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San Diego 2018

August 21-22, 2018 | Hyatt Regency La Jolla

Produced by: Life Science Leader
Supported by: OutsourcedPharma.com


Sponsors

Cambrex

ISR Reports

Life Science Training Institute

Outsourced Pharma

Recro Gainesville

Skyland Analytics


Exhibitors

Adesis, Inc

Albemarle

AMPAC Analytical Lab

Avista Pharma Solutions

Boston Analytical

Coating Place, Inc.

CordenPharma

Dottikon Exclusive Synthesis

Emergent Biosolutions

FAREVA

IDT Biologika

Jubilant Chemsys

Lifecore Biomedical

LuinaBio Pty Ltd

Metrics Contract Services

Olon Ricerca Bioscience LLC

Pacific BioPharma Logistics, Inc.

PCI Pharma Services

Pharmatech Associates, Inc

Piramal Pharma Solutions

Procos S.p.A.

Quotient Sciences

Raffles PharmaTech

Rondaxe

Selvita, Inc.

Sherpa Clinical Packaging

Singota Solutions

STA Pharmaceutical, a WuXi AppTec company (WuXi STA)

SynConnection

Nitto Avecia Pharma Services

Lonza Pharma & Biotech


Agenda

Tuesday 8/21/18

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.

  • Marilyn Bruno, CEO | Aequor
  • Sandra Dunn, Founder & CEO | Phoenix Molecular Designs
  • Rick Panicucci, SVP, CMC | QED Therapeutics
  • Brian James, SVP Operations | Rondaxe Pharma (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
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 
  • David Enloe, President & CEO | Ajinomoto Althea, CMO
  • Jason Foss, Managing Director | Results Healthcare
  • Gil Roth, President | Pharma & Biopharma Outsourcing Association (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
Audits & 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, VP Quality | Inovio Pharmaceuticals
  • Tara Caiano, Production Manager, External Manufacturing | Biogen
  • 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 & Lipid Biology: 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 in 2016 (Pharmatek to Catelent).  Now he's placed bets on the emerging science of glycobiology and lipids.  He'll be joined by another locally 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 music!


Wednesday, 8/22/18

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.

  • Julio Baez, Head of Technology - Biologics | CBT
  • Marilyn Bruno, CEO | Aequor
  • Fred Defesche, CEO | Beloteca
  • Mark Glassy, CEO | Nascent Biotech
  • Mitchell Rosner, VP QC/QA & Analytical Development | Aridis Pharmaceuticals (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
Case Study: Inside A (Small) Drug Sponsor - (Big) CDMO Relationship

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 & CEO | Phoenix Molecular Designs
  • Erik Flahive, CMC - API | Phoenix Molecular Designs
  • Grace Furman, President/CEO | Paracelsus, Inc.
  • Wenjie Li, Sr. Director of Process R&D | STA Pharmaceutical, a WuXi AppTec company (WuXi STA)
  • Gerrit Los, CSO | Phoenix Molecular Designs
  • Youchu Wang, VP of Process R&D | STA Pharmaceutical, a WuXi AppTec company (WuXi STA)
12:00pm
Networking Lunch

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

1:00pm
Tools & Tactics For A Successful CDMO/CMO Relationship

Aligning expectations from quality systems, validation, and change control; agreeing and executing to standard timelines; establishing and holding each other accountable through effective communication channels; all are essential for a successful outsourcing relationship. So what should be done before alignment issues become critical? How should situations be escalated through Governance on both sides? Our panelists have been through successful — but also difficult times with their service providers. They’ll provide case studies, and discuss your approach.

  • Doug Bakan, EVP Technical Operations | Arena Pharmaceuticals
  • Rick Seibert, SVP Innovation & Technology Services  | Sharp Packaging Services
  • Shay Tabani, Global Head of Quality | Bird Rock Bio
  • Thomas Holmes, Sr. Director Global External Manufacturing | Biogen (Moderator)
2:00pm
Networking Refreshment Break

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

2:30pm
Spotlight Leadership Company: California Institute for Biomedical Research (Calibr)

Vadim Klyushnichenko of Calibr will give our community a detailed presentation on: Development Of Modern Biologics And Cell Therapy Products Through Global CMOs. As always, audience participation is welcome.

  • Vadim Klyushnichenko, VP Pharmaceutical Development & Quality | California Institute for Biomedical Research (Calibr)
  • Louis Garguilo, Chief Editor & Conference Chair | Outsourced Pharma (Moderator)
3:20pm
Conference Chair Closing Remarks

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

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