19 - 20 March, 2019 | Crowne Plaza Berlin - Potsdamer Platz, Berlin, Germany

Conference Day Two

8:30 am - 9:00 am Registration and Welcome Coffee

9:00 am - 9:05 am Pharma IQ Welcome

9:05 am - 9:10 am Chairman's Opening Remarks

Roger Cassidy - Managing Partner, Tamesis Pharma
img

Roger Cassidy

Managing Partner
Tamesis Pharma

9:10 am - 9:55 am Deciding Whether To Manufacture In-House Or Outsource

- Determine your parameters by examining your capabilities in the three key decision making areas: economics, technical capabilities and in-house capacity
- Analyse the timeline impact of outsourcing selection vs in house capability scale up to ensure timely development
- Understand how to secure the quality and efficiency metrics required to meet your manufacturing timelines

9:55 am - 10:40 am When to Cut The Cord: Moving On From Your CMO Partner As A Research Based Biotech

- Understand the biggest differences in CMO relationship paradigms between Big Pharma, Biotechs and research stage Biotechs
- Identify the warning signs that should encourage you to review whether you outsource or in-house manufacture
- Create a strategy to transition from outsourced manufacturing to in-house manufacturing that minimizes production downtime and process disruption

10:40 am - 11:15 am Coffee Break

11:15 am - 12:15 pm Back By Popular Demand: Interactive Crisis Management Workshop

Unexpected challenges can arise anywhere, anytime- leaving you very little time to prepare or regroup. In our highly popular interactive session, attendees will divide into small groups to work through a given ‘crisis management’ scenario. Your task, as a team, is to devise a strategy that ensures production suffers as little interruption as possible, whilst protecting the necessary high quality levels.

12:15 pm - 1:00 pm Panel Discussion: When To Move On From Your CMO

- Discuss the best strategies for coping with unforeseen partner hurdles such as investigations with your CMO
- Learn how to correct communication misalignment and ensure that you are getting the information you need to make an informed decision
- Analyse the most common warning signs – how can you recognise when a partnership has broken down

1:00 pm - 2:00 pm Networking Lunch

2:00 pm - 2:45 pm Generating A Return On Investment and Sustainable Supply Strategy; Differences Between the Big Pharma Perspective and the SME Reality

- Discover the real benefits of outsourced manufacturing for the sponsor – how you can use your network to generate an efficient development network whilst minimizing internal development risk without the resources of a big pharma company
- Ensure that your partnership format reflects your return on investment metrics: equal partners, strategic partners or an interim measure
- Discuss how to communicate your needs to your partners through the lense of a CMC outsourcing partnership and SME Company perspective

2:45 pm - 3:25 pm Technology Innovation Showcase

Hear from 3 CMOs on the latest technology innovations and manufacturing capabilities to give you a clearer understanding of what is available. Take this opportunity to meet with some of the companies showcasing their capabilities at the forum!

3:25 pm - 3:55 pm Coffee Break


3:55 pm - 4:40 pm Generating A Lean and Efficient Partner Management Model That Is Aligned With Your Program’s Critical Success Factors

- Discuss the real benefits of outsourced manufacturing for the sponsor – how you can use your network to generate an efficient development network whilst minimizing internal development risk
- Examine the key KPIs for your outsourced program; what do you need to achieve and what should your external network parameters be?
- Ensure that your partnership format reflects your KPI metrics and lean deliverables: equal partners, strategic partners or an interim measure
- Create an external network integration road map to ensure that your CMOs are conforming to internal outsourcing protocols and ongoing deliverables timelines
- Discuss how to communicate your KPI metrics to your partner to ensure that delivery targets your critical success factors

4:40 pm - 5:25 pm Creating an End to End Outsourcing Strategy – Why One Size Fits All Just Won’t Work When Looking At Rare Diseases

- Discuss how to define an effective partnership and when a partnership becomes strategic rather than reactive
- Analyse different relationship models and how they can help to structure optimal external partnerships
- Understand the different limitations and challenges of each relationship model and identify which model will fit with your existing supplier network

5:25 pm - 5:35 pm Chairman's Closing Remarks