"10th Contract Manufacturing for Pharmaceuticals and Biotech Conference

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Pharmaceutical and biotech companies are being influenced by the financial and operational benefits of outsourcing further aspects of their manufacturing processes. As a result of this, it is important for a company to mitigate risks, while maximizing profit and production.

For our 10th Contract Manufacturing for Pharmaceuticals and Biotech conference, we have gathered many high-level industry experts together to provide insights and unique solutions for the most common challenges faced within the industry today.

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"10th Contract Manufacturing for Pharmaceuticals and Biotech Conference

  1. 1. The MUST ATTEND Contract Manufacturing event of the year! 10th Contract Manufacturing for Pharmaceuticals and Biotech TM Mitigating Risks, Ensuring Compliance, and Improving Efficiency May 10-12, 2010 for Domestic and International Outsourced Manufacturing San Francisco, CA Key topics include: • Assessing Risk Management of the Quality System of Your • Analyzing the CMO Market: Tools for Choosing a CMO Preferred CMO • Roche/Genentech's Risk-Based Approach to CMO • A Regulatory Approach for Contract Manufacturing Management • Understanding the Essential Elements for Successful • Mitigating the Risks When Outsourcing Pharmaceutical Technology Transfer Manufacturing • Using CMOs as a Resource to Tap into a New Product • Working with an Overseas CMO to Gain FDA Inspection Market and Approved Status Register by 3/26/2010 and pay only $2,199 all access (saving $698) for the all access pass Learn from Leading Innovators Including: Jim Browne, Director, Contract Manufacturing, Europe, GlaxoSmithKline Prasad Gogineni, Associate Director, Pharmaceutical Technology, Watson Laboratories Paul Kanan, Vice President, Operations, Agensys, Inc. Earl Sullivan, Chief Executive Officer, Landela Pharmaceutical, Inc. Tim Sirichoke, Head of Commercial Operations, Novartis Paul Hingst, Senior Manager, Contract Manufacturing, Amgen Franco Pasquale, Senior Manager, Roche Contract Manufacturing Operating Unit Nicole S. Ferrari, Engineering and Contract Manufacturing Manager, Bausch & Lomb Pharmaceuticals Rebecca Tholmer, Manager, Quality Systems, Baxter Healthcare Alex Badal, Director, Global Strategic Sourcing Supply, Valeant Pharmaceuticals Doris St. John, Manager Supplier Quality GPS, Johnson & Johnson Jim Damon, Regional Director, External Manufacturing, Johnson & Johnson Consumer Healthcare Sponsored by: Media Partner: www.PharmaContractManufacturing.com
  2. 2. 10th Who will attend? Contract Manufacturing Vice Presidents / Directors / Heads from Pharmaceutical, Biotech, Animal Health, Contract Manufacturing Organizations, Consultants and Service Providers working in for Pharmaceuticals and Biotech TM the following: • Manufacturing and Operations • Outsourcing Dear Colleagues, • Supply Chain The pharmaceutical and biotech • Contract Manufacturing and Transfers industry has been increasingly influ and operational benefits of outsourc enced by the financial • Engineering ing further aspects of their manufac achieve faster time to market on drug turing processes to products. As a result of this, it is impo • Operational Excellence company to mitigate risks, while maxi rtant for a mizing profit and production. • Strategic Process Optimization For the 10th Contract Manufacturin • Release Coordination g for Pharmaceuticals and Biot have gathered many high-level indu ech conference, IQPC stry experts together to provide insig • Compliance and Validation solutions for the most common chall hts and novel unique enges faced within the industry toda organizations efficient, economically-v y to help assist your • Process Development iable and compliant manufacturin g supply chain. By attending this conference, you • Quality Assurance / Quality Control will hear industry-specific case stud addressing: ies and examples • Procurement • The current shape of the contract man • Key ufacturing industry requirements for an effective man • Max agement system imizing innovation: Addressing the • In-Ho use vs. outsource: How to decide importance to small biotech’s and and then how you can generate savin start-ups Past Attendee Profile maintaining quality and efficiency gs whilst Job Title Breakdown from our Previous • Susta ining a mutually beneficial operation Contract Manufacturing for • And al relationship with your CMO many more sessions including over Pharmaceuticals and Biotech Conference 4+ hours of scheduled networking, interactive panel discussions and a insightful series of interactive workshops. Benefit from industry participation from Roche, GlaxoSmithKline, Nova Johnson, Baxter Healthcare, Valea rtis, Amgen, Johnson & nt Pharmaceuticals, Watson Laborator pharmaceutical and biotech industry ies and many more experts. Engage in dynamic conversation with your industry peers at our multiple and work closely with many Cont networking sessions, ract Manufacturing industry experts. yourself and a team of key people Be sure to register for this important event today! We look forward to seeing you in San Francisco in May! ■ 16% Quality Assurance Best Regards, ■ 10% Engineer/Engineering Manager P Highly interactive .S. ■ 10% Director ■ 10% Supply Head and informative pre- ■ 7% Executive confer ence workshops! ■ 7% Business Development Simon Curtis Conference Director Se e page 5 for details ■ 7% Operational Head PharmaIQ ■ 3% Professor ■ 3% Capital Markets Manager ■ 3% Clinical Supplies ■ 3% Regulatory Manager Comments from IQPC’s Past Contract Manufacturing for ■ 3% CEO Pharmaceuticals Conferences: ■ 3% Business Manager “Interesting participants and concrete business options.” – CEO, Labiana ■ 3% R&D Direct Pharmaceuticals “Nice blend of topics – not much, if any, repetition.” – Director, Pharmaceutical Operations, Arena Pharmaceuticals “Great speakers!” – Site Assessment Officer/Compliance Coodinator, Health Canada For Registration Information and to “Good opportunity to hear from all sides (sponsors, CMO’s, consultants).” – Download the Complete Brochure Vice President, Supply Chain, Impax Laboratories Visit our website at www.PharmaContractManufacturing.com “Very experienced speakers.” – Manager, CMQA, Solvay Pharmaceuticals or Call 1-800-882-8684 “Good selection of speakers, who cover a wide spectrum of experiences; in- For sponsorship opportunities, please depth information provided to audience.” – Director, API Development, Intermune contact Mario Matulich at 212-885-2719 or at sponsorship@iqpc.com 2 REGISTER ONLINE AT www.PharmaContractManufacturing.com OR CALL US AT 1-800-882-8684
  3. 3. Main Conference Day 1 Tuesday, May 11, 2010 7.45 Registration and Coffee • Process chemistry and route scouting: When a CMO has a good idea • Quality: Who's in charge; harmonizing SOPs • Contracts and reports: Understanding and reaching customer 8.30 Welcome Address and Chairpersons’ Opening Remarks expectations Justin D. Noll, Senior Vice President, 8.45 Opening Keynote: Industry Overview - The current Plant Manager, Cherokee Pharmaceuticals LLC shape of the Contract Manufacturing Industry • Discussing the direction the contract manufacturing market is heading 12.30 Networking Lunch • Changing environment & dynamics of contract manufacturing opportunities and commercialisation 1.30 Sustaining a Mutually Beneficial Operational • Evaluating in-house vs external manufacturing options Relationship with Your CMO • Examining the emergence & challenges of domestic and overseas • Managing risk with CMO – Developing an aligned approach to outsourced manufacturing benefit both parties • Considering manufacturing opportunities for small biotechs and • Addressing the importance of Process Development and Change start-ups Control in contract manufacturing • Discussing new strategies and creative partnerships for improving • Handling strategies by inventory projections • Choosing a Contractor – A multidirectional audit approach to arrive success Jim Browne, Director, Contract Manufacturing, Europe, at the CMO best fit for your needs. • Inspecting supplies – Who is supplying to your CMO? GlaxoSmithKline Tim Sirichoke, Head of Commercial Operations, Novartis Effective CMO Sourcing and Relationship Management Operational Benefits of Post-CMO Collaboration 9.30 Panel Discussion: Analyzing the CMO Market: Tools for Choosing a Preferred CMO 2.15 Using Your CMO as a Resource to Tap into a New • Understanding the scientific background and capabilities of tentative Innovative Product Market CMOs • Gaining the competitive edge on manufactured products through • Addressing a CMO's experience developing a biologic product from CMO-utilized tools and technologies • Identifying novel product design and re-launch technologies from early clinical stages through regulatory review and commercialization • Assessing a CMO's necessary facility, equipment and personnel your CMO • Unveiling novel product revamping technologies for post patent- infrastructure for successful commercialization of a biologic drug product expired products • Examining the importance of quality agreements • Optimizing your marketed product pipeline with innovative drug • Assessing the potential of a CMOís global reach with regards to delivery and manufacturing capabilities from your CMO • Extending product lifecycle through new product launches manufacture, supply channels, quality/regulatory requirements • Compiling a data set in order to rank and risk assess potential CMOs Adam Sabouni, Ph.D., President & CEO, PharmaArtz, Inc. Jim Browne, Director, Contract Manufacturing, Europe, GlaxoSmithKline 3.00 Afternoon Networking Break Paul Kanan, Vice President, Operations, Agensys, Inc. Alex Badal, Director, Global Strategic Sourcing Supply, Valeant 3.45 Due Diligence within the Selection Process of Pharmaceuticals Your CMO Adam Sabouni, Ph.D., President & CEO, PharmaArtz, Inc. • Reviewing the internal J&J due diligence process for CMO selection • Examining key points critical for future success • Managing risk with CMO – Developing an aligned approach to 10.15 Morning Networking Break benefit both parties • Maximizing product lifecycle with an aligned approach with a “like- 11.00 Creating a Sourcing Strategy within Your minded” CM Organization • Developing the future due diligence relationship for a CMO from • Strategizing opportunities to increase a large biotech's ability to both a business and compliance angle create a suitable sourcing strategy • Recognizing late product lifecycle: Outsourcing to maintain product Jim Damon, Regional Director, External Manufacturing, Johnson & Johnson Consumer Healthcare market performance, while saving costs • Maximizing product lifecycle with an aligned approach with a ìlike- mindedî contract manufacturer 4.30 Maximizing Innovation: Addressing the Importance • Maximizing product lifecycle through an aligned approach with a to Small Biotech’s And Start-Ups “likeminded’ contract manufacturer finding/locating/attracting a • Identifying successful strategies in order to go about suitable CMO finding/locating/attracting a suitable CMO • Unearthing the breakdown of manufacturing costs: How to locate Paul Hingst, Senior Manager, Contract Manufacturing, Amgen cost-saving solutions and techniques within your outsourcing supply 11.45 Successfully Organizing and Adapting Your Internal chain • Locating the correct CMO geared to working with small-scale/ start- Structure to Effectively Handle a CMO up companies As big pharma sheds its in-house manufacturing sites, more and more • Discussing the importance on focusing on your pilot projects from companies are turning to Custom Manufacturing Organizations start to finish (CMOs). A successful collaboration involves harmonizing many • Discussing case study examples different activities. This panel discussion will discuss a number of the Michael Ramsay, Contract Managing Expert, Biopharmassist, Inc key drivers for success in a relation with a CMO. • Successful selection of a CMO: What to look for in a partner • Technology transfer: The elements for speed, accuracy and success 5.15 Chairpersons’ Closing Remarks and End of Day One 3 Sponsored by:
  4. 4. Main Conference Day 2 Wednesday, May 12, 2010 7.45 Registration and Coffee 12.30 Networking Lunch 8.30 Welcome Address and Regulatory Compliance and Compatibility Chairpersons’ Opening Remarks 1.30 A Regulatory Approach for Contract Manufacturing Risk Management and Mitigation • Addressing the impact of the FDA draft guidelines on manufacturing process 8.45 Mitigating the Risks When Outsourcing • QBD initiatives: How does your organization compare on trend Pharmaceutical Manufacturing monitoring data • Discussing Q9 – Design process • Understanding the range of Quality and Business risks you may need • Examining Q10 – Commercial to manage • Developing with partner a common understanding of which party is • Becoming compliant as the key to continuous improvement • Developing a robust risk mitigation strategy to prevent negative managing which risk • Displaying the importance of constant risk management rather than consequences of non-compliance by the CMO just an initial assessment Prasad Gogineni, Associate Director, Pharmaceutical Technology, • Examining best practice risk management strategies and the Watson Laboratories practicalities of managing risk • Evaluating lessons learnt and how that knowledge has and can be 2.15 Working with an Overseas CMO to Gain FDA applied to future projects Inspection and Approved Status Rebecca Tholmer, Manager, Quality Systems, Baxter Bioscience • Discussing due diligence with foreign CMOs to determine best candidates for success 9.30 Understanding the Essential Elements for Successful • Examining common obstacles to overcome within the transfer or Technology Transfer development process and getting to FDA approvable status • Outlining contract types and deal points when helping a foreign • Establishing the project plan: site readiness, suppliers, raw material inventories, and risk assessment CMO gain an FDA inspection • Monitoring the project plan: milestones, anticipate slippage early, • Displaying a specific Case study of Italian CMO back-up plans/strategy Earl Sullivan, Chief Executive Officer, Landela Pharmaceutical, Inc. • Understanding the latest compliance requirements and performing a gap assessment with the initial product validation 3.00 Afternoon Networking Break • Managing the financials (considering approval and delivery timelines for capital expenditures i.e. new processing equipment) Multiple Project and Cost-Effective Strategies Nicole S. Ferrari, Engineering and Contract Manufacturing Manager, Bausch & Lomb Pharmaceuticals 3.30 Panel Discussion: In-House Vs. Outsource: How to Decide and Then How You Can Generate Savings 10.15 Morning Networking Break Whilst Maintaining Quality and Efficiency • Outlining the key factors considered when looking to outsource: 11.00 Roche/Genentech's Risk-Based Approach to CMO • Economics, technological capabilities and in-house capacity Management • Reviewing the decision-making process and timelines involved • Preliminary evaluation of contract manufacturers: How do you cover • Discussing how Roche and Genentech's reliance on contract manufacturing has dramatically increased over the past 10 years all the bases? • Examining why the company put into place a Contract Management • Parameters that lead you to make a decision on your manufacturing Operational unit with a goal to manage a global network of CMOs operations • Displaying how both Roche and Genentech's outsourced clinical and • How do you handle the relationship and generate savings in commercial products external supply chains within the current economic climate? • Relying on the management of risk throughout the CMO lifecycle; Jim Browne, Director, Contract Manufacturing, Europe, from selection to decommissioning, CMO risk profiles serve as the GlaxoSmithKline basis for decision-making Doris St. John, Manager Supplier Quality GPSG, Johnson & • Evaluating a flexible approach depending on the product Johnson development phase, the CMO performance history and the scope of Prasad Gogineni, Associate Director, Pharmaceutical Technology, CMO activities Watson Laboratories Franco Pasquale, Senior Manager, Roche Contract Manufacturing Operating Unit 4.15 Execution of Multiple Outsourcing Projects • Designing a framework for your organization when considering 11.45 Assessing Risk Management of the Quality System of multiple projects with a CMO at one time Your CMO • Successfully managing several small and medium size projects • Utilizing a risk-based auditing approach simultaneously • Realizing warning signs from outsourced projects and providing • Using a monitoring plan for your suppliers in lieu of an audit • Evaluating ongoing quality performance of your suppliers mitigation plans • Importance of Quality Agreements • Prioritizing projects in terms of importance and delivery date • Discussing qualification of suppliers from a quality standpoint Ralph L. Dillon, Director, Compliance Surety Associates • Key areas for supplier audits Doris St. John, Manager Supplier Quality GPSG, Johnson & 5.00 End of Conference & Chairpersons’ Closing Remarks Johnson 4 REGISTER ONLINE AT www.PharmaContractManufacturing.com OR CALL US AT 1-800-882-8684
  5. 5. Pre-Conference Workshops Monday, May 10, 2010 Workshop A 11.00am – 2.00pm (Registration at 10.30am, Lunch Included) Simplifying Outsourcing Decisions and Project Execution with Cloud Computing and SaaS (Software-as-a- Service) Solutions This workshop will evaluate functionality and TCO of traditional What you will learn: procurement systems ranging from enterprise systems to desktop software • Displaying solutions through procurement systems used for emailed RFPs with an emphasis on cloud computing and SaaS • Evaluating systems used for emailed RFPs with an emphasis on cloud solutions used by industry-leading organizations including Genentech and computing and SaaS solutions Amylin. This will discuss security considerations in the adoption of these • Discussing security considerations in the adoption of these systems systems and in the transfer of data from legacy systems. • Examining the transfer of data from legacy systems Intended Audience Benefits of attending: Any person involved in screening vendors using RFPs or executing projects Most companies outsource, whether it's product development to CMOs, IT services with external partners for services and products including: or HR, to conserve resources and focus on core competencies. Very often, the cost 1. Capital equipment purchases of the outsourcing process is underestimated if calculated at all. Most companies 2. Construction projects do not realize that there are cost-effective solutions that are accessible to them 3. CMO projects regardless of size- SAP and Oracle are no longer the only options. 4. HR services Your Workshop Leader: 5. IT services Premila Anand, Managing Director, SourceSolution 6. Sales and marketing services Workshop B 2.30pm – 5.30pm (Registration at 2.00pm, Coffee Served) Using a CMO Model as the Fastest and most Cost Effective Path from Development Though Marketed Product Optimizing manufacturing operations externally can be a challenging Benefits of attending: responsibility. This workshop will address and analyze the CMO model as • Financial leaders will be interested in this workshop as a means to use scarce an option for developing and manufacturing your product in the most capital more effectively by shortening the investment to return cycle and cost-effective manner, without jeopardizing quality. reducing risk • Technical staff will be interested in this workshop as a means to extend What will be covered: scarce talent resources and achieve their business objectives more quickly • CMO dosage development • Relevant for HR & training professionals as a means to train qualified • CMO qualification batches and market launch product • Concurrent capital project development at NDA holder people more effectively before the initiation of a new production line • Tech transfers, training, and rapid precise start-up deployment Your Workshop Leader: • Regulatory agency considerations (FDA EMEA etc.) Ralph L. Dillon, Director, Compliance Surety Associates • NDA management strategic and financial advantages Registration Information Sponsorship and Pricing Register and Pay Register and Pay Standard Exhibition Opportunities By 3/26/2010 By 4/16/2010 Price Conference Only $1,199 (save $600) $1,599 (save $200) $1,799 Sponsorships and Exhibits are excellent opportunities for your company to showcase its products and services to All Access $2,199 (save $698) $2,599 (save $298) $2,799 (save $98) high-level, targeted decision makers attending10th Contract Manufacturing for Pharmaceuticals and Biotech. Workshops $549 each $549 each $549 each Pharma IQ and the International Quality & Productivity Center (IQPC) help companies like yours achieve sales, * All prices include lunches, refreshment and detailed conference For IQPC’s Cancellation, Postponement and Substitution Policy, marketing and branding objectives by setting aside a materials. Contact us at 1-800-882-8684 for special dietary please visit www.iqpc.com/cancellation limited number of event sponsorships and exhibit spaces – requirements. MAKE CHECKS PAYABLE IN U.S. DOLLARS TO: IQPC all of which are custom-tailored to help your company * Discount cannot be combined Details for making payment via EFT or wire transfer: create a platform to maximize its exposure at the event. Team Discounts JPMorgan Chase Contact Customer Service at 1-800-882-8684 for the following Penton Learning Systems LLC dba IQPC: 957-097239 discounts: ABA/Routing #: 021000021 Visit us on the web and see what other exciting and TEAM: Only one discount may be applied per registrant. Reference: Please include the name of the attendee(s) and the event information-packed conferences are being offered by NON-PROFIT, GOVERNMENT, ACADEMIA: Call for more information. number: 10854.005 the International Quality and Productivity Center! To PAYMENT INFORMATION: Special Dietary Needs: If you have a dietary restriction, please contact find out more about upcoming Pharma IQ events, A $99 processing charge will be assessed to all registrations not Customer Service at 1-800-882-8684 to discuss your specific needs. contact Mario Matulich at (212) 885-2719 or via accompanied by credit card payment at the time of registration ©2010 IQPC. All Rights Reserved. The format, design, content and email at sponsorship@iqpc.com. Payment Policy: Payment is due in full at the time of registration. arrangement of this brochure constitute a trademark of IQPC. Your registration will not be confirmed until payment is received and Unauthorized reproduction will be actionable under the Lanham Act may be subject to cancellation. and common law principles. About Our Sponsor: Cherokee Pharmaceuticals Website: www.cherokee-pharma.com Cherokee Pharmaceuticals is a custom manufacturer located in the heart of rural Pennsylvania. Formerly a dedicated production facility for Merck, Cherokee offers route scouting, optimization and scale-up of complex, multi-step chemistry from phase one through commercial supply. Complete analytical support including method development and validation are also provided. Cherokee has a background with all major chemistries and has unparalleled experience in working with anti-infectives, including anti-viral compounds, and oncology products in an FDA regulated environment 5 REGISTER ONLINE AT www.PharmaContractManufacturing.com OR CALL US AT 1-800-882-8684
  6. 6. International Quality & Productivity Center REGISTRATION CARD 535 5th Avenue, 8th Floor YES! Please register me for New York, NY 10017 10th Contract Manufacturing for Pharmaceuticals and Biotech TM ❑ Conference only (11-12 May 2010) ❑ Workshop(s) Only ❑ A ❑ B ❑ All Access (10-12 May 2010) (10-12 May 2010) 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_______________________________ E-mail__________________________________________________________________ 5 EASY WAYS TO REGISTER: ❑ Please keep me informed via email about this and other related events. 1 Web: www.PharmaContractManufacturing.com ❑ Check enclosed for $_________ (Payable to IQPC) 2 Call: 1-800-882-8684 or 1-646-378-6026 ❑ Charge my __Amex __Visa __Mastercard __Diners Club 3 Email: info@iqpc.com Card #__________________________________Exp. Date___/___CVM Code_____ 4 Fax: 1-646-378-6025 Details for making payment via EFT or wire transfer can be found on 5 Mail: IQPC preceding page. 535 5th Avenue, 8th Floor, ❑ I cannot attend, but please keep me informed of all future events. New York, NY 10017 10854.005/D/KR The MUST ATTEND Contract Manufacturing event of the year! 10th Contract Manufacturing for Pharmaceuticals and Biotech TM Mitigating Risks, Ensuring Compliance, and Improving Efficiency May 10-12, 2010 for Domestic and International Outsourced Manufacturing San Francisco, CA Key areas this conference will be focusing on include: • Assessing Risk Management of the Quality System of Your CMO • Analyzing the CMO Market: Tools for Choosing a Preferred CMO • Roche/Genentech's Risk-Based Approach to CMO Management • A Regulatory Approach for Contract Manufacturing • Mitigating the Risks When Outsourcing Pharmaceutical Manufacturing • Understanding the Essential Elements for Successful Technology • Working with an Overseas CMO to Gain FDA Inspection and Approved Transfer Status • Using CMOs as a Resource to Tap into a New Product Market Sponsored by: Media Partner: Register Today! Call 1-800-882-8684 visit www.PharmaContractManufacturing.com

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