May, 2018


Welcome to Tunnell's inaugural newsletter!  The goal of this quarterly newsletter is to provide you with a little bit of the latest information about Tunnell...our thought leadership, our people and the events at which we participate.  We hope to inform and enlighten you!   

Today's newsletter focuses on our life sciences consulting business.  In the future we will highlight Tunnell Government Services, the part of our company focused on supporting the mission of various government agencies, and Turesol, our recruiting and staffing division.

We welcome your thoughts or feedback. 

Let's keep in touch!

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

Losing Sight of the Intended Purpose of Specifications Has Consequences For the CMO-Sponsor Relationship

If you're reading this article, you probably spend most of your working hours focused on creating a reliable supply of medicines at a reasonable cost. But most of us also have been customers for the products we manufacture. When we reach for a bottle of tablets or brace ourselves for an injection at the doctor's office, we depend on that medicine being safe and effective in treating or preventing disease.

What matters to us as consumers is that the product embodies all the characteristics needed to treat or prevent our condition at the time we receive it. It's an extremely rare patient who can describe in detail those characteristics. We take for granted that someone behind the scenes has figured out those requirements.

Sponsors of a new medicine submit an application defining critical quality attributes and their acceptable ranges. Health authorities review the application and then negotiate those attributes and limits with the sponsor. The resulting quality profile should provide us (consumers) assurance that the medicine is acceptable for its intended use. This fundamental purpose of specifications is a cornerstone of the ICH Guidelines for Specifications for both chemical and biotechnological/biological products.
Who We Are...
Julia O'Neill
Principal and Statistician

Julia O’Neill has been with Tunnell for three years and has built a thriving portfolio of projects applying statistics in development and manufacturing.  She keeps a very busy speaking schedule on topics from CPV to specification setting, with a focus on biotechnology (vaccines, biologics, cell & gene therapy, and microbiome). She has moderated on topics such as “Help!  The 7 Critical Areas Where Sponsors Need More Support” at the Outsourced Pharma Conferences in San Diego, San Francisco, and Boston and recently presented on “Control Strategy for Cell & Gene Therapy Products” at the 2018 Process Validation Summit   A direct result of Julia’s networking and speaking efforts were projects with a number of emerging biotech companies. Julia gets a chance to do a wide variety of statistics and engineering support for several fast-moving companies, moving through accelerated approval for their first products.

A native of Maine, Julia returns often to visit family and friends.  In her limited spare time, she likes to cook, bicycle and swim.   She and her husband, Joe, are proud parents to two daughters. Their older daughter Liz is employed as a lab technician in plant ecology at the University of Pittsburgh. Kathleen is a junior in psychology at San Diego State University. Their two cats, Rocky and Ginger, provide entertainment while the girls are away.

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

PDA Midwest Chapter - May 10, 2018 in Northbrook, IL
--Julia O'Neill spoke on "The Goldilocks Principle:  Setting Limits That Are Just Right"
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 will moderating a session on: "Negotiating Strategies for Quality and Supply Agreements"

Outsourced Pharma - August 21-22, 2018 in San Diego, CA
--Julia O'Neill will moderate a session on: "Audits and Inspections:  Gaining Unparalleled Insights Into Your CDMO"
Process Validation Summit - May 17-18, 2018 in Philadelphia, PA
- Julia O'Neill spoke on: "Control Strategy for Cell & Gene Therapy Products"

We Hope To See You At The Upcoming Events!

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

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