Program Partner: OMPI
Audiovisual Sponsor: CMC Biologics
Beverage Break Sponsor: BioVectra Inc.
Networking Reception Sponsor: Boehringer Ingelheim
DCAT members have the option to register for the networking reception only, click here.
With increased product development in biologics, pharmaceutical and biopharmaceutical companies and suppliers face crucial questions in their biomanufacturing strategies for drug substances.
Biopharmaceutical executives share how their companies are resolving these issues in the near and long term. Get the answers to these questions from leading industry experts who will examine the following:
Biopharmaceutical Market Overview: The latest developments of the biologics market, including current and projected product performance, including global growth rates with market estimates by molecular type and geography. Plus a review of the top-selling biologics and pipeline candidates for innovator drugs and biosimilars.
Susan Dexter, Managing Director, Latham BioPharm Group
Biomanufacturing 2027: A Vision for the Future
Will the biomanufacturing systems of today suit the needs of the future? In the pharmaceutical industry, 10 years is a “short” future due to the length of time required to bring a product from discovery to commercialization. Multiple years are needed to build and validate a new manufacturing facility, and more than 20 years is needed to fully depreciate a drug substance biomanufacturing site. One biopharmaceutical executive shares his perspective of biomanufacturing of today and of the future in terms of technology, scale, facility type, and equipment.
Roberto Silveira, Vice President, Biomanufacturing Sciences Group, Pfizer
Biomanufacturing Investment: The Hows, Whys, and Whats
Learn from one leading biopharmaceutical executive of the decision criteria used for its biomanufacturing investment to meet demand for current and near-term needs.
Stephen Hill, Vice President & General Manager, AstraZeneca
Biomanufacturing for Niche Products
Emerging pharmaceuticals, such as chimeric antigen receptor T cell (CAR T) therapies, offer promise for delivering targeted therapies in keeping with the promise of personalized medicines, but do the production economics work? Learn from one biopharmaceutical company of its biomanufacturing strategy for CAR T therapies.
Tim Moore, Executive Vice President, Technical Operations, Kite Pharma
Attendees should pre-register and pre-pay for DCAT Week programs and events before March 15, 2017 (5pm ET). Confirmations and receipts will be emailed to registrants when payment is received.
Member Badges: On or about Thursday, March 16, 2017, DCAT members will receive an email with an e-ticket attachment confirming all of their pre-registrations for DCAT Week. Attendees should print the e-ticket (or store it on their phone) and bring it with them to DCAT Week. The QR code on the ticket can be used to quickly print a member badge or to scan attendees into all of the programs and events they have pre-registered for throughout the week. A separate badge system will be used for non-member registrants.
Badge Pickup Locations during DCAT Week:
Walk-ins are welcome if space permits. All walk-ins must pay with a credit card or check. Walk-ins cannot be invoiced.
Speaker bios have been requested from presenters and will be posted here as they are received.
Susan Dexter is a Managing Director at the consulting company of Latham Biopharm Group. She has more than 30 years of experience in CMC (chemistry, manufacturing, and control) aspects of drug development and business development in the biotechnology industry. Ms. Dexter worked as a scientist doing research in cell culture, animal models and small-scale manufacturing before moving into the business of science for contract manufacturing and CMC- related services. As chief business officer at Xcellerex (now part of GE Healthcare), Susan was involved in the development and commercialization of new and disruptive single-use technologies for bioprocessing. She has held executive management roles at contract manufacturers, including Collaborative BioAlliance and Dow Chemical’s Biopharmaceutical Services, and as Associate Director at Lonza Biologics. She currently serves on the Board of Directors for Sartorius Stedim Biotech, a vendor/supplier of bioprocessing technologies. Since joining Latham Biopharm Group as a consultant, Susan has provided strategic business consulting fostered through market research, interim executive management positions for multiple CMOs, including Hospira, Laureate Pharma (now part of Patheon) and Kalon Biotherapeutics (now part of FujiFilm Diosynth), primarily engaged in supporting CMC related business activities in biomanufacturing for biotherapeutics and cell-based vaccines. At Latham Biopharm Group, Ms. Dexter also supports government contract activities related to pandemic responsiveness.
Stephen Hill is Vice President Operations, Site Head at the AstraZeneca Frederick Manufacturing Center. The Frederick Manufacturing Center is the largest biologics manufacturing facility within the company’s global network and a worldwide industry leader in cell culture manufacturing. The center is an FDA licensed, large-scale cell culture production facility, with more than 500,000 square feet of administrative, production, warehouse, laboratory and utility space.
He also served prior roles as Executive Director, Manufacturing Technologies leading manufacturing global networks and as Executive Director, Plant Manager leading clinical drug substance operations. In his corporate role he led manufacturing of the future, operations strategy, high reliability performance and manufacturing global network initiatives. In his plant manager role he was an effective change agent driving productivity improvement while increasing output to deliver multiple pipeline new product introductions annually.
Mr. Hill joined Amgen from ICOS Corporation where he executed GMP clinical plant start-up and led manufacturing, ultimately transitioning the operation into a contract manufacturing business. He started his career at Immunex Corporation as an operator manufacturing Enbrel.
He holds a Master in Business Administration (MBA) and Bachelor's in Microbiology (BS) and Political Science (BA) from the University of Washington.
Tim Moore is Executive Vice President, Technical Operations, Kite Pharma. He has more than three decades of leadership experience in biopharmaceutical manufacturing and operations. Prior to joining Kite Pharma, he most recently served as Senior Vice President, Head of Global Technical Operations, Biologics at Genentech, Inc. and was a member of the Genentech Executive Committee beginning in 2010. In this role, Mr. Moore oversaw global leadership for more than 7,500 professionals across 10 internal sites and more than 37 contract manufacturing organizations as well as global manufacturing and end-to-end quality supply performance of more than 20 biological product families.
Prior to that, Mr. Moore was Genentech’s Senior Vice President, Global Supply Chain and Global Engineering from 2007 to 2010. Previously, Mr. Moore served as Vice President, Operations at ZLB Behring (formerly Aventis Behring). He is currently a member of the International Society for Pharmaceutical Engineering (ISPE) and the Parenteral Drug Association (PDA) and has been a part of the Executive Committee of BioPhorum and the Manufacturing Leadership Council. Mr. Moore received a B.S. in Chemical Engineering from Tulsa University and a M.S. in Engineering Management from Northwestern University.
Roberto Silveira is Vice President, Bio-Manufacturing Sciences Group at Pfizer where he is responsible for MSAT (Manufacturing Science & Technology) for Biological Products from the drug substance to the final formulation and filling in Pfizer Global Manufacturing for Bios. A position that he has held since 2009. In addition he is responsible for the technical support for aseptic operation.Previously, Mr. Silveira moved through various assignments related to bioprocessing support, including Sr. Director/Team Leader of Bio-process Support responsible for bios drug substance, new product introduction and marketed product support. After joining Pfizer in 1989 at the Pfizer Guarulhos Site in Brazil as production supervisor in the API plant, he held positions of increasing responsibilities in the fermentation facility and in 1994 moved to Pfizer in New York as DS Manager for Asia/South America.Mr. Silveira earned a B.Sc. in Chemical Engineering from Sao Paulo University in Brazil, and a Ph.D. in Fermentation Technology from Hiroshima University in Japan.
Following the presentations, attendees are invited to a Networking Reception in the Grand Ballroom in the InterContinental from 4:30 to 6:00 pm.
InterContinental Barclay (Grand Ballroom)
111 East 48th Street
New York, New York 10017
Map & Directions
To cancel your program registration and receive a refund, you must call the DCAT office by March 15, 2017 (5pm ET) at +1-800-640-3228.
Refunds with receptions may be subject to a processing fee due to hotel guarantees.
The DCAT organization regrets that no refunds can be given after March 15, 2017 (5pm ET).
Registration payments made by credit card will be refunded within two to three business days from the date of cancellation.
Registration payments made by check will be refunded within 20 days of the program date.
Education program topics for DCAT Week are selected and developed by members of DCAT's Education Committee and other volunteer task forces of the organization. Speakers are selected based on their expertise and/or experience related to these topics, their ability to impart important information and concepts, and their willingness to do so without promoting specific business interests. By advance meetings with speakers, reviewing materials and slide presentations, DCAT volunteers make every effort to ensure that each program is a relevant, value-added experience for our members.
The Drug, Chemical & Associated Technologies Association (DCAT) is a not-for-profit, global business development association whose unique membership model integrates both innovator and generic drug manufacturers and suppliers of ingredients, development and manufacturing services, and related technologies. We are committed to provide programs, events and services that help our members meet their business objectives, expand their network of customers and suppliers, and gain insight into industry trends, markets, and those issues impacting pharmaceutical development and manufacturing.