innovation regulation commercialization 2018 BPSA SINGLE-USE SUMMIT From Evolution to Revolution: How SUTs Accelerate Life-Saving Therapies

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1 2018 BPSA SINGLE-USE SUMMIT From Evolution to Revolution: How SUTs Accelerate Life-Saving Therapies innovation regulation commercialization JULY 9 11, 2018 WASHINGTON, DC FOUR SEASONS HOTEL AGENDA > SPEAKERS >

2 BARCELONA How Single-Use Technologies Drive Innovation SEPTEMBER 26 28, 2018 BARCELONA, SPAIN CROWNE PLAZA HOTEL 2ND EUROPEAN SINGLE-USE SUMMIT

3 BPSA S 8TH ANNUAL INTERNATIONAL SINGLE-USE SUMMIT: WE RE TURNING QUESTIONS INTO ANSWERS Dear BPSA Members and Industry Colleagues: On behalf of the BPSA Board of Directors, it is our distinct pleasure to welcome you to Washington, D.C. and the 2018 edition of the BPSA International Single-Use Summit. John Boehm CPC Chairman, BPSA This is our 8th Annual Summit here in DC. We began this consecutive string of successes in 2011 at this very venue. At that time, there was an opinion among some, a skeptical few, that we could never draw a crowd to DC in July to just talk about single-use and, it s hot there in July! Well, in spite of the weather, we once again have a full house this week, thanks to you, our loyal members. We thank you. We believe that much of our success is tied not only to the crafting of content-rich agendas that allow you to take business nuggets and insights home with you, but also to the fact that BPSA remains the unique voice and technical reference point for all things for and about the business of single-use. This speaks to the intrinsic value of BPSA, and your legitimate expectation that BPSA provide you a return on investment. To this point, and to capture what we believed to be the essence of BPSA in a legitimate public opinion poll, we recently put out a call for testimonials to several of you. The question was rather simple: Why Do You Belong to BPSA? The responses were numerous and insightful. Among the dozen responses, two stood out: From a Supplier Member: Unlike other industry associations, BPSA focuses exclusively on single-use technologies; not only does this ensure the most cost effective and efficient use of membership resources, it allows me to focus my time and energy in a technology that I feel makes a real difference to the industry. The other, from an End-User, which wins the award for brevity and impact, is this: BPSA turn my questions into answers. So, there you have the basic building blocks of an effective industry association, as spoken by the stakeholders: focus; cost effectiveness; a group where you feel your participation makes a difference; and, an effective way to solve problems turning questions into answers. So, we come into this eighth Summit with another set of interesting challenges and questions some of them iterations of legacy challenges we continue to address with you and for you, and others which are new, and in need of immediate focus BPSA International Single-Use Summit

4 What are these issues? We will address them over the three days of this event: emerging markets for single-use; innovation and growth strategies; regulatory requirements; system integrity; cell and gene therapy manufacturing hurdles; advances in continuous processing; extractables and leachables; change control implementation; market data capture; and last but certainly not least, sustainability the disposal of used plastics and packaging, an ever-growing public interest concern. So, where are the answers? We ll give you a hint. During our sessions, if you look to your left and your right, to the podium and screen and to the row behind you, you will see the answers they are us, and our unique collective commitment to excellence in single-use as we pursue the goal of enabling and accelerating life-saving therapies to market using innovative, safe and effective Single-Use Systems. We thank you for your participation this week, and wish you a memorable and productive visit to our nation s capital. Now let s raise the curtain on the 2018 BPSA Summit. The answers can t wait! John Boehm CPC Chairman of the Board Bio-Process Systems Alliance (BPSA) Kevin D. Ott Executive Director Bio-Process Systems Alliance (BPSA) Washington, D.C. BARCELONA How Single-Use Technologies Drive Innovation SEPTEMBER 26 28, 2018 BARCELONA, SPAIN CROWNE PLAZA HOTEL BPSA International Single-Use Summit connect collaborate succeed the business of single-use

5 BPSA 2018 SUMMIT PROGRAM COMMITTEE A conference of this caliber would not be possible without the support of our sponsors and member volunteers. We thank the 2018 Summit Program Committee for their time and effort on behalf of BPSA and its members. Chairs Jessica Frantz Sartorius Stedim Biotech Greg Love Bürkert Fluid Control Systems Brendan Lucey ILC Dover Sandra Medlin SaniSure Inc. Derek Pendlebury CPC Mark Sitcoske High Purity New England Janmeet Anant Millipore Sigma Todd Andrews CPC James Barry Pall Biotech John Boehm CPC Stephen Brown BE Vaccines Jeff Carter GE Healthcare Life Sciences Dominic Clarke Charter Medical Ralph Daumke Filtrox Ken Davis Nordson Medical Mike Felo Millipore Sigma Mike Ginsberg Qosina Eric Isberg Entegris Jayanthi Grebin Entegris Eva Heintz Solvay BPSA International Single-Use Summit

6 BPSA 2018 Summit Program Committee, continued Scott Herskovitz Qosina Corp. Charlotte Masy GSK Richard Mirro Eppendorf Hernán Parma American Renolit Mark Petrich Merck & Co., Inc. Joseph St. Laurent Chemic Kirsten Strahlendorf Sanofi Pasteur Mike Tangreti AdvantaPure/NewAge Industries Deanna Whelan Qosina Clive Wingar Thermo Fisher Scientific Hélène Pora Pall Biotech BPSA is always striving for a better Summit experience. Fresh ideas and perspectives are always welcome. Please consider joining the 2019 Summit Program Planning Committee. To Join: Jeanette McCool at mccoolj@socma.com. Kevin, Jeanette and Leslie would like to thank our Summit support team, who year after year bring their very best, so that you can experience the very best: Tommy Southall, graphics designer extraordinaire! Judy Thayer, meeting planner without compare! Caron Turner, our remarkable registration director BPSA International Single-Use Summit

7 PROGRAM SPONSORS BPSA sponsors support BPSA events and sustain BPSA s advocacy of single-use manufacturing technologies. The 8th Annual International Single-Use Summit would not be possible without their generous support. Become a BPSA sponsor by contacting Jeanette McCool at mccoolj@socma.com. PLATINUM SPONSOR GOLD SPONSOR GOLD SPONSOR GOLD SPONSOR GOLD SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR SILVER SPONSOR BPSA International Single-Use Summit

8 2018 BPSA BOARD OF DIRECTORS John Boehm BPSA Chair CPC Jeff Carter, PhD BPSA First Vice-Chair GE Healthcare Life Sciences Mark A. Petrich, PhD, PE BPSA Second Vice-Chair Merck & Co., Inc. Eric Isberg BPSA Treasurer Entegris, Inc. Janmeet Anant, PhD BPSA Secretary Millipore Sigma Charlotte Masy GSK Vaccines Hélène Pora, PhD Pall Biotech Paul Priebe Sartorius Stedim Biotech Joseph St. Laurent Chemic Laboratories, Inc. Kirsten Strahlendorf Sanofi Pasteur Clive Wingar ThermoFisher Scientific Ken Baker AdvantaPure/NewAge Industries Stephen Brown, PhD BE Vaccines Kenneth R. Davis Nordson Medical Eva Heintz, PhD Solvay Specialty Polymers CHAIRMEN EMERITI Kenneth L. Bibbo Jerold Martin Richard Sullivan BPSA International Single-Use Summit connect collaborate succeed the business of single-use

9 AGENDA MONDAY, JULY 9, 2018 Noon 6:00 PM Summit Registration ALCOVE MEETING LEVEL 4:00 6:00 PM BPSA Annual Meeting THE DOUGLASS ROOM All BPSA Members MEETING LEVEL 6:00 7:00 PM Welcome Reception SEASONS MEZZANINE LEVEL The wireless Internet pass code is BPSA18 TUESDAY, JULY 10, :00 AM 5:00 PM Summit Registration CORCORAN BALLROOM FOYER, MEETING LEVEL ALL GENERAL SESSIONS CORCORAN BALLROOM SALON A, MEETING LEVEL 8:00 AM Continental Breakfast CORCORAN BALLROOM MEETING LEVEL 8:30 AM Chairman s Opening Remarks John Boehm, Business Unit Manager, Bioprocessing, CPC, BPSA Chair 9:00 10:00 AM OPENING KEYNOTE INNOVATION MADE EASY Jeff Havens 10:00 10:15 AM BREAK 10:15 11:15 AM Innovation Saves James C. Greenwood, President and CEO, Biotechnology Innovation Organization (BIO) 11:15 AM 12:15 PM NIIMBL: An Industry-Academic-National Laboratory Consortium to Solve Challenges in Biopharmaceutical Manufacturing Christopher Roberts, NIIMBL Associate Institute Director 12:15 1:30 PM NETWORKING LUNCHEON CORCORAN BALLROOM SALON B continues BPSA International Single-Use Summit connect collaborate succeed the business of single-use

10 BPSA 2018 International Single-Use Summit AGENDA, continued 1:30 2:00 PM A Tribute to Ken Bibbo: BPSA Founder & Champion 2:00 5:45 PM AFTERNOON PANELS SUT INNOVATION, REGULATION & COMMERCIALIZATION 2:00 2:45 PM Designing Consumables and Systems to Enable Continuous Processing Moderator: Jessica Frantz, Technology Expert: Aseptic Transfer, Sartorius Stedim Biotech Modernizing the Pharmaceutical Manufacturing Base: The Regulatory Requirements Around Continuous Processing James D. Vogel, Founder & Director, The BioProcess Institute The wireless Internet pass code is BPSA18 Supplier Perspectives on Near-Term Adoption of Continuous Processing in Biopharma Manufacture James Hathcock, Senior Director, Regulatory and Validation, Pall Corporation Paul Priebe, Director, Fluid Management Technologies, Sartorius Stedim Biotech 2:45 3:30 PM Integrity Assurance in Single-Use Systems: Advancing the Implementation of Best Practices Hélène Pora, PhD, Vice President Technical Communication & Regulatory Strategy, Pall Biotech Kirsten Strahlendorf, Senior Scientist, Sanofi Pasteur Integrity Implementation Review and Uptake Direction of Organization Bodies Q&A 3:30 3:45 PM Break 3:45 4:30 PM Education: Traditional and Virtual Excellence-in-Training Regimens for Single-Use Ken Baker, President and CEO, AdvantaPure/NewAge Industries Frank Maggiore, Chief Futurist, Apprentice.io 4:30 5:15 PM The Last Straw? How BPSA Members are Tackling Challenges in Sustainability Mark A. Petrich, PhD, Director SUS Engineering, Merck & Co., Inc. Meredith Daley, Manager, EHS, Productivity, & Sustainability, Thermo Fisher Scientific 5:15 5:45 PM What s On Your Mind? Open Mic Discussions on Current & Future Perspectives Around the Business of Single-Use continues BPSA International Single-Use Summit connect collaborate succeed the business of single-use

11 BPSA 2018 International Single-Use Summit AGENDA, continued 6:30 8:30 PM Evening Reception On The Potomac River MI VIDA RESTAURANT ON THE DISTRICT WHARF (Buses will begin loading at 6:00 PM in front of hotel; buses will return folks to hotel beginning at 8:15 PM) WEDNESDAY, JULY 11, 2018 GENERAL SESSION CORCORAN BALLROOM SALON A, MEETING ROOM LEVEL 8:00 AM Continental Breakfast CORCORAN BALLROOM, MEETING LEVEL The wireless Internet pass code is BPSA18 8:15 8:45 AM Opening Remarks Jeff Carter, PhD, Strategic Projects Leader, GE Healthcare Life Sciences, BPSA Vice Chair 8:45 9:15 AM Gene and Cell Therapy Market Acceleration: How Big, How Soon, How Fast? Eric Langer, President and Managing Partner, BioPlan Associates 9:15 AM 12:45 PM CELL & GENE THERAPY PANEL THE CHALLENGE OF DEFINING, MAPPING AND MEETING THE COMPLEX USER EXPECTATIONS IN THE EMERGING CELL, GENE AND TISSUE THERAPY ARENAS: A DISCOVERY SESSION FOR THE SINGLE-USE INDUSTRY Moderator: Eric Isberg, Director, Life Sciences, Entegris, Inc., Board Sponsor, BPSA Cell & Gene Therapy Committee 9:30 AM 9:40 AM BPSA Process Flow Map Introduction Derek Pendlebury, PhD, Global OEM Sales Manager, CPC 9:40 AM 9:50 AM Extractables & Leachables in Cell & Gene Therapy Equipment Paul Cummings, General Manager, Analytical Services, Smithers Rapra 9:50 AM 10:45 AM Implication of Single-Use Technologies for Viral Vector Manufacturing A CMO Perspective Elie Hanania, PhD, Head of Process Development, Millipore Sigma 10:45 AM 11:00 AM Break and Hotel Checkout Business & Technical Challenges in the Development & Manufacture of Cell Therapies: Partner Perspectives 11:00 AM 11:20 AM International Society of Cell & Gene Cell Therapy, ISCT Ohad Karnieli, PhD, CEO and Co-Founder, ATVIO Biotech Ltd. and Chair, ISCT Process & Product Development Committee continues BPSA International Single-Use Summit

12 BPSA 2018 International Single-Use Summit AGENDA, continued 11:20 AM 11:40 AM The Standards and Coordinating Body, SCB Jiwen Zhang, PhD, Executive Director, Regulatory Affairs, Tmunity Therapeutics Incorporated and President, SCB The wireless Internet pass code is BPSA18 11:40 AM 12:20 PM Production Challenges with Scale-Out of Autologous Cell Therapies Darius Pillsbury, Director of Quality Lifecycle Management, Adaptimmune LLC 12:20 12:50 PM PANEL Q&A 12:50 1:00 PM Wrap Up & Next Steps John Boehm, CPC, BPSA Chair BARCELONA How Single-Use Technologies Drive Innovation SEPTEMBER 26 28, 2018 BARCELONA, SPAIN CROWNE PLAZA HOTEL BPSA International Single-Use Summit

13 SPEAKERS KEN BAKER NEWAGE INDUSTRIES/ADVANTAPURE Ken Baker is the CEO of NewAge Industries, a plastic and rubber tubing and hose manufacturer and RFID tag solutions provider located in Southampton, Pennsylvania. The company originated in 1954 and Ken joined in 1985 as the second generation of his family to carry on its successes. NewAge provides solutions to many Fortune 500 companies and services customers worldwide. Ken has over 25 years of experience in the tubing and hose industry. He is a majority owner of Colex International, NewAge s sister plant in Leicestershire, England. In 2001, Ken led NewAge in the launch of AdvantaPure, the company s high purity tubing and hose division, and has since worked to develop several innovative Single Use disposable solutions. He is a co-inventor on five patents in RFID tagging technology for the company s Verigenics RFID division and is a co-founder in the RFID in Healthcare Consortium. Ken is also a board member of the BPSA Bio-Process System Alliance, an industry trade organization. In 2006, Ken established the company s Employee Stock Ownership Plan (ESOP), and its employees now own 49% of the company. He is a founding member and Chairman of Pennsylvania Center for Employee Ownership (PCEO), a new organization designed to raise awareness and increase the number of employee owned companies in Pennsylvania. In addition, Ken spends time speaking about ESOPs to other CEOs at local and national events. Ken invites area high school students to intern at NewAge Industries each summer and is on the Foundation board of Montgomery County Community College. Ken is also a generous contributor to local and national charities. JOHN BOEHM COLDER PRODUCTS COMPANY John Boehm is responsible for CPC s bioprocessing business. He joined CPC in 2001 and has held leadership positions in engineering, marketing, and business development. John holds a Bachelor of Science in Mechanical Engineering from Grove City College, PA and a Master of Business Administration from the University of St. Thomas in St. Paul, MN. John is presently serving as Chairman of the Bio-Process System Alliance (BPSA). His participation in BPSA has included vice chair, education chair and connector subcommittee chair working on projects including component quality test matrices, technical white papers, educational road shows and the annual International Single-Use Summit. His industry involvement includes authoring and presenting on connection solutions, aseptic processing and implementation of single-use technologies BPSA International Single-Use Summit connect collaborate succeed the business of single-use

14 JEFF CARTER, PHD GE HEALTHCARE LIFE SCIENCES Jeff has been active in organizations such as the Parenteral Drug Association, ASTM E55, BPOG, and ASME-BPE, and is first vice chair of the BioProcess Systems Alliance. His present role within GE is to serve as a voice for evolving regulatory and de facto expectations related to the global implementation of single-use manufacturing. Dr. Carter holds a PhD degree from Penn State University in molecular microbiology. PAUL CUMMINGS SMITHERS RAPRA Paul is the General Manager for the Smithers Rapra Analytical Services laboratory located in Akron, OH. The laboratory specializes in extractables and leachables studies for the medical device, pharmaceutical and food industries along with other analytical laboratory services. Paul s specialty areas of expertise include mass spectrometry with a significant background in small molecule structure elucidation. He also has extensive experience in extractables and leachables and other areas of packaging testing such as container closure integrity. Paul brings over 35 years of experience in chemistry and leadership in the pharmaceutical industry. Paul holds a Bachelor of Science degree in Chemistry from Old Dominion University and a Master of Science Degree in Analytical Organic Chemistry from Villanova University. He also served his country in the United States Army. MEREDITH DALEY THERMO FISHER SCIENTIFIC Meredith Daley started working at Thermo Fisher Scientific in She runs productivity and customer sustainability projects for the Life Sciences Solutions Division of Thermo Fisher Scientific. She is also the Frederick, MD site Environmental, Health, and Safety Manager. Some of her greatest achievements include: launching the Worldwide SeqStudio Cartridge Recycling Program, preparing sites for Zero Waste and OSHA VPP Star Certifications, becoming the only company to win the Maryland Green Registry Leadership Award three times in a row, and leading the lab of the future initiative. Since 2012, she has saved Thermo Fisher Scientific $1.1 Million from implementing productivity sustainability. She completed her Master of Public Health (MPH) in Environmental Health Sciences from the University of Maryland and is certified as a Radiation Safety Officer (RSO) and in RCRA/ DOT. She is passionate about solving the challenging problems that prevent us from implementing cost effective environmental sustainability solutions BPSA International Single-Use Summit

15 JESSICA FRANTZ SARTORIUS STEDIM BIOTECH Jessica Frantz is the current Technology Expert for Sartorius Stedim Biotech s Aseptic Transfer Technologies. In this position she focuses on Single-Use solutions for systems involving the movement of components and fluids into and out of aseptic manufacturing spaces. Prior to this she was the Product Manager for Bosch Packaging Technology s Single-Use Dosing Systems where she specialized in the development, qualification and validation of their disposable dosing technologies. Jessica has also worked as a Project Engineer for Eli Lilly, where she focused on the specification, purchase, installation, qualification & validation of aseptic filling equipment. Jessica received a Bachelor of Science in Chemical Engineering from Rose-Hulman Institute of Technology, assisted in authoring a section of the PDA Single-Use Guidance, has been a Board member and is a current active member of the BPSA and is an active member of ISPE. JAMES C. GREENWOOD BIOTECHNOLOGY INNOVATION ORGANIZATION James C. Greenwood is President and CEO of the Biotechnology Innovation Organization (BIO) in Washington, D.C. BIO represents 1,000 biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 countries worldwide. BIO members are involved in the research and development of innovative healthcare, agricultural, and industrial & environmental biotechnology products. BIO also produces the annual BIO International Convention, the world s largest annual gathering of the biotechnology industry, as well as other major investor and business conferences across the world. Greenwood represented Pennsylvania s Eighth District in the U.S. House of Representatives from 1993 to During his time in Congress, he was a senior member of the Energy and Commerce Committee and widely viewed as a leader on health care and the environment. He crafted legislation to reform the Food and Drug Administration, and he led the fight in Congress to allow stem-cell research to be conducted by U.S. scientists to treat disease. Mr. Greenwood is married with three children and resides in Upper Makefield, Pennsylvania BPSA International Single-Use Summit connect collaborate succeed the business of single-use

16 ELIE HANANIA, PHD MILLIPORE SIGMA Elie Hanania, PhD, Head of Process Development at Millipore Sigma (Carlsbad, California) has a PhD in Cell and Molecular Biology from the University of Texas Medical Branch. Following a Postdoctoral Fellowship at M.D. Anderson Cancer Center in Houston, Texas working on breast and ovarian cancer gene therapy application, Elie joined SyStemix A Novartis Company in Palo Alto, California where he developed state-of-the art assays for minimal residual diseases related to stem cell transplants. As the Associate Director at Cyntellect in San Diego, California, Elie managed the research and clinical applications for the Company s laser ablation device (LEAP). In his role as Manager, Process Development at Progenitor Cell Therapy global cell therapy CDMO service platform of Hitachi Chemical Advanced Therapeutics Solutions, LLC in Mountain View, California, he focused on T-cell clinical application in conjunction with gene therapy. At Millipore Sigma Carlsbad, Elie manages a productive team of Principal and Senior Scientists and works with crossfunctional groups in the area of viral vector production/purification for gene therapy and vaccines applications. Elie has extensive laboratory experience in academic, clinical and industry set ups, in areas of molecular and cell biology, virology, mammalian cell lines, primary and stem cells, device validation, process development, Tech transfer, process characterization, animal models and assay development with implementation of up-to-date enabling technologies. JAMES HATHCOCK PALL BIOTECH Dr. James Hathcock is Senior Director of The Regulatory and Validation Consulting Team at Pall BioTech, which includes responsibility for the extractables and leachables characterization strategy to support the safe and successful end-user implementation of technologies enabling pharmaceutical manufacturing. He is an active member of ASTM, PDA, ISPE, and BPSA as well USP <665> panel volunteer. Since joining Pall in 2008, James has led chemical and performance characterization of Medical and BioTech components, as well as relevant technical packages supporting regulatory filings. Prior to joining Pall, James was a professor of hematology at the Mt. Sinai School of Medicine in New York City, where he served as director of the protein purification core laboratory BPSA International Single-Use Summit

17 JEFF HAVENS HUMOROUS CORPORATE SPEAKER AND COMEDIC AUTHOR Over the past decade, Jeff Havens has become one of the most in-demand presenters in North America. His truly unprecedented ability to deliver high quality, extensivelyresearched Education in an undeniably entertaining way has earned him dozens of repeat clients, all of whom appreciate Jeff s insistence that we ll all improve better and faster if we actually enjoy the learning process. By combining the content of the traditional presentation with the entertainment value of a comedy show, Jeff has found enthusiastic audiences in government, academia, small businesses and several Fortune 50 companies, all while still (somehow) being one of the youngest members of the professional speaking circuit. Jeff firmly believes that making learning fun is the quickest, cheapest, and most effective way to create a culture where people are eager to continually improve. Whether you want to improve your leadership or inspire more innovation, communicate more effectively or eliminate generational tensions if it s important to you, Jeff will make it fun. ERIC ISBERG ENTEGRIS, INC. Eric Isberg is the Director of Life Sciences at Entegris, Inc., a provider of high-purity components for the biopharmaceutical industry. He has over 25 years of experience in bioprocessing and aseptic processing, working for both end-users and suppliers in the biopharma industry, with a particular focus on the increased use and implementation of single-use systems. His career includes 13 years in biopharmaceutical manufacturing, technical services and validation at Protein Design Labs and Biogen Idec where he led the design and implementation of single use storage and mixing systems for use in commercial manufacturing. He also has 12 years in product management and marketing of single use systems at Bosch, Thermo Fisher, and ATMI/Pall. In his current role at Entegris, he leads the Life Science business unit and single use product portfolio. He is a frequent writer and lecturer on the subjects of single use systems and advanced aseptic processing. Eric is a BPSA Board Member and sponsor of the BPSA Cell and Gene Therapy Committee, a member of the BPSA Marketing Committee, the BPOG/ BPSA Supplier Change Notification team, the BPSA Particulates Working Group and past member of the PDA Single-Use Systems Task Force and contributor to TR 66. Eric earned his degree in Biology from Gustavus Adolphus College BPSA International Single-Use Summit connect collaborate succeed the business of single-use

18 OHAD KARNIELI, PHD ATVIO BIOTECH LTD Dr. Karnieli earned his PhD in Biotechnology focusing on Cell & Gene Therapy from the Sacler school of Medicine at Tel Aviv University and an MBA from the Haifa University school of management. Dr. Karnieli served in several executive rolls in the field of cell therapy and medical devices with his last position being the VP of Technology & Manufacturing at Pluristem Therapeutics. A well-known expert in the field of cell therapy process development and serves on several industry committees including chairing of the process & product development committee of the International Society for Cell Therapy and an expert member in the ISO TC276 Bioprocessing committee. Dr. Karnieli is the founder of Karnieli Ltd and ADVA Biotechnology. ERIC LANGER BIOPLAN ASSOCIATES Eric Langer has over 20 years experience in biotechnology and life sciences international marketing, strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published, edited and authored numerous books, reports, and major studies on topics including Advances in Biopharmaceutical Technology in China, Advances in Large-scale BioManufacturing, etc. He lectures on pricing and channel management, and teaches at Johns Hopkins University and American University: Biotech Marketing, Services Marketing, and Marketing in a Regulated Environment. He has launched and managed marketing programs for product lines ranging from $500k to $500 million. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, assessment and marketing strategies to biotech and healthcare organizations. FRANK MAGGIORE APPRENTICE.IO Frank Maggiore is the Chief Futurist and VP of Customer Accounts at Apprentice.io, a company which specializes in Augmented Reality and Smart Glasses technologies for regulated industries like Biopharma. He has more than 20 years experience in biopharma and more than 14 years experience in Augmented Reality. He is the inventor with patents in a number of technologies for AR as well as for single use technologies including Singleuse biological 3D printing, an over-pressurization preventer for single-use containers, tactile buttons input integrated with single-use products, and single-use enclosures for manufacturing BPSA International Single-Use Summit

19 JEANETTE MCCOOL ROQOPS Jeanette McCool is the principal partner of RoqOPS, an event and operations management firm based in Silver Spring, MD. McCool is also employed by Ott Consulting, LLC, assisting with the firm s various projects and clients, including BPSA. McCool s varied career experience includes owner of a professional men s basketball team, paralegal and law office manager, and seventeen years at the National Association of Manufacturers, serving as Vice President, Meeting Management and Assistant Corporate Secretary. McCool is a native of Washington, D.C. and a product of its Catholic schools, Immaculata Preparatory School for Young Women and Georgetown University. KEVIN OTT OTT CONSULTING, LLC Kevin Ott is the principal partner of Ott Consulting, LLC, based in McLean, Va. Ott serves as Executive Director of the Bio-Process Systems Alliance (BPSA), a national corporate trade association comprised of the producers and users of disposable plasticsbased bio-process manufacturing platforms used in drug therapy production. BPSA is an independent affiliate of the Society of Chemical Manufacturers and Affiliates (SOCMA) based in Washington, D.C. Ott spent twelve years as Group Vice President of the Elastomers Product Division of the Rubber Manufacturers Association, and another seven years as an offshore oil and gas leasing advocate for the National Association of Manufacturers in their Environment and Natural Resources Division. Ott is a native of Washington, D.C. He is a graduate of the University of Virginia with a degree in Environmental Sciences BPSA International Single-Use Summit connect collaborate succeed the business of single-use

20 DEREK PENDLEBURY, PHD COLDER PRODUCTS COMPANY Derek has a masters from Leeds University and a doctorate from Manchester University, both in the UK, in the field of the development of novel technologies for the prevention of marine fouling. Derek taught at the University of London for 4 years before moving into the supply side of the Biopharmaceutical industry in Where he held positions at Sartorius in sales, marketing, product and sales management before moving to the US in 1993 as Director of Sales and Marketing for Sartorius NA. In 1997 he joined Biopath Inc. as co-owner and VP of Microbiology Contract services. Following the sale of Biopath in 2001 Derek has held multiple executive positions with Pall Corporation, Charter Medical Ltd, ATMI Life Sciences, 3M Purification, Agilent Technologies and joined Colder Products in November 2016 as manager of the Global Bio-OEM Sales operation. Derek has authored multiple papers and presented at many conferences on the use and application for single use technologies in the purification of biomolecules and is a member of PDA, ISPE, AMA and is affiliated through company membership with BPOG and BPSE. MARK A. PETRICH, PHD MERCK & CO., INC. Mark A. Petrich is Director Single Use Systems Engineering at Merck & Co. Inc., and serves as second vice chair of the Bio-Process Systems Alliance (BPSA). Mark s team is responsible for developing best practices for deploying single use technologies in vaccine and biologics manufacturing. His activities in BPSA have included End User Committee chair, initiation of the Sustainability Committee, co-authorship of the BPSA white papers on particles, quality agreement template, and integrity, and participation on the organizing committees for several Summits. Mark has been a panelist and speaker at several Summits including delivering the keynote address at the 2016 European Summit (Barcelona). BioProcess International selected Mark for their 2016 Industry Champion award BPSA International Single-Use Summit

21 DARIUS PILLSBURY ADAPTIMMUNE Darius Pillsbury currently works at Adaptimmune, a T-cell therapy company based in the UK and Philadelphia. Darius is the head of the Quality Lifecycle Management team with focus in Quality Risk Management and the implementation of a product and process lifecycle approach. He has worked in the biotechnology industry for 19 years in the areas of Process Development, Manufacturing Science, and Quality. Prior to Adaptimmune he worked for the rare disease company, Ultragenyx, and at ImClone Systems and Eli Lilly in the Manufacturing Science and Technology department, where he worked on the successful commercialization of multiple drug products. Darius is a graduate of Tufts University with a BS in Chemical Engineering. Darius recently began to collaborate with the BPSA as part of the Cell and Gene Therapy working group. LESLIE PIZARRO BPSA Leslie Pizarro is the Associate Director of Member Engagement and Digital Experience with BPSA, joining the association in March of Her previous experience includes over 5 years at The Advisory Board Company (Optum) in a number of positions focused on digital marketing and website design and strategy. Leslie is a native of the Washington, D.C. area. She graduated from James Madison University with a degree in Media Arts and Design and a minor in Writing and Rhetoric. HÉLÈNE PORA, PHD PALL BIOTECH Dr Hélène Pora is Vice President Technical Communication & Regulatory Strategy within Pall Biotech. Hélène has been instrumental in the development of Pall single use technologies for the last 20 years. She is heavily involved in quality and regulatory aspects of single use technology. Hélène has over 30 years of experience working for the biopharmaceutical industry, the last 27 years within Pall Corporation. She speaks regularly at conferences about single-use technology with a strong focus on validation and over all process integration aspects, she is as well involved in different working groups in the industry involved in standards development and is a member of the BPSA Board BPSA International Single-Use Summit connect collaborate succeed the business of single-use

22 PAUL PRIEBE SARTORIUS STEDIM BIOTECH Mr. Priebe has almost 20 years of experience in process filtration and single use technologies in the biopharmaceutical industry. Through his career, he has held positions in manufacturing, engineering, sales, product management, marketing and marketing management. Mr. Priebe joined Sartorius in 2002 as a Product Manager for Sterilizing Grade Filtration Products. From 2004 to 2007, he was Head of Product Management for Process Filtration and Disposable Technology. Today he is the Director of Fluid Management Technologies for Sartorius Stedim Biotech, with responsibility for all single use fluid handling technologies in the Americas. Mr. Priebe was a contributing author of PDA Technical Report 66, Application of Single Use Systems in Pharmaceutical Manufacturing and is a published author on the subjects of membrane filtration selection, sterile filtration, single use technology and the biopharmaceutical industry. He is a board member of the BioProcess Systems Alliance (BPSA) and an active member of the PDA, ASME BPE & ASTM E55. CHRIS ROBERTS UNIVERSITY OF DELAWARE Dr. Roberts is a Professor in the Department of Chemical and Biomolecular Engineering at the University of Delaware (UD). He is the Associate Director for the National Institute for Innovation in Manufacturing of Biopharmaceuticals (NIIMBL), and the Director of an industry-university research consortium (the Biomolecular Interaction Technology Center, BITC). He received a Bachelors of Chemical Engineering degree from UD, and a PhD in Chemical Engineering from Princeton University. Prior to joining UD in 2002, he worked in the pharmaceutical industry as a formulation scientist for protein and small-molecule based drugs. The Roberts laboratory focuses on fundamentals and applications of protein physical and chemical stability, (mis)folding, aggregation, statistical mechanics, molecular modeling, and kinetics and thermodynamics to address questions of biopharmaceutical product design, stability, and manufacturing BPSA International Single-Use Summit

23 KIRSTEN STRAHLENDORF SANOFI PASTEUR For the last 13 years, Kirsten Strahlendorf has been working as a Senior Scientist in Research and Development at Sanofi Pasteur in Toronto. She holds a Professional Engineering license, an honours degree in Biological Engineering from the University of Guelph, and a Master s of Engineering from the University of Toronto. Kirsten takes a seat on the Board of Directors for the Bio-Process Systems Alliance. A driver in the bioprocessing community, she has published several journal articles. Kirsten manages a bioprocess design and scale-up laboratory for vaccine formulations. Her focus lies in automation and isolation systems for novel biotechnology products decades away from being marketed. In her personal life, Kirsten enjoys her three small children who understand that their mother makes needles with medicine for work. JAMES DEAN VOGEL, PE THE BIOPROCESS INSTITUTE James Dean Vogel, PE, is the Founder and Director of The BioProcess Institute (BPI). He has more than 35 years of experience in the biopharmaceutical, food and cosmetic industries including expertise in facility design, operations management, fit-for-use testing, performance and exposure testing, bioprocess engineering and biopharmaceutical manufacturing. He currently serves as Director of The University of Rhode Island s College of Pharmacy s GMP facility and as the leader of its Introduction to Biopharmaceutical Manufacturing program. Jim s consulting expertise lies in all areas and all levels of engineering, management, cgmp, and single-use applications. He also facilitated Single- Use News Letters, a free collaborative online resource for information and updates on the exploding role of Single-Use Technologies in the world of bioprocess science. Jim is a licensed professional engineer in NJ, has a Masters of Engineering in Chemical Engineering from Manhattan College and a Bachelor s of Science in Biochemical Engineering from Rutgers University. When Mr. Vogel is not at The BioProcess Institute, he stays busy with his family in Rhode Island, plays tennis, races his bicycle, and tries to sail BPSA International Single-Use Summit connect collaborate succeed the business of single-use

24 JIWEN ZHANG, PHD TMUNITY THERAPEUTICS, INC. Dr. Jiwen Zhang heads the regulatory affairs group at Tmunity Therapeutics, Inc. Before joining Tmunity, she had worked at GE Healthcare and biopharmaceutical companies including Johnson & Johnson, Merck, Wyeth Pharmaceuticals, and Sanofi-Aventis. Dr. Zhang is currently leading various industry initiatives through the International Standards Organization (ISO), Alliance for Regenerative Medicine, and Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee (APEC RHSC). Dr. Zhang obtained her Bachelor of Science degree in Biology from University of Science and Technology of China and her PhD in Neuroscience from the joint program at Rutgers University and University of Medicine and Dentistry of New Jersey BPSA International Single-Use Summit

25 Evening Reception on the Potomac River Buses will begin loading at 6:00 PM in front of hotel; buses will return folks to hotel beginning at 8:15 PM. 98 DISTRICT SQUARE SW WASHINGTON, D.C.

26 BPSA MEMBERS THE LIFE SCIENCES DIVISION OF ALPHA ANALYTICAL, INC. ErtelAlsop The First Name in Liquid Filtration

27 BPSA MEMBERS DoverPac containment solutions ULTRASONIC SOLUTIONS

28 BPSA MEMBERS BPSA MISSION TO FACILITATE, GLOBALLY, THE DEVELOPMENT AND MANUFACTURING OF BIOPHARMACEUTICALS THROUGH THE IMPLEMENTATION OF ROBUST, SAFE AND SUSTAINABLE SINGLE-USE TECHNOLOGIES. The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines. For more information, please visit or contact Kevin Ott, Executive Director, at