CMO Quality Oversight & Risk Management, April 2011, Boston


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Managing CMOs to Deliver Your Product to Your Quality & Time Requirement

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CMO Quality Oversight & Risk Management, April 2011, Boston

  1. 1. REGISTER BY FeBruary 25 AND SAVE $400! CMo Quality oversight & risk ManageMent Managing CMOs to Deliver Your Product to Your Quality & Time Requirements April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA Featured Presentations: sPeaking FaCultyregulatory Perspective on Quality assurance within the evolving dhan amaria, Director, Quality Assurance,Contract Manufacturing relationship NEKTAR THERAPEUTICSsandra roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS rhonda Fendelet, Director, External Supply Integration Quality – PDMS, JANSSEN SUPPLY CHAINapplying a risk Management system to the Contracting Process rolf hartmann, Procurement Director,to sustain the highest level of Quality from a CMo/sponsor GLAXOSMITHKLINErelationship Juanita hawkins, Vice President, GlobalCaroline o’Brien, Associate Director QA Sourcing, Pharmaceutical Quality Assurance and Compliance, CELGENEDevelopment, ASTRAZENECA Jeff huth, Ph.d., Leader, Quality & Compliance, JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH &how overall Product lifecycle and Product Phases including DEVELOPMENTCommercialization Can Factor into the Contract Manufacturing denise Mcdade, Senior Director, Qualityrelationship Assurance, AMYLIN PHARMACEUTICALSJeff huth, Ph.d., Leader, Quality & Compliance, robert o’hagan, Director Quality Operations,JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT ABBOTT BIORESEARCH CENTER Caroline o’Brien, Associate Director QA Sourcing, Pharmaceutical Development, ASTRAZENECA Featured Panel disCussion: sandra roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALSglobal Considerations and Business differences when Contracting Prashant savle, Ph.d., Director, Sourcing,an off-shore CMo Partner: how Close are We to a harmonized Global Procurement, MERCK SHARPE & DOHMEstandard of gMP? Michael semo, Global Sourcing Manager, VirtualPanelists: CMC Team, ELI LILLY & COMPANYPrashant savle, Ph.d., Director, Sourcing, Global Procurement,MERCK SHARPE & DOHME g. sean Williams C.P.M., sCor-P, Associate Dir, Global Facilities Procurement,Michael semo, Global Sourcing Manager, Virtual CMC Team, BRISTOL-MYERS SQUIBBELI LILLY & COMPANY Janice B Wilson, Phd, Vice Presidentdhan amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS Corporate Quality Assurance, ELAN PHARMACEUTICALS To R e gister Call 866-207-6528 or visit c m o
  2. 2. Dear Colleague, This Summit is specifically designed for C-Levels, DepartmentThere is industry agreement that a substantial investment must be made to Heads, Vice Presidents, Directorssupport the life-cycle of a pharmaceutical product from the developmental stage and Managers at pharmaceutical,to commercial production. There is also definitive data that shows in addition to biotechnology and medical devicethe FDA, regulatory bodies worldwide are becoming more and more conservative companies from the followingwith the candidates they approve for commercial access. departments:Within the contract manufacturing relationship, pharmaceutical companies aretaking the necessary steps to adjust to this changing industry trend, providing  Contract manufacturingincreased resources to ensure control and consistency in the manufacturing of  manufacturing Operationstheir products to avoid unnecessary delays including regulatory action.  Regulatory AffairsJoin us April 28th - 29th where presentations dedicated to the successful CMO  Regulatory Compliancepartnership dynamic will be shared, including best practices in management such  Validationas quality oversight, risk management, and ensuring time requirements are met.  ComplianceThe FDA has made it clear that if your name is on the label, you are responsible  Quality Assurancefor what’s inside the package.  Quality OperationsLook forward to seeing you in Boston!  Quality Development  OutsourcingSincerely,  Sourcing  Supply Chain  Operational ExcellenceMatthew MillmanSenior Conference Sponsorship and Exhibit Opportunities OmNI PARkER HOuSE HOTEl Do you want to spread the word about your organization’s solutions 60 School Street and services to potential clients who Boston, MA 02108 attend this event? Take advantage of P:617-227-8600 the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL works closely with youAs you pass through the sculpted bronze doors of this luxury Boston hotel, you to customize a package that suits all ofwill be enveloped by the timeless beauty that has made the Omni Parker House your needs.a landmark since 1855. Experience the perfect blend of modern amenities andhistoric charm at America’s oldest continuously-operating hotel. Walk to Beacon To learn more about these opportunities,Hill, Faneuil Hall Marketplace, Quincy Market, the Financial District, shopping and contact Eric Morrin, Businessmore. Just 2.5 miles (10-15 minutes) from Logan International Airport. Development Manager by calling 212-400-6228 or by emailingroom reservations: If you require overnight accommodations, please contact the hoteland state that you are with ExL’s CMO Quality Oversight & Risk Management Conference for on our discounted room rates. We encourage conference participants to makereservations by Wednesday, April 6th with our designated venue as our discounted roomrates are limited. To R e g i ster Call 866-207-6528 or visit m o
  3. 3. day one – aPril 28th, 2011 Pre-ConFerenCe WorkshoP8:00 Registration Opens and Continental Breakfast is Served for Workshop Attendees9:00 selecting a CMo Partner How Including Quality Early in the Selection Process can Ensure a Stronger Overall Partnership Led By: Janice B Wilson, PhD, Vice President Corporate Quality Assurance, ELAN PHARMACEUTICALS • Including quality in the selection process - Transparency and accessibility of a potential partners’ quality history - What quality factors to look for from a partner - What issues can kill the deal? • Designing quality agreements with clear criteria that define the responsibilities of an outsourced partner - Identifying the important deliverables that need to be included in the Quality Agreement - Customizing a Quality Agreement that fits a specific project aspect - Determining which types of agreements to use – technical versus quality? What is the difference? - Modifying a Quality Agreement to reflect existing regulations and industry standards*There will be a 30-minute coffee and networking break during the workshop12:00 Lunch for Workshop Attendees / Registration Opens for Main Conference Main ConFerenCe 3:00 networking & refreshment Break1:15 Chairperson’s Welcome and Opening Remarks 3:30 Case study: integrated Facilities1:30 keynote talk: CMo Management outsourcing ManageMent strategy Thinking with the End in Mind: Driving a Streamlined Global Integrated Facilities Management Outsourcing Deal from Concept Aligning Your Corporate Philosophy and Your CMO Outsourcing to Implementation Strategy to Achieve Business Objectives G. Sean Williams C.P.M., SCOR-P Associate Dir, Global Facilities Juanita Hawkins, Vice President, Global Quality Assurance and Procurement, BRISTOL-MYERS SQUIBB Compliance, CELGENE • Evaluating the pros and cons to understand whether an IFM program fits into your • Gaining internal buy-in and understanding the risk related to strategy company’s strategic planning • Critical decision making for internal, external or hybrid manufacturing allocation • Building the appropriate quality and performance measurements in the negotiation • Clarity for expectations, delegating work versus responsibility, and control to prevent post implementation margin erosion • Key drivers of Service Provider downselecting outside of cost2:15 regulatory Perspective 4:15 Communication The Roadmap for Successful Communication within a Partnership that Regulatory Perspective on Quality Assurance within the Drives Quality Oversight Success Evolving Contract Manufacturing Relationship Rhonda Fendelet, Director, External Supply Integration Quality – PDMS, Sandra Roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS JANSSEN SUPPLY CHAIN • Agency concerns over business procedures • The governance model and deployment of Communication Plan • Expectations for both sponsors and contract sites during inspections and GMP • Clarifying roles & responsibilities within the relationship to avoid dysfunction assessments • Using metrics and feedback as the key performance indicators for success • Best practices to ensure that sponsors, contract manufacturers and regulatory agencies are all on the same page • Upcoming anticipated guidance for selection of a contract facility and conducting audits 5:00 Close of day one To R e g i ster Call 866-207-6528 or visit m o
  4. 4. day tWo – aPril 29th, 2011 international Considerations Main ConFerenCe 11:45 PANEL DISCUSSION: Global Considerations and Business Differences when Contracting an Off-Shore CMO Partner: How Close are We to 9:00 Chairperson’s Day Two Welcome and a Harmonized Standard of GMP? Opening Remarks Panelists Include: Dhan Amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS Prashant S Savle, Ph.D., Director, Sourcing, Global Procurement,9:05 lifecycle Considerations MERCK SHARPE & DOHME Michael Semo, Global Sourcing Manager, Virtual CMC Team, How Overall Product Lifecycle and Product Phases Including ELI LILLY & COMPANY Commercialization Can Factor into the Contract Manufacturing • What are the differences between a domestic partner and an international Relationship one, if any? Jeff Huth, Ph.D., Leader, Quality & Compliance, • What cultural considerations should be made prior to commencement of the JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT partnership and how do these affect the level of communication and expectations? Contract Manufacturing Organizations face an evolutionary dilemma in trying to • How does risk acceptability vary between a sponsor and a contract partner? establish their business plan strategy and technical capabilities every day. While clearly there is a capital investment consideration in this regard, there are also key technical, operational, and regulatory considerations. 12:30 lunch This Session will Examine: • Elements associated with pharmaceutical product life-cycle as they relate to the technical, operational, and regulatory issues 1:30 Metrics • Discussion on the significance of the partnerships required to successfully manage Using KPIs and Operational Excellence to Ensure Quality in an the evolutionary pharmaceutical product life-cycle Outsourced Supply Chain • How ICH guidance concepts (in particular, ICH Q10) can provide a platform to not Denise McDade, Senior Director, Quality Assurance, only manage the relationship, but to enhance it. AMYLIN PHARMACEUTICALS • Setting quality oversight standards that drive the level of performance measurement and data collection • Building a corporate culture that can create a strategy to meet the standards 9:45 risk Management necessary for quality excellence Applying a Risk Management System to Vendor Assurance and Supplier • Adopting risk-shared principles that extend accountability to a project-wide scope Management in Development Caroline O’Brien, Associate Director QA Sourcing, Pharmaceutical 2:15 aPi development Development, ASTRAZENECA Keys for Successful Contract Manufacturing of Biological API’s to • Clearly and thoroughly translating risk factors for materials, processes and suppliers Support Clinical and Commercial Material • Understanding of Supply Chain and application of risk managed supplier auditing Robert O’Hagan, Director Quality Operations, • Development and maintenance of the holistic approach to Supplier Management ABBOTT BIORESEARCH CENTER • CMO Selection Considerations • Successful Business Model for CMO through product lifecycle 10:30 networking & refreshment Break • Quality Agreements and Regulatory Considerations 3:00 Closing Panel disCussion:11:00 spotlight session: outsourcing and Decommissions, Facing Problems, and Accepting that the Partnership Quality in latin america is Faulty – What Should be Done to Minimize the Failure Considerations when Contracting a CMO Partner in Latin America: Featuring Conference Presenters Regional Benefits & Constraints • What are the initial steps to be taken once a partnership is disconnected? Rolf Hartmann, Procurement Director, GLAXOSMITHKLINE • How to calculate the financial implications from the missteps that have occurred? • Examining cost differences between CMOs in Latin America and other Regions • Determine what the consequences are and if they can be fixed? • Ensuring quality standards and regulatory requirements are met and kept when • What are the public and reputational damage that has been done? working with an international CMO • Latin America regional snap-shot: contracting in traditional versus non-traditional countries 3:45 Close of Conference To R e g i ster Call 866-207-6528 or visit m o
  5. 5. Five Ways to register RegistRation Fees FoR attending exl’s CMo Quality oversight & PHOnE: 866-207-6528 risk ManageMent ConFeRenCe: EMAIL: OnLInE: Best value REgISTER By FRIDAy, FEBRuARy 25TH AnD SAvE $400! FAx: 888-221-6750 COnFEREnCE + WORkSHOP | $1795 MAIL: ExL Events, Inc. COnFEREnCE OnLy | $1495 555 8th Ave, Ste 310 new york, ny 10018 early-Bird PriCing REgISTER By FRIDAy, MARCH 25TH TO TAkE ADvAnTAgE OF EARLy-BIRD PRICIng:Group Discount proGram: COnFEREnCE + WORkSHOP | $1995 COnFEREnCE OnLy | $1695save 25% Per Person When registering FourFor every three simultaneous registrations from yourcompany, you will receive a fourth complimentary standard PriCingregistration to the program (must register 4 at one REgISTER AFTER MARCH 25TH:time). this is a savings of 25% per person. COnFEREnCE + WORkSHOP | $2195save 15% Per Person When registering three COnFEREnCE OnLy | $1895Can only send three? You can still save 15% off ofevery registration. to find out more on how you can visit WWW.exlPharMa.CoM/CMotake advantage of these group discounts, please call TO VIEw OuR VAluE JuSTIfICATION DOCumENT!866-207-6528.Make checks payable to exl events, inc. and write code mEDIA PARTNERSP742 on your check. You may also use Visa, MasterCard,discover or american express. Payments must be received infull 2 weeks prior to the conference.Cancellations: if you need to cancel your registration for anupcoming exL conference, please note the following policiesderived from the start date of the event: • Four weeks or more: a full refund (minus a $95 processing fee), or a voucher to another exL event valid for two years from the voucher issue date Four weeks or less: a voucher to another exL event valid for two years from the voucher issue date. • to receive a refund or voucher, please fax your request to 888-221-6750. • there will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague occurring within five business days of the conference.Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation,every effort to find a suitable replacement will be made. ExL Pharma’s liability is limited to the conference registrationfee in the event of a cancellation*The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL Events, Inc.* QuESTIONS? COmmENTS? do you have a question or comments 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 director, Matt Millman at
  6. 6. Fax: Telephone: Email: Zip: State: City: Address: Dept.: Company: Title: Name: PLEASE MENTION PRIORITY CODE: P742  I wish to receive email updates on ExL Pharma’s upcoming events New York, NY 10018  I’m interested in marketing opportunities at this event 555 8th Avenue, Suite 310 Please contact me: Yes! Register me for the conference only  Signature: Yes! Register me for the conference and workshop:  Name on Card: Exp. Date: Card Number: New York, NY 10018 MasterCard  Visa  Discover Amex Card Type: 888-221-6750 555 8th Avenue, Suite 310 Make checks payable to ExL Events, Inc. 866-207-6528 ExL Events, Inc.  Check Credit Card Method of Payment: Registration Form: REGISTER BY FeBruary 25 AND SAVE $400! CMo Quality oversight & risk ManageMent Managing CMOs to Deliver Your Product to Your Quality & Time Requirements April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA Featured Presentations: sPeaking FaCulty FroM these CoMPaniesRegulatory Perspective on Quality Assurance How Overall Product lifecycle and Product Phaseswithin the Evolving Contract manufacturing Including Commercialization Can factor into the NEKTAR THERAPEUTICS NOVENRelationship Contract manufacturing Relationship PHARMACEUTICALS MERCK ELI LILLY & COMPANYApplying a Risk management System to the Global Considerations and Business Differences GLAXOSMITHKLINEContracting Process to Sustain the Highest level of when Contracting an Off-Shore CmO Partner: How BRISTOL-MYERS SQUIBB CELGENEQuality from a CmO/Sponsor Relationship Close are we to a Harmonized Standard of GmP? ELAN ASTRAZENECA PHARMACEUTICALS To R e gister Call 866-207-6528 or visit c m o