8:00 am Breakfast & Registration

9:00 am Chair’s Opening Remarks

Combination Products – The Fast Evolving Landscape

9:10 am Keynote Address: Who Is in Charge? Securing Early Support from the FDA

Synopsis

  • Who should you engage within the FDA for your CP approval? The establishment of combination products office
  • The challenges with drug-device combinations and different regulatory approval pathways
  • What data should you provide? Human factors to clinical evidence

9:40 am Panel Discussion: How to Handle Regulatory Uncertainty and What Does It Mean to Your Combination Products’ LCM?

  • Suzette Roan Director, Global Regulatory Affairs, Sanofi
  • Helen Kim Associate Director, RA, Device & Combination Products, Allergan
  • Kristina Lauritsen Combination Products Regulatory Advisor, FDA

Synopsis

The changing requirements of EU MDR and post-marketing reporting have created a lot of concerns among drug and device manufacturers. We’ll be asking panelists their thoughts and experiences in handling this:

  • FDA’s current guidelines on combination products and post-market surveillance?
  • Collaboration between RA and commercial and drug-device teams – ensuring a smooth transition and compliant combination product
  • Are you ready for 2020? Handling the drastic change of EU MDR and its implications on combination products
  • Where to start? Expectations from EMA for filing and securing your CE mark
  • Impacts beyond EU – reference approval for APAC and Japan markets

10:20 am Morning Refreshments & Speed Networking

From Product Development Pathways to Program Management

11:30 am Innovation Talk: Leveraging Medical Device Expertise to Develop Combination Therapies

  • Will Sutton VP Engineering & Technology, Minnetronix Medical

Synopsis

When integrating a drug and delivery system into a combination therapy, developers need to consider a number of factors beyond their traditional processes. Understanding the medical device mindset and framework – including timing, risk management, design controls, and systems complexity – can help leverage concurrent development processes to a successful market introduction. Will will discuss key factors from a medical device perspective. Topic points include:

  • Critical attributes of a drug delivery system / medical device development partner
    • Medical device quality and regulatory expertise
    • Proven design controls from requirements through verification
    • Usability – improving delivery accuracy, simplicity and compliance while reducing risk
    • User interface and human factors design
    • System architecture and integration of complex systems
    • Embedded software, electronics and electromechanical design
    • Scalability from prototype to trial to delivery system manufacturing
    • DFx – design for manufacturing, test, safety, usability, etc.
  • State-of-the-art med device technologies beneficial to the pharmaceutical industry
    • Sensors, connectivity, wireless power, miniaturization, complex software/hardware integration, batteries, data analysis, etc.

11:45 am Embedding Lifecycle Management Early On – but How Early?

  • Leonel Vanegas Quality Assurance Director, Medical Devices & Combination Products, Merck & Co.

Synopsis

  • Why you should think about LCM at R&D stage?
  • Balancing speed-to-clinic, commercial and quality aspects for a unique product
  • Addressing the differences between drug and device development plans
  • Pre- vs. post-launch considerations and risk mitigation strategy
  • Having a clear roadmap to drive next generation products in a cost-effective and timely manner

12:15 pm Lunch & Networking

1:15 pm Excellent Integration of Design Control throughout LCM

  • Margaret Kelly Device Manager, Device Development & Commercialization, Novartis

Synopsis

  • Can you integrate drug and device product design and design control for a seamless and collaborative program?
  • Design control is not just documentation – it is a tool to help you develop and differentiate your product!
  • How to manage change to minimize risks, costs and disruptions?
  • From verification to validation – communication with your project teams and external suppliers to be audit-ready

1:45 pm From ICH Q12 to ISO Assessments – Delivering a Quality Drug- Device Combination Product with Continuous Improvements Post-Commercialization

Synopsis

  • Update on ICH Q12 and its impacts on product LCM post-launch
  • The roles of CMC and QA: Establishing a robust quality management system to capture feedback for continuous improvements
  • Challenges with change and multi-site operations – what’s your best practice?

Session Reserved for Program Partner

2:15 pm Roundtable Discussion

Synopsis

Based on the morning sessions, audience can choose a specific topic to discuss and share their challenges with colleagues. Through open dialogues, we hope to facilitate knowledge exchange and spark inspirations to help you find solutions to your daily problems.

This is your opportunity to have direct and candid dialogue with your combination products colleagues. We will split the audience into mini-group of 10. Each group will be nominating a leader at the kick off of a 30mins high-paced discussion.

The objective is to offer 1 top tip for the rest of the delegation. 

Track 1: Pharma needs to catch up on LCM – but who should be in charge?
Track 2: How should CMC and Regulatory Affairs engage with other functional teams to plan for PMS and EU MDR?

3:30 pm Afternoon Refreshments & Networking

4:00 pm Kaleo’s Successful Injectable Story – From Concept to Product Commercialization

  • Michael Roe Director – Device Development & Industrialization, kaleo

Synopsis

  • A winning product starts from early concept and engaging with the right stakeholders – from the FDA to ISO
  • Ensuring a unique differentiator in your combination product design
  • Is connectivity the answer?

4:30 pm Be Smart – Strategic Platforming for Your Combination Products

  • Stephen Fournier Director – Device Platform Management, Alnylam Pharmaceuticals

Synopsis

  • Optimizing development time, costs and reducing risks through platforming
  • How do you select your platform device and what are the important considerations during your LCM?
  • It’s not a one size fits all solution and due diligence is required

5:00 pm Chair’s Closing Remarks & Close of Day 1