Heather Callahan Email and Phone Number

The Scientific Investment Advisory Committee for the Gates Institute at the University of Colorado Anschutz Medical Campus provides advice for the selection of promising projects in regenerative medicine for funding and support through the Gates Institute Grubstake Awards.

Allander is a preIND stage company developing a topical protein therapeutic to treat unmet medical needs related to tissue damage from excessive inflammation in oral mucositis, radiation dermatitis, atopic dermatitis and aberrant wound healing.

Hired, trained, and led a team of seven licensing professionals to provide business development and licensing for all Cleveland Clinic (including Lerner Research Institute) intellectual property assets across all domains in healthcare (e.g. therapeutics, diagnostics, biological materials, research tools, medical device, digital health, and data). Designed processes and systems for efficient review, marketing and industry outreach including building a team of five business development interns to prepare marketing collateral and assist with industry outreach. Together with the Ventures team, identified opportunities to create startups from Cleveland Clinic intellectual property and collaborated across Cleveland Clinic to ensure alignment around strategic goals.

Provided services at the intersection of invention, patents, product development, and business. Typical clients were early-stage biotech companies spun out of universities.

Established and led a team of four licensing professionals and two patent administrators. Designed invention, patent review, industry marketing, and licensing processes for efficiency and responsiveness, including building a team of six Venture/Licensing Fellows and an Intellectual Property Fellow. Managed a patent budget focused on invention development and revenue generation.

Entrepreneur in Residence focused on developing and commercializing technologies from the Department of Ophthalmology, Department of Dermatology, and the Gates Center for Regenerative Medicine. Operationalized and managed the Gates Grubstake Fund and Startup Toolbox. Mentored inventors from invention development, patent preparation and prosecution, technology licensing, startup formation, pre-IND preparation, and SBIR funding.

The Gates Center accelerates the translation of scientific breakthroughs in regenerative medicine into clinical practice through collaboration among basic scientists and clinical researchers, and a commitment to commercialization. As part of the commitment, they provided the resources and expertise to ensure patent protection for inventions and management of the patent portfolio.

Taiga is a pre-clinical, privately held, biotechnology company focused on stem cell and protein biologic therapies. As Legal Counsel and Corporate Secretary, I was part of the management team and participated in strategic decision-making. I established the patent portfolio strategy and managed outside counsel. I participated in the Series B raise, including review of the associated investment documents. I shared drafting responsibilities for the business plan for the raise and several pre-IND packages successfully filed with the FDA.

Intellectual Ventures is a private company focused on developing and licensing intellectual property. It was one of the top-five owners of U.S. patents, as of 2011.• Directed and managed an international team of approx. 4 patent attorneys and 9 paralegals across Japan, South Korea, China, India, Singapore, and the US.• Introduced efficient and cost-effective systems to the patent group, including a system for review and oversight of outside counsel, a high volume, low cost patentability search and analysis system, and an e-billing system for prosecution matters. • Provided strategic counsel on patent issues including developing comprehensive patent landscapes of competing portfolios, options for design-around, and freedom to operate.• Conducted intellectual property due diligence including patentability analyses for inventions considered for acquisition and development.• Reviewed and advised on intellectual property terms in out-licensing, research, and collaboration agreements.• Provided intellectual property training to internal and external scientists, inventors, outside counsel, operations, finance, and business people. • Drafted and prosecuted foreign and domestic patent portfolios in product safety, green technologies, biotech, medical device, tissue engineering, telemedicine, medical device, and non-invasive surgery.

Hollis-Eden was early clinical-stage, semi-virtual pharmaceutical company.• Drafted and prosecuted domestic and foreign small molecule pharmaceutical patent portfolios. • Conducted intellectual property due diligence including validity, design around, and freedom to operate analyses to inform decisions regarding potential acquisitions of pharmaceutical or nutraceutical portfolios or companies.• Monitored competitor activities and performed related validity, infringement and freedom to operate analysis.• Maintained good communication among scientists and inventors, outside counsel, and the product development, regulatory, and business teams. • Negotiated and drafted a variety of agreements, including confidentiality, material transfer, research, clinical, consulting, and license agreements.• Negotiated and resolved vendor and research disputes and assisted in an arbitration related to the small molecule patent portfolio. • Drafted and prosecuted the trademark portfolio in the U.S. and Europe.

Genset was a genomics company.• Drafted and prosecuted domestic and foreign patents in functional genomics (included biologics pharmaceuticals) and statistical genomics.• Monitored the progress of the scientific teams including notebook review, and maintained close collaboration with the scientists and inventors during drafting and prosecution of patents.• Maintained prosecution of the trademark portfolio.• Assisted with business development out-licensing the functional genomics patent portfolio.

Lyon & Lyon was a boutique intellectual property law firm located in California.• Drafted and prosecuted foreign and domestic biotech, apparatus, chemical, and pharmaceutical patents for start-up and multi-national companies as well as academic institutions. • Met with clients to educate and solicit invention disclosures.

• The Division of Experimental Therapeutics focussed on identification of new treatments for diseases important to the armed services. • U.S. Army Medical Unit - Brazil focussed on monitoring and studying infectious diseases of interest to the armed services. • Efforts included molecular, biochemical, cell, and immunological research into the efficacy of treatments and mechanisms of drug resistance.• Designed and implemented in vitro screens for new drug candidates, and to monitor the evolution of drug resistance in patient isolates.