Michael Gilkey Email & Phone Number

Atlanta, Georgia, United States

Atlanta, Georgia, United States

Key Accomplishments* Identified, organized, prepared, submitted and managed grant proposals for submission to federal agencies - $17.1M. Helped craft grant specific aims and budgets, negotiated contracts, provided monitoring and deviation reporting to management and funding agency, and provided directed project development efforts and resource allocation. Secured $15.4M in new funding from the VA including the VA Hub for Computer Vision and Machine Learning in Precision Oncology (CoMPL).* Member of the Lung Precision Oncology Program (LPOP), Precision Oncology Program for Cancer of the Prostate Cancer (POPCaP), LPOP work groups (Radiology and LCS Scientific Radiomics Sub-workgroup), and Actively Managed Portfolio Initiative.* Identified, established collaboration with, and secured new regulatory approval for Cleveland into new nationwide VA Central IRB prostate cancer biorepository network. Now working to create a national slide scanning operation to advance development of AI tools for cancer and aggregate data for cancer research.

Cleveland, Ohio, United States

Cleveland, Ohio, United States

* Project manager for all VA research projects involving Dr. Anant Madabhushi and the Center for Computational Imaging and Personalized Diagnostics.* Serve as a technical resource and advisor on research and regulatory issues.* Organize and support the research team’s grant application efforts and post-award management of research milestones. Assist in the development of multi-PI, multi-component, multi-site collaborative grant proposals.* Responsible for overseeing the recruitment of patients into studies conducted by the PI and developing partnerships across other VA medical centers to assure a high level of awareness and eventual participation in the study.* Responsible for creating submissions and maintaining compliance with Institutional Review Board (IRB) regulations. Responsible for overseeing all necessary chart review and record abstraction and providing periodic reports detailing time completion rates, enrollment reports and preliminary statistical analyses.* Serve as primary liaison and establish and maintain appropriate systems for managing intellectual property applications, invention disclosures and institutional research collaboration agreements.* Responsible for acquiring images and clinical data and maintaining project databases for the various research projects using the VA PALMS Biorepository.

Cleveland, Ohio, United States

Part-time Instructor for Biol 491: Biotechnology Innovation Fall 2022:This course examines critical thinking and physical limitations to cutting edge technologies and the use of biotechnology innovation to identify potential opportunities for new venture creation. The course provides experience in thinking like a biotech entrepreneur and how to get a business started. The culmination of the class is for students to work from currently available technologies to write a Small Business Innovation Research (SBIR) grant.Part-time Instructor for Biology 214L Lab Fall 2021 and running 4 sections:The course objectives are to:(1) Comprehend basic concepts about genes and evolution and develop scientific writing skills.(2) Appreciate genetic and evolutionary principles by conducting descriptive and hypothesis- driven investigations using the scientific method.(3) Develop oral and written communication skills critical for all fields of biology.(4) Appreciate the collaborative nature of biology by working and communicating with other students in lab.

Cleveland/Akron, Ohio Area

CLeveland Understands Biotech (CLUB) facilitates the development of start-ups leading to rapid growth, cost containment, greater productivity, pitfall avoidance, and a quicker return. Our experienced professionals will define strategy and create a roadmap tailored for your company.The CLUB is made up of serial entrepreneurs, researchers, and support personnel focusing on biotechnology. We have in the trenches understanding from basic start-up activities to complex cooperative interactions. Our goal is to achieve tangible business solutions increasing your return on investment, usability, adherence to industry standards, and speed of implementation. Our business experience coupled with appropriate due diligence ensures compliance the first time.

I created a consulting business to help guide company formation, perform business planning, create initial marketing collateral and raise seed capital for biotechnology startups. The following companies have retained Gilkey Biotechnology Consulting's services: Antria, LLC (2010-2017), BioInVision, LLC (2012-2013), Case Western Reserve University (2021-present), Cleveland Cord Blood Center (2007-2010), Emory University (2022), Garrett's Mill Brewery (2019-present), GTCbio (2017-2018), Invenio Therapeutics (2007-2010), The Jolly Scholar Brewery (2019-present), Michigan and Ohio Chapters of the Alexander Graham Bell Association (2010-2018) and Pathfinder Biotech (2013-2016)

Cleveland/Akron, Ohio Area

SHARE is a microtransit service created for the trips you take the most. We partner with employers, schools, senior living communities, municipalities, and healthcare facilities to provide a transportation solution backed by proprietary technology. At SHARE, we believe access to transportation means access to opportunities. We are creating the blueprint for transportation in Smart Cities with the goal of introducing autonomous vehicles to our fleet.I am responsible for establishing and amplifying the SHARE brand while engaging within the community. As a member of the sales team, I define, articulate and execute the vision and strategy for SHARE’s growth into new cities. This role is dynamic and touches every aspect of the business, working across operations, product, community, partnerships, and government relations. My primary mission is to establish and oversee the initial operations for this new city and maximize partnerships and new customers.

Cleveland

Red5 Pharmaceuticals is an emerging start-up company based in Cleveland, Ohio that is developing novel companion diagnostic assays and chemotherapeutics that prospectively determine whether a patient will respond to chemotherapy. With funding from the Ohio Third Frontier and Great Lakes Innovation and Development Enterprise, Red5 is continuing to develop a personalized genetic medicine approach for clinicians to have specific information on how to treat a patient’s cancer. SD-352 will also be pursued in combination with DNA damaging agents for treatment of leukemias, lymphomas and solid tumors. My primary duty is to develop SD-352 into a marketable companion diagnostic and combination drug.

GTCbio is a leading information center that provides quality forums, which facilitate the exchange of biopharmaceutical and biomedical intelligence between industry leaders, academic and government organizations, and the financial community.Duties:• Perform business development related initiatives for GTCbio, with an immediate focus on recruiting Program Partners, developing strategic business development engagements, joint conference development initiatives with other businesses, and participation in conferences.• Identify potential sponsors/exhibitors for GTCbio and facilitate introductions and building relationships.

Cleveland, Oh

Trailhead Biosystems merges developmental biology and cell therapeutics with cutting edge hardware, and computerized experimental design and analysis to perform process-specific parameter optimization for customers seeking to develop cell therapies. Duties:▪ Full responsibility over and effort towards all aspects of the business including project management, customer interfacing and business development, sales, operations, finance and accounting, supply chain and ordering, contract negotiation, human resources, and marketing.▪ Created all aspects of corporate marketing and communication including website, social media, handouts, press releases, PowerPoint presentations, and scripts for external relations.▪ Built partnerships to address supply chain and enter into new markets.Key Accomplishments:▪ Created new business venture from CWRU grant and identified and solicited new funding – $4.8M.▪ Designed and executed plan for new service introduction - year 1 revenues of $0.5M.▪ Created business plan and capital raise pitch deck of $10M.▪ Managed the work of 7 FTE with operating budget of $1M/year.▪ Identified, organized, prepared, submitted and managed grant proposals for submission to federal, state and extramural agencies - $50M▪ Interviewed by CBS affiliate Channel 19 News Cleveland and quoted in multiple press releases.

Cleveland, Ohio

The mission of NCRM to utilize its multi-institutional structure to rapidly translate cutting-edge adult and pluripotent stem cell and tissue engineering laboratory research into clinical and commercial arenas to treat human disease.Duties:▪ Primary duties included project management, planning and leading meetings with key corporate personnel, negotiating new corporate sponsorship, serving as a resource for the companies, developing new strategies for collaboration, and serving as point person for institutional agreements.▪ Supported the execution of the biannual international adult stem cell and cancer conferences, which included program generation, speaker management, marketing, sponsorship, attracting attendees, and execution.▪ Prepared NCRM quarterly and annual reports for various oversight organizations such as the Ohio Third Frontier, government relations, other funding agencies and institutional management.Key Accomplishments:▪ Managed grant spending and oversight of $4.8M in Ohio State funding. Released multiple requests for proposals from these funds and coordinated the review, selection, and contracting for selected projects.▪ Created a new core facility, OH-Alive, from CWRU grant and created Trailhead Biosystems to transfer this service platform to.▪ Created 4 new pieces of intellectual property, of which 3 were licensed.

Cleveland/Akron, Ohio Area

Duties:▪ Performed all financial budgeting for organization including audits, budget projections, expenditure and revenue forecasts, and cash flow analyses.▪ Directed all aspects of the bi-annual international adult stem cell and cancer conferences, which included program generation, speaker management, marketing, sponsorship, attracting attendees, and execution.▪ Prepared quarterly and annual reports for various oversight organizations including the Ohio Third Frontier, government relations, other funding agencies and institutional management.▪ Developed, facilitated, sought and managed funding to implement innovative University and regional educational programs to train the local workforce and provide educational resources for the public.▪ Identified, organized, prepared, submitted and managed commercially-oriented grant proposals for submission to federal and extramural agencies.▪ Assessed and helped develop new intellectual property from NCRM faculty.Key Accomplishments:▪ Managed grant spending and oversight of $6.6M in Federal Appropriations and $42M in Ohio State funding. Released multiple requests for proposals from these funds and coordinated the review, selection, and contracting for selected projects.▪ Submitted and received over $25M worth of new grants.▪ Instrumental in the planning and execution of 6 three-day international stem cell conferences with over 300 attendees from 27 countries and 127 institutions and revenues of $180,000+ for each event from corporate sponsorship and registration.▪ Responsible for design, content, and maintenance of institutional websites.▪ Helped establish and coordinate sensitive multi-institutional oversight committees to review research programs including the Stem Cell Research Oversight Committee.▪ Chosen by BIO to live blog the Eleventh Hour TV show.▪ Launched web-based education modules about stem cells with <9M unique users and programmed into three kiosks.

Cleveland, Ohio

Duties:▪ Led commercial, economic development and management efforts with the end result of creating academic-commercial joint projects, sponsored research, research agreements, and licensing opportunities for faculty members.▪ Performed all financial budgeting for organization including audits, budget projections, expenditure and revenue forecasts, and cash flow analyses.▪ Directed all aspects of the annual international adult stem cell conference, which included program generation, speaker management, marketing, sponsorship, attracting attendees, and execution.▪ Assessed and helped develop new intellectual property from NCRM faculty. Worked closely with faculty and respective technology transfer offices of CWRU, University Hospitals and Cleveland Clinic to take ideas from an invention disclosure to a license.Key Accomplishments:▪ Managed and coordinated the work of 7 employees in the commercialization and development of over 20 research projects and a budget of over $2 million annually.▪ Submitted and received over $75M worth of new grants.

Cleveland, Ohio

Cleveland, Oh

Duties:▪ Prepared quarterly and annual reports for various oversight organizations such as the Ohio Department of Development, government relations, and institutional management on financial, IP, and marketing matters.▪ Organized monthly seminar series to promote collaboration and education of Center members from local, national and international speakers.▪ Advised potential clinical trial participants and the public in locating and understanding beneficial internal and external clinical trials in a wide range of therapeutic areas.Key Accomplishments:▪ Submitted and received over $16M worth of new grants.▪ Brought cutting-edge stem cell science to the classroom of middle school and high school students in order to inspire these students to pursue science and medicine in college.

Columbus, Ohio

Mba, Bioscience Entrepreneurship And Marketing

Ms, Biomedical Engineering

Bs, Biological Engineering