Fall, 2020
I hope you are your family are safe and well as we enter the last few months of what has turned out to  be a very unusual year.  We are busy and doing well at Tunnell despite all of the unexpected changes  that 2020 has brought us!

Given our focus on Life Sciences, we have stayed very busy at Tunnell while transitioning to new  ways of working.  We have adapted quickly as our clients and internal teams have, for the most part,  worked virtually since March.  It’s been fun to learn how to work in a very different way!

While we continue to support our regular client needs, we have also had the opportunity to support  clients directly on their efforts to combat COVID-19.  Many of our existing offerings that we have  helped clients with over the years are particularly important at this time; e.g. vaccine manufacturing  production scale-up, laboratory operational improvement and commercialization support.

Tunnell Government Services is supporting a variety of agencies as the government focuses on rapid  vaccine, therapeutic and diagnostic development.  Our recruiting and expert staffing agency, Turesol,  is also playing a key role in helping organizations scale up their teams to handle these unexpected  COVID-19 related needs.

We are pleased to have the opportunity to contribute to the battle against COVID-19 while continuing  to help our clients with their "normal" activities.  I hope you continue to stay safe and healthy during  this very unique time.
Maryann Gallivan
President and CEO
What We're Saying...

Build CMO Relationships with Effective
Management Practices
Bio/pharma companies range from large, well-established pharma or biotech organizations with extended supply chains to virtual companies that focus on research and development while outsourcing all development, manufacturing, and fulfillment operations. Some bio/pharma companies work with a large number of contract manufacturing organizations (CMOs), others with just a few. No matter the size of the company or volume of outsourcing, there are some common ingredients to success.

Two separate areas to consider when developing a strategy that incorporates contract development manufacturing organizations (CDMOs) and CMOs are sourcing CDMO/CMO services and managing CDMO/CMO services.

Five areas are essential in cultivating a strong and successful ecosystem of CDMOs and CMOs: a smart supply chain, communication/collaboration, a strong governance structure, risk management, and data-driven metrics and analytics. These ingredients come with challenges, chief among them is cultivating a quality culture that promotes collaboration and communication—not just internally—but throughout the entire supply chain and with all partners.
By Bill Connell

Computer Software Assurance:
Value Beyond Compliance
The Life Sciences marketplace is taking on many of the characteristics of the retail marketplace–speed to market, global competition, generic products, and a variety of challenging pricing models. Getting to market is incredibly important and significantly challenging to Life Sciences companies. One of their most significant challenges is successfully providing that their systems are safe and can produce effective and safe products.

In order to overcome that hurdle companies have been required to perform a Computer System Validation (CSV) of their business systems for safety reasons. Unfortunately, for the amount of time and resources needed to perform the validation, it has returned little value to the business. It is for this reason, and other associated reasons, companies are moving away from the traditional CSV to the more innovative Computer Software Assurance (CSA) approach.
By Rick Ruiz
Who We Are...

Marian Preston
Director of Human Resources

Marian has been at Tunnell for an amazing 39 years! As Director of Human Resources, she is responsible for planning, directing and implementing HR strategies, policies and projects in all HR areas including compensation & benefits, ESOP, employee relations, performance/talent management & development, succession planning, Strategic Workforce Planning, HR strategy, and compliance, as well as supporting the Board of Directors.

Her previous positions include HR Business Partner for the Tunnell Government Services business unit, HR Generalist, HR Associate, and Assistant to the President and Executive Assistant. She has been a member of the Board of Directors since 1998 and, in 2001, became an officer of the firm as Corporate Secretary.

In her spare time Marian is busy with her family and helping to plan a wedding!
Where We've Been, Where We're Going...

ISPE - 2020 Annual Meeting and Expo - Nov. 2nd - 6th
Philippe Cini, Ph.D. and Michael Rutledge, Ph.D. will deliver a presentation on "Creating Process Understanding & a Process Control Strategy that Passes Regulatory Scrutiny"

Life Sciences PA - C-Suite Event - May 20th - A Conversation with Spark and Roche Therapeutics
Tunnell Consulting was a proud sponsor of this virtual event.

Life Sciences PA - Life Sciences Future – MedTech - July 15th
Tunnell Consulting was a proud sponsor of this virtual event.

Life Sciences PA - Annual Award Event
- July 29th
Tunnell Consulting was a proud sponsor of this virtual event.

Life Sciences PA - Life Sciences Future - BioPharm - Sept. 30th - Oct. 2nd
Tunnell Consulting was a proud sponsor of this virtual event.

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PDA Midwest - "Understanding and Mitigating Viral Contamination" - May 19th  
Tunnell Consulting was a proud sponsor of this webinar.

PDA - Annual Conference - July 20th - 22nd
Tunnell Consulting participated in this virtual event.

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Philadelphia Business Journal - "It's In Our Genes" - November 5tth  
Tunnell Consulting is a proud sponsor of this event.

We Hope To "See" You At Upcoming Virtual Events!

Check out Tunnell's sister companies, Turesol Staffing Solutions and Tunnell Government Services!

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