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.
Larry has over 25 years experience in healthcare, ranging from managed care pharmacy to pricing & reimbursement. Beginning his career in 1993 as a Pharmacist at the University Of Kentucky, he has held leadership positions from 2000 to 2014 at AdvancedPCS, CVS Caremark, Louisville Health Information Exchange, AMCP and Kentucky Pharmacists Association.
In January 2011, Larry was Senior Vice President, Strategic Services at Hobart Group Holdings, where he lead a team that provided payer expertise and strategic input into customer projects, driving innovation through organic development and partner relationships. He was promoted to Executive Vice President, Managing Director in March 2013 overseeing and managing Hobart Innovations, a service and product development division of Hobart Group Holdings, focused solely on managed market strategic consultation and tactical execution.
From May 2012 to May 2017, Larry served on the Business Development and Finance Committee for the Kentucky Health Information Exchange Coordinating Council and in 2014, also held the position of Executive Vice President, Managing Partner at Precision For Value, where he led payer strategy and global market access services for life science companies.
Currently serving as Executive Vice President, Managing Partner at Precision Xtract, Larry co-leads specialists in health economics & outcomes research, pricing, reimbursement and payer analytics, working to extract valuable insights while unlocking the science, strategies and solutions that produce results in global market access.
Larry completed his managed care pharmacy residency training at Advance Paradigm and the University of Maryland School of Pharmacy and holds a Doctor Of Pharmacy from the University of Kentucky.
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.
Manfred has over 24 years experience working in the healthcare industry, focused on Innovation Management, Entrepreneurship, Oncology, Molecular Biology, and Biotechnology. Beginning his career as a Post Doctoral Research Associate at the Max Delbrück Center in Berlin and Ulm University, he established research groups to investigate the role of chromosome translocations in cancer development and molecular analysis of the role of transcription factors in cell models.
In March 1997, Manfred was Senior Scientist at the Deutsches Diabetes Forschungsinstitut, where he established quantitative methods for gene expression analysis and array fabrication. As Scientist Development Molecular Diagnostics at Variom Biotechnology AG in 2001, Manfred established new biochip detection systems for diagnosis of human hereditary disease profiles and genetic predispositions.
From August 2001 to December 2005, Manfred served as Senior Scientist und Project Manager Microarray Technology at Scienion, a manufacturer of cutting-edge miniaturisation devices for pharma and biotech applications. He then joined BioRegio STERN Management, a non-profit association for the support of life science businesses in greater Stuttgart region where he oversaw regional marketing, economic development and public relations for the cluster. His worked encompassed consultation with entrepreneurs, founders, scientists, and political stakeholders in Europe and the United States.
Currently, Manfred is Department Director at the University of Hohenheim in Stuttgart, Germany, overseeing research promotion, technology transfer and start-up activities.
Manfred holds Bachelor and Masters degrees in Biology from the University Konstanz in Marburg, Germany and a PhD in Tumor Biology from the Institute for Molecular Biology and Tumor Research from Philipps University in Marburg, Germany.
Lisa has devoted most of her career addressing complex regulatory and compliance matters for life science companies. With a speciality in FDA requirements, Lisa has been counsel on issues ranging from documentation, assessment strategies, regulatory agency standards and controls, policies and regulations.
She began her career in December 1999 at GE Medical Systems, acting as a regulatory liaison with the FDA and other international medical device regulatory bodies. From 2003 to 2005, Lisa held the positions of Manager Of Regulatory Affairs and then Manager Of Corporate Compliance Assessments And Supplier Quality for Baxter Healthcare. During her tenure there, she designed and implemented effective regulatory and quality compliance controls, led pre-market submission and post-market vigilance activities, developed corporate compliance assessment strategies and led quality systems and regulatory assessments of global Baxter operations, business units and suppliers.
Lisa has held executive level positions at Smith & Nephew, Wright Medical Technology, L2M Consulting and Oriel STAT A MATRIX, where she directed global compliance programs and provided strategic leadership and managerial oversight of the Medical Device and Life Sciences divisions.
Since August 2015, Lisa has held the positions of Associate General Counsel, Regulatory Expert and General Counsel, Regulatory Expert for Regulatory Compliance Associates, providing legal subject matter expertise on domestic and international regulatory guidelines, policies, oversight and compliance practices for global product registration and submissions.
Lisa holds a Bachelor Of Science from the University Of Wisconsin-Madison, a Juris Doctorate from the University Of Tulsa College of Law and a Masters Of Science in Organizational Leadership and Quality from Marian College Of Fond du Lac.
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.
Russ is an attorney with over 24 years experience specializing in complex IP matters, including patent trials, appeals and expert witness testimony.
He began his career as an attorney in 1994 at Schwegman Lundberg & Woessner, a boutique law firm dedicated to the practice of intellectual property law, where he drafted and prosecuted extensive numbers of patent applications in all technology areas including mechanical, software and integrated circuit related inventions. He then founded Fogg Slifer & Polglaze, an IP Litigation and Patent Prosecution law firm, serving as CEO & President managing financial, legal and employee issues.
Russ held leadership positions from 2006 to 2015 at the Intellectual Property Owners Association, Micron Technology and the Association Of Corporate Patent Counsel, promoting and maintaining alliances with external corporate entities, managing and formulating patent portfolios while establishing operational budgets and providing patent related input and support.
From July 2014-January 2017, he was selected to join the United States Patent and Trademark Office (USPTO), first as Director, Rocky Mountain Region Patent Office and later as the Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the USPTO. Initially overseeing operations and outreach efforts for inventor communities in Colorado and the western part of the United States, Russ later performed as the Chief Operating Officer and was responsible for managing all operations of the USPTO.
In June 2017, Russ returned to Schwegman Lundberg & Woessner as Principal, where he provides counseling in portfolio development, post-grant proceedings, expert testimony and IP policy.
Russ holds a Bachelor Of Science In Electrical Engineering from Iowa State University and a Juris Doctorate from Northern Illinois University.
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.