th gilead cmo - exl eventsinfo.exlevents.com/rs/exlevents/images/c564_web.pdfsetting expectations...

5TH

CMOCMOCMOAPRIL 23-24, 2015 | WYNDHAM BOSTON BEACON HILL | BOSTON, MA

CMOCMOCMOCMOCMOCMOStrategic Insights on Drug Development Outsourcing to a Contract Manufacturing Organization in an Evolving Regulatory Landscape

Top Reasons to Attend:

ü Get up to date on the latest FDA policies and their impact on a CMO partnership

ü Network and connect with CMO, pharma and biotech professionals, and take away valuable insights to help prevent costly mistakes in forming and executing external partnerships

ü Learn to identify individual risks and their effect on a project when considering outsourcing; reduce risks to patients, operations and supply chains through preemptive detection and product oversight

ü Draft creative contracts and quality agreements that incentivize CMOs to produce timely, high-quality results

ü Identify the right supplier for emerging, niche or start-up companies

Firelli Alonso-Caplen, Ph.D, Senior Director, BioTherapeutics & Vaccines Outsourcing, PFIZER

Michael Butera, Director, External Manufacturing, REGENERON PHARMACEUTICALS

Scott Duncan, Director of Chemistry, Technical Operations, STEALTH BIOTHERAPEUTICS

Heidi Hoffmann, Senior Director, Manufacturing, SUTRO BIOPHARMACEUTICALS

Todd Mabe, Head of Biologics, Drug Substance, External Quality, PTQBX, ROCHE

Timothy Scott, President, PHARMATEK LABORATORIES

Wanda Tormos, Senior Manger, Chemical Development Outsourcing, GILEAD

Dan Trimberger, Director, Quality Assurance, MOMENTA PHARMACEUTICALS

Distinguished Speaker Faculty Includes:

“This is one of the best conferences that I’ve attended in my 30+ years of experience” — Senior Manager, GILEAD

Amnon Eylath

Senior Director, Quality

Assurance, GENZYME

IDENTIFY RISKS AND WEAKNESSES ASSOCIATED WITH SERVICES, SYSTEMS AND PRODUCTS OF A CMO BY IMPLEMENTING QUALITY BY DESIGN (QBD) PRACTICES Ben Locwin, Former Head of T&D, Global Head of Center of Excellence, LONZA

CASE STUDY: LEARN CMO AND LICENSE HOLDER INTEGRATION AND ATYPICAL VISIBLE PARTICLE REDUCTION Jonathan Patroni, Vice President, US Quality Assurance, SHIRE

Conference Chairman:

Featured Sessions:

QUALITY OVERSIGHT & RISK MANAGEMENT

PROCESS PERFORMANCE QUALIFICATION, PAI READINESS, PAI EXECUTION AND POST APPROVALLee Fox, Third Manufacturing Quality Manager, BRISTOL-MYERS SQUIBB

SUMMIT

Sponsor:

To Register: Call 866-207-6528 or Visit www.exlevents.com/CMO

CMOCMOCMOCMOCMOCMOCMOCMOCMOCMOCMOCMODear Colleague,The use of contract manufacturing organizations (CMOs) in the life science industry has been growing at a rapid pace over the past decade, and the trend is projected to continue across all industry sectors, including pharmaceutical, biotech and medical device. As professionals continue to turn to external partners at a rapid rate, experts predict that the global CMO market value will exceed $60 billion by 2018. Thus, e� ective quality oversight and risk management have become even more essential to ensuring successful partnerships, GMP compliance and a lucrative completion of the product’s outsourced manufacturing supply chain.

The 5th CMO Quality Oversight & Risk Management Summit brings together industry innovators to connect and discuss the latest outsourcing trends and hot button issues in pharmaceutical, biotechnology and medical device contract manufacturing.

The conference is designed to optimize partnerships between sponsors and CMOs, serving as a networking platform and o� ering professionals vital information on how to strategically navigate the outsourcing and quality oversight of CMOs in an evolving regulatory landscape. Additionally, this event o� ers vigorous tactics to track and prevent GMP failures and other adverse events.

A mutual understanding of risk involved for each project and a transparent working relationship are both key prerequisites for a successful client/CMO partnership. This conference will o� er a unique tool kit to help design the right manufacturing and development program, establish a sense of co-ownership and responsibility for the CMO and client, execute a uni� ed contract, and identify roles and responsibilities for each member of a project.

Additional topics include best practices to e� ectively oversee and manage external manufacturers, tips on utilizing big data analytics to improve CMO results, the newest FDA policies and their impact on CMO partnerships, e� ective risk management strategies for life science companies and CMOs, the latest outsourcing trends, and strategies for creative contracting.

You asked for content speci� cally addressing the topics below. We are thrilled to provide you with unique case studies, panels and interactive sessions on:

ü Drafting creative contracts and quality agreements that incentivize CMOs

ü Identifying the right supplier for emerging, niche or start-up companies

ü Pinpointing risks and weaknesses by implementing Quality by Design (QbD) practices

Join industry leaders and quality professionals to discuss best practices for successful CMO management and partnerships.

I look forward to seeing you in Boston this April!

Sincerely, Charleen FamigliettiConference Production Director ExL [email protected]

WHO SHOULD ATTEND:

This conference is of interest to CMO, pharmaceutical, biotechnology and medical device professionals specializing in:

• Quality Assurance

• R&D Quality Management

• Manufacturing Compliance/GMP/Operating

• External Manufacturing/Contract Manufacturing

• Product Quality/Development

• External/Supplier Quality

• Training and Development

• Strategic Outsourcing

• Chemical Development

• External Quality

• Auditing

• Risk Management

• Regulatory A� airs/Compliance

• Technology Transfer

• Process Development/Optimization

• Outsourcing/Strategic Sourcing

• Supply Chain

• Operational Excellence

• Strategic Sourcing

• API Development

• Biologics

• Technology Transfer

This conference is also of interest to:

• Quality Manufacturing Service Providers

• CMO Auditing Software Companies

• Regulatory/Compliance Consultants

Venue Information: WYNDHAM BOSTON BEACON HILL5 Blossom Street | Boston, MA 02114

Room Reservations: If you require overnight accommodations, please contact the hotel to book your room. ExL Pharma has reserved a block of rooms at a discounted rate for conference participants. We encourage conference participants to make reservations by April 1, 2015. To make reservations guests can call 617-742-7630 and request the negotiated rate for “ExL’s April Meeting” Please book your room early as rooms available at this rate are limited.

5TH QUALITY OVERSIGHT & RISK MANAGEMENT

SPONSORSHIP AND EXHIBITION OPPORTUNITIESDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to sponsor, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that suits all your needs. To learn more about these opportunities, please contact Andrew Sinetar, Managing Director, at 212-400-6237 or [email protected].

SUMMIT


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Day One Thursday, April 23, 2015

8:00 Registration and Continental Breakfast

9:00 Chairman’s Opening Remarks

Amnon Eylath, Senior Director, Quality Assurance, GENZYME

9:15 Identify Best Practices for Selection and Oversight of CMOs

• Consider critical elements while evaluating and selecting CMOs • Review components of quality agreements and Master Service

Agreements, including elements excluded from FDA guidance or EU GMPs

• Gain insight to successful, productive CMO-Sponsor partnerships

Brian Clark, Executive Director, Quality, IMMUNOGEN

10:00 An Integrated Approach to Contract Manufacturing and Utilizing a CMO

• Review best practice for pre-qualifying and executing a partnership with a CMO

• Establish a mutually eff ective collaboration between a sponsor and CMO

• Discuss varied approaches to utilizing and managing a CMO• Develop a strategic partnership arrangement

Daniel Eylath, Manufacturing Compliance Specialist, MASSBIOLOGICS

Heidi Hoff mann, Senior Director, Manufacturing, SUTRO BIOPHARMA

Firelli Alonso-Caplen, Ph.D, Senior Director, BioTherapeutics & Vaccines Outsourcing, PFIZER


Brian Clark, Executive Director, Quality, IMMUNOGEN

Wanda Tormos, Senior Manager, Chemical Development Outsourcing, GILEAD

10:45 Networking Break

11:15 Quality and Manufacturing Considerations for a CMO Site With Multiple Customer Products

Lisa Thimmesch, Customer Quality Manager, McPherson, Kansas; HOSPIRA INC.

12:00 Develop a Creative Quality Agreement and Multi-Level Contracts when Working with a CMO Partner

• Form contracts with clear, thought-out objectives in mind• Build incentives into contracts to encourage yield and long-term

effi ciency improvements• Drive a more attuned look at contracts and legal aspects protecting

the supply chain• Learn integration of supply chain legal documents and ensure they are

in sync with one another

Scott Duncan, Director of Chemistry, Technical Operations, STEALTH BIOTHERAPEUTICS

12:45 Luncheon

1:45 Evaluate the Industry Risk Profi le of Using CMOs Versus In-House Manufacturing

• Evaluate your organization’s current capabilities and competencies • Identify advantages and disadvantages to outsourcing • Learn how contracting can lead to dispersed risk, accelerated time to

market and reduced costs for drug development• Drive a new management mindset to deal with loss of control and

critical dependence on the supplier

Daniel Eylath, Manufacturing Compliance Specialist, MASSBIOLOGICS

2:30 Select a CMO and Align Interface for Robust Tech Transfer

• Select a CMO using good planning and a consistent robust approach • Allocate responsibilities between a sponsor and a CMO• Ensure adequate compliance and good business sustainability• Utilize CMO selection tools such as RFI, RFP/RFQ, term sheets, and the

vendor selection matrix

Michael Butera, Director, External Manufacturing, REGENERON PHARMACEUTICALS


3:45 Best Practices for Working Together with a Sponsor to Achieve Seamless Execution of Product Development

• Understand the CMO’s perspective of the partnership• Implement an eff ective internal CMO management structure • Discuss frequent challenges CMOs face regarding contract

negotiations, liability and risk assessment

Timothy Scott, President, PHARMATEK

4:30 Interactive Roundtable Discussions — Apply Contract Manufacturing Problem-Solving Skills

In this interactive session, you will get a chance to discuss your contract manufacturing and outsourcing problem-solving skills with peers and exchange views, fi nd out what worked and didn’t work for others, and learn how they tackled various challenges.

Please come prepared with one challenge you’d like to discuss.

Challenges to be explored could include:

• What do you do when you fi nd out your CMO has been issued a 483?• What do you do in the event of a public recall? • What role should the sponsor take in the aftermath of an adverse

event? • How much responsibility should a CMO be expected to take on in the

event of a public recall?

5:15 Day One Concludes

“Extremely relevant and applicable presentations”

— Director, Supplier Quality Management, MEDIMMUNE


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DAY TWO Friday, April 24, 2015

8:00 Continental Breakfast

9:00 Chairman’s Day One Recap


9:15 Identify Risks and Weaknesses Associated with Service Systems and Products of a CMO by Implementing Quality by Design (QbD) Practices

• Ensure transparent communication is in place between sponsor and CMO for quality risk management

• Ascertain the process for communicating new and existing risks through a process diagram

• Identify red fl ags of product quality issues• Maintain control and transparency through the manufacturing process• Examine the amount of risk sponsor companies think CMOs add

Ben Locwin, Head of T&D, Global Head of Center of Excellence, LONZA


10:30 Cultivate Smart Guidelines for Collaborating with External Vendors in Emerging Markets

• Identify the right international partners for your organization• Navigate the Asian CMO market • Draft quality agreements to ensure GMP compliance• Align your CMO operating model with FDA guidelines for partnering

overseas


11:15 Learn CMO and License Holder Integration and Atypical Visible Particle Reduction

• Examine the Atypical Visible Particle Reduction initiative and compliance to USP <790> (Visible Particulates in Injections)

• Understand eff ective usage of specialist-in-plant • Utilize communication strategies including governance • Integrate new vendors into an existing external partnership model by

setting expectations and making it a two-way street

Jonathan Patroni, Vice President, US Quality Assurance, SHIRE

Will Tilton, Vice President, US Supply Chain, SHIRE

12:00 Luncheon

1:00 Identify the Right Suppliers for Emerging, Niche or Start-Up Companies

• Implement a structured process to defi ne objectives and identify candidates

• Assess the profi ciency and structure of the supplier through an integrated approach to CMO qualifi cation

• Align your network with the quality standards, management and liabilities of the CMO

• Evaluate fi nancial impact on your organization


2:00 Process Performance Qualifi cation, PAI Readiness, PAI

Execution and Post Approval• Learn how to develop successful process performance qualifi cations

for biologics bulk drug substances • Prepare CMO for PAI readiness and execute fl awlessly as partners • Implement and maintain post-approval commitments from health

authorities while continuing to launch in multiple markets

Lee Fox, Biologics External Manufacturing Quality Manager, BRISTOL-MYERS SQUIBB


3:00 Incorporate CMO Oversight into Your Organization’s Governance Structure

• Defi ne methods for managing CMO and performance accountability• Assign roles for key parts of the supply chain

3:45 Explore Best Practices for a Mutually Eff ective Collaboration with a CMO

• Take strategic steps to initiate a partnership and request a proposal • Understand the evaluation process while reviewing a CMO’s proposal• Execute an eff ective kick-off meeting

Wanda Tormos, Senior Manager, Chemical Development Outsourcing, GILEAD

4:30 Chairman’s Closing Remarks


4:45 Conference Concludes

“The CMOs sessions were very relevant to the outsourcing world”

— Outsourcing Project Manager,

BRISTOL-MYERS SQUIBB

“This was a great topic, very relevant in the current environment.” — Director, CUBIST PHARMACEUTICALS


Media Partners:

Registration Fees:

EARLY BIRD PRICING* $1,895Register by March 13, 2015

GROUP DISCOUNT PROGRAMS:*Offers may not be combined. Early Bird rates do not apply.*

SAVE 25%For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). A savings of 25% per person.

SAVE 15% Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 212-400-6240.

Payments must be received in full prior to the commencement of the conference.

Payment:Make checks payable to ExL Events, Inc. and write code C564 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other o� ers and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. Cancellation and Refund Policy:If you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event:

• Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.• Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.

If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less.To receive a refund or voucher, please fax your request to 888-221-6750.Credit Vouchers are valid for 12 months from date of issue. Credit Vouchers are valid towards one (1) ExL Event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is no longer applicable now or in the future. Once a Credit Voucher has been applied towards a future event, changes cannot be made. In the event of cancellation on the attendees’ behalf, the Credit Voucher will no longer be valid.Substitution Charges:There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within fi ve business days of the conference.ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare, hotel or any other costs incurred by registrants.

ExL Events’ liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speakers or venue.

*The opinions of ExL speakers do not necessarily re� ect those of the companies they represent, nor ExL Events, Inc.

Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, signi� cant e� ort to � nd a suitable replacement will be made.

STANDARD PRICING* $2,095Register After March 13, 2015

ONSITE PRICING* $2,195

*Includes Sales Tax and Service Fees

Questions? Comments?

Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader?

Please email Conference Producer Charleen Famiglietti at [email protected].

Outsourcing -Pharma.com

Five Ways to Register Mail: ExL Events, Inc.494 8th Avenue, 4th FloorNew York, NY 10001

Fax: 888-221-6750

Phone: 866-207-6528

Email: [email protected]

Online: www.exlevents.com/CMO

5TH

CMOCMOCMOAPRIL 23-24, 2015 | WYNDHAM BOSTON BEACON HILL | BOSTON, MA

CMOCMOCMOCMOCMOCMO“This is one of the best conferences that I’ve attended in my

30+ years of experience” — Senior Manager, GILEAD

QUALITY OVERSIGHT & RISK MANAGEMENT

Strategic Insights on Drug Development Outsourcing to a Contract Manufacturing Organization in an Evolving Regulatory Landscape

SUMMIT

o Yes! Register me for the Conference

Please contact me:

o I’m interested in marketing opportunities at this event

o I wish to receive email updates on ExL Pharma’s upcoming events

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Company:

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Make checks payable to ExL Events, Inc.

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Signature:

494 8th Avenue, 4th FloorNew York, NY 10001

Amnon Eylath

Senior Director, Quality

Assurance, GENZYME

Conference Chairman:Top Reasons to Attend:

ü Get up to date on the latest FDA policies and their impact on CMO partnerships

ü Learn to identify individual risks and their effect on a project when considering outsourcing; reduce risks to patients, operations, and supply chain through preemptive detection and product oversight

ü Draft creative contracts and quality agreements that incentivize CMOs to develop timely, high quality products


Five Ways to Register

Mail: ExL Events, Inc.494 8th Avenue, 4th FloorNew York , NY 10001

Fax: 888-221-6750

Phone: 866-207-6528

Email: [email protected]

Online: www.exlevents.com/CMO

th gilead cmo - exl eventsinfo.exlevents.com/rs/exlevents/images/c564_web.pdfsetting expectations...

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