Training: Universal Technology Transfer Methodologies for Biopharmaceuticals

Stephen M. Perry, PMP and Vladimir Kostyukovsky, Ph.D. of Kymanox will be teaching the course next week, July 27-28, 2009, 8:30 AM – 4:30 PM at NC State BTEC.


The Midwest office is excited to see another round of training coming up at BTEC and know how value-added the training will be for all who attend.







Universal Technology Transfer Methodologies for Biopharmaceuticals Course Description:

Discover how to set-up a team of professionals essential for the success of tech transfer. Assess feasibility, business, and regulatory impact. Identify necessary actions and create detailed assay and process transfer plans. Monitor, evaluate progress, and manage proactively the ongoing technology transfer project. Define criteria and document success of the technology transfer. Defend the rationale for and the outcome of the transfer in front of US and international regulatory bodies.


Best regards,


Justin Pawlik

Project Management in Drug Development: Phase III to Commercialization and Beyond

I attended the two day training last week from 20JUL09 - 21 JUL09 provided by Stephen M. Perry, President of Kymanox at NC State BTEC and was extremely impressed. The course was yet another example of how Kymanox provides Ideal Knowledge Transfer (IKT).

As a new drug candidate enters late‐stage clinical development, project managers must shift their focus from development to preparing to enter the marketplace. A few of the challenges associated with Phase III and Commercialization include regulatory submission, manufacturing scale‐up, and promotional launch. In order to successfully transfer from Phase III to Commercialization, project managers must learn how to apply the fundamentals of cross‐functional project management to these later stages of drug development. Particular skills are needed to effectively implement, monitor, and control late stage projects. By following the procedures and using the tools and templates provided, this course will allow you to successfully manage late‐stage drug development projects and avoid costly delays during the shift from Phase III to Commercialization.

The course was intense and very informative. Upon completion I was able to:

• Select the right cross‐functional team to ensure project success


• Effectively communicate with internal and external stakeholders and prevent communication breakdowns


• Develop useful project objectives and project plans


• Apply risk management strategies when developing project objectives and making risk‐based decisions


• Create and manage an achievable timeline and budget


• Successfully transition from Phase III to commercialization and avoid costly delays

I definitely recommend the training and am looking forward to the next topic on Universal Technology Transfer Methodologies for Biopharmaceuticals which will also be at BTEC on 27-28JUL09.


Please feel free to contact me with any additions, comments, or questions.


Best regards,

Justin Pawlik