San Diego 2017
August 22 -23, 2017 | Hyatt Regency La Jolla
Sponsors
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Fermion OY, Orion Group Life Science Leader Life Science Training Institute Procos USA |
Exhibitors
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Adesis, Inc. Advinus Therapeutics Albemarle Alcami Corporation Althea CMO Avara Pharmaceutical Services\ Avista Pharma Solutions Berkshire Sterile Manufacturing Cambrex Corporation CordenPharma DavosPharma Dottikon ES America Dupont Protection Solutions
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EAG Laboratories Emergent Biosolutions FAREVA Full Spectrum Analytics JRF Global Korber Medipak Systems NA Inc. Metrics Contract Services Mikart, Inc Olon Ricerca Bioscience LLC PCI Pharma Services Pharmatech Associates Piramal Pharma |
Solutions Quotient Clinical Rondaxe Sherpa Clinical Packaging Siegfried USA, LLC Scientist STA Pharmaceutical, A WuXi AppTec Company SynConnection Triclinic Labs Unither Manufacturing LLC Yourway Transport |
Agenda
Tuesday 8/22/17
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Registration and Exhibit Hall open, Networking Breakfast 8:00AM |
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Welcome & Conference Chair Opening Remarks 9:00AM |
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The fast and slow of tech transfer: Success in the balance 9:15AM Sponsors often focus tech transfer on cost cutting and speed, minimizing engineering or pilot runs. This makes it difficult for CMOs to demonstrate robust process control, let alone think about new technology or innovation. Is there a happy median?
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Networking Refreshment Break 10:15AM |
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Is your CMO listening? Different breeds and different needs of sponsor companies 11:00AM Tips on effectively communicating your organization’s specific needs to your CMO and strategies for helping your CMO be more responsive. Are you asking too much? Or are you settling for too little?
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Networking Lunch 12:00PM |
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Antibody-drug conjugates: ADCs as an innovation model for outsourcing 1:15PM Pfizer presents on the ins-and-outs of outsourcing a complicated and disruptive innovation like antibody-drug conjugates (ADCs), followed by a discussion of how ADCs can serve as a model for managing outsourcing and implementing innovations.
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Networking Refreshment Break 2:15PM |
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Spotlight Technology: Yes, you need to take the pulse of packaging now 3:00 pm Think it’s too early to think ahead to your potential drug’s primary packaging? Think again. Panelists provide real experiences on why innovations in packaging can impact your upstream development activities, and even selection of CMOs. It pays to plan ahead.
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Networking Reception 4:00PM |
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Day One Concludes 6:00PM |
Wednesday, 8/23/17
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Exhibit Hall Opens, Networking Breakfast 8:00AM |
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Conference Chair Day Two Opening Remarks 9:00AM |
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Regulatory dynamics for innovation: Safety first, please 9:15AM Often innovation enters drug development at Phase 1 study. Yet sponsors prioritize innovation by cost and time savings. The FDA welcomes innovation, but is concerned the industry is losing sight of “safety first.” We’ll discuss this dynamic from all angles.
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Networking Refreshment Break 10:15AM |
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You can't outsource data integrity 11:00AM Ensuring the integrity of all your data is codified in regulatory guidance … and negatively expressed in the proportion of FDA citations related to data. Don’t be next. This session provides practical steps for your struggles with managing data in an outsourced environment.
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Networking Lunch 12:00PM |
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New methods for qualifying your service providers and benchmarking performance 1:15PM Your drug programs are reliant on new technologies and platforms, and advancing outsourcing relationships. So how can today’s drug developers qualify and then accurately benchmark the performance of service providers? Here’s a look at some updated methodologies for better outsourcing outcomes.
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Networking Refreshment Break 2:15PM |
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Spotlight Leadership Company: Pfizer Global Supply 3:00 pm 25-year veteran of Pfizer, and former US Air Force captain Thomas Wilson, sits down with chief editor Louis Garguilo to talk about Wilson's experiences in drug development and manufacturing outsourcing, and offer some best practices, advice and actionable information for drug owners, and service providers alike.
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Conference Chair Closing Remarks 3:50PM |
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Conference Concludes 4:00PM |