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DTSTART;TZID=America/New_York:20250520T113000
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UID:1532-1747740600-1747749600@biostrategypartners.org
SUMMARY:To Build or Not To Build: The CLIA Lab Dilemma for Startups
DESCRIPTION:BioStrategy Partners May 2025 Practical Knowledge Series  \n\n\n\nLocation: Center for Diagnostic Discovery (206 Welsh Rd. Horsham\, PA 19044)\n\n\n\nFor entrepreneurs developing diagnostics\, the decision to build an in-house CLIA-certified lab-or to partner with existing labs–can define the trajectory of the business. Our expert panelists will demystify the complexities of the Clinical Laboratory Improvement Amendments (CLIA) framework and explore how it intersects with regulatory pathways for medical devices\, diagnostics\, and lab-developed tests (LDTs). We will dive into strategies for regulatory pathways\, reimbursement\, and how to operationalize your own CLIA-lab vs. how best to outsource your commercial development. With real-world insights from seasoned lab executives and regulatory experts\, this panel will provide you with a clear pathway to appropriately classify your product\, reach your target market\, and decide whether to build\, buy\, or partner3:30pm-4:00pm – Registration 4:00pm-5:00pm – Panel5:00pm-6:00pm – Tour & NetworkingModerator:Alexandra Smythe\, Director of Regulatory Affairs\, IDE GroupSpeakers:Robert Middleberg PhD\, Core Laboratory Director\, NMS LabsMartin Till\, President & CEO\, HNL Lab MedicineRobert Boorstein\, MD\, PhD\, Founder & Director\, ClasGroup LLC.
URL:https://biostrategypartners.org/event/to-build-or-not-to-build-the-clia-lab-dilemma-for-startups/
LOCATION:Center for Diagnostic Discovery\, 206 Welsh Rd.\, Horsham\, Pennsylvania\, 19044\, United States
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DTSTART;TZID=America/New_York:20250911T070000
DTEND;TZID=America/New_York:20250911T090000
DTSTAMP:20260403T152744
CREATED:20250813T054353Z
LAST-MODIFIED:20250815T231354Z
UID:1562-1757574000-1757581200@biostrategypartners.org
SUMMARY:From Cutbacks to Co-Development: Surviving and Advancing Research in the Current Funding Landscape
DESCRIPTION:BioStrategy Partners Practical Knowledge Series \n\n\n\nLocation: Innovation Nest\, Temple University (3223 N. Broad St.\, Suite 490 Philadelphia\, PA)  \n\n\n\n\n\n\n\n\n\nWith federal research funding becoming increasingly competitive and uncertain\, researchers and innovators must look beyond traditional funding pathways and explore new ways to sustain and progress their research. This panel will dive into creative strategies to advance early-stage technologies\, including leveraging institutional core facilities\, partnering with industry for co-development\, and conducting international research and clinical trials. Topics covered include: \n\n\n\n\nLeveraging institutional resources for capital efficiency\n\n\n\nInternational collaborations & early-stage development\n\n\n\nCo-development and collaborative grant writing with industry\n\n\n\n\nSpeakers \n\n\n\n\nStephen Nappi\, Associate VP of Technology Commercialization and Business Development\, Temple University (Moderator)\n\n\n\nHeather Steinman\, PhD\, MBA\, SVP of Business Development & Executive Director\, Technology Transfer at The Wistar Institute\n\n\n\nMax Lelu\, Senior Investment Officer\, Global Affairs Canada\n\n\n\nNadea Leavitt (To be confirmed)\, Senior Director\, AI for Healthcare & MedTech\, IQVIA\n\n\n\nIzabel Nelson (To be confirmed)\, Strategic Accounts Leader\, Life Sciences Solutions\, Global\, Thermo Fisher Scientific
URL:https://biostrategypartners.org/event/from-cutbacks-to-co-development-surviving-and-advancing-research-in-the-current-funding-landscape/
LOCATION:Pennsylvania
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20251216T100000
DTEND;TZID=America/New_York:20251216T120000
DTSTAMP:20260403T152744
CREATED:20251202T034302Z
LAST-MODIFIED:20251202T034839Z
UID:1579-1765879200-1765886400@biostrategypartners.org
SUMMARY:The Hidden Value of Data: Capturing Institutional Opportunity in the Age of AI
DESCRIPTION:As artificial intelligence transforms biomedical research\, data has become one of the most valuable yet inconsistently managed assets in healthcare and academic institutions. Much of its potential remains untapped\, trapped in biobanks that are difficult to access\, or siloed in legacy systems. Partnerships involving data are frequently being managed under outdated agreements that never anticipated its strategic worth. With no clear framework for valuing\, assigning\, or structuring data-driven partnerships\, institutions faced with opportunity and risk. This session will bring together leaders from research and industry to discuss how to identify\, protect\, and responsibly capture the value of data in the AI era. \n\n\n\nSpeakers: \n\n\n\n\nTom Thornton\, Vice President\, Jefferson Ventures\, Jefferson\n\n\n\nSangeeta Bardhan-Cook\, PhD MBA\, Chief Innovation Officer\, Fox Chase Cancer Center\n\n\n\nMichael Halaiko\, CIPP/E \, Baker Donelson\n\n\n\n\nLocation: Biolabs Advanced Therapeutics (601 Walnut St. Fl 8\, Philadelphia\, PA)
URL:https://biostrategypartners.org/event/the-hidden-value-of-data-capturing-institutional-opportunity-in-the-age-of-ai/
LOCATION:Biolabs Advanced Therapeutics\, 601 Walnut St. Floor 8\, Philadelphia\, Pennsylvania\, United States
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20260212T150000
DTEND;TZID=America/New_York:20260212T170000
DTSTAMP:20260403T152744
CREATED:20260114T082517Z
LAST-MODIFIED:20260209T185928Z
UID:1592-1770908400-1770915600@biostrategypartners.org
SUMMARY:Your Tech Transfer Office as a Chief Navigation Office: Guiding Innovation from Lab to Impact
DESCRIPTION:As life sciences transactions grow more data-drive and partnership-oriented\, the role of the Technology Transfer Office (TTO) is shifting. This session examines how forward-thinking offices are acting as Chief Navigation Offices to help guide inventors\, startups\, and industry partners through IP strategy\, data and AI considerations\, federal reporting requirements\, and complex deal structures. Designed for entrepreneurs\, corporate alliance professionals\, and ecosystem leaders\, the discussion will highlight how research institutions help translate discovery into scalable products\, partnerships\, and commercial impact.  \n\n\n\n\nZev Sunleaf\, VP\, Technology Transfer & Commercialization (Moderator)\, Children’s Hospital of Philadelphia\n\n\n\nAdam Van Dyke\, PhD\, AVP\, Innovation & Translational Development\, Fox Chase Cancer Center\n\n\n\nJustin Crotty\, PhD\, JD\, Partner\, Saul Ewing LLP\n\n\n\nGreg Jackson\, PhD\, Executive Vice President\, Life Sciences Greenhouse Investments
URL:https://biostrategypartners.org/event/your-tto-office-as-a-chief-navigation-office-guiding-innovation-from-lab-to-impact/
LOCATION:Biolabs Advanced Therapeutics\, 601 Walnut St. Fl 8\, Philadelphia\, Pennsylvania\, 19106\, United States
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