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9th Contract Manufacturing Tlsse.Pd

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Analyzing the CMO Market: Tools for Choosing a ...

Analyzing the CMO Market: Tools for Choosing a
Preferred CMO
• Understanding the Impact of an Economic Downturn
on Overseas Outsourcing
• Execution of Multiple Outsourcing Projects
• Influencing the Ability to Sustain Validation and Process
Compliance – Post CMO Collaboration
• Understanding the Essential Elements for Successful
Technology Transfer
• Addressing Product Quality Issues

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    9th Contract Manufacturing Tlsse.Pd 9th Contract Manufacturing Tlsse.Pd Document Transcript

    • Register by March 6 and Save $500 off the standard price 9th Contract Manufacturing Pharmaceuticals and Biotech TM for Mitigating Risks, Ensuring Compliance, and Improving May 11-13, 2009 Efficiency for Domestic and International Outsourcing San Francisco, California Conference Highlights Include: Analyzing the CMO Market: Tools for Choosing a Influencing the Ability to Sustain Validation and Process • • Preferred CMO Compliance – Post CMO Collaboration Understanding the Impact of an Economic Downturn Understanding the Essential Elements for Successful • • on Overseas Outsourcing Technology Transfer Execution of Multiple Outsourcing Projects Addressing Product Quality Issues • • Learn from Leading Innovators Including: Schering Plough King Pharmaceuticals Pfizer Inc. Human Genome Sciences Sangamo BioSciences Inc Genentech, Inc. Landela Pharmaceutical, Inc. Inspire Pharmaceuticals Amgen Inc. Compliance Surety Associates Bristol-Myers Squibb IDM Pharma Inc Johnson & Johnson Bausch & Lomb Merck &Co. Inc. And Others Sponsored by: Media Partners: Register Today! Call Sam at 416-597 4719 or e-mai l: sam.eid@iqpc.com
    • Past Attendee Profile 9th Contract Manufacturing Job title Breakdown from our Previous Contract Pharmaceuticals and Biotech Manufacturing for for TM Pharmaceuticals and Biotech Conference Dear Colleagues, ■ Quality Assurance In an ever turbulent economy, phar ■ Engineer/Engineering Manager maceutical and biotech companies are being influenced by the financial and operational bene fits of outsourcing further aspects ■ Director of their manufacturing processes. As a result of this, it is important for a company to mitig ate risks while maximizing profit and production. ■ Supply Head ■ Executive At our 9th Contract Manufacturin g for Pharmaceuticals and Biotech conference, we have gathered many high-level industry ■ Business Development experts to provide insights and uniq ue solutions for the most common challenges faced in this industry. Our sessions and work ■ Operational Head shops will help assist your organization’s efficient, econ omically-viable and compliant man ufacturing supply chain. ■ Professor By attending this conference, you ■ Capital Markets Manager will hear industry-specific case studies and examples addressing: ■ Clinical Supplies Analyzing the CMO market: Indispens • able tools for choosing a preferred CMO Due diligence in the emerging mark • ■ Regulatory Manager ets Execution of multiple outsourcing • projects ■ CEO Maximizing innovation: Addressing • the importance to small biotech’s and start-ups Influencing the ability to sustain valid • ■ Business Manager ation and process compliance – Post CMO collaboration ■ R&D Director Monitoring and ensuring the qual • ity of outsourced manufactured pack aging And much more including over 4+ • hours of scheduled networking, insig htful interactive panel discussions and a series of inter active workshops. Engage in dynamic conversation with your industry peers at our multiple networking sessions Special Thanks to Our and work closely with many Cont ract Manufacturing industry experts. Be sure to register yourself and a team of key people for this important event today! Advisory Board: We look forward to seeing you in San Francisco in May! Shawn Eisenberg, Ph.D., Director, Global Operations Planning, Amgen Best Regards, Raj Rajamani, Senior Manager, CQA, P.S Highly interactive Corporate Regulatory Compliance, Pfizer Inc. and informative Jonathan Walker, Director, Manufacturing workshops! See page Simon Curtis and Supply Chain, Bristol-Myers Squibb Conference Director 5 for details PharmaIQ Nick Anousis, Ph.D, Associate Director, Material and Capital Procurement, Merck & Co. Inc. Ralph L. Dillon, Managing Director, About Our Sponsor: Compliance Surety Associates Siegfried is a globally active, independent Swiss company. As a supplier and service provider for the worldwide pharmaceutical industry, we specialize in the Carl Tatsuguchi, Director, TPM Support, development and production of controlled substances, custom-manufactured APIs Manufacturing Science and Technology, and finished drugs. We focus on maintaining the highest level of competence, Global Pharmaceutical Operations, working together with our clients as partners. Our specific know-how in process development, chemical Abbott Laboratories and pharmaceutical production, and managing complex outsourcing projects is used to contribute significantly to the success of our customers Jeff Ulmer, PE, PMP, Global Launch Leader, Elanco Animal Health – A Division of Eli Lilly & Co. Elise Brownell, PhD, Founding Partner, Zephyr Biotech, LLC, Former Head of Project Management and Senior Director, Aerovance, Inc. Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com 2
    • Main Conference Day 1 Tuesday May 12, 2009 Panel Discussion: Understanding the Impact of an Welcome Address and Chairpersons’ Opening 2:15 8:50 Economic Downturn on Overseas Outsourcing Remarks Sponsored by: Developing and managing your communication and demands • with your overseas CMO Assessing Risk Management of the Quality • Addressing and openly communicating demand and supply issues 9:00 System of your CMO with your CMO in a turbulent economy • Discovering alternative investment and outsourcing opportunities Utilizing a risk-based auditing approach • from emerging markets Using a monitoring plan for your suppliers in lieu of an audit • • The demand for growth of an international regulatory culture • Evaluating ongoing quality performance of your suppliers overseas • Importance of Quality Agreements • Understanding market trend analysis in order to project a suitable • Discussing qualification of suppliers from a quality standpoint timescale to perform tech transfer during touch economic • Key areas for supplier audits conditions overseas Doris St. John, Manager Supplier Quality GPSG, Johnson & Moderator: Raj Rajamani, Senior Manager, CQA, Corporate Johnson Regulatory Compliance, Pfizer Inc. Analyzing the CMO Market: Tools for Choosing a Panelists: Shawn Eisenberg, Ph.D., Director, Global Operations 9:45 Preferred CMO Planning, Amgen Inc. Dave Lamoureux, Associate Director Contract Manufacturing, Understanding the scientific background and capabilities of • IDM Pharma Inc tentative CMOs • Addressing a CMO's experience developing a biologic product Networking Break 3:00 from early clinical stages through regulatory review and commercialization Execution of Multiple Outsourcing Projects 3:30 • Assessing a CMO's necessary facility, equipment and personnel Designing a framework for your organization when considering infrastructure for successful commercialization of a biologic drug • multiple projects with a CMO at one time product • Successfully managing several small and medium size projects • Importance of quality agreements simultaneously • Assessing the potential of a CMO’s global reach with regards to • Realizing warning signs from outsourced projects and providing manufacture, supply channels, quality/regulatory requirements, etc. mitigation plans • Compiling a data set in order to rank and risk assess potential CMOs • Prioritizing projects in terms of importance and delivery date Sarah Thomas, Vice President, Quality, Human Genome Sciences • Case study example: Managing more than 8 projects with a single Networking Break CMO or multiple CMOs concurrently 10:30 Nick Anousis, Ph.D, Associate Director, Material and Capital Establishing the foundation for a Successful Procurement, Merck &Co. Inc. * 11:00 Project, Part 1 - Criticality of a High-Quality, Addressing Product Quality Issues Accurate Request for Quotation 4:15 Addressing the role of quality in the selection and management of Addressing long-term benefits • • contractors • Evaluating risks of short-changing the RFQ • Influencing and encouraging product quality assurance • Addressing the value of cross-functional input • Inspecting CMO supplies – Security of supplies to a CMO: Are • Discussing the opportunity to gain initial Client-Provider alignment they compliant? Shawn Eisenberg, Ph.D., Director, Global Operations Planning, • Tools - Discussing options for quality agreements , coordinating Amgen Inc. and ensuring effective communication, and resolving disputes - Establishing the foundation for a Successful Maintaining product quality and supply chain cost together 11:45 Project, Part 2 - Selecting the Right Contractor • Highlighting the role of multiple QAs in your supplies Joseph Noferi, Director, Compliance Surety Associates Assembling cross-functional selection team • Leveraging contractors’ proposals, site visit and audit data • Maximizing Innovation: Addressing the 5:00 • Weighing choices, making decision Importance to Small Biotech’s and Start-ups • Highlighting importance of post-decision follow-up Identifying successful strategies in order to go about Karen Riley, Contract Manufacturing Manager, Contract • finding/locating/attracting a suitable CMO Manufacturing Operations, Amgen Inc. • Unearthing the breakdown of manufacturing costs: How to locate Networking Lunch cost-saving solutions and techniques within your outsourcing 12:30 supply chain Due Diligence in Emerging Markets (EM) • Locating the correct CMO geared to working with small- 1:30 scale/start-up companies Due diligence process- Common mistakes and areas of focus • • Discussing the importance on focusing on your pilot projects from Examining China versus India • start to finish • Contract negotiations with EM partners • Discussing case study examples • How to structure and implement quality agreements with partners Bao-Lu Chen, Director of Manufacturing and Process Development, in EM Sangamo BioSciences Inc • Displaying structure of the partnership for a positive outcome for both parties Chairpersons’ Closing Remarks and End of Day One 5:45 • Addressing challenges in communication, time zones, and culture • Evaluating options for CMO options in EM 6:00- 9:00 Mid-Conference Workshop • Displaying specific details on a current project in China Content to be confirmed – Earl Sullivan, Chief Executive Officer, Landela Pharmaceutical, Inc. Sponsored by: Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com 3
    • Main Conference Day 2 Wednesday May 13, 2009 Networking Lunch Welcome Address and Chairpersons’ Opening 12:30 9:00 Remarks Sponsored by: Monitoring and Ensuring the Quality of 1:30 Outsourced Manufactured Packaging A regulatory Approach for Contract Role of the audit in CMO selection 9:10 • Manufacturing Ensuring appropriate action at the CMO - Aseptic filling/ • lyophilization/ capping/ labeling/ final packaging/ distributors role Addressing the impact of the FDA draft guidelines on • • Exploring differing supply chain approaches for different product manufacturing process markets - Clinical supplies/ orphan drugs / cold chain products/ • QBD initiatives: How does your organization compare on trend sunset products/ blockbusters monitoring data • Role of bar coding / RFID with hospital requirements and • Discussing Q9 – Design process legislation mandating tracking • Examining Q10 – Commercial Ralph L. Dillon, Director, Compliance Surety Associates • Becoming compliant as the key to continuous improvement • Developing a robust risk mitigation strategy to prevent negative Challenges in Biopharmaceutical Outsourced 2:15 consequences of non-compliance by the CMO Scale-up (across three continents and a host of Robert Guzman, Associate Director, Corporate Quality and different specialized CMOs) Compliance, Inspire Pharmaceuticals Discussing product description • Creating an Outsourcing Strategy to Improve Leveraging product history to make successful product runs with 9:55 • Development Lead-time and Product Lifecycle new people and equipment • The manufacturing challenge – Developing the supply chain Overview of strategies to maximize product life cycle management • • The business challenge – Demonstrating comparability without Discussing CMO selection process and relationship governance • performing additional clinical trials • Recognizing late product lifecycle: Outsourcing to maintain • Supplying a market in Need - Current Status product market performance, while saving costs Dave Lamoureux, Senior Director, Contract Manufacturing, IDM • Displaying product lifecycle case study examples Pharma Inc. Nkere Ebube, Director of Technical Operations, King Pharmaceuticals Networking Break 3:00 Networking Break 10:40 Sustaining a Mutually Beneficial Operational 3:30 Relationship with your CMO as an Ongoing Understanding the Essential Elements for 11:00 Course of Action Successful Technology Transfer Managing risk with contractors – Developing an aligned approach Discussing people aspects: Monitor milestones, anticipating • • to benefit both parties slippage early, site readiness, managing suppliers, raw material • Addressing the importance of change control in contract inventories and monitoring risks manufacturing • Establishing the project plan: - Monitor milestones, anticipate • Handling strategies by inventory projections slippage early, site readiness, suppliers, raw material inventories, • Auditing contractors from a variety of directions – Uncovering a and monitoring risks series of approaches to consider when producing a risk-based • Managing the financials (Considering approval and delivery analysis for your choice of CMOs timelines for capital expenditures i.e. new processing equipments) • Inspecting supplies – Who is supplying to CMO, and will these • Discussing people aspects: Monitor milestones, anticipating materials be compliant with regulatory guidelines? slippage early, site readiness, managing suppliers, raw material Cortney Atkinson-Caudill, Senior Site Manager, Contract inventories and monitoring risks Manufacturing, Genentech, Inc. * Christopher Haas, Ph.D, Senior Director, Pharmaceutical Technology, Global Technical Services, Global Supply Chain, Supply Chain Sustainability - CMO Collaboration 4:15 Schering Plough Post-Technology Transfer Panel Discussion: Moving from Transactional to Development of internal business processes to manage CMO 11:45 • Strategic Partnerships - Understanding Big- collaboration - roles and responsibilities Pharma Requirements of Contract Manufacturers • CMO change control management • Employment of CMO supply chain, technical excellence and Identifying the complexities of the CMO client relationship • quality and compliance key performance indicators Understanding the importance of quality assurance, regulatory • • Utilizing internal information management systems compliance, technical capabilities and timescale • Resource allocation in CMO support • Discussing effective approaches for creating partnerships and Jonathan Walker, Director Manufacturing Technology, Technical strategic alliances with your CMO Operations, Bristol-Myers Squibb* • Re-evaluating value, cost, price and risk management Moderator: Raj Rajamani, Senior Manager, CQA, Corporate End of Conference & Chairpersons’ Closing 5:00 Regulatory Compliance, Pfizer Inc. Remarks Panelists: Scott Cassity, Global Quality Manager, Contract Manufacturing, Bausch & Lomb Ralph L. Dillon, Director, Compliance Surety Associates * Subject to final confirmation Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com 4
    • Pre-Conference Workshops Monday May 11, 2009 Workshop A 2:30pm – 5:30pm Registration at 2:15pm Implementing Quality Agreements Across your Supply Chain A Key Management Tool Quality Agreement Supporting tools, including Quality Release Maps – a • What will be covered: graphical tool for tracking product availability & status Reasons for a Quality Agreement Telecommunication systems, Computers and their use in Document Routing • • Quality agreement role in FDA/EMEA inspections Quality Agreements as a tool for working through 483s. Warming letters, and • • Cost savings/cost justification for this effort Consent Decrees (What if a link in your supply chain weakens?) • Dispute resolution tool • Your Workshop Leaders: Tracking & assessment tool for Adverse event (such as intermediate/Product • Joseph Noferi, Director, Compliance Surety Associates Quarantine or recall) Ralph L. Dillon, Director, Compliance Surety Associates Outline of quality agreement - What should be included as well as Quality • Jim McAndrew, Vice President of Operations, Pharmpro Services Agreement formats and Examples * Please check conference website for further updates Research, development and marketed product stage • Workshop B 6:00pm – 9:00pm Registration at 5:45pm Using a CMO Model as the Fastest and most Cost Effective Path from Development Though Marketed Product An Innovative Approach to Preserve Precious Capital Technical staff will be interested in this workshop as a means to extend scarce • What will be covered: talent resources and achieve their business objectives more quickly CMO DOSAGE development Relevant for HR & training professionals as a means to train qualified people • • CMO qualification batches and market launch product more effectively before the initiation of a new production line • Concurrent capital project development at NDA holder • Tech transfers, training, and rapid precise start-up deployment Your Workshop Leaders: • Regulatory agency considerations (FDA EMEA etc.) Jim McAndrew, Vice President of Operations, Pharmpro Services • NDA management strategic and financial advantages Rob Rigney, Director of Business Development, Pharmatek • Ralph L. Dillon, & Joe Noferi ‡ Director, Compliance Surety Associates Benefits of attending: Speaker To be Confirmed, Lead Engineering Contact, Fluid Air Inc. Financial leaders will be interested in this workshop as a means to use scarce * Please check conference website for further updates • capital more effectively by shortening the investment to return cycle and reducing risk Mid-Conference Workshops Tuesday May 12, 2009 Sponsored by: Workshop C 6:00pm – 9:00pm Registration at 5:30pm Workshop content to be confirmed shortly Registration Information Register and Pay Register and Pay Register and Pay Standard End User Pricing By March 6 By March 13 After April 3 Price Conference Only (save $500) $1,299 (save $400) $1,399 (save $200) $1,599 $1,799 Sponsorship and Each Workshop $549 $549 $549 $549 Exhibition Opportunities Best ALL ACCESS PASS $2,099 $2,199 $2,399 $2,999 Value! Sponsorships and Exhibits are excellent Register and Pay Register and Pay Standard Vendor Pricing opportunities for your company to showcase its By March 13 After April 3 Price products and services to high-level, targeted Conference Only (save $600)$1,999 (save $300) $2,299 $2,599 decision makers attending the conference. Pharma IQ and the International Quality & Each Workshop $549 $549 $549 Productivity Center (IQPC) help companies like Best yours achieve sales, marketing and branding ALL ACCESS PASS Value! $2,699 $2,999 $3,299 objectives by setting aside a limited number of * All prices include lunches, refreshment and detailed conference MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC event sponsorships and exhibit spaces – all of materials. Contact us at 1-800-882-8684 for special dietary requirements. Details for making payment via EFT or wire transfer: which are custom-tailored to help your company * Discount cannot be combined JPMorgan Chase create a platform to maximize its exposure at TEAM DISCOUNTS Penton Learning Systems LLC dba IQPC: 957-097239 the event. Visit us on the Web and see what Contact S am Eid at 416-597 4719 for the following discounts: ABA/Routing #: 021000021 TEAM: Only one discount may be applied per registrant. Reference: Please include the name of the attendee(s) and the event other exciting and information-packed NON-PROFIT, GOVERNMENT, ACADEMIA: Call for more information. number: 10854.005 conferences are being offered by the PAYMENT INFORMATION: Special Dietary Needs: If you have a dietary restriction, please contact International Quality and Productivity Center! A $99 processing charge will be assessed to all registrations not Customer Service at 1-800-882-8684 to discuss your specific needs. accompanied by credit card payment at the time of registration ©2009 IQPC. All Rights Reserved. The format, design, content and Payment Policy: Payment is due in full at the time of registration. Your arrangement of this brochure constitute a trademark of IQPC. registration will not be confirmed until payment is received and may be Unauthorized reproduction will be actionable under the Lanham Act and subject to cancellation.For IQPC’s Cancellation, Postponement and common law principles. Substitution Policy, please visit www.iqpc.com/cancellation Register Today! Call Sam Eid at 416-597 4719 or e-mail: sam.eid@iqpc.com 5
    • International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor New York, NY 10017 YES! Please register me for 9th Contract Manufacturing Pharmaceuticals and Biotech TM for ❑ Conference only ❑ Conference plus 2 workshops ❑ Conference plus 1 workshop ❑ Conference plus 3 workshop See Page 5 for pricing details. Your customer registration code is: When registering, please provide the code above. Name__________________________________ Job Title ________________________ Organization____________________________________________________________ Approving Manager______________________________________________________ Address_______________________________________________________________ City__________________________________State______________Zip___________ Phone________________________________Fax_______________________________ 3 EASY WAYS TO REGISTER: E-mail__________________________________________________________________ ❑ Please keep me informed via email about this and other related events. 1 E-mail: sam .eid@iqpc.com ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-416-597 4719 ❑ Charge my __Amex __Visa __Mastercard __Diners Club Fax: 1-416-598 7934 3 Card #____________________________________Exp. Date___/___ Details for making payment via EFT or wire transfer can be found on preceding page. ❑ I cannot attend, but please keep me informed of all future events. 10854.005/D/KV Register by March 6 and Save $500 off the standard price 9th Contract Manufacturing Pharmaceuticals and Biotech TM for Mitigating Risks, Ensuring Compliance, and Improving May 11-13, 2009 Efficiency for Domestic and International Outsourcing San Francisco, California Conference Highlights Include: Analyzing the CMO Market: Tools for Choosing a Influencing the Ability to Sustain Validation and Process • • Preferred CMO Compliance – Post CMO Collaboration Understanding the Impact of an Economic Downturn Understanding the Essential Elements for Successful • • on Overseas Outsourcing Technology Transfer Execution of Multiple Outsourcing Projects Addressing Product Quality Issues • • Sponsored by: Media Partners: