Skip to the content

San Francisco 2017

October 17-18, 2017 | Hyatt Regency San Francisco Airport


Sponsors

DPT Laboratories

Skyland Analytics

Symbiosis Pharmaceutical Services

PharmaAssist Analytical Laboratory

Pfizer CentreOne

Life Science Leader

Life Science Training Institute


Exhibitors

Adesis, Inc.

Albemarle

Alcami Corporation

Althea CMO

AMPAC Analytical Lab

Aphena Pharmaceutical Solutions

Avara Pharmaceutical Services

Avista Pharma Solutions

B. Braun Medical OEM

Berkshire Sterile Manufacturing

BioDuro

Boehringer Ingelheim

Cambrex Corporation

Boston Institute of Biotechnology LLC

Cambrex Corporation

CMC Biologics

Cytovance Biologics

DavosPharma

Dottikon ES America

Eurofins Alphora

FAREVA

Flamma S.p.A.

FUJIFILM Diosynth Biotechnologies

Full Spectrum Analytics

Jubilant Chemsys

LI-COR Biosciences

Metrics Contract Services

Multipharma Inc.

Olon Ricerca Bioscience LLC

PCI Pharma Services

PCI Synthesis

Pharmatech Associates

Piramal Pharma Solutions

Quotient Clinical

Recro Gainesville

Rondaxe

SafeBridge Consultants, Inc.

Scientist

Sherpa Clinical Packaging

SHL Group

Siegfried USA, LLC

SMC, Ltd.

Therapure Biopharma

Triclinic Labs

Unither Manufacturing LLC

Yourway Transport

Rondaxe

Sherpa Clinical Packaging

Siegfried USA, LLC

Scientist

STA Pharmaceutical, A WuXi AppTec Company

SynConnection

Triclinic Labs

Unither Manufacturing LLC

Yourway Transport


Agenda

Tuesday, 10/17/17

Registration & Networking Breakfast

8:00AM

Welcome & Conference Chair Opening Remarks

9:00AM

Data integrity meets knowledge transfer

9:15AM

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.

  • 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)

Networking Refreshment Break

10:15AM

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

11:00AM

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.

  • 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)

Networking Lunch

12:00PM

Aligning motivations for sponsor and supplier innovation

1:15PM

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.

  • 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)

Networking Refreshment Break

2:15PM

Spotlight technology: Outsourcing assistance for cell and gene therapies

3:00 pm

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.

  • 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)

Networking Reception

4:00PM

Day One Concludes

6:00PM


Wednesday, 10/18/17

Exhibit Hall Opens, Networking Breakfast

8:00AM

Conference Chair Day Two Opening Remarks

9:00AM

Teaming up for regulatory advancements

9:15AM

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.

  • 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)

Networking Refreshment Break

10:15AM

Your workforce: Challenges in hiring new and skilled employees

11:00AM

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.

  • 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)

Networking Lunch

12:00PM

Putting it together: Evaluating your provider network

1:15PM

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.

  • 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)

Networking Refreshment Break

2:15PM

Spotlight Leadership Company: Achaogen

3:00 pm

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.

  • 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)

Conference Chair Closing Remarks

3:50PM

Conference Concludes

4:00PM

Check out our current agendas

Join our community at an event near you.