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Philadelphia Agenda

Fundamentals for Outsourcing Drug Development and Manufacturing

 

8:00am
Registration, Exhibit Hall Open, & Networking Breakfast

Collect your badge at registration and head over to the catered breakfast spread to enjoy while you mingle with fellow attendees.

9:00am
Welcome & Conference Chair Opening Remarks

Louis Garguilo, Chief Editor / Conference Chair of Outsourced Pharma, kicks off the morning with opening remarks.

9:15am
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.

  • Vimal Gandhi, Director, Global Biosimilar Operations and Strategy | AstraZeneca
  • Henry Wolfe, SVP | Antares Pharma
  • Scott Gangloff, VP Biologics Product and Process Development | Incyte
10:15am
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

11:00am
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.

  • Diane Blumenthal, Head of Technical Operations | Spark Therapeutics
  • Dennis Knox, Sr. Manager Quality | Elusys Therapeutics
  • Maria Maccecchini, President | QR Pharma
  • Sean Johnston, Principal | Sean M Johnston Consulting (Moderator)
12:00pm
Networking Lunch

Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.

1:15pm
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.

  • Dawn Rubel, SVP, Quality & Regulatory Affairs | Drive DeVilbiss Healthcare
  • Ken Sabatino, Senior Director Global API Biologics | Janssen
  • Kip Wolf, Senior Managing Consultant | Tunnell Consulting (Moderator)
2:15pm
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

3:00pm
Spotlight Technology: Cell and Gene 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 “Cellicon 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.

  • Scott Shandler, Founder and CEO | Longevity Biotech
4:00pm
Networking Reception

You're invited to join us for an open bar reception featuring heavy hor d'oeuvres, desserts, and live music!

8:00am
Exhibit Hall Open & Networking Breakfast

Head over to the catered breakfast spread to enjoy while you mingle with fellow attendees.

9:00am
Conference Chair Day Two Opening Remarks

Louis Garguilo, Chief Editor / Conference Chair of Outsourced Pharma, kicks off day two with opening remarks.

9:15am
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 ______________.

  • Robert Matje, Principal | RamTech (Moderator)
10:15am
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

11:00am
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.

  • Vimal Gandhi, Director, Global Biosimilar Operations and Strategy | AstraZeneca
  • Patrick McMahon, Fast Trak Services Bridge Manufacturing Services Operations Leader | GE Healthcare
12:00pm
Networking Lunch

Lunch is served! Take the hour to fill up (if you haven't already!) and network with exhibitors and peers.

1:15pm
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.

  • Chhaya Shah, SVP Technical Operations | Synergy Pharmaceuticals
  • Warren Horton, EVP, Global Quality Assurance & Regulatory | Avara Pharmaceutical Solutions
  • Ken Sabatino, Senior Director Global API Biologics | Janssen
2:15pm
Networking Refreshment Break

Head over to the exhibit hall to grab a quick snack while you digest the previous discussion with your peers.

3:00pm
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.

3:50pm
Conference Chair Closing Remarks

Louis Garguilo, Chief Editor of OutsourcedPharma.com, finishes the afternoon with closing remarks.

Agenda topics and speakers subject to change.

The conversations we had were of the exceptional quality to be expected given the experience of the attendees. These led to an inquiry for services from a company we had never met. We were granted a project within weeks.

Joel Lirot, VP Business Development, Rondaxe

Interested in sharing your expertise?

Outsourced Pharma is looking for innovative executives with a passion for improving sponsor-provider relationships and outcomes in drug development and manufacturing outsourcing.

Join us at an upcoming Outsourced Pharma conference.