News from Tunnell Consulting

How this year has flown! It seems like it was just summer and now here we are about to celebrate Thanksgiving!

Although COVID is still very much in our collective cross-hairs, we at Tunnell continue to work with our clients following CDC guidelines so we can safely continue to support their very important missions, projects and resourcing needs.

All the best for a happy Thanksgiving! I hope you have a chance to relax and enjoy the holiday with family and friends.

Stay safe!

Trained as a medical entomologist, Colonel (Retired) Russ Coleman, Ph.D., spent more than 25 years with the U.S. military’s medical research organizations, most recently as Commander/CEO of the U.S. Army Medical Material Development Activity (USAMMDA) and the DoD’s Joint Project Management Office for Medical Countermeasure Systems (JPM-MCS). In these roles, Russ was responsible for developing medical products designed to protect the U.S. military from naturally-occurring and weaponized chemical and biological threats. Since retiring from the military in 2016, he has continued to consult in that arena, serving as Business Development Executive for Military Health at the Battelle Memorial Institute and Vice President for Federal Business Development at Rho Inc.

Upon joining Tunnell in Fall 2020, Jerry Robinson, Senior Vice President of Tunnell Government Services (TGS), stated that "we are excited that Russ brings his vast experience in Army medical research and development to Tunnell. His skill set is a perfect match for our primary goal of using our deep talent to assist our government clients accomplish their incredibly challenging missions." In his new role at Tunnell, Russ oversees our support to the Center for Devices & Radiological Health (CDRH) at the Food and Drug Administration (FDA). The mission of CDRH is to protect and promote the public health by assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Russ is responsible for ensuring the success of our CDRH contract and growing our business with the FDA.

In his spare time, Russ and his daughter Natalie volunteer on the slopes to help wounded warriors learn how to enjoy the beautiful sport of skiing.

A deviation may take one of two forms: It may occur when instructions regarding a specific activity, such as those laid out in the standard operating procedures (SOP), batch record instructions, or other guidelines, are not carried out, are delayed, or are performed incorrectly; or a deviation may also be defined as a difference between normal and expected value in the pharmaceutical laboratory process. In some cases of course, the two types of deviations may cross over if an unexpected value is the result of a procedural error. It is those deviations and errors – and the subsequent actions that must be taken to address them – that cause an already long development cycle to become even longer. In the event of a public health crisis, time is of the essence, and measures must be taken to reduce the development cycle time while maintaining quality.

We are very proud to announce that Managing Consultant Charlotte (Eberle) Hoffman was recently honored as a "One to Watch" by Consulting Magazine. This year they received over 500 nominations worldwide for outstanding consultants under the age of 35. Charlotte exemplifies Tunnell's client-centric values and continues to make an exceptionally strong impact on the company’s diverse clients in the life sciences industry. She has experince helping pharmaceutical, biopharmaceutical and vaccine clients with quality and manufacturing processes develop improved compliance and decreased risk. With her collaborative approach, Charlotte has helped numerous clients implement Quality Management Systems.

Her excellent program leadership and customer focused skills allow her to prioritize her clients’ needs, resulting in a laser-sharp focus on critical risk areas and improved systems that eliminate gaps in real time. For example, Charlotte’s leadership on a particular client’s global supply network allowed the client to determine the multi-factor risk profile for each of their respective sites, resulting in a plan and structured oversight to ensure uninterrupted supply of critical medical devices and pharmaceuticals during the COVID-19 pandemic. Her collaboration and insight resulted in the client saving over $100,000 in supplier oversight costs.

She has helped to structure new company offerings that meet our key client needs and has developed best practice templates. She has become a thought leader in developing critical client GMP (Good Manufacturing Processes) documentation such as batch records, Standard Operating Procedures and material specifications. She is passionate about what she does. Charlotte is a great consultant, role model and mentor.