Lyophilisation USA Conference


Boston, MA, United States

We are pleased to invite you to the 5th Annual Lyophilization USA Conference arranged to take place on the 23rd and 24th October 2019, in Boston.

The current list of FDA-approved biopharmaceuticals contains up to 50% of injectables and approximately a third of all parenterals being lyophilized, which suggests it is the optimal way of ensuring stability in products that are unstable in aqueous solution. This instability or degradation can result in suboptimal product performance and even toxicity in worst cases indicating the need for lyophilization despite it's inherently expensive running costs and time-consuming process.

However, despite being a relatively old process, there is much need for improvements to circumvent the high costs and extended process times with much room for innovation. Next year's projections for the lyophilization equipment market are approximately $5.7 billion, which is 8% CAGR. This surge is fuelled by the urge to perfect lyophilization processes in areas that characterise the product to better inform formulation and process developments while consequently improving efficiency and reducing capital investment.

Join us this year to explore novel and developing technologies that tackle the most pressing challenges and push innovation in world of lyophilization. Benchmark and network with industry leaders and discuss the most up to date and relevant topics that delve into alternative lyophilization approaches, applied statistical modelling, fresh views on scaling up and tech transfer, pre- and post-product characterization. regulation and beyond.

Benefits of Attending

Participating in this year's Lyophilisation USA 2019 conference provides a chance to connect with research and industry leaders with the aim of tackling the most pressing hurdles in multiple areas of interest within lyophilisation:
  • Gain valuable insight into the most current challenges and considerations when working with highly concentrated and sensitive formulations
  • Explore new and innovative approaches in model-based studies that utilise the power of statistical analysis to improve process development and understanding
  • Discuss the future outlook of lyophilization through trends in alternative approaches
  • Discover updates on the leading PAT technologies such as controlled nucleation, continuous freeze drying, low-frequency Raman, vacuum-foam drying and more.
  • Listen to key opinion leaders and experts from regulatory bodies speak about expectations and the assessment of reliable technologies in the market

Who should attend

VPs, Directors, Chiefs, Heads, Principals, Managers and Analysts of:
  • Lyophilization/Freeze-drying
  • Formulation Scientists
  • Principal Scientist
  • Process Development/Engineer
  • Sterile/Fill-Finish
  • Production
  • PAT
  • CMC
  • Chemistry
  • Manufacturing
  • Quality Assurance/QA

Plus Two Interactive Half Day Post Conference Workshops | Friday 25th October 2019

Workshop A: Current and Future Freeze-Drying Technologies and Methods
Workshop Leader: Dena Flamm, Business Development Manager, Optima
Alexander Tambovzev, Project Engineering and Development Leader, Optima Pharma
08:30 - 12:30

Workshop B: Lyophilization process design for a given formulation. Principles of process scale up and transfer, introduction to the design space
Workshop Leader: Serguei Tchessalov, Principal Research Scientist, Pfizer
13.30 - 17.30

Speakers

  • Alexander Tambovzev, Project Engineering and Development Leader, OPTIMA pharma GmbH
  • Bernhardt Trout, Professor of Chemical Engineering, MIT
  • Chakradhar Padala, Director, Amgen
  • Charlie Tang, Director, Formulation Development, Regeneron Pharmaceuticals, Inc.
  • Ehab Moussa, Senior Scientist, AbbVie, Inc.
  • Ekneet Sahni, Senior Process Development Scientist, Pfizer
  • Evgenyi Shalaev, Executive Director, Allergan Plc
  • Fabrice Schlegel, Senior Engineer, Amgen
  • Fawziya Ali, Senior Associate Scientist, Pfizer
  • Justin Stanbro, Associate Principal Scientist, Merck & Co.
  • Lauren Fontana, Principal Scientist , Sanofi
  • Madhushree Gokhale, Principal Scientist, Bristol Myers Squibb
  • Pouya Tavousi, Postdoctoral Fellow, University Of Connecticut
  • Richard Denk, Head Sales Containment, Skan
  • Sara Yazdi, Senior Scientist, Takeda Vaccines
  • Swapnil Pansare, Principle Scientist, Bristol-Myers Squibb Co
  • Tai Hsi Fan, Associate Professor , University of Connecticut

Venue

Sheraton Boston Hotel
39 Dalton Street,
Boston, MA, USA