american pharma outsourcing summit 2018 - … · american pharma outsourcing summit 2018 program...

AMERICAN PHARMA OUTSOURCING SUMMIT 2018

OCTOBER 2-3, 2018

CROWNE PLAZA HOTEL PHILADELPHIA • CHERRY HILL, NJ

posummit.com

+1-416-298-7005

[email protected]

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


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


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


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


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


3:45 pm – 5:05 pm


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


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




Sponsored By:



JAIME SANTANA


Compliance


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




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



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


Compliance

PATRICIA TURNEY

VP, External Supply


10:05 am – 11:05 am


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


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,


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


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


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







CHAIR’S CLOSING REMARKS AND SURVEY PRIZE GIVEAWAY

JAIME SANTANA


Compliance

3:40 pm – 3:45 pm

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