Upcoming program agendas

Participants have described our sessions as “electric.” High energy comes from the earnest (and yes, sometimes heated, but always civil) discussions. We dive into everything from new FDA regulations and tech-transfer best practices, to the competition between outsourcing in the East and West … and the very future of the industry.

See what we have planned for our upcoming programs!

San Francisco 2017

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San Francisco 2017 Agenda

Transference In Drug Development and Manufacturing Outsourcing

Tuesday 10/17/17

8:00 am

Registration and Exhibit Hall open, Networking Breakfast

9:00 am

Welcome / Conference Chair Opening Remarks

9:15 am

Data integrity meets knowledge transfer

Data integrity is mission critical. But project success also relies on turning your data into a “knowledge transfer” with your outsourcing partners. We’ll discuss the best ways to both ensure data accuracy, and ensure you are transferring useful knowledge to and from all your partners.

 

  • Panelists:
    Jane M. Kreis, Training Officer | FDA
    Vinita Kumar, VP QA / QC | Versartis, Inc.
    Michael Mulkerrin, Head of CMC | ADC Therapeutics
    Sue Wollowitz, President | Wollowitz Associates (Moderator)

10:15 am

Networking Refreshment Break

11:00 am

The geography of outsourcing: How important is your project’s location?

How critical is physical location to the success of your project? Does proximity outweigh purpose, or geography mean as much as specific capabilities? We’ll outline all the variables (e.g., distance, country, equipment, platforms, capacity, and capabilities) you must consider to select the best location of your next project and outsourcing partner.

 

  • Panelists:
    Marilyn Bruno, CEO | Aequor, Inc.
    Michael Mulkerrin, Head of CMC | ADC Therapeutics
    Sriram Naganathan, Senior Director, Chemical Development | Dermira
    Thomas W. Sun, VP, Nonclinical Development | Nuredis
    Jens Vogel, President & CEO, BI Fremont Inc | Boehringer Ingelheim
    John McShane, Managing Partner | Validant (Moderator)

12:00 pm

Networking Lunch

 

1:15 pm

Aligning motivations for sponsor and supplier innovation

Even small “i” innovations at your service providers can lead to big outcomes. So how do you align motivations for innovation through your supply chain? We’ll discuss what actually motivates providers to innovate, and how to ensure that matches up with your needs and goals.

 

  • Panelists:
    David Larwood, CEO & President | Valley Fever Solutions
    Sriram Naganathan, Senior Director, Chemical Development | Demira
    David Upchurch, VP, Supply Chain | Jaguar Animal Health
    Jens Vogel, President & CEO, BI Fremont Inc | Boehringer Ingelheim
    Sami Karaborni, Co-founder | KO Pharma R&D (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight technology: Outsourcing assistance for cell and gene therapies

When science advances through new therapies and companies, how do external partners expand capabilities, or new service providers emerge? Is there a supporting cast of outsourcing companies for the development of new cell- and gene-based therapies? We’ll hear from sponsors what they need, where to get it, and equally important, what not to expect.

 

  • Panelists:
    Jason Carstens, Principal Consultant | Cyathlon Bioscience
    Peter Emtage, SVP, Research | Cell Design Labs
    Ali Javadian, Director, Biotherapeutics & Vaccines Outsourcing | Pfizer
    Mary Mallaney, Senior Engineer | Juno Therapeutics
    Catherine McIntyre, Sr. Dir., Global Manuf. Support | PCT Cell Therapy Services (Hitachi Group)
    Bryan Steadman, Chief Technology Officer | Universal Cells (Moderator)

4:00 pm

Networking Reception

 

6:00 pm

Day One Concludes

 

Wednesday 10/18/17

8:00 am

Exhibit Hall Opens, Networking Breakfast

9:00 am

Conference Chair Day Two Opening Remarks

9:15 am

Teaming up for regulatory advancements

The process to drug approval and manufacturing compliance should feel like a three-way partnership for advancing common goals. Are you effectively teaming up with your external partners to work with regulatory authorities to make this happen? We’ll provide real-world case studies on how drug sponsors, service providers, and regulators can successfully operate together.

 

  • Panelists:
    Wayne Frost, VP, Regulatory Affairs | FibroGen
    Federico Goodsaid, Principal | Regulatory Pathfinders (former FDA official )
    Umar Hayat, Principal | Hayat Pharmaceuticals Consulting
    Vinita Kumar, VP QA / QC | Versartis, Inc.
    Bikash Chatterjee, President | Pharmatech Associates (Moderator)

10:15 am

Networking Refreshment Break

11:00 am

Your workforce: Challenges in hiring new and skilled employees

In any industry, finding and maintaining new and skilled employees is a major factor in operational continuity and business advancement. In this session, biopharma experts will take up our industry’s current and specific workforce challenges, and provide some implemented and potential solutions to overcome them.

 

  • Panelists:
    Jeff Evans, CEO | PharmAssist
    Wayne Frost, VP, Regulatory Affairs | FibroGen
    Mary Mallaney, Senior Engineer | Juno Therapeutics
    Jennifer Troia, SVP, HR & Organizational Development | Assembly Biosciences.
    Dave Perritt, Vice President | Rondaxe (Moderator)

12:00 pm

Networking Lunch

1:15 pm

Putting it together: Evaluating your provider network

It’s not enough to measure service providers in isolation. How effective are partners within the entire continuum of your project development and manufacturing network? We’ll learn best practices, including a matrix-based approach to evaluation, and reasons why traditional partner benchmarking can be sending you the wrong signals

 

  • Panelists:
    Ulrich Ernst, SVP, Tech Operations | Amunix Pharmaceuticals
    Ali Javadian, Director, Biotherapeutics & Vaccines Outsourcing | Pfizer
    Thomas W. Sun, VP, Nonclinical Development | Nuredis
    David Upchurch, VP, Supply Chain | Jaguar Animal Health
    John McShane, Managing Partner | Validant (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Leadership Company: Achaogen

Members of Achaogen will provide insight and advice on the successful outsourcing of various activities and functions. And they’ll take your questions on how they’ve achieved such success to date.

 

  • Panelists:
    Tina Larson, VP Technical Operations | Achaogen
    Kirin Jamison, Director, Antibody Process Development | Achaogen
    Jim Kirchner, Senior Director CMC | Achaogen
    Amelia Milani, Senior Director Supply Chain | Achaogen
    Louis Garguilo, Conference Chair and Chief Editor | Outsourced Pharma (Moderator)

3:50 pm

Conference Chair Closing Remarks

4:00 pm

Conference Concludes

* Agenda and panelists subject to change.