ISPE Canada Affiliate d ff l
Presentation
Ottawa, Canada Monday 21 September 2015
Monday, 21 September 2015
John Bournas
President & CEO
1
Agenda
•
•
•
•
•
Background
Organizational developments
Organizational developments Strategic Plan 2016‐2019
New Drug Shortages Gap Analysis Tool g
g
p
y
Upcoming Conferences
2
Background 3
4
5
New Senior ISPE Leadership
p
John Bournas h
ISPE President & CEO Former CEO/Executive Director, World Federation of ,
Hemophilia
Senior Director, International, American College of Cardiology Senior Director, Cardinal Health
Senior Director, Cardinal Health Diplomat 6
Biogen Idec and Sobi to donate 1 billion international
units of clotting factor to support treatment of hemophilia
in developing world – May 2014
7
• Why I came to ISPE
Why I came to ISPE
“We
We owe patients worldwide a sense of security by meeting their
expectations for a reliable and continuous supply of the
medications that are so important to them and their families.
Accordingly when members of the pharmaceutical industry
Accordingly,
discover and put to work the valuable insights included in the
Drug Shortages Plan, particularly those promising to strengthen
the integrity of the supply chain and those describing how to
place a greater emphasis on end‐to‐end quality, a real difference
patients.”
can be made in the lives off p
8
• What you can expect from me
What you can expect from me
‐
‐
‐
‐
‐
Attentive to your interests
Attentive
to your interests
Continuous innovation management
Prudent fiscal decisions
Prudent fiscal decisions
Best practice association skills
Strong interest in Globalization and Emerging g
g g
Markets
‐ Active outreach and networking with Global Reg lator agencies
Regulatory agencies
9
Organizational developments
g
p
10
New Senior ISPE Leadership
p
Susan Krys
Shane Osborne
Anna Maria di Giorgio
11
PE M
PE Magazine i
Adding more human interest stories
I
Increasing coverage of i
f
ISPE events around the world
Profiling YPs
Lightening overall look
Lightening overall look and feel PE Magazine
PE Magazine PE M
PE Magazine: Looking ahead
i
L ki
h d
2016
Complete overhaul • New design
N d i
• New content
• Global collaborators
• Global coverage
• Weekly online news, webinars, videos
New Senior ISPE Leadership
p
Maria Robertson Meredith Ellison New Global Regulatory Affairs Lead to be announced this week ! 15
ISP C Office
ISPE DC Office
•
7200 Wisconsin Ave / Suite 305
7200 Wisconsin Ave / Suite 305 •
3 minute walk to Bethesda Metro Station
•
15 minutes to FDA
•
25 minutes to DCA / 35 minutes IAD / 45 minutes to BWI •
Conference room available to Chapters, Affiliates & Members ISPE DC Office
ISPE DC Office ISPE Training Institute
Tampa, Florida
l d
• Regular
Regular fixture offered fixture offered
for Training purposes
• 2,200 sq
,
q feet of training g
space
p y 50 • Max occupancy –
attendees in classroom style
• 42 courses to be offered during 2016
18
ISPE Tampa Training Institute
ISPE Tampa Training Institute
19
2016 – 2019 ISPE Strategic Plan 20
Stakeholder Input
Stakeholder Input
• Input
Input received from 97 total individuals received from 97 total individuals
through surveys, focus groups and interviews
– 38 Affiliate/Chapter Leaders 38 Affiliate/Chapter Leaders
– 10 Knowledge Network Leaders
– 33 ISPE Staff and Advisors 33 ISPE Staff and Advisors
– 16 Industry Thought Leaders
21
Purpose Statement
Purpose Statement
ISPE delivers technical and
operational solutions to support our
Members across the global
pharmaceutical and biopharmaceutical
industry in the manufacture of quality
medicines for patients
22
23
24
New Drug Shortage Gap Analysis Tool 25
ISPE is Focused On Preventing Drug Shortages
2012
2013
2014
2015
• ISPE Drug Shortage Team
Shortage Team formed
• Survey developed
• Results shared across industry
across industry and with regulators
• Drug Shortage P
Prevention ti
Plan developed
• Developing Tools and
and Implementation
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
ISPE and the Drug Shortages g
g
Prevention Initiative – Our Vision
ISPE is the recognized global leader in the identification and delivery of programs and tools for assuring the continuous availability of quality pharmaceuticals to patients.
availability of quality pharmaceuticals to patients. Through its community of experts, ISPE provides education, guidance and tools which enable manufacturing and compliance
guidance and tools, which enable manufacturing and compliance excellence through the product life cycle.
In doing this, ISPE is contributing to Drug Shortages prevention. Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
Drug Shortages in Canada
Drug Shortages in Canada
“Drug shortages and discontinuations are an immediate,
pressing challenge to patient safety in Canada. Under the
present voluntary reporting system, Canadians and those
responsible for the provision of their health care are not being
adequately informed of drug shortages and discontinuations,
and thus are not able to make well-informed, timely
mitigation decisions”
egu at o s Amending
e d g the
t e Food
ood and
a d Drug
ug Regulations
egu at o s
Regulations
(Shortages and Discontinuation of Sale of Drugs) Health
Canada June 2015
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
28
Drug Shortages in US
ug S o tages US
Shortages of drugs and biologics pose a Shortages
of drugs and biologics pose a
significant public health threat, delaying, and in some cases even denying critically
and in some cases even denying, critically needed care for patients. Preventing drug shortages remains a top priority for FDA
shortages remains a top priority for FDA.
Strategic
g Plan for Preventing
g and Mitigating
g
g Drug
g Shortages,
g ,
FDA, 2013
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
Corporate Culture
Management responsibilities
‘I
ti
’ tto promote
t and
d
‘Incentives’
sustain quality and safety
Building Capacity
Improving the scientific
and technical knowledge
and capabilities of
individuals and
organisations
Communication
with Authorities
Facilitating Agencystakeholder interactions
Leveraging communication
mechanisms to foster
better interactions
Crisis management and
communications plan
Culture of risk management
across supply chain with
common language and
framework
ISPE Drug Shortages
Shortages Prevention Plan
Business Continuity
Planning
Risk based approach for
manufacturing warning
signs and mitigation
strategies
Contingencies and
red ndancies identified for
redundancies
rapid supply restoration
Robust Quality
System
Quality function integrated
into supply chain
management
‘Lessons Learned’ (CAPA),
especially following an
interruption
ICH Q9 integrated across
supply chain
Metrics
P f
Performance
indicators
i di t
(leading)
Supply chain reliability and
resilience indicators
Quality measures
Culture measures
ISPE’s Drug Shortages Initiative Phase I. Survey – 2012 ‐ 2013
Phase II. Drug Shortage P
Prevention Plan ‐
ti Pl
2014
Phase III…..
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
ISPE’s Drug Shortages Initiative Phase 3:
Awareness, Action, Advancement
Assisting Members with Preparedness Assessment Gap Analysis and Remediation
Assessment, Gap Analysis and Remediation Guidance
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
ISPE Drug Shortage Assessment and g
g
Prevention Tool
Purpose
• Take
Take drug shortages prevention from theory drug shortages prevention from theory
to practice
• An
An easy‐to‐use tool for self assessment and continual easy to use tool for self assessment and continual
improvement
• Help
Help industry develop strategies and practices industry develop strategies and practices
for each of the DSPP’s six dimensions
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
ISPE Drug Shortage Assessment and Prevention Tool
Framework
• Six sections corresponding to DSPP six dimensions
• Each section incudes
h
– A summary of the desired state
– Gap assessment questions
Gap assessment questions
• Globally applicable
– Initial focus on US and EU Initial focus on US and EU
– Living document, to be updated
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
ISPE Drug Shortage Assessment and Prevention Tool
How it will be used
• By industry to
– improve robustness of product supply chain
– potentially
potentially satisfy regulator questions regarding satisfy regulator questions regarding
preparedness to prevent or mitigate drug shortages
• Supported by ISPE training (webinars, conference sessions, eLearning) on the use of the tool
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
ISPE’s Drug Shortages Initiative Phase 3:
Awareness, Action, Advancement:
,
,
ISPE’s Good Practice Tool
How we are • Supporting patients
• Assisting Members
• Reducing shortages
with
Preparedness Assessment, Gap Analysis
and Remediation best practices
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
2015: Help the Industry Ensure Continuous Availability of Supplies
Awareness
Action
• Leverage Affiliates & Chapters for
local language & regulator
awareness
• Global and local workshops &
conferences
• 3rd party collaborations
• Continuing support to EMA and
Association initiatives
• Industry and Regulator training
• Action on DSPP
recommendations
•A
Assisting
i ti
Industry
I d t
with gap analysis
Advancement
Phase I
Phase II
• Linkage to Metrics
• New association partnerships
• Global regulatory liaison
Phase III
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
The ISPE Gap Assessment Tool
Enables a company (or a regulator) to assess their preparedness for preventing or managing a supply disruption across the six dimensions AND for the product portfolio
across the six dimensions AND for the product portfolio
Is product
availability at
risk?
Current State
Gap Assessment
Maturity Assessment
Desired State
As defined by contributions and case studies from members (Industry and Regulators) (Industry and Regulators)
globally Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
For Each of the 6 Dimensions
How far are you from the desired state?
Capability Building
Capability Building
Desired State
Maturity Level (1‐5)
References to supporting documentation
Comments
Drug Shortage Prevention Control framework
Is a shortage prevention control framework in place lf
ki l
for each product in the supply chain?
A well
A
well‐developed
developed
definition of potential drug shortage within the organisation and everyone in the entire supply chain
in the entire supply chain is aware of this definition.
Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
Next Steps
Next Steps
•
•
ISPE’s membership world‐wide remains committed to support patients through the reliable supply of high quality medicines.
Implementation is ‘business
Implementation is business as usual
as usual’ for ISPE members:
for ISPE members:
– 2 or 3 telecons every week with some 50 members engaged
– Conference sessions, collaborations with other groups in Europe and the USA
•
The ISPE Good Practice Tool is a first ‐ a unique contribution to the prevention of medicine shortages
– Assists all stakeholders to assess their corporate systems and product risks and embark upon remediation and continual improvement
upon remediation and continual improvement
– Globally applicable
– Will be launched on November 9th and made freely available to all ISPE members
•
Complemented by comprehensive and wide‐ranging offering of training that will support corporations, senior managers and production team leaders, and all those who regulate the production of medicines. Copyright © 2015 International Society for Pharmaceutical Engineering. All rights reserved.
Upcoming Conferences 41
Expectations into Execution:
p
Developing the Lifecycle Approach
p g
y
pp
Take Your Knowledge of FDA’s Process Validation Guidance to the Next Level!
g
y and industry
y leaders to improve
p
your
y
Work with regulatory
company’s compliance, quality and supply reliability
through the application of PV concepts
Ask specific
f questions, benchmark with other professionals
f
and practice
application of compliant approaches
http://www.ispe.org/2015-Process-Validation-Conference
Co-Sponsored by:
Annual Meeting 2015 Facts
Annual Meeting 2015 Facts
8 – 11 November Philadelphia Marriott Downtown
New Paradigms for Manufacturing Excellence
5 Tracks + Innovation Showcase Sessions
70 Education Sessions
O
Opening General Session, Featured Speakers i G
lS i
dS
k
and Panels
• 3 manufacturing facilities to tour
3 manufacturing facilities to tour
• Tuesday Night private party for delegates at Reading Terminal Market with a member band playing!
•
•
•
•
•
•
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Annual Meeting 2015 | Exhibit Hall
g
|
• 225
225 Exhibit Spaces: 197 table tops Exhibit Spaces: 197 table tops
28 booths
• Exhibit Hall is 5,000+ square feet
All 10x10 booth space is sold out 10x10 booth space is sold out
• All
Table tops available
• 96 exhibiting companies already contracted
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Education Tracks
Education Tracks
End‐to‐End Supply Chain Management – Noreen Mallabar: Constitution of Clinical Trials: Forming a More Perfect Union among Innovation, Regulation, Clinical Sites and Patients
Product Development and Production Systems – Steve Miller:
Next Generation Pharmaceutical Product Development and Production: Innovative Solutions & Next Generation Pharmaceutical Product Development and Production: Innovative Solutions &
Emerging Trends in Continuous Processing, Single Use Technology, Capacity Analysis and Antibody Drug Conjugates
Regulatory Compliance and Quality Systems – Eric Thostesen:
Enhancing Quality and Regulatory Processes through Science and Risk Based Approaches
Facilities and Equipment – Michelle Gonzalez:
The Best of Design, Construction, and Technology: Setting the Stage for Quality Pharmaceutical Manufacturing
Information Systems – Mike Rutherford:
Pragmatic Approaches to Data Integrity throughout the Lifecycle: From Clinical Trials through Track & Trace to Managing Mobile and Cloud‐Based Information
Innovation Showcases
Innovation Showcases
• New
New sessions featuring individual presentations sessions featuring individual presentations
focused on innovative  strategies
g
 operations  facilities  processes
 equipment
Keynote
y
Speakers
p
John G. Cox
Executive Vice President
Pharmaceutical Operations
gy
and Technology
Biogen
Kathryn Wengel
Vice President
Supply Chain
Johnson & Johnson
S
See you in Philadelphia!
i Phil d l hi !
• What I ask you to consider…
What I ask you to consider
In 1965, Marshall McLuhan predicted world connectivity…
II would ask you as our Volunteers to be our would ask you as our Volunteers to be our
Connectors, Innovators and Society Ambassadors. Ambassadors.
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Merci / Thank you !
Merci / Thank you ! 51
ISPE Board
Andrew D. Skibo Chair
Regional VP, Biologics‐Supply
Medimmune/AstraZeneca
Joseph C. Famulare Vice Chair
VP, Global Compliance & External Collaboration, Pharma Technical Quality, Collaboration,
Pharma Technical Quality,
Genentech/Roche
Michael A. Arnold, R.Ph.
Treasurer
Sr. Dir., Strategic Partnerships, Invest Prods
Invest. Prods. Pfizer Global Clinical Supplies
Timothy P. Howard, PE, CPIP
Secretary
VP, Global Operations
Commissioning Agents, Inc.
Damian J. Greene
Past Chair
Global Network Strategy Leader, Zoetis
oetis
Joanne R. Barrick, R.Ph.
,
Advisor, Global Validation
Eli Lilly & Co.
Jennifer Lauria Clark, CPIP
SE Mgr Technical Services
Commissioning Agents, Inc.
Jeffrey A. Biskup, P.E.
y
p,
President and CEO
CRB Consulting Engineers, Inc.
Mark W. Fitch
Mark
W. Fitch
Retired
Britt James Petty, Sr.
Dir. Of Global Mfg Strategies & P
Program Mgmt
M
Biogen Idec
James A. Breen, Jr.
,
VP Worldwide Eng‐Technical Ops
Johnson & Johnson (JJSC)
Thomas B. Hartman
VP, GMP Operations
GlaxoSmithKline
Christopher J. Reid
I
Integrity Solutions
i S l i
Robert E. Matje, CPIP
Sr. Director, Engineering
Endo/Qualitest Pharmaceuticals
Frances M. Zipp
President
L h
Lachman
C
Consultant Services, Inc.
l
S i
I
(formerly EVP TEVA Pharmacuticals USA)
52