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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 & Strategy | AstraZeneca
  • Amlan Dutta, Head Biologics Quality Operations External Manufacturing | Merck
  • Scott Gangloff, VP Biologics Product & Process Development | Incyte
  • Sam Mathur, Procurement Lead for Contract Manufacturing | Shire
  • Ray Sison, VP Pharmaceutical Outsourcing & Tech Transfer | Xcell Strategic Consulting (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
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, Associate Director QA | Amicus 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
  • Todd Mabe, Director Drug Substance Quality | Merck
  • Hal Craig, Principal | Trout Creek Consulting
  • Kip Wolf, Principal | 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, and newly FDA-approved gene therapies are all happening in the Philadelphia area. So much so that some are calling the area “Cellicon Valley.” But growth is contingent upon a vibrant ecosystem of networking and support, including from various service providers.


At Outsourced Pharma's Philadelphia event, stakeholders from the local life sciences community discuss the challenges and opportunities in growing an innovation cluster, and how incorporating a line of communication between patients and CDMOs in the outsourcing strategy will improve the final outcome.

You won't want to miss -
This session will also include a presentation by Nicole Gularte, a leukemia cancer survivor from Philadelphia, who was part of the historic Novartis CAR-T-cell therapy study. Nicole has established a patient advocacy group called The Inspired Heroes.

  • Nicole Gularte, Co-Founder | The Inspired Heroes
  • Laurie Actman, Chief Marketing, Communications & Program Officer | Penn Center for Innovation
  • Dora Mitchell, VP Operations | Carisma Therapeutics
  • Heather Rose, Director of Technology Licensing | Thomas Jefferson University
  • Scott Shandler, Founder & CEO | Longevity Biotech
  • Matt Cabrey, Executive Director | Select Greater Philadelphia Council (Moderator)
4:00pm
Networking Reception

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

  • Elias Mattas, Global Pharmaceutical Technology | Allergan
  • Jeff Meltzer, VP Quality Management | Trevena
  • Pamela Rizos, Program Manager/Associate Director, Business Ops & Strategy, Regulatory Affairs & Clinical Safety | Merck
  • Rose Cook, CEO & Co-Founder | The FlexPro Group
  • Robert Matje, Principal | RemTech (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 & Strategy | AstraZeneca
  • Kenneth Wexler, GMP Quality Assurance | Boehringer Ingelheim
  • Patrick Guertin, Global Technical Manager | GE Healthcare
  • Kelly Waldron, Senior Consultant | ValScource (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
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
  • Ken Sabatino, Sr. Director Global API Biologics | Janssen
  • Ratna Shekhar, Head of External Site Operations | Shire
  • Kip Wolf, Principal | 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 Leadership Company: Spark Therapeutics

The decision process at Spark Therapeutics on how best to utilize internal and external resources has evolved as the company has matured from a small start-up to mid-sized with a commercial product and an extensive pipeline. Join the manufacturing team from Spark Therapeutics at Outsourced Pharma in Philadelphia as they share how they have learned to optimize their resources and accelerate timelines. Each member of the panel will cover an area related to their particular expertise.

  • Company Overview
    • Diane Blumenthal, Head of Technical Operations
  • Conducting a successful process tech transfer to a third-party manufacturer (a discussion of lessons learned)
    • Christi McDowell-Patterson, Upstream Process Development Lead
  • What makes a company decide to outsource manufacturing? Selecting the best CMO for your needs and building a collaborative and productive relationship.
    • Christopher Stevens, Head of Manufacturing
  • When does outsourcing release and in-process testing make sense? What are the key elements to consider when selecting an external Contract Testing Laboratory? Is there an optimal time to bring testing back in house and what considerations should be taken prior to making this decision?
    • Mark Galbraith, Head of Quality Control
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.