF IRREPARABLY DEFECTIVE ARTCLES”
  3/18 Natural Products ExpoWEST, Anaheim, CA
  "PREVENTING THE REINTRODUCTION OF ADULTERATED AND/OR
  UNLAWFUL MATERIALS
  INTO THE SUPPLY CHAIN”
  5/18 Annual Practitioner Channel Forum, Hollywood Beach, FL
  "FUTURE SHOCK: HOW CAN PROFESSIONAL DS BRANDS THRIVE IN
  FUTURE TIMES?”
  3/19 Natural Products ExpoWEST, Anaheim, CA
  "BOTANICAL ADULTERANTS PREVENTION PROGRAM: CONTRACT AND
  SOP PROGRESS UPDATE TO HALT THE RESALE OF IRREPARABLY
  DEFECTIVE INGREDIENTS INTO THE DIETARY SUPPLEMENT SUPPLY
  CHAIN”
  11/19 SupplySide West, Las Vegas, NV
  "DON'T RETURN IT…. BURN IT: ADDRESSING ADULTERATION BY
  DESTROYING IRREPARABLY DEFECTIVE INGREDIENTS” Central Stage Panel
  Discussion presented by American Botanical Council, NOW Foods and Pharmavite
  9/20 Virtual Webinar
  "FTC AND FDA BASICS FOR PRACTITIONERS DURING COVID” Holistic
  Primary Care and American Association of Naturopathic Physicians, [Pre-recorded
  and Live Roundtable with FTC, Attorneys and Medical Doctor.
  3/23 Virtual Webinar
  "INTRODUCTION TO IRREPARABLY DEFECTIVE ARTICLES AND BAPP'S
  BEST PRACTICES SOLUTION”
  Vitafoods Europe
  5/23 Virtual Webinar
  "QUALITY CONTROL FOR DIETARY SUPPLEMENTS AT AMAZON.COM”
  Society for Medicinal Plant and Natural Products Research, Germany
  Selected Publications
  Pizzorno, Joe with Levin, Michael D: "FDA's Natural Products cGMPs – a Missed
  Opportunity” IMCJ Vol 6 No 5, Oct/Nov 2007
  Levin, Michael D,” re: Meta-Analysis of Chondroitin for Osteoarthritis of knee and hip”: Letters, Annals of Internal Medicine, Vol 147, No 12, p 884, April 2007
  Markman, Levin et al "Assuring Dietary Supplement quality for cancer patients: An integrated formulary systems approach” Accepted for publication, Am Soc of Clinical Oncologists, April 2013 (Abstract # 114671)
  Markman, Levin et al "Assuring Dietary Supplement quality for cancer patients: An integrated formulary systems approach” Presented at Society of Integrative
  Oncology, October 2013
  Levin, Michael D. "The Current Good Manufacturing Practices and Their Effect on
  Dietary Supplement Quality”, Int Med Clin Jrnl Vol 15, No 5, October,2016, pp 22-24
  Lammersfeld, C, Levin, M.D., Reilly, P, Coyne, J, Birdsall, T., and Markman, M.
  "Assuring Quality of Dietary Supplements for Cancer Patients: An Integrative
  Formulary Systems Approach” Integrative Medicine: A Clinicians Journal, Vol 16,
  No 5, October
  2017, pp 38-44
  Affiliations
  Referee: eCAM (Evidence-based Complementary and Alternative Medicine) – since 2008
  Columnist: The Integrator Blog (www.theintegratorblog.com) 2007 – 2021
  Member, Advisory Board: Cancer Nutrition Centers of America, 2002 – 2014
  Member, Directors Circle: American Botanical Council, 2011 – current
  Member, Board of Directors, Lifespan Laboratories, Inc – 2014 – 2015
  Member, Board of Governors and Advisors, Placencia Healthcare System, Belize –
  2014 to 2017
  Member: Flint Task Force, Integrative Healthcare Policy Consortium, 2016
  Member, United Natural Products Association, 2016-current
  Member, Hemp/CBD Task Force, United Natural Product Association, 2019-current
  Supporting Member and Advisor, American Association of Naturopathic Physicians
  (AANP) – 2019-current
  Invited Observer, NSF International, Joint Committee on Dietary Supplement
  Standards, NSF/ANSI Standard 173 (includes Hemp) 2019-current
  Member, NSF International Standards, Dietary Supplements (ANSI 173 and 455)
  Member, NSF International Standards, OTC Drugs (ANSI 455) – current
  Member, NSF International Standards, Cosmetics (ANSI 455)- current
  Member, NSF International Standards, Ingredient Acceptability (ANSI 173)-2025
  Member, NSF International Standards, Adulterants (ANSI 173) – current
  Chair, NSF International Standards, Irreparably Defective Articles 2022-2023
  Advisor: Associates in Transformational Oncology Management, 2016
  Advisor: Antera Therapeutics, Inc, 2015 – 2017
  Advisor and Director's Circle: American Botanical Council
  2016 – current
  Advisor: Integrative Medicine Consortium, 2017 – current
  Advisor: Council for Federal Cannabis Regulation 2020 – current
  Task Group Leader, NSF International, cGMP Standards Development Sections
  455 and 173; 2022- Current
  Contributing Editor, United States Pharmacopeia, 2022-current
• 
  MICHAEL D. LEVIN
  503-753-3568 (direct)
  12042 SE Sunnyside Road; PMB 585
  Clackamas, OR 97015
  [email protected]
  
• Thanks for Michael Levin and Stephen Lukawski for another Cran-tastic interview on KISC My Health Radio.

You can always tune in to the other KISC My Health Radio shows on https://kiscmyhealth.com and as usual a Special Thanks for Step Change Innovations for sponsoring the KISC My Health Radio Shows https://stepchangego.com
Our newest corporate sponsor is Caldic North America https://caldic.com

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