UIC Engineering Design Expo Outcome

The 2011 UIC Engineering EXPO was a success and I was happy to connect with students, faculty, and colleagues. Kymanox sponsored the Production Methods and Facilities category and awarded 1st place to the Plasma Gasification of Municipal Solid Waste project and 2nd place to the Acetic Acid Synthesis via Methanol Carbonylation project. Congratulations!!

Kymanox Sponsors UIC Engineering Design Expo

I will be a judge and Kymanox

will be a sponsor at the University of Illinois at Chicago's upcoming Engineering Design Expo on 26APR2011.

As a UIC Chemical Engineering graduate and former Expo 1st place winner of the Process Design-Production award from Abbott


and 2nd place winner of the EPA Air Quality Award,
it is exciting to be a part in the growth and development of talented seniors and I look forward to seeing what innovations await from the class of 2011.

KymaSTORE

Kymanox has expanded KymaSTORE so there are even more templates and training packages available than before.

We have greatly increased the amount of cGMP (current Good Manufacturing Practices) Training and cGDP (current Good Documentation Practices) Training sales and in-house delivery of both packages.


Some of the Topics covered in the GMP Training presentation include:

• cGMPs at a High Level
• cGMP Requirements
• cGMP Consistency Worldwide
• Components of cGMPs
• Organizations and People
• Good Documentation Practices at a High Level (GDPs)
• Corrective Action and Preventative Action (CAPA)
• Linking Compliance, Regulations, and cGMP
• The Impact of Non-Compliance
• and More!

Kymanox Midwest Business Development

Greetings and salutations!

On Friday, 21 August I will be attending the 5th Annual Golf Outing hosted by the PDA (Parenteral Drug Association) Midwest Chapter at Chevy Chase Country Club in Wheeling, IL. Last year was very enjoyable and hope the same for this year.

11:00 am - Check in and Lunch begins

12:00 pm - Shotgun (Best Ball) begins

~4:00 pm - Award ceremonies and cocktails

Kymanox is sponsoring the event and we are expecting a great turnout. Several members from our midwest office will be in attendance including myself, Kevin Brown, and Alyson Stevans.

So if you have not already signed up for the event, please do so. I look forward to seeing you there!

Best regards,

Justin Pawlik

Kymanox 5th Year Anniversary

Today, 03AUG09, Kymanox celebrates our 5th year anniversary!

Kymanox (ki'-mah-noks') is committed to delivering Ideal Knowledge Transfer™ to its clients. A variety of services are available, such as technical project management, process operations, and engineering for the biotech, pharmaceutical and life science industries.

We also offer a variety of products available for download from our KymaSTORE™ website - templates, training packages, procedures, equipment packages, and more. Click the logo below to see what KymaSTORE can offer your company.
Ideal Knowledge Transfer Tip:

Perfecting the last 1 to 10% of an individual task may take a disproportionate amount of time and resources and usually does not provide a positive overall return. Instead of perfection, strive towards a state of overall robustness where multiple strategies help ensure the desired outcome.

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