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Integrated Development of Drug Delivery Devices

07.11.2016

Phillips-Medisize will show specialized visitors its expertise in designing, developing and manufacturing drug delivery devices as well as pharmaceutical primary packaging made of plastics at stand 616 during the Pharmapack exposition in Paris on 10-11 February 2016.

Phillips-Medisize will show specialized visitors its expertise in designing, developing and manufacturing drug delivery devices as well as pharmaceutical primary packaging made of plastics at stand 616 during the Pharmapack exposition in Paris on 10-11 February 2016.

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A wide variety of products will be displayed, ranging from special drug delivery devices, dosage systems, disposable insulin pens, inhalers, mixing injectors, bottles and caps, on to sterile multi-chamber bags. Phillips-Medisize offers customers complete end-to-end service, from the idea to the finished solution, inclusive of drug handling and supply chain support. Its strong points on the market are especially drug delivery and dosage systems, which undergo cross-process inspection through high-priority quality assurance in accordance with ISO 13485 and FDA standards as well as GMP (Good Manufacturing Practice).
During the Pharmapack Europe Conference 2016 – on 10th February 2016, at 4 pm – Bill Welch, Chief Technology Officer, Phillips-Medisize Corporation, will give a lecture entitled Integrated Development and Scale-Up of Combination Products.
Key Points:
• Smaller and smarter combination products to support the trend toward patient-administered drug delivery
• Integrating HFE and DFM/DFA as foundations of the combination product development process
• Early manufacturing involvement to speed up time-to-market and reduce risk by “getting it right the first time”
• Development of a manufacturing scale-up strategy, concurrent with the development process

Abstract:
The combination of drug, with an appropriately designed delivery device, can have a profound effect on the intended user. However, there are many challenges to creating a successful combo-product including regulatory, clinical, human factors and drug/device interactions. Add to these challenges the need to manage complicated supply chain logistics, from design, testing and development through low volume clinical trial manufacturing and scale up into higher-volume production for commercialization. Project success and the ability to control the many variables in combination product development, depends upon the ability to select the right device development and manufacturing partner, with the right mix of development support and commercial manufacturing service offerings to help guide the project. This presentation discusses a well-rounded approach for biopharma companies interested in developing and commercializing successful combination products, by highlighting key device development and scale-up activities as well as their relationship to the overall combination product development process.

Speaker Info:
Bill Welch, Chief Technology Officer, Phillips-Medisize Corporation
Bill Welch has over 25 years of contract design, development, and manufacturing experience, primarily serving customers in the drug delivery, medtech, and diagnostics markets. In his current capacity as Chief Technology Officer at Phillips-Medisize, he leads a global, 450+ person development, engineering, tooling, program management, and validation organization with more than 75 concurrent programs. He also has responsibility for the company’s China operations, including recently developed capabilities such as the manufacture of Class 2 drug delivery devices and CFDA registration services for its customers. Bill has been with Phillips-Medisize since 2002, and was previously employed in the injection molding and electronic circuit fabrication/assembly contract manufacturing segments. Bill holds a BS from the University Minnesota - Duluth.

Press Conference:
Phillips-Medisize will give a one-hour press briefing during the Pharmapack show, which will include an industry update by Matt Jennings, Chairman and CEO. Key topics will cover:
• Continued growth and expansion of our design, manufacturing, and supply chain capabilities in a changing regulatory landscape to support customers on combination products.
• The impact of continued growth of large molecule injectable therapies for the development of wearable drug delivery devices, such as on-body infusers.
• Update on how leading medical device and pharma companies are leveraging Phillips-Medisize’s design, manufacturing and regulatory support footprint in China, for the Chinese market.


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