tHIS LIST WILL BE UPDATED AS WE ADD MENTORS TO OUR PROGRAM
Elizabeth Cho-Fertikh, PhD
Elizabeth Cho-Fertikh, PhD, is Founder of ECF Biosolutions, a WSH-DC based life science advisory practice comprised of MDs, PhDs & MBAs, dedicated to assisting life science start-ups efficiently navigate the path from launch to obtaining FDA IND and 510K approval for their biologics, companion diagnostics and medical devices. The practice has successfully garnered both nondilutive and dilutive seed and Series A funding, licensing opportunities, recruited Board and Scientific Advisory Board members comprised of KOLs, and developed the most cost-effective roadmaps towards regulatory IND/510K filings. Her own cross-functional expertise is rooted in 20 years of cancer biology/therapeutics bench research in academia, a decade of grants administration experience for the NIH, DoD & Cancer Prevention Institute of TX, operating management roles at biotech start-up companies, and angel investment activity. She is an Advisory Board Member of the Johns Hopkins Alliance for Science & Technology, Board of Director of Bloosurf, LLC, and Board Observer of Kitotech, LLC. She also currently serves as the Director of Science and Business Development of VLP Therapeutics, LLC, a preclinical stage vaccine start-up company with pipelines in infectious diseases, cancer and neurologic disorders. She obtained her BA from the Johns Hopkins University, her MS from Georgetown University, her PhD from Thomas Jefferson University, and completed her postdoctoral training at the NIH/NIAMS and Harvard Medical School in cancer epigenetics.
Dr. Cho-Fertikh has successfully coached numerous start-up teams in developing “winning” investors pitches for various competitions; this is her 2nd year mentoring for the JHU Carey School Entrepreneur Bootcamp.
Cathy Becker has worked as an early stage sales consultant for a variety of healthcare startups, from a pediatric mobile health app to a medication management system for seniors. Her sweet spot is market discovery: working with customers to understand their needs, problem solving to determine how the product may play a role to meet them, then developing and initiating pilots to measure ROI. She leads sales, often managing communications and marketing and contributing to product development as well. Cathy began her career as an MIT Chemical Engineer, then managed NYC accounts in pharma before supporting startups, and currently leads outreach for a private-public partnership focused on healthcare payment reform operated by the MITRE Corporation.
JIM KYUNG-SOO LIEW, PHD
Dr. Jim Kyung-Soo Liew is an Assistant Professor of Finance at Johns Hopkins Carey Business School and revels in pushing the boundaries of financial knowledge and product development both as an academic and FinTech Data Scientist. He has published pioneering research in the intersection of social media big data and financial markets. He currently teaches "Big Data Machine Learning," "Advanced Hedge Fund Strategies," and "Leading Entrepreneurship and Innovation" at the Johns Hopkins Carey Business School. Additionally, he serves as the Chairman of the Johns Hopkins Innovation Factory and has received the Dean’s Award for Faculty Excellence in 2015 & 2016. He also serves on the Editorial Board of Journal of Portfolio Management and co-authored the most read Invited Editorial "iGDP?".
He founded SoKat Consulting, LLC, which provides world-class Machine Learning / AI services to primarily large hedge funds, government agencies, select-startups, and academic institutions. SoKat unlocks the hidden value of data through thoughtful, creative solutions, comprising of actionable insights, data analytics, and predictive modeling. Previously, Jim has been with the Carlyle Asset Management Group, Campbell and Company, and Morgan Stanley. He holds a BA in Mathematics from the University of Chicago and a Ph.D. in Finance from Columbia University.
He currently lives just outside of Baltimore with his wife and two daughters, who he plans to raise as the next generation disruptors.
Newsweek's AI & Data Science Advisory Board Member -- http://www.aidataconf.com/advisory-board--speaker-biographies
NaisA Board's Executive Committee --
James (Jim) Power has guided medical device products from concept through market release for more than twelve years as part of the R&D process at Medtronic, Covidien and Datascope. During his time at Covidien, he worked with many entrepreneurs helping guide their efforts so as to maximize clinical and economic value. As a Director of Covidien/Medtronic’s Shanghai based China Technology Center he led the effort in moving breakthrough technologies from academia and small entrepreneurs to commercial success.
Thomas is the Director of Customer and Market Discovery at Chesapeake Visions, LLC. He has experience with multiple startups across various industries, with roles ranging from operations to sales, marketing, and business development. He helps projects attain funding with extensive customer discovery and commercialization planning. Leveraging a background that includes research, entrepreneurship, and customer development, Thomas fosters relationships with professionals across industries to uncover key market trends and insights. Understanding the importance of raw data collection and establishing strategic relationships, Thomas allows Chesapeake Visions to effectively understand, reach, and pursue target markets.
Steven S. Brooks, MD MBA FACC
Steven Brooks is a multi-faceted health care consultant, publisher, cardiologist and clinical trialist. Steve’s interests include regulatory strategy, scientific and medical due diligence, and medical technology commercialization. Currently, Steve is a Senior Analyst with Popper and Company, an Expert Consultant with NDA Partners, as well as a principal in Brooks Medtech, LLC. In these consulting roles Steve is active in developing thought leadership, content and consultation on multiple interconnected strategic areas. Client services included Market entry strategy, market segmentation, combined market, regulatory and reimbursement strategy, clinical trial design, and evidence development. By leveraging a large network of contacts in academia, government, including the FDA and CMS, and industry, nuanced guidance is developed for diverse client needs.
Steve is a Product Development Contributor to StepWise Medical, a medical device accelerator formed as a collaboration of medical device experts, engineers and commercialization partners. It manages the critical steps in the development of medical devices: from innovation to acquisition. In addition, Steve serves as Chief Medical Officer of Global Interconnect, a US-Asia design, engineering, and manufacturing firm with a primary focus in electrosurgical devices. Steve provides thought leadership and assists in the design process for innovative device designs.
Previously, Steve served from 2015 to 2016 as the Vice President of Regulatory Affairs and Health Economics for Ablative Solutions, Inc., a medical device manufacture with a catheter based product which performs renal denervation for the treatment of hypertension. The product is CE marked, and enrolling a post-market study in Europe. In September 2016 ASI’s 100 patient Phase 2b IND was approved by FDA and will begin enrollment. Steve facilitated the regulatory strategy including the Request For Designation which determined its status to be regulated as a drug, and led the Pre-IND and IND process for the company, with contributions to the clinical development and clinical trial design. In addition, Steve led reimbursement interests, setting up a meeting with CMS and determining reimbursement of the IND clinical trial, and efforts to obtain reimbursement of the IND trial by CMS. An Orphan Drug Designation application was submitted for a secondary indication.
Prior to joining Ablative Solutions, Steve was the Chief Innovation Officer at Sage Growth Partners (SGP), a healthcare consulting firm with expertise in healthcare. At Sage, Steve developed the Medtech Practice and managed the Canton Health Ventures incubator, managing incubator tenants, as well as launching ISOSight Medical, Inc, a line-of-sight ultrasound device company which is based off of intellectual property licensed from the University of Pittsburgh.
Previously Steve served as a medical officer for the Food and Drug Administration in the Peripheral Interventional Devices Branch and Interventional Cardiology Devices Branches. In this role he performed medical device review of cardiac and vascular-related products throughout the full product lifecycle. From the pre-submission stage, he worked collaboratively with engineers, chemists, veterinarians, statisticians to assist in design testing and risk mitigation, as well as planning pre-clinical and clinical testing programs. A large role involved clinical trial design, review of clinical trial data, and assessment of the total data submission for the purposes of product clearance and approval. Steve worked collaboratively with the Office of Compliance for consideration of Health Risk Assessments and product recalls.
Prior to joining the FDA in 2007, Steve was an Interventional Cardiologist, triple boarded in Internal Medicine, General Cardiology and Interventional Cardiology. Steve completed an MBA at the Johns Hopkins Carey School of Business in the Business of Medicine Program, and has continued to interact with the program as an adjunct faculty member lecturing on drug and device regulation and business strategy and consulting with students on their projects in the “Discovery to Market” course and the graduate and undergraduate programs as an advisor to the Johns Hopkins Centre for Bioengineering Innovation & Design (CBID). He is also a grant reviewer for the Maryland State TEDCO program for multiple funds and a medical executive in the mdPACE commercialization program.
Dean Papadopoulos was a founder and Chief Executive Officer of Bay Bridge Decision Technologies. Founded in 2000, Bay Bridge developed, sold, and supported CenterBridge, a contact center strategic planning, budgeting, and analysis software solution for Fortune 100 enterprises. Bay Bridge was acquired by Interactive Intelligence in 2012.
Before founding Bay Bridge, Dean served as Managing Director, Marketing and Analysis for the start-up credit card company Partners First., Partners First grew to become the 20th largest Visa and MasterCard issuer in the U.S. At Partners First, Dean was responsible for all customer marketing, acquisition, and management activities; as well as customer financial and behavioral analysis, operations research, predictive modeling, CRM systems, and web-based marketing and customer servicing. Partners First was sold to Wachovia Bank in 2000.
Before joining Partners First, Dean was a Principal at First Annapolis Consulting, Inc., where his industry practice areas included bankcard issuing (particularly card marketing, marketing information systems, and the financial evaluation of technology investments), merchant acquiring, mortgage banking, and ATMs. He also specialized in the functional areas of business valuation, information systems, and operational re-engineering. Prior to First Annapolis, Dean served as Chief Operating Officer and Director of First Bank, in Houston, Texas, as part of a team restructuring the bank for its sale to Marquette Bankshares; as a management consultant at Strategic Planning Associates in Washington, DC; and as a member of the founding team of Capital One Bank.
Dean holds four patents relating to the simulation and modeling of complex multi-site contact center performance. He received his M.B.A. from the Harvard Business School and an M.Sc. in Economics from the London School of Economics. He received his B.A. in Economics, magna cum laude, from Williams College.