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San Francisco 2016

November 1-2, 2016 | Hyatt Regency San Francisco Airport

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Produced by: Life Science Leader, Biocom
Supported by:, Rondaxe, ISR Reports




Fisher Scientific


Tepnel Pharma Services



Almac Group

Althea CMO



Ash Stevens

Avara Pharmaceutical Services

Avista Pharma Solutions

Axcellerate Pharma, LLC

B. Braun

Berkshire Sterile Manufacturing

Boehringer Ingelheim Biopharmaceuticals GmbH



Catalent Pharma Solutions

CMC Biologics


Cytovance Biologics


EAG Laboratories

Emergent BioSolutions

Eurofins Advantar Laboratories, Inc.


Fermion Oy and Orion Corporation

Flamma S.p.A.

FUJIFILM Diosynth Biotechnologies

Hetero USA



Lifecore Biomedical


Metrics Contract Services

Paragon Bioservices


PCI Pharma Services

PCI Synthesis


Pfanstiehl, Inc.

Pfizer CentreOne

Pharmasol Corporation

Ricerca Biosciences


Science Exchange

Sherpa Clinical Packaging

Siegfried USA, LLC.

Solid Form Solutions


Tepnel Pharma Services

Therapure Biopharma

Toxikon Corporation

Triclinic Labs

Unither Pharmaceuticals



Yourway Transport


Drug development and manufacturing outsourcing in an era of technology

Tuesday 11/1/16

Registration Opens

Exhibit Hall Open, Networking Breakfast


Welcome & Conference Chair Opening Remarks


Pharma’s invitation to “innovation partners” in the outsourced supply chain


Defining “innovation” in outsourcing of drug development and manufacturing
Pharma/Bio discuss their ideal technology and innovation partners in drug development and manufacturing
What new technology service providers are entering the supply chain?
How can CMOs become more innovative – or are they actually already?

  • Bernie Huyghe, Sr. Director | Pfizer
  • Tina Larson, VP Technical Operations | Achaogen
  • Rod MacLea, Director Supply Chain | Amgen
  • David Enloe, President and CEO | Althea CMO
  • Louis Garguilo, Chief Editor | Outsourced Pharma (Moderator)

Networking Refreshment Break


A view from afar: Silicon Valley on drug development and manufacturing


Technology companies provide analysis – visions and solutions – for improving aspects of the outsourced drug development and manufacturing continuum
Examples of how the technologies of today are already serving the bio/pharma industry
Questions from Tech companies for the bio/pharma industry

  • Vince Kosewski, VP, Supply Chain Operations | Sunovion Pharmaceuticals
  • Bob Sheroff, SVP, Technical Operations | Agios Pharmaceuticals
  • Steve Cook, Head, Global Biologic Supply Chain Ops | MedImmune
  • Anand Ekambaram, Executive Director, Global Technical Operations | Merck
  • Franco Negron, President, Drug Product Services | Patheon
  • Brian Scanlan, Managing Partner | Freedom Bioscience Partners (Moderator)

Networking Lunch


Sponsored by Bio-Rad

Bridging cultures: Sponsors, CMOs, Tech … and Millennials


How can all parties learn the same language, bridge cultural chasms, and bring an innovation revolution to bio/pharma’s external development and manufacturing industry
Outsourcing renewed: Some ideas from younger members of our industry

  • Alekhya Gummaregula, Sr. Project Manager - CMC Lifecycle Management | Amgen
  • Prem Ramiya, ED API Synthesis & Formulation Development | Intarcia Therapeutics 
  • Sheila Babnis, Innovator In Residence, Advisory Board | Launch Pad Central
  • Joe Rothman, VP Compliance & Services | Skyland Analytics
  • Louis Garguilo, Chief Editor | Outsourced Pharma (Moderator)

Networking Refreshment Break


Short stories on outsourcing innovation

3:00 pm

Panelists and the audience provide and discuss their real-world examples of sponsors and providers teaming up to advance drug development and manufacturing - be sure to have your OP Events app open!

  • Judy Chou, VP Pharmaceutical Operations | Pfizer
  • Michael Mulkerrin, VP, Head of CMC | ADC Therapeutics
  • Shawn Comella, CEO | Triclinic Labs
  • Louis Garguilo, Chief Editor | Outsourced Pharma (Moderator)

Networking Reception


Sponsored by Pfizer Centre One

Day One Concludes


Wednesday, 11/2/16

Registration Opens


Exhibit Hall Opens, Networking Breakfast


Data deluge: Has the tech disruption started?


Creating higher “Supply Chain Visibility”
Can we learn to manage supply chain data and optimization from other industries?
How does more data help optimize innovation in the supply chain

  • Margaret Faul, Executive Director | Amgen
  • Sriram Naganathan, Sr. Director Chemical Development | Dermira
  • Louis Sehl, Executive Dir. Manufacturing & Technical Operations | MyoKardia, Inc.
  • Ken Shultis, CEO | Rondaxe
  • John McSherry, 2017 Program Committee | Biotechnology Innovation Organization (BIO) (Moderator)

Networking Refreshment Break


Quality and the FDA in an era of tech transformation 


The FDA and the idea of “innovation” in drug development and manufacturing
Do we hide behind “compliance” and “regulatory bodies”?
What do the Quality professionals have to say on advancing innovation?

  • Thomas Templeman, SVP Pharmaceutical Operations | Medivation
  • Mike Thompson, Sr. Director, Chemical Development | FibroGen
  • Bikash Chatterjee, President & CSO | Pharmatech Associates
  • Shawn Comella, CEO | Triclinic Labs
  • Julia O'Neill, Principal | Tunnell Consulting (Moderator)

Networking Lunch


Sponsored by Tepnel Pharma Services

We’ve already been innovative: Continuous manufacturing, single-use equipment, new development platforms


A look at some of the innovations already in our supply chain
Whose idea was it? Where did the innovation and new technology come from? Is there a model for replication?

  • Judy Chou, VP Pharmaceutical Operations | Pfizer
  • Umar Hayat, Sr. Dir. Pharmaceutical Development, Manufacturing & Supply Chain | Anthera
  • Sami Karaborni, VP Development Operations | XenoPort
  • Kevin Haehl, General Manager North America | Unither Pharmaceuticals
  • Timothy Scott, President | Pharmatek Laboratories (Moderator)

Networking Refreshment Break


Future shock: Our age of outsourcing enters the era of technology

3:00 pm

An open discussion on what we can strive for in the next three years to create more supplier innovation
How can sponsors incentivize all their service providers in the supply chain to adopt a culture of innovation?
What role – or anchor – will regulations play?

  • Bernie Huyghe, Sr. Director | Pfizer
  • Michael Mulkerrin, VP, Head of CMC | ADC Therapeutics
  • Frank Sorgi, President & CEO | FLAG Therapeutics
  • Timothy Scott, President | Pharmatek Laboratories
  • John McSherry, 2017 Program Committee | Biotechnology Innovation Organization (BIO) (Moderator)

Conference Concludes


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