San Francisco 2016

Bio-Rad

Dottikon

Fisher Scientific

Solvias

Tepnel Pharma Services

Alcami

Almac Group

Althea CMO

Amatsigroup

AMRI

Ash Stevens

Avara Pharmaceutical Services

Avista Pharma Solutions

Axcellerate Pharma, LLC

B. Braun

Berkshire Sterile Manufacturing

Boehringer Ingelheim Biopharmaceuticals GmbH

Cambrex

Capsugel

Catalent Pharma Solutions

CMC Biologics

CordenPharma

Cytovance Biologics

DavosPharma

EAG Laboratories

Emergent BioSolutions

Eurofins Advantar Laboratories, Inc.

Fareva

Fermion Oy and Orion Corporation

Flamma S.p.A.

FUJIFILM Diosynth Biotechnologies

Hetero USA

Hovione

IDBS

Lifecore Biomedical

Lonza

Metrics Contract Services

Paragon Bioservices

PCAS

PCI Pharma Services

PCI Synthesis

Pfanstiehl, Inc.

Pfizer CentreOne

Pharmasol Corporation

Ricerca Biosciences

Rondaxe

Science Exchange

Sherpa Clinical Packaging

Siegfried USA, LLC.

Solid Form Solutions

SynConnection

Tepnel Pharma Services

Therapure Biopharma

Toxikon Corporation

Triclinic Labs

Unither Pharmaceuticals

Wacker

XiltriX

Yourway Transport

Registration Opens

Exhibit Hall Open, Networking Breakfast

8:00AM

Welcome & Conference Chair Opening Remarks

9:00AM

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

9:15AM

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

10:15AM

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

11:00AM

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

12:00PM

Sponsored by Bio-Rad

Bridging cultures: Sponsors, CMOs, Tech … and Millennials

1:15PM

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

2:15PM

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

4:00PM

Sponsored by Pfizer Centre One

Day One Concludes

6:00PM

Registration Opens

7:00AM

Exhibit Hall Opens, Networking Breakfast

8:00AM

Data deluge: Has the tech disruption started?

9:15AM

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

10:15AM

Quality and the FDA in an era of tech transformation 

11:00AM

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

12:00PM

Sponsored by Tepnel Pharma Services

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

1:15PM

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

2:15PM

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

4:00PM