ISPE-CaSA Technology Conference 2016
 
Keynote Speaker:

Morten Nielsen
Senior Vice President, Novo Nordisk, Clayton, NC
 
Claus Abildgren
Consultant Partner
NNE Pharmaplan
Claus Abildgren is Consulting Partner with NNE Pharmaplan Inc., responsible for early phases consulting engagements with client to help them make better decisions on how to bring products to market most effectively. Claus has close to 20 years of experience within management, consulting, sales and business development as well as project management of complex projects within pharma, automation and IT. From work with numerous global pharmaceutical companies adopting manufacturing IT software systems to reduce costs, increase operational discipline and enable lean and more agile supply chain processes, Claus offers detailed expertise around MES / MIS / Historian / Scada / ERP integration (S95) / Batch control (S88).
 
Mike Arnold R.Ph.
Senior Director
Pfizer
Michael is a licensed, registered pharmacist and is the Business Process Owner for Investigational Products and Senior Director of Strategic Partnerships for Pfizer's Global Clinical Supply Chain. He has worked in the Pharmaceutical Industry for the past 33 years. His responsibilities have included managing Pfizer’s Global Clinical Supply Operations, directing Supply Chain Management activities, Clinical Supply Forecasting, warehousing, packaging, labeling and distribution, comparative agent manufacturing, writing manufacturing sections supporting Investigational New Drug Applications, establishing a Pfizer Import/Export process, designing, validating and implementing new clinical supply computer systems, and establishing Pfizer's outsourcing program for packaging, labeling, warehousing, distribution of clinical supplies and placebo and comparator agent manufacturing. Michael is currently Vice Chairman of the International Society of Pharmaceutical Engineers International Board of Directors, Chairman of ISPE’s Quality Metrics Leadership Team, Chairman of the ISPE New Content Advisory Group, a member and Past-Chair of the ISPE Investigational Products Community of Practice, a member and Past-Chair of the ISPE Community of Practice Council, a member of the ISPE Board Executive Committee, an ISPE Regulatory Subcommittee member and a member of the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF). In collaboration with the European Medicines Agency (EMA), the International Society of Pharmaceutical Engineers (ISPE), and Health Canada, he directed the publication of an Industry Good Practice Guide on the use of Interactive Response Technology (IRT) to manage clinical supply use-by dates and Program level pooling of clinical trial supplies. He has published other Webcasts and White Papers on Clinical Trial Supply processes. He has made numerous international presentations on clinical supply processes and supply chain security.
 
Gretel Benavides
Vice President, Lachman Consultant Services
Lachman Consultant Services
Gretel Benavides, Vice President of Lachman Consultant Services, Inc. Gretel Benavides is Vice President in the Lachman Consultants’ Compliance Practice and has more than 25 years of experience in the pharmaceutical industry. She develops strategies and implements quality programs to drive change and sustainable compliance. During her career she has held positions of increasing levels of responsibilities, including executive-level positions in quality and compliance. Ms. Benavides is an innovative thinker with a proven track record for pragmatic and systemic solutions in the development and implementation of robust quality systems. She is a results-driven leader, able to motivate teams to deliver in difficult situations such as FDA Application Integrity Policy, Warning Letters, and Consent Decrees. Ms. Benavides is a strategic quality professional who integrates risk-based approaches into quality programs that have been successfully inspected by international regulatory authorities such as FDA and MHRA. For more than 30 years, Lachman Consultants has been the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries. With its strong and extensive cadre of consultant specialists and an unparalleled management team, its Compliance, Science & Technology, and Regulatory Practices provide the most expert counsel and array of services available. Lachman Consultants is proud of its tradition of supporting industry efforts to develop and ensure safe, effective and high-quality medical products. It remains committed to helping the industry anticipate and address its challenges through the development and implementation of practical, sustainable and cost-effective solutions based on the integration of scientific principles, evolving regulatory expectations, and technology.
 
Scott Billman
Director, Manufacturing Facilities
Biogen
Scott Billman is the Senior Director of Engineering for Biogen’s manufacturing facility in RTP, NC. He is past President of the Carolina South Atlantic Chapter for ISPE and has been very involved with ISPE for the past 20 years. He has extensive experience in the scoping, design, construction, and qualification of cGMP facilities and equipment. In his current role he is also responsible for organizational development and site governance as a member of the Site Leadership Team. Scott has had the opportunity to work as a design Engineer and Project manager on the consulting side as well as work on the manufacturing side in Global and Site based Engineering positions.
 
Jim Breen
Vice President, Engineering
Johnson & Johnson
James A. Breen Jr, PE, is the Vice President, Worldwide Engineering and Technical Operations for Johnson & Johnson. In this role Jim is responsible for J&J’s Real Estate, Facility Management Operations, Engineering and Large Capital Project Execution. Jim is a member of the J&J Supply Chain Leadership Team. He has been employed by Johnson & Johnson since 1997. Prior to this, he worked for the General Electric Company and Hercules Incorporated in both domestic and international assignments. Jim is presently a member of the International Society of Pharmaceutical Engineers (ISPE) Board of Directors. He is a registered Professional Engineer and LEED AP. Jim holds a Bachelors of Engineering from Stevens Institute of Technology, an MBA from Drexel University, and a Masters of Engineering in Technology Management from the University of Pennsylvania. Jim is an Adjunct Professor for Drexel University in the Graduate Construction and Engineering Management Departments.
 
Bob Chew
President/CEO
CAI
In addition to serving as the company’s President and CEO, Robert Chew is an internationally recognized compliance consultant in the areas of risk-based qualification, validation, ASTM E2500, and ICH-Q9, Quality Risk Management. Mr. Chew has provided quality risk management consulting to some of the largest pharmaceutical and biotechnology companies in the world. Over the past decade, he has spoken at international conferences in the US, Europe, Asia, and South America. He is a member of the Global Pharmaceutical Manufacturing Leadership Forum. Mr. Chew served on ISPE’s International Board of Directors from 2004 – 2007 and was the society’s 2008 Member of the Year. He served on the task team that created ASTM E2500 to improve how the industry does qualification, and was a member of the task team updating ISPE’s Commissioning and Qualification Baseline Guide. He is former chairman of ISPE’s North American Education Committee, ISPE’s International Education Executive Committee, and former President of the Great Lakes Chapter of ISPE. Mr. Chew has a B.S. in Chemical Engineering from Case Western Reserve University, and is a registered Professional Engineer.
 
Jennifer Lauria Clark CPIP
Executive Director, Technical Services
Commissioning Agents, Inc.
Jennifer Lauria Clark, CPIP is the Executive Director of Technical Services for Commissioning Agents, Inc., where she is responsible for business development, commissioning and qualification planning, protocol development and execution, project startup and coordination, consulting support among other duties. She has over 10 years of experience in regulated industries. Previously she held positions at Yonkers Industries where she provided services for Merck, BD, GSK, Biogen and others. Jennifer Lauria Clark has been a Member of ISPE for more than 10 years and actively involved in the Society's local and international activities. She is Past President of the ISPE CaSA Chapter, is a member and Past Chair of ISPE’s Young Professionals Committee, and a past member of ISPE’s Pharmaceutical Engineering Committee. Currently Jennifer Lauria Clark is a Director on the ISPE International Board. She has a degree in Industrial Engineering from North Carolina State University. Jennifer Lauria Clark earned her ISPE CPIP designation in 2012.
 
Neil Corman
Sr. Manager of Automation Engineering & Operational Technology
bioMerieux
Neil Corman is the Sr. Manager of Automation Engineering and Operational Technology at bioMérieux in Durham, NC. Neil actively designs and manages large scale automation and infrastructure projects to provide Operational Technology solutions for the Durham site, which manufactures medical diagnostics for a global market. Neil began his career with Kline Process Systems as a systems integrator working with several Fortune 500 companies including Nestle, Unilever, and Kraft Foods. With over 20 years automation and controls experience, he has designed, implemented, and managed large turnkey industrial automation projects in a variety of industries including Pharmaceutical, Food & Beverage, Pulp and Paper, and Web Handling. Neil earned a Bachelor of Science degree in Electrical Engineering from the University of Delaware in 1992 and is a licensed electrical contractor in North Carolina. Neil lives with his wife and children in Apex, NC.
 
Lindsey Daniel
Process Engineer
CRB
Lindsey Daniel is a Process Engineer with CRB Engineers and graduated from Virginia Tech in 2012 with a B.S. in Chemical Engineering. She currently resides in Minneapolis, MN but is working full time onsite at Baxalta in Covington, GA. Lindsey has worked on numerous large scale projects for clients such as Genentech, Amgen, Alexion, Isis Pharmaceuticals, Baxalta and Shire. She is very passionate about ISPE and is the past Chair of the ISPE YP International Committee.
 
Eric Danielson AICP
Director Strategic Relationship, Investigational Products Business Process Owner
JE Dunn
Eric Danielson, AICP |Director of Science & Technology |JE Dunn Construction Eric joined JE Dunn Construction and its Science & Technology team in 2013 building on a successful career that includes planning and economic development. Prior to joining JE Dunn, Eric worked as a research facility planner for Treanor Architects. He worked closely with research and development teams to create an environment where investigators were able to perform their work. His experience spans the public and private sectors, planning higher education research and teaching laboratories as well as similar facilities for pharmaceutical and biotech manufacturers of human and animal health products. Eric uses his planning background to support the implementation of plans through the construction services provided by JE Dunn. He is the past president of the ISPE Midwest Chapter.
 
Dr. Donald Duncan
VP Quality Europe
Yourwaytransport Biopharma Services
Duncan J Donald, QP & VP Quality EU Yourway Transport Biopharma services, has had experience of all aspects of pharmaceutical operations. He has served as a QP and Pharmaceutical Expert for both human and veterinary manufacturers. He has performed audits of both finished product manufacturers and raw material manufacturers and is recognized by the MHRA as a Qualified Person and the Veterinary Medicines Directorate as a Pharmaceutical Expert. He holds degrees from Hertfordshire University, Open University and the University of Florida. He is a member of the Royal Society of Chemistry and is a Chartered Chemist. Duncan played rugby at county level (current world cup) and has continued this interest through coaching kids.
 
Frank Emsick
Program Manager, IL-31 Expansion
Zoetis
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Damien Hallet
Senior Director of CMC
Heat Biologics
Damien Hallet joined Heat Biologics in November 2014 as the Sr. Director of CMC and is responsible for all aspects of CMC development and manufacturing for the production of the allogeneic whole cell cancer vaccine materials currently used in clinical trials. Damien has a Biochemical Engineering Degree from INSA de Toulouse, Grande Ecole and a Masters of Advanced Studies in Industrial Microbiology from Ecole Doctorale de Toulouse, France. He has 15 years of experience with the Chemistry, Manufacturing and Control of many types of biologic medical products (cell therapy products, mAb, Fab, gene therapy adenoviral and plasmid DNA vectors). Before joining Heat Biologics, Inc., Damien was employed at Gencell SAS, Sanofi, and UCB Pharma.
 
Ashley Harp
Lead Process Engineer
CRB
Ashley Harp, PE, is a Lead Process Engineer with CRB, where she provides process design and implementation services to pharmaceutical and biotech manufacturers. She joined the CRB team in 2007 and has since worked closely with process Owners to lead a range of phases of project design, from feasibility through equipment start-up and validation. Ashley has led an international team through design, operability assessment, construction, and mechanical/functional testing of process equipment. Prior to joining CRB, Ashley held positions at Mallinckrodt (formerly Tyco Healthcare) and Unilever. She has a degree in Chemical Engineering from Rensselaer Polytechnic Institute and earned her Professional Engineering License in 2012.
 
Larry Kranking
Director, Consulting
CAI
Larry Kranking is a pharmaceutical executive with more than 40 years of experience and has a record of extraordinary accomplishment leading start-ups, responsible for design and construction of new facilities, implementing innovative regulatory strategies and aligning operational rollout with product launch for best efficiency & fastest time to market. He is an expert at business turnaround, staff development, efficiency improvements with direct experience in oral solid dose (OSD), parenteral, biologics (blood fractionation), in the biopharmaceutical health industries. Kranking is a recognized industry C Level Executive with assignments from start-ups to multinational pharmaceutical giants to working directly with the FDA in leading various teams of scientists, engineers and regulatory experts. He was been instrumental in the green-field start-ups of facilities for Boehringer Ingelheim and Eisai. He is a past Chairman of the Board of ISPE, is a long standing member of the International Leadership Forum, is the former chair of the SUPAC similar equipment team
 
Edwin Martinez
Principal Engineer, Corporate VI CoP
Hospira a Pfizer Company
Edwin Martinez is a Principal Project Engineer and Subject Matter Expert with Hospira a Pfizer. He has over 20 years of manufacturing operations experience in the development, integration and the support of automated processes, in combination with his BS on Electrical Engineering with a concentration in controls and mechatronic. For the past 10 years, he has supported numerous projects at several of the company facilities, for the integration and qualification of new automated systems, applied to most of phases of the manufacturing process; filling, sealing, inspection, serialization, and finishing and packaging equipment. He is currently a task team member for the company Visual Inspection and Packaging CoP’s (Community of Practice).
 
Phil McDuff
VP, Global Engineering
Biogen
I currently work for Biogen as the Vice President of Global Engineering. In that role, I oversee the process engineering, project engineering, automation, validation, maintenance, and instrument/controls functions for the company. I have been with Biogen for 13 years, working in multiple areas of engineering. During my tenure at Biogen I have contributed to increasing facility capabilities within our production facilities to up to 10 times their design basis and have been instrumental in establishing design and operation principles that reduced microbial contamination rates to below industry standard. Prior to Biogen, I worked at Roche Vitamins as a process/project engineer supporting multiple unit operations and process tech transfers. I received a BS in Chemical Engineering from Auburn University and I have held various roles in engineering for over 22 years.
 
Jim McGlade
Client Leader
BDHP Architecture
Jim McGlade is a Science Client Leader with BHDP Architecture. Jim's focus is on helping clients solve their facility challenges to support their strategic goals. Jim's 20-plus year career has included the opportunity for involvement in a variety of complex science projects. He is responsible for leading multi-disciplinary project teams in the development and delivery of technical solutions. His experience includes all phases of teh entire project lifecycle. Jim is a registered architect and a Leadership in Energy and Environmental Design (LEED) Accredited Professional. He is a past-president of hte ISPE Carolina-South Atlantic Chapter, past chairman and current member of the ISPE Facility of the Year Awards Committee, and current steering committee member of the Project Management Community of Practice.
 
Patrick McGrath
President
Berlinger USA
Patrick McGrath is General Manager for the Swiss instrument manufacturer Berlinger Company and has worked in the Pharmaceutical Cold Chain industry for 15 years with extensive knowledge of cold chain packaging, logistics and temperature monitoring. As the North American General Manager for Berlinger, Patrick has introduced unrivaled Swiss precision, accuracy, reliability and innovation to the world of temperature monitoring in the pharmaceutical, biotech, and vaccine industry, having launched 5 groundbreaking products in the past 3 years. Prior to his time at Berlinger, Patrick was Director of Sales at ThermoSafe, the worlds’ foremost designer and supplier of cold chain packaging materials to leading vaccine and biotech manufacturers worldwide. In 2011 Patrick was invited to serve on the CDC’s Equipment Sub-committee whose focus was to develop new guidance for temperature monitoring of vaccines in storage. In November 2012 the CDC issued and adopted this new guidance.Patrick obtained an MBA from Temple University in Philadelphia. He Co-authored the article “The changing landscape for vaccine administration” published in Contract Pharma July/August 2011. He is a long-standing member of the Parental Drug Association (PDA) and the US Pharmacopeia (USP).
 
Christa Myers
Sr. Pharmaceutical Engineering Specialist
CRB
Christa Myers is a Senior Pharmaceutical Engineering Specialist with 20+ years of experience providing clients with insight as to how innovative technologies apply to process and facility designs. Her involvement starts with the strategic concept and continues through construction and startup of projects. After project completion, Christa continues to evaluate whether the design elements worked properly, or should be re-evaluated for future projects. With an extensive background in the design of fill-finish facilities, chemical kilo labs, pilot plants, API research and manufacturing facilities, bulk pharmaceutical chemical facilities, highly hazardous compound containment, and biotech process facilities, Christa’s broad range of expertise benefits her clients in the design of their facilities.
 
Morten Nielsen
Senior Vice President Diabetes API US at Novo Nordisk
Novo Nordisk
Morten Nielsen is Senior Vice President in Novo Nordisk – a global healthcare company with more than 90 years of innovation and leadership in diabetes care. At Novo Nordisk Morten is currently responsible for the company’s diabetes API expansion project establishing a new API production capacity in Clayton, North Carolina. Morten brings more than 20 years of experience from the pharmaceutical industry. During his career he has focused primarily on pharmaceutical investment projects. Most recently he served for 5 years as CEO of NNE Pharmaplan – a wholly owned subsidiary of Novo Nordisk and one of the world’s leading engineering and consulting company focused on pharma and biotech. Additionally, Morten has been responsible for multiple investment projects within Novo Nordisk. Amongst others he was responsible for the company’s drug finished product expansion in Brazil and multiple investment projects in Denmark. Positions from which he brings valuable experience into his current position on how to orchestrate the multifaceted efforts required to bring forward large scale capex projects.
 
Michael Parks
Associate Director, Site Technical Operations
Pfizer, PGS Vaccine Manufacturing
Michael is the Associate Director Site Technical Operations, Pfizer, PGS vaccine manufacturing. Michael has led teams in many areas including Fermentation, Purification, and Chemistry for many bacterial based vaccines. He is a site SME for Multi-Product processing and was instrumental in establishing multi-product capabilities at the Pfizer site in Sanford, NC. Michael has over twenty-five years of diverse knowledge and experience in the areas of validation, technical transfer, multi-product operations, startup of new facilities and processes, regulatory submissions, and process optimization/continuous improvement. Experience in the manufacture of vaccines as well as OTC and Rx oral dosage form finished pharmaceuticals.
 
Kristina Pumphrey
Operations Improvement Specialist
CRB
Kristina Pumphrey is a licensed Professional Engineer (PE) and a certified Lean Six Sigma Black Belt. Her areas of expertise include process design, project management, potent compounds, and hazard analysis. Her process-focused background provides faster understanding of client processing and offers keen insight when recommending improvements for manufacturing environments. In her 16 years of experience, she has performed design, commissioning and qualification for chemical and biopharmaceutical projects. Her educational background includes a Bachelor’s degree in Chemical Engineering from Pennsylvania State University and a Master’s degree in Management & Technology from Widener University. In the last six years, Ms. Pumphrey has applied her process expertise to improve operations within the pharmaceutical industry and within her internal organization. An active ISPE member serving on the program committee in her local chapter, Ms. Pumphrey has spoken at numerous ISPE events including the annual meeting and has authored a white paper on the benefits of an Operations Improvement approach to lab planning.
 
Bonnie Reimer
Associate Director, Logistics
Merck Research Laboratories
Bonnie (Gulyas) Reimer has worked in Logistics and Trade Compliance over the last 20 years for global and multinational companies. Working in Plastics, Retail, Flooring, and Pharmaceutical industries, she has managed Transportation providers from more than 30 countries. She has traveled to terminals in 17 countries in Latin America, Europe, and Asia. Bonnie has built trade compliance programs and cargo security programs such as C-TPAT, and spoken at conferences on Trade Strategy and SaaS integration. She is currently the Associate Director of Logistics for Merck Research Laboratories (MRL). Her role at Merck is managing the diverse and talented US Import and Export Trade Operations teams that present clinical and research materials, medical devices, capital equipment, Lab supplies, and Ancillary Supplies to US Customs to satisfy multiple agency regulations. Bonnie has two girls, ages 8 and 5. She continues to build skills in leadership, networking and mentoring to achieve key bucket list goals of serving on a board of directors and being a Godmother to a container ship! She holds a BA from the University of Texas at Arlington, is a Certified Project Manager (CPM), and is a Licensed Customs Broker (LCB).
 
Melissa Seymour
Vice President, Global Quality Control
Biogen
Melissa Seymour is the Vice President of Global Quality Control for Biogen, Inc., assuming responsibility for the comprehensive strategy and implementation for Global QC testing of Raw Materials, Drug Substance, Drug Product and Finished Goods worldwide. Prior to this, Melissa served as the Vice President of Corporate Quality with responsibility for global compliance and quality systems including management of Quality Systems, Internal and External Auditing and Global Affiliate GMP oversight. Melissa holds BS degrees in both Biological Sciences and Biochemistry from North Carolina State University and an executive MBA from Duke University. Melissa has over 20 years of experience in the quality arena including quality positions at Novo Nordisk pharmaceuticals and Glaxo Smith Kline. Melissa has been highly active in the Southeast chapter of PDA for the last 5 years as a member of the local board, serving as Vice-President, President, and most recently, Past President. She was recently elected to the Board of Directors for PDA. Melissa is an ASQ Certified Quality Engineer, Certified Quality Auditor and Certified Quality Manager and has previously served on the Board of Directors for the Rx-360 Consortium focused on supply chain security.
 
Scott Sigethy
Sr. Engineer for Bacterial Fermentation
Pfizer
Scott Sigethy is a Senior Engineer for Bacterial Fermentation in the Manufacturing Science and Technology department at Pfizer, located in Sanford, NC. Scott has 12 years of experience in industry running bacterial fermentations in recombinant E. coli and other organisms, many for vaccine candidates. Scott began his career working in the bacterial fermentation group at Enteris Biopharma in Fairfield, NJ. He later worked at Wyeth Vaccines Research in Pearl River, NY running bacterial fermentations for vaccine candidates. Following Wyeth, Scott worked as a fermentation scientist at GlaxoSmithKline in the Biological Reagents and Assay Development group in Research Triangle Park. Subsequently, he moved on to Pfizer’s Manufacturing Science and Technology group. Scott has a Master’s degree in Molecular Biology from Montclair State University, and a Bachelor’s degree in Biology from Duke University.
 
Pat Sullivan
Project Manager - Industrial Automation
Avid Solutions
Pat Sullivan has been in/around the Control Systems Integration field for the last 25+ years. Throughout his career, a primary focus has been on process automation system design, programming and application consulting for pharmaceutical, biotech and other industries. He has held positions in Engineering, Project Management, Technical Operations Management, Technical Trainer, and Application Consultant. He has extensive experience in PLC/SCADA and Batch Process Control for Manufacturing, GAMP Project Lifecycle Methodology, 21 CFR Part 11, and development/execution of Validation protocols. Project experiences in manufacturing areas include Aseptic and Sterile Filling, Solid Oral Dose (Granulation, Blending, Tableting, and Coating), Packaging and BMS/Utility systems. In addition, he has provided strategic consulting in subject areas such as platform standardization, Data Historians, MES integration and regulatory reporting systems. He holds a BS in Electrical Engineering from New Jersey Institute of Technology and actively participates in ISPE, ISA and industry events.
 
Todd Talarico
Vice President Process Development
Medicago
Todd was responsible for overseeing Medicago’s completion of an aggressive design-build, government funded project resulting in rapid construction and deployment of a NC facility designed to produce more than 10 million pandemic influenza vaccine doses in 30 days. This vaccine is produced in and purified from tobacco plants. Todd just completed leading a second government-funded project to produce anti-Ebola monoclonal antibodies in the same plants. He has a history with Research Triangle Park companies and has been responsible for development of a hemoglobin-based biotherapeutic for Apex Bioscience and an alphavirus replicon RNA delivery system for AlphaVax in the past. Todd received a BS in Chemical Engineering from Penn State and a Ph.D. in Microbiology from NC State.