Colorado BioScience Association (CBSA) is proud to partner with Innosphere Ventures, a leading incubator with a 25-year track record of success supporting high-tech startups, on a new program designed for Colorado’s early-stage life sciences companies, the CBSA and Innosphere Ventures Workshop: Strategizing Clinical Excellence.

The program is designed to help companies plan a sound regulatory and clinical strategy for successful commercialization of their new health innovations.

Join us at Fitzsimons Innovation Community in Aurora, across the street from the University of Colorado Anschutz Medical Campus, for an insightful workshop and networking with leaders and founders of early-stage life sciences companies.

Why Participate?

Embarking on the right regulatory and clinical path from the onset not only ensures that you’re advancing in the correct direction but also significantly enhances your narrative when appealing to potential investors and partners. It’s about communicating that you’re not just aiming for success, but you’re equipped to achieve it.

Workshop Topics

Regulatory Strategy

• Charting the Pathway: Identifying the most efficient route through the regulatory maze.
• Harnessing Expertise: Determining the caliber of regulatory acumen your journey requires.
• Status Check: Ascertaining requisite regulatory nods and mapping the quest to achieve them.

Clinical Validity and Utility

• Grasping the bedrock: Identifying the scientific and clinical pillars upholding your product or service.
• Navigating Clinical Data: Pinpointing the exact clinical evidence required to fortify your product’s standing.
• Understanding Validation: Demystifying clinical validation and its nuances.
• Benchmarking with Standard Care: Is your product at par, or does it surpass existing standards in efficacy, safety, and cost?
• Evaluating Clinical Utility: Determining and showcasing the tangible benefits your product brings to healthcare.

This workshop was originally developed for companies selected for the Colorado Life Sciences Incubation Program, offered through a partnership with Innosphere Ventures, CBSA, and Colorado BioScience Institute and partially funded by an Advanced Industries Business Accelerator Grant from Colorado’s Office of Economic Development and International Trade (OEDIT).

Because of the workshop’s impact for participants in the Colorado Life Sciences Incubation program, we are proud to offer it to all startups in our state’s life sciences community.

Presenters

David Poticha, M.S., J.D., CIPP/US – General Counsel and Director of Business Development and Compliance Matters, the Colorado Prevention Center (CPC)

David Poticha, JD, MS, is an attorney licensed to practice in Colorado with a background in intellectual property and transactional law, also trained in microbiology and immunology prior to becoming a lawyer, who is currently serving as General Counsel and Director of Business Development and Compliance matters at the Colorado Prevention Center (CPC). At CPC David handles or manages all legal matters, focusing heavily on contract negotiation, clinical and regulatory compliance, and data privacy matters.

David earned his legal degree from the University of Colorado Boulder Law School in 2002 and his Master’s in Microbiology and Immunology at the University of Colorado Health Sciences Center in 1999. He received his undergraduate degree in Microbiology and Immunology graduating magna cum laude from UCLA in 1993. David is a licensed patent attorney and has also received his certification as a U.S. privacy law expert. David has been with CPC since March of 2022.

David began his career as patent and corporate in-house counsel for Myogen Pharmaceuticals, a cardiovascular disease focused pharmaceutical company in Westminster, CO where he went through his first IPO. From there he went to the University of Colorado and worked at the Technology Transfer Office at the Anschutz Medical Campus for 9 years. That was followed by work at Greenberg Traurig as a patent attorney, then followed by 6 years as the head of the legal department at Biodesix, Inc., a medical diagnostics company in Boulder. While with Biodesix, David led the legal side of 2 corporate acquisitions, 7 product launches and a successful IPO.

Jodi Scott – Partner, Hogan Lovells

Jodi Scott developed and honed her practical, realworld sensibility and business acumen during the time she spent as an in-house FDA counsel with Medtronic PLC, the world’s largest medical device manufacturer.

Today, she uses that background to solve the challenges that confront her clients in areas that include MDRs, regulatory due diligence, importing and exporting medical devices, advertising and promotion, preparing for and managing FDA inspections, developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses), developing digital health technology, and securing the necessary state medical device manufacturer and distributor licenses.

Jodi assists the medical device industry in navigating the complex requirements so as to maintain compliance with the U.S. Food and Drug Administration’s (FDA) quality system (QSR) and other post-market regulatory rules. She spends much of her time developing and implementing strategies to manage FDA-initiated enforcement actions, such as FDA inspections that result in FDA Form 483s, untitled letters, Warning Letters, investigations, and consent degrees of permanent injunction. She has received ISO 13485 auditor certification and assists companies in preparing for managing and responding to ISO and MDSAP audits.

She also guides her clients through complex medical device recalls by helping them work through the difficult decisions of whether a recall is warranted and, if so, how to execute it in a way that best achieves a balance between patient and customer risk and the agency’s interests, while also demonstrating the company’s commitment to safety and its regulatory obligations.

She also applies her regulatory knowledge in assisting clients with regulatory due diligence related to mergers and acquisitions and funding, such as private equity deals, initial public offerings, and other financial transactions.

Carolina Ahrendt, MBA, PMP – Principal, Halloran

Carolina Ahrendt has over 20 years of experience in program and portfolio management for the development of pharmaceuticals and biologics across multiple therapeutic areas. She has provided program leadership in all phases of development and managed numerous INDs, BLAs, and NDAs. She has extensive knowledge in guiding cross-functional teams with strategic planning, marketing application preparation, and integrated development plan analysis throughout the product life cycle (from early to late stage development). Carolina has supported programs in therapeutic areas such as diabetes, inflammation, oncology, ophthalmology, pain, rare diseases, schizophrenia, and viruses.

Prior to joining Halloran, Carolina held a leadership position for regulatory project management at EVERSANA’s consulting division. In this role, she managed several original IND applications and IND maintenance projects, acted as the liaison between the Sponsor and FDA Regulatory Project Manager, and supported the preparation for various FDA meetings. Prior to that, she was a Development Program Manager at Array BioPharma progressing clinical development programs from candidate nomination, Phase 1, 2, 3 and NDA for various products in the pipeline. Her role included facilitating cross-functional collaboration, managing alliances and partnerships, and high-level stakeholder communications. Earlier in her career, Carolina was a formulation scientist and analytical chemist at Array BioPharma and Geneva Pharmaceuticals.

This event is complimentary for CBSA life sciences members, and $50 for non-members

Thank you to our event sponsor:

Thank you to our host:

Thank you to our sustaining sponsor: