- Designed studies and outsourced a series of GLP pharmacokinetic (PK), pharmacodynamic (PD), and toxicology studies for diabetes drug. The PK/PD relationship was used to determine the optimal dosage for clinical studies. The drug is now in Phase II.
- Designed and implemented IND-enabling preclinical/translational strategy for small molecule oncology therapeutic now in Phase II. Selected and directed CROs to perform a series of in vitro/in vivo studies including cytotoxicity, mechanism of action, efficacy in orthotopic and metastatic xenograft models, PK, and ADME studies.
- Developed and implemented lead optimization strategy for a series of biologics; the lead was selected, taken through IND-enabling studies, and is now in Phase I. Studies required included: in vitro activity/mechanism of action, immunoassay development for biomarker assessment, in vivo efficacy in preclinical/translational models of multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease, dose optimization, pharmacokinetics, and toxicology.
- Evaluated half-life extension technology as applied to a variety of peptide and protein drugs. Designed and implemented pre-IND studies including multi-species PK, efficacy in predictive animal models, immunogenicity, histopathology, and toxicology. Two therapeutic agents have advanced into the clinic and are currently in Phase I and Phase II trials.
- Designed and implemented the pre-IND activities of targeted oncology therapeutic. Studies included in vitro activity, and in vivo efficacy and toxicity both as a single agent and in combination with standard cytotoxic drugs. Compound is now in Phase I.
Provided scientific evaluation of new corporate venture. Assessed scientific and clinical data and evaluated input from thought leaders in the field. Compound was chosen for internal development and further development strategy was proposed and undertaken.
Performed assessment of competitive space for a variety of therapeutic agents. Compounds were evaluated according to clinical indication, mechanism of action, and technology niche.
Evaluated scientific merit and intellectual property position of a variety of therapeutic agents for potential new partnership opportunities. Drafted Target Product Profile, Project Plan and Executive Summary for chosen product candidates.
Served as company champion for therapeutic projects. Initiated successful collaborations with industrial, academic and government institutions.
- Worked with team to write and submit INDs for therapeutics in oncology, endocrinology, autoimmunity, diabetes, infectious disease and regenerative medicine. Wrote Phase 1 clinical investigator brochures.
- Compiled study data from different study sources including CROs and internal laboratory notebooks and wrote series of summary project reports for inclusion in IND.
- Assisted business development department and wrote business plans and executive summaries.
- Wrote patents, grants, manuscripts, and abstracts. Prepared posters and represented company at scientific meetings.
Ben Spink, Director, Protein Purification
“I had the pleasure of working with Susan at Amunix for over 2 years. Susan was responsible for the planning, management and reporting of more than 30 preclinical studies ranging from pharmacokinetic and pharmacodynamic studies to complex efficacy studies in animal disease models across multiple indications including oncology, autoimmune diseases, diabetes, and pain. To do this she developed internal systems to manage data and samples, interacted with multiple CROs, and analyzed and presented significant amounts of data. All of this work was exemplary however, the highlight of working with Susan was her clear analytical thinking and ability to engage intellectually on all manner of topics relating to the business. Her maturity, professionalism and breadth of knowledge helped her not just to be good at her job, but to be a valuable resource for strategic decisions within the company such as: the selection of targets to which our half-life extension technology could be applied, evaluation of personnel, and determination of strategic project milestones. She was a willing participant in discussions and an excellent team member. I cannot describe the true value of Susan to the organization, it was tremendous.”
Alshad S. Lalani, Director, Translational Oncology
“I have known Susan for several years and have worked with her on preclinical development of a variety of oncology therapeutics at several companies including Novacea. Susan helped develop and execute the overall strategic plan including performing background research on the compounds and appropriate predictive models, designing and implementing studies, managing CROs and external collaborators, analyzing data and writing study reports. Susan also worked with business development on strategic evaluation of new product in-licensing opportunities. Her broad knowledge base enabled Susan to optimize the project plan and specific study designs for each individual compound. Susan was a pleasure to work with, and I recommend her without hesitation if you are seeking an experienced preclinical scientist/consultant in the life sciences industry.”
Shanta Bantia, Executive Director
“I have had the pleasure of knowing Susan for over 2 years. She has helped BioCryst in writing pharmacology reports and worked with research/development /clinical/regulatory team to analyze and review, and write up data for IND submission. She is a sharp individual with pharmacology/preclinical development/clinical development experience in various disease areas. She is purpose-minded and I have enjoyed working with her and enthusiastically recommend her.”
Lou Dietz, Principal, Lou Dietz Consulting
“I had the opportunity to work with Susan at two biotech companies. In both cases Susan impressed me with her ability to quickly understand the needs of the project she was hired for, and only take on a project if she thought that she could add value. Susan has a broad knowledge base; I have worked with her on projects as diverse as performing comprehensive literature reviews for projects in cancer and inflammatory disease, to designing and managing studies for autoimmune disease and asthma/allergy. Susan is great at working with people with diverse backgrounds (for example, I am an engineer) and she understands the importance of meeting timelines. I highly recommend her and look forward to working with her again.”
Willem ‘Pim’ Stemmer, CEO
“We have worked with Susan extensively and she has been a great asset to oversee our preclinical studies. Her vast preclinical development experience across a wide range of clinical areas is instrumental as we advance our technology platform into diverse therapeutic programs (intestinal disease, endocrinology, cancer supportive care, hematology, cancer, autoimmune disease, pain). Susan is very knowledgeable about drug development and is excellent at explaining her subject matter to our more technical employees. Although she always makes her best recommendation and backs it up with the necessary supporting information, Susan is very flexible and is open to alternate suggestions and ideas. She is particularly skilled in meeting scientific and business objectives, leading internal project teams, and managing external contract groups and collaborators. Susan has my highest recommendation.”
George Dunbar, President and CEO
“I had the pleasure of working with Susan several years ago in an early stage biotech company that was attempting to develop payload targeted oncology drug delivery; and I would highly recommend Susan for any aspect of early stage and preclinical development. Susan works very collaboratively as well as independently, and is quietly efficient delivering and achieving consistent results.”