Leading the development of new technology from concept through FDA clearance. Australis Scientific is poised to bring advanced Overactive Bladder therapy from the clinic into the comfort of patient's homes.-Harvard Presidents Innovation Challange Grand Prize Winners (Health and Life Sciences) 2023-Australian New South Wale Medical Device Fund Grant Recipient 2022-Closed and Oversubscribed Seed Round-Multiple granted and pending patents

-Developed 3 new device technologies for biospecimen collection, transport, and preservation of multiple specimen types including saliva, blood, and urine (patents pending).-Conducted technical due diligence for the acquisition of two companies to expand business offerings via forward vertical integration.-Managed studies and wrote documents for FDA 510(K) submissions for class II medical devices that received approval.-Managed 3 clinical trials from IRB application through study execution (patient content, follow-up, and sample collection) in accordance with good clinical practice (GCP) and good laboratory practice (GLP) guidelines.-Wrote company white papers and provided scientific support to sales and business development opportunities.

A Fellowship that teaches the next generation of healthcare innovators how to harness technology, engineering, business, and cutting-edge science to define a new standard of medical care. This fellowship embeds teams in clinical settings to expose urgent, unmet healthcare needs, then design and test innovative solutions with guidance from mentors in the medtech, healthcare, and innovation sectors.• Identified unmet clinical needs doing while shadowing physicians in the Brigham and Women’s Hospital in both clinical and surgical settings (Focused on Urology, Breast Surgery, and Vascular Surgery divisions). Presented needs and plans for innovation to department leadership.• Established the Junior HealthTech Fellows program at Brooks High School as part of the inaugural mentoring group and prepared the Biodesign Curriculum (healthcare innovation and entrepreneurship)• Developed three new technologies disclosed to the Harvard Innovation Office

Santé invests at the leading edge of innovation in healthcare and technology.• Created a development plan for a new biotechnology being brought into the Santé accelerator program.• Assisted in due diligence on incoming company proposals in MedTech and BioTech domains.

I am assisting in starting up a laboratory from bare benches at Massachusetts General Hospital. I am co-mentored by Siam Oottamasathien M.D. and Jeff Karp Ph.D. at Brigham and Women's Hospital. Within the first year:Set up a new laboratory space from bare benches at Massachusetts General Hospital including obtaining equipment (inter-institutional transfer, purchase, etc.), setting up protocols (Lab Safety, IRB, IACUC, etc.), purchasing accounts, recruited and hired laboratory staff, and published and presented research out of the space. Received a $100K prize from the US Air Force for developing new concepts in biofluid management technology.Wrote, revised, and coordinated substantial portions of 8 internal and external funding applications to organizations such as the National Institute of Health, the Department of Defense, and nonprofit foundations on behalf of the Oottamasathien lab and Karp Labs.

• Invented radiopaque recombinant protein-based materials for embolizing cerebral aneurysms and arteriovenous malformations• Developed a system for the self-assembly of silk-elastinlike protein polymer nanogels for use as stimuli responsive drug delivery vehicles for use in metastatic cancer• Created in situ gelling device for prophylactically preventing radiation-induced proctitis in patients receiving lower abdominal radiotherapy for cervical, bladder, prostate, or ovarian cancer• Wrote research strategies and other documents for grants, which resulted in over $690,000 in awards to the Ghandehari lab and its direct collaborators. • Wrote the Introduction to Resubmission, Specific Aims, Vertebrate Animal, and Research Strategy sections for a 5-year NIH RO1 grant that received a 6th percentile impact score. This grant is funded for $1,989,162 and was not included the funding values listed in the previous point.

• Led a research project that led to the development of a 510(K) FDA cleared medical device that disinfected IV connectors 6 times faster than the next best clinically available technology at the time, while protecting the device from subsequent contamination for up to 30 days after use • Established GLP procedures and processes within a university lab for medical device testing• Developed SOP’s for disinfection studies on medical devices for various clinically relevant bacteria and fungi

This was a second 6-month competitive supplement to NSF GRFP award to receive training from industry to complement academic research training. I received two instances of this award to receive training at TheraTarget, Inc.• Lead a successful in vivo pilot study to validate a nuerointerventional device in partnership with a outside contract research organization• Assisted in the procurement and negotiation for laboratory equipment to support research and development efforts• Wrote a funded Small Business Technology Transfer (STTR) phase one grant and assisted in writing a funded STTR phase II grant• Presented research and development findings to senior company leadership and advised on commercialization strategies.

This is a 6-month supplement to NSF GRFP to allow graduate students to receive training from industry to complement their academic research training. My internship with TheraTarget, Inc. focused on understanding grant writing for the STTR/SBIR initiatives, FDA and CE regulatory considerations for medical device development, and obtaining venture capital funding for new medical technologies. https://theratarget.com/

• Wrote sections of a 510(K) application and prepared data for submission, which was accepted by the US FDA and audited by various international regulatory bodies• Primary researcher and significant writing contributor for the following company white papers “IV administration sets are vectors of infection because of Biofilm contamination.” and “IV stands and medical devices hanging from IV stands are vectors of infection.” • Managed product verification and validation testing and assisted in the development of two successful product lines for the prevention of catheter related blood stream infections• Wrote, revised, and developed over 50 standard operating procedures, test methods, quality forms, and manufacturing procedures• Supervised the quality assurance program and signed off for lot release