• Which biosimilars have been approved?
• Which are available on the market and how are they administered (device/PFS/vial)?
• Litigations or other obstacles preventing launch of approved products
• What lies ahead?
• The importance of consistent bolus formation in the performance of LAIs
• Design considerations when developing an autoinjector for LAI delivery
• The methodologies best used to understand bolus shape and position
• The impact of various delivery parameters on bolus formation
• The market for biosimilars is growing rapidly, creating a vital but challenging need for companies to devise
robust biosimilar defence strategies to maintain their market share
• Simple user experience mapping methods will be demonstrated to show how truly original opportunities to
improve the patient and professionals' experience can be identified
• Technology mapping from these opportunities will then be used to discover how the latest technologies, from digital to
formulation, can provide unique strategic propositions to underpin a compelling biosimilar defence strategy
• Innovation Map revealing emerging application areas in pharmaceutical packaging
• Visualizing Innovation: heatmaps of startup activity, technologies and trends
• Opportunities of working with cutting-edge start-ups
Hybrid systems are electronic devices where traditional silicon integrated circuits are embedded within functional smart substrates comprising flexible batteries, sensors, interconnects, antennae and displays and represent the only viable solution to integrate sophisticated functionalities in miniaturized systems in a cost-effective way. Such systems are the natural endpoint of the rush to ubiquitous computing and while still in their early days, are ultimately aimed to be deployed in a number of industries from logistics to medical devices, from consumer electronics to industrial sensing in mass volumes (hundreds of millions to billions per year) and usually have ultra-low target prices (few tens of cents).
The design and development of these tiny but complex devices poses tight constraints from system design to process development, and from materials selection to assembly equipment design.
In this work we present the unique challenges presented in the development of a new generation of flexible hybrid electronic devices and the critical role of such systems to unlock new applications for disposable.
• From the perspective of a polymer based component and device manufacturer
• On the examples of silicone based micro and 2-component parts for smart, wearable combination products to implantable
drug eluting devices
• Shoulder-to-shoulder development between drug, device and components
• From concept to serial production via scalable process development
• Design for Manufacture (DFM) and process integrated quality
In partnership with Voisin Consulting Life Sciences.
• Drug delivery technologies: smart devices, selective, targeted delivery…
• Regulatory background: MDR (EU) 2017/745 new requirements for drug delivery devices and drug-devices combination medicinal products and directive 2001/83/EC amendment (scrutiny and clinical evaluation, article 117)
• Discussion on implementation issues, impact on device’s technical file and medicines MAA dossier and new challenges and business perspectives for manufacturers
Drug delivery devices are becoming increasingly complex and integrated, combining various advanced technologies (digital, coated, nanoparticles…) allowing to deliver the right dose at the right time and right location. They can be ruled as medical devices on their own, as well as device’s part of drug-device combination products regulated as medicinal products. We will explain in practical terms the regulatory requirements of the Medical Device Regulation (EU) 2017/745 (MDR) for these products (including for their digital components), with a focus on the clinical evaluation scrutiny by an expert panel prior to the placing on the market and on the article 117 which clarifies that the medical device constituent part of a medicinal product shall comply with MDR general safety and performance requirements. Finally, we will discuss the new business challenges and operational model implied by this regulation for pharma and medtech industries.
• China FDA regulatory update on drug packaging & drug delivery devices and the impacts for new drug registration
• Expectations and suppliers management from Chinese pharma companies perspective
• Business opportunities and advices for China market entry
Developing and bringing a biological drug to market is very expensive and involves risks in every stage of the project. Primary packaging is an integral part of the drug and selecting the right packaging components is crucial for the success of the project. Drug developers and manufacturers who do not understand the full impact of primary packaging on their drug product are taking a significant risk in terms of product stability, patient safety and regulatory scrutiny. The new biological drugs also demand innovative primary packaging solutions.
Learn about the next generation of packaging solutions for biological drugs to avoid the common pitfalls and put your biological drug on a “fast track” to success.
• An innovative answer to cGMP Annex 1 requirements on vial sealing
• Improving process efficiency by suppressing vial crimping
• Creating an integrated ecosystem to enhance adoption of RayDyLyo
• Ready to Use packaging components: Market evolution
• Moulded Glass Vials RTU: why do we need them?
• The strengths of moulded and especially with new products
• Value Proposition of SGD Pharma Sterinity Platform
• How artificial intelligence helps to optimize respiratory therapies by improving adherence and inhaler technique
• How to make medical information clear and improve patient engagement with connectivity and digital solutions
• Importance of compliance for treatment efficacy
• Innovative devices for nasal delivery: Advancia, new generation pump platform
• Correlating enhanced compliance and patient experience
• How QbD process differs from traditional process in terms of focus, approach, and quality assurance
• How QbD process is needed in order to meet demands of advances in: biologic and complex small-molecule drug products, high-value treatments, stricter regulations, and self-administration systems
• How QbD process can be applied to design and manufacture of plungers, resulting not only in plungers of higher quality, but better performance.
• System integration of a prefillable syringe in an autoinjector
• Safe and effective drug delivery to patients
• Benefits of system integration and lessons learned after 8 years of BD Physioject™ commercialization