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August, 2018

Hi

It's hard to believe the Summer of 2018 is almost in the rear view mirror!  We hope you enjoyed it and spent some time relaxing and soaking up some vitamin D (let's not talk about those record busting temps!)    

Here at Tunnell, we have definitely been busy. Between working with our clients, conferences, speaking events and authoring interesting articles we have been on a roll.

We hope this newsletter lets you see a bit of what we've been up to!  


Maryann Gallivan
President and CEO
What We're Saying...

PAI Readiness: A Journey Not an Event


Being ready for a Pre-Approval Inspection (PAI) is a key milestone for the successful approval of a new product and can significantly impact the approval timeline and time to market. For companies who have experience in product development and commercialization,
getting ready for a PAI is built into their development process, but small companies and biotech startups who want to get their first product approved often struggle to determine if they are ready for a PAI. Avoiding this uncertainty requires thorough preparation. Utilizing external, independent reviews and assessments minimizes the risk of surprises and maximizes the best use of limited internal resources.


Using Lean Strategy To Improve Efficiency in
Pharmaceutical QC LABS

The QC lab is often seen as outside of the pharmaceutical production process,
and, as a result, opportunities for improved efficiency and operational excellence
are missed. A major source of complexity and poor utilization of resources is
often lab throughput time — the time between the arrival of a test sample in the
lab, completion of testing, and release of the data.

Who We Are...

Greg Anthos
Principal

Greg has been with Tunnell for 4 years and has spearheaded several major projects with small biotech companies and large top ten pharma firms to improve operations in manufacturing, quality, supply chain and technical operations to meet customer demand and business goals. The projects cover diverse topics such as Lean Labs, increase manufacturing capacity, accelerate new product launches, develop manufacturing expansion strategy, streamline quality systems and PAI readiness to name a few. He brought to Tunnell over 30 years of life sciences industry experience at Merck & Co., most recently as Executive Director, Business Consulting, where he was a program leader for a transformation of a 2,000 person global regulatory affairs function designed to provide a competitive advantage for Merck. Previously he was Sr. Director, Merck Lean Six Sigma Program which trained over 5000 employees and had significant bottom line impacts to the company. He has experience in Engineering, New Product Development, Operations, Supply Chain, and Quality. He is a certified Lean Six Sigma Master Black Belt as well as Change Agent II and Process Improvement Master.

A native of upstate New York, Greg enjoys spending his time with his wife, son and daughter. He enjoys the outdoors and likes to go skiing in the winter and golfing in the summer. He also still plays ice hockey, staying true to his roots in upstate New York.  

Where We've Been, Where We're Going...

Outsourced Pharma - May 14 & 15, 2018 in Boston, MA
- Julia O'Neill moderated a panel on: "Help! The 7 Critical Areas Where Sponsors Need More Support".

Outsourced Pharma - July 18-19, 2018 in Philadelphia, PA
- Kip Wolf moderated two sessions: "Negotiating Strategies for Quality and Supply Agreements" and "Make Outsourcing More About Patients" and Julia O'Neill moderating a session on "Regulations 'Round the World:  How to Navigate International Outsourcing".

Outsourced Pharma - August 21-22, 2018 in San Diego, CA
- Julia O'Neill moderated a session on: "Audits and Inspections:  Gaining Unparalleled Insights Into Your CDMO".

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Life Sciences PA -  August 23, 2018 - King of Prussia, PA
Tunnell SMEs provided strategic advice to Life Sciences entrepreneurs at the Med-Tech Start-up Stadium.  


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Process Validation Summit - May 17-18, 2018 in Philadelphia, PA
- Julia O'Neill spoke on: "Control Strategy for Cell & Gene Therapy Products"


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ISPE Annual Meeting 2018 - November 4-7, 2018 in Philadelphia, PA
Tunnell Group Vice President, Philippe Cini, PhD. will be a session leader for a workshop on "The Use of Descriptive Statistics in the Pharmaceutical Industry."



We Hope To See You At Upcoming Events!


Check out Tunnell's sister company, Turesol Staffing Solutions - - - the solution to your staffing needs!

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