ISPE-CaSA Technology Conference 2017
Keynote Speaker:

Nick Valvano

0Ali Abdulhay
Full Stack Engineer and COO
Digidose LLC
Addie Anderson
StrengthsFinder Coach; Lead Process Engineer & Project Manager, Associate
Addie is a certified Gallup StrengthsFinder Coach and her top 5 strengths include: arranger, relator, analytical, responsibility and harmony. In addition to leading CRB's StrengthsFinder efforst, Addie has served as a Project Manager and Lead Process Engineer for 16 years. Addie has extensive knowledge with scaling ultrafiltration and depth filtration equipment, and specifying and procuring process modules. Recent project experience includes managing facility upgrades for ethanol-based processing, studies on hydraulic and vaccum systems and dust collection, and several small projects including fermentation, recovery, purification, chemistry and buffer distribution modifications.
Roger J. Ashton
Valve Systems Specialist, Equipment Division, Sanitary
Alfa Laval Inc.
Roger has 48 years’ experience in beverage, dairy, food, pharmaceutical and personal care industries and is tenured with Alfa Laval’s valve division. Throughout his career, Roger has worked with many types of valve systems and applications with innovative companies which include Tri-Clover and G&H Products Corp. For 24 years, Roger’s main focus at Alfa Laval is mix-proof and diaphragm valves, the process and mix-proof valve applications. Since the mid 1990’s, he’s been instrumental in bringing Alfa Laval mix-proof valve models to market in conjunction with Alfa Laval’s research and development teams in Kolding, Denmark. Roger holds a degree in Mechanical Design from Gateway Technical Institute and is based in Kenosha, WI
Susan Beckert
External Manufacturing Operations Director for DDS and Devices
Susan Beckert has been working for Merck for over 19 years in various roles within the Merck Manufacturing Division. Susan started her career at Merck in 1997 and has gained valuable experience through positions of increasing responsibility within the Merck Manufacturing Division. She began her career in Packaging Technology at the West Point PA site, focusing on Sterile and Vaccine products. She completed a 2 year assignment at the Haarlem NL facility, focused on Site Packaging Operations and Cold Chain Management. Susan then transitioned to the Durham, NC VMF (Vaccine Manufacturing Facility) to support Technology Transfer of Varivax® and MMR® in the Tech Ops organization. She joined GES (Global Engineering Solutions) in 2009, where her previous responsibilities included the C&Q (Commissioning & Qualification) and Start-Up Lead for VMF (Vaccine Manufacturing Facility)-102, Technology Director for the Southeast, and the Large Molecule LoB (Line of Business) - Business Integrator supporting domestic and international sites. Susan is currently the External Manufacturing Operations Director for DDS (Drug Delivery Systems) and Devices, for Large and Small Molecule Drug Products. This role includes direct oversight of day to day operations across all of the Merck DDS/Devices External Manufacturing Partners. Susan holds a B.S. from Rochester Institute of Technology (RIT) in Rochester, NY.
Allan Bream
Lead Biopharmaceutical Specialist
Allan has more than 30 years of engineering and manufacturing experience including 25 years in the biotechnology industry. His expertise encompasses large-scale bacterial fermentation, mammalian cell culture, vaccines, downstream processing, protein purification and immobilization, and GMP facilities design, operations and assessment. Allan’s facilities experience includes all phases of process design including master planning, conceptual and detailed design, construction services and equipment procurement across the United States, Puerto Rico, Europe and Asia. His experience also includes BL2-LS and BL3-LS facility design projects.
Robert Chew

Mr. Chew is President and CEO of Commissioning Agents, Inc.  Commissioning Agents is a leader in helping companies achieve faster project delivery and higher levels of performance and reliability from their GMP-regulated manufacturing operations.  The company has operations in North America, Europe, and Asia.  Mr. Chew is an internationally recognized consultant to the pharmaceutical and biotechnology industries, focusing on capital project delivery, manufacturing operations, and regulatory compliance.  Over the past two decades, he has spoken at international conferences in the US, Europe, Asia, and South America to promote innovation in GMP-regulatory compliance and operational excellence.  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. Mr. Chew began his career as an US Naval Officer, serving on a nuclear submarine.  He has a B.S. in Chemical Engineering from Case Western Reserve University, and is a registered Professional Engineer.

Megan Crum
Plant Engineer, Maintenance
Megan Crum has eight years of experience supporting Biologics, Fill Finish and Bulk Operations. She is currently a Plant Engineer at Biogen in RTP, holding responsibilities for Utilities and HVAC within the Maintenance Organization. Previously, Megan held Engineering and Facilities Management roles at Merck in Durham, N.C. She has experience in root cause analysis, regulatory compliance, equipment reliability, process optimization, predictive maintenance technologies and project execution. Megan first joined ISPE as a student in 2008 and has remained active in the local chapter. She holds a B.S. in Biological Sciences from North Carolina State University, and was the first recipient of the BTEC Biomanufacturing Minor, specializing in Downstream Operations.
Peter Denmark
Director of Sales - Americas - MCAD
After graduating from Wake Forest University, Peter went on to earn a master’s degree in exercise physiology from Furman University, and an MBA from Eastern Michigan University. Throughout it all, Peter has always had a strong interest in the medical sciences. At EnvisionTEC, he found a company that was a world leader in 3D bioprinting with its 3D-Bioplotter series. EnvisionTEC’s robotic additive manufacturing technology — the Viridis3D RAM 123 — also falls under Peter, where it’s currently being offered in the marketplace to bring sand molds and cores for the foundry industry.
Heather Denny
President and CEO
McDonald York Building Company
Heather Denny is the President and Chief Executive Officer of McDonald York Building Company, a Triangle-based General Contractor, founded in 1910. Ms. Denny has built her career at McDonald York. In 2010, she became the fifth President, and the only non-family president in the company’s history. In 2013, she was named CEO. She is known for her problem-solving capabilities, consensus team-building skills, clear communication style, and commitment to active community service. Ms. Denny is passionate about serving the community and helping others. She is actively involved in many professional and non-profit organizations, and serves in leadership roles within a majority of these groups. Heather chooses volunteer organizations that are both professionally and personally meaningful; that allow her to make a significant impact within the community. Currently, her activities include board positions with NC State’s Civil Construction and Environmental Engineering (CCEE) department’s advisory board, the Carolina South Atlantic (CASA) Chapter of International Society for Pharmaceutical Engineering (ISPE), Union Bank, the John Rex Endowment, Fostering Bright Futures, and the City Club of Raleigh. Additionally, she is the chair of the Triangle Area Chapter of the American Red Cross. Ms. Denny has received numerous awards including, “Top 50 Business Leaders to Watch,” by the Triangle Business Journal; Engineering News Record’s, “20 Under 40”; Triangle Business Journal's,”40 Under 40”; CREW Network’s, “20 Under 40”; Triangle Business Journal's, “Women in Business”; and Business Leader Magazine's, “Women Extraordinaire”. Ms. Denny is a graduate of North Carolina State University with a Bachelor of Science in Civil Engineering.
Ken Ewan
Leadership Coach
KME Leadership, LLC
Ken Ewan is an executive coach and facilitator. He brings to coaching and consulting 45+ years of experience in the chemical, biotechnology, and pharmaceutical fields. Ken has held senior level positions at Genentech, MedImmune, Amgen, Skanska USA Building, GlaxoSmithKline, and DuPont in engineering and project management. Ken enjoys working with technical and creative professionals and leaders. He works with leaders to explore new ways to view situations, individuals, possibilities, and to develop new approaches, plans, strategies and actions. Ken believes in the power of coaching to be transformational for leaders, leading to unforeseen possibilities, and higher levels of achievement and growth, both professionally and personally. A 25+ year member of ISPE - International Society of Pharmaceutical Engineering, Ken has held international leadership roles having chaired both the Education Committee and the Professional Certification Commission. At the local level, Ken was on the Board of Directors for ISPE Chesapeake Bay and for ISPE CaSA. Ken is currently serving on the Board of Directors of three companies: PCI-LLC, a leading provider of calibration, instrumentation, consulting, and commissioning services within the Life Sciences industry, Tunnell Consulting, Inc., a provider of Strategic, operational and technical solutions for biotech and pharmaceutical organizations, and WithersRavenel, Inc., a full-service civil and environmental consulting engineering firm. Ken is a graduate of Clemson University in South Carolina and Drexel University in Philadelphia in Architecture and has a post-graduate certificate in Leadership Coaching from Georgetown University. He is a member of the International Coach Federation and holds the credential of Associate Certified Coach (ACC).
Wendy Haines PHD
Project Manager
Mangan Biopharm
Wendy Haines, PhD Project Manager at Mangan Biopharm Dr. Haines has 19+ years of experience in both the research and biopharmaceutical arenas, encompassing process design, analysis, validation, project/protocol management and scientific writing. She has successfully integrated herself in both the research and commercial areas of business. Dr. Haines has been a long standing member and active participant within ISPE and has held integral roles of responsibilities that have helped shape our local, national and international rules and guidelines and she is currently the CaSA Chapter Vice President. John R. Hodge IV, Project Manager at Mangan Biopharm Mr. Hodge has 12+ years of experience in Validation and Automation Engineering in the field of pharmaceutical manufacturing. He has completed Serialization, Building Management System, and Virtualization projects by combining the roles of Validation Specialist and Automation Engineer to deliver fully developed, integrated, and qualified systems to Mangan’s clients. Mr. Hodge believes that acting as a single point of contact for developing, documenting, implementing, and verifying system changes can accelerate project schedules and reduce risk of gaps.
John R. Hodge IV
Project Manager
Mangan Biopharm

Mr. Hodge has 12+ years of experience in Validation and Automation Engineering in the field of pharmaceutical manufacturing. He has completed Serialization, Building Management System, and Virtualization projects by combining the roles of Validation Specialist and Automation Engineer to deliver fully developed, integrated, and qualified systems to Mangan’s clients. Mr. Hodge believes that acting as a single point of contact for developing, documenting, implementing, and verifying system changes can accelerate project schedules and reduce risk of gaps.

Greg Hottell

Greg Hottell is a Director in the Clinical Interface team at GSK, where he is responsible for the cost-effective, patient-focused supply of investigational product for GSK’s pharmaceutical development portfolio. Since joining GSK in 2011, Greg implemented an end-to-end planning platform for clinical supplies, helped redesign GSK’s approach to clinical supply blinding and unblinding risk management, was a core team member for the Investigational Material Supply strategic planning initiative, all while consistently delivering top-tier performance with on-time supply of investigational product to patients.Greg has been a Supply Chain professional since 1999, most recently holding positions of increasing responsibility at Eli Lilly & Company and Fisher Clinical Services prior to joining GSK.  Greg has a diverse background in the Pharmaceutical Industry spanning roles that include clinical trial materials management, demand planning, site inventory management, IRT utilization, drug product supply planning, temperature excursion management, study drug expiry dating extensions, customer service, operations planning & scheduling, and procurement.Greg holds a bachelor’s degree in Operations Management, an MBA, and is a Certified Fellow in Production and Inventory Management (CFPIM) through APICS.

Edison Hudson
CEO and Co-Founder; CTO & Founder
Panacea BioMatx, Inc.; Panaceutics, Inc.
At Panacea BioMatx, Edison led the design of a novel automated compounding machine and the launch of GMP operations to produce personalized dietary supplements. Prior to co-founding Panacea BioMatx, he led several technology and robotics companies, including iRobot, and RedZone Robotics. He has over 16 patents in machine design, control systems, machine vision, robotic algorithms, and semiconductor processes. He was a Morehead Scholar in physics and computer science at the University of North Carolina, studied artificial intelligence at Oxford University, UK, and received an MBA from Duke University.
Jeff Hutchins, Ph.D.
Chief Scientific Officer and Senior Vice President of Preclinical Development
Heat Biologic
Dr. Hutchins oversees Heat Biologic's research efforts, with over 24 years of research and clinical development experience from both large pharmaceutical and biotechnology companies. Most recently, Dr. Hutchins served as Vice President of Preclinical Research for Peregrine Pharmaceuticals, Inc., a biopharmaceutical company developing therapeutics to fight cancer and infectious diseases. Dr. Hutchins was responsible for building out the research program for Peregrine's lead product candidate, bavituximab, a chimeric monoclonal antibody designed to target phosphatidylserine. Prior to joining Peregrine in 2012, Dr. Hutchins served as Vice President, Preclinical Development at Inhibitex Inc, which was acquired by Bristol-Myers Squibb From 1991 to 2000, Dr. Hutchins held several senior scientist positions in Discovery Research at Burroughs Wellcome and Glaxo Wellcome, with a visiting professor appointment at Rush Medical College. Dr. Hutchins earned a B.S. in Biology from Oral Roberts University, a Ph.D. in Biomedical Sciences from the University of Texas, Health Science Center at the M.D. Anderson Cancer Center and conducted postdoctoral training in the University of Southern California's Department of Microbiology at the Norris Cancer Center. Dr. Hutchins' publications and patents span the fields of oncology, infectious disease, osteoarthritis and immunology.
John Hyde
Founder / Principal Consultant
Hyde Engineering + Consulting
John Hyde is Chairman and Founder of Hyde Engineering + Consulting, Inc., a firm of 220+ engineers and scientists, founded in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. Hyde Engineering + Consulting, Inc. have operations in the United States, Europe, Singapore, and India. For nearly two years before the formation of Hyde Engineering + Consulting, Inc., John was Senior Project Engineer with Synergen, a biopharmaceutical research, and manufacturing company located in Boulder, CO. His work at Synergen included design, start-up, and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm's large scale and clinical manufacturing facilities. From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of biopharmaceutical, food, and beverage process systems and the application of CIP technology. Hyde has presented papers at numerous engineering conferences and short courses on topics including biopharmaceutical process systems design, automatic cleaning system design and implementation, and control system design for pharmaceutical processes, and he has published numerous articles on these topics. He, as a member of the PDA Subcommittee for Biopharmaceutical Cleaning Validation, contributed two chapters to a book on the subject, and he has also contributed a book chapter on PAT as applied to CIP operations. John is a member of the editorial board of the Journal of Validation Technology and he has been a regular speaker at conferences presented by Pharma Conference, the Institute of Validation Technology (IVT), the International Society of Pharmaceutical Engineers (ISPE), the American Institute of Chemical Engineers (AIChE) and other professional societies. John has also provided training to FDA CBER personnel on cleaning and cleaning validation practices. He holds Bachelors degrees in Food Science and Business Administration, and a Masters degree in Food Engineering, all from the Ohio State University.
0Randy Karsten
Managing Director, Strategic and Corporate Sponsorships
The V Foundation for Cancer Research
Randy serves as Managing Director, Strategic and Corporate Sponsorships at the V Foundation. He is a cancer survivor who joined the organization to honor and fight for the legacy of family members and friends who have been lost to cancer. Prior to joining the V Foundation he served as a Global VP with Catalent Pharma Solutions where he led global business development, marketing, strategy, R&D operations and business transformation teams.
0Shane Kelly
Maintenance Systems Manager
Shane Kelly is the Maintenance Systems Manager at Shire in Social Circle, GA. He received his B.S in Chemical Engineering from the University of Louisville, before beginning his career in pharmaceutical manufacturing. During his 18 year career, he has worked for several biopharmaceutical companies ranging from small-scale biologics to large-scale plasma fractionators. He has been involved with two substantial green-field pharmaceutical builds; responsible for Engineering design, plant startup and operations establishment on the client side. Shane is an avid reader and enjoys hunting, gardening and beekeeping. He currently resides in Social Circle with his wife Dana and daughter Isabella.
Jennifer Lauria Clark
Executive Director of Strategic Development
Commissioning Agents, Inc.
Jennifer Lauria Clark, CPIP is the Executive Director of Strategic Development for Commissioning Agents, Inc., where she is responsible for business development, their key account management program, commissioning and qualification planning, protocol development and execution, project startup and coordination, consulting support among other duties. She has over 11 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 12 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 has just finished a four year stint as 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.
Rick Lawless
Associate Director, Strategic Programs
Rick is a manager and instructor at the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at NC State University. As an independent consultant, he also provides GMP expertise to emerging companies such as Panacea BioMatx. Prior to joining BTEC in 2006, Rick accumulated more than 20 years of industry experience with companies such as Eastman Kodak, Johnson & Johnson, and Wyeth. He was involved in the start-up of four biomanufacturing facilities and has managed several GMP production units that manufactured commercial quantities of clinical diagnostic products and vaccines. He received a BSE in Chemical Engineering and BS in Microbiology from University of Michigan - Ann Arbor, and a MBA from State University of New York at Buffalo.
Gary Lohr
Project Director – Site Support and Deputy Site Head
Novo Nordisk
Gary Lohr has been with Novo Nordisk since 2005 when he joined Novo Nordisk site Clayton as the Validation Project Leader for the first major expansion project at the Site that included Aseptic and Finished Production. Mr. Lohr assumed responsibility for operations of the newly installed FlexPen® manufacturing lines and Finished Production Process as Shift Manager in 2007. Starting in 2010, he became responsible for establishing the FlexTouch® capacity in the US as the Senior Project Manager for PDS290 Phase 3&4. In 2012, Mr. Lohr accepted the role of Director, Production Support. Since the announcement of the Diabetes API, US project in August 2015, Gary has held the position of Project Director – Site Support and Deputy site head. Gary is the community face of the project as first contact with state officials and local regulators.
Juha Mattila
Senior Product Manager
Juha Mattila is Senior Product Manager for STERIS FINN-AQUA Sterilization systems. He joined STERIS in 2000 and has over 16 years of experience in the design, development and product management of pharmaceutical and research process equipment, including several years in Research and Development for STERIS FINN-AQUA products and systems. He has worked with several clients in the designs and installations in Europe, North America and Asia, is an active conference presenter, and has contributed as author/co-author for articles in professional journals. Juha is a member of ISPE Nordic Board of Directors, PDA, and Finnish Biosafety Network.
Phil McDuff
VP, Global Engineering
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
Science Market Leader
BHDP 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 has more than twenty-five years of professional experience in the science industry. Jim’s background includes all phases of project services including marketing/business development, client leader, programming, planning, design integration, contract negotiations, developing construction documents, and construction administration. Jim is registered architect and a Leadership in Energy and Environmental Design (LEED) Accredited Professional. Jim is a Past-President of the ISPE Carolina-South Atlantic Chapter, Past-Chairman and current member of the Facility of the Year Awards Committee, and current steering committee member of the Project Management Community of Practice.
0Cathy Middleberg
Jeff Miller
IS Department Manager
Avid Solutions, Inc.
Jeff Miller Avid Solutions Inc. Department Manager for Information Solutions Department For more than 20 years, Miller has led world-class programs in the fields of process automation, machine automation and electrical design. He has consulted with Procter & Gamble, Dannon, DHL, Kroger, Toyota, Ford and others to optimize their manufacturing and operations. His primary focus is on promoting data flow vertically and horizontally to those within an organization in order to positively affect quality, efficiency and profit. This translates to delivering the right data, to the right people, at the right time, so that they can make the right decisions. With a degree in electro-mechanical engineering from Miami University and several years spent as a cryptologist in the military in Naval Intelligence, he has vast experience in manufacturing execution systems (MES), information solutions, custom software development, and is a thought leader for the Industrial Internet of Things (IoT).
Tolga Musa
Associate Director, Process Engineering
Tolga is the Associate Director of Process Engineering at the Biogen, RTP, NC facility. Tolga holds a Chemical Engineering degree from the Georgia Institute of Technology and a Master’s degree in Business Administration from the University of North Carolina, and is registered as a Professional Engineer (state of GA).
Christa Myers
Senior Pharmaceutical Engineering Specialist
Christa Myers is a Senior Pharmaceutical Engineering Specialist at CRB with more than 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. Building on her years as an operator, Christa has used her first hand approach and understanding to assist her clients in designing facilities and equipment – each facility being unique, with different drivers, different products and different dosing mechanisms. With 20+ years of operating and designing filling equipment experience, Christa has been instrumental in many fill finish projects—both retrofits and new construction. 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.
Kim Nguyen
Director, Process Development
Precision Biosciences
Kim Nguyen currently heads the Process Development team at Precision Biosciences, focusing on the scale-up and manufacturing of allogeneic CAR-T cell therapeutics. She received her AB in Chemistry from Princeton University, her PhD in Chemistry from Columbia University, and subsequently completed a postdoctoral fellowship with Ian McNiece at the University of Miami focused on both the scientific and regulatory aspects of preclinical process translation and clinical cGMP scale-up of MSC, dendritic cell, and HSC cultures. Subsequently Kim joined Terumo BCT in Lakewood, CO and served as Principal Scientist and Senior Manager for Cell Processing R&D, focusing on the development of automated platform technologies for cell and gene therapies. She also currently serves as an Affiliate Investigator at Blood Systems Research Institute in San Francisco, CA.
Marisol Patino
Process Engineer
Sartorius Stedim Biotech
Marisol just recently joined Sartorius Stedim Biotech as an Integrated Solutions Sales Manager for the southeast US. In her role, she provides process support for the design of large scale bioprocesses and custom bioprocessing solutions. Previously, Marisol worked as a Process Engineer at Fujifilm Diosynth Biotech, a contract manufacturer. She was responsible for downstream technology transfer and process validation. Other roles have included learning specialist, supporting manufacturing training, and bioprocess technician. She is currently the Chair of the ISPE-CaSA Student Affairs Committee and serves on the ISPE International Young Professionals Committee.
Carsten Nicolai Petersen
Nick Petersen has over 20 years of international Project Management expertise and has executed large scale capital projects in USA, Denmark, Indonesia, Ireland, and China. Mr. Petersen joined NNE in Denmark in 1996 as a Project Manager and has participated in several of the large Novo Nordisk expansions around the world and is very familiar with the Novo Nordisk way of executing large projects. From 2000-2004, Mr. Petersen headed the partnership between NNE and Fluor where the team executed two large Construction Management projects in Europe. Starting in 2007 Mr. Petersen opened NNE’s office on the US West Coast based in San Francisco and transferred to the NNE US HQ in RTP in 2010 where he has held positions as Director of South East, Project Director, and Director of Project Governance. Mr. Petersen is currently supporting the new Novo Nordisk DAPI expansion in Clayton to help apply well-proven Project Execution methodologies and to coordinate the NNE team’s role as Owners representative.
Bryan Raborn
Process Engineer
Bryan Raborn is a Process Engineer at CRB with three years experience. Bryan graduated from North Carolina State University with degree in Chemical Engineering and had participated in the design of several biotech facilities.
Ardarion Richardson
Process Engineer III, Process Engineering
Ardarion Richardson has been employed with Biogen for 6 years in the Process Engineering department, RTP, NC Facility. He has served the company as a subject matter expert for Harvest and Downstream purification processes. Ardarion has supported multiple therapeutic products by working cross-functionally to provide guidance on equipment design, functionality and capability to ensure success. Ardarion has a Bachelor’s and Master’s of Science degree in Industrial & Systems Engineering with research focused in Bio-manufacturing and Tissue Engineering.
Derek Schorzman
Executive Director, Manufacturing Sciences
Liquidia Technologies, Inc.
Dr. Derek Schorzman holds the position of Executive Director, Manufacturing Sciences, at Liquidia Technologies, Inc. He has been a key contributor to the research, development, and implementation of the continuous PRINT® nanoparticle fabrication platform since joining Liquidia in 2006. Prior to joining Liquidia Technologies, Dr. Schorzman conducted research and development of biomedical devices for diabetes care and ophthalmic materials, while at Becton Dickinson and Bausch & Lomb, respectively. Dr. Schorzman served a post-doctoral appointment at UNC Chapel Hill, received his Ph.D. in Chemistry from Virginia Commonwealth University, and a B.S. in Chemistry from Utah State University. He holds 31 U.S. patents and has authored six publications.
0Robert Smith
Sr. Manager, Automation
Robert is the Sr. Manager of Automation Engineering at the Biogen, RTP, NC facility. Robert holds an Electrical Engineering degree from the University of North Carolina at Charlotte.
David Summers
ESE Commercial Manager – Valves, Equipment Division, Sanitary
Alfa Laval Inc.
David Summers, ESE Commercial Manager – Valves, Equipment Division, Sanitary. With more than two decades of international business experience in the food and beverage process and pharmaceutical equipment industry, David recently transitioned from Alfa Laval Kathabar in New York where he focused on liquid and dry desiccant dehumidification systems for food and pharma. David brings a wealth of knowledge to Alfa Laval and to our customers with an effective ability to cultivate trust and rapport and works with Transfer Technologies as Alfa Laval's Commercial Manager – Valves, Sanitary Equipment Division in the United States. He’s tenured with Alfa Laval in Australia and The Netherlands and is multilingual in English, Dutch, German and Friesian. Educated in Australia, David holds a Certificate III in Engineering from RMIT University, diplomas in Media Studies from the Australian College of Journalism, and a degree in International Business from The University of New England’s Graduate School of Business. He also holds Graduate Certificates in Project Management and Marketing with Villanova and Tulane Universities. He’s a member of ASHRAE engineering society and is based in Tampa, Florida. 
Richard Tree
Vice President
Commissioning Agents, Inc.
Richard is a hands-on senior consultant with 33 years of leading maintenance, reliability, commissioning, and performance improvement teams. His leadership has consistently strengthened the client’s bottom line by improving efficiency and eliminating waste. He leads a team that develops unified strategies to help clients improve Overall Equipment Effectiveness (OEE) through enhanced human performance and asset management practices. A lean operations expert, he is personally credited with the lean transformation of 9 manufacturing sites, mentoring over 34 manufacturing sites in advanced lean operations, and designing and implementing asset management strategies at 15 manufacturing sites. Richard’s leadership roles began in the US Navy, where he was responsible for operations, training and staff performance, maintenance and quality of power generation, propulsion, and cooling systems on four nuclear-powered submarines. He was hand selected by the Director of Naval Sea Systems Command, Reactors to lead the initial manning, testing and commissioning of a first-in-class nuclear submarine with a never-before operated and tested nuclear reactor. His leadership and success led to numerous commendations. He has held several key operations leadership roles in manufacturing companies prior to joining Commissioning Agents, Inc. Richard is currently working toward a PhD in Operations Management, at the University of Texas Arlington where his research has focused on Behavioral Operations and Statistics. He holds an MBA from Southern Methodist University and a Bachelor of Science degree in Information Technology from Columbia College.
Brian Urban
Associate Director, Quality Systems & Enterprise Management
Brian is the Associate Director of Quality Systems & Enterprise Management within the Corporate Quality organization at the Biogen, RTP, NC facility. Brian holds a Chemical Engineering degree from North Carolina State University as well as being a certified Six Sigma Black Belt.
0Nick Valvano
President Emeritus
The V Foundation for Cancer Research
Nick Valvano, Jim’s brother, served as Chief Executive Officer of the V Foundation for Cancer Research from 1999-2012, and has been a member of the Board of Directors since its inception. Valvano brought years of senior management and sales experience to the V Foundation through his work with Xerox, Wang and Olivetti. Valvano began his professional career in education, teaching and coaching high school basketball for 10 years. Today, Nick serves as President Emeritus for the V Foundation. He enjoys golfing and cooking Italian masterpieces for his wife Karen.
Kevin Ventura
Process Engineer
Kevin is a Process Engineer with four years experience. He is a graduate from North Carolina State University, majoring in Chemical and Biomolecular Engineering with a minor in Biotechnology. Since joining CRB, Kevin has been involved in the design of several biotech and life science projects.
Joshua Walker
Senior Engineer I, Technical Development
Joshua has been employed for 12+ years in the Technical Development (TD) department. He is a Harvest / Clarification subject matter expert with several years of Pilot-scale experience. Joshua serves as the TD technology transfer lead for several Harvest and Downstream purification processes, where he works closely with various cross-functional departments (Manufacturing Sciences, Process Engineering, etc..) to ensure successful process transfers to manufacturing scale. Joshua has a Bachelor’s of Science degree in Chemical Engineering.
0Gavin Wendel
Senior Validation Specialist
Gavin Wendel is a Senior Validation Specialist with Pfizer. With a BS degree from Virginia Tech he has worked for 15 years in the pharmaceutical industry. For the past 11 years he has worked at the vaccine manufacturing facility in Sanford, NC in various roles including validation, project management and clinical manufacturing. He is currently responsible for equipment qualifications and board of health commitments for the areas of sterilization, lyophilization, cold storage and warehousing.
0Gregory Westby
Clinical Compounding Pharmacist
Duke University Health System
Gregory Westby is a clinical pharmacist and student preceptor at Duke University Hospital. He received his pharmacy degree from the University of North Carolina at Chapel Hill and his Master's in Clinical Research from Campbell University. During his 27 years at Duke, he has worked in both the inpatient and outpatient settings and serves on Duke Hospital’s Sterile Preparations Oversight Committee. He spent 15 years in the Investigational Drug Service Pharmacy collaborating on government, industry and investigator sponsored research projects. This collaboration has included IND submissions, pharmacy manuals, and the development and implementation of masking and packaging strategies for investigational products. Currently, he works with the Duke Compounding Facility as a quality assurance and compounding pharmacist. Greg has served as a primary reviewer for the Duke University Health System IRB since 2003. He has received "Patient Care" and "Medication Safety" awards and has interests in medication safety, quality assurance and regulatory affairs.
David Yarley
Director of Training and Development
Fujifilm Diosynth Biotechnologies USA, Inc.
David Yarley serves as the Director of Training and Development for Fujifilm Diosynth Biotechnologies USA, Inc., located in Morrisville, North Carolina. Fujifilm Diosynth Biotechnologies is a contract manufacturing organization (CMO) that produces bulk active pharmaceutical ingredients (APIs) using fermentation and cell culture processes. Prior to this position, he served as the Director of Bioprocess Training at the BioNetwork Capstone Center located at the NCSU BTEC facility and in management positions in technical support, marketing, and manufacturing at Ajinomoto AminoScience LLC. David received his MS degree in chemical engineering at the University of Virginia and his BS in chemical engineering at North Carolina State University.