Bergen Washburn

Lead representative for toxicology studies of antisense oligonucleotides, in addition to study monitoring responsibilities defined below. - Manage nonclinical timelines based on regulatory filing deadlines and author, review, and/or QC toxicology sections of regulatory submissions using appropriate reporting requirements for CTD sections M2.6.1-2.6.7, annual safety updates, IND, CTA, Briefing Book, IB, and BLA submissions - Serve as toxicology subject matter expert for multidisciplinary investigative efforts and communicate toxicology study findings to management and program teams - Contribute to the design and implementation of the toxicology strategy for programs in various stages of development - Actively participate in drug discovery providing toxicology input and guidance - Provide scientific collaboration within the Product Development team and across discovery groups to help evaluate and nominate drug candidates - Actively evaluate and apply new scientific methodologies in order to maintain scientific excellence, increase productivity and meet our research and drug registration needs - Main toxicology point of contact for external partners - As needed, act as a toxicology subject matter expert in the evaluations of potential in-licensing opportunities - Implemented offsite long-term archival for all toxicology studies - Collaborate cross-functionally with the BA, DMPK, CMC and QA departments - Main point of contact for business development representatives at multiple CROs

Lead Study Monitor and representative for toxicology studies of antisense oligonucleotides. - Study Monitor for non-GLP and GLP studies conducted at CROs, responsibilities inclusive of protocol review, regular site visits, status report generation, data interpretation, and report review - Manage outsourcing of nonclinical studies (GLP and non-GLP) including pharmacokinetic, general toxicology, biodistribution, safety pharmacology, DART, and juvenile toxicity studies in multiple species (mice, rats, non-human primates, and rabbits) - Verify data collected in nonclinical studies is consistent with protocol and ensure quality control checks on all studies and GLP compliance on all GLP studies - Verify data collected in nonclinical studies is consistent with protocol and ensure quality control checks on all studies and GLP compliance on all GLP studies - Primary liaison to all parties involved in the study with regular contact with Study Directors, Principal Investigators, and study teams - Responsible for CRO selection, study design, contract review, scheduling, and material projections and shipments - Work closely with the Bioanalytical team to ensure robust study design, schedule sample analysis and reporting, and review PK/TK data and reports

Lead Study Monitor and Representative for discovery and development pharmacology and toxicology studies of biologic therapeutics (fusion proteins) - Manage outsourcing of nonclinical studies (GLP and non-GLP) including pharmacokinetic, general toxicology, biodistribution, safety pharmacology, DART, and juvenile toxicity studies in multiple species (mice, rats, non-human primates, and rabbits) - Responsible for CRO selection, study design, contract review, scheduling, and material projections and shipments - Study Monitoring responsibilities inclusive of protocol review, regular site visits, status report generation, data interpretation, and report review - Primary liaison to all parties involved in the study with regular contact with Study Directors, Principal Investigators, and study teams - Work closely with the Bioanalytical team to ensure robust study design, schedule sample analysis and reporting, and review PK/TK data and reports - Verify data collected in nonclinical studies is consistent with protocol and ensure quality control checks on all studies and GLP compliance on all GLP studies -Nonclinical Representative on cross functional teams to bring discovery candidates into development and to the clinical stage to support product registration - Attend and present strategy, nonclinical timelines, material requirements, and study findings at regular department, program team and research and CMC subteam meetings - Manage nonclinical timelines based on regulatory filing deadlines and author, review, and/or QC of PK and toxicology sections of regulatory submissions using appropriate reporting requirements for CTD sections M2.6.1-2.6.7, annual safety updates, IND, CTA, Briefing Book, IB, and BLA submissions - ACE-1334 IND, Briefing Book, IB, and DSUR: Authored nonclinical overview and toxicology sections and authored and/or QC of PK sections - Sotatercept BLA – Review and QC of nonclinical overview and toxicology sections

Additional responsibilities of a Nonclinical Associate Scientist - Study representative for dose formulation analysis method transfer, development, and validation for preclinical candidates for IND submission - Conduct scientific qualification inspections of potential CROs to assess the suitability of the site to conduct future animal studies - Identify potential issues or problems with a CRO and communicate those to senior staff - Oversight of offsite archival facility for all nonclinical studies per GLP requirement - Knowledge in animal care technical procedures including but not limited to record keeping, animal identification, sexing, collecting specimens, euthanasia, and necropsy

Lab technician focused on bioanalytical assay development and non-GLP PK/TK sample analysis - Supported multiple phases of PK and toxicology studies including dose verification, biomarker assay development and determination of serum drug concentration via ELISA method development and qualification - Conducted non-GLP BA sample analysis, PK/TK data interpretation, and authored technical reports - Ensured all testing was conducted in accordance with appropriate protocols, SOPs and/or applicable guidelines - Adhered to project deadlines and completed technical work to high standards

Lab technician focused on formulation optimization for discovery and development programs - Experienced with preformulation characterization and formulation evaluation, including solubility determination, dissolution, viscosity, pH, moisture analysis, solid-state characterization and analytical testing of chemical stability - Conducted protein characterization via capillary electrophoresis, gel electrophoresis, N-terminal sequencing, peptide mapping and mass spectrometry - Evaluated stability of selected formulations at various durations, storage conditions, and freeze/thaws - Improved formulas and processes with independently designed formulation experiments leading to the development of a stable product - Conducted small scale fill and lyophilization studies that lead to scale up and transfer of manufacturing process - Authored technical reports

- Prepared buffers and materials for protein formulation development - Conducted and supported the liquid and lyophilized formulation studies - Protein characterization analysis - Developed standard operating procedures for lab equipment - Presented experimental data - Maintained chemical inventory program and updated MSDS logs

- Implemented protocols for testing, manufacturing, and scale up fireproofing materials - Managed product development timeline - Implemented design of experiments for intumescent formulation work and developed and maintained long term aging plan for intumescent formulations - Created and maintained database for all laboratory and pilot scale batches of intumescent coatings - Performed regular patent searches for projects in development