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Philadelphia 2018 Agenda

Fundamentals for Outsourcing Drug Development and Manufacturing

Wednesday 7/18/18

8:00 am

Registration and Exhibit Hall open, Networking Breakfast

9:00 am

Welcome / Conference Chair Opening Remarks

9:15 am

5 Steps To Select The Right CDMO

Our panel of experts has devised a system comprised of 5 key steps drug sponsors should take when assessing service providers. Few decisions will have a larger impact on the future of your program. The panel’s advice is helpful to the new and/or virtual company, as well as established drug owners.

  • Panelists:
    Vimal Gandhi, Director, Global Biosimilar Operations and Strategy | AstraZeneca

10:15 am

Networking Refreshment Break

11:00 am

Get It Right The First Time: Tech Transfer To External Partners

Once you select a partner, establishing your project(s) with them becomes a science all its own. Successful sponsors know the activity must be highly collaborative and include the right project managers. Clear communication of budgets, goals, and timelines is paramount. Panelists tackle these topics and challenges head on.

  • Panelists:
    Maria Maccecchini, President | QR Pharma
    Dawn Rubel, SVP, Quality & Regulatory Affairs | Drive DeVilbiss Healthcare

12:00 pm

Networking Lunch

 

1:15 pm

Negotiating Strategies For Quality And Supply Agreements

This session unfolds in three acts. First, learn strategies for negotiating your quality agreement. Next, find out how to better negotiate your supply agreement. Finally, and most important, learn how to ensure both agreements are consistent and actually work together to achieve your – and your provider’s – goals.

  • Panelists:
    Kip Wolf, Senior Managing Consultant | Tunnell Consulting (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Technology: Cell Therapies Growing Strong in Philadelphia

T-cell innovation, genome editing, newly FDA-approved gene therapy – all happening in the Philadelphia area. Some are calling this “Cellacon Valley.” But growth is contingent upon a vibrant ecosystem of networking and support, including from various service providers. Stakeholders in the Philly life sciences community discuss the challenges and opportunities in growing an innovation cluster, both here and beyond.

4:00 pm

Networking Reception

 

6:00 pm

Day One Concludes

 

Thursday 7/19/2018

8:00 am

Exhibit Hall Opens, Networking Breakfast

9:00 am

Conference Chair Day Two Opening Remarks

9:15 am

Project Managers From The Frontlines: Four Battles To Avoid

Ever wonder what’s really happening during the management of your outsourced drug development and manufacturing projects? A panel of professionals from the frontlines of managing a variety of projects and service-provider relationships complete this sentence for you: We could shorten timelines, improve reliability, and save you money if we could only ______________.

10:15 am

Networking Refreshment Break

11:00 am

Regulation 'Round The World: How To Navigate International Outsourcing

Working with an international partner or in global markets? Then listen closely to these case studies and advice from a panel of internationally experienced experts. They’ll compare and contrast international settings, and demonstrate how regional regulatory environments can enable or hinder you from achieving development goals.

  • Panelists:
    Vimal Gandhi, Director, Global Biosimilar Operations and Strategy | AstraZeneca

12:00 pm

Networking Lunch

1:15 pm

Make Outsourcing More About Patients

Does the outsourcing of drug development and manufacturing only benefit sponsors and service providers? What about the actual patients? Sponsors and their CDMOs should challenge each other to better serve and connect the patient to the outsourcing model. In fact, this panel of experts demonstrates how doing so can helps ensure the success of everyone involved.

  • Panelists:
    Chhaya Shah, SVP Technical Operations | Synergy Pharmaceuticals
    Warren Horton, EVP, Global Quality Assurance & Regulatory | Avara Pharmaceutical Solutions

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Leadership Company: TBD

A well-known and successful company from the Bio/Pharmaceutical industry presents a working model, and best practices, in the art of outsourcing drug development and manufacturing. We’ll announce our Spotlight Leadership Company in the coming weeks.

3:50 pm

Conference Chair Closing Remarks

4:00 pm

Conference Concludes



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