We have a network of > 80 BioMentors who are available to provide pro bono advice and assistance to promising life science entrepreneurs across the State of Oregon. Our BioMentors have valuable expertise in a wide range of business topics that are integral to the success of early-stage life science companies, including:
In addition to his role at RevMedx, Mr. Barofsky is executive vice president and general counsel for the Oregon Biomedical Engineering Institute, Inc. (OBEI) where he is responsible for all aspects of technology commercialization, contracting, operations and financial management. He also provides strategic input on research and development strategies for OBEI.
Previously he was a member of the intellectual property and business groups of Schwabe, Williamson & Wyatt, P.C. a leading Pacific Northwest law firm. Before that he practiced law at Boston-based Testa, Hurwitz and Thibeault, LLP, a global legal services provider for emerging growth companies.
Mr. Barofsky began his career as a scientist at the Oregon Medical Laser Center where he helped establish the center’s biomaterial program. He currently serves on the board of the Oregon Translational Research and Development Institute (OTRADI), the Oregon Bioscience Association and the University of Portland Center for Entrepreneurship’s Technology Entrepreneurship Certificate Program.
He earned his BS in biochemistry from the University of Oregon and his JD and MBA from Boston College. Mr. Barofsky is a registered patent attorney and a member of the Oregon State Bar and the Bar of the Commonwealth of Massachusetts.
“I can help entrepreneurs with questions regarding intellectual property and patents, startup funding, government funded research and development, medical device regulatory and quality, product development and manufacturing.”
Tom is a hospitalist physician taking care of sick patients admitted to the hospital. He has 20 years of clinical experience. As a hospitalist, he has been able to stay abreast of leading clinical needs and technologies and has experience at the national level with clinical thought leaders. He is also a physician entrepreneur and has founded a biotech startup in the diagnostics area. He has experience collaborating with bioengineers for over 10 years and understands the importance of multidisciplinary teams. His expertise is in assessing clinical applications for technology.
“I can assist in clinical applications for technology for patient care. My knowledge as a physician with clinical ecosystems from health care industry to large systems of care to the single patient can assist in identifying opportunities for biotechnology applications. I can also assist in clarifying pressure points and likelihood of adoption of technology.”
Since 1989, Dr. Bates has been president of Applied Concepts LLC consulting. As an international consultant, he has helped clients to evaluate and develop numerous medical products for ultrasonic imaging and therapy, transducer design, blood pressure monitoring sensors, cardiac EKG and phonocardiography, medical Doppler instrumentation, intravascular acoustic imaging, semi-conductor wafer inspection, laser interferometry, and atomic force microscopy.
He has assisted management with acquisitions, product evaluations, product development, quality control, and hiring of key technical personnel. Periodically Dr. Bates organizes and leads teams of consulting engineers in the development of product designs for client corporations. On two occasions he has taken temporary senior managerial roles to aid clients with more extensive projects.
“I can help entrepreneurs understand the business aspects of technical innovation and its impact on product development, particularly the development of medical devices.”
I was a reviewer at the Center for Devices at FDA. I have dealt with devices and combination products as an FDA employee and as a consultant for more than 20 years. I specialize in products which don’t fit neatly into classification boxes. I can help your firm get an idea of their regulatory path and the testing requirements.
I can give companies an idea of when the best time is to talk to FDA about the submission requirements for their device. I will provide an initial read on their path and testing requirements as long as the submitted material is less than 60 pages. I can also review the regulatory section of grants.
Utilizing communication tools and techniques, Jane works with individuals and organizations to improve corporate culture, drive change, and encourage a positive working environment.
“If you have the idea, I can help you pitch it! I’ll work with you on speaking techniques that will keep your audience engaged, inspire action, and leave them wanting more.”
Chris Brasfield has over 8 years of experience with all aspects of grant accounting and administration. In this time he has overseen these tasks on more than 40 awarded SBIR grant programs. As Controller of a biotech in North Carolina, he has set up accounting structures from scratch, managed A-133 audits, and negotiated F&A rates with the government.
“I can assist companies with any questions involving accounting and administration of SBIR grants. This includes the application process/submission, setting up chart of accounts, handling an A-133 audit, and negotiating your F&A rate.”
SUMMARY OF EXPERIENCE:
Mark Bruns is a Senior Director with Waters Corporation, a specialty measurement company focused on the pharmaceutical, food, materials and clinical diagnostics markets. At Waters, he has served as General Manager for Waters clinical diagnostics global business, led Strategy and Business Development for its Health Science business, and led Strategic Marketing across the organization. Previously, he held multiple executive positions with Abbot Laboratories, Diagnostics Division, a global in vitro diagnostics manufacturer, including Director of Business and Strategy Development, Product and Brand Management, Product Development and Commercial Operations.
Prior to working in the medical industry, Mark held technical and commercial roles in the microelectronics and micromechanical systems markets.
Mark completed his doctorate in Chemistry at the University of Illinois at Urbana-Champaign. He graduated with a B.S. in Chemistry and as an Honors College Scholar from Valparaiso University. He also completed a two-year marketing program at the University of California, Berkeley.
MENTORING SERVICES PROVIDED:
“I can assist with global IVD product development, regulatory strategy and process, reimbursement strategy and process, market development strategy and process, go-to-market strategy, product launch, lifecycle management, strategy development and execution, marketing plan development, and market research. Cover all IVD therapeutic areas. Cover all segments of IVD market. Precision medicine, companion diagnostics, novel biomarkers, novel technologies.”
Dr. Carlson is an experienced scientist and patent agent with more than 10 years of experience in the preparation and prosecution of US and foreign utility patents. She specializes in the following areas: biotechnology (including molecular and cell biology), plant biology, biochemistry, oncology, genetics, infectious diseases and immunology. Her experience includes prior art searches and patentability analyses. Dr. Carlson also has more than 10 years of practical laboratory experience. Her doctoral studies focused on the molecular processes that control retinoid transport and metabolism in the mammalian eye. Postdoctoral research has included the examination of the molecular events that regulate the growth and development of normal and leukemic blood cells.
“I can discuss the general principles and practice of patent prosecution with entrepreneurs/companies, as well as the tools and strategies that can be used prior to filing a patent application and the pitfalls to avoid. These initial discussions will not involve details of the invention itself. I am available for general consulting relating to scientific projects of all kinds.”
Claire Celeste has been with Providence for eight+ years, parlaying her experience in telehealth, digital, and interactive strategies into her role on the venture team, where she has been a partner for the past year and a half. Combining her passion for the consumer experience with knowledge of health care technology solutions, Claire Celeste is focused on early stage companies.
Prior to Providence, Claire Celeste spent a decade at Intel, including stints in new business, internet marketing, sales and management. Before Intel, Claire Celeste spent two years in brand management, three years in advertising, and worked for a start-up until its acquisition. She received her master’s degree from the Kellogg School at Northwestern University and her undergraduate degree from Washington State University.
“I can help companies improve and refine their strategies and develop or refine their go-to-market plans. I can provide feedback from the perspective of a prospective investor.”
Mr. Carroll has more than 30 years of experience in the medical device area, including regulatory, research and product development, marketing and sales distribution. He has been a key individual in product and market development for Medtronic, EMPI, Greenleaf Medical Systems, NeuroMotion and RS Medical. Mr. Carroll’s area of interest is in electrical stimulation of living tissues, and he has co-authored numerous papers, protocols and guidelines in the field. He holds 13 U.S. patents and has six patent applications pending. He is on the board of directors of OTRADI, Oregon Biosciences Association, Meagan Medical and Neuronano AB.
“I can provide advice and assistance in development of reimbursement and regulatory strategies in the medical device and biologics areas. I also offer new product development and intellectual property strategies.”
As a life sciences strategy consultant, Anne answers strategy questions for biotech and pharma companies. She has experience in strategic forecasting, opportunity assessments, franchise-level acquisition strategy, pricing and market access, buy-side due diligence, and indication prioritization. Anne’s expertise is primarily in novel therapeutics, with modest experience in medical devices.
Anne is also experienced in evaluating precision medicine options for oncology patients, and facilitating conversations regarding possible personalized treatment approaches and clinical trial options.
Anne holds a Ph.D. from Harvard University in biological chemistry and molecular pharmacology, and a BA from Oberlin College. She is a native Portlander who currently lives in Boston, MA.
“I can help refine ideas and offer advice regarding clinical and commercial development strategies. This includes discussion of target patient populations, trial design strategies, potential payer management of new therapies, and competitive positioning.”
SUMMARY OF EXPERIENCE:
Among other professional activities, Dr. Clark serves or has served as Consultant/Collaborator to NSF’s Extreme Science and Engineering Discovery Environment at the University of Illinois’ National Center for Supercomputing Applications and Biological Collaborative Research Environment at the University of Illinois’ NIH Center of Macromolecular Modeling and Bioinformatics; Senior Scientist/Vice President of Finance and Partnership Development of the Complex Biological Systems Alliance (an Ivy League/Oxbridge consortium); Computational Neurolinguist/Ethnobiologist for the Alliance for Linguistic Diversity and Google’s The Endangered Languages Project: Member of the IEEE Brain Initiative: Member of NASA Global Exploration Roadmap Workshop and Virus Focus Group at the NASA Astrobiology Institute; Guest Expert of National Academies Project on Astrobiology Science Strategy, Project on Public Health Emergencies, and Workshop on Emerging Neurotechnologies Legality; Science/Business Advisor to many proprietary and independent nonprofit organizations promoting new, rediscovery, and translational medical science, clinical practice, and biotechnology; Analytics Platform Consultant for IEEE; Postdoctoral Research Fellow at the Max-Planck Institute for Biological Cybernetics: Laboratory Coordinator and Basic/Clinical Science Predoctoral Research Fellow in Departments of Psychology, Physiology, and Plant Biology at Southern Illinois University: Member of many professional societies: Editor for numerous professional journals and technical books; and Manager/Technical Advisor/Mentor for STEAM scholastic, entrepreneurial, and community outreach programs sponsored by the Society for Neuroscience, the Howard Hughes Medical Institute, and NSF. He also has (co)authored over 60 peer-review scientific journal articles and book chapters, helped generate millions of US dollars in research funding, licensed several patents, and received extensive multimedia press attention for his collaborative science, entrepreneurial, and charitable activities.
Dr. Clark’s award-winning research and patented inventions improving learning, memory, and recovery from traumatic brain injury through peripheral neuromodulation gained recognition from MacArthur fellow Dr. James McGaugh and other members of the National Academy of Sciences, USA. This work involving cognitive-emotional restructuring helped launch the field of targeted neuroplasticity training and was instrumental in the US Food and Drug Administration’s decision to approve Vagus Nerve Stimulation (VNS) for complex-partial seizures — the only medical device currently marketed for treatment of convulsive epilepsy. It has since encouraged potential derivative medical indications for VNS, including treatments for Alzheimer’s disease, traumatic brain injury, post-traumatic stress disorder, and tinnitus, among other pathologies. Dr. Clark now combines his efforts on targeted neuroplasticity training with innovative machine-learning platforms to achieve more personalized realtime medical prophylaxes/treatments for neuropsychiatric conditions. Complementing these areas of endeavor, his more recentwork, stemming from collaborations with the late Dr. Sidney Fox, student and colleague of Nobelists Thomas Hunt Morgan and Linus Pauling, concentrates on rational design and application of smart pharmaceuticals, including drugs as well as nano-/microscale devices. Dr. Clark’s successes in nano-/microbioscience show promising advances in repurposed and next-generation smart technologies useful for theragnostic and regenerative medicine, in addition to other medical, industrial, and national defense purposes.
MENTORING SERVICES PROVIDED:
As a peer-respected scientist, technologist, educator, community liaison, and business leader, Dr. Clark demonstrates a history of creating local, national, and global (urban and rural) community outreach, educational, and business programs that improve career pipelines and workforce diversity, personalized and team instruction.
Marilyne is a marketing strategist who is passionate about technology-based innovations in health and life sciences that improve care delivery, disease prevention, and disease detection and management.
Her background encompasses 15 years of experience in a variety of marketing leadership roles within the health and life sciences space. This experience includes 10 years of leading marketing and thought leadership efforts for Intel’s healthcare IT and telehealth solution portfolios, and a combined 5 years of experience working with several early-stage organizations that were developing technology-based software platforms for healthcare organizations.
Marilyne has first-hand knowledge of healthcare systems worldwide and expertise in creating value propositions, orchestrating product introductions, building customer and partner relationships, and developing content that resonates with key audience segments. She has received FDA training for communications of medical devices.
Marilyne holds an advanced degree in international management from Thunderbird Graduate School of Global Management (ASU).
“I can help you with your go-to-market strategies. In particular, I can help you understand the market and competitive landscape for your products, identify target customers, and develop value propositions and messages that can be understood by technical and non-technical audiences.”
Allegory Venture Partners is a venture capital firm jointly based in Portland and Houston. Previously, Dr. Corcoran has held executive roles leading corporate development, first at Isis Pharmaceuticals and subsequently at AccelRx Pharmaceuticals.
In addition, she spent several years as a National Association of Securities Dealers (NASD)-licensed, sell-side equity research analyst covering the small cap biotechnology/life sciences sector. She was also a founding associate editor of the journal Cancer Cell.
Dr. Corcoran graduated from Swarthmore College with a B.A., earned her Ph.D. in Pharmacology from Duke University, and was recipient of the first annual Harold M. Weintraub National Graduate Student of the Year Award. She also serves on the board of directors of the Oregon Bioscience Association.
“I can offer advice to companies and entrepreneurs regarding funding opportunities and business evolution, and I am also interested in connecting with prospective executives with operational experience in life sciences businesses.”
Mr. Craw has 20 years’ experience in the pharmaceutical industry including 8 years at Merck, 5 years at ACADIA & 5 years at International Stem Cell Corporation. Ex-board member of UCSD Ext. bioinformatics program and Lifeline Skin Care a commercially successful dermatology business. He is an expert in investor relations, financing, business development, commercial and technical operations.
“I can help refine and validate ideas, business plans, market analyses, investor pitches and out-licensing opportunities. I can advice management on best practices in setting up corporate communications programs, operational and IT infrastructure.”
Mr. Curci specializes in intellectual property, technology and business law. His clients include companies in the bioscience and high tech industries. He represents these clients in a broad range of intellectual property issues and other commercial transactions including: patent/technology licensing; multi-party collaborations; clinical trial agreements and research matters; technology transfer issues; overall protection, commercialization and use of the client’s intellectual property rights, including patents, copyrights, trademarks and trade secrets; and corporate formations and the corporate governance and operations of that business entity.
Mr. has developed a bioscience practice in the Pacific Northwest, representing bioscience companies and bioscince research institutions. He is also active in bioscience-related associations. At present he is a member of the Board of Directors Cancer Research and Biostatistics, a Seattle-based institution. He is an Advisory Board member of the OTRADI Bioscience Incubator (OBI). He also is an organizer of the Pacific Northwest Life Sciences Executive Forum, a roundtable for C-level executives from bioscience research institutions.
“I represent companies in all the above referenced matters, including technology/intellectual property, patent/technology licensing, multi-party collaboration agreements and the overall protection, commercialization and use of clients’ intellectual property rights. I specialize in research matters, including clinical trial agreements, material transfer agreements, bioscience collaboration agreements, sponsored research with universities, and other research issues. As mentioned above, I also work with these companies on corporate matters, such as company formation and the governance of those entities.
I provide a no-charge consultation of approximately one hour for each bio company I mentor. This can be used for general discussion, but not for review of specific contracts.”
SUMMARY OF EXPERIENCE:
Keith is an engineering leader with thirty years of product design, test, and operational experience. He has served both as an individual contributor and manager to drive applied research and the creation of new products, intellectual property, test and analytical platforms, and manufacturing processes to satisfy customer requirements resulting in successful new product launches. He has product development and clinical testing experience in orthopedics, drug delivery devices, medical cable interconnects, and forestry applications. Keith applies his passion for mechanics, materials, and product design to accomplish something of value in companies from start-ups to large established companies. He has lectured at the collegiate level and internationally on design process, design controls, design review, failure mode effects analysis, and risk analysis and has published several scientific articles and book chapters. He has served on an international ISO team to write and implement a new medical device standard, Oregon State University Mechanical Industrial Manufacturing Engineering Department Industry Advisory Board, and the Oregon Bioscience Association steering committee that created the BioPro Workforce Training.
Keith lives in Portland, Oregon and has a BS in mechanical engineering from Oregon State University and a MS in the same with a biomedical device focus from Rensselaer Polytechnic Institute. He is licensed as a Professional Engineer (mechanical) in the State of Oregon and holds three U.S. patents.
MENTORING SERVICES PROVIDED:
“I would like to assist with mentoring individuals or teams and provide feedback on product design and development, testing, and launch of new products under NDA as needed. It is fun and I’d like to help.”
Over 22 years of experience in all facets of clinical research including 20 years in medical device clinical research. My experience includes time at one of the top-three medical devices companies as well as having experience in the start-up atmosphere. I have been responsible for the development and management of over thirty (30) IDE studies including protocol development through final report/submission to regulatory authorities. My experience includes primarily Class III devices with indications in neurology (spinal cord and deep brain stimulation), cardiac (pacemaker, ICD, valves and LVAD), vascular (stents), and orthopedics. Geographically, I have significant experience managing trials in the United States, Canada, Europe, and Hong Kong/China including extended assignments within these regions. Through various roles within the industry, I have proven excellence in the management of clinical trials and associated regulatory interaction; therapeutic and technological expertise; and KOL development and management.
“I am able to help guide the discussion around clinical trial strategy and design for medical devices from FIM through post-market.”
Dr. Down is a professor at the University of Portland’s Pamplin School of Business. His interests in teaching, research and consulting blend strategy, entrepreneurship and finance in technology environments.
Example projects include leading a study of the state of entrepreneurship in Portland and an examination of how firms achieve the right balance of strategic flexibility in their planning systems.
His degrees include a BS in Mechanical Engineering from Oregon State, an MBA from Harvard Business School and a PhD in strategic management from University of Washington.
“I am able to help companies and entrepreneurs think about and articulate their business model and strategies.”
Mr. DuFresne has 35 years of experience in the biopharmaceutical and medical device industries. He currently is CEO of Medrock, a Portland-based medical device firm, CBO of TomegaVax, a vaccine firm spun out of OHSU, as well as a partner in Alignment Ventures. Previously he served as CEO of Ischemix, Pacgen, Zelos Therapeutics, ConjuChem, Inc and Anika Therapeutics. Duffy has raised more than $200 million in equity for the companies he has run and negotiated a large number of partnering/licensing agreements. His medical device and pharmaceutical industry experience includes general management at Baxter Laboratories and Boots Pharmaceuticals.
Mr. DuFresne serves on several corporate boards as well as the board for the Portland chapter of the Association for Corporate Growth. He also is a strategic advisory group member at OHSU. He earned an MBA from the Harvard Business School.
Mr. DuFresne can provide early stage life science firms with advice related to raising finance, developing business plans, negotiating partnering agreements, in-licensing intellectual property, structuring business presentations and general strategy/planning.
Mr. Dunlap has more than 17 years of experience in finance and accounting, including the role he assumed at Galena in 2012. Prior to that he was in public accounting at large national and regional accounting firms working principally with technology and life science clients.
His career also includes positions in financial management with manufacturer Vestas Wind Systems and Nike, Inc. where he planned and executed business process and financial audits and had a leading role in Sarbanes Oxley implementation.
Mr. Dunlap holds a BS degree in accounting from University of Oregon. He also serves on the board of directors of the Oregon Bioscience Association, and as its treasurer.
“As a CPA for more than 17 years in both public accounting and industry, I have helped high growth companies get to the next level. I am prepared to assist with issues around financial reporting, fundraising, investor relations, enterprise risk management and fiscal strategy. I also can be helpful with mergers, acquisitions and other collaborative arrangements, out-licensing and in-licensing, SEC compliance, business processes, corporate governance and organizational leadership development.”
Mr. Eastman has 35 years of experience in the life science industry as an executive who develops and launches products and startup ventures in biotechnology, medical devices, systems and software. Formerly he was interim CEO at Yecuris; Chairman, OHSU Venture Start Up Advisory Group; BOD, MagnetoOrganics and NeuraMedica; senior product marketing executive at Becton Dickinson, Fresenius and Cordis Dow Medical; and managed or consulted in the launch of 26 Oregon life science venture startups.
Mr. Eastman actively works with Oregon life science scientists and physicians inventors in launching their startups. He also mentors doctoral and MST/MBA students at OHSU, PSU, U of P, OSU and UO. He is active in the Oregon venture community through the Oregon Bioscience Association and the Oregon Entrepreneur Network.
Mr. Eastman holds a BS in marketing from the University of North Colorado, an MS in marketing, business and design from the University of Oregon and has an Executive Medical Product Marketing MBA certificate from the UCLA Anderson School of Management.
“I have long term experience in working with scientist and physician inventors, high technology inventors and founders and semiconductor industry inventors in the areas of executive management, strategic planning, marketing strategy, business plan development, new markets’ research, operations/finances, product management, new product launch, angel/venture investment, strategic partnering, channel sales relationships, international distribution and industrial design implementation.”
I perform regulatory strategy for digital health companies on potential paths free of FDA regulation and regulatory/quality affairs services for FDA regulated digital health and medical device companies. I developed and run kBLASTER®, an actionable insight SaaS search of the entire contents of publicly available FDA 510(k) summaries when seeking a predicate for a 510(k) submission. kBLASTER® also offers consulting for customers needing 510(k) submissions services.
I strategically assist companies ranging from pre-revenue to mature medical device and/or digital health companies when trying to navigate the FDA regulatory landscape for their product(s). I also perform regulatory affairs and quality affairs services for FDA regulated medical device and/or digital health companies, so they can meet their FDA compliance requirements, including 510(k) submissions for FDA clearance to market product.
Mr. Elsenbach has been active in commercial real estate in Portland for more than 15 years. His focus is on companies and organizations in the technology and biotechnology sectors.
Prior to JLL he was managing principal, Cresa Partners. His awards and honors include being named Costar Power Broker of the Year six times.
Mr. Elsenbach has a BS degree in Economics from Portland State University.
He has assisted several startup companies in securing leases that are “flexible, cost effective and support each company’s vision with minimum cash outlay and maximum security.”
“I can assist startup companies in navigating the real estate market, planning for the right space and negotiating lease terms by dealing with issues that often arise for early stage businesses; such as who pays for tenant improvements and how much of a security deposit is required.”
Dr. Farrell has 35 years of research experience in coagulation, hemostasis and thrombosis, with 21 of those as Principal Investigator; Professor of Surgery, OHSU; Co-Chair of the American Heart Association Thrombosis BSci 2 Study Section; elected Fellow of the American Heart Association; Director of the OHSU Health Sciences Technology Entrepreneurship Certificate Program. He also serviced on SBIR/STTR study sections for the National Institutes of Health and is a recipient of SBIR and STTR grants. He founded Gamma Therapeutics in 2009.
“I can provide mentoring in non-dilutive funding sources, particularly SBIR/STTR and Department of Defense grants. I also can provide advice on commercializing translational research in a university setting.”
Summary of Experience:
David is a member of the firm’s Entrepreneurial Services, Corporate Finance & Transactions, and Mergers & Acquisitions practice groups. He advises emerging, small and mid-market private companies in their general corporate, financing, and transactional matters, and help founders, managers, and investors recognize and achieve their strategic goals. David also works with founders, managers, and investors who use their resources to promote the development and implementations of Benefit Company policies and practices.
Areas of his legal experience include corporate finance, mergers and acquisitions, and business counseling. David is an active civic volunteer that participats in numerous community related events and forums.
Mentoring Services Provided:
“I will provide guidance in all areas of growth and corporate governance from the initial choice of entity to exit strategies. I also can serve as a resource for financing, including clarifying investor’s expectations for different investment rounds both before and after the investment is made.
Mr. Friess is CEO of WELVU, an enterprise patient engagement platform bringing data-driven, mobile patient engagement solutions to clinics, hospitals, and health systems as those organizations seek to empower patients with actionable health information that leads to higher satisfaction, lower costs, and improved outcomes. He also currently acts as an Executive-in-Residence for OHSU Technology Transfer and Business Development, supporting the needs of principal investigators, clinicians, and scientists at Oregon Health and Science University seeking to commercialize their innovative research and inventions.
Prior to his current roles, Mr. Friess worked as Senior Vice President, Strategy & Corporate Development for Krames StayWell, following three years as President of Krames Video Solutions. Prior to joining Krames, Mr. Friess served as CEO and Chairman of wired.MD, a market-leading video patient engagement company he co-founded in 2000, which Krames acquired in 2008.
Mr. Friess has also served in leadership or founding roles at StarveUps, a non-profit peer mentoring organization for entrepreneurs, and Cancer Awareness Group, a non-profit dedicated to cancer screening education. He has participated in medical informatics and biotechnology research at the Oregon Health & Science University School of Medicine, Baxter Healthcare, and Abbott Labs. Mr. Friess studied two years of medicine at the OHSU School of Medicine, before his patient education research became the genesis of wired.MD. He holds a Bachelor of Science in Microbiology and a minor in Management from Brigham Young University.
MENTORING SERVICES PROVIDED:
“While my personal career focus has been in Health IT and Digital Health, I have mentored companies across a broad range of disciplines, markets, and status of company life cycle. If I can add value to your efforts I am eager to support your entrepreneurship and innovation across all areas of medicine, healthcare, and biotechnology.
Mr. Galen has worked in medical device companies for 30 years and released more than 50 products. He has worked as an engineer, project manager, director, VP and CEO. His experience working at all levels in the business enables him to understand the details, as well as the “big picture,” which results in successful solutions and high quality product launches.
Mr. Galen has had two successful company exits, the most recent a company focused on preventing blindness, Quantum Catch Corp. This was sold to an Australian non-profit company. He also co-founded and ran CardioDigital, Inc. to Covidien (formerly Tyco Healthcare).
Mr. Galen’s experience in product development and manufacturing began in Asia in the late 80s and included setting up a Welch Allyn R & D affiliate in Singapore for emerging companies. He also managed a large cardiovascular lab for Hewlett Packard.
Mr. Galen has had more than 16 patents issued and 15 more that are pending. He serves on several boards and helps two universities with their translational activities. He has a BS in Biomedical Engineering from Case Western Reserve University and an MS in Electrical Engineering with a biomedical focus from the University of Washington.
“I can help companies determine a good business model and product development strategy. I also can assist with funding sources, licensing and sale trade-offs.”
Dr.Gautschi teaches organic chemistry and performs research with his students on the natural product chemistry of genetically-modified fungi for antibiotic potential. Previously, he worked in business and science directorship roles at Bend Research and Agere Pharmaceuticals. He holds patents and publications on in vitro drug species testing for advanced drug delivery technologies.
“I am happy to share my experiences and background as a chemist involved in multiple start-ups. As the first employee of Agere Pharmaceuticals from its start-up days, I had to wear many hats, from research chemist to business and corporate development to hiring manager to janitor! Growing pains can be real, but many of the rewards are well worth the efforts, diligence, and patience needed to move a bioscience company from a few employees to tens of employees.
As a science writer for the start-up CyberEd in the late nineties, I played detailed roles as that garage-based firm grew and was sold to Penguin Eduction. As a business development director at Bend Research during their transition to a multi-client business, I experienced first-hand the need to sell your ideas and science to the science community worldwide.”
Ms. Gerlach has more than 25 years of experience including mergers and acquisitions, securities offerings, international structures and transactions, pharmaceutical licensing, corporate and individual taxation and estate planning.
“I have experience in many areas of business and tax law and can counsel companies/individuals in these areas. I can answer questions about legal entities, tax situations and protection of technology and other rights and am not now representing clients in these areas.”
Grant Gibson is a Senior Partner with CONX Partners, a strategic medical technology market development company dedicated to enabling international growth. Previously, he has held multiple executive positions with Welch Allyn, Inc., a global medical device manufacturer, including Director of Global Vital Signs Monitoring and Director of Global Patient Monitoring. He also served as the Director, International Category Management for Welch Allyn during a three-year expatriate assignment overseas. Prior to that, he served as Group Product Director and Group Product Manager of Welch Allyn Monitoring. Previously, he was the Director of Marketing and Communications for Protocol Systems, Inc., a worldwide patient monitoring systems manufacturer, acquired by Welch Allyn, Inc. in September 2000. Gibson was the first marketing professional hired by the start-up company Protocol Systems in 1988. He has conducted major assignments in the areas of marketing management, product management and development, strategic planning, business development and investor and public relations.
Prior to working in the medical industry, Gibson held marketing communications management positions in the scientific engineering computing industry working for Floating Point Systems, Inc. from 1984 to 1987.
A 1978 graduate of the Professional School of Journalism of the University of Oregon, Gibson earned an Accredited Public Relations Society of America (APR). Gibson has won numerous awards for marketing, communications and investor relations excellence including those from the National Press Club, NAIC and American Business Communicators among others. He is a published author with numerous titles and holds multiple patents and patent applications.
Mentoring available in the following areas: “I have successfully “lived” the startup business experience and can help companies and individuals navigate the process. I have spent many years in the medical device industry and have amassed many highly effective skills and processes, particularly in the disciplines of marketing and sales, that others can benefit from learning.”
Michael Gursha is an Entrepreneur, Executive, Board Member & Startup Advisor.
Gursha is currently the Chairman & CEO of Rookie Road, Inc., a digital media technology company focused on creating unique and engaging educational content. He became CEO in 2016 after serving as a special advisor to the founder.
Previously, Gursha was appointed as the inaugural entrepreneur-in-residence at the S.I. Newhouse School of Public Communications at Syracuse University, one of the nation’s top schools of communications. At Newhouse, he worked with students, faculty & staff on entrepreneurship & innovation, lectured at Newhouse and other schools on Syracuse University’s campus and helped administration/senior leadership with new strategic ideas around innovation. Before Newhouse, Gursha was the vice president of strategic initiatives at Curemark, LLC, a New York-based biotechnology company focused on the treatment of neurological disorders. Gursha was one of the initial team members at Curemark and, over the years, held various positions with the company, including director of business development.
Gursha has extensive experience in tech, media, biotechnology and healthcare. Gursha currently serves on various boards including New York On Tech, the Whitman School of Management & SXSW Accelerator. He graduated Magna Cum Laude from Syracuse University with a dual degree in both the S.I. Newhouse School of Public Communications & the Martin J. Whitman School of Management.
Mentoring available in the following areas: Partnerships, Business Development, Corporate Development, Strategy, Financing, Intellectual Property, etc… Happy to help early stage companies with strategy and planning.
After 16 years of recruiting, I still love what I do. As the owner of Acumen Executive Search and Acumen Talent Search, I see myself as, more than anything, a matchmaker, bringing together two parties so they may partner in accomplishing business goals. At Acumen, we value innovation, creativity, and dedication in order to produce results transcending values across most fields. As Bio-Tech companies set out to explore new innovations, having the right people with the needed technical skill set as well as soft skills is what helps to drive the innovation. Without the right people, with a common mindset, goal, and complementary work style, tasks cannot be completed, and finding those people is what makes my job so fun. At Acumen, we believe that all great companies start with it’s people. I am thankful to have been included in the OBI Bio Mentor Program.
“I can help organizations identify current employee needs and aligning them with future goals by helping with workforce strategies, organizational development, and job descriptions.”
Dr. Hanson is residency trained in preventive and aerospace medicine. He has an MPH degree in epidemiology with a genetics concentration from Johns Hopkins. He was formerly Division Chief of Science and Technology at the US Air Force Surgeon General’s Office. Dr. Hanson has founded five companies, including Advanced Medical Imaging and Genetics.
His current company, Tier 7, identifies biomedical technologies that improve the delivery of health care for service personnel in war situations. Tier 7 connects the technologies of industry with researchers in DOD and other federal agencies. In total, Dr. Hanson has been awarded more than $68 million in research grants as a PI. He has published four books, 24 articles and eight patents. He is an affiliate Associate Professor at OHSU in the Department of Medical Informatics and Clinical Epidemiology.
Dr. Hanson serves on several science advisory boards and is President of the St. Andrew Foundation Board of Directors.
“I work with companies whose biomedical technologies can improve the delivery of healthcare for our warfighters. I can assess if your technology fits desired Department of Defense capabilities/requirements and determine what innovations would be required for operational use. I can assist in connecting your company with Cooperative Research and Development Agreements (CRADA) with DoD that can improve your likelihood of award success.”
Mr. Hoffman has more than 40 years of experience as an engineer, entrepreneur and venture capital investor. His career includes nuclear physics, the semiconductor industry, electronic design automation software, business consulting, university-based technology commercialization and venture capital. During his career he has started eight separate intrapreneurial and entrepreneurial ventures and served as a founder and senior executive in all of them. His governance experience includes public and private corporate board memberships as well as non-profit memberships and chairmanships. His education spans physics, electrical engineering, business and biotechnology.
As a BioMentor Mr. Hoffman can provide advice and assistance in the areas of business creation, investment strategies and capital sources, market-entry and growth strategies, corporate governance and advisory boards and for companies with origins in the academic/research sector, advice and assistance in working with institutions and researchers.
Ms. Hunt has 15 years of experience as a consultant in a wide array of industries. She specializes in startup businesses; helping young companies develop accounting systems and processes.
She has particular expertise in the technology, life sciences and nonprofit sectors.
“I can advise on basic bookkeeping services, GAAP-based financial statements and preparation for audits or tax return filings.”
Mr. Hurwitz has a blended professional background from public accounting and industry. He has served a variety of companies as CFO, controller and finance director, principally in the bioscience industry. Areas of expertise include process improvement, managerial finance, financial reporting, cross-functional team management, strategic planning, financial analysis, and startup support.
“My approach to helping young companies is to know about their dreams and try plan realization within the constraints of available resources. In addition I encourage the formation of a good accounting infrastructure to support the company and let others know this is a real enterprise.”
SUMMARY OF EXPERIENCE:
Dr. Harsh Jain has a strong research background in drug delivery of nucleotide and oligonucleotide molecules. He has 7+ years of post-Ph.D. experience of working in the Office of Biotechnology Products at US Food and Drug Administration (FDA). From 2014-2018, he reviewed several pre-IND and IND stage protein (e.g., antibodies and enzymes) therapeutic applications submitted to FDA.
MENTORING SERVICES PROVIDED:
“I can help with preparing and reviewing CMC portion of pre-IND and IND applications of protein therapeutics for submission to US FDA. Also, I can help in identifying translational potential of oligonucleotide based therapeutics.”
Andrea S. Jones (MS, MBA, PMP) has been consulting on Process Improvement and Project Management in Portland, OR since 2006 and is an associate member of the Northwest Center for Performance Excellence (NWCPE). She brings order to chaos in the initial project definition and scoping phases, and helps clients organize and structure projects for success. Andrea is a graduate of the Massachusetts Institute of Technology’s Leaders for Operations program, earning an MBA and Masters in Engineering with a focus on Lean Enterprise. She is also a certified Project Management Professional (PMP).
When beginning in business, it is easy to rely on tribal knowledge and ignore the need to document how operational processes/activities/tasks should occur. AJC specializes in designing operational processes to streamline value and minimize waste from sales to manufacturing, supply chain, and ISO preparation.
Mr. Jones is an experienced corporate manager who has served at senior manager and executive levels at a publicly listed Japanese company in Tokyo, Japan for more than a decade. He successfully led small teams working on specific projects in Operations Management, Human Resources and Corporate Sales to managing the entire country operations which included hundreds of employees.
Mr. Jones served in the US Army and was a combat engineer. He now brings together his dedication for excellence, superior customer service and integrity at Merrill Lynch Wealth Management. Mr. Jones develops custom financial strategies for his clients, both personally and for their businesses. He earned a BS from Marylhurst University in business leadership and an MBA in finance from Norwich University.
“I can advise in the areas of general management and leadership, working with business owners. I also can address banking solutions, credit and lending, company benefits planning and investment management.”
SUMMARY OF EXPERIENCE:
Dr. Kawahara has over 25 years of biotechnology industry experience in business development, M&A, in-/out-licensing, technology assessment, strategic marketing/market analysis, patent portfolio management, and R&D management. His work has spanned the spectrum of the life sciences industry: multiple therapeutic areas (oncology, inflammatory & autoimmune diseases, infectious disease, CNS, CV); discovery to late-stage development; a range of therapeutic classes (small molecule, peptides, biologics), therapeutic and preventive vaccines; platform technologies; diagnostics; and research products.
Dr. Kawahara is currently President & CEO of Elex Biotech (Portland, OR), a company developing novel drugs for the treatment of arrhythmia and heart failure. He remains active as a business and corporate development consultant with a focus on startup and early-stage biotechnology companies and has worked with >25 clients across the US and Canada. Previously, he was Executive Vice President, Corporate Development for Oligos Etc. (Wilsonville, OR), an FDA-certified manufacturer of custom GMP oligonucleotides for the molecular diagnostics industry. Prior to that, he was Vice President, Business Development, at Receptor BioLogix (Palo Alto, CA), a biopharmaceutical company focused on the discovery and development of novel biotherapeutics for the treatment of cancer and autoimmune diseases, Senior Director, Business Development, at Anesiva, Inc. (fka Corgentech, South San Francisco, CA), a developer of drugs for treating pain and inflammation, and Director, Corporate Development, at GeneTrol Biotherapeutics (Oakland, CA), a developer of therapeutic proteins for the treatment of cancer, viral infections and autoimmune diseases. He was a member of the founding management team and Corporate Director, Planning and Business Development, for Xenogen Corporation (Alameda, CA), and held positions of increasing responsibility at Becton Dickinson and Company (San Jose, CA) including Director, Reagents and Applications Development, for the Cellular Imaging Systems Division, and Manager, Licensing and New Business Development for the Advanced Cellular Biology Division. Dr. Kawahara was Director of Research, Children’s Hospital Orange County, and a post-doctoral fellow at the University of California, Los Angeles. He holds a bachelor’s degree in biology from the University of California, San Diego, an MBA in finance from California State University, Long Beach, and a Ph.D. in microbiology (immunology) from the University of Rochester School of Medicine and Dentistry. He is also a Certified Licensing Professional.
MENTORING SERVICES PROVIDED:
“I provide hands-on experience in business and corporate development (in-/out licensing; partnering; M&A), strategic marketing, preparation of business plans and investor presentations for start-up and early stage companies. I bring industry experience in multiple therapeutic areas (oncology, inflammatory/autoimmune diseases, infectious disease, CNS, CV, regenerative medicine), preventative and therapeutic vaccines as well as platform technologies and diagnostics. In addition, I have an extensive international network in pharma, biotech and venture capital communities.”
Dr. Khoury (PhD, University of Texas at Dallas) is an Assistant Professor of Management and Strategy at Portland State University and teaches the senior capstone strategic management course within the School of Business Administration. His research focuses on the role of institutions and social forces within entrepreneurship and innovation processes. Within these domains he explores how both formal (reforms; legal and political systems) and informal (social, cultural dimensions) institutions enable or constrain the strategic pursuits of entrepreneurial actors within developing countries and emerging industry settings. His work has been published in the Strategic Management Journal, Journal of World Business, Journal of Management, Research Policy, Entrepreneurship Theory & Practice, Management Decision and Global Strategy Journal.
Dr. Khoury also holds a BSE from the University of Michigan, an MSE from the University of Texas at Austin, both in mechanical engineering and an MBA from the University of Illinois at Chicago. Prior to pursuing his doctorate in organizational studies, he worked for 12 years in the area of micro/nanotechnology in various senior management and consulting roles related to research and development and product development strategies. He also is the inventor of 42 US patents.
Dr. Khoury’s area of expertise is with regard to alliance strategies-how they can be effectively leveraged towards an IPO or within licensing relationships. He would be happy to answer questions about how to select a good alliance partner, how to manage these relationships effectively, but would not be able to seek alliances or partners or draw up agreements to support these relationships.
Dr. King leads Virogenomics’ early stage diagnostic and therapeutic development projects. Previously he was senior manager of lead validation at Rosetta Inpharmatics and manager of compound profiling at Acacia Biosciences.
His degrees include a BS in engineering physics from the University of Arizona and a PhD in biophysics from University of California at Berkeley. He conducted postdoctoral research on DNA repair at the University of California, San Francisco and was a Human Frontier Postdoctoral Fellow at the University of Bern, Switzerland.
“I can provide guidance on SBIR/STTR applications and evaluation of early stage technology and intellectual property.”
Mr. Kirschner has worked with universities in licensing technologies and headed startups for telecom, biotech, nanotech and aerodynamic tech. Experienced, strong and able from a hands-on perspective.
He recently wrote a startup manual, written for the non-business entrepreneur, a comprehensive primer on what to do and not to do, what to expect and how to be successful. The manual has 27 appendices, each of which is a hands-on tool for success.
More information on Robert’s background can be found at www.linkedin.com/pub/robert-kirschner/54/775/27a.
“I am the business guy. Much like a house needs a strong foundation for it to not fall, so too a startup needs a strong business foundation to not fail. The founder can and should focus upon development and commercialization of products and services. S/he should be able to rely on the business foundation being a positive and not a negative. I have few limits-one is drug commercialization experience. Otherwise my startup experience (JD, MBA, BBA/CPA) and capability are without equal and an excellent fit for entrepreneurs and their startups. I can help avoid the ‘big surprise’-the fatal mistake that serves to kill the opportunity. Other ways I can help include assessing opportunities from investor perspectives, mentoring entrepreneurs to raise money and pre-qualifying startups to investor selection criteria.”
Ms. Kubisiak has more than 15 years of executive-level experience in marketing, sales and business development at companies ranging form startup to Fortune 500. Her background encompasses a broad range of technology-based business-to- business markets.
Before moving to the Portland area, she was General Manager and Vice President for the $180 million Kodak Health Imaging western region. She moved to Portland to join a dental device startup as Vice President of Marketing and Sales. Ms. Kubisiak also has served as Marketing Director at MedicaLogic, Director of Corporate Marketing and Global Sales Operations at Planar and Vice President of Marketing and Business Development at PacStar. Most recently she was Director of SaleS and Marketing at CP Medical, where she led marketing, sales and customer service.
Ms. Kubisiak has a BS in chemical engineering from Washington University in St. Louis and an MBA from Stanford University.
“I can facilitate strategic planning efforts, and, in particular, assist with the marketing and sales strategies. I also can help convert the marketing and sales strategies into specific “Go to Market” tactics. Having rebranded three companies, I can be a resource for any brand development activities.”
Jill Lam brings over 20 years experience in financial and operational leadership roles in healthcare, software development, retail and service industries, primarily with companies in high growth phases of their development. Jill brings solid experience and skills in accounting, functional resource optimization and alignment, data-driven business modeling and analysis, process development and controls, financial reporting, data-mining/informatics, and operations. By aligning people, processes and systems, Jill enables her clients to both effectively manage their current business and efficiently scale their accounting/finance function to manage growth. Jill has served as Director of Consulting for AxiomEPM, a financial software company, Director of Finance for FamilyCare Health Plans, Financial Software Implementation Consultant for Business Objects, and Operations Manager for Northwest Medical Services. Jill is currently a Principal with PlusPoint Consulting.
“I can provide guidance in setting up and managing your accounting and finance systems to support your organization.”
“I specialize in positioning and crafting messaging specific to your target audience. I can also help identify the target audience and translate complex technical jargon into something that a 5th grader can understand.”
Mr. Lillegard was the co-founder of Floragenex, a genomics company created to commercialize technology from the University of Oregon. His experiences at Floragenex included building a team, raising capital and commercial launch.
“I am very interested in helping entrepreneurs navigate the early stages of an idea and how to build value around innovation. I understand early stage IP and licensing issues and am happy to help with the early market validation. My passion is helping entrepreneurs understand that the business model is the product they need to develop.”
Molly Lindquist, a mom and breast cancer survivor, founded Consano, a 501(c)(3) crowdfunding platform for medical research, after her cancer diagnosis in 2011 at the age of 32. Molly graduated from Stanford University with a degree in economics and went on to work as an investment banking analyst in the consumer group at Robertson Stephens. After her stint in banking, Molly transitioned into the corporate world, traveling the globe sourcing products for World Market and then doing company planning for the Banana Republic brand of Gap Inc. Molly blogs about her cancer experience for the Huffington Post and was named a 2014 Knowledge Networks Rising Star by Portland Monthly magazine, a 2014 Orchid Award Winner and a 2015 “40 Under 40” award recipient by the Portland Business Journal and a 2015 Honoree of the one hundred. She is also the proud recipient of a “Best Mom in the World” mug.
“My pre-Consano work experience focused on corporate finance and strategy so I am happy to chat about financial modeling and strategic planning. Given Consano is a crowdfunding platform, I am happy to also chat about alternative funding opportunities and strategies (including crowdfunding).”
Dr. Lovely was a founding team member and key technologist for Photon Kinetics, Inc., Fiber SenSys, Inc. and AirAdvice Inc. He is a multi-disciplinary physicist and consultant with deep experience in instrumentation and metrology problems, including biomedical instrumentation, optics, performance enhancement, low-cost design, patents & intellectual property issues, mathematical modeling, analytical methods & algorithms, and finding meaning in data.
“I would enjoy assisting entrepreneurs whose primary technology is biomedical (such as molecular biology), but who need good instrumentation and/or analytic methodology to exploit the value. I enjoy developing the vision of a path to commercialization, identifying key technical obstacles and challenges, choosing technical approaches and architectures with the most promise, defining work to be done in partnership with other entities such as academic labs, and analyzing intellectual property positions.
Kate is currently a Senior Product Specialist for Mosaic at KeyBanc Capital Markets. Previously, Kate has worked in operations for Blackstone, Exo, and Capital Good Fund. She has her MBA from Providence College.
“I can provide investor perspective on the digital health landscape and potential barriers to entry for healthcare technology companies. In addition, having worked for startups in the past, I can assist with basic company formation question.”
Mr. Mace is, and has been a medical device business consultant and has expertise in technology assessment, market analysis, strategic planning, investor presentations, fundraising, public relations and strategic partnerships.
He has been a vice president of research and development and headed general and technical management of corporate R&D, strategic product planning, clinical trials management, intellectual property management, OEM and contract technical sales, multidisciplinary product development, and high technology manufacturing operations.
Before that Mr. Mace was founder and vice president of product development, during which he led business development, product planning, market analysis, product development, regulatory compliance and technology licensing.
Mr. Mace specializes in medical device technology assessment, market research, clinical needs assessment, business strategy, technology licensing, product development, non-invasive medical sensors, physiological monitoring and program management.
“I have more than 35 years in various product development management roles that cover a wide range of medical device technologies. I maintain close contact with senior industry specialists as well as keep current with new industry advancements. I am best suited to advise senior management of early stage medtech companies.”
Mr. Makar is a successful life sciences executive with both US and global experience in strategic leadership, business development and general management; as well as raising capital for both startup and established organizations. His efforts have resulted in the exceptional growth of multiple billion dollar blockbuster brands including Diovan®, Lipitor® and Voltaren® through innovative strategic leadership supported by securing hundreds of millions of dollars in resources. He also has excelled in smaller startup ventures and ran a public company as CEO.
In December 2013 he assumed his current position with Azure Biotech, a privately held women’s healthcare company. Previously he was a consultant to senior level executives and board members with various companies in the pharmaceutical and other sectors.
Mr. Makar served as president, CEO and director for Bioject Medical Technologies Inc. (BJCT) from October 2007 through November 2011. Prior to that he engaged in a number of entrepreneurial ventures providing consulting services with a focus on specialty pharmaceuticals and technology. He led business development and fund raising efforts for Keisense Inc., a technology startup, and co-founded Mesa Therapeutics, an emerging specialty pharmaceutical company, where he retains an advisor role.
Between 2000 and 2005 Mr. Makar served as vice president of marketing, then general manager, for the therapeutic business unit at Berlex Labs, the US division of Schering AG, which later became Bayer Health Care. Prior to that he held strategic and tactical marketing positions at Novartis and Parke-Davis.
Mr. Makar earned a BS in pharmacy from Rutgers College of Pharmacy in Piscataway, New Jersey and an MBA from Columbia Business School in New York. Currently he is on the board of directors of the Oregon Bioscience Association and Mesa Therapeutics. He also is a member of the Dean’s Leadership Council to the Ernest Mario School of Pharmacy at Rutgers.
“I can provide strategic and operational guidance to life science organizations. This can involve strategic planning, corporate structuring, board development, financing, early stage R&D, marketing plans, business development, clinical strategies and raising capital in sectors including digital health, medical devices, pharmaceuticals and cosmetics.”
Mr. Malhotra has 20 years of experience in the high tech industry. At present he works with commercial real estate, adapting his expertise to solve real estate needs for entrepreneurs. Informally known as “the geek who can speak tech, business and real estate,” Mr. Malhotra blends his technology expertise with the requirements of business owners and managers. He has had senior executive roles at public multinationals such as Intel and Cadence, in addition to VC-backed startups in software and clean tech.
“I am deeply connected in the Portland and startup angel/VC community. I have been a mentor at PIE (Portland Incubator Experiment) and TiE Oregon. Because of this I can assist with making connections to this community, or I can guide new business owners with marketing, positioning and pricing. I also can assist companies with finding office space locally, nationally and internationally. This includes leasing, labor analytics and workplace strategy.”
Ms. Malone is a patent attorney with a background in biotechnology.
For more than 12 years, she has been drafting and prosecuting patent applications in the areas of pharmaceuticals, novel chemical compounds, immunology, immunotherapy, inhibitors of cellular differentiation, cellular assays, transgenics, siRNA, neurology, biomimetics, biosensors, nanotechnology, bioinformatics, molecular biology, immunology, cell signaling, diagnostics, genomics, medical devices, proteomics, software and nanotechnology.
Ms. Malone began her practice at Kilpatrick and Townsend in Atlanta, Georgia, and currently practices independently in Portland, Oregon.
“I can discuss overall strategic development of a patent portfolio and potential pitfalls that exist prior to filing; as well as tools and strategies for protecting intellectual property.”
Ryan Miller has been designing insurance strategies since 1990. He has worked with hundreds of startups and has witnessed the different milestones of business development. From garage startups to International software companies with 300 + employees he and his team have seen the mistakes and successes at each stage. Ryan holds designations as a Certified Insurance Counselor (CIC) and Certified Work Comp Advisor (CWCA). His team is passionate about educating clients and helping owners accelerate their business models.
You’ve got a product, an idea, a stalemate.
We’ll tell your story.
Moore Creative helps clients sift through the all the latest-and-greatest digital marketing possibilities with a simple goal: to make your communications not just creative but strategic.
We deliver content marketing, branding, public relations, web content and social media projects based on analytics, on the digital and offline channels that make the most sense.
For more than 25 years, principal consultant Merry Ann Moore has helped corporations, startups, PR agencies, government, small businesses and NGOs reach and persuade their audiences. Moore Creative can help you, too.
Branding (company and product naming, taglines, brand differentiation pyramids). Content marketing (explainers, blogging, white papers, video, infographics). Earned media (press releases, blogger/influencer outreach).
Mr. Murray has more than 20 years of experience in executive management experience in medical devices. He is President at Murray Consultants LLC, an operations strategy and program management consulting firm focused on the bioscience, wireless and related industries. Clients include start-ups, companies with existing revenue streams, and the Private Equity community. Areas of focus include executive guidance, organizational development, fundraising, product design, launch planning and supply chain design.
Mr. Murray spent 20 years at Welch Allyn, a global provider and manufacturer of medical devices. Mr. Murray had served on the Oregon Bioscience Association for 10 years and was chair in 2012. He earned a BS degree in Mechanical Engineering from the University of California, Santa Barbara and a MS in Manufacturing Engineering and an MBA from Boston University.
” I have many years of medical device experience in areas of product development and launch, commercialization, supply chain development, and related areas. I am happy to help develop effective operational strategies and assist in their implementation.”
Dr. Newman has more than 30 years of experience as a scientist, engineer, entrepreneur and venture capital investor. He started his career as a scientist at MIT, developing and validating techniques for planning and delivery cancer therapies based on non-ionizing radiation. His discoveries led to four patents. He left MIT to found a start up based on this research.
Dr. Newman then entered the venture industry to focus on early-stage investments, launching NTV in 2002. He serves on numerous corporate boards within the NTV portfolio and spends time advising students and entrepreneurs on strategies for business launch and growth.
As a BioMentor, Dr. Newman can provide advice and assistance in the areas of business creation, investment strategies and capital sources, market-entry and growth strategies, and, for companies with origins in the academic/research sector, advice and assistance in working with institutions and researchers.
SUMMARY OF EXPERIENCE:
Michael Phillips represents domestic and international clients in securities, mergers, and acquisitions, general corporate and business law in the life sciences and high tech industries. He assists clients in private offerings, formation of joint ventures, and ongoing compliance with state and federal securities laws. Michael also provides corporate governance and business advice to boards of directors and executive officers.
MENTORING SERVICES PROVIDED:
“With 35 plus years of advising businesses, including 2 years as in-house counsel, I can bring not only the required legal expertise to help a company and its founders achieve their goals and succeed, I offer the experience of having been through complete histories of startups, from startup through initial public offerings and acquisitions.”
Mr. Philouze is an executive with a track record of building novel businesses in purpose-driven industries such as Health, Food & Nutrition, and Industrial biotechnology, to create value for investors. Avid learner looking to apply his relentless drive, executive presence and broad scientific aptitudes to bring novel technologies and products to market for maximal differentiation. ACCOMPLISHMENTS: Built revenue-generating industrial biotech from the ground up in less than four years. Attracted >$20M financing. Built industry-wide brand equity for innovative plant cell culture technology. Health & Nutrition industry recognition as laureate of the 2013 NBJ Innovation Award and Frost & Sullivan 2014 Global Visionary Innovation Leadership Award. Managed a multi-site >$30M business in the context of a challenging integration. Attracted and developed key talent to carry change momentum in a growing company. Jointly built private equity mid-cap life sciences practice. CAPABILITIES: Strategic vision setting for blue ocean opportunities. Partnership development. Product Development to target market unmet needs. Strategic selling for novel concepts. Superior learning ability in a science-driven context. Relentless drive to succeed. High self-awareness. Strong resilience vs. uncertainty. Well-rounded multi-cultural management. Deep understanding about value creation process for investors SPECIALTIES: CEO | President | Boards | Private Equity | Full P&L | Innovation | Strategic M&A | Post Merger Integration | Product Portfolio Optimization + Management | Change Leadership | Cross-functional Alignment | Consumer Products | Food + Beverage | Biotechnology company | Team Building | Process Improvement | Corporate Development | Life Sciences company | Growth financing | Innovation process | Regulatory approval | GMP compliance | New Product Development | Claim substantiation
“I can offer CEO-level business advisory services including corporate strategy, business plan development, product strategy, product launch, press coverage, scientific advisory board management, business development, M&A sourcing and execution, fundraising.”
Dr. Piniewski is a health tech enthusiast with many years of healthcare experience most recently as Chief Medical Officer of PeaceHealth Laboratories serving Alaska, Washington and Oregon.
She inspires multidisciplinary collaboration with multiple academic centers and passionately supports consumer health strategies.
“I have many years of experience from every angle of healthcare as a physician, a researcher and an author. I am happy to help hone effective healthcare strategies, optimize clinical utility of solutions and provide feed back from the healthcare perspective.”
Dr. Polliack has more than 20 years of experience in new product development, product launch and executive management experience in the medical device area. He is principal at Bridge Biomedical, a management consulting firm, where he assists startups and emerging businesses with new product development and launch, business development and business strategy. Dr. Polliack spent 13 years at SAM Medical, a global provider and manufacturer of medical devices for trauma. At this company he was President and COO for the last eight years.
Previously he was research and development manager at Derma Safe Systems, a medical materials startup. Before that he was project manager at the Rehabilitation Engineering Research Center at Rancho Los Amigos National Rehabilitation Center. During this tenure, he also was adjunct faculty for the Department of Biomedical Engineering at the University of Southern California.
Dr. Polliack serves on industry association boards, including the Oregon Bioscience Association, which he chaired in 2013. He holds numerous patents worldwide. He earned a BS degree in chemistry from the University of Michigan and a PhD in biomedical engineering from Oxford University, England.
“I offer broad area consultation in the medical devices, biomaterials, diagnostics/biomarkers and healthcare space. My areas of focus include executive/founder guidance to those who might not have adequate business knowledge. I also offer new product development strategy, road mapping and management, market research and go-to-market strategy and business development, especially internationally. Additional areas of guidance include patent, supply chain and regulatory advice.”
Vinay Rao is an experienced entrepreneur and a Data Scientist. Biology and life sciences are becoming increasingly Data Problems. Machine Learning and Artificial intelligence can augment life science research and innovation significantly. Vinay has cofounded a machine learning platform called RocketML, built to handle complex life science datasets and use cases efficiently.
Vinay is happy to help anyone with Machine Learning and Data Science problems. He is also a co-organizer of meetup called Portland Data Science with more than 2000 members. In addition, Vinay is an obsessive product editor with deep expertise in listening, interpreting and inventing on Customer needs and wants. He can also help startups with Marketing, Product Management and Outbound Sales advice.
I can help with Machine Learning, Data Science and Customer engagement strategies. Plus any startup related topics.
SUMMARY OF EXPERIENCE:
Brendan has nearly twenty years of experience in licensing, business development, and strategy consulting for life science companies.
He has been responsible for leading the academic technology transfer groups at both OHSU and UCLA, and has been personally involved in 4 start-up companies.
Brendan received his undergraduate degree from Harvard College and M.B.A. from Harvard Business School.
MENTORING SERVICES PROVIDED:
“I have written two VC-funded business plans, and been a judge for multiple pitch competitions. I can help with business planning, commercial assessment, presentation development, and technology licensing.”
Mr. Replogle is the Projects Director of ScienceDocs, Inc., a leading provider of specialized SBIR grant writing and other support services. Mr. Replogle has a broad educational background that includes business, writing, science and epidemiology. He is one of the founding members of ScienceDocs and has a broad perspective that enables him to understand the needs of small scientific and medical businesses.
Mr. Replogle can advise on positioning a startup for SBIR/STTR funding and also can provide further support for proposal writing, editing and patent support.
A senior level marketing strategist that is revenue driven. Having started as a mechanical engineer in college, Holly understands how difficult it can be to translate the story behind the science into a market reality. Born and Raised in Texas, Holly pursued marketing at the University of Maryland. She has lived and worked in the Caribbean, France, Utah, Washington DC, and Texas, until finding her home in Oregon. She founded the B Corp certified, strategic marketing & branding firm, Green Rising Marketing in 2008. She most enjoys helping CEOs who are willing to take action, go the full mile, test new theories, and be accountable.
Holly works with CEO’s to pair an operational understanding with marketing process to help businesses reach their potential. Unlike your average marketer, we will regularly review your P&L, funnel, and marketing efforts to realize quantifiable change. We will set milestones, track KPI’s, and push you out of your comfort zone with marketing processes that make sense for a start-up, that are actionable, and attainable on a budget. This work is for those with excellent follow-through, who just need a little accountability, encouragement, and marketing skills to point the way.
Dr. Ryan has significant experience in the pharmaceutical industry, engineering and scientific research. She founded the Ryan Consulting Group, a company that focuses on medical, commercial and partnership strategies. Dr. Ryan holds a PhD in Biomedical Engineering from the University of Utah, a post doc at the Cardiovascular Research and Training Institute, a BS from the University of Colorado in aerospace engineering and has more than 20 years of experience with Fortune 500 companies in both engineering and pharma.
Dr. Ryan serves on a hospital institutional review board, is a scientific advisor with several for profit businesses and holds leadership positions with several science-related non-profit organizations.
Dr. Ryan provides business development consulting to life sciences organizations and has strong expertise in medical, commercial and partnership strategies for concept, startup and mid-size well established companies. Dr. Ryan’s broad range of expertise positions her to offer a global perspective and offer diverse knowledge from a range of disciplines.
Mr. Rylander has more than 40 years in the pharmaceutical, biotech and medical device industries. His experience ranges from sales to management, operations, managed care, distribution, orphan diseases, human resources, fundraising, and other areas related to these business areas. He focuses on startups.
“I can help people and companies from early concept development through commercialization, including building a case for funding, evaluation assessment and organization an environment for success. I also can develop presentations to multiple audiences.”
An investment partner with Seven Peaks Ventures and director, management & operating engagements with the Cascadian Consulting Group, Ms. Schmid also serves on the board of Amplion, Inc, is steering committee member for the Bend Bio Consortium, and was a panelist and judge at the 2014 Bend Venture Conference. She also volunteers as a mentor in Bend’s top accelerator, Founder’s Pad and with other local organizations and charities in the Bend community.
Previously she served nine years as business director for several products and medical device divisions at Philips in locations from Bend, Oregon to Vienna, Austria. She scaled up small acquisitions for the corporation, helped with turnaround, product-line divestiture, business growth strategy, new market penetration, and overall general management for stand-alone facilities.
Prior to that, she led product management teams at two start-ups; one in medical software serving the pharmaceutical industry, and the other partnering with AT&T in the telecom market.
Ms. Schmid graduated from Boston College with a BA in human development/psychology, and received an MBA from Portland State University.
“I can provide introductory strategic guidance on the venture capital investment landscape, critical business growth and change stages as business scales, and/or leadership mentorship and support.”
Ms. Sego is a financial manager with more than 30 years of investment banking, treasury, corporate finance and CFO experience with companies ranging from early stage to Fortune 500. She has raised more than $1 billion of equity during her tenure–$125 million in change of control transactions, $10 million of angel funding, and $900 million in domestic and international structured financings.
Ms. Sego’s industry experience encompasses the high tech industry, utility industry, healthcare and banking. She is known as a problem solver in startup, turnaround and workout situations using her strong marketing, technical, transaction and team-oriented skills. Ms. Sego passed her Series 7, 24 and 63 securities license exams. More background and contact information is available on Ms. Sego on LinkedIn.
“I am most helpful in mentoring on topics of corporate structure, advising on funding options, setting up financial systems and financial modeling. I also can assist the entrepreneur in writing executive summaries, business plans and presenting to investment audiences.”
Ron did his academic training at Princeton, Stanford and Harvard Medical School and is a 15 year veteran of Biotech in the Bay Area working at Affymetrix and also as a serial biotech startup entrepreneur. Being an early adopter and scientific advisor to the Do-it-Yourself Bio (DIYBio) movement has influenced the flavor of lean startup models being created at IndieBio. IndieBio SF is the most prolific Biotechnology Accelerator in the world, funding 30 companies a year.
“I can do pitch and business plan assessments.”
Ms. Shortell has a passion for product innovation and an engineering mindset that is always searching for the simplest solution to complex problems. She leads Simplexity Product Development, a firm of approximately 85 people across four west coast offices. Simplexity has been selected by leading technology and bioscience firms to design their products and equipment. In 2017 Simplexity was selected by Inc. Magazine as one of the Best Workplaces in America and by the San Diego Business Journal as one of the top 100 Fastest Growing Companies.
Ms. Shortell graduated at the top of her class from Loyola Marymount University and earned a master’s degree in mechanical engineering from Stanford University with a focus on design. She is a National Science Foundation fellow, Tau Beta Pi fellow, Institute for the Advancement of Engineering fellow and a US patent holder. Ms. Shortell was recognized by the Portland Business Journal as one of the region’s top business leaders as a 2013 Fourty under 40 Award winner and one of the twelve 2017 Executives to watch. She is also a featured speaker on topics related to women in technology and leadership and encouraging students to pursue careers in STEM.
Ms. Shortell can advise in the areas of engineering, product development, medical device design, and commercialization for companies and entrepreneurs. This includes helping estimate the development plan and engineering budgets needed to bring a product to market, including compliance with ISO 13485 medical device design standards. Her team of engineers can also help advise the best product architecture when transferring from a prototype to a product that will be producted in mid to high volumes.
Mr. Smith specializes in advising providers of software, data, analytics, information and services solutions to the global healthcare and life science industries. He is the former CEO and President, Lippincott Williams and Wilkins, the medical publisher headquartered in Philadelphia. Prior to that he was President, Kluwer Academic Publishers, the science publisher headquartered in the Netherlands. He is a graduate of Duke University and the University of Wisconsin.
Mr. Smith offers services to the life sciences and healthcare technology areas in mergers and acquisitions, business development, strategy and market intelligence; international markets and trends; management and organizational development.
Mr. Smits has more than 25 years of hands-on experience in all aspects of the medical devices industry, ranging from various startups to global OEMs and business-to-business suppliers. His experience includes a variety of clinical applications and technologies, including diagnostic, therapeutic, imaging, surgical, interventional and implantable devices. He has the ability to synthesize complex strategic market opportunities and direct and execute new business toward growth. Mr. Smits can offer assistance with strategy, business development, strategic marketing, market development and technical sales, research and development and engineering management, business plans, SBIR funding, regulatory, IP development, licensing, outsourcing and supply chain.
Mr. Smits also can assist with talent management to build strong, high-performance teams. In addition to his role at Medspire, Mr. Smits is the current Chair, Board of Directors, Oregon Bioscience Association.
Mr. Smits can offer assistance with strategy, business development, strategic marketing, market development and technical sales, research and development and engineering management, business plans, SBIR funding, regulatory, IP development, licensing, outsourcing and supply chain.
Mr. Starr has more than 30 years in marketing and operations for medical products. His experience includes product definition, market research and analysis, commercialization/adoption path, market development, fundraising and business development for medical and consumer healthcare devices.
He was part of the original DeskJet printer introduction team that presided over rapid growth from $200M to more than $3Bn in five years. At HP Medical he developed the defibrillator strategy that led to tremendous growth in use of this technology beyond hospital settings.
Mr. Starr also co-founded Inovise Medical, developer of the Atlas patient monitor, which was ultimately funded and distributed by Welch-Allyn as the first low cost patient monitor for outpatient surgery environments.
As CEO of Sonivate, he led the restart and turnaround, shedding more than $1M in debt and raising nearly $5M, including $3.5M in non-dilutive funding. His degrees include a BA, cum laude, from Pomona College and an MBA from the University of Chicago.
“I can assist companies in strategic planning, product definition, marketing/sales strategy, clinical/economic modeling, business development and financing strategy including non-dilutive funding.”
Dr. Staton has a DVM, MBA with strong marketing, strategy and business planning background.
“I can help companies think about market assessment, market research, forecasting, marketing strategy, product differentiation and positioning.”
Accomplished senior executive automated manufacturing system architect, product designer and entrepreneur.
Acknowledged for producing innovative concepts and “out of the box” solutions.
Driven to provide elegant solutions to complex design problems.
Vast experience in automated manufacturing and processing systems for the medical device, bio-diagnostic, pharmaceutical fields.
Extensive knowledge in product and process development with emphasis on design for automated manufacturability.
Strong background in the evaluation of products, parts, and processes for cost efficiency, scalability and reliability.
Solid leadership skills, highly effective at managing, and directing the efforts of engineering and design/development staff.
Proven record of building engineering teams and successfully managing productive development projects with outcomes exceeded timing and profit expectations.
Specialties: Product Design + Process Development + Program Management + Automation Design + Design for Manufacturability + Commercialization + Cost Management + Quality Systems + FMEA + SolidWorks + Design Engineering + Engineering Management + Team Building & Leadership + IP Strategies + Customer Relationship Management + Salesmanship + Job Costing + Proposal Building + Contract Negotiation + Business Development + Entrepreneurial Leadership + Infrastructure Development + Human Capital Management
Expertise in medical device development, design for manufacture and scale-up, lean development focused on expediting the time to market. Pragmatic approach to regulatory strategies around 510k’s.
Mr. Sullivan brings more than 15 years of experience in public accounting, working with both publicly held and privately owned companies. He primarily works with middle market and emerging companies in a variety of industries and is actively involved in the local life science and technology industries. With a passion for bringing financial clarity and direction to every client, Mr. Sullivan’s aptitude and knowledge for these industries provides clients with invaluable service.
Mr. Sullivan’s primary focus is providing tax planning and compliance services to companies and business owners, including merger and acquisition structuring, state and local tax minimization, tax incentive consulting, financial statement modeling and stock option planning. He also has extensive experience with ASC740, accounting for income taxes.
“I am passionate about working with emerging companies and their founders. My goal is to become a trusted advisor who helps these companies with proactive planning, based on sound and timely financial data. My background is primarily in tax, but as part of one of the largest local CPA firms in the Portland area, we also can provide additional expertise in accounting, assurance or IT consulting.
Ms. Thomas has over 15 years of experience in the medical industry. She has guided companies through the medical device regulatory maze to successfully register and launch products globally. She initially worked as a product development engineer and then transitioned to the Regulatory Affairs department. She has her RAC (Regulatory Affairs Certification) professional credential from the Regulatory Affairs Professional Society. Her medical product experience ranges from research on novel devices, to orthopedic implants, jet injection devices, orthodontic devices, and more. Alyssa is currently the principal consultant at Allegiance Regulatory Consulting LLC. Prior to her work in the medical industry, Alyssa worked as a process engineer, engineering manager and supplier quality engineer in the high-tech industry.
Alyssa can provide advice and assistance on regulatory strategy planning, global new product registration submissions, compliant quality management systems, regulatory authority interactions, compliant product labeling and interpretation of global standards, guidance documents and regulations. She can provide guidance on compliant product development activities that will allow companies to efficiently navigate the regulatory maze in order to launch products and generate revenue quickly.
Dr. Tucker’s company is developing pioneering molecular-targeted therapies for the world’s deadliest blood clotting diseases including stroke and heart attack. He also is a part-time faculty member in the department of biomedical engineering at OHSU.
His academic research is focused on molecular nature of blood coagulation and its role in helping develop new and safer antithrombotic treatments. He has authored 27 scientific articles, and received several recognitions including the Young Investigator Award from the International Society on Thrombosis & Haemostasis and a T32 National Research Service Award from the National Institutes of Health.
Dr. Tucker has directed nine Small Business Innovation Research (SBIR) grants as principal investigator, and regularly serves as a reviewer for NIH SBIR/STTR grant applications. He also helped negotiate a strategic alliance with Bayer Healthcare.
His achievements were recognized in 2015 when he was selected as a member of the Portland Business Journal’s “40 under 40” class. His educational credentials include a BS degree from University of Oregon and a PhD in biomedical engineering from OHSU.
“I can assist in areas of business creation, formation of a good accounting infrastructure to support Federal grants and general management and leadership. In addition, I can advise on negotiating partner agreements, licensing technology from academic institutions, preparing for A-133 audits and all aspects of SBIR/STTR grants. I also can consult on biologic drug development in the preclinical stage.”
I have worked in project management for approximately 15 years, and consulting for the last three. During that time, I have worked with biotech clients (drug development). One of those was in Oregon. At my prior employer, I worked directly with Oregon State University’s Ocean Sciences program for approximately three years. Academically, I have an MBA and professionally I hold my PMP.
My firm works with many biotech companies, and also served as an in-house consultancy for BARDA.
“I can help with questions on structuring projects, tracking performance, aligning schedules and budgets, and planning/executing projects. In short, I can help young companies with project management.”
Ms. White is a medical device executive with a career focus on commercialization of innovative technology. She is currently CEO of Hemex Health, Inc., which focuses on new medical device solutions for the developing world and underserved markets. Ms. White’s background is in developing and launching new consumer and medical technology, identifying global distribution channels, creating strategic partnerships, and building new companies. After a 13-year career at Hewlett Packard in marketing, R&D and international, Ms. White was co-founder and CEO of Inovise Medical, successfully raising $70M in venture, corporate and grant funding and developing three product lines distributed by corporate partners. Ms. White was also the VP and General Manager of RS Medical in the pain medicine market and then the Chief Commercial Officer for Brien Holden Vision Diagnostics, a social enterprise focused on eye care and traumatic brain injury. Ms. White has an MBA from The Wharton School at the University of Pennsylvania and a BA in international business from the University of Washington. She is also an active Northwest mentor for Springboard Enterprises, an organization dedicated to building success for women-led start-ups and improving access to equity markets.
“I can help start-ups with business and marketing strategy, customer understanding, revenue model development, partnering strategy and how to communicate your company to investors and partners.”
Mr. Wittenbrock has directed full-cycle product development programs for early-stage and Fortune 50 companies in more than 40 industries. He has worked as a designer, project manager and CEO. He has extensive experience with innovation methodologies, new product development strategies, user-centered design, environmental and regulatory compliance, manufacturing, and management of multidisciplinary product development teams.
He is committed to vigorous collaboration toward strategies that produce market-altering concepts, while mitigating the risk of failed product introductions. Mr. Wittenbrock holds numerous design and utility patents. He has received national and international design recognition for his compelling solutions.
“I can provide insight and guidance on development plans for innovative physical and digital products including functional specifications, material selection, user-centered design goals, proof-of-concept development, commercialization timelines and budgets. Initial discussions and guidance are provided at no charge.”
Leon Wolf is a grant proposal expert with deep expertise on SBIR/STTR submissions. He provides research, writing and submission assistance to emerging companies looking to leverage SBIR/STTR Phase 1 grants from the 12 participating federal agencies. To date, he has helped more than 80 companies prepare competitive grant submissions, improving their odds at funding. He has a BS & MS in Chemical Engineering and works on contract at the FAST-funded Oregon BEST SBIR/STTR Support Center.
Consulting, review and critique on SBIR proposals including NIH and NSF.
Dr. Wolfe has a BS in chemistry from UCLA, a PhD in physical chemistry from the University of Washington, and a postdoctoral fellowship from UCSF. He has more than 20 years of experience in the biotech field, and has worked for Nalorac, Incyte Pharmaceutical, Large Scale Biology, Predictive Diagnostics and Advanced Ideas in Medicine.
A specialist in bioinformatics, informatics and instrumentation, Dr. Wolfe has built sophisticated bioinformatics tools from scratch, and developed custom laboratory information management systems for both genomic and proteomic high throughput workflows. He also has experience in artificial intelligence software development in applications such as genetic algorithms, Hopfield models and support vector machines.
“I can assist new and existing companies on how to correctly and efficiently create a bioinformatics platform that will effectively address the issues that surround data analysis, data storage and growth; how to effectively hire the correct individuals and what platforms to use for software development, as well as how to set up projects between interdisciplinary groups within a company.”
Dr. Yager has more than twenty years of experience in design, development and validation of molecular diagnostic assays for hereditary disease mutations, infectious diseases, multiple-analyte assays, pharmacogenomics and companion diagnostic assays.
He has managerial and strategic level consulting experience with several startup companies, and has done 510k and PMA submissions to the FDA for class II and class III medical devices.
His academic and healthcare affiliations have included University of Oregon, Weizmann Institute, Kings College London, Hospital for Sick Children (Toronto), and cross-appointment to the department of Molecular/Medical Genetics, University of Toronto.
“I can provide both strategic and ‘nuts and bolts’ tactical advice on all aspects of molecular diagnostics assay development. This can include design control, calibrators and controls, performance and validation studies for analytical and clinical validation and bridging studies. I also can assist with design, testing and validation of algorithms and software for data analysis and diagnostic decisions; comprehensive risk analysis and mitigation for design workflow, process and software risk.”
Dr. Yamamoto is a technical leader in new technology product development and quality assurance of implantable components used in pacemakers, cardiac defibrillators, neurostimulators and drug pumps for pain and diabetes.
In her 11 years at Medtronic Cardiac Rhythm Disease Management she focused on new business development and management of interdisciplinary, multi-cultural projects with internal business partners, external companies and in targeted collaborations with national labs and universities.
Prior to joining Medtronic she was a scientist at Motorola where she was involved in flat panel display and wireless communication technologies. She has 25 patents in the US and Japan.
Her degrees include a BS in ceramic engineering from UIUC, and an MS in ceramic science and engineering and a PhD in solid state science, both from Penn State.
“My particular expertise is providing guidance in medical device technology development and sourcing related topics.”
Mr. Youngentob is a scientist and business professional, with a background in molecular biology, biochemistry, venture startups, product/market strategies, incubation, and acceleration of high-growth companies.
“The main thing I can do is identify elements of business operations and strategies that lack internal expertise. I can use my network to connect entrepreneurs and business owners with partners who can help them reach their goals.”