Conference Day One - [Timings in GMT]

1:25 pm - 1:30 pm Opening Remarks and PharmaIQ Welcome

1:30 pm - 2:10 pm Building your Roll-Out Network from The Ground Up for An Ultra Rare Disease

Maarten Van Geffen - Senior Director, Late Phase CMC lead, ProQR Therapeutics
  • Discuss how to define an effective partnership and identify your critical success factors when considering the parameters of an Ultra Rare Disease product
  • Hear how ProQR utilised concurrent validation requirements to spread out batch production and reduce both cost and wastage
  • Analyse ProQR’s approach to building a new Roll-Out network of external partners ready for launch – challenges, opportunities and unforeseen hurdles!

Maarten Van Geffen

Senior Director, Late Phase CMC lead
ProQR Therapeutics

  • During this discussion, panellists will look at partner evaluation criteria from both the CMO and the sponsor perspective
  • Our panellists reflect on their partnership management both pre, and during, Covid-19 to identify any process changes under Covid and any key success factors they will take forward for 2021. 
  • Panellists will also analyse the repercussions from partner evaluation and identify potential challenges on the back of the evaluation and assessment process moving forward
  • Discussions will conclude by benchmarking strategies for the successful termination of a partnership and on boarding of new partners to minimise disruption to supply and inventory management

David Boisvert

Senior Director for Process Development, Manufacturing and Supply Chain
Arch Oncology


Ayse Hizli

Senior Strategic Procurement Manager
Helm AG


Denis Le Hazif

Director External Manufacturing Organisation
Ipsen Consumer Healthcare


David Caron

Ayala Pharmaceuticals

3:00 pm - 3:30 pm Content Break

3:30 pm - 4:10 pm Establish Data Visibility and Improve Process Performance using Cloud-based Systems in Sponsor/CMO Networks

Bob Di Scipio - CEO, Skyland Analytics
Steve Lam - Former Head of Biologics, Pharmaceutical Services, Thermo Fisher
Joe Kauten - Head of Process and Technology Transfer, Incyte
  • How cloud-based process information management systems improves collaboration and process performance
  • The role of a shared, persistent knowledge library in accelerating scale-up, tech transfer, and regulatory and business reporting
  • Best practices to successfully engage and onboard your CMO
  • Key requirements and timing for evaluating process information management solutions

Bob Di Scipio

Skyland Analytics


Steve Lam

Former Head of Biologics, Pharmaceutical Services
Thermo Fisher


Joe Kauten

Head of Process and Technology Transfer

4:10 pm - 4:50 pm The Critical Aspects to consider when choosing the Right CDMO for HPAPI Development and Manufacturing

David O’Connell - Director of Scientific Affairs, PCI Pharma Services

With the complexities involved in the safe handling of potent molecules and increasing regulatory requirements, it is imperative to choose the right partner for the successful development and manufacturing and ultimate commercialisation of such molecules. Identifying a partner with the relevant capabilities, expertise and experience to collaborate with through this journey is a critical decision point for any company looking to outsource. Key takeaways include:

  • The key considerations in the development and manufacturing of highly potent products
  • The complexities involved with the processing of highly potent molecules, including OEL assessment, safe processing and cleaning procedures
  • Regulatory guidelines and best practice for the safe handling of highly potent molecules
  • The key considerations when identifying and evaluating a potential CDMO partner for HPAPI development and manufacturing

David O’Connell

Director of Scientific Affairs
PCI Pharma Services

4:50 pm - 5:30 pm Benefits and Challenges of External Partnerships to Address Biologics Development

Ulrich Rumenapp - Head of Launch Preparation - Product Supply, Bayer AG
  • The benefits, risks and special challenges in outsourcing biologics development and manufacturing
  • Look at external partnerships as a basis for supporting innovation
  • Make vs. Buy – what should you outsource and what to do in-house?
  • How to best select and manage your CDMO
  • Decrease time to market by identifying critical partners for your biologics development

Ulrich Rumenapp

Head of Launch Preparation - Product Supply
Bayer AG

5:30 pm - 5:30 pm Chair's Closing Remarks and Close of Webinar Day One