PLEASE NOTE: THESE SLIDES MAY NOT DISPLAY PROPERLY ONLINE, BUT THEY ARE READABLE IF DOWNLOADED. October 28, 2018 This one-day conference explored the current pharmaceutical pricing landscape by bringing together leaders from the pharmaceutical industry, policymakers, legal practitioners, and scholars to engage in novel, interdisciplinary discussions to better understand current challenges and articulate best practices to address these issues. Participants assessed the current challenges presented in drug pricing policy, from development to delivery, in both the United States and international context. We also explored and articulated best practices to expand access to medicines and worked toward developing a plan for disseminating these practices more widely.

2. USP Standards
Ronald T. Piervincenzi, Ph.D.
Chief Executive Officer, USP
October 24, 2018
Facilitating a fair and
competitive marketplace
and advancing public health

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Standards help promote market entry
 Reduce risk to new market
entry
 Build quality environment
for medicines
 Increase competition
Competition in
marketplace
Quality medicines
& advanced drug
manufacturing
systems
Lowers floor on
quality & leads to
substandard
products

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 USP overview
 Standards and quality
 Research and innovation
 Promoting access
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5. USP overview
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7. Need for standards
 11 Founding members
with a vision
 Legal recognition
 Official compendium
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8. ”
Today: Our mission
To improve global
health through public
standards and related
programs that help
ensure the quality,
safety, and benefit of
medicines and foods.
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9. We work globally
USP site
USP site with
laboratory
USP-US
Rockville, MD
Frederick, MD
Washington, DC
USP-BRAZIL
Sao Paulo
USP-GHANA
Accra
USP-NIGERIA
Lagos
USP-
SWITZERLAND
Basel
USP-ETHIOPIA
Addis Ababa
USP-INDIA
Hyderabad
USP-CHINA
Shanghai
USP-INDONESIA
Jakarta
USP-SINGAPORE
Singapore
USP-PAKISTAN
Islamabad
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10. Global staff presence
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11. Partners in
industry
R&D companies and
generic
manufacturers
Partners in science
With academics,
practitioners
Partners in
government
With regulatory and
health authorities
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Partnerships at the heart of quality

12. USP staff and volunteer experts partner to
develop standards
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13. Standards and quality
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14. Overview
 What is a standard?
 How do standards reduce
risk to manufacturer
market entry?

15. Standards reducing risk at market entry
 USP Standards
– Limit risk for manufacturers by
providing for regulatory (e.g. FDA)
compliance by equipping
manufacturer with:
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Quality
API
Quality
process
Promoting
quality
medicine

16. Practitioner/Patient
Uphold practitioner and
patient confidence in
medication therapy
Industry
Reduce risk to manufacturers in
entering the marketplace
Government
Regulators ensure
quality medicines
reach patients
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Public standards benefit:

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Quality is at each step of USP standards development
Pharmaceuticals Food ingredients Healthcare quality
Dietary supplements
and herbal medicines
Global public health
Suppliers
Manufacturers
Wholesale/
Distributors
Pharmacies/
Hospitals
Healthcare
Patients
Public view
Supply
chain view

18. USP Standards
Documentary standard
Provides information and methods
needed to assess quality
Reference standard
A benchmark against which to
compare tested material
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19. Documentary standards
 Monographs
– Name of substance and definition
– Analytical procedures and criteria needed
to ensure strength, quality and purity of
drug
 General chapters
– Broadly applicable procedures and
methods
– Water content, residue on ignition, etc.
 General notices
– Interpretation and application of standards,
tests and other specifications of the USP-
NF
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20. Reference standards
Characterized physical specimens used
in tandem with USP monographs to
demonstrate identity, strength, quality,
and purity of a product
 Active pharmaceutical ingredient (API)
– Testing of raw material (drug ingredient)
 Excipient
– Component of finished drug product other than
API added during formulation for a specific
purpose like stabilizing an API
 Impurities
– Controlling of related organization impurities in
drug product and API
– USP helps identify and test impurities to promote
quality
Build confidence in quality active
ingredients and excipients for drug
entry to marketplace
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Developing standards
Parallel tracks to create integrated
documentary and physical
standards for simultaneous use

22. Standards reducing risk at market entry
 Facilitates manufacturer entry to
marketplace with benchmark for quality
 Ensure the quality of products across
all monographs
– Example: Dissolution testing ensures
uniform active ingredient in entire batch
– Identification of impurities
 Speed to manufacturer entry is faster
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23. Broad applicability
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USP standards
are used in over
140 countries

24. Research and innovation
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25. USP Research to advance quality standards
 Up to date
 Quality institute
 Emerging technologies

26. Up to date: Ongoing revisions
 Updating quality standards:
– Revising standards to reflect “state of
the industry” practices
 Identify gaps:
– Ensuring components are clear,
complete and correct
– Removing unnecessary tests
– Providing appropriate selection of
reference standards
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27. USP Quality Institute research
 Aims to generate a rigorous evidence
base to advance medicines quality by :
– Informing discussions among
stakeholders
– Informing public policy & regulatory
reforms
– Providing rationale for investments in
quality medicines
– Partnering with leading academic
institutions on research fellowships
• Current research: How poor-quality
medicines contribute to AMR
• Next up: Research on excipients quality
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28. Emerging technology
 Exploring emerging technologies
 Defining quality in new paradigms
 Examples:
– Pharmaceutical continuous
manufacturing
– qNMR and digital reference standards
– 3-D printing
– Next generation biologics and cell/gene
therapy
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29. Promoting access
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30.  Public standards support manufacturer
entry to marketplace
 Building capabilities across the globe
because manufacturing system is
global
USP promotes quality medication access
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Building capabilities across the globe
USP Education-
Hyderabad
Training Institute
USP APEC Center
of Excellence
USP Advocacy-
Opioid Roundtable

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USP-Global Public Health
Access to quality medicines to protect patients and improve outcomes
34+ countries supported to strengthen health systems through improved quality assurance and
regulatory systems
28+ manufacturers supported to receive SRA approval or WHO pre-qualification
4,000+ regulatory and manufacturing professionals trained
Strengthening regulatory systems to
ensure access to quality medicines
Providing technical assistance for:
 Dossier evaluation
 Market authorization
 Inspections
 Post-marketing surveillance
 Testing and quality control of medical products
Supporting manufacturers to increase
the supply of quality medicines
Provide end-to-end support to
manufacturers to:
 Implement strong quality systems
 Identify and address corrective actions
 File dossiers for product approval
 Prepare for inspections

33.  Coalition of regulators, non-
governmental organization, academics
and other key stakeholder groups
 Sharing evidence, generating human
stories
 Call to Action
World wide advocacy
#MedsWeCanTrust campaign
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34.  Facilitate a fair and
competitive marketplace
 Advance public health
 Reduce risk to manufacturer
entry to drug marketplace
USP standards:
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35. @RonPiervincenzi | www.usp.org | @USPharmacopeia