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AMERICAN PHARMA OUTSOURCING SUMMIT 2018
OCTOBER 2-3, 2018
CROWNE PLAZA HOTEL PHILADELPHIA • CHERRY HILL, NJ
posummit.com
+1-416-298-7005
TOMORROW’S CONNECTION TODAY
Driving business performance through process and technological innovation
PROGRAM
American Pharma Outsourcing Summit 2018 Program • Page 1
DELEGATE REGISTRATION AND LIGHT BREAKFAST
CHAIR’S WELCOME AND OPENING REMARKS
STEVE COOK
Head, Global Supply Chain Strategy and Biologics Supply Chain
PLENARY MANAGING PRODUCT SUPPLY RISK IN YOUR OUTSOURCING STRATEGY
• What are the greatest challenges most organizations need to overcome to be successful at outsourcing?
• Seeing outsourcing as a critical node in your end-to-end supply chain
• Strengthening your supply operations with novel and effective partnerships
• Developing innovative partnerships with CMOs to build capacity reservations
• Creating mutually beneficial contracts for establishing flex capacity
• Utilizing 70-80% internal capacity while outsourcing 20-30%
• What are the benefits to supply chain risk mitigation?
• Creating a contract that allows time to flex capacity up or down based on business requirements
• Sourcing reliable partners that can deliver a high-quality stable supply the right cost
6:45 am – 7:45 am
7:45 am – 7:50 am
8:25 am – 9:00 am
PROGRAM DAY ONE
JONATHAN ADAR
VP and Head, Third-Party Operations - Americas
KEYNOTE THE KEYS TO SUCCESSFUL THIRD-PARTY OPERATIONS MANAGEMENT
• What are the keys to successful externalization of supply operations?
• Establishing consistent programs and techniques for improving supplier management
• Unlocking opportunities for cost benefits, shortened timelines and technical expertise
• Case study: Examining examples of outsourcing projects at Teva
7:50 am – 8:25 am
Sponsored By:
*JOIN US FOR THE PRE-EVENT HAPPY HOUR ON OCTOBER 1 AT 6:00 PM – 7:00 PM
MARK FROMHOLD, PH.D.
Director, Biologics Outsourcing
EXTERNAL MANUFACTURING CHAIR EXTERNAL QUALITY CHAIR SUPPLY CHAIN MANAGEMENT
THIERRY BILBAULT, PH.D.
Head, Technical Operations
JAIME SANTANA
Director, Global Quality
Compliance
American Pharma Outsourcing Summit 2018 Program • Page 2
9:40 am – 11:20 am
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS (100 MIN.)
11:25 am – 12:00 pm
9:00 am – 9:35 am
PLENARY WHAT'S NEEDED TO ADVANCE THE SUPPLY CHAIN?
• Key opportunities to your advance supply chain strategy over the next 10 years
• Examining industry trends and drivers, and their impact on internal and external product supply
• Restructuring and rethinking your distribution and channel strategy
• Building a patient-centric supply chain
• Being open-minded to outside-the-box cross-industry thinking
KEVIN COOK
VP, Head of Supply Chain, Demand Planning and Customer Service
EXTERNAL QUALITY DATA INTEGRITY AND DATA GOVERNANCE: BEST
PRACTICES FOR GMP AUDITING AND ASSESSING
OUTSOURCE PARTNERS AND CONTRACTORS
• Examining data integrity expectations and
enforcement practices of the FDA and other
regulatory bodies
• Improving the testing of drug product
intermediates, APIs, excipients and raw materials
critical to product quality
• What are the best QC laboratory control systems
for audit trails?
• Discussing computer system classification,
validation and controls that can be implemented
• Case study: Examining the application of the
Data Integrity Audit Manual in conjunction with
other standards to improve quality
SUPPLY CHAIN MANAGEMENT CREATING A "VIRTUOUS CYCLE" WITH CMOS AND
3PLS THROUGH THE BAYER RELATIONSHIP MODEL:
SHARED GOALS AND COLLABORATIVE APPROACHES
• Providing a snapshot of Brail's political-
economical scenario
• Discussing the impact on infrastructure, its
challenges, and the need for real relationships to
overcome challenges
• Productivity vs. costs: Striving for productivity
and excellence
• Turning suppliers into partners via three key
relationship principles
• Case study: Improving external relationship
management for more reliable product delivery
LUIZ ALBERTO BARBERINI
Operations Manager, External
Manufacturing - Latin America
EXTERNAL MANUFACTURING HOW TO EFFECTIVELY TRANSFER WORK TO A CMO
WHILE RETAINING TOTAL CONTROL AND
OVERSIGHT THROUGHOUT THE CONTRACT LIFE
CYCLE
• Minimizing risk and maximizing the effectiveness
of outsourced activities
• Ensuring your oversight and control are well-
established
• Preparing your organization for a relationship
with contractors:
• Beginning steps
• Technology Transfer
• Contract termination
• Overcoming issues of executing on a contract
• How to best manage difficult situations
• What makes a relationship with a partner
successful?
SUNIL JAIN, PH.D.
Regional Technical Director,
North and Latin America,
External Supply Pharma
JIM FRIES
CEO
JAMES HENDERSON
Associate Consultant, Quality
Assurance
American Pharma Outsourcing Summit 2018 Program • Page 3
12:05 pm – 12:40 pm
WORKSHOP HOW TO PREPARE FOR A SUCCESSFUL
TECHNOLOGY TRANSFER TO A CMO
• Understanding what the CMO's expectations will
be from the sponsor during the tech transfer
process
• Evaluating what to look for in a CMO when you
are outsourcing an injectable product
• Summarizing what information should be
available from the sponsor to prepare for
successful technology transfer
WORKSHOP BEST TOOLS AND TECHNIQUES TO CUT THIRD-
PARTY COMMUNICATION TIME IN HALF TO
EFFECTIVELY MEET COMPLIANCE DEADLINES
• Discussing the benefits of an effective request
management platform for FDA Quality Metrics,
specification updates and more
• Utilizing a metrics dashboard for request
oversight and compliance improvements
• Eliminating missed timelines through a trackable
request system
• Improving processes for document/agreement
transfers, periodic reviews, specification updates
and quality agreements with your manufacturers
and suppliers
• How to collect and view data from your third-
party operations, such as lot acceptance rates,
on-time in-full manufacturing data and
manufacturer capabilities data
WORKSHOP YOUR SUPPLY CHAIN IS NO STRONGER THAN ITS
WEAKEST LINK: IMPROVING PRODUCTIVITY ACROSS
YOUR ENTIRE SUPPLY CHAIN
• Propelling communication and collaboration
with CMOs to a new level
• Leveraging AI and business intelligence to deploy
automated systems to detect abnormal
performance
• Deploying automated management alarms and
escalation systems
• Using emails and text messages to accelerate
response to performance-impacting events
• Creating real-time management dashboards and
alerts, tailored for each role
• Connecting and integrating data across multiple
platforms, such as PLCs, ERPs, QMS, LIMS, etc.
SHAWN CAIN
COO
GREG BRIGHAM
System Development
JAIME VELEZ
Partner
ADAM BURKE
President
American Pharma Outsourcing Summit 2018 Program • Page 4
12:45 pm – 1:45 pm
LUNCH AND LEARN ROUND-TABLE DISCUSSIONS
Benefit from additional learning by joining a moderated round-table discussion on pressing issues in the industry. Choose from:
COMPARATIVE ANALYSIS OF BOTTLE AND CARBOYS
VS. BAGS IN SINGLE-USE MANUFACTURING
MULTI-TIER MAPPING: REALIZING THE VALUE OF
YOUR INVESTMENT IN SUPPLY CHAIN RISK
OPTIMIZING YOUR CONTRACT SUPPLY CHAIN
PARTNERSHIPS: A CPO PERSPECTIVE
ALICE MOLTENI
Director, BioProcess Sales
JON SUNDSTROM
Regional Director, Sales
JEFF BENEDICT
SVP, Global Business
Development
HELPFUL STRATEGIES FOR A SUCCESSFUL
RELATIONSHIP WITH YOUR CDMO
DATA INTEGRITY THROUGHOUT THE ENTIRE
PRODUCT LIFE CYCLE
RICKI A. CHASE, M.S.
Director, Compliance Practice
NAVIGATING THE CRITICAL AND COMPLEX SUPPLY
CHAIN NEEDS OF THE PHARMACEUTICAL INDUSTRY
CHRIS CASSIDY
President, Global Healthcare
Strategy
WES WHEELER
CEO
Seating is limited, so please sign up early. Sessions will start at 12:45 PM and run for one hour. Additional seating will be provided to discuss other topics.
OPERATIONAL EXCELLENCE FOR THE QUALITY
CONTROL LAB OF THE FUTURE: FROM
TRANSFORMATION TO OPERATION
NIGEL SMART, PH.D.
President
60 YEARS OF OUTSOURCING TRENDS: WHAT CAN
PHARMA LEARN FROM OTHER INDUSTRIES?
PATRICK HAFFEY
CEO
CHALLENGES TO MAINTAINING CONSISTENCY OF
VALIDATION PRACTICES FROM THE OPERATING
COMPANY TO A CMO
MICHAEL GATTA
Principal
GARY CARLETON
President, Healthcare Sales
EFFECTIVE AND COMPLIANT CLEANING AND
DISINFECTION PROGRAMS: NAVIGATING
REGULATORY CHANGES
LESLIE L. CURRY
VP, Global Regulatory Affairs
and Technical Consulting
RAY KACZMAREK
President
CHRISTOPHER J. MACKLIN
Partner
American Pharma Outsourcing Summit 2018 Program • Page 5
EXTERNAL MANUFACTURING CRITICAL ATTRIBUTES TO CONSIDER WHEN
CHOOSING AN APPROPRIATE CDMO TO
MANUFACTURE YOUR BIOSIMILAR PRODUCTS
• Understanding the developers’ perspective on
finding the right CDMO
• How do we evaluate the capability and fit of a
potential CDMO?
• What role does CDMO culture and flexibility play
when choosing the right partner?
SUPPLY CHAIN MANAGEMENT ACHIEVING COMPLIANT, COST-COMPETITIVE
MANUFACTURING WITH A SUPPLIER THROUGH
INCREASED COLLABORATION AND RELATIONSHIP
MANAGEMENT
• What should you look for in a supplier or a
contract manufacturing organization?
• Discussing key supplier attributes:
• Quality and EHS compliance
• Continuous Improvement mindset
• Communication and flexibility
• Techniques for converting a non-GMP supplier
with right mindset into a reliable and compliant
cGMP supplier
• Case study: On-boarding a CMO into a supplier
• Planning for support and back-up when
executing a technology transfer
• Helping suppliers plan for future needs, such as
staffing, facilities, technology, etc.
VIMAL GANDHI
Director, Global Biosimilar
Operations and Strategy
1:50 pm – 2:25 pm
EXTERNAL QUALITY ENSURING QUALITY OVERSIGHT IN CONTRACT
MANUFACTURING AND OUTSOURCED ACTIVITIES
• Establishing and sustaining quality culture with
partners in your network
• Ensuring QbD processes are in place for
outsourced activities and raw materials
• Analyzing the performance of contractors and
suppliers: What tools can be applied?
• Rolling out continuous improvement plans to
enhance performance
KEVIN BRODBECK, PH.D.
VP, Pharmaceutical Develop-
ment and Manufacturing
RICKI A. CHASE, M.S.
Director, Compliance Practice
PLENARY HOW TO MANAGE QUALITY GLOBALLY
• Understanding challenges pharmaceutical firms face in achieving quality finished products from contract partners
• What do regulators expect for compliance with established regulations?
• Ensuring proper oversight of production, testing, and distribution at multiple different sites worldwide
• Proven techniques for managing quality and compliance across a complex global supply chain
2:25 pm – 3:00 pm
PRASHANT S. SAVLE, PH.D.
Director, Commercialization
Projects, Global Procurement
American Pharma Outsourcing Summit 2018 Program • Page 6
3:45 pm – 5:05 pm
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS (80 MIN.)
5:10 pm – 5:55 pm
PANEL DISCUSSION CMO/CDMO SELECTION AND MANAGEMENT TECHNIQUES FOR SMALL TO MEDIUM-SIZE COMPANIES
• What are the greatest challenges for companies with specialized processes?
• Important considerations when developing product manufacturing and quality strategies with partners
• Competing with large pharma and biopharma for relationships, cost, and prioritization
• Best practices for contract negotiation with vendors for goal alignment
• How to ensure a successful sponsor-provider relationship
BRIAN MCCOLLUM
VP, Supply Chain
JAMES HENSHILWOOD
Senior Director, Contract
Manufacturing
GEORGE DONATO
SVP, Global Operations
TIMM CROWDER
SVP, Technical Operations
3:05 pm – 3:40 pm
WORKSHOP SELECTING A CDMO WITH THE RIGHT EXPERTISE
FOR SUSTAINED RELEASE AND EXTENDED RELEASE
FORMULATIONS
• Why finding the right partner is vital to the
success of your product
• Achieving the manufacture of complex products
to your exact standard
• Conducting an effective technology transfer
• Delivering responsive project management and
effective, efficient communication
WORKSHOP NAVIGATING THE REGULATORY LANDSCAPE IN
YOUR OUTSOURCED STRATEGY
• Keeping up with the changing regulations in
pharmaceutical outsourcing
• Using cutting-edge compliance and managed
consulting solutions
• What is the EngiLifeSciences 3PO Model, and
how can it help?
• Unraveling the complexity of regulatory
compliance Improving processes for quality
systems
HEIDI J. HOFFMANN, PH.D.
Executive Director, CMC and
Supply Chain
JAYANT APHALE, PH.D.
EVP, Technical Operations
WORKSHOP MANAGING POTENT COMPOUND SAFETY IN AN
OUTSOURCING PARADIGM
• How compound potency and toxicity are
evaluated
• Systematically approaching the safe handling of
research compounds and “unknowns”
• Establishing acceptable limits for worker safety
for APIs and establishing targets for controls
• Conducting quantitative exposure assessments
by developing validated air and surface
monitoring methods and conducting industrial
hygiene air and surface monitoring studies
• Elements of a comprehensive health and safety
program for the safe handling of potent
pharmaceuticals
ALLAN ADER, PH.D.
Managing Director
MYKE SCOGGINS
Process Development Manager GREGORY W. PIERCE
CEO
American Pharma Outsourcing Summit 2018 Program • Page 7
5:55 pm – 6:30 pm
PLENARY DRIVING GROWTH AND PERFORMANCE: CURRENT STATE AND POTENTIAL FUTURES IN THE CDMO LANDSCAPE
• Exploring megatrends, challenges, and opportunities impacting the CDMO industry
• Identifying key drivers and events that will impact the pharma and biopharma industry
• Asking the strategic questions:
• What is driving growth and influencing the industry?
• What is the contract services industry’s ability to meet demand and performance expectations?
• What does increased M&A and consolidation mean for the suppliers and their sponsors?
• Examining legislative and regulatory issues and PBOA priorities for 2019-20
GIL ROTH
Founder and President
CHAIR’S CLOSING REMARKS
NETWORKING DRINKS RECEPTION
6:30 pm – 6:40 pm
6:40 pm – 7:40 pm
MARK FROMHOLD, PH.D.
Director, Biologics Outsourcing
EXTERNAL MANUFACTURING CHAIR EXTERNAL QUALITY CHAIR SUPPLY CHAIN MANAGEMENT
Sponsored By:
THIERRY BILBAULT, PH.D.
Head, Technical Operations
JAIME SANTANA
Director, Global Quality
Compliance
American Pharma Outsourcing Summit 2018 Program • Page 8
KEYNOTE CHANGING THE ORGANIZATIONAL MINDSET FROM A FULLY IN-SOURCE TO A PARTIAL OUTSOURCE MODEL FOR BIOLOGICS PRODUCTION
• Developing a holistic strategy for increasing outsourcing activity for drug product and biologics production
• Training and onboarding internal staff to make outsourcing a core function
• Examining the selection of partners for technology, quality systems, and cost
• Establishing performance management frameworks and Continuous Improvement initiatives with CMOs, CROs and 3PLs:
• Quality Management and Quality Systems
• Expectation management
• Compliance with CGMPs
• Case study: Managing internal cultural change and mindsets
• Planning for the future: Ensuring partners have both clinical and commercial capabilities, including device assembly and packaging
THOMAS MAIER
Global Head, Third-Party Management
CHAIR’S OPENING REMARKS
7:00 am – 8:00 am
8:00 am – 8:10 am
PROGRAM DAY TWO
8:10 am – 8:45 am
MARK FROMHOLD, PH.D.
Director, Biologics Outsourcing
EXTERNAL MANUFACTURING CHAIR EXTERNAL QUALITY CHAIR SUPPLY CHAIN MANAGEMENT
NETWORKING BREAKFAST
WOMEN IN LEADERSHIP ROUNDTABLE
Enjoy breakfast refreshments and informal networking in the Exhibition Hall. We also invite our attendees to network at a Women in Leadership Roundtable with
discussion from inspirational leaders in outsourcing. Seating is limited, so please sign up early.
MICHELE JOHNSON
Head, External Supply Opera-
tions Procurement, Americas
THIERRY BILBAULT, PH.D.
Head, Technical Operations
MALENE LYSBECK MIKKELSEN
Director, Strategic Sourcing
Outsourcing and Energy
MADELINE FISHER
Director, Quality Operations
RACHAEL ATLEE
Director, External Manufacturing,
Tech Transfer
TAMMI HOGAN
Associate Director, Chemical
Development and Manufacturing
JAIME SANTANA
Director, Global Quality
Compliance
PATRICIA TURNEY
VP, External Supply
American Pharma Outsourcing Summit 2018 Program • Page 9
10:05 am – 11:05 am
PRE-ARRANGED 1-2-1 BUSINESS MEETINGS AND REFRESHMENTS (60 MIN.)
EXTERNAL QUALITY DEVELOPING A CULTURE OF QUALITY AND
COMPLIANCE INTERNALLY AND EXTERNALLY
• Aligning external manufacturing, quality
objectives and KPIs to ensure compliance
• Achieving reduced errors and faster cycle times
with partners
• Developing clear compliance expectations
governed by the quality agreement
• How to influence your partner's quality culture
and established processes
• Encouraging staff to make decisions that are
good for quality
9:25 am – 10:00 am
EXTERNAL MANUFACTURING REVIEWING BEST PRACTICES FOR PRE-QUALIFYING
AND EXECUTING A PARTNERSHIP WITH A CMO
• Selecting CDMOs/CMOs for complex
therapeutics, such as monoclonal antibodies, cell
therapies, gene therapies, and fusion proteins
• What are Pfizer's guiding principles for
externalization?
• Make vs. buy decisions: Understanding your
internal capacities and capabilities
• Finding a flexible contract manufacturer that is
willing to share risk
• Establishing a mutually effective collaboration
between the sponsor and CMO
• Benefiting from new ideas and innovations
through partnering
FIRELLI ALONSO, PH.D.
Senior Director,
Biotherapeutics and Vaccines
Outsourcing
BRID ROONEY
Head, Quality Operations
CRAIG LICHTENSTEIN
VP and Head, Technical Operations
PLENARY CREATING MODERN-DAY OUTSOURCING ACTIVITIES AND RELATIONSHIPS
• Working with CDMOs to improve your manufacturing capacity, agility and ability to bring novel antibiotics to market
• What motivation do small molecule CMOs/CDMOs need to modernize?
• Asking the tough questions:
• Are your partners geared for large-scale need?
• Will my partner help us achieve speed-to-market?
• How can CDMOs better serve you and your customers?
• Learning from successful outsourcing activities and functions
• Not waiting for innovation from your partners - creating it!
8:45 am – 9:20 am
SUPPLY CHAIN MANAGEMENT KEY STRATEGIC CONSIDERATIONS IN THE EXTERNAL
MANUFACTURE OF ACTIVE PHARMACEUTICAL
INGREDIENTS
• Building an external supply chain for
intermediates and API
• Developing a network of suppliers to meet the
portfolio demands from development to
commercial manufacture
• Technology capabilities needs across a network
(i.e. flow, high potent, etc.)
• Assessing and mitigating process and
operational risk
• Considerations for process knowledge and
regulatory filings
JASON HAMM
Head, API Delivery, R&D
External Manufacturing
American Pharma Outsourcing Summit 2018 Program • Page 10
EXTERNAL QUALITY DEVELOPING AN OUTSOURCING STRATEGY FOR THE
ANALYSIS OF COMPLEX ASSAYS FOR NEW
MODALITIES
• Assessing the decision-making process for
determining what testing is performed in-house
vs. outsourced
• Considerations for outsourcing complex
Oligonucleotide assays
• Ensuring technical expertise, experience and
ability is top-of-mind
• What strategic tools are needed to develop a
good partnership?
• How to improve transparency and gain access to
more data
• Setting aside resources and time for necessary
training and Continuous Improvement
EXTERNAL MANUFACTURING APPROACHING OUTSOURCING RELATIONSHIPS
WITH GREATER COLLABORATION AND
TRANSPARENCY
• Working closely with fewer, but bigger supply-
chain partners
• Determining synergies and common goals to
gain stronger partners
• Determining strategic and cultural alignment,
relationship sophistication, supplier
management mechanisms, and performance
metrics
• Understanding what both parties need to get out
of the relationship
• Adding value and efficiencies across the supply
chain
JESSICA STOLEE, PH.D.
Senior Scientist
11:10 am – 11:45 am
EXTERNAL QUALITY HOW AN EMERGING COMPANY CHANGED ITS
SUPPLY CHAIN METHODOLOGY — AND WHAT IT
LEARNED
• Utilizing tools developed by the FDA and Xavier
University's Supply by Design (SbD) Initiative
• Best techniques for transitioning a supply chain
from clinical trials to commercial manufacturing
• Establishing a new framework for supply chains
vs. utilizing legacy models
• What are the main components of the SbD
processes and tools?
• Managing a third-party supply chain to support
commercialization
• Lessons learned along the way
• Establishing and sustaining quality culture with
partners in your network
MARK HENDERSON, PH.D.
Executive Director,
Contract Manufacturing
HAL HUNT
Director, Technical Operations
and CMC Supply Chain
JACK SOLOMON
Team Leader, Supply by Design
Initiative
CASE STUDY BUILDING PARTNERSHIPS WITH CDMOS FOR LAUNCHING INNOVATIVE PRODUCTS UNDER ACCELERATED TIMELINES
• Understanding the unique challenges in drug-substance development and manufacturing
• Outlining the criteria for selecting high-quality, reliable contract development and manufacturing organizations
• Discussing the specialized technologies required for handling high potency API manufacturing
• Strategies for resolving questions and challenges from the regulatory agencies
11:50 pm – 12:25 am
TANGQING LI, PH.D.
Executive Director, Program Management
GEORGE WU, PH.D.
VP and Presidential Fellow, Pharmaceutical Sciences,
American Pharma Outsourcing Summit 2018 Program • Page 11
12:30 pm – 1:30 pm
DEVELOPING A CENTER OF EXCELLENCE (COE):
DRIVING OUTSOURCING LEADING PRACTICES AND
BRING ADDED VALUE TO THE COMPANY
ENHANCING SUPPLY CHAIN PROCESSES FOR MORE
AUTOMATION AND LESS MANUAL INTERVENTION
LUNCH AND LEARN ROUND-TABLE DISCUSSIONS
Benefit from additional learning by joining a moderated round-table discussion on pressing issues in the industry. Choose from:
Seating is limited, so please sign up early. Sessions will start at 1:15 PM and run for one hour. Additional seating will be provided to discuss other topics.
KURT WOLF, PH.D.
Director, Externalization Center
of Excellence
ESTABLISHING CONSISTENT GLOBAL WAYS OF
IMPROVING SUPPLIER MANAGEMENT
MARK HOLDER
Executive Director, Regional
Supply North America
KEY TECHNIQUES FOR MANAGING THE
DEVELOPMENT LIFE CYCLE WITH OUTSOURCED AND
CONTRACT VENDORS
RICHARD J. HOLL, PH.D.
Senior Director, Development
Operations
STRATEGIES FOR EFFECTIVELY MANAGING
CONTRACTS WITH OUTSOURCE PARTNERS AND
CMOS
ROBERT LARSON
Head, Global Contract Records
Management
ROB HAXTON
VP, Global External Supply
Operations
WHAT SHOULD BE INCLUDED IN YOUR
MANUFACTURING AND COMMERCIALIZATION
PREPAREDNESS ACTIVITIES WITH CDMOS?
PARTNERING WITH SUPPLIERS FOR IMPROVEMENTS:
A GLOBAL SUPPLIER COLLABORATION PERSPECTIVE
JAY PATEL
Global Supplier Quality
Management
TECHNIQUES FOR PROCURING TECHNOLOGIES
FROM EXTERNAL SUPPLIERS
TARA YOKOMIZO PONCE
Senior Category Manager,
Global Pharma Procurement
TECHNIQUES FOR OVERSEEING EXTERNAL PROJECTS
IN A SPECIALIZED START-UP BIOTECH
EDWARD BALLESTEROS
Director, Supply Chain and
Logistics
SELECTING THE RIGHT CMO/CDMO FOR THE
PROJECT AS A SMALL OR VIRTUAL COMPANY
BETTE MONNOT-CHASE, PH.D.
Director, CMC and Quality
DAUPHINE BARONE
VP, Manufacturing Logistics
BEST TECHNIQUES FOR DRIVING OPERATIONAL
EXCELLENCE WITH CONTRACT MANUFACTURING
ORGANIZATIONS
MIKE GILBERT
Associate Director, Contract
Manufacturing
American Pharma Outsourcing Summit 2018 Program • Page 12
CLIVE PATIENCE, PH.D.
SVP, Technical Operations
PLENARY ENSURING THE RELIABILITY OF SUPPLY IN YOUR OUTSOURCED SUPPLY CHAIN
• Performing audits focused on compliance with cGMPs and quality
• Assessing the ‘business health’ and ‘business climate’ at your CMO
• Ensuring capacity for increased production at the contract manufacturer
• Discussing the importance of demand planning and risk management
• Reviewing quality and performance metrics on a constant basis
2:20 pm – 2:55 pm
PANEL DISCUSSION TECHNIQUES TO MAXIMIZE COLLABORATION WITH CONTRACT PARTNERS
• What is the client’s role in establishing ways to improve the effectiveness the relationship?
• Strengthening your relationships to ensure on-time, on-quality results
• Examining techniques to prevent supply chain or timeline interruptions
• Managing the lifecycle of contract manufacturing, development and logistics activities
• Launching Continuous Improvement initiatives to help aid in your contracting success
2:55 pm – 3:40 pm
PANEL DISCUSSION ESTABLISHING EFFECTIVE, MUTUALLY BENEFICIAL QUALITY AGREEMENTS WITH CDMOS
• Techniques for finding and developing high quality reliable suppliers
• How to successfully commercialize with Phase III CDMOs
• Building a quality framework into your outsourcing strategy
• Establishing a voice at the table to ensure the right quality controls in place
• Examining the biggest product supply and product quality risks at your third-party suppliers
• How to properly manage risk and audits with partners
1:35 pm – 2:20 pm
JANA SPES
Head, CMC and Supply Chain
W. SCOTT WILLETT, PH.D.
VP, Biopharmaceutical
Development
JAIME SANTANA
Director, Global Quality
Compliance
SCOTT GANGLOFF
VP, Biologics Product and
Process Development
BRIAN BIRD
Global Head, Devices and Combi-
nation Products, External Supply
Quality Operations
AMIT DESAI
Global Head, Strategy and
Program Management Office
ROB HAXTON
VP, Global External Supply
Operations
STEVEN JOHNSON
Head, Quality Systems, External
Biologics
THANH NGUYEN
Global Head, Large Molecules
External Development
Collaborations
GERRI MIRKIN
Director, Global Sourcing
ALI JAVADIAN, PH.D.
Director, Biotherapeutics and
Vaccines Outsourcing
MADELINE FISHER
Director, Quality Operations
American Pharma Outsourcing Summit 2018 Program • Page 13
MARK FROMHOLD, PH.D.
Director, Biologics Outsourcing
EXTERNAL MANUFACTURING CHAIR EXTERNAL QUALITY CHAIR SUPPLY CHAIN MANAGEMENT
THIERRY BILBAULT, PH.D.
Head, Technical Operations
CHAIR’S CLOSING REMARKS AND SURVEY PRIZE GIVEAWAY
JAIME SANTANA
Director, Global Quality
Compliance
3:40 pm – 3:45 pm