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.
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.
Michael is a 25-plus year veteran of the life sciences, having lead government affairs, public policy, and advocacy teams both in the U.S. and globally. Recently, he served as Vice President of Global Government Affairs and Advocacy at Novelion, as the company transitioned prior to being acquired by Amryt. He was responsible for market access-oriented government affairs and advocacy development in support of launches in Europe, South America and Japan.
While he has spent a number of years in larger global companies, he transitioned to the emerging life sciences where he led efforts in patient services, market access, payer strategies, product focused government affairs, and patient-oriented advocacy. Currently, Michael is a partner at Acuity Strategic partners where he has a practice that encompasses the life sciences, as well as the diagnostics and broader health care industry. In addition, Michael is a partner at Bridgewater Partners where he works with companies to develop compliant sales and marketing initiatives. Beginning in 2016, Michael also formed and leads a coalition of emerging, mid to large cap, and pre-market rare diseases companies and patient advocates known as the Rare Access Action Project. There he serves as the Executive Director with a focus on providing solutions to enhance patient access to rare disease therapies.
John Heffernan is currently principal at Park Street Strategies, LLC, which he founded in 2014. He represents a diverse clientele focused on biotechnology and life sciences, as well as other sectors within the innovation economy. John is a seasoned professional in association management, coalition building, government affairs and economic development. He was formerly a member of the senior management team at MassBio, the largest life sciences trade association in the world, where he oversaw federal and state policy, as well as economic development. He spearheaded efforts to create and maintain a climate in which the life sciences industry can thrive. He also led an effort to revitalize the Massachusetts Biotech Caucus, which creates a venue to educate legislative staff, elected and appointed officials and other stakeholders on the vital role innovation plays in the local economy and global healthcare.
John is a native of Boston and received a Bachelor of Arts from Fordham Universityand successfully completed the Emerging Leaders Program at the Center for Collaborative Leadership at the University of Massachusetts, Boston.
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.
As a corporate executive and Attorney with more than 23 years' experience institutionalizing global regulatory compliance in highly regulated markets, Lisa Michels is the Founder and Chief Executive Officer of L2M Global Regulatory Consulting, PLLC. Lisa possesses extensive subject matter and technical expertise in the areas of global regulatory strategy and submissions, FDA crisis consulting related to 483s and Warning Letters, and Quality Management System Implementation and/or Improvement for the medical device and pharmaceutical industries. Ms. Michels has vast medical device, combination product, and other healthcare product experience including software as a medical device, mobile medical apps, and other novel technologies ranging from low-risk (Class I), to medium-risk (Class II), to the highest-risk class products (Class III/IV - life-sustaining and/or life supporting).
Lisa has been recognized in the top 10% of lawyers in the United States and she was a recipient of the 2017 Lawyers of Distinction Award for In-House Counsel. Lisa holds a Juris Doctorate from the University of Tulsa-College of Law in Tulsa, Oklahoma; a Master’s of Science in Organizational Leadership & Quality from Marion College in Milwaukee, Wisconsin; and a Bachelor of Science in Sociology from the University of Wisconsin-Madison.
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.
Dan Remund is the President and founder of Remund Group, LLC, a Colorado based consulting firm that helps client companies increase access to and utilization of their products and services in Department of Defense (DoD) Military Health System, Veterans Health Administration, Indian Health Service and Federal Bureau of Prisons.
Dan served for 28 years as a pharmacy officer in the United States Army and completed his military career as the Director of the DoD Pharmacoeconomic Center (PEC) and Co-Chair of the DoD Pharmacy and Therapeutics Committee. After retiring from active duty in 2005, he was employed by Lockheed Martin and served as a Senior Consultant to the PEC. He joined the WSI Pharmaceutical Business Group in 2007 where he served as the Director of DoD Business Operations. In 2011 Dan formed Remund Group, LLC, where he and his colleagues have provided consulting services for more than 100 client companies.
Dan received a Bachelor of Science in Pharmacy from South Dakota State University, a Master of Science in Business Administration from Boston University, and a Master of Health Administration from Baylor University.
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.
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.