CSSi LifeSciences and Innosphere Ventures, in collaboration with the Israel Economic Mission to the West Coast (USA), are presenting a free webinar series to early stage and emerging growth life science companies looking to make successful market entry and commercialization in the United States. The topics and descriptions of each webinar can be found below:
October 19, 2020 10:30 AM ET / 7:30 AM PT
Part 1: Presentation by Janice Cattano, MSN | CSSi LifeSciences
The pathway from design to commercialization for a new medical device can
be ambiguous and complex. Regulations and requirements change frequently
and vary by notified bodies, country, level of risk, specific product claims,
and intended use. Based on your medical device classification and current
stage of development, there are a variety of US FDA CDRH submissions to
consider. This program will help you to understand the regulatory pathways
and strategies to address regulatory concerns and minimize additional FDA
questions.
Part 2: Q&A with Michael Hassman I scPharmaceuticals
Following the presentation, there will be the opportunity to pose questions
to Michael Hassman, Senior Vice President, Operations scPharmaceuticals.
scPharmaceuticals is a pharmaceutical company focused on developing and
commercializing innovative solutions to enhance the potential of outpatient
care. The company is working with a device manufacturer with operations
in Israel and Mr. Hassman can share key learnings.
Time & Date To Be Determined
The pathway from discovery to commercialization for a new drug or medical device can be unclear and complex. Regulations and new guidance requirements from the US FDA can be ambiguous and are often subject to a reviewer's discretion. This program will help you gain an understanding of the applicable regulations, risks and requirements that will provide you with a roadmap to success.
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This program will help you to understand the importance of strategically aligning your preclinical and nonclinical research to support a US FDA drug approval. Vital issues will be considered, such as choosing the right indication and patient population within the competitive landscape, “must have” and “nice to have” studies, selection of appropriate test species, and outsourced facility selection criteria. In addition, we will discuss how to best leverage the FDA Special Designations (i.e., Orphan, Fast Track, Breakthrough, etc.) to accelerate your technology while mitigating risks and driving value.
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Quality Management Systems (QMS) are a worldwide requirement for marketing medical device products. Unlike the rest of world and Israel, the US FDA follows a unique QMS system, known as 21 CFR part 820. This program will help you to understand the differences, the US FDA CDRH requirements, and ways in which you can cost effectively harmonize your QMS to comply with both ISO 13485 and 21 CRF part 820 requirements.
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This webinar will discuss FDA guidance on the discussion paper entitled “Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)”. The FDA’s traditional medical device regulation was not designed for these new technologies and under the current approach to software modifications, the FDA anticipates that many of these AI/ML software changes to a device may need a premarket review. The total product lifecycle-based regulatory framework would allow modifications to be made from real-world learning and adaptation, while still ensuring that the safety and effectiveness of the software as a medical device is maintained.
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SmartConnect™ provides a strategic roadmap and direct access to a network of experts and capital to guide your journey from concept to market. Our extensive industry experience, deep subject matter expertise, market intelligence and network of strategic capital partners all work in harmony to rapidly accelerate your research discovery to a commercial reality. As you begin your journey, let CSSi LifeSciences start you off in the right direction.
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Have you heard an investor express interest but not want to lead the deal? This webinar covers the strategy to get the first lead investor and syndicate other interested parties through proper investor relationship management.
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Do you know how to develop relationships with your future customers in the US? This webinar discusses the optimal way to start, develop, and sell into your targeted accounts.
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Do you understand your customers problems, processes, and current methods to manage those issues? Then your message can be heard and understood. This webinar outlines the customer discovery process that yields a methodology to maximize your value proposition to your target customers.
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Tops down forecasting from the Total addressable market is not enough. Investors want to know how you will obtain your first customers. This webinar discusses how to build a bottoms up forecast that is believable, actionable, and fundable.
Previous Webinar
Investors give you one chance to make a lasting impression. This webinar discusses the content required in the first and subsequent meetings to keep the relationship positive and beneficial to both parties.
VIEW RECORDINGPrevious Webinar
Investors give you one chance to make a lasting impression. This webinar discusses the content required in the first and subsequent meetings to keep the relationship positive and beneficial to both parties.
VIEW RECORDING