Tunnell Consultants Offer Deep Industry Experience.

Tunnell is comprised of exceptionally qualified life sciences consultants who not only know the industry inside and out, but who also truly understand your business and what it takes to be successful. Below is just a representative sampling of our industry consultants.

Consultants Page

Consultants

Katalin Abraham
BACKGROUND AND EXPERTISE

Kati is a seasoned regulatory affairs professional with over 30 years’ experience in the Life Sciences and a strong multifunctional regulatory, quality and technical background. Her regulatory experience spans pre-IND through BLA submissions to life cycle management, forging pathways for new technology products, sustaining product supply and developing a viable regulatory compliance infrastructure for clinical sample testing laboratories. She has extensive experience in cross-functional teams to develop, negotiate and implement regulatory strategy in alignment with the regulations and business goals, with significant experience and successful interaction, both formal and informal, with the FDA and other regulatory authorities.

 

Prior to joining Tunnell, Kati worked in the biopharmaceutical industry both in biotech and in big biopharma. At VaxInnate Corporation, she was VP, Regulatory Affairs with responsibilities for development and execution of regulatory strategy for the products at all stages of development as well as for managing QA and support for the company’s contracts and partnerships. At Merck & Co, Inc., Kati held roles with increasing responsibility in the vaccine analytical laboratories, QC, CMC regulatory, regulatory compliance management for vaccine clinical testing and regulatory affairs international for I/O. While at GSK, she worked in North American Regulatory Affairs, supporting licensed and in development flu vaccines, including adjuvanted, cell culture-based and pandemic indication products, and she filed the first adjuvanted pandemic indication avian flu vaccine in the US. Kati’s first position in industry was in R&D at Centocor (now Janssen Biotech). Kati started her career at Children’s Hospital of Philadelphia where she worked in infectious diseases and cancer research.

 

Contact Kati at katalin.abraham@tunnellconsulting.com

EDUCATION
  • BS, Medical Technology, University of Pennsylvania
  • Medical Virology Graduate Work, St. Thomas Hospital Medical School, London
Ramon Abreu
BACKGROUND AND EXPERTISE

Ramon Abreu has nearly 40 years of experience in the pharmaceutical industry, including extensive experience in product development, technology transfer, process validation and manufacturing operations. A member of the Tunnell team for more than 15 years, he provides consulting, technical and managerial support for development, technology transfer, validation, product launch, manufacturing processes and operations and quality assurance. In addition, he is adept at designing and managing projects as well as building consensus and partnering with cross-functional peer groups and management business partners to achieve operational improvement.

 

Prior to joining Tunnell, he worked in a broad range of manufacturing and science roles. He was a facility manager at Andrx Pharmaceuticals. Prior to that he was a plant manager at Pralex Corporation, a senior pharmaceutical scientist at Schering-Plough Products, and a manufacturing supervisor at Baker Norton Pharmaceuticals and SmithKline and French Laboratories (now GlaxoSmithKline).

 

Contact Ramon at ramon.abreu@tunnellconsulting.com

EDUCATION
  • B.S., Social Sciences, University of Puerto Rico
  • Associate Degree, Chemistry, University of Puerto Rico
Greg Anthos
BACKGROUND AND EXPERTISE

Greg brings to Tunnell over 30 years of experience in the life sciences industry, including over a decade of consulting experience in all business functions. He is adept at strategy development and execution, change management, operations management and program / project management. He is a seasoned operations leader with significant experience in engineering, organizational transformation and supply chain.

 

Prior to joining Tunnell, he spent 30 years at Merck & Co., most recently as Executive Director, Business Consulting, where he was a program leader in charge of transforming a 2,000 person global regulatory affairs function in order to provide a more competitive advantage for Merck. Previously he was Sr. Director, Merck Sigma Program and Training and MMD Operational Excellence Director where he developed a worldwide Lean Six Sigma Training program that was adopted by over 5,000 employees. He is a Lean Six Sigma Master Black Belt as well as Change Agent II and Process Improvement Master.

 

Contact Greg at greg.anthos@tunnellconsulting.com.

EDUCATION
  • MBA, James Madison University
  • B.S., Industrial Engineering and Operations Research, Virginia Tech
Xachariah Kibbie
BACKGROUND AND EXPERTISE

Xach brings to Tunnell over 17 years of project and program management experience in the fields of clinical development, tech transfer, engineering, validation (computer, process, and equipment), product launch, consent decree programs  for biologics, device and combination products.    His areas of expertise include distribution, contract manufacturing of clinical and commercial products and management.  He is an experienced business transformation leader with a demonstrated track record in risk management, operational excellence, product strategy and stakeholder communication.

 

Prior to joining Tunnell, Xach was Senior Program Manager for Shire HGT where he specialized in the planning of multiple product launches from clinical to launch, business continuity/risk management program development and operational excellence. He managed high profile product launches and facilitated commercial, supply chain, regulatory and technical operation strategies.  At Shire, Xach won two awards for recognition for the development and facilitation of Merger and Acquisition programs based on Risk and OE methodologies, as well as the successful program management for Shire’s most lucrative product launch; a methodology adapted for every other product due to its success.   Previously, Xach was Senior Program Manager for Genzyme / Aventis Sanofi where he specialized in the program management and business transformation of a consent decree organization for engineering, tech transfer, manufacturing and equipment, utility and process validation functions, recognized by the verifiers as the bench mark of all consent decree programs.   Earlier positions included Tech Transfer project management at Pfizer Biotech (managing the launch against Pfizer’s competition for Pfizer’s most lucrative drug) and Manufacturing/Validation Engineering Project Manager at Formatech (Finish/Fill and Drug Development CMO); Validation Project Management (Utilities, Computer Systems, Process, and Equipment) at TKT, OI, and Lonza.

 

Contact Xach at xachariah.kibbie@tunnellconsulting.com.

EDUCATION
  • Graduate Studies:  Business, Pharmaceutical Processing, Computer Science, MIT PMP PDU’s
  • B.A., Lesley University, Cambridge, MA
  • A.A., Indian River State College, Ft. Pierce, FL
Glenn Lawrence
BACKGROUND AND EXPERTISE

Glenn Lawrence has 38 years of global experience in the pharmaceutical industry managing and executing process engineering activities for the design, construction, validation and startup of manufacturing facilities. His technical expertise includes vaccine processing, therapeutic protein processing, chemical processing, solid oral dose, sterile supply facilities and clean utilities. He has extensive knowledge in the design and execution of modular process equipment, single use bio-processing equipment, sterile processing, CIP and SIP and clean rooms. In addition, he is experienced in process safety management, potent compound containment and bio safety hazard control. He is also highly qualified in technology transfers, Six Sigma and Lean Manufacturing, regulatory and product licensure and quality and validation.

 

Prior to joining Tunnell, he spent 37 years with Merck & Co., where he held a variety of critical roles, including: Director, Engineering, Global Process Safety; Director, Engineering, Global Bio and Vaccine Process Engineering; and Director, Engineering, API/Chemical Process Engineering. He is a licensed Professional Engineer (P.E.), an ISPE “Certified Pharmaceutical Industry Professional” (CPIP) and a Six Sigma Green Belt.

 

Contact Glenn at glenn.lawrence@tunnellconsulting.com.

EDUCATION
  • B.S., Chemical Engineering, Michigan Technical University
Frédéric Lefebvre
BACKGROUND AND EXPERTISE

Frédéric brings to Tunnell over 15 years’ experience in the pharmaceutical industry, developing and implementing account strategies while also managing global and regional industrial pharmaceutical clients.

 

Prior to joining Tunnell, Fred was Global Account Director, Life Sciences with M+W Group, and engineering & construction organization where he strategically had responsibility for developing business and supporting major international pharmaceutical companies. Previously he was Account Manager at Catalent Pharma Solutions, CMO, where he was responsible for the development of manufacturing contracts and R&D services in Switzerland, France, Belgium, Israel and Eastern European countries. He also worked at Capsugel (a division of Pfizer), capsules and equipment producer, as Multinational Account Manager for Europe, Middle East and Africa.

Fred is fluent in French and English and skilled in Spanish.

 

He can be reached at frederic.lefebvre@tunnellconsulting.com

EDUCATION
  • Baccalaureat, Degree in Business and Marketing
Walter Matzmorr
BACKGROUND AND EXPERTISE

Walter brings to his role more than 28 years’ experience in plasma protein and biopharmaceuticals, process development, manufacturing and engineering. His expertise also includes aseptic processing, filling and lyophilization, good manufacturing practices (GMP), and process f