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San Diego Agenda

Navigating an Ocean of Drug Development & Manufacturing Outsourcing

 

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
Reaching The Right CDMO: Is There A Map To Follow?

There are a many decisions when it comes to outsourcing. But at the same time, there is a defined process that can be implemented by any sponsor company in your search for the right partner. Our experienced panelists will share the steps they took to success, for both small and large molecule projects.

  • Shay Tabani, Global Head of Quality | Bird Rock Bio
  • Sandra Dunn, Founder and CEO | Phoenix Molecular Designs
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
The M&A Impact: How To Sail Through Changes At Your CDMO

Your CDMO is acquired, merging, or under new leadership: How do you navigate through the changes … or decide to make a move elsewhere? Our panelists will provide some real-world scenarios, and detail some specific steps you should take to ensure you don’t get lost in an M&A storm.

  • Daniel Cohen, Managing Director | RBC Capital Markets 
  • Jason Foss, Managing Director | Results 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
Audits And Inspections: Gaining Unparalleled Insights Into Your CDMO

Nothing matches the insights drug sponsors can obtain from competently conducting quality or other on-site audits and inspections. That insight can start with the process to simply gain access, and end with how your CDMO follows up with you. From beginning to end, we’ll detail best practices for making your visits – and outcomes – more valuable.

  • EJ Brandreth, Vice President Quality | Inovio Pharmaceuticals
  • Julia O'Neill, 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: Glycobiology: Less Understood, Now Coming of Age (in San Diego)

San Diego based TEGA Therapeutics founder and CEO Tim Scott sold the CDMO he co-founded (Pharmatek to Catelent) in 2016.  Now he's placed bets on the emerging science of glycobiology and lipids.  He'll be joined by San Diego based startup, DTx co-founder and CEO Arthur Suckow.  They'll explore the advancing sciences of carbohydrates, glycomics and lipidomics, and how the CDMO industry will be impacted by these technologies.

  • Timothy Scott, CEO | TEGA Therapeutics
  • Arthur Suckow, CEO/CSO | DTxPharma
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
Strategies For Small Biotechs To Get (And Keep) The Attention Of CDMOs

Start-ups, virtuals, biotechs and smaller pharma compete with bigger sponsors for capabilities, capacity, better pricing … and just to maintain a service provider’s full attention. Some small organizations break through, while others feel marginalized. Our experienced professionals will offer strategies to help, and also discuss your experiences.

  • Fred Defesche, CEO | Beloteca
  • Marilyn Bruno, CEO | Aequor
  • Julio Baez, Head of Technology - Biologics | CBT
  • Mark Glassy, CEO | Nascent Biotech
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
Case Study:Inside A (Small) Drug Sponsor - (Big) CDMO Relationship

In this all San Diego panel of three companies, Sandra Dunn, founder and CEO of Phoenix Molecular Designs, and members of her senior leadership team, present a detailed case study and insight into her virtual biotech’s working relationship with CDMO WuXi (San Diego operations), and toxicology service provider Paracelsus, Inc.

  • Sandra Dunn, Founder and CEO | Phoenix Molecular Designs
  • Gerrit Los, Chief Scientific Officer | Phoenix Molecular Designs
  • Erik Flahive, CMC - API | Phoenix Molecular Designs
  • Youchu Wang, VP of Process R&D | WuXi AppTec
  • Wenjie Li, Senior Director of Process R&D | STA Pharmaceutical US (WuXi AppTec)
  • Grace Furman, President/CEO | Paracelsus, Inc.
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
How To Overcome Challenging CDMO Relationships

Introducing new processes; working through deviation management and change control; working out timelines; all these can stress an outsourcing relationships. What should sponsors do when the situation reaches a critical level? Our panelists have been through difficult times with their service providers. They’ll provide case studies, but also want you to discuss your challenges.

  • Paul Maffuid, VP Pharmaceutical Development | MabVax Therapeutics
  • Thomas Holmes, Sr. Director Global External Manufacturing | Biogen
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: California Institute for Biomedical Research (Calibr)

Vadim Klyushnichenko of Calibr will start this session with a presentation on: Development Of Modern Biologics And Cell Therapy Products Through Global CMOs. He’ll then lead a panel of CMC leaders from biopharma in a discussion of strategic outsourcing, including key best practices and specific examples. As always, audience participation welcome — bring your specific examples and needs to the session.

  • Vadim Klyushnichenko, VP Pharmaceutical Development and Quality | California Institute for Biomedical Research (Calibr)
  • Louis Garguilo, Chief Editor and Conference Chair | Outsourced Pharma (Moderator)
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.

Outsourced Pharma is an intimate setting where the speakers are approachable, no question is off limits, and people who have “been there, done that” from both the service side and consumer side are there to openly dialogue without a corporate agenda getting in the way.

Frank Sorgi | President and CEO

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.

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