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Design and Leverage Regulatory Strategy and Regulatory Engagement to De-Risk and Fundraise
Design and Leverage Regulatory Strategy and Regulatory Engagement to De-Risk and Fundraise

Design and Leverage Regulatory Strategy and Regulatory Engagement to De-Risk and Fundraise

A strong regulatory strategy and successful regulatory engagements remain approaches companies can take to de-risk products for investors. Learn how you can leverage these to meet your milestones and goals in this complimentary, in-person discussion, including lunch and a tour of the CHTC facility

Time & Location

Aug 28, 2024, 10:00 AM – 2:00 PM

CHTC Greenwood Village Grand Conf. Room, 5800 S Quebec St, Greenwood Village, CO 80111, USA

Event Overview

Establishing rapport and credibility with a regulatory agency, such as the US Food and Drug Administration (FDA), early in a life sciences company’s journey is a critical factor for its success. It will have an impact on the company’s ability to fundraise, meet milestones, meet budgets, and of course, make its product available to the patients and providers who need it.

Knowing when and how to engage with a regulatory agency to facilitate an ideal outcome is an art. The nuances and subtleties of which complicate an already ever-dynamic life sciences regulatory landscape. As a CEO or other executive, it’s important to have confidence that the regulatory strategy for your product is innovative and sound, and that when you meet with FDA you know what to say, when to say it, and who to bring. This is not only important for you, but also for your Board, your investors, your team, and your market.

Join us from 10am-2pm at the Colorado Health and Tech Centers Greenwood Village facility for a complimentary in-person discussion on leveraging regulatory strategy and regulatory engagement for fundraising activities. Lunch and a tour of the CHTC facility are included.

In this event, you will learn:

  • Considerations for designing a regulatory strategy
  • Types of pre-market submissions, and the associated general costs and timelines you can expect
  • Avenues to engage with FDA and receive feedback
  • Best practices for formal and informal FDA interactions
  • How to leverage a regulatory strategy and FDA engagement to de-risk a product for fundraising

The individuals who will receive the most value from this session are executives of biotech or medtech companies with a product portfolio which includes medical devices (including digital health), in vitro diagnostics, or medical devices with a drug or biologic component.

Speakers:

Emily Becker, Chief Regulatory Officer, OnemataDC

Emily’s career in Regulatory Affairs began at Reglera, which was acquired by Dohmen Life Science Services (DLSS) in 2012. She progressed from Intern to Senior Manager of Regulatory Affairs in five short years. Her rapid-trajectory career path exposed her to regulatory strategy and successful strategy execution for a variety of technologies and therapeutic areas. When DLSS was acquired by EVERSANA in 2017, Emily was made the company’s Regulatory Affairs Director, responsible for management and growth of the Regulatory Affairs Consulting team and the development, leadership, and execution of client regulatory strategy across the highly regulated medical device, pharmaceutical, biologic, combination product, and human tissue industries all over the globe. This responsibility included acting as the client liaison with the US Food and Drug Administration and similar International regulatory agencies. She was responsible for advising on GDPR compliance for clients performing clinical trials in the EU and also assumed the responsibilities of HIPAA Privacy Officer for both EVERSANA and client companies.

Emily is responsible for implementing and maintaining OnemataDC’s global Regulatory Affairs program and is also responsible for OnemataDC’s Government Affairs, liaising with state and federal legislative bodies and government agencies to represent the company’s viewpoints and actively participate as a stakeholder. Emily has a passion for living in the grey of regulations to creatively and innovatively achieve compliance with unwavering integrity in support of OnemataDC and our clients' efforts.

Jeff Dupont, Chief Executive Officer, OnemataDC

Jeff’s career in Quality, Operations, and Compliance began at Reglera, which was acquired by Dohmen Life Science Services (DLSS) in 2012. Starting as an intern, he progressed into a key member assigned to strategic clients and development of internal products/service offerings which resulted in the rapid and sustained growth of Reglera into a valuable acquisition target. Jeff’s advancement continued at DLSS, moving to Vice President, Quality overseeing all Quality consulting products/services. When DLSS was acquired by EVERSANA in 2017, his role/responsibilities expanded further to include oversight of all Quality, Regulatory Affairs, Regulatory Compliance consulting and outsourcing products/services, as well as overall Strategy.

Jeff’s almost 20 years of Quality, Compliance, and Operations experience has involved responsibility from research and development to post market with a significant number of small start up to Fortune 50 companies within the medical device, tissue, and combination product industries. He is extremely well versed in design and development, product launch to market, compliance and compliance remediation, as well as working with R&D, regulatory, marketing, sales, legal, operations, manufacturing, and supply chain organizations. This has provided extensive background in quality/compliance strategy development and execution in areas such as; quality systems, engagement with regulators, software, combination products, design control and risk management, design and process verification/validation (including cleaning & sterilization), corrective/preventive action, supplier qualification/management, complaint handling/reporting, organizational effectiveness, as well as personnel technical and leadership development. He has also managed the start-up and ongoing operation of multiple medical device manufacturing facilities, domestically and internationally.

Jeff joined Onemata in 2020 as Chief Operating Officer and moved into the role of President & CEO in 2022. He also co-founded OnemataDC. His hands-on experience managing the business out of a challenging financial position and transitioning the company away from high-risk clients and vendors made Onemata a Mobile Location Data industry leader with an unwavering commitment to personal privacy and regulatory compliance. At the end of 2023, Jeff led the sale of Onemata’s assets to allow for the organization’s full focus on OnemataDC. Jeff’s passionate about Quality, Compliance, and Operations and excited to share his industry experience with OnemataDC’s clients every day.

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