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

Transcription

1 5 TH This is one of the best conferences that I ve attended in my 30+ years of experience Senior Manager, GILEAD QUALITY OVERSIGHT & RISK MANAGEMENT SUMMIT Strategic Insights on Drug Development Outsourcing to a Contract Manufacturing Organization in an Evolving Regulatory Landscape APRIL 23-24, 2015 WYNDHAM BOSTON BEACON HILL BOSTON, MA Conference Chairman: Top Reasons to Attend: Amnon Eylath Senior Director, Quality Assurance, Featured Sessions: IDENTIFY RISKS AND WEAKNESSES ASSOCIATED WITH SERVICES, SYSTEMS AND PRODUCTS OF A BY IMPLEMENTING QUALITY BY DESIGN (QBD) PRACTICES Ben Locwin, Former Head of T&D, Global Head of Center of Excellence, LONZA PROCESS PERFORMANCE QUALIFICATION, PAI READINESS, PAI EXECUTION AND POST APPROVAL Lee Fox, Third Manufacturing Quality Manager, BRISTOL-MYERS SQUIBB Get up to date on the latest FDA policies and their impact on a partnership Network and connect with, pharma and biotech professionals, and take away valuable insights to help prevent costly mistakes in forming and executing external partnerships 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 CASE STUDY: LEARN AND LICENSE HOLDER INTEGRATION AND ATYPICAL VISIBLE PARTICLE REDUCTION Jonathan Patroni, Vice President, US Quality Assurance, SHIRE Distinguished Speaker Faculty Includes: Draft creative contracts and quality agreements that incentivize s to produce timely, high-quality results 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 Sponsor: To Register: Call or Visit

2 5 TH QUALITY OVERSIGHT & RISK MANAGEMENT SUMMIT Dear Colleague, The use of contract manufacturing organizations (s) 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 market value will exceed $60 billion by Thus, effective 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 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 s, serving as a networking platform and offering professionals vital information on how to strategically navigate the outsourcing and quality oversight of s in an evolving regulatory landscape. Additionally, this event offers 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/ partnership. This conference will offer a unique tool kit to help design the right manufacturing and development program, establish a sense of co-ownership and responsibility for the and client, execute a unified contract, and identify roles and responsibilities for each member of a project. Additional topics include best practices to effectively oversee and manage external manufacturers, tips on utilizing big data analytics to improve results, the newest FDA policies and their impact on partnerships, effective risk management strategies for life science companies and s, the latest outsourcing trends, and strategies for creative contracting. You asked for content specifically addressing the topics below. We are thrilled to provide you with unique case studies, panels and interactive sessions on: Drafting creative contracts and quality agreements that incentivize s Identifying the right supplier for emerging, niche or start-up companies Pinpointing risks and weaknesses by implementing Quality by Design (QbD) practices Join industry leaders and quality professionals to discuss best practices for successful management and partnerships. I look forward to seeing you in Boston this April! Sincerely, Charleen Famiglietti Conference Production Director ExL Pharma cfamiglietti@exlevents.com Venue Information: WYNDHAM BOSTON BEACON HILL 5 Blossom Street Boston, MA 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, To make reservations guests can call and request the negotiated rate for ExL s April Meeting Please book your room early as rooms available at this rate are limited. WHO SHOULD ATTEND: This conference is of interest to, 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 Affairs/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 Auditing Software Companies Regulatory/Compliance Consultants SPONSORSHIP AND EXHIBITION OPPORTUNITIES Do 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 or asinetar@exlevents.com. To Register: Call or Visit

3 Day One Thursday, April 23, :00 Registration and Continental Breakfast 9:00 Chairman s Opening Remarks 9:15 Identify Best Practices for Selection and Oversight of s Consider critical elements while evaluating and selecting s Review components of quality agreements and Master Service Agreements, including elements excluded from FDA guidance or EU GMPs Gain insight to successful, productive -Sponsor partnerships Brian Clark, Executive Director, Quality, IMMUNOGEN 10:00 An Integrated Approach to Contract Manufacturing and Utilizing a Review best practice for pre-qualifying and executing a partnership with a Establish a mutually effective collaboration between a sponsor and Discuss varied approaches to utilizing and managing a Develop a strategic partnership arrangement Daniel Eylath, Manufacturing Compliance Specialist, MASSBIOLOGICS Heidi Hoffmann, Senior Director, Manufacturing, SUTRO BIOPHARMA Firelli Alonso-Caplen, Ph.D, Senior Director, BioTherapeutics & Vaccines Outsourcing, PFIZER Dan Trimberger, Director, Quality Assurance, MOMENTA PHARMACEUTICALS Brian Clark, Executive Director, Quality, IMMUNOGEN Wanda Tormos, Senior Manager, Chemical Development Outsourcing, GILEAD PANEL DISCUSSION 12:00 Develop a Creative Quality Agreement and Multi-Level Contracts when Working with a Partner Form contracts with clear, thought-out objectives in mind Build incentives into contracts to encourage yield and long-term efficiency 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 Profile of Using s 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 and Align Interface for Robust Tech Transfer Select a using good planning and a consistent robust approach Allocate responsibilities between a sponsor and a Ensure adequate compliance and good business sustainability Utilize selection tools such as RFI, RFP/RFQ, term sheets, and the vendor selection matrix Michael Butera, Director, External Manufacturing, REGENERON PHARMACEUTICALS 10:45 Networking Break 11:15 Quality and Manufacturing Considerations for a Site With Multiple Customer Products Lisa Thimmesch, Customer Quality Manager, McPherson, Kansas; HOSPIRA INC. Extremely relevant and applicable presentations Director, Supplier Quality Management, MEDIMMUNE 3:15 Networking Break 3:45 Best Practices for Working Together with a Sponsor to Achieve Seamless Execution of Product Development Understand the s perspective of the partnership Implement an effective internal management structure Discuss frequent challenges s 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, find 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 find out your 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 be expected to take on in the event of a public recall? 5:15 Day One Concludes To Register: Call or Visit

4 DAY TWO Friday, April 24, :00 Continental Breakfast 9:00 Chairman s Day One Recap 9:15 Identify Risks and Weaknesses Associated with Service Systems and Products of a by Implementing Quality by Design (QbD) Practices Ensure transparent communication is in place between sponsor and for quality risk management Ascertain the process for communicating new and existing risks through a process diagram Identify red flags of product quality issues Maintain control and transparency through the manufacturing process Examine the amount of risk sponsor companies think s add Ben Locwin, Head of T&D, Global Head of Center of Excellence, LONZA 10:00 Networking Break 10:30 Cultivate Smart Guidelines for Collaborating with External Vendors in Emerging Markets Identify the right international partners for your organization Navigate the Asian market Draft quality agreements to ensure GMP compliance Align your operating model with FDA guidelines for partnering overseas Dan Trimberger, Director, Quality Assurance, MOMENTA PHARMACEUTICALS 11:15 Learn 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 effective 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 CASE STUDY 12:00 Luncheon 1:00 Identify the Right Suppliers for Emerging, Niche or Start-Up Companies Implement a structured process to define objectives and identify candidates Assess the proficiency and structure of the supplier through an integrated approach to qualification Align your network with the quality standards, management and liabilities of the Evaluate financial impact on your organization 2:00 Process Performance Qualification, PAI Readiness, PAI CASE STUDY CASE STUDY Execution and Post Approval Learn how to develop successful process performance qualifications for biologics bulk drug substances Prepare for PAI readiness and execute flawlessly 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 2:45 Networking Break 3:00 Incorporate Oversight into Your Organization s Governance Structure Define methods for managing and performance accountability Assign roles for key parts of the supply chain 3:45 Explore Best Practices for a Mutually Effective Collaboration with a Take strategic steps to initiate a partnership and request a proposal Understand the evaluation process while reviewing a s proposal Execute an effective kick-off meeting Wanda Tormos, Senior Manager, Chemical Development Outsourcing, GILEAD 4:30 Chairman s Closing Remarks 4:45 Conference Concludes The s 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 To Register: Call or Visit

5 Five Ways to Register Mail: ExL Events, Inc th Avenue, 4th Floor New York, NY Fax: Phone: Online: Media Partners: Outsourcing -Pharma.com Registration Fees: EARLY BIRD PRICING* $1,895 Register by March 13, 2015 STANDARD PRICING* $2,095 Register After March 13, 2015 ONSITE PRICING* $2,195 *Includes Sales Tax and Service Fees 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 Payments must be received in full prior to the commencement of the conference. 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 Conference Producer Charleen Famiglietti at cfamiglietti@exlevents.com. 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 offers 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 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 five 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 reflect 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, significant effort to find a suitable replacement will be made.

6 Five Ways to Register Mail: ExL Events, Inc th Avenue, 4th Floor New York, NY o Yes! Register me for the Conference Fax: Phone: Online: Please contact me: o I m interested in marketing opportunities at this event o I wish to receive updates on ExL Pharma s upcoming events Method of Payment: o Check o Credit Card Make checks payable to ExL Events, Inc. Card Type: omastercard ovisa odiscover oamex Card Number: Name on Card: Signature: 494 8th Avenue, 4th Floor New York, NY Exp. Date: Name: Title: Company: Dept.: Address: City: State: Zip: Telephone: Fax: 5 TH 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 APRIL 23-24, 2015 WYNDHAM BOSTON BEACON HILL BOSTON, MA Conference Chairman: Top Reasons to Attend: Get up to date on the latest FDA policies and their impact on partnerships Amnon Eylath Senior Director, Quality Assurance, 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 Draft creative contracts and quality agreements that incentivize s to develop timely, high quality products To Register: Call or Visit