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Summer 2025
It's been a busy year here at Tunnell as we have been responding and adapting to the changing environment in the life sciences industry.  I had the pleasure of attending the BIO Annual Conference a few weeks ago in Boston, and it was great to meet friends, old and new, as well as colleagues from all over the world. Being with so many talented people who are focused on such important missions is always so inspirational!

Please take time to relax and enjoy the summer!

Maryann Gallivan
President and CEO
maryann.gallivan@tunnellconsulting.com
Who We Are
Nichole Hartz
Nichole works with life sciences clients to deliver tailored, strategic solutions that drive operational and quality improvements. She has successfully led cross-functional teams on a variety of impactful initiatives, including process optimization, quality system enhancements and facility-related workstreams.

Her experience includes supporting regulatory response efforts, improving quality management systems and implementing electronic solutions to replace outdated processes. She brings a strong blend of technical and project leadership capabilities to each engagement, ensuring client goals are met with efficiency and precision.

Nichole's data science knowledge adds to her work with experience building machine learning classification and imaging processing models, as well as using data to paint a picture. She applied this advanced analytical methodology to multiple initiatives, streamlining workflows and supporting data-driven decision-making.

Nichole continues to grow her capabilities and is currently pursuing her PMP certification and expanding her knowledge in change management.  Based in Philadelphia, Nichole enjoys hiking, cooking and spending time with friends and family. She’s a fan of nature shows—both documentaries and reality—and often visits Pittsburgh.

What We're Saying...Our Latest Thought Leadership

Achieving More With Less: The Case for Turnkey and Outsourced Quality Management in Biopharma

Biopharmaceutical companies are under constant pressure to meet stringent regulatory standards and deliver safe, effective products to the market quickly. In-house quality management systems (QMS) often struggle to keep pace with evolving regulations, limited resources, and the increasing complexity of the industry. To overcome these challenges, many organizations are adopting turnkey and outsourced quality management solutions to ensure compliance, enhance efficiency, and address these issues effectively.
By Scott Myers and Charlotte Hoffman


Where We've Been, Where We're Going...
Life Sciences PA - 3/12/25 Annual Dinner
Tunnell was a sponsor of the Dinner and Board of Trustees reception.

Life Sciences PA - 5/30/25 Next Opportunities for our Workforce:  Position Yourself
Tunnell provided guidance and advice on employment in the life sciences.

Portal Innovations - 3/4/25
Tunnell consultants
Melissa Allensworth, Stacey Bain and J Edgar Guerzon presented on the topic of "Artificial Intelligence within the Drug Development Lifecycle".

Catalyst Northern Island Bootcamp - 3/19/25
Tunnell participated in Catalyst's Northern Ireland Bootcamp FDA/Regulatory roundtable discussion led by Tunnell’s Melissa Allensworth and held one-on-one meetings with companies in order to provide guidance on their US market strategies.

Austrade - 4/2/25
Tunnell participated in this webinar to assist Australian companies prepare for BIO 2025. Dr. Hausheer, representing Tunnell, presented on "De-Risking US Market Entry – Strategic Considerations for Scientific Risk Mitigation of New Therapeutics Development".

PDA Annual Conference - 4/6-11/25
Tunnell consultants Scott Myers and Charlotte Hoffman attended this conference.
Khidi - 4/20/25
Tunnell consultants Stacey Bain and Melissa Allensworth collaborated with Korea Health Industry Development Institute on this webinar and discussed "Artificial Intelligence within the Drug Development Lifecycle".
World Vaccine Conference - 4/22-24/25
Tunnell consultant Kristy Miller attended this conference.

One Nucleus Boston Bootcamp 4/29/25
Maryann Gallivan, President & CEO of Tunnell Consulting and Alice Sloan, Consultant, presented their "Perspectives on the Boston/Cambridge Ecosystem" to a group of UK companies participating in a One Nucleus Boston Bootcamp.

Nucleate Boston – The Forum  5/22/25
Tunnell Principal Melissa Allensworth participated in a breakout session on “Spinning Out From Your University”.


PA Biotech - Entrepreneur Spotlight  6/5/25
Tunnell was a sponsor of this event.

BIO Annual Conference 6/16/25-6/19/25
Tunnell consultants Maryann Gallivan, Melissa Allensworth, Scott Myers, Lisa Cozza and Alice Sloan attended this conference.
International Cancer Cluster 6/16/25
Tunnell was a sponsor of this event,




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