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

Conference Day Two

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

8:00 am - 9:55 am Why Cheaper Isn’t Always Better: Establishing A Strategic And Proactive Partner Management Strategy

With the pharmaceutical industry increasingly challenged to reduce their investment in external
partnerships and cut down their number of outsourced manufacturing providers, the conversation
always seems to center around cost. In this interactive workshop delegates will look beyond cost,
taking into consideration the ‘non-commercial’ aspects to external supply base planning and
asking themselves the question: ‘Is cheaper actually better?’
This workshop is designed to ensure that attendees are focused on the most effective ways to
identify and generate real value from their outsourcing activity.

10:00 am - 10:10 am Chairman's Summary of Day 1

Roger Cassidy - Managing Partner, Tamesis Pharma
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Roger Cassidy

Managing Partner
Tamesis Pharma

10:10 am - 10:50 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

10:50 am - 11:30 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

11:30 am - 12:00 pm Coffee Break

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

12:00 pm - 1:30 pm Interactive Crisis Management Think Tank

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.

1:00 pm - 1:40 pm Optimising Selection Processes for your CMO when Entering Unfamiliar Markets

- Examine a variety of CMO selection processes that can be applied in regional markets such as the LATAM region
- Identify the key considerations for a successful alignment of expectations between pharma and external manufacturers
- Discuss how to establish a robust development strategy to meet the production timelines on a global scale and avoid
critical gaps in production cycles or timing misalignments

1:40 pm - 2:40 pm Networking Lunch


2:40 pm - 3:20 pm Patient-Centric Approaches To Optimize Medicine Acceptance And Adherence In Pediatric Patient Populations

Holger Neecke - Director Business Development, Adare Pharmaceuticals
- Discuss the need to formulate medicines that are convenient to administer to children to optimize acceptance, encourage adherence and improve health outcomes
- Examine the application of Taste Masking Technology and Multiparticulates to address these challenges
- Analyse a series of real life case studies to demonstrate the value of implementing these technologies to optimise patient adherence and acceptance

Holger Neecke, Director Business Development, Adare Pharmaceuticals

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Holger Neecke

Director Business Development
Adare Pharmaceuticals

3:20 pm - 4:00 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

4:00 pm - 4:30 pm Afternoon Coffee Break

4:30 pm - 5:10 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

5:10 pm - 5:20 pm Chairman's Closing Remarks