tJûn17 Life Sciences Advisors, LLC (@tjun17)
Medical Equipment - South Hamilton, MA, US
tJûn17 Life Sciences Advisors, LLC (@tjun17) Employees
Stephen Amato
Principal Advisor & Chief Regulatory Affairs, Market Access and Pricing Strategist
Stephen Amato
Principal Advisor & Chief Regulatory Affairs, Market Access and Pricing Strategist
tJûn17 Life Sciences Advisors, LLC (@tjun17) Details
Commercializing IVD's, specialty pharmaceuticals, medical devices, and other healthcare products even in the most favorable market conditions is risky & complex - the onset of the COVID-19 pandemic has also introduced unique challenges. Normally, biomedical product launches include, but are not limited to pre-clinical, regulatory, reimbursement, pricing, manufacturing, supply chain, and quality assurance and post-market surveillance challenges. Moreover, the aforementioned variables evolve continuously and rapidly, and is driven both by public health concerns, as well as technological advancement . Therefore, despite the existence of unmet clinical and individual patient needs, release of safe and effective healthcare products is, in and of itself, not enough to drive demand and/or maximize market penetration in any global market. With over 25 years of professional experience, tJun17 Life Sciences Advisors, LLC works with IVD, medical device, specialty pharma, biotech, and other global stakeholders to facilitate the commercialization of innovative, and cost effective healthcare technologies. Moreover, tJun17 Life Sciences Advisors supports its globally-based clients in part, but not exhaustively, through the preparation of regulatory/reimbursement strategies & applications, HCPCS Level II coding applications and payment strategies, and meeting of post-market surveillance obligations. Examples of our client work includes the following:• Development and implementation of comprehensive regulatory and reimbursement/market access landscape assessments & strategies• Formulation of clinical development, regulatory, pricing and reimbursement (coverage, coding & payment) strategies, including FDA, EMA, CMS, state Medicaid submissions• Development of comprehensive product launch strategies, including pricing• Private payer AMCP value dossier prep submissions Let us know how we can help you achieve your healthcare product commercialization objectives.
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