Our Experiences & Accolades
We have the great fortune of living near South San Francisco, the birthplace of biotechnology. This proximity allowed us to learn from the best including Genentech, BioMarin, Sangamo Therapeutics, Actelion and Novartis. We’ve led dozens of successful programs and have lessons learned from others. We keep these experiences in the forefront of strategy development for our customers.
“ Denise is a dedicated, driven and highly experienced program leader. Denise keeps programs moving efficiently according to team timelines and budgets. Denise is also personable and easy to work with. Denise would be an asset to any pharma or biotech organization in need of an experienced program leader.”- Suzy Benedict, VP Regulatory, Aditum Bio
“Denise was a fantastic colleague during our time together at Compugen. She joined the company as head of Program and Alliance Management as we were preparing to submit our first IND, which was a hectic and stressful time. She kept the project team and CROs focused and accountable. I view her as an excellent leader who consistently delivers on her responsibilities.”- John Hunter, CSO, Fibrogen
“ Denise is a terrific asset to any team of drug developers. I worked with her for over a year at Via Nova Therapeutics, where she was our lead Project Manager, shepherding 4 molecules through the development process, one of which went through a successful IND on her watch. She is highly organized, disciplined, team-oriented and very experienced, having worked at several large and small firms in different capacities. This has given her great perspective on all aspects of the development process” -Don Ganem (Donald Ganem - Wikipedia)
Lead engineer responsible for the facilties infractstructure to deliver this product approved for cystic fibrosis
Program lead initiating studies for gastrointestenal cancers (mCRC) which is now an approved indication in addition to several other oncology conditions
Managed commercial launch team ensuring that all things commercial were in place: publication plans, reimbursment, supply chain, payor position. Efforts resulted in a timely launch 2 months after FDA approval and sales exceeding targets within 6 months
Initial program lead on the ONLY approved therapy for designed to increase linear growth in children with achondroplasia, a genetic condition that affects bone growth, Managed relations with patient groups opposed and for the therapy
Commercial program lead responsible for managing and planning sales meetings ,ensuring marketing materials and sound from a regulatory perspective and that reimbursement and access road blocks are not at risk for the patient
Initial program lead responsible for initiating Ph 1 studies at BioMarin prior to MedImmune/Pfizer buyout- now approved for HER2 indicated cancers
CMC program lead for Ph II and injectable device concept now approved for multiple allergic and inflammatory conditions
Lead engineer responsible for responding to market research/commercial decisions for alternative configurations
Lead validation engineer- responsible for authoring regulatory submissions detailing the validation studies and overall program
CMC program lead and engineering lead working on refining dosing and cobinations therapies (hypertonic saline) to improve efficacy
Program lead for Ph II/III resulting in the the commercial product launch. Managed controversy over Avastin use prior to Lucenis launch.