Presented by expert speakers, our workshops will give you advance insight into topics that will be covered at the event.

Can’t make the date? Still register to receive the workshop recording afterwards.

Inhalation Webinar

The Design And Development Of A Connected Inhalation System To Help With Monitoring And Patient Adherence

Wednesday, 15 January 2020 | 8:30am PST / 11:30am EST / 4:30pm GMT

Hosted by Paul UphamHead, Smart DevicesGenentech 

  • Understanding the unmet needs for clinical trials and commercial use of a connected inhalation system 
  • Selecting design and development partners for a connected ecosystem 
  • Describing the critical clinical and patient workflows that drive adoption 
  • Ensuring you have an engaging and motivating user experience 

Our complimentary webinar is for respiratory and inhalation experts interested in learning more about the latest innovations in digital health. This is a free event open to all, so why not register and benefit from the expertise of our speakers? 

Paul is the Head of Smart Devices at Roche / Genentech. Paul has 20 years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.

Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business. Paul and his team were responsible for all upstream and downstream marketing strategy for BD’s self-injection business, including pen injectors, autoinjectors, and wearable patch injectors.

Prior to that role, Paul was with WellDoc, Inc. as Director of Product Marketing, where he built and led the marketing team and was responsible for product management activities for WellDoc’s portfolio of mobile health solutions. He was also the Core Team Leader for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for type 2 diabetes.

Paul’s prior experience includes 10 years at BD in the Diabetes Care business. Paul was responsible for the development and launch of the award-winning BD InterActiv® Diabetes Software, and was a member of the joint BD / Medtronic core team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

Paul holds four issued patents in medical software and drug delivery devices and multiple patent applications covering software and medical devices. He is also an author and co-author of numerous peer-reviewed articles in medical informatics and in diabetes. His education background includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.

Biomanufacturing Digital Workshop

Improving your Biologic and Advanced Therapy Drug Formulation Strategy in a Regulated World

Tue, September 08, 2020 02:00 PM - 05.00 PM BST

Advanced Instruments, invites you to the Biomanufacturing Digital Workshop

Developments in MAb and Cell and Gene therapies and the need for “warp speed” vaccine development all bring challenges to the formulation of drug products. This is especially the case in a more heavily regulated biopharmaceutical environment. In this workshop, you’ll hear how osmolality measurements aid formulation development strategies to ensure consistent and painless injection whether of rapidly developed vaccines, biologic drugs or cryo-preserved cell therapies. You’ll also hear how new osmometer technology aids compliance of formulation processes to 21CFR Part 11 and regional pharmacopeia

  • Shweta Nair, Senior Product Manager Biotechnology, Advanced Instruments

  • Dr Zoltan Kis, Biotechnologist and Bioprocess Engineer, Imperial College London

  • Dr Kristeena Wright, Application Scientist, Advanced Instruments

  • Kevin Lin, Process Development Associate II, Alexion Pharma, Boston, Massachussets

  • Shweta Nair is the Senior Product Manager for the Biopharma portfolio, at Advanced Instruments, a manufacturer of scientific analyzers serving the biotech and pharma industry. Previously Shweta held a global product management role at Merck and academic research roles including at MIT
 
  • Dr Zoltan Kis is a Biotechnologist and Bioprocess Engineer and currently applies techno-economic and bioprocess modelling for Quality by Design to optimize the operation of rapid-response vaccine production platform technologies
 
 
  • Dr Kristeena Wright is an Application Scientist at Advanced Instruments, having previously held both academic research posts, for example at Boston Children’s Hospital and industrial roles in the process development field.

     

  • Kevin Lin currently specializes in the development of liquid parenteral formulations for biotherapeutic drugs intended to treat rare diseases at Alexion Pharmaceuticals. His past industry experience includes quality control (cGMP) for small molecules and specialty chemicals. He has also worked in the medical diagnostics industry and has a Bachelor’s of Science in Biochemistry from UCLA.

14:00 – 14:10

Using Osmomality Measurement for Drug Formulation Development – Introduction

Shweta Nair, Senior Product Manager Biotechnology, Advanced Instruments

14:10 -14:35

Warp speed RNA vaccine development and manufacturing in the Covid Age: How can we mass produce high-quality vaccines faster and cheaper?”

Dr Zoltan Kis, Biotechnologist and Bioprocess Engineer, Imperial College London

Overcoming pandemics, such as the current Covid‐19 outbreak, requires the manufacture of several billion doses of vaccines within months. This is an extremely challenging task given the clinical testing timelines involving multiple phases and large‐scale drug substance and drug product manufacturing. To tackle these challenges, regulatory processes are fast‐tracked, and rapid‐response manufacturing platform technologies are used. In this presentation, Zoltan Kis from Imperial College London will discuss differences between “warp speed” RNA versus “conventional” vaccine development and manufacturing. The RNA platforms, especially the self‐amplifying RNA (saRNA) platform, offer a high productivity estimated at over 1 billion doses per year with a small manufacturing footprint and low capital cost facilities. The RNA platform technology can be complemented by an a priori Quality by Design analysis aided by computational modelling in order to assure product quality and further speed up the regulatory approval processes when these platforms are used for epidemic or pandemic response in the future. 

14:35 – 15:00

Practical use of Osmomality Measurement in Vaccine Formulation Development

Dr Kristeena Wright, Application Scientist, Advanced Instruments

Final vaccine products require measured and documented osmolality before reaching the market. But in what ways does osmolality serve as an in-process parameter during their formulation development and production? We will discuss the use cases for this robust test across different vaccine sources and modalities, including mAbs, mRNA and viral vaccines.

15:00 – 15:10

Break

15:10 – 15:30

Practical Applications of Osmolality in Biologic Formulation Development

Kevin Lin, Process Development Associate II, Alexion Pharma, Boston, Massachussets

Osmolality is a critical component of successful liquid formulation development for biologic drugs. Ensuring the proper osmotic pressure of injectable formulations is key to guaranteeing patient comfort and safety. This talk covers some of the practical applications and theoretical aspects of using the Advanced Instruments OsmoTECH PRO in biotherapeutic liquid formulation development.

15:30 – 16:00

Osmolality for QC of Cell Therapy Cryo-Preservative Formulations

Dr Kristeena Wright, Application Scientist, Advanced Instruments

The trend towards cell therapies demands innovative ways to store products before administration to patients. Cryo storage of cells may be the solution in most cases. Hear how new osmometer technology provides a valuable tool for formulation development for cryo-preserved products

16:00 – 16:20

Open Forum/Moderated Discussion

Dr Shweta Nair, Senior Product Manager Biotechnology, Advanced Instruments

16:20 – 16:40

Summary

16:40 – 16:50

Wrapping up & Thank you

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