Minneapolis, Minnesota, United States
My passion lies in building, leading and inspiring world class teams to target the right treatments optimized for the patient's condition at the right time in the ideal dose. As in rowing, working together with precision while leveraging diversity to achieve extraordinary results. At Gila Therapeutics, we're at the forefront of developing cutting-edge treatments for obesity & metabolic disorders, harnessing the untapped potential of the tongue-brain axis. Leading the charge as Co-Founder and Chief Scientific Officer, my focus encompasses the orchestration of drug development processes, from candidate selection to clinical trial execution. It's our mission to revolutionize how metabolic diseases are treated, prioritizing patient safety and efficacy. Our team's collaborative efforts propelled us beyond Phase I clinical endpoints, and we're actively advancing into Phase II trials. My hands-on involvement with industry-leading partners like Eli Lilly has been instrumental in creating innovative peptide drugs. We are committed to delivering groundbreaking therapies that promise to improve the quality of life for those battling obesity and related metabolic conditions.
We are developing novel treatments for metabolic disorders exploiting the tongue-brain axis, a completely novel pathway. We stimulate specific brain regions via topical application of natural satiety hormones to the oral mucosa: • Activating the full satiety response; more effectively than systemic delivery or food intake • No systemic absorption • No evidence of safety or tolerability issues Having met our phase I clinical endpoints, we are moving into phase II In this role I manage all aspects of drug candidate development and selection, pre-clinical laboratory testing, IND-enabling activities and clinical trial planning and execution. • Worked with Eli Lilly peptide design team to create a superior NCE PYY (NPY2 receptor agonist) • Screened pre-clinical testing labs in Europe and the US to select commercial CROs and academic labs for MOA studies, clinical candidate screening and selection of development candidates • Managed pre-IND activities for clinical trials: API and other reagent manufacturing, CMC, compounding, bioanalytical methods development, toxicology, etc. • Designed and planned clinical trials to be executed in the US and Europe • Expanded the IP portfolio to include receptor agonists for additional metabolic hormones • Support ongoing fund-raising activities
In-licensed technology, hired team, raised financing, and oversaw development from preclinical through phase I in 18 months. • Negotiated exclusive license with U of Florida • Contributed to and filed additional drug formulation and combination patents • Raised $6MM venture and angel financing • Hired world class operations teams • Managed all development activities from preclinical, through IND and phase I o Established contracts with vendors, contractors, consultants and clinical sites o Quality system establishment, implementation and maintenance o API production o CMC – formulation, stability testing and assay development o Toxicology o FDA communications and IND submission o Clinical trial site selection, design and execution
Led business development, sales, marketing, genetics and bioinformatics; manage clinical and scientific advisory boards • Negotiated and executed the company’s first major pharma contract • Built genetics and bioinformatics teams
Led clinical development of in vitro diagnostics for oncology prognostics and therapy guidance. Coordinated and led the development of new gene signatures for clinical validation and application including companion diagnostics with large pharma and key academic medical collaborators. • Established contracts with clinical sites patient sample access • Identified, accessed and verified new, innovative gene signatures • Contributed to the invention of a novel analytical technique: qNPA • Contributions led to two issued patents • Led the development process for candidate high value diagnostic assays • Identify and prioritize new applications for HTG’s core technology and coordinate development of technology roadmaps • Accessed personal global investor network to enable $16.5M series D financing
Led new assay development for oncology prognostics and therapy guidance • Managed high value assay development for lung, breast, hematologic and colorectal cancers • Developed and led novel process for assay concept ideation, screening and validation to create a $4 billion product portfolio with a $100 million net present value • Identified key unmet medical needs for cancer diagnosis, prognosis, and therapy guidance • Managed global network of key opinion leaders who assisted in assay concept identification and validation • Identified new cancer diagnostic assay concepts and developed through pilot validation to fill product pipeline to the ten-year horizon
Global biotechnology opportunity identification and assessment -- Developed groundbreaking therapies by combining Medtronic’s delivery technologies and drugs from the biotechnology and pharmaceutical industry • Led pre-clinical studies of peptide hormone drugs for obesity and metabolic syndrome in South Africa at the Chris Barnard Cardiovascular Research Unit • Launched a first-for-Medtronic infectious disease therapy clinical trial in the Netherlands • Initiated and led a phase I clinical study employing pump-delivered satiety hormones in subjects with obesity at University College, London, UK • Managed >$4 million investment in a novel implantable pump technology and served on the company’s board of directors • Played a pivotal role in Medtronic’s investment strategy and R&D efforts for development of genomic and proteomic diagnostics for patient population segmentation in the cardiac and spine therapeutic areas • Key advisor for the Medtronic-Genzyme joint venture for cardiac cell therapy and the Alnylam siRNA neurological therapy development program • Served as technical advisor for the >$300 million minority investment portfolio in more than 70 companies