Prescription/Non-Prescription
Stakeholder Forum
Meeting 7
Webinar
June 3, 2015
Chemical Medicines
Jon Clark
Vice President, Chemical Medicines
June 3, 2015
2015-2020 Related Resolutions

Resolution 1 - Collaboration with the U.S. FDA:
USP to increase collaboration with the FDA
– USP will increase communication and collaboration with
the U.S. Food and Drug Administration (FDA) to promote
alignment with FDA’s regulatory and scientific policies
from the inception of the standards planning and
development process. USP will work with FDA, industry,
and other stakeholders throughout the process to
increase understanding of the regulatory impact of such
proposals.
3
2015-2020 Related Resolutions

Resolution 2 - USP-NF Monograph Modernization:
USP to meet the needs of FDA, industry, and other
stakeholders for modern monographs within USPNF
– USP will work to eliminate the existing backlog of
monographs in need of modernization and proactively
evaluate and update monographs to maintain their
relevance given scientific advances and evolving
manufacturing and regulatory approaches. USP will work
with industry and FDA to explore new strategies for
sharing analytical methods and specifications needed to
modernize monographs.
4
Input from Convention Meeting

USP needs to maintain contact with the stakeholders and
be sure there continues to be mutual benefit to the effort.
Engagement with USP has improved.

USP should be transparent about which modernizations
are from internal lab work and which are donated and
provide validation details for internal work.

Glad to see that USP is increasing identity test specificities
using orthogonal methods.

Utilize Expert Panels to update monographs
5
Input from Convention Meeting

USP needs to provide a faster platform for
stakeholders to communicate with Staff and review
submissions.

International Pharmacopoeias extensively and
widely use USP-NF and would like to participate in
the USP Up-to-Date effort.
6
Input from Convention Meeting

FDA Engagement Networking Luncheon
– Engage better by training, ensuring frequent staff
interaction, and providing venues for engage of scientific
interaction
– Opportunities for engagement include USP-NF Up to
Date, analysis of how jointly to prevent drug shortages
through improvements in quality, USP participation in
FDA's CERSIs, industry consortia, education of global
stakeholders on manufacturing standards, drug/device
combinations, harmonization, supplementation of FDA
guidelines
– Industry, other pharmacopoeias are important partners
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Elected Chairs

Chemical Medicines 1
 Richard A. Blessing, M.S., Senior Scientist III, AbbVie
Incorporated

Chemical Medicines 2
 Ernest Parente, Ph.D., Senior Principal Analytical
Chemist, Mallinckrodt Pharmaceuticals

Chemical Medicines 3
 Bernard A. Olsen, Ph.D., Consultant, Olsen
Pharmaceutical Consulting, LLC
Elected Chairs

Chemical Medicines 4
 Kim C. Huynh-Ba, M.S., Principal Consultant,
BARDA/PATH

Chemical Medicines 5
 Amy J. Karren, B.Sc., Microbiologist, W.L. Gore and
Associates

Chemical Medicines 6
 David A. Fay, Ph.D., Technical Fellow, Mallinckrodt
Pharmaceuticals
Strategy Summary

Chemical Medicines 1 focus:
– Antibiotic, antiviral, and antimicrobial drug substance and
drug product monographs

Chemical Medicines 2 focus:
– Cardiovascular, cough, cold and analgesics drug products
and drug product monographs

Chemical Medicines 3 focus:
– Gastrointestinal, renal, endocrine, ophthalmology,
oncology, dermatology, and veterinary drug products and
drug product monographs
10
Strategy Summary

Chemical Medicines 4 focus:
– Psychiatric, psychoactive, neuromuscular, aerosol, and
imaging agent drug substance and drug product
monographs

Chemical Medicines 5 focus:
– Pulmonary and steroids drug substance and drug product
monographs

Chemical Medicines 6 focus:
– Over-the-counter drug substance and drug product
monographs
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FDA Engagement Strategy Summary
 Evolve
Government Liaison program
 Evaluate
staff functions that manage interactions
 Develop
and extend communication program
 Maximize
engagement through identification of
collaborative opportunities
 Create
information exchange opportunities through
training
12
Opportunities for Stakeholder Engagement

Stakeholder Forums
– PNP Stakeholder Forums and Project Teams
– Veterinary Drugs Stakeholder Forums
– http://www.usp.org/meetings-courses/stakeholder-forums

Workshops
– http://www.usp.org/meetings-courses/workshops

Industry/regulatory consortia and scientific meetings

Convention Committees and other activities Observing
Official EC/EP meetings
– http://www.usp.org/meetingscourses/calendar?type%5B%5D=event_expert_committee_meeting

Global Education and Training Program
– https://uspharmacopeia.csod.com/LMS/catalog/Welcome.aspx?tab_p
age_id=-67&tab_id=20000339
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Biologics
Tina S. Morris, Ph.D.
Senior Vice President, Biological Standards
June 3, 2015
2015-2020 Related Resolutions

Resolution 6—Standards For Biological
Medicines
– USP will promote alignment with stakeholders to
develop quality standards for biological medicines,
ensuring that innovation and availability are facilitated
and complemented.
16
Input from Convention Meeting

Biologics Panel at the USP Convention
– Explored the dynamic between the drivers of innovative
therapy approaches, patient access, and assuring that these
new therapies are safe.
– Patient-individualized therapies, coupled with advanced
diagnostic read-outs hold great promises, but demand
paradigm-shifting approaches from manufacturers, regulators,
and standard-setters.
– Recent public health crises like the Ebola outbreak also have
shown the immense power of global collaboration in spurring
the immediate and creative use of scientific, regulatory, and
public health resources.
– USP has a role as a unique scientific convener and can help
enable solution development by providing modern
measurement tools and procedures to underpin the quality of
these modern medicines.
17
Input from Convention Meeting

Biologics Networking Luncheon
– The Biologics Networking luncheon carried forward some of the
themes discussed at the biologics panel.
– The majority of the tables raised the formidable issue of cost of
biologics but recognized that this is an area that USP may not be
able to address; however, the participants thought that USP should
be mindful of activities that might add to the cost of a product (e.g.,
standards that are unnecessarily complex).
– Participants thought that if USP supported biosimilars it may be
helpful to decrease cost and ultimately increase access to new
biologics.
– There were also discussions about the composition of an
“appropriate” pharmacopeial standard.
– Some additional specific suggestions for USP to undertake included:
development of new guidance for stability testing, cold chain
management, biologics packaging, expanding outreach and
education/training, and striking the right balance in monographs
assuring quality and safety without being overly complex.
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Elected Chairs

B&B Monographs–Complex Biologics Expert
Committee


Edward K. Chess, Ph.D., Principal Consultant,
BioPhia Consulting, Inc.
B&B Monographs–Peptides Expert Committee

Michael R. De Felippis, Ph.D., Senior Research
Fellow, Eli Lilly and Company
Elected Chairs

B&B Monographs–Proteins Expert Committee


Michael G. Mulkerrin, Ph.D., Head of CMC, ADC
Therapeutics
General Chapters–Biological Analysis Expert
Committee

Wesley E. Workman, Ph.D., Associate Research
Fellow, Pfizer, Inc.
Strategy Summary
Continue to develop and improve USP’s portfolio of quality
standards for biological medicines:
 Continue
to modernize standards for legacy products
 Continue
to eliminate animal-based bioassays
 Grow
portfolio of ancillary and raw materials standards
 Grow
portfolio of procedural and system suitability tools for the
analysis of all biologics
 Development
new standards for biologics based on broad
understanding of public health, regulatory, and technology
impact
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Opportunities for Stakeholder Engagement

Applicable Stakeholder Forums and meetings

Observing EC/EP meetings

Upcoming topic workshops:
– 6th Workshop on the
Characterization of Heparin Products, August 6–7, 2015, Saõ Paulo,
Brazil
– 1st Workshop on Glycoprotein and Glycan Analysis, August 25–26,
2015, USP Headquarters
– 2nd Workshop on Synthetic Therapeutic Peptides –Regulations,
Standards and Quality, November 2-3, 2015, USP Headquarters
– http://www.usp.org/meetings-courses/workshops
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Dietary Supplements and
Herbal Medicines
Gabriel Giancaspro, Ph.D.
VP, Foods, Dietary Supplements and Herbal Medicines
June 3, 2015
2015-2020 Related Resolutions

Resolution 9—Quality Standards For Dietary
Ingredients And Dietary Supplements
– USP will expand development of standards for dietary
ingredients and dietary supplements, focusing on new
and high-impact areas, and engage with stakeholders to
promote the awareness and adoption of it standards.
25
Discussion topics at the 2015 Convention
Meeting

Dietary Supplement Standard Setting

Stakeholder Engagement

Research & Innovation

Verification Program
26
Input from Convention Meeting
– USP needs to educate public and medical professionals to
raise awareness regarding standards. Clarify the ways industry
could use USP standards ("USP" and USP-verified).
– The prioritization criteria for standard-setting activities is
appropriate.
– Define the stakeholders for the USP activities and engage
them.
– Work with the industry to develop new performance testing
methods, especially for new dosage forms. e.g. orally
disintegrating tablets.
– The naming of novel dosage forms and performance testing for
“gummies” is a priority
– DSVP can be used by the FDA to identify companies that are
low risk.
– Partner/educate the FDA DS inspectors in the program benefits
to gain better compliance.
27
Elected Chairs

Dietary Supplements and Herbal Medicines Expert
Committee
 Robin J. Marles, B.Sc., M.Sc., Ph.D., Senior Scientific
Advisor, Food Directorate, Health Canada

Dietary Supplements Non-Botanicals Expert
Committee
 Dennis K. J. Gorecki, B.S.P., P,h.D., Professor
Emeritus of Pharmacy, University of Saskatchewan
Strategy Summary

Optimize and grow portfolio of MG/ RS production,
focusing on key growth areas

Proactively engage with regulators

Pursue stakeholder partnerships

Grassroots engagement strategy to drive adoption
through consumer/advocacy groups
29
Opportunities for Stakeholder Engagement

Dietary Supplements Stakeholder Forum

Observing EC/EP meetings

Additional opportunities
– Creation DS Adulteration Database based on Food Fraud
DB
– Standards for New Dietary Ingredients, including
Probiotics
– Adulteration of Dietary Supplements with Drugs Expert
Panel
– Development of standards for new dosage forms
– Application of DNA methods to the analysis of Dietary
Ingredients
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Healthcare Quality Standards
Shawn C. Becker, M.S., B.S.N.
Senior Director, Healthcare Quality Standards
June 3, 2015
2015-2020 Related Resolutions

Resolution 7—Quality Standards For Compounded
Medicines
– USP will continue working with stakeholders to develop and maintain
practice and quality standards for sterile and non-sterile
compounding. USP will increase the availability of its compounding
standards, expand stakeholder engagement and education, and
promote adoption of these standards by compounding professionals
and regulatory authorities.
Resolution 8—Healthcare Quality Standards
– USP will collaborate with stakeholders to develop, strengthen, revise,
and promote adoption of healthcare quality standards that address
quality and safety related to the use of medications and that are of
value to patients and practitioners.
33
Input from Convention Meeting

Networking luncheon at the Convention:
– Considerable interest in compounding standards
– Need for education and training for all compounding,
nomenclature, and healthcare quality standards
especially in the healthcare schools (pharmacy, medicine,
nursing, and technician schools)
– USP should invest in efforts aimed at addressing health
literacy issues; actively partnering with other stakeholder
member associations
– Standards for CPOE systems, screen views and common
order sets are needed
34
Elected Chairs

Compounding Expert Committee
 Gigi Davidson, R.Ph., DICVP, Director, Clinical
Pharmacy Services, North Carolina State University
College of Veterinary Medicine

Nomenclature and Labeling Expert Committee
 Stephanie Crawford, Ph.D., Associate Professor and
Associate Department Head, University of Illinois

Healthcare Quality Expert Committee
 Dennis E. Doherty, M.D., Chairman of Professor of
Medicine–Tenured, University of Kentucky College of
Medicine
Strategy Summary

Expand compounding impact and reach
– Increase partnerships with state boards of pharmacy to enable adoption of
USP’s compounding standards
– Expand opportunities for training and education
– Enhance the Compounding Compendium through increased development of
compounding preparation monographs and revisions to general chapters

Expand the USP Medicare Model Guideline Database into emerging
health informatics applications
– National healthcare payment reform is expanding and requiring
implementation of healthcare quality tools, especially those electronically
aligned with US marketed drugs

Enhance global electronic integration of USP Dictionary’s chemical
information, and expand the database
– Tools are needed to efficiently manage the volume of chemical information
and allow advanced search strategies internally at USP and for stakeholders
needs and current users of the USP Dictionary.
36
Opportunities for Stakeholder Engagement

Observe during Compounding, Nomenclature, and
Healthcare Quality Expert Committee meetings

Applicable Stakeholder Forums and Workshops

Apply to participate on Expert Panels. Possible efforts
include:
–
–
–
–
Health Literacy
Allergy/Intolerance Classification
Safe Medication Use in Electronic Environments
Parenteral Nutrition Safety
37
2015-2020
CoE Process Updates
Scott Kuzner, Ph.D., Manager, COE Support
June 3, 2015
Work Plans Audience and Purpose

Audience
– Public (FDA, industry, healthcare practitioners
stakeholders), volunteers, USP staff

Purposes
–
–
–
–
State EC’s charge and Key issues they plan to address
Compile a running, cumulative list of EC’s ballot results
Offer preview and updates of EC activities
Provide an opportunity for stakeholders input
40
Work Plan Proposal

Content
–
–
–
–
–
–
–
Roster: EC members and USP staff contacts
EC scope: 1-2 paragraphs of EC’s charge and focus
Key issues: special projects, hot topics, or initiatives
Subgroups: EPs, Subcommittees, Advisory Groups
Ballot results, including deferrals and cancellation info
EC meeting updates: Links to EC executive summaries
List of upcoming official meetings
*Outside of Work Plan: Create searchable function to identify EC responsible for a standard
41
42
43
Ballot Results: Approvals, Deferrals,
Cancellations
44
Timeline

July 2015
– Post EC rosters and general information
– ECs begin introductory discussions at Collaborative Group breakouts


July- ~October 2015: Evaluate Work Plans at first F2F
meetings; rolling Web posting after each meeting and open
continuous dialog
December 2015: Publish ballot results from 1S

April 2016: Publish final Work Plans

Ongoing:
– Review Work Plans at each official meeting; create exec. summaries
– Update details at end of each major ballot (3 times per year) or
accelerated revision (up to 6 times per year)
– Submit all updates in monthly posting and communicate update in
Compendial Updates e-blast
45
Training and Onboarding

July 20-21, 2015: EC Member Training
– Day 1: New members and Chairs
• Overview of Standards-development and USP
• Collaborative Group breakout introductions
• Government Liaisons (both days)
– Day 2: All members and Chairs
• Governance, resolutions, and strategic planning
• Scientific processes
• Stakeholders
• Roles and responsibilities
• Full Collaborative Group breakouts
– Some first F-2-F meetings to follow – see meeting
calendar on USP.org
46
Revisions to Rules and Procedures of the CoE

JS3: Joint Standards-Setting Subcommittee
–
–
–
–

Formed in collaborative group areas
JS3 Chairs and slates voted on by CoE
Representative sampling of R/C lots for RSs
Could be used in other areas
Government Liaisons
– Eligible to participate as an EC member
– If EC member, represent their views, not the agency
– Agreement signed by individual and agency in advance of
selection as an EC member
47
“Pending” Monographs
Jon Clark, M.S.
Vice President, Chemical Medicines
June 3, 2015
Allow Access to Standard Setting to People
Engaged in the FDA Approval Process
Current Situation::
Transition Starting 41(5); Finishing 42(1)
Separate Posting Outside PF:
Post All Monograph Proposals in PF:
• Managing two systems for notice and
comment, PF and Pending Web Page
• “Pending” terminology may be replaced as
process is implemented; Briefing to ID proposals
• Ineffective Rules for Pending; different
from PF
• Normal Process when not ready for USP-NF,
proposal is differed; more than two deferrals, need
another PF proposal
Other Challenges:
• “Pending” Terminology can be difficult
to learn and confusing
• Special Process used only when FDA application
holder needs different criteria in monograph, very
late in process
• Lingering Proposals that can be
unpredictable when moving to USP-NF
Clear Rules for PF:
• Lack of Transparency for revision
processes supporting late arriving
revisions linked to FDA approval
• Application Filed at FDA; or DMF referenced
• Bulk RS; delivered to USP
Normal Request for Revision USP-NF Process
50
USP Websites
Changes to Pending Monographs Program
http://www.usp.org/usp-nf/pending-monographs/changes-pending-monographs-program
Pending Monograph Guideline
http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/pendingStandards/2015-06-01pending-monograph-guideline.pdf
51