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Speakers:

Arlen Meyers, MD, MBA

• Emeritus Professor, University of Colorado School of Medicine
• Faculty, University of Colorado Denver Business School
• President and CEO, Society of Physician Entrepreneurs (SoPE)
• Linkedin: https://www.linkedin.com/in/ameyers/
• Editor in Chief: Medscape Reference, Otolaryngology-Facial Plastic Surgery
• Senior Advisor, www.MI10.ai

Sabing Lee, Co-chair of the Medical Devices and Procedures Group, Knobbe Martens

Sabing is a Partner in the Orange County office of Knobbe Martens.  His practice encompasses all aspects of intellectual property law, including strategic patent procurement, patent portfolio management, intellectual property due diligence and general counseling on infringement, licensing, international IP protection and post-grant proceedings. Sabing represents clients in a wide range of technologies, with an emphasis on medical devices and procedures and materials science.  In the medical device field, Sabing has been involved in the intellectual property strategy and acquisitions of ev3 (acquired by Covidien), IDev Technologies (acquired by Abbott), CardiAQ Valve Technologies (acquired by Edwards Lifesciences), and Tornier/Wright Medical (acquired by Stryker).  Sabing currently services on Octane’s Board of Directors.

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David Byram, Senior Principal, Eversana Management Consulting

David brings 31 years of pharmaceutical, biotechnology, device and diagnostic industry leadership experience in market access, reimbursement, HEOR government affairs, sales and marketing.

David has an extensive background in life sciences management consulting focused on the disciplines of market access, launch planning, pricing, payer contracting, value dossier creation, channel and distribution, coding and reimbursement and public policy supporting rare disease, oncology, specialty, controlled substances and general medicine.

Prior to joining Eversana, David spent 5 years in market access, reimbursement and HEOR consulting leadership with Syneos Health LLC and Biotech Health Strategies, LLC.  Throughout his career, David has helped build and lead multiple startup organizations in the US and ex-US with organizations such as Janssen Biotech, formerly Centocor, Inc., Braeburn Pharmaceuticals, Orexo US, Indivior, Immunex Corporation and Sanofi formerly Marion Labs. For the past 22 years, David has led the access, pricing, reimbursement, channel and government affairs efforts for each of the commercial organizations he served.

David co-led the development of the reimbursement methodology for biologic medicines as part of the 2003 Medicare Modernization Act and supported the development of the essential health benefits as part of the 2010 Affordable Care Act.

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Beryl St. Jeanne, Manager, Global Regulatory Affairs Solutions, Syneos Health

Beryl St. Jeanne has been a medical device regulatory consultant for five years, providing clients regulatory solutions at Syneos Health, medical research organization NAMSA, and law firm Pathmaker FDA Law. She earned advanced certification and education, holding a Regulatory Affairs Certification (RAC-US), master’s degree in Regulatory Affairs and Services, and graduate certificate in International Regulatory Affairs.

Beryl has led many meetings with FDA and authored regulatory submissions, including numerous pre-submissions, three IDEs, eleven 510(k)s, two Health Canada medical device licenses and license amendments, and EU Notified Body response. She also authors regulatory assessments, strategies, plans, risk mitigations, competitive surveillance, gap analyses, negotiations, critical reviews, quality checks, and due diligence.

Beryl has supported clients in cardiovascular, dental, dermal, ENT, gastroenterology, general surgery, neurological, obstetrics and gynecology, ophthalmic, orthopedics, renal, respiratory, and urology therapeutic areas.

Beryl specializes in navigating the premarket pathways to commercialization for medical devices. She enjoys taking complex regulatory requirements and making them understandable and relatable for her clients. Moreover, she takes pride in being a strong advocate, helping each client advance and achieve their unique regulatory and business goals.

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Mike Daniel, Regional Director of the Orange County Inland Empire Small Business Development Center Network

Mike Daniel is the Regional Director of the Orange County Inland Empire Small Business Development Center Network, which assists current business and aspiring entrepreneurs throughout Orange, San Bernardino, and Riverside Counties and provides direct one-on-one consulting and training.  The Orange County Inland Empire SBDC is the largest business development program in the region and consists of nine service centers with more than 125 employees and small business consultants.  The OCIE SBDC is hosted at California State University, Fullerton through the College of Business and Economics.

As a business owner and entrepreneur himself, Mike started his career as the owner of a Rocky Mountain Chocolate Factory location in Manhattan Beach.  He has gone on to open several additional locations throughout the region and currently owns stores in Huntington Beach and Long Beach.  Mike is also the owner of Sugar Daddies Sweet Shoppe in Long Beach, CA, which is an old-time candy store based on “fill-it yourself” options.

Mike is a graduate of California State University, Fullerton and resides in Huntington Beach.  He has been married for 20 years and has two children that he is grooming to take over his businesses, so that he can retire.