Legal, FDA, Marketing, Insurance, Managed Care & Reimbursement, Intellectual Property. For every step required for the complicated U.S. Market entry process, BioPortUSA’s team can support you and provide expert guidance. Our advantage? Industry leaders in their respective fields working on your behalf to create a seamless experience for your company.
Mark is the President and CEO of BioPortUSA, an international business development consultancy specializing in facilitating United States market entry for foreign-based life sciences companies. He has been instrumental in securing and building relationships for international clients such as Siemens, FedEx and GE while bridging Trans Atlantic relations involving foreign trade and investment. Mark is a peer reviewer for the Johns Hopkins Bloomberg School of Public Health and is an active participant in several med-tech clusters both in the USA and Europe.
BioPortUSA provides management services uniquely tailored for foreign-based life sciences companies wishing to enter the US market. Our experience and knowledge of this highly regulated and complex healthcare industry enables our clients to accelerate the path to commercialization within a framework that maximizes cost-efficiencies.
Adam Brown has more than 19 years of experience in commercial insurance and risk management services. Adam began his career while as an intern in the risk management department of a leading northeast regional independent insurance broker. He quickly achieved the necessary credentials and experience to advance to commercial insurance account executive. In 2001, the agency was acquired by a leading national broker. Based on Adam’s rapid growth of his commercial insurance business, he was elevated to assistant vice president of commercial insurance.
Adam joined OneGroup in 2007 as senior commercial insurance account executive. In 2010 he was promoted to commercial lines sales manager with responsibility for a fast-growing commercial insurance sales department while continuing to grow his expertise. In 2015, Adam earned the title of vice president before being promoted to senior vice president, manufacturing and distribution risk specialist in 2017.
Adam provides commercial insurance and risk management programs to clients in a variety of business sectors. He specializes in providing programs that are designed to fit each client’s particular needs and risk exposures.
Keith is a Creative Director with over 28 years experience collaborating with companies to craft their brand and identify opportunities for increased customer recognition, sales and long-term growth. Using clear communication and engaging design as tools, he has strategically created campaigns to help companies grow their business.
Spending the first 20 years of his career from 1989 to 2009 at Hachette-Filipacchi Media US, first as an art director at ELLE Magazine and later as the Design Director at Metropolitan Home Magazine, Keith oversaw the design, visual direction and execution of both global brands including the magazines, books, websites and corporate marketing initiatives.
In November 2009, Keith became Principal & Creative Director at D’Mello+Felmus Design in New York, a communications design firm he co-founded where he worked on brands including American Express, The Bermuda Stock Exchange, Weitzner Limited and the Coalition For Innovative Media Measurement, as well as private equity and venture capital clients.
In 2014, Keith was Director Of Brand Development for the furniture manufacturer L. & J.G. Stickley, where he planned and directed all activities related to the development of Stickley’s brand and provided strategic solutions to increase customer acquisition while directing Stickley’s in-house Marketing and Advertising agency.
Since June 2017, Keith has held the position of Managing Partner, Creative Director of 76West, a brand consultancy focused on creating a message and experience for clients that targets business growth, increased brand awareness, consumer trust, brand loyalty and increased profitability. Keith holds a Bachelor Of Fine Arts in Communications Design from Syracuse University.
Mary Ellen (Ellie) is a Principal in the Fust Charles Chambers LLP Tax Department with over 25 years of experience in public accounting and legal industries. She provides income tax planning, compliance and advisory services to the Firm’s commercial, not-for-profit and healthcare clients operating in the form of proprietorships, partnerships and corporations. She also provides income tax planning and compliance to the owners and executives associated with such entities.
Ellie has her CPA license from New York and is a member of the American Institute of Certified Public Accountants, the New York State Society of Certified Public Accountants (NYSSCPA) and is admitted to the New York State and Massachusetts Bar.
She received her JD from Suffolk University Law School and her LLM in Taxation from Boston University Law School. In addition, Ellie is certified in the National Incident Management System (NIMS) through FEMA. She has assisted many Healthcare and Not for Profit clients in developing and implementing Emergency Preparedness plans and procedures.
Rob Packard is President of Medical Device Academy, a quality and regulatory consulting firm that specializes in helping small and mid-size medical device companies obtain device clearance from the US FDA. Rob has more than 25 years of experience in the medical device, pharmaceutical and biotechnology industries. He is a graduate of University of Connecticut in Chemical Engineering. In his career to date, Rob has held the role of senior manager at several medical device companies—including President/CEO of a laparoscopic imaging company. His quality management system experience covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certification. His regulatory experience includes 510(k) and De Novo submissions to the FDA, CE Marking applications, and Canadian Medical Device Licensing. From 2009-2012, he was a lead auditor and instructor for BSI. The most favorite part of his job is training others.
Ryan Polakoff is a supply chain professional with experience in sales, supply chain optimization, logistics operations, marketing and project management.
Since 2003, Ryan has held a variety of positions for Nexterus- A supply chain engineering and technology firm that helps small and medium companies compete through the power of supply chain. Nexterus’ unique approach of modeling, optimizing and managing gives clients the freedom to build their business without being distracted by a multitude of supply chain challenges. In his current role, Ryan oversees the corporate sales, marketing, account management & professional services teams and is the head of franchise development. Nexterus was founded in 1946 by Ryan’s Great-Grandfather, making Ryan the 4th generation of the Polakoff family to work for the company.
Ryan enjoys public speaking, having guest lectured at several colleges and is a recurring guest speaker at Towson University and York College. Ryan frequently attends supply chain and related industry conferences and is an active member of The Council of Supply Chain Management Professionals (CSCMP). Ryan studied at Shippensburg University with a primary concentration in supply chain management and a secondary concentration in marketing. Ryan was also a board member for the University’s Logistics Club.
David has spent most of his career focusing on contracting, risk management, regulatory hurdles and succession. With clients ranging from medical devices, drug development and manufacturing, he has worked with life science companies within the United States and internationally.
Initially beginning his career in 1985 practicing real estate law at Hancock Estabrook and later Scolaro Schulman, David entered the life sciences arena as Assistant Counsel, Bio-Chem Division at Bristol-Meyers Squibb, where he counseled on general business matters, audits, compliance and multi-year criminal investigation. During his tenure there, he also held positions as Associate Counsel and Associate Counsel, Pharma HeadQuarters, advising marketing, licensing and regulatory groups on DOJ compliance, FDA regulations, IP management and product exclusivity matters.
In September 2002, David was Senior Counsel at Bayer Pharmaceuticals Corporation, working on FDAMA, promotional, compliance, life-cycle and implant issues for emerging technologies. He then addressed FDA related compliance issues, medical device approvals and regulations, as well as facility and product acquisitions, licensing, sales and U.S. Customs Duty & Trade procedures.
He has generated opportunities for dozens of governments, not-for-profits and businesses and helped them find ways to work together while navigating complex legal landscapes.
David is currently Of Counsel for Schuster Aguilo, in San Juan, PR, assisting U.S. based clients with labor and regulatory matters in Federal Courts, an Adjunct Professor for Syracuse University College Of Law and President of Reed CNY Business Law, specializing in acquisition, divestiture and FDA regulatory compliance.
David holds a Bachelor Of Arts in Political Science and Government from Dartmouth College and a Juris Doctor in Business, Real Estate and International Law from Syracuse University College Of Law.
During a career spanning 28 years, John has been a results-oriented leader with proven success. He has managed all aspects of reimbursement and health policy activities necessary for commercialization of diagnostic products and medical devices.
From 1992-2000, John held various roles for the State of Florida at the Florida Medical Association and the Florida Department of Health, where as Bureau Chief, he managed and administered the statewide public health program. He also was a registered lobbyist, developing strategies and tactics to influence the Florida legislature to act on issues that impacted the physician community.
John’s specialization in reimbursement has spanned 5 organizations where he has held senior-level positions, including the American Urological Association, Roche Diagnostics, diaDexus, Ventana Medical Systems and Exact Sciences. He was responsible for finding solutions for coding, coverage, procedures, policy and regulatory matters. In 2015, John founded Reimbursement Innovations to assist clients by developing and implementing innovative reimbursement approaches to mitigate barriers and capture value for product adoption. He has been published and given numerous lectures and presentations across the United States.
John holds a Bachelor of Science in Interdisciplinary Social Science and a Masters of Science from Florida State University.
Marc is a leading advisor to both foreign and domestic healthcare and food companies with expertise involving the United States Food and Drug Administration. Focusing on international trade, he advises clients on regulatory requirements and strategic corporate considerations that affect the importation, distribution and exportation of FDA regulated products. As a frequent national speaker on compliance issues affecting the food, dietary supplement and medical device industries, he is also considered a leading voice in understanding the U.S. Food Safety Modernization Act.
In 2010, Marc founded Contract In-House Counsel and Consultants, LLC, currently serving clients across the US, EU, China, and the Middle East. By utilizing a cost effective model of adding a contact in-house attorney to small and mid-sized companies, he provides expert counsel and advises clients on issues related to FDA and United States Department of Agriculture’s Food Safety and Inspection Service regulatory requirements.
He has been an Adjunct Professor at Northeastern University in the Regulatory Affairs Online Program since 2013, covering Regulatory Submissions and Food Law in the United States, along with Comparative Law and Regulatory Lifecycles focused on Europe and Japan.
Marc holds a Bachelors in Business Administration, Finance from the University of New Mexico, a Masters in International Commerce and Policy from Valparaiso University and a Juris Doctorate from Lewis and Clark Law School.
Jayson S. Slotnik is a Principal and founding member of Health Policy Strategies, Inc., a Washington, D.C. based consulting firm representing innovative biotech, pharmaceutical, device, and diagnostic companies.
Jayson specializes in, and counsels clients on, the impact that Medicare and Medicaid coverage, payment, reimbursement, coding, and government policies have on commercial success. He also has experience as a healthcare strategist with demonstrated success in developing and implementing both pre- and post-launch strategies as well as life cycle management tools for pharmaceutical, biotechnology, diagnostic, and device manufacturers.
Prior to establishing Health Policy Strategies, Inc., Jayson served as the Vice President of Reimbursement and Innovation Strategies for United BioSource Corporation (UBC). There, he was responsible for developing technology-related marketing and sales strategies for current internal and new external customers in the branded specialty pharmaceutical space. Jayson partnered with the business development team to market technology strategies to over 20 branded specialty manufacturers. In addition, he maintained his policy practice, which helped distinguish UBC’s market access technology as well as affording his clients the ability to have the business drive the policy and not the reverse.
Before joining UBC, Jayson practiced law at two prominent Washington, D.C. law firms where he counseled clients on many complex health care regulatory and legal issues related to coverage, coding and reimbursement. Before returning to private practice, Jayson served as in the initial Director of Medicare Reimbursement and Economic Policy at the Biotechnology Industry Organization (BIO), the industry’s leading advocacy group. Jayson served as the liaison between BIO and Congress, CMS, and other federal agencies to implement market access policies that stimulate and reward innovation while maintaining appropriate patient access to cutting edge therapies.
Jayson serves on the editorial boards for Value-Based Cancer Care and Specialty Pharmacy Times. He speaks regularly at various healthcare reform and market access conferences. Jayson received a Bachelor of Arts degree in English from the University of Rochester, his Master in Public Health with a concentration in Epidemiology and Biostatistics from George Washington University, and his Juris Doctor degree in Health Law from the University of Maryland School of Law.
Mary Vater is an experienced Biomedical Engineer turned Medical Device Regulatory Consultant. Mary spent her early career at Biomedical Devices of Kansas, a medical device contract manufacturer, wearing several hats during her time in R&D, Engineering, and Quality Assurance. She had the privilege of working on many different diverse projects from inception through regulatory clearance and product launch. Projects included laser-based surgical devices, electromechanical surgical tools, mobile healthcare technologies, and aseptically processed injectable medical devices.
Mary now works on a QA/RA Consulting team called Medical Device Academy, where she coaches and consults dozens of client companies from around the world, helping them receive market approvals and achieve regulatory compliance. In her first year as a consultant, Mary led complex electromechanical 510(k) projects involving over 100 device variations and received six 510(k)s for the client company. In the years since, Mary has continued to specialize in FDA requirements and submissions for devices including reprocessed medical devices, surgical sutures, software-only medical devices, in vitro diagnostics, and orthopedic implants.
Mary holds a Bachelor of Science degree in Bioengineering from Wichita State University. She is active in the Society of Women Engineers and enjoys serving on the Industry Advisory Board for the Biomedical Engineering Department at Wichita State.
Bill is a Partner at Fust Charles Chambers LLP and has 30 years of experience providing accounting, audit and advisory services for healthcare and not-for-profit industries. Bill has significant healthcare reimbursement experience and has advised clients on feasibility studies, bond offerings, debt restructuring, debt capacity analysis and corporate restructuring in multiple entity networks.
Bill devotes one hundred percent of his time to provide audit, accounting and consulting services to healthcare organizations.
He maintains membership with many professional organizations including the American Institute of Certified Public Accountants (AICPA), New York State Society of Certified Public Accountants (NYSSCPA) and he is an advanced member of the Healthcare Financial Management Association (HFMA). Bill was a Regional Executive for HFMA (representing New York State & Puerto Rico), as well as past President of HFMA’s Central New York chapter.