Welcome to the CMC Strategy Forum

Welcome to the CMC Strategy Forum

We are pleased to welcome you to the CMC Strategy Forum. The purpose of the CMC Strategy Forum

is to provide a venue for biotechnology/biological product discussion. The meetings focus on relevant

CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and

regulatory interactions. The Forum strives to share information with the regulatory agencies to assist

them in merging good scientific and regulatory practices. Outcomes of the Forum meetings are

published in an appropriate peer-reviewed journal.

Each meeting will focus on a CMC related issue such as product characterization, comparability,

specifications, etc. The format of each meeting will consist of case studies and presentations by Industry

and/or FDA experts to introduce the topic and the key issues of concern. Breakout sessions will then be

conducted to allow for additional discussion on the technical and regulatory details of the topics. It is

envisioned that the final outcome of the workshop discussions will be the development of a document to

be submitted to the appropriate Regulatory Agency designees for their consideration in developing

and/or clarifying good regulatory practice guidelines for biotechnology derived products.

The success of the CMC Strategy Forum will depend on your active participation in discussing and

raising issues pertaining to development of biologics. We encourage you to participate wholeheartedly

in the workshops that have been designed to stimulate exchange of ideas and information.

We would like to thank the speakers who are giving generously of their time and resources, and to you,

for your attendance. We acknowledge the generosity of our program partners: AbbVie, Inc., Amgen

Inc., Biogen Idec, Eli Lilly and Company, Genentech, a Member of the Roche Group, Genzyme, A

Sanofi Company, Janssen Pharmaceutical R&D, LLC, MedImmune, Merck and Pfizer, Inc. We are

grateful for the expert management assistance of Karen Bertani and Stephanie Flores at CASSS. Their

experience, guidance and skill in the preparation of this meeting have been invaluable.

ACKNOWLEDGEMENTS

CMC STRATEGY FORUM GLOBAL STEERING COMMITTEE

Siddharth Advant, Kemwell Biopharma, USA

John Dougherty, Eli Lilly and Company, USA

Christopher Joneckis, CBER, FDA, USA

Steven Kozlowski, CDER, FDA, USA

Junichi Koga, Daiichi Sankyo Co., Ltd., Japan

Rohin Mhatre, Biogen Idec, USA

Anthony Mire-Sluis, Amgen Inc., USA

Wassim Nashabeh, Genentech, a Member of the Roche Group, USA

Ilona Reischl, BASG/AGES, Austria

Anthony Ridgway, Health Canada, Canada

Nadine Ritter, Global Biotech Experts, LLC, USA

Thomas Schreitmüller, F. Hoffmann-La Roche Ltd., Switzerland

Mark Schenerman, MedImmune, USA

Karin Sewerin, BioTech Development AB, Sweden

CMC STRATEGY FORUM NORTH AMERICA PROGRAM COMMITTEE

Siddharth Advant, Kemwell Biopharma

Yves Aubin, Health Canada

John Bishop, CBER, FDA

Barry Cherney, Amgen Inc.

JR Dobbins, Eli Lilly and Company

Julia Edwards, Genentech, a Member of the Roche Group

John Hennessey, Novadigm Therapeutics, Inc.

Joseph Kutza, MedImmune

Kimberly May, Merck & Co., Inc.

Anthony Mire-Sluis, Amgen Inc.

Stefanie Pluschkell, Pfizer, Inc.

Nadine Ritter, Global Biotech Experts, LLC

Reb Russell, Bristol-Myers Squibb Company

Timothy Schofield, MedImmune

Zahra Shahrokh, ZDev Consulting

Jeffrey Staecker, Genzyme, A Sanofi Company

Patrick Swann, CDER, FDA

Andrew Weiskopf, Biogen Idec

The Organizing Committee gratefully acknowledges the

pharmaceutical and biotechnology industry for their generous support

of the CMC Strategy Forum series:

SUSTAINING DIAMOND PROGRAM PARTNER

Genentech, a Member of the

Roche Group

SUSTAINING PLATINUM PROGRAM PARTNER

Biogen Idec

SUSTAINING GOLD PROGRAM PARTNER

AbbVie, Inc.

SUSTAINING SILVER PROGRAM PARTNER

Pfizer, Inc.

PROGRAM PARTNERS

Amgen Inc.

Eli Lilly and Company

Genzyme, A Sanofi Company

Janssen Pharmaceutical R & D, LLC

MedImmune

Merck

EXHIBITOR PROGRAM PARTNER

KBI Biopharma, Inc.

LEADING MEDIA PARTNERS

BioProcess International

International Pharmaceutical Quality

MEDIA PARTNERS

The Analytical Scientist

BioProcessing Journal

BioTech International

Genetic Engineering & Biotechnology News

LCGC North America

Technology Networks Limited

RSC Advances

Wiley / Journal of Separation Science

Forum Abstract

Effective Management of Contract Organizations: Sponsors, Contract Organizations, Health

Authorities and Patients - Keeping the Product Pipeline Moving, Compliant and Available

Contractors are from Mars, Sponsors are from Venus: Building Effective Relationships between

Sponsor and Contractor

FORUM CO-CHAIRS:


Julia Edwards, Alnylam Pharmaceuticals, Inc.

Jeffrey Staecker, Genzyme, a Sanofi Company

SCIENTIFIC ORGANIZING COMMITTEE:

Qiao Bobo, CBER, FDA

Hal Hopkins, AbbVie, Inc.

Patricia Hughes, CDER, FDA

Bernie Huyghe, Pfizer, Inc.

Stephen Liebowitz, NPS Pharmaceuticals

Ben Locwin, Lonza Biopharmaceuticals

Shawn Novick, Seattle Genetics, Inc.

Troy Wright, Amgen Inc.

Both small and large biopharma companies are increasingly pursuing the outsourcing of manufacturing

and testing throughout the product lifecycle. The growing use of Contract Manufacturing Organizations

(CMOs) and Contract Testing Organizations (CTOs) has led to increasing complexity within the

biopharmaceutical industry as more third party sites are leveraged to support global markets.

This Forum will look at these trends and challenges associated with outsourcing and identify best

practices to ensure the safety, efficacy and quality of products produced and tested by CMOs and CTOs.

Four focus areas for the program are proposed:

1. Building Quality into the Relationship

2. Manufacturing at the CMO

3. Contracting Analytical Testing at the CMO & CTO

4. Most of the World Experience (Outside the EU and US)

For each of the focus areas, the session will take a critical look at the risks and best practices associated

with contract manufacture and testing of biological products throughout development and

commercialization. Presentations from sponsors, contractors and health authorities will use case studies

and experiences to foster discussion on best practices and recommendations on effectively developing,

manufacturing and testing biological drug substance and product globally.

The following questions will be discussed and hopefully answered at this Forum:

What are the key principles that should be followed when establishing Quality Agreements in

accordance with the FDA’s draft guidance?

What are the primary business & regulatory challenges and risks from both the sponsor and

contract organization’s perspective with regards to the manufacture and testing of

biopharmaceuticals?

What are the unique challenges to globalization of contract manufacturing and testing that

contractors, sponsors and regulators should be aware?

CMC Strategy Forum Program Summary

Effective Management of Contract Organizations: Sponsors, Contract Organizations, Health

Authorities and Patients - Keeping the Product Pipeline Moving, Compliant and Available

Monday, July 21, 2014

07:30 – 17:30 Registration in the Washingtonian Ballroom Foyer

07:30 – 08:30 Continental Breakfast in the Washingtonian Ballroom Foyer

08:30 – 08:45 CASSS Welcome and Introductory Comments in Salons D - G

Nadine Ritter, Global Biotech Experts, LLC

CMC Strategy Forum Welcome and Introductory Comments in Salons D - G

Jeffrey Staecker, Genzyme, A Sanofi Company

Building Quality into the Relationship In Salons D - G

Session Chairs: Julia Edwards, Alnylam Pharmaceuticals, Inc. and Stephen Liebowitz, NPS

Pharmaceuticals

08:45 – 09:15 CBER Expectations Regarding Contract Manufacturing

Qiao Bobo, CBER, FDA, Rockville, MD USA

09:15 – 09:45 CMO Oversight: The Role of Quality

Susan Kalk, NPS Pharmaceuticals, Bedminster, NJ USA

09:45 – 10:15 CMO Compliance Oversight Best Practices

Margit Olson, Tunnell Consulting, King of Prussia, PA USA

10:15 – 10:45 AM Break in the Washingtonian Ballroom Foyer

10:45 – 12:00 PANEL DISCUSSION – Questions and Answers



Susan Kalk, NPS Pharmaceuticals

Christian Lynch, CBER, FDA

Tracey McKennon, Seattle Genetics, Inc.


Margit Olson, Tunnell Consulting

12:00 – 13:15 Hosted Lunch Break in the Washingtonian Ballroom Foyer

Monday, July 21 continued…

Manufacturing at the CMO In Salons D - G

Session Chairs: Bernard Huyghe, Pfizer, Inc. and Ben Locwin, Lonza Biopharmaceuticals

13:15 – 13:45 FDA's Perspectives on Cross- Contamination in CMO Facilities: Considering

High Risk Products

Bo Chi, CDER, FDA, Silver Spring, MD USA

13:45 – 14:15 Case Study: How to Succeed in Vaccine Externalization and Technology

Transfer Firelli Alonso-Caplen, Pfizer, Inc., Pearl River, NY USA

14:15 – 14:45 CMO Innovator Partnerships to Improve Quality and Reduce Risk

Jesús Zurdo, Lonza Biologics plc, Cambridge, United Kingdom

14:45 – 15:15 PM Break in the Washingtonian Ballroom Foyer

15:15 – 15:45 Review Challenges When a Contract Manufacturing Strategy is Used

Nancy Green, Health Canada, Ottawa, ON Canada


Firelli Alonso-Caplen, Pfizer, Inc.

Bo Chi, CDER, FDA

Nancy Green, Health Canada

Brandon Leveille, Biogen Idec


Aria Tavana, Alnylam Pharmaceuticals

Jesús Zurdo, Lonza Biologics plc

17:00 – 18:30 Networking Reception in the Washingtonian Ballroom Foyer

18:30 Adjourn Day One

Tuesday, July 22, 2014

07:30 – 17:00 Registration in the Washingtonian Ballroom Foyer

07:30 – 08:45 Continental Breakfast in the Washingtonian Ballroom Foyer

Contracting Analytical Testing at the CMO and CTO

In Salons D - G

Session Chairs: Hal Hopkins, AbbVie, Inc. and Shawn Novick, Seattle Genetics, Inc.

08:45 – 09:15 Pitfalls and Best Practices: Biologics Testing in an Outsourced Model

Anne Kowal, Takeda Pharmaceuticals International Co., Cambridge MA USA

09:15 – 09:45 Effective Oversight of Analytical Method Development, Qualification, and

Testing for a Bio-product Portfolio in a FIPNET World

Melissa Clague, Eli Lilly and Company, Indianapolis, IN USA

09:45 – 10:15 Communication and Information Sharing - Best Practices from the

Biotechnology CTO Viewpoint Eric Nottingham, CMC Biologics, Bothell, WA USA

10:15 – 10:45 AM Break in the Washingtonian Ballroom Foyer


Melissa Clague, Eli Lilly and Company

Dean Clodfelter, Covance Greenfield Laboratories

Chana Fuchs, CDER, FDA

Anne Kowal, Takeda Pharmaceuticals International Co.

Edwin Moore, University of Illinois

Eric Nottingham, CMC Biologics

12:00 – 13:15 Hosted Lunch in the Washingtonian Ballroom Foyer

Most of the World Experience (Outside the EU and US)

In Salons D - G

Session Chairs: Patricia Hughes, CDER, FDA and Troy Wright, Amgen Inc.

13:15 – 13:45 Global Regulatory Oversight for Better or Worse? A Regulatory Perspective

on Emerging Trends Carmelo Rosa, CDER, FDA, Silver Spring, MD USA

13:45 – 14:15 An Effective Third Party Manufacturing Model for Speedy Technology

Transfer and Quality Oversight Simon Hsu, Bristol-Myers Squibb Company, East Syracuse, NY USA

Tuesday, July 22 continued…

14:15 – 14:45 Sponsor Oversight of CMOs Across Quality Systems, Cultures and Time

Zones John McShane, Genentech, a Member of the Roche Group, South San Francisco,

CA USA

14:45 – 15:15 PM Break in the Washingtonian Ballroom Foyer

15:15 – 15:45 Biologics Outsourcing to India – Factors to Consider

Siddharth Advant, Kemwell Biopharma, Belle Mead, NJ USA



Pankaj Amin, CBER, FDA

Laurie Graham, CDER, FDA

Simon Hsu, Bristol-Myers Squibb Company

John McShane, Genentech, a Member of the Roche Group

Carmelo Rosa, CDER, FDA

17:00 – 17:30 Recap of Program

Summary Slide Presentation


Invitation to the CMC Strategy Forum

January 26, 2015

The Mayflower Hotel, Washington, DC USA

17:30 Adjournment

Presenters Abstracts

CBER Expectations Regarding Contract Manufacturing

Qiao Bobo

CBER, FDA, Rockville, MD USA

This presentation will address contract manufacturing arrangements for biological products under a

Biologics License Application, including FDA recommendations on the responsibilities and

expectations of the licensed manufacturer and the contract manufacturer. The presentation will also

provide an overview of key aspects of the Draft Guidance for Industry - Contract Manufacturing

Arrangements for Drugs: Quality Agreements. Case studies and lessons learned will be discussed.

NOTES:

CMO Oversight: The Role of Quality

Susan Kalk

NPS Pharmaceuticals, Bedminster, NJ USA

While the outsourced pharmaceutical model has certain advantages, such as allowing experts in their

fields to manufacture, test and release products on sponsor’s behalf, the regulatory requirements have

become the focus of the FDA and other agencies. Sponsor responsibilities are clearly defined and

enforced. As companies struggle to meet the regulatory expectations of effective oversight, the message

is clear – if the CMO is not compliant, the FDA will question the effectiveness of sponsor oversight.

Therefore, the sponsor quality responsibilities cannot be under stated. Effective quality oversight is a

key component of the Supplier Management program, with ensuring that Quality Assurance are

involved in all phases of the CMO lifecycle; from due diligence through contract termination. QA will

bring a different focus to CMO selection, evaluating areas possibly overlooked by other departments

such as the capabilities of the QA department and leadership or understanding the CMO regulatory

experience in sponsor intended jurisdictions.

Furthermore, a Quality Agreement must be established that clearly outlines both sponsor and CMO

responsibilities and ensures that each of their internal quality systems interface effectively. There are

however, challenges to accomplishing this objective. The CMO may not be willing to readily share

internal SOP’s and processes and the sponsor is frequently bound by Corporate Quality standards. Most

CMO’s simply cannot allow deviations from their established quality systems to accommodate different

sponsors. So a “joint” quality system must be established that works within the confines of the both the

sponsor and CMO’s existing quality systems and still meets the regulatory requirements. In addition,

joint quality metrics should be established that clearly define CMO and sponsor contributions as well as

shared metrics for the overall success of the project.

Quality Risk Management is a critical component of effective QA oversight. This includes the

identification of compliance, quality and business risks by continually re-evaluating CMO data,

performance history and using that data to drive the level of QA oversight. Since each new batch,

campaign or audit, represents a new data point, an effective oversight program will allow for changes in

the level of sponsor oversight aligned with the perceived level of risk.

Establishing the QA to QA relationship is key to an effective sponsor/CMO partnership. An aligned

approach to risk-based decision making will ensure that when issues arise –the QA groups are able to

find common ground and a compliant path forward for both organizations.

NOTES:

CMO Compliance Oversight Best Practices

Margit Olson

Tunnell Consulting, King of Prussia, PA USA

The importance of CMO compliance oversight has been emphasized by recent FDA activities aimed at

enforcing the responsibilities of brand owners for the quality of drug products produced by CMOs. This

is, of course, not a new FDA expectation; however, questions from industry regarding those

expectations have led to the publication in May of 2013 of the draft FDA guidance on Contract

Manufacturing Arrangements for Drugs: Quality Agreements. At the same time, brand owners have

increasingly moved towards establishing mutually beneficial long term agreements with CMOs as it is

clear that the regulatory implications for changing CMOs are rather daunting. This has in turn resulted in

placing more emphasis on the up front due diligence and assessment of the CMO prior to contract

agreement. Likewise, CMOs have responded to this increased pressure by moving towards harmonized

Quality Systems that meet global regulatory requirements and expectations as well as by increasing the

transparency of data and their level of collaboration with brand owners. The presentation will focus on

the importance of selecting the right CMO and on effectively managing the relationship with CMOs as

well as on best practices for managing both the selection process as well as the ongoing relationship

with the CMO to ensure reliable supply of product that meets quality standards and regulatory

expectations.

NOTES:

Building Quality into the Relationship

Workshop Session One

Panel Discussion – Questions and Answers



Susan Kalk, NPS Pharmaceuticals

Christian Lynch, CBER, FDA

Tracey McKennon, Seattle Genetics, Inc.


Margit Olson, Tunnell Consulting

This session will highlight building quality into the Sponsor-Contract Organization relationship. The

Quality agreement, change control and compliance oversight will be presented from the perspective of

different regulatory agencies and pharmaceutical industry. Case studies and lessons learned will be

discussed.

The following questions will guide the panel discussion:

1. How do you structure a Quality Agreement to assure roles and responsibilities are defined in

both the conduct of routine activities and unforeseen events?

2. What is the linkage between Sponsor and Contract Organizations Quality and Business

agreements?

3. How do you harmonize practices/expectations classifying and governing change notifications

and approvals between Sponsors and Contract Organizations?

4. What is the impact of continuous process improvements on Quality and Business agreements?

5. How to manage producing product to a single quality standard to conform to multiple

international Health Authority regulatory requirements and expectations?

NOTES:

NOTES:


FDA's Perspectives on Cross- Contamination in CMO Facilities: Considering High Risk Products

Bo Chi

CDER, FDA, Silver Spring, MD USA

Recent FDA inspections and reviews have identified new challenges faced by sponsors and CMOs

engaged in the production of potent and toxic biotech products in multiproduct manufacturing facilities.

The presentation will focus on regulatory expectations for cross-contamination controls in multiproduct

CMOs manufacturing high risk products. Some case studies will also be discussed.

Slides were not available at the time of printing.

NOTES:

Case Study: How to Succeed in Vaccine Externalization and Technology Transfer

Firelli Alonso-Caplen

Pfizer, Inc., Pearl River, NY USA

By outsourcing, virtually any biopharmaceutical company can conduct vaccine clinical trials quickly,

without having to deal with the staggering capital expenditures associated with building a manufacturing

facility. But successful externalization cannot occur without a careful selection process for the right

CMO, and execution of a well-designed technology transfer plan. We have concluded a major vaccine

contract at a CMO, producing Phase III clinical supplies and completing process validation. We will

recount the selection process, the establishment of Service and Quality Agreements, and more

importantly, the complex technology transfer process for production processes and analytical test

methods – what worked and what did not work – and why.

NOTES:

CMO Innovator Partnerships to Improve Quality and Reduce Risk

Jesús Zurdo

Lonza Biologics plc, Cambridge, United Kingdom

Quality (fit for purpose) appears as the one of the main aspects to drive success of new drug candidates

during both preclinical and clinical development. Bio-manufacturing processes are still complex, largely

unpredictable, and very much linked to the nature of the product to be made. In most cases, risk and

uncertainty is managed with extensive screening, testing and analysis, which is tremendously costly and

time-consuming.

One of the main challenges to effectively manage risk and drive Quality relates to the lack of integration

between discovery and development activities, which it is particularly challenging when these also are

divided between sponsor (innovator) and subcontractor (CMO) organisations.

We present some alternative approaches to development that have a greater emphasis in the

development of closer partnerships that bridge the discovery-development divide. These involve the

design and selection of the therapeutic candidate for optimal safety, stability and formulability,

combined with faster approaches for early material generation. The potential impact in streamlining

clinical development and reducing quality issues and attrition will be discussed.

NOTES:

Review Challenges When a Contract Manufacturing Strategy is Used

Nancy Green

Health Canada, Ottawa ON Canada

The use of Contract Manufacturing and Organizations will continue to be an important tool to bring new

biologics to market or to maintain supply of current products. In addition to the contractor client

relationship there is the relationship between the regulators, the client (the sponsor) and the contractor.

Planning how to nurture those relationships so as to obtain smooth regulatory review and approval will

help to avoid some common review challenges.

NOTES:

Manufacturing at the CMO

Workshop Session Two


Firelli Alonso-Caplen, Pfizer, Inc.

Bo Chi, CDER, FDA

Nancy Green, Health Canada

Brandon Leveille, Biogen Idec


Aria Tavana, Alnylam Pharmaceuticals

Jesús Zurdo, Lonza Biologics plc

Session Two addresses the importance and role of contract manufacturing organizations (CMOs) in the

pharma ecosystem. Contract manufacturing of pharmaceuticals represents a significant investment in

time, effort, and resources (financial and otherwise). Communication is “KEY”. When development

occurs between two or more companies, there are additional risks which need to be realized. In this

session we will discuss some of the technical and Regulatory challenges that arise in the client/CMO

relationship. The presentations and panel discussion will provide best practices and lessons-learned by

case studies from both the client and CMO perspectives.


1. What are the most challenging aspects of the relationship?

i. Technical?

ii. Regulatory?

2. What is the best way to transition from clinical development to commercial manufacture at a

CMO?

3. What is the most effective way to plan a relationship-based development strategy?

4. What are the best ways to communicate between partners?

NOTES:

NOTES:


Pitfalls and Best Practices: Biologics Testing in an Outsourced Model

Anne Kowal

Takeda Pharmaceuticals International Co., Cambridge, MA USA

Given the technical complexities associated with analysis of biologics, there are a number of critical

elements that need to be considered and addressed to enable both sides to succeed. Sponsors must make

decisions about what work to outsource and then carefully select CTOs to meet those needs. Good

communication and a willingness to build a partnership are essential, starting from the kick-off meeting

through continuing GxP testing. Some specific hazards that may be encountered in outsourced projects

and approaches to manage them will be discussed.


NOTES:

Effective Oversight of Analytical Method Development, Qualification, and Testing for a Bio-

product Portfolio in a FIPNET World

Melissa Clague

Eli Lilly and Company, Indianapolis, IN USA

Analytical method development and testing frequently need to be spread across a network of sites and

organizations, creating additional complexity beyond the standard analytical development requirements.

Several models, including in-sourcing, outsourcing testing alone, and outsourcing testing bundled with

other development activities, will be discussed. The presentation will cover the challenges of selecting

appropriate testing laboratories, providing effective oversight, and building collaborative, stable,

mutually beneficial relationships. Case studies will highlight particular technical challenges and their

solutions.

NOTES:

Communication and Information Sharing - Best Practices from the Biotechnology CTO Viewpoint

Eric Nottingham

CMC Biologics, Bothell, WA USA

Communication and CMO oversight are essential elements in executing successful biotechnology

projects at CMOs. Biotechnology projects are more complex than ever before. Projects often cross

cultural and geographic boundaries. Sponsors may have little biotech experience. Timelines are

impossibly aggressive, budgets are tight, and the consequences of failure on both organizations are

severe and lasting. The degree to which a biotechnology project succeeds or falls short may hinge on the

exchange of timely, unambiguous and purposeful information that considers all of these variables. The

business development process, business and quality agreements, project management plans, and team

charters should define governance structures within a project and internal and external communication

responsibilities and expectations for Sponsors and CMO in detail. Tools, training and technology,

applied effectively, can greatly facilitate the intensive information sharing and efficient decision-making

required to successfully execute today's challenging biotechnology projects.

NOTES:

Contracting Analytical Testing at the CMO and CTO

Workshop Session Three


Melissa Clague, Eli Lilly and Company

Dean Clodfelter, Covance Greenfield Laboratories

Chana Fuchs, CDER, FDA

Anne Kowal, Takeda Pharmaceuticals International Co.

Edwin Moore, University of Illinois

Eric Nottingham, CMC Biologics

This session will focus on key elements associated with the relationship between the sponsor and the

contract testing facility. Both ends of the equation have needs which must be met to ensure compliance,

business continuity, and technical ability. These are most easily satisfied by careful consideration upon

choosing a CTO and ensuring effective communication tools are in place and agreed upon for all phases

from method development or transfer through commercial testing. In this session we hope to provide

viewpoints and case studies from both a CTO and a Sponsor which highlight the challenges and some

successful remedies for method transfer and control of method performance through product lifetime.


1. What are the key elements that should be evaluated when choosing a CTO?

2. Are there any regulatory requirements for specific regions or countries related to the analytical

testing to consider?

3. How to transfer and validate test methods, ensure they are performing as expected and monitor

the performance?

4. How to provide effective communication and oversight?

5. What is the optimal process to facilitate investigations and root cause analysis at the CTO?

6. What is an effective strategy to agree upon product specifications for the business contract?

NOTES:

NOTES:


Global Regulatory Oversight for Better or Worse? A Regulatory Perspective on Emerging Trends

Carmelo Rosa

CDER, FDA, Silver Spring, MD USA

Abstract was not available at the time of printing.


NOTES:

An Effective Third Party Manufacturing Model for Speedy Technology Transfer and Quality

Oversight

Simon Hsu

Bristol-Myers Squibb Company, Syracuse, NY USA

Bristol-Myers Squibb has been sourcing manufacturing need to Korea since 2005. BMS expanded

manufacturing agreement with Samsung Biologics (SBL) in April 2014 to further increase our biologics

manufacturing capability and to give us the flexibility to respond to increased demand in order to meet

the global needs of patients. Extensive in-house experience and significant resources investment are

keys to become successful with technology transfer to Korean CMOs. BMS Biologics TPM model is

based on 10 years of experience with CMOs across US, Europe, and Asia. BMS TPM departments are

100% dedicated to TPM oversight of biologics third party manufacturing. BMS committed full time QA

and technical PIP coverage during initial technology transfer, PPQ, and PAI campaigns. BMS also set

up TPM quality/technical offices in Asia and Europe as an integrate part of our TPM oversight

worldwide.

NOTES:

Sponsor Oversight of CMOs Across Quality Systems, Cultures and Time Zones

John McShane

Genentech, a Member of the Roche Group, South San Francisco, CA USA

Sponsor working relationships with contract manufacturers is multi-faceted. Business and regulatory

requirements drive the relationship at a high level, but there are options in implementation.

Implementation methodology is important and can positively impact the relationship particularly when

working in different size organizations. Working across different cultures, long distances with large

clock time differences create additional challenges. Example mitigations are discussed.

NOTES:

Biologics Outsourcing to India – Factors To Consider

Siddharth Advant

Kemwell Biopharma, Belle Mead, NJ USA

India has traditionally been one of the largest exporters of OTC and traditional prescription drugs to US

(accounting for approximately 35-40% of consumption). As companies, especially Big Pharma, continue

to find ways to lower the cost for development and manufacturing of biopharmaceuticals, India seems to

be emerging as a possible destination for outsourcing biologics. Although the cost to produce medicines

in India is significantly cheaper than in Western countries, concerns about lack of quality and IP issues

could be pose potential challenges as companies look to outsource to India. This presentation will

address these and additional factors that should be evaluated when considering outsourcing biologics

development and manufacturing to India

NOTES:

Most of the World Experience (Outside the EU and US)

Workshop Session Four



Pankaj Amin, CBER, FDA

Laurie Graham, CDER, FDA

Simon Hsu, Bristol-Myers Squibb Company

John McShane, Genentech, a Member of the Roche Group

Carmelo Rosa, CDER, FDA

This session will present some of the challenges in managing CMOs world-wide while ensuring global

quality oversight. Specific challenges related to managing different expectations by world-wide

regulatory agencies, including specific in-country import testing requirements or manufacturing

practices will be discussed. Harmonization strategies for global process development and analytical

harmonization will be explored.”


1. What are the biggest challenges in managing CMOs world-wide while ensuring consistent and

high quality standards across all regions from the CMO, sponsor or regulatory perspective?

2. What should a sponsor do when in-country import testing requirements vary with the US and EU

quality requirements?

3. What should a sponsor do if the world wide testing provides conflicting information regarding

product quality? Under what circumstances should a sponsor initiate world-wide product recalls

based on specific in-country testing results that are at odd with US or EU results?

4. What efforts could be implemented to improve harmonization of process development and

analytical testing requirements?

5. What are some of the differences we experience when managing domestic CMOs vs. those

worldwide?

NOTES:

NOTES:

Documents

Welcome to the CMC Strategy Forum