ISPE-CaSA 2019 Technology Conference
Keynote Speaker:

Andy Stober, AveXis
 Senior Vice President, Technical Operations & Chief Technical Officer


“Breaking Barriers in Gene Therapy Manufacturing"

 This talk focuses on the incredible story of AveXis’ novel gene therapy platform and the company’s transformational work that has the potential to dramatically change the lives of patients diagnosed with devastating genetic diseases such as spinal muscular atrophy. This exciting new modality introduces new challenges to manufacturing and supply for patients. Attendees will gain insights into the success factors and lessons learned in the journey from the clinic to commercial manufacturing, and how this pathway was anything but status quo.

 In his role at AveXis, Andy is responsible for manufacturing the company's gene therapy products and oversees supply chain, engineering, manufacturing science and technology, and program management functions related to the delivery of these products.

His keynote presentation will take place following the 
General Session Opening Remarks at 10:00am on March 12.

Addie Anderson
Associate, Core Team Leader
Addie is a team leader and project manager with 19 years of experience at CRB in the biotechnology industry. Addie has extensive experience with complex biotech retrofits, which often require complex scheduling and construction staging, creative piping or equipment solutions, and an investigative spirit to solve and achieve success. Addie has managed process-driven biotech projects from conceptual design through construction, with a strong focus on project tracking metrics, inter-disciplinary coordination and client communications. Addie has a Master of Science in Food Science, Minor in Chemical Engineering and a Bachelor of Science in Biological Engineering from North Carolina State University. Addie is also a Gallup-Certified Strengths Coach.

Harry Benson
Director, Human Performance
Harry Benson leads a team of experienced professionals at CAI who develop and execute programs, processes, and tools with industry organizations that standardize and improve the performance of their people. A former nuclear-trained submarine officer and Master Training Specialist, he is an expert in organizational effectiveness, performance improvement, human error reduction, and learning design and delivery with over 20 years of experience in driving results-based performance improvements within a variety of highly technical environments. Harry has a Bachelor’s degree from the U.S. Naval Academy, and a Master’s in International Business Administration from Wright State University.
Matt Brawner
Director, Sales Execution
Matt has over 18 years of experience working with drug and medical device companies within the Biopharmaceutical Industry. As a Lean/6 Sigma Black Belt with experience holding various roles within Quality, Engineering, Automation, IT, Manufacturing, and Organizational Excellence, Matt strives to deliver innovative and high-value quality solutions. Matt was most recently recognized for his leadership in a successful regulatory action remediation, as well as consolidating quality systems (QMS) following a merger between two global companies. Matt attributes his success to the capable teams with which he has worked. He is currently a Director with Sequence Inc. based out of Morrisville, NC.
Allan Bream
Process Engineer
Allan Bream has more than 30 years of engineering and manufacturing experience, including 25 years in the biotechnology industry. His expertise includes large-scale bacterial fermentation, mammalian cell culture, vaccines, downstream processing, protein purification and immobilization and Current Good Manufacturing Practice facility design, operations and assessment. Bream’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 biosafety level 2 and biosafety level 3 facility design projects. He has also worked in corporate engineering, process development and biomanufacturing positions for Chiron Corp. and Baxter Healthcare. Bream has a Master of Science in biochemical engineering and a Bachelor of Science in chemical engineering from the University of Iowa.
Megan Crum
Plant Engineer
Megan Crum has ten 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. 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.
Blake Derrick
Sr. Talent Acquisition Consultant
Derrick has been with Seqirus for 5+ years in Talent Acquisition, recruiting roles at the Holly Springs site and now all U.S. locations and Canada. Prior experience includes additional 7 years experience recruiting technical roles in the NC area for biotech, manufacturing, and life-science companies. Derrick hold a B.S. Biology from Wofford College and Professional Science Masters in Biotechnology from the University of South Carolina.
Charlie Dunn
Lean Planning and Innovation
DPR Construction
Charlie tells a good story. From cash rich development on the Las Vegas strip, to oil fueled expansion in Edmonton, Alberta, to energy plant upgrades throughout the Southeast, he thrives in the challenging delivery gap between “as is” conditions and the “to be” designed state. His career highlights include the on-site project management of over 2.5 million square feet of new distribution space across North America with zero recordable injuries, and recent WANO (World Association of Nuclear Operators) recognition for the use of 4D technology in project delivery. He knows that projects succeed because of people—what they believe, strategy—as it supports creativity and innovation, and tools—to deliver value and drive out waste. Charlie joined DPR Construction in 2016 where he continues to learn about the power of autonomy and the passion to build great things.
Chandler Foote
Business Development Manager and Thermal Validation Equipment Specialist
PSC Biotech
Chandler Foote is a Business Development Manager at PSC Biotech, where she facilitates validation, qualification and commissioning projects and equipment sales/rentals in the life sciences industry. In addition to providing project management and business development support, Chandler is a next-generation thermal validation equipment specialist and resource to PSC consultants and clients. Chandler has a Bachelor of Science in Cell and Molecular Biology from the University of Michigan and 7 years of experience in the biotech, medical device, and pharmaceutical industries.

Leigh Fuller
Associate Director QAV
bluebird bio
Leigh has over 16 years combined experience in API, dosage and biotechnology industries. Leigh has managed site and corporate validation teams, software quality, quality systems, quality operations and quality control organizations in her previous roles. She is currently serving as Associate Director of Quality Assurance Validation (QAV) at bluebird bio in Durham, NC. In her current role she is responsible for site commissioning, qualification and quality validation activities required for bringing up bluebird bio’s first manufacturing site. Leigh previously had responsibility for managing the execution of a site data integrity program and now has oversight of ensuring the creation a corporate wide program for bluebird bio through her QAV team. Leigh holds a BS in Pharmaceutical Sciences from Campbell University.
Adam Hoots
Life Sciences Sr. Project Manager
DPR Construction
Adam Hoots is DPR Construction Life Sciences core market leader for Upstate South Carolina. In the past 15 years, Adam has successfully completed more than $400 million in life sciences and high tech laboratory construction including all aspects from building shell to process connections and commissioning. Nationally, Adam has worked on life sciences and cleanroom projects for clients including: Stanford University, Oregon Health Science University, National Institute of Standards & Technology (NIST) and the University of Florida (NIMET). A highly technical builder, Adam excels in efficiency, action, communication and continuous improvement through the use of Lean principles. Adam is a member of the Lean Construction Institute and is Green Globes Certified as well as a LEED Accredited Professional in Building Design and Construction by the United States Green Building Council (USGBC). Adam and his wife, Brittany, founded a non-profit organization, kidSney, to promote kidney transplant awareness and assist families that have been impacted by kidney disease. Adam, himself, received a kidney from his mother in 2014 after being on kidney dialysis for more than a year. He was diagnosed with IGA Nephropathy and Medullary Sponge kidney disease at a young age but has lived a relatively normal life since his transplant. Adam’s passion and experience has led him to serve on the board of directors for the National Kidney Foundation SC for the past three years.
George Kafes
Senior Manager, Talent Acquisition
George Kafes works within AveXis’s Human Resources Department and is based in Durham, NC at the company’s newest Gene Therapy Manufacturing facility. Before joining AveXis, George served from 2015-2018 as Talent Acquisition Director at Patheon, a part of Thermo Fisher Scientific. Prior to that, he worked for 10 years within Biogen Idec’s Talent Acquisition team supporting multiple Pharmaceutical Operations functions including Engineering & Facilities, Manufacturing, Quality, Supply Chain, and Technical Development. In total, George has over 20 years of experience in the field of professional recruitment. George holds a Bachelors of Science in Education from the University of Georgia and is passionate about innovation within the field of Talent Management.
Peter Khoury
President and CEO
Ology Bioservices
Peter Khoury joined Ology Bioservices in August 2016 as Chief Commercial Officer, becoming the President and CEO in June 2017. Before Ology Bioservices, Peter held roles with Cornell University, Merck and Co., Baxter International, and the Bill & Melinda Gates Foundation. With over 20 years in vaccines and biologics commercialization, Peter’s experience spans US domestic, international, private, public, and government sectors of the industry.
David Kirk
Global Lab IT Manager
As Global Lab IT Manager, Dave is responsible for the installation and management of computerized instruments in manufacturing, quality control, technical development, and research and development labs. With over 20 years of IT experience, Dave has recently focused on areas such as data integrity, process improvement, and compliance. He enjoys implementing new technologies while applying industry best practices surrounding health authority regulations. Dave completed his bachelor’s degree in Business Administration at the University of North Carolina Wilmington.

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.
Keith Ledwith
Senior Manager
Johnson and Johnson
Keith Ledwith is a senior manager at Johnson & Johnson in the Engineering and Property Services group. As a project manager in E&PS, Keith manages capital projects across all of Johnson & Johnson’s family of companies. He has been with the company for over three years and has managed key projects in the medical device sector, vision care sector, and corporate functions. Prior to joining Johnson & Johnson, he worked in construction management in the New Jersey and Pennsylvania region for over 16 years, managing multi-million dollar pharmaceutical, research, and higher education projects, and multi-family high-rise construction. Keith holds a Bachelor of Science in Civil Engineering degree from The Catholic University of America.
Dawn Losinger
Senior Recruiter
Precision BioSciences
Dawn is part of the Human Resources department at Precision BioSciences in downtown Durham. Dawn has her Bachelor's of Science in Biotechnology from the Rochester Institute of Technology and started her career in manufacturing research at Regeneron. Dawn has recruited for many different industries, including telecom, IT, and global health. Most notably, Dawn spent 7 years as a Technical Recruiter at Biogen supporting Quality, Research and Development, and Patient Services. Dawn is thrilled to be back in the biotech space and looks forward to helping Precision BioSciences expand well into the future.
Cindy Moorhead
Director, Contract Management
Fluor Enterprises
Cindy has more than 30 years of contract management experience. Clients have recognized her as a leader in industry market analysis, procurement buy-out strategy, and leading challenging projects to a successful completion. Her experience includes projects valued up to $2.6 billion that includes federal, state, local and private funding sources. She has successfully lead the Contract Management team on the current Novo Nordisk DAPI-US $2 plus billion project located in Clayton, NC.
Sherry Nelson PMP
Sr. Validation Engineer
United Therapeutics
Sherry has over 18 years of experience within the Biopharmaceutical Industry, including 12 years of consulting throughout the triangle and U.S. She specializes in Computer System Validation, including systems such as TrackWise, LIMS, RAM, ProCal etc. As a Project Management Professional (PMP), she has managed projects throughout industry including full facility expansions, CSV and IT system restructuring, Packaging Line installations and LIMS implementations all with the ability to manage multiple sites/projects simultaneously. Sherry has recently completed a company-wide QC and Manufacturing Data Integrity Audit/Assessment involving multiples sites. Sherry has a B.S. in Chemical Engineering and a minor in Business Management from N.C. State University. She is currently a Senior Validation Engineer with United Therapeutics Corporation in RTP, NC.
Samir Patel
VP Information Systems
Sequence, Inc.
Samir Patel is currently VP of Business Technology at Sequence, Inc. and has over 18 years of multifaceted experience in the Life Science industry. Within his current role, Samir provides innovative Business Technology and strategic solutions for both Sequence and its clients. Samir is also one of the founding members of Sequence, who have transformed the company from a four-person validation team into a multi-services company with over 180 consultants serving companies globally. In tandem with Sequence's strategic initiatives, Samir has led many consulting projects for life science clients that range from an IT-based Data Integrity program for lab systems operations to implementation and validation of numerous lab systems and enterprise applications. Samir is an active member of ISPE, volunteers on the Xavier AI Continuous Product Quality Assurance AI development initiative, is a member of the East Carolina School of Computer Science Corporate Advisory Board, and an active angel and real estate investor.
Kristy Piasecki
Science and Technology Planner
Flad Architects
Kristy Piasecki is an architect and planner at Flad Architects focusing on the strategic planning and design of science and technology facilities. With over 17 years of experience, she has led and supported the programming, planning, design, and construction of research, production, GMP, distribution, and office facilities for corporate, government, healthcare, and academic clients. Kristy holds a Master of Architecture degree as well as a Bachelor of Science in Architectural Studies from the University of Illinois at Urbana-Champaign(UIUC) where she was awarded the Third Edward L Ryerson Traveling Fellowship. She is a registered architect with LEED AP and CDT certifications.
Tracy Sapp
Sr. Manager, Quality Systems
Tracy works within AveXis’s Quality Assurance department and is based in Durham, NC at the company’s newest gene therapy manufacturing facility. Before joining AveXis, Tracy held various roles within the Quality organization at Thermo Fisher Scientific, most recently as Director of North America Quality for the Drug Product Services business unit. Prior to that, Tracy spent nearly 9 years working within the Pharmaceutical Operations & Technology business area at Biogen, supporting Manufacturing, Automation Engineering, and Quality Engineering. Tracy holds a B.S. in Chemical Engineering from North Carolina State University, and an M.S. in Regulatory Science from the University of Maryland, School of Pharmacy. In her spare time, Tracy enjoys HIIT work outs, trip planning (this year to Reykjavik) and learning to juggle.
Al Schwarzkopf
Associate Director – Engineering
Al Schwarzkopf has nearly 24 years of experience with Merck in Operations and Capital projects. The last 19+ years Al has managed numerous small and medium capital projects from concept phase to Post OQ support both nationally and abroad.  Al is a certified Green Belt and is currently Merck’s Lean Leader for the Americas.   Al has been Chairman of the CURT Project Excellence Committee since 2005. This Committee serves to promote the development of Better and Lean Practices, shift the paradigm and behavior to one of value add and waste elimination and promote contracting strategies that fosters effective collaboration between all parties. Al has been instrumental in the development of the CURT Construction Industry Project Excellence awards and planning of the CURT Consortia Lean Summit now in its 12th year. Additionally, Al is active in Lean Construction Institute, is a certified trainer for LCI and is a founding participant in the Carolina’s and North Philadelphia Communities of Practice. Al has a bachelors degree in Engineering from Colorado School of Mines and is a Qualified Submarine Warfare Officer and Naval Nuclear Engineer with the United States Navy.

David Smith
Talent Acquisition Lead - PO&T North America
Over the last 19 years, David has worked with tens of thousands of job candidates and has been involved in hiring thousands of individuals. Today, as Talent Acquisition Lead at Biogen, Inc., David works out of the company’s RTP, North Carolina, facility where he is responsible for talent acquisition for Biogen’s Pharmaceutical Operations and Technology division. In his role, David has responsibilities for workforce planning, university relations, diversity engagement and ensuring Biogen has access to the best talent available for present and future business needs. Prior to joining Biogen, David has held leadership roles at Kelly Services, Health Decisions and US Tech Solutions. A chemist by training—he has an undergraduate degree in chemistry with a minor in biology from Stephen F. Austin State University in Texas. David worked offshore in the oil and gas industry to get himself through school, and upon graduation, he served as a chemist in the semiconductor chemical industry. He has served on several boards and committees with organizations such as ISPE, NC Biotech Center, PDA, NC Bio and others. He is active in the community supporting K-12 STEM education efforts, and he is a regular speaker and panelist for workforce related events.
Gretchen Smith
Director, Vector Manufacturing
bluebird bio
Gretchen Smith currently serves as Director of Vector Manufacturing at bluebird bio. bluebird bio is a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic diseases and T cell-based immunotherapies for cancer. Prior to bluebird, she was the Executive Director of Manufacturing at Humacyte for a bioengineered human tissue product and was Head of Downstream Manufacturing at Seqirus. Gretchen obtained her B.S. in Biomedical Engineering from Tulane University.
Ken Smith
Senior Manager
Johnson and Johnson Ethicon
Ken Smith is a Senior Manager at Johnson & Johnson. He is part of the site leadership team for the Ethicon Medical Device plants located in Georgia where biomaterials supporting wound closure and repair are manufactured. Over the past 28 years with J&J, Ken has held positions in Manufacturing, Engineering, and Facilities. A key focus throughout his career has been the development and implementation of technology based solutions and manufacturing process improvements. For the past several years he has been leading large value strategic projects and developing and deploying the site master plan. Ken is a certified J&J Six Sigma Green and Black Belt and certified in Asset Management as well as a Certified Plant Maintenance Manager by the Association for Facilities Engineering. He also holds a bachelors degree in Electrical Engineering from Kennesaw State University.
Andy Stober
SVP, Technical Operations & Chief Technical Officer
Andy Stober brings more than 20 years of experience in biopharmaceutical manufacturing and engineering to his role as Senior Vice President of Technical Operations and Chief Technical Officer at AveXis. Andy is responsible for manufacturing the company’s gene therapy products and oversees supply chain, engineering, manufacturing science and technology, and program management functions related to the delivery of these products. Andy oversees all manufacturing activities at sites in Libertyville, IL, and Durham, NC, including process improvements and technology transfer activities. He manages relationships with external manufacturers and critical suppliers and is also responsible for global engineering, including capital projects and infrastructure management. Prior to joining AveXis in 2017, Andy spent a decade working at Biogen, where he most recently served as Senior Director of Manufacturing and was responsible for the company’s manufacturing facilities in North Carolina and Denmark. He was previously responsible for cell culture operations at Amgen and spent 10 years at Merck in various roles supporting vaccine bulk manufacturing, lyophilized drug product filling and small molecule development. Andy holds a Bachelor of Sciences degree in Chemical Engineering from Lehigh University.
Emily Thompson
Process Engineer
Emily Thompson is a Process Engineer at CRB, specializing in biological process and facility design. Over the last 16 years working in the biotechnology industry, she has gained expertise in designing facilities for monoclonal antibodies, vaccines, and gene therapy production, both in stainless steel and single-use. Emily is a specialist in process simulation and modeling and experienced in a number of different commercially available software programs. A graduate of North Carolina State University, Emily holds two degrees: a Bachelor of Science in Chemical Engineering and Bachelor of Science in Biochemistry. She is also a licensed Professional Engineer in the state of North Carolina.
John Urbanowicz
Associate, Core Team Leader
John is the Southeast Operations Leader/Associate and Project Manager with more than 20 years of experience in engineering and technology. His project knowledge covers biotechnology, power and energy, and commercial building applications. As a Project Manager, John has managed all aspects of a capital project and manufacturing operations including project organization / set-up, resource loading, scheduling, budget/change management, client interface and discipline coordination. As the Southeast Operations Leader, John is responsible for developing and implementing a business plan to serve clients, primarily in the Southeast region of the United States. John actively manages a multi-discipline team including architects, engineers, designers, project managers and administrators. His Team Leader responsibilities include direct oversight of proposal development, project execution, personnel management, recruiting, and financial reporting to support a profitable business unit.