Vectura Group plc

https://globalmeet.webcasts.com/starthere.jsp?ei=1693808&tp_key=60c9a6adc1

Initially, nearly all biologic molecules are developed as injectable dosage forms. However, the lungs present an appealing route of administration for localised delivery as well as rapid systemic absorption. Biologic formulations can be tailored and refined for lung delivery, whether in liquid or dry powder format. This optimization process necessitates considerations of lung physiology, biologic drug stability, and interactions between the drug and the delivery device used.

Understand benefits for pulmonary administration of biologics: targeted delivery or rapid absorption.

Learn characteristics for nebulization: particle size, stability, viscosity, device interactions, efficacy.

Explore key properties for optimizing biologic dry powder formulations: stabilize molecule, ensure device compatibility, maximize therapy effectiveness.

Team Leader - Formulation and Process Innovation

https://globalmeet.webcasts.com/starthere.jsp?ei=1693808&tp_key=60c9a6adc1 

Webcasts

Webinar Date/Time: Thu, Nov 14, 2024 11:00 AM EST


Biologic therapies: Charting the path from injectables to inhalation

This presentation will outline considerations for product design and characterization.

https://www.pharmtech.com/pt_w/bioequivalence-regulatory-landscape

The regulatory landscape for bioequivalence continues to evolve, leveraging a broader suite of characterization techniques. These not only provide deeper product understanding, but also utility for generic product development as the potential for replacement of costly clinical studies becomes more of a reality. In addition, a holistic approach to product/device design is critical to the success of a generic product. This presentation will outline considerations for product design and characterization.

Understand the current and evolving regulatory pathways

Learn about product/device design considerations for generic products

Identify tools and resources that support product-specific characterization

VPs of R&D within small to mid-sized pharma companies

Senior scientists within small to mid-sized pharma companies

C-Suite executives/CTOs/CMOs/CEOs/CSOs within small to mid sized pharma companies


Director, Pharmaceutical Development
Vectura

Amanda Jenkins is responsible for complex generic and DPI product development programs and has 26 years of experience in pharmaceutical product development, including 22 years of inhaled product development. Amanda joined Vectura in 2002 and has worked on a number of product development programs, spending a significant portion of this time focusing on the development of generic DPIs for the EU and US markets. Amanda holds a BPharm (Hons) degree from the University of Nottingham and a masters degree in Applied Project Management from Northumbria University.




Director, Pharmaceutical Development
Vectura

Richard Poole leads a center of excellence group at Vectura, with the remit of ensuring best practice in product development is understood and implemented across Vectura’s projects. He has over 20 years’ experience working with inhaled products, with 19 years in product development. Richard has been with Vectura since 2004 and has worked on a range of DPI products at all stages, from feasibility to late-stage generic development for the US market. Richard holds a BSc (Hons) in Pharmacology from Sheffield University.





Director, Device Development
Vectura Limited

Phil Swanbury has worked in the device development group based in Cambridge, UK, for 19 years. He has been responsible for the Design Assurance and Human Factors team for many years, and latterly the Concept Development team. Phil has led the design and development of single and multi-dose dry powder inhalers including some which are now successfully marketed by our licensees, as well as nebulisers and connected device technology. Phil holds a BSc (Hons) in Mechanical Engineering from the University of Nottingham.



Webinar Date/Time: Tue, Jul 30, 2024 11:00 AM EDT


Leveraging the Evolving Bioequivalence Regulatory Landscape to Enhance Product Design & Development

Vectura provides formulation, device, and development services to help customers bring inhaled medicines to market.

With expertise in powder and liquid formulations, as well as a portfolio of proprietary device and formulation technologies, Vectura can support programs for small molecules, biologics, or complex combinations.

Customers can access the delivery technology best suited to the needs of their development program, including unit-dose and multi-unit dose DPIs, pMDIs, and smart nebulisers, suitable for home or hospital applications.

With extensive analytical testing facilities, Vectura can undertake the comprehensive array of test methodologies and physical properties characterisation required for inhaled products, in addition to stability studies and device verification testing.

Vectura also offers seamless scale-up from laboratory to pilot to commercially-representative scale as well as GMP drug product and device manufacturing for clinical trials.

With more than 20 years’ experience, the company’s track record of success offers customers confidence in Vectura as a trusted development partner for their inhaled product candidate. Being able to provide customers with a single partner from early development to late-phase clinical trials and beyond offers benefits in terms of continuity, shortened timelines, and reduced costs.

Articles

Vectura helps customers bring inhaled medicines to market with a combination of formulation science, device technology, and inhaled product development expertise.  

Vectura – Helping You Succeed with Inhaled Product Development

http://www.pharmtech.com/pt_w/key_considerations


	Dry powder inhalers are an important technology for the delivery of therapies for both respiratory and non-respiratory disease areas. The development of such drug-device combination products is highly complex and several factors can have a significant impact on the success of the program. This webcast discusses the key considerations to reduce risk when developing a DPI product from early clinical trials through to scale-up, and provides insights for both novel and generic development programs.

		Understanding different options for dry powder inhaler technology

		Key considerations for DPI product development

		Manufacturing strategies for seamless transition and scalability from lab to commercial scale

		Relevant regulatory guidance and risk-based approaches to process development and device design 

		Device strategies for novel and generic inhaled development programs

Andreas Meliniotis, Director, Device Development, Vectura Group plc.

Wednesday, Jun. 24, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after final airing Jun. 24, 2021

Dry powder inhalers (DPIs) are an important delivery technology for inhaled medicines in both respiratory and non-respiratory disease areas. Andreas Meliniotis, director of device development at Vectura, helps navigate the complex area of DPI product development and highlights the key considerations for both novel- and generic-drug programs.

Live: Wednesday, Jun. 24, 2020 at 11am EDT |8am PDT |4pm BST |5pm CEST

On demand available after final airing Jun. 24, 2021

Register free