Massachusetts Biomanufacturing Roundtable Update

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1 Massachusetts Biomanufacturing Roundtable Update Mass Biotech Council December 7, 2011 Elisabeth Reynolds Executive Director, MIT IPC

2 2 Mission of the MA Biomanufacturing Roundtable To Support and Promote the Retention and Growth of Biomanufacturing in Massachusetts by: Engaging companies that represent a broad spectrum of biomanufacturing Small and large molecule; start ups and more mature; product and CMO companies; device companies, vendors All stages of the life cycle, from clinical to commercial Promoting innovation in biomanufacturing as well as in other emerging bio-related industries Identifying gaps in the marketplace and in the region for particular aspects of manufacturing (contract analytical development, drug product manufacturing) where Massachusetts could compete, as well as in critical inputs such as education, training, supply chains, and manufacturing capacity Leveraging the resources in the region from industry, academia and the nonprofit/public sectors to address priorities set by the roundtable MLSC took over from the MTC as official sponsor of the Roundtable as of July, 2011

innovation in biomanufacturing as well as in other emerging bio-related industries Identifying gaps in the marketplace and in the region for particular aspects of manufacturing (contract analytical

3 Biomanufacturing Capacity Worldwide Online and Projected, ( 000 Liters) Capacity by continent (thousand litres) 1,600 1,400 1,200 1, Global Mammalian Manufacturing Volume 3,500 3,000 2,500 2,000 1,500 1, Global capacity (thousand litres) Year Europe North America Asia Total Includes only GMP-approved facilities and mammalian cell culture fed-batch and perfusion processes; Includes those facilities that are in planning, construction or validation phases through Analysis: Elisabeth Reynolds, MIT Industrial Performance Center; Data from Bioprocess Technology Consultants

2013 Year Europe North America Asia Total Includes only GMP-approved facilities and mammalian cell culture fed-batch and perfusion processes; Includes those facilities

4 Includes only GMP-approved facilities and mammalian cell culture fed-batch and perfusion processes; Includes those facilities that are in planning, construction or validation phases through Analysis: Elisabeth Reynolds, MIT Industrial Performance Center; Data from Bioprocess Technology Consultants

construction or validation phases through 2013.

5 Recent Reductions in Manufacturing Capacity Year 2009 Location of Facility Change in Volume (thousand liters) Change in plans/decommi ssion Company Roche/Gene ntech Vacaville, CA 200, Novartis Singapore 120, Roche Penzberg, Germany 75,000 Eli Lilly/Imclon Branchburg, 2010 e NJ 30,000 Likely Reemergence 2010 Genmab Brooklyn, MN 22, Amgen Fremont, CA 12, Roche Nutley, NJ 12, Pfizer Shanbally, Ireland 10,000 Source: Company announcements, MIT IPC research.

Germany 75,000 Eli Lilly/Imclon Branchburg, 2010 e NJ 30,000 Likely Reemergence 2010 Genmab Brooklyn, MN 22,000 2011 Amgen

6 Industry Trends and Regional Impact Global Capacity Excess capacity for large-scale production; not necessarily small scale Consolidation and mothballing/resale of facilities Regional Impact: Fewer companies engaged in significant expansions; smaller, more niche production; demand for more educated workforce Contract Manufacturing Increased use of CMOs at all stages; New entrants in Asia (Samsung, Fujifilm) Regional Impact: Growth opportunity for the region in innovative cmos Regulatory Decrease in inspections; increase in recalls Increased focus on compliance and enforcement Regional Impact: More hurdles for smaller companies Emerging Technologies Significant innovation taking place in the industry in both drug substance and drug product (delivery) Regional Impact: Opportunity for the region to be a world leader in new technologies/platforms 6

(Samsung, Fujifilm) Regional Impact: Growth opportunity for the region in innovative cmos Regulatory Decrease in inspections; increase in recalls Increased focus on compliance and enforcement

7 Current Roundtable Strategic Priorities 1) Enhance the Regional Capabilities and Innovation Ecosystem Drug Product/Delivery Systems Company-to-Company Exchange (common validation techniques) Emerging Products and Technologies: Regional Strengths and Opportunities 2) Improve Human Capital/ Talent in the Region Community college internships/ co-ops 3) Expand Bio-Related Networks Combination products/medical devices Biofuels Industrial biotech (particularly food industry) 4) Improve Communication Within and Outside the Region University/Industry R&D Network Website; directory BIO 2012 in Boston Other (newsletters, conference, etc) 5) Create a Supportive Policy Environment State tax incentives (MLSC tax credits, other) 7

Bio-Related Networks Combination products/medical devices Biofuels Industrial biotech (particularly food industry) 4) Improve Communication Within and Outside the Region

8 Preliminary Overview: Emerging Products and Technologies Emerging Products Biodefense Biofuels Biosimilars Cell therapies (including stem cells) Conjugated Therapies Combination (fixed dose) Therapies Industrial Enzymes Molecular Diagnostics Nucleic Acid (RNAi, other) Non-mAb proteins Regenerative/Tissue engineering Recombinant Vaccines Emerging Technologies Drugs Culture/Fermentation Parallel microreactors for process optimization Single use cell culture/fermentation Single use purification Media improvement Ozone sterilization Production organisms: yeast, plant, insect Continuous production Process tomography and intelligent process control Advanced colloidal and foam systems Purification Simulated moving bed purification Instrumentation: protein characterization (folding, glycosylation, other) continuous production monitoring Production Processes for New Product Types Tissue engineering Recombinant vaccines Autologous (per patient) cell therapy production Drug Product Nano-pills Nano encapsulation, lipo-capsules Stability: Lypholization improvement or replacement Adjuvants enabling oral biologics

Parallel microreactors for process optimization Single use cell culture/fermentation Single use purification Media improvement Ozone sterilization Production organisms: yeast, plant, insect

9 Emerging Products/Massachusetts Participants Emerging Bio-Product Type Manufacturer University Technology Providers Classic Biologics (mabs) Multiple per IPC analysis UMass, MBL, WPI, MIT Multiple Biodefense Pfenex MIT, BU, Tufts Vet? Xcellerex Biofuels Agrivida, Joule, Mascoma, Qteros UMass Amherst, MIT Biosimilars Cell therapies (including stem cells) Arteriocyte, Boston Biomedical, Targeted Cell Therapies, UMass Stem Cell Bank, Viacell/PE Harvard, MIT, UMass, Tufts Neostem Conjugated Therapies Acceleron, Alkermes, Amgen, AZ, BiogenIdec, Boston BioCom, Celldex, Immunogen, EMD Serono, Pfizer, Repligen, Sanofi, Takeda Combination (fixed dose) Therapies Industrial Enzymes & biodegradable mmetabolics UMass Amherst, MIT Diagnostics for All, New England BioLabs, Molecular Diagnostics Perkin Elmer, ThermoFisher, Novartis, T2 Biosystems MIT Nano-Particle T2 Biosystems, Nucleic Acid (RNAi, other) UMass, Harvard, MIT, BU, Alnylam, Rxi, Avecia, ModeRNA Clark, Tufts, Non-mAb proteins Regenerative/Tissue engineering Recombinant Vaccines 12/16/2011 Alexion, Alkermes, BiogenIdec, Boston Biomedical, Curis, CytRx, Dyaz, Eisai, Eleven Biotherapeutics, EpiVax, IPSEN, Merck, EMD Serono, Novartis, OPK Biotech, Genzyme, Organogenesis, Pfizer, Stryker Alnylam, Biogen Idec, Boston BioComm, Celldex, CytRx, EpiVax, Genocea, EMD Serono, Novartis, Pfizer, Repligen, Sanofi Brown, BU, Harvard, MIT, UMass Amherst, UMass Dartmouth, UMass Med School,Tufts Harvard Bioscience, Organogenesis Biomanufacturing Roundtable:

Xcellerex Biofuels Agrivida, Joule, Mascoma, Qteros UMass Amherst, MIT Biosimilars Cell therapies (including stem cells) Arteriocyte, Boston Biomedical, Targeted Cell Therapies, UMass Stem Cell Bank,

10 Next Steps Finish survey of firms (November) Communications Working Group Meeting (November 9 th) Members: Dale Blank (Consultant, former Wyeth), Mickey Koplove (Pfizer, Retired), Karin Maag (Lonza), Andrew McQuilken (MLSC), Gina Nugent (Consultant), Paul Vigeant (U Mass Dartmouth) Emerging Technologies Working Group (November 30) Mark Bamforth (Gallus Biopharma), Parrish Galligher (Xcellerex), Sudha Kadiyala (ATRM),Mickey Koplove (Pfizer, Retired) Bob Steininger (Acceleron) Mark Trusheim (Consultant, Co-Bio), John Ward (Joule) Next Roundtable Meeting, Friday, December 12, 3-5pm Agenda: Communications Strategy, Emerging Technologies Strategy 10

(November 30) Mark Bamforth (Gallus Biopharma), Parrish Galligher (Xcellerex), Sudha Kadiyala (ATRM),Mickey Koplove (Pfizer, Retired) Bob Steininger (Acceleron)

11 APPENDIX 11

12 MA Biomanufacturing Roundtable Members 10/2011 First Last Title Company INDUSTRY Bill Aitchison Head, Global Manufacturing Genzyme Mark Bamforth CEO Gallus Biopharmaceuticals Andrew Bulpin, Ph.D. Vice President, EMD Millipore Abbie Celniker CEO Eleven Biotherapeutics William Ciambrone Senior VP, Technical Operations Shire Mike Cicio VP Operations and Site Manager Lonza Mario DiPaola Chief Scientific/Operating Officer and Co-founder Bluestream Parrish Galliher Founder, President and CTO Xcellerex Sudha Kadiyala Sr. Director, Business Development & Strategic Planning Advanced Technologies and Regenerative Medicine (ATRM) Fazal Khan Vice President of Manufacturing Merrimack Pharmaceuticals Mickey Koplove, Ph.D., Co-chair VP, Biotech Manufacturing Pfizer (Retired) Ralph Lambalot Divisional Vice President, Biologics Development and Manufacturing Launch Abbott Bioresearch Center Howard Levine Founder and President BioProcess Technology Consultants 12

Vice President, EMD Millipore Abbie Celniker CEO Eleven Biotherapeutics William Ciambrone Senior VP, Technical Operations Shire Mike Cicio VP Operations and Site Manager Lonza Mario DiPaola Chief

13 MA Biomanufacturing Roundtable Members Industry (cont.) and Academic First Last Title Company Ray Lockard Associate Director, QA Alnylam Pharmaceuticals Gregory MacMichael, Ph.D. Global head of Biologics Process Research and Development VP Research, Development and Dan McCormick Engineering Novartis Pharma AG Waters John Nystrom VP, Pharmaceutical Operations Takeda Ron Peeples Vice President, Pharmaceutical Development Pfizer Bob Steininger, Co-chair Senior VP, Manufacturing (co-chair) Acceleron Pharma John Ward, Co-chair SVP, Production Joule Unlimited ACADEMIA Charles Cooney Professor, Faculty Director Chemical Engineering, Deshpande Center for Technological Innovation Stephen Flavin Associate Provost and Dean Worcester Polytechnic Institute Barry Karger Director Barnett Institute, Northeastern Carl Lawton Director Jean Poteete Senior Planner Liz Reynolds Executive Director Massachusetts Biomanufacturing Center, UMass Lowell Tufts University Cummings School of Veterinary Medicine MIT Industrial Performance Center/MLSC 13

Global head of Biologics Process Research and Development VP Research, Development and Dan McCormick Engineering Novartis Pharma AG Waters John Nystrom VP, Pharmaceutical Operations Takeda Ron

14 MA Biomanufacturing Roundtable Members Non-Profit/Government/Other NON PROFIT/GOVERNMENT/OTHER Peter Abair Director, Economic Development MassBio Dale Blank Consultant William Jacobsen Principle Jacobsen Consulting Services Doyle Johnson Treasurer and Past President ISPE Boston Chapter Mark Trusheim Consultant UMass Susan Windham-Bannister President and CEO Massachusetts Life Sciences Center 14

Jacobsen Consulting Services Doyle Johnson Treasurer and Past President ISPE Boston Chapter Mark

Production in an Innovation Economy: The Globalization of Biomanufacturing and Implications for the Geography of Innovation

Production in an Innovation Economy: The Globalization of Biomanufacturing and Implications for the Geography of Innovation Industry Studies Association Pittsburgh, June 1, 2011 Elisabeth Reynolds, Ph.D.