MORRIS Z. ROSENBERG
`12915 195th Place NE, Woodinville, WA 98077
`P: 425.892.3408 Email: mrosenbergconsult@gmail.com
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`Executive Summary
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`Biopharmaceutical Executive with 28 years experience in the development of
`therapeutic agents to treat a variety of human diseases. Participated in the
`development and launch of AdcetrisTM,AvonexTM, AngiomaxTM, XigrisTM, and
`ForteoTM. As part of the executive management team at Seattle Genetics, played a
`key role in building a commercial biopharmaceutical company focused on the
`development of antibody-drug conjugate technology for the treatment of cancer. I
`have experience building highly successful product development teams and
`supervising process sciences, manufacturing, quality control, quality assurance,
`preclinical research, bioanalytical, and project management.
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`2013 - Present
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`Employment History
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`MRosenberg BioPharma Consulting, LLC
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`General consulting on the development of biologics, antibodies, antibody drug
`conjugates, and biosimilars. I have consulted for 12 companies over the past two years
`during which time I have helped formulate the CMC outsourcing strategy for several
`biologics and antibody drug conjugates, assisted in the make/buy decision for a biologics
`and ADC manufacturing facility, and overseen the design and construction of a Phase 1
`enabling cGMP ADC conjugation facility.
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`Seattle Genetics, Bothell, WA
`Executive Vice President, Process Sciences
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`2001-2012
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` As part of the Executive Management Committee I helped build Seattle Genetics from an early start up
`company to a commercial biopharmaceutical company with a cancer therapy on the market in the
`United States and a strong portfolio of antibody-drug conjugates in preclinical and clinical
`development for as treatments for a variety of cancers.
`• Responsible for establishing process sciences and manufacturing at Seattle Genetics. Over the course
`of 11 years I recruited and trained 150 scientists, engineers and quality specialists that were responsible
`for the process development and manufacturing of our clinical candidates.
`• Established the clinical and commercial supply chain network for antibody and antibody drug
`conjugate.
`• Oversaw the manufacture of clinical supply materials for 9 antibody and antibody drug conjugate
`programs over a span of 11 years.
`• Experience in establishing highly potent compound (band 4 potency compounds) manufacturing
`facilities for antibody drug conjugation at Seattle Genetics and for antibody drug conjugation and
`fill/finish at contract manufacturing facilities in support of the Seattle Genetics pipeline
`• Responsible for the process development, manufacture, validation, and approval of the AdcetrisTM
`commercial manufacturing process.
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`• Played a key role in defining a CMC strategy that allowed for the accelerated approval of AdcetrisTM,
`the first new treatment for Hodgkin’s Lymphoma in over 30 years (approved August 2011). In
`particular my group was able to fast track the BLA submission by over one year allowing a far earlier
`market launch.
`• Defined the structure of the CMC Section of the AdcetrisTM BLA. Played a key role in influencing the
`FDA with respect to how BLA’s incorporating both large molecule (antibody) and small molecule
`(cytotoxin) data packages should be constructed for easy and rapid review and approval.
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`Eli Lilly & Company, Indianapolis, IN
`Head, Fermentation and Cell Culture Process Development
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`1998-2001
`1998-2001
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` Built a department of 65 people responsible for the development of biopharmaceutical manufacturing
`processes. Group responsibilities include cell and molecular biology, fermentation, cell culture,
`bioreactor scale up, clarification, analytical methods development and production of Phase I/II cGMP
`supplies. Group had ongoing programs in recombinant E coli, mammalian cell culture, and natural
`products fermentation.
`• Developed cell culture process for the manufacture of Xigris (approved USA Nov 2001). Responsible
`for process development, technical transfer and scale up to Lonza, and filing of the CMC section of the
`BLA.
`• Developed recombinant E. coli fermentation process for Forteo (approved USA Nov 2002).
`• Group designed, built and managed a 500L cell culture pilot plant responsible for manufacturing
`preclinical drug supplies. Managed $6M capital budget and 18 month construction and installation
`timeline.
`• Recruited 32 scientists and engineers from world class biopharmaceutical companies and integrated
`new individuals with diverse backgrounds and new capabilities into a department containing scientists
`who have been involved in biopharmaceuticals development since the inception of recombinant DNA
`technology.
`• Established a high throughput pilot plant for the production of large numbers of novel proteins for
`preclinical studies. Produced over 200 secreted recombinant proteins in two years.
`• Helped establish new business processes for managing a portfolio of recombinant protein and natural
`product candidates. Includes establishment of a management team to review development programs
`against goals and objectives and the creation of functional integrated process core teams responsible
`for tactical development and execution of processes.
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`Biogen, Inc., Cambridge, MA
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`Section Head, Biochemical and Process Engineering
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`1991-1998
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`1995-1998
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` Managed a group of 19 scientists and engineers responsible for the development of protein therapeutic
`manufacturing processes. Responsible for cell culture, fermentation, clarification, ultrafiltration unit
`operations and for cost modeling activities.
`• Led Process Development team responsible for the development of the cell culture production process
`for Avonex ( approved USA May 1996; EU 1997).
`• Team leader for the development of a manufacturing process for a humanized antibody that reached
`Phase II clinical trials. Completed design of Phase III/market launch manufacturing process.
`• Chaired committee responsible for creating and implementing an improved fast track approach to
`process development. Resulted in identification of roughly 50 percent time savings in ability to move
`a protein therapeutic from discovery to clinical trials.
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`1990-1994
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`Senior Scientist I,II
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`• Responsible for the development of the Avonex (interferon-beta-1a) cell culture manufacturing
`process. Included process development, participation in the design and validation of the pilot
`manufacturing facility and drafting of the CM&C sections of the BLA.
`• Team leader for the development of a process to produce a recombinant semi-synthetic peptide derived
`from recombinant E coli fermentation. Effort included significant interactions and technology transfer
`to a contract manufacturer.
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`Invitron Corporation, St. Louis, MO
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`Scientist
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`1987-1990
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`1989-1990
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`Marketing Manager
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` Managed a group of seven scientists with responsibilities for the development of perfusion based
`mammalian cell culture processes on a contract basis for biopharmaceutical companies. Produced
`erythropoietin, Factor VIIIc, tissue plasminogen activator, and more than a dozen murine and chimeric
`antibodies for clinical use.
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`1987-1989
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` Responsibilities included identification of clients for contract manufacturing, negotiation of contracts
`and project management of contract clinical manufacturing programs.
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`Education
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`DSc. Chemical Engineering, 1989
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`M.S. Chemical Engineering, 1985
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`B.S. Chemical Engineering, 1982
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`B.A. Biology, 1982
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`Washington University, St. Louis, MO
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`Washington University, St. Louis, MO
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`Washington University, St. Louis, MO
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`Washington University, St. Louis, MO
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`Selected Publications
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`1. Schill, N.A., Rosenberg, M., Dabora, R.L., “Influence of Cultivation Conditions on
`Glycosylation Pattern: A Fed-Batch and Continuous Culture Study”, Proceedings of the 15th
`Annual European Society of Animal Cell Technologies, Tours, France, Sept 15, 1997.
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`2. Kelley, B., Rosenberg, M., Chiou, T., Wang, D.I.C., “Industrial Animal Cell Culture”,
`Chapter Two of Bioprocessing, Vol 3. Of Biotechnology: A Comprehensive Treastise,
`Springer-Verlag Press, ed. G. Stephanopolis, 1994.
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`3. Rosenberg, M., Dunlop, E., Namdev, P., “Effect of Fluid Shear Forces on Plant Cell
`Suspensions”, Chemical Engineering Science, Vol. 49, pp. 2263-2276, 1994.
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`4. Hope, J., Rosenberg, M., Tolbert, B., “Development of Mammalian Cell Culture
`Manufacturing Processes”, in Production of Biologicals from Animal Cell Culture, ed. R.E.
`Spier, J.B. Griffiths, and B. Meignier, pp. 363-369, 1991.
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`5. Prokop, A., Rosenberg, M., “Bioreactors for Mammalian Cell Culture”, in Advances in
`Biochemical Engineering, ed. A. Fiechter, pp. 29-71, 1989.
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`Selected Presentations and Courses
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`Rosenberg, M., Wang, D., Cooney, C., Lodish H., “ Fermentation Technology, MIT, 2003-
`2014. 5 lectures as part of a week long course of cell culture, fermentation, and process
`economics. Course has been offered at MIT for the past 50 years.
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`Rosenberg, M., Galliher, P., Dotten, R., “Advanced Course in Bioprocess Fermentation and
`Scale Up”, a three day intensive workshop taught at the American Society of Mechanical
`Engineers Annual Meeting, 1997-2002.
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`Rosenberg, M. “Antibody Drug Conjugation Scale Up Workshop, Oct 30, 2014, World ADC
`2014 Meeting San Diego, CA.
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`Rosenberg, M. “Antibody Drug Conjugates Process Development and Manufacturing
`Workshop, BPI Europe Meeting, Prague, CZ, April 12014.
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`Rosenberg, M., “Antibody Drug Conjugates: Past, Present and Future, BioProcess
`International Conference, Feb 17, 2012, Hunington Beach CA.
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`Rosenberg, M., “The Impact of Antibody Drug Conjugates on Process Development and
`Manufacturing of Antibody-Based Therapies”, BioProcess International Conference, Nov 3,
`2011, Long Beach, CA.
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`Rosenberg, M., “BioPharmaceutical Development and Manufacturing of Novel Molecules”,
`IBC BioProcess International Production Week, Bellevue, March 18, 2011 Bellevue, WA.
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`Rosenberg, M. “Evaluation of a High-Throughput Clone Selection Technology for a
`Recombinant CHO Cell Line”, Cell Line Development and Engineering Conference, June 27,
`2006, San Diego, CA.
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`Rosenberg, M., “How to Find the Best Cell Line: The Long and Winding Road”, Cell Line
`Development and Engineering Conference, Nov 15, 2005, St. Louis, MO.
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`Rosenberg, M., “Impact of Highly Potent Antibody-Drug Conjugates on the Process
`Economics of Antibody Related Drugs”, IBC Process Development and Manufacturing
`Conference, Sept 19, 2005, Boston, MA.
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`Rosenberg, M., “Development Costs and Process Economics of Recombinant Proteins
`Produced in E. Coli, Mammalian Cell Culture, and Natural Products Derived Products: A
`Comparative Analysis”, IBC Conference on the Economics of Biopharmaceuticals, San
`Diego, Nov 12, 2000.
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