John Robblee

Leading Tech Ops, Analytical, and Process Development activities

CMC/Tech Ops consultant

-Build an analytical team (currently 7 people) with capabilities in molecular biology, functional assays, physicochemical characterization, and encapsulating drug product characterization of ceDNA (team was 3 molecular biology scientists at my hire). ceDNA is a novel non-viral genetic medicine with the potential to cure diseases through titratable, redoseable, non-integrating therapies across a wide range of potential disorders. -Lead the Analytical Development team which provides assay development for this novel modality, process support to upstream, downstream, and external groups, and certificate of analysis testing and release for pre-clinical ceDNA lots -Define the attributes and appropriate characterization assays for ceDNA DS and DP. As ceDNA is a novel modality with limited regulatory precedent, these attributes are either defined de novo based on our scientific understanding of ceDNA, or defined based on experience in related fields where appropriate (e.g. AAV or encapsulating nucleic acid formulations) -Integrate characterization strategy with overall corporate objectives to define specific goals for the team, provide the appropriate tools to maximize success of each team member, and further career development of the analytical development team -Work cross-functionally with other CMC and Research groups to further new assay development and ceDNA understanding -Enable significant improvements in ceDNA quality through development of a robust and informative characterization platform of qualifiable assays across all relevant ceDNA properties

-Strategic contributor to technical and regulatory approaches for multiple biosimilar programs, and creator of briefing book documents for regulatory interactions with FDA and EMA. This is the primary role of this new group within Momenta, and relies on understanding and communicating relationships between functional and physicochemical results -Prepare briefing books for multiple FDA interactions in 2017 for multiple biosimilar programs -Co-lead of cross-functional group to that has defined what fingerprint-like similarity is and has applied this definition to one of our biosimilar programs with the aim of significantly reducing clinical trials required by regulatory agencies for biosimilar approval. -Cross-functional contributor to CMC teams for most Momenta biosimilars

-Designing and implementing a strategy for gaining FDA approval of Momenta biosimilars with limited or no clinical data, based on the strength of the characterization approach and a thorough understanding of the biology and disease indication, and achieving significant cost savings for patients. -Strategic contributor to technical and regulatory approaches for multiple biosimilar programs, and creator of briefing book documents for regulatory interactions with FDA and EMA. -Design of reference product characterization strategy across the FOB platform, and implementation of this strategy for the M730 and M740 programs. This strategy is also used as a platform for comparison of a biologic to its reference product, and ensures that all relevant product attributes are examined. -Key technical leader for analytical characterization of biosimilars in the Analytical Development group -Cross-functional contributor to CMC teams for most Momenta biosimilars

-Contributor to team developing the risk assessment and ranking approach for the M923 program -Wrote key sections of FDA briefing books for the M923 program -Implemented a characterization strategy for determination of higher-order structure in biologics based on in-depth review of literature -Larger-picture contributor to biologics strategy and intellectual property generation -CMO management for external cell line development work on one of our early stage biosimilars -Senior technical and strategy contributor to investigation teams for biosimilars programs in the development stage -Lead Research technical and strategic contributor for multiple biosimilars programs (M834, M597, M730, M740, M710, M615, and M706) on analytical characterization and design and implementation of similarity assessments

Group leader for the Research Follow-on Biologics characterization team for 923, 834, and 511 programs -Develop physicochemical characterization methods and transfer to Analytical Development -Develop higher-order structure characterization strategy and perform characterization -Regulatory strategy development -Mentor development of 3-5 scientists (Senior Research Associate to Senior Scientist)

-Helped to design and execute physicochemical assays to determine potential immunogenicity of M-Enox complexes relative to Lovenox in response to FDA requests -Helped to successfully demonstrated equivalence of immunogenic potential of M-Enox relative to the brand product Lovenox, contributing to FDA approval of M-Enoxaparin Sodium in July 2010 -Received the Monomer Award (June 2009)

Thesis title: XANES, EXAFS and Kbeta Spectroscopic Studies of the Oxygen-Evolving Complex in Photosystem II