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Boston Agenda

Tuesday, May 7, 2019

8:00am
Registration & Networking Breakfast

Collect your badge at registration and head over to our 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.

Morning Sessions

Outsourcing Service Models And Negotiations For All Phases of Drug Development And Manufacturing

Time & materials, fee-for-service, FTEs, clinical material agreements, commercial supply contracts, milestones, risk-sharing - there are numerous ways to obtain services from CDMOs.

Learn how to select and put in place the best outsourcing model for your company’s needs, as well as how to negotiate the most successful working relationship with your partner.

9:15am
PART ONE

With multiple service models available for contracting services, how do you decipher which is the best option for your small to mid-sized biotech? What new models are emerging that you aren't aware of?

Our presenters will walk you through the items to consider before making your decision, including:

  • What is your budget (how long will that last)?
  • What phase are you in?
  • What is your pipeline?
  • What are your internal resources?
  • What is your ability to stomach risk to the program?
  • Do you have an existing relationship with a CDMO?
  • How do you work these details into a contract?
    1. What kind of risk sharing should you ask your partner to take on?
    2. Why would I want milestones included in my contract?
10:00am
Networking Refreshment Break

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

10:45am
PART TWO

Now that you've heard the nitty-gritty details of each model, we'll dive into two case studies presented by drug sponsors who followed through with a contracting service model decision and gain insight into their working relationship with their partner.

 12:00pm
Networking Lunch

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

Afternoon Sessions

Discussion on Domestic vs. International Outsourcing & Regulatory Updates 

Every global region presents particular opportunities and challenges. This is an afternoon devoted to learning about different regions and their regulatory bodies so you can make more informed decisions for a domestic vs. offshore solution to your outsourcing needs.

1:15pm
PART ONE

Q&A with Rosemary Gibson, author of China Rx-Exposing the Risks of America's Dependence on China for Medicine, giving an outside world perspective into the use of international suppliers for manufacturing and development outsourcing.

1:45pm
PART TWO

Demystify the regulatory issues that accompany working with an international partner. A experienced professional who specializes in life science compliance will speak to topics including finance, legal, IP, and import/export free trade zones.

2:15pm
Networking Refreshment Break

Continue the conversation as you fill up on locally inspired treats!

 3:00pm
PART THREE

Our panelists (including both sponsors and partners!) lend their personal experience with both domestic and international partners including:

  • How can you best manage your international partner - application of GMPs, IP, supply chain complexity, operational issues, exchange of data, quality related GMP risks?
  • Are you feeling pressure to look to international partners based on price? What complexities might accompany those cost-savings?
  • What project management strategies work best for both domestic and international partners?
  • What laws or policy pose a risk to the supply chain that your company may not fully understand?
  • How to verify a partner can work with your technologies/platforms/programs?
3:45pm
Conference Chair Closing Remarks

Louis Garguilo, Chief Editor & Conference Chair of Outsourced Pharma, sums up the day's takeaways.

4:00pm
Networking Reception

You're invited to join us for an open bar reception featuring dinner and desserts!

6:00pm
Conference Concludes

 

Agenda topics and speakers subject to change