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Latest Headlines
Blister Packaging Thermoformer Provides Expanded Services for Xcelience
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| Xcelience Strengthens Development Services with Addition to Executive Team
The formulation development company’s services are led by an industry pioneer.
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| Xcelience and Its CEO Are Finalists for Three Prestigious Business Awards
The Tampa-based CRO and its chief executive are voted as best company and CEO of the year.
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The Executive Team
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Derek G. Hennecke, MBA
President and CEO
Derek Hennecke is a founding member of Xcelience. Prior to this, he managed the same business and oversaw two others as Vice President and General Manager, Pharmaceutics and Biopharmaceuticals of MDS Pharma Sciences, Inc. from 2004 to 2006. In this capacity, he was responsible for the business and operations of MDS’s CRO formulation development including capsule development, tablet formulation, modified release tablets, suspensions, solutions, suppositories, creams, ointments, and gels.
Before joining MDS, Mr. Hennecke held various drug development management positions in Canada, Egypt, The Netherlands and Mexico for DSM. In these roles, he built the operations or businesses to introduce various drug products to Europe or the USA.
During his career, Mr. Hennecke has worked in Germany and Canada for Roche’s research activities. He earned his BSc from the University of Alberta (Canada) and his MBA at the Erasmus University in Rotterdam, (The Netherlands). |
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Randall H. Guthrie
Vice President
Randall Guthrie has over 29 years of experience in the Pharmaceutical Service Industry. In his role as Vice President at Xcelience, he oversees all Business Development and Marketing. Prior to the launch of Xcelience, Mr. Guthrie led MDS Pharma Services and legacy Phoenix International, as Vice President of Business Development and Vice President of Strategic Development. Having hands on experience in MDS’ business segments, he is well versed in the drug development continuum and the needs and requirements of the formulation development process.
Mr. Guthrie was instrumental in creating the sales department and launching Lancaster Laboratories as Manager of Pharmaceutical Development Services. He also spent 11 years with Johnson Matthey in which he held roles in Research & Drug Development, Bulk Drug Production & Corporate QA.
Mr. Guthrie received his BSc degree in Biology from Gannon University in Erie, PA in 1977 and completed several graduate level courses at Pennsylvania State University and West Chester State University. Over the years, Randall has been involved with teaching several quality improvement programs, which included Juran & Philip Crosby. He is currently on the planning committees for the University of Wisconsin School of Pharmacy’s Bioanalytical Conference & Drug Metabolism and Pharmacokinetics Conference. |
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Steve J. Bannister, Ph.D.
Scientific Director
Dr. Steve Bannister provides guidance through project design, drug development and execution. He has over 20 years of experience in the pharmaceutical development industry. Dr. Bannister works with early stage virtual companies with promising compounds that perform strongly in pharmacology and safety data. He then helps them to develop and critically analyze options for the design, formulation development and manufacturing requirements.
Dr. Bannister received his BSc in Pharmacy from The University of Georgia and his MS and PhD in Pharmaceutical Chemistry from the University of Kansas. At Sandoz Pharmaceuticals (pre-Novartis), he was Group Leader, Bioanalytics, within Drug Safety and Metabolism working on preclinical and clinical pharmacokinetics studies and participating on U.S. and international project teams. At Ivax he was Director of Preformulation Development. In 1998 he joined Ivax' drug-substance partner, NaPro BioTherapeutics, a development-stage natural products company in Boulder, Colorado. From 2000-2003 he was Vice President of Drug Development, accountable for programs in natural-product analog design, manufacturing development, and novel drug delivery system development. |
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Irene E. LoJacono
Director, Project Management
Irene LoJacono has been responsible for the project management, contracts, and administrative/accounting groups at Xcelience (formerly MDSPS Tampa) for over seven years.
Prior to working at MDSPS, she worked at Bausch & Lomb Pharmaceuticals Division as a Master Planner, and International/Contracts Planner, at Johnson & Johnson as a Forecast/Planning Manager and at Bristol-Myers Squibb as a Master Planner. She is a 33–year veteran in the formulation development industry and maintains a membership in APICS. |
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Thomas M. Kolessar
Director of Quality Affairs
Thomas Kolessar played a major role in developing the Quality Systems at Xcelience and has been responsible for compliance to Federal, DEA and State Regulations since the start-up of the company in 1998. He has led the company through numerous regulatory inspections of which contributed to a clean regulatory history.
Prior to working at Xcelience he was Q.A. Director at Separation Technology and was employed at Wyeth-Ayerst Laboratories for fifteen years where he served in the capacity of GLP and GMP Auditor, Coordinator II-QC, and Supervisor, Stability Services, QA. He has gained the experience and understanding of the governing regulations, including cGLP’s and sGMP’s, and developed a risk-based approach necessary to meet the compliance challenges presented during early stage drug development. He leads a dedicated team of quality assurance experts responsible for ensuring Xceliences’ compliance to current regulations as well as the unparalleled satisfaction of Xcelience’s clients.
His education includes a B.S. in Biology from Delaware Valley College, PA. |
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Theodore S. Koontz
Director, Operations
Theodore Koontz manages the Manufacturing, Warehouse and Facility Departments at Xcelience. He helps to ensure that all drug products manufactured by Xcelience meet or exceed cGMP requirements, as well as servicing the wide-ranging and stringent demands of Xcelience's many customers.
Mr. Koontz has nearly fourteen years of industry experience with solid oral dosage forms in the areas of manufacturing, operations, analytical and formulation development. He is renowned for his ability to apply his considerable experience, creativity and knowledge of cGMPs to develop processes which allow customers to utilize unconventional methods to create clinical trial materials that meet a wide variety of needs.
As a founding member of the Manufacturing Department when it was part of MDS Pharma Services, Mr. Koontz played the key role in developing the manufacturing systems and facilities, as well as expanding the manufacturing team as the company grew. Mr. Koontz left MDS in 2003 to serve as manager of GMP Operations at Shire Labs, Inc. (currently known as Supernus Pharmaceuticals, Inc.). He returned to Xcelience in 2006 to lead the Manufacturing Department again, and has since taken leadership responsibility for the Warehouse and Facilities Departments.
Mr. Koontz also has prior experience with Somerset Pharmaceuticals, Inc., in formulations development and analytical chemistry. |
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Paul Skultety, Ph.D.
Director, PDS
Paul Skultety has a unique background in Pharmaceutical development
combining extensive experience with contract development and pharmaceutical
companies. At Xcelience, his role is to provide leadership to
Pharmaceutical Development Services. This includes analytical chemistry
and formulation development. Prior to Xcelience, he has held such positions as Vice
President of Pharmaceutics at Quintiles, Director of Solids Formulation Development
for Hoechst Marion Roussel and various management positions within Marion Merrell Dow
and Marion Labs which were predecessors to HMR. Dr Skultety has a successful track record
of developing new chemical entities from pre-IND to commercialization.
He has 9 US formulation and composition patents. He has written a number of publications and
made numerous scientific presentations. He has been a member of AAPS since it’s inception.
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