Regulatory Compliance. It is Required
Entrepreneur’s Network
Register: https://boston-enet.org/event-3892678
(Please note capacity is limited, so pre-registration is necessary. Registration closes at 3pm on February 16, 2021.)
Are you concerned with giving away too much equity to finance your start up? Do you know all the start up funding options available?
This panel will focus on getting initial money from non-traditional sources when VCs and angels will not help, and friends and family will stress you out.
Investors want to see something before they invest. Yet it takes money to make your company into something to interest investors. It is a catch-22. This panel offers techniques to show you how to break out of that conundrum – to take your company from nothing to something, and to do so without VC or angel funding. These questions and more will be discussed and answered in this Webinar.
Agenda:
5:30 – 6:45 – Networking on Grapevine Network
7:00 – 7:10 PM – ENET Chairperson’s announcements
7:10 – 7:25 PM – eMinute Pitch – Up to 3 Startup companies’ presentations
7:25 – 8:10 PM – 4 expert speakers on the night’s topic
8:10 – 8:30 PM – Moderator and Audience Q & A with the speakers
8:30 – 9:00 PM – Networking on Grapevine Network
(all times are USA Eastern Daylight time) (all times are USA Eastern Daylight time)
A question and answer session will follow the panel discussion, and panelists will be available afterward for responses to individual questions.
Panel Members
Joanne LaValle, MSHS, RAC, Principal, Regulatory Affairs, Halloran Consulting Group
Joanne LaValle has more than 20 years of experience in regulatory affairs and drug/device development with a diverse background in regulatory strategy and submissions in small molecules, biologics, vaccines, and medical devices. She has extensive experience in drug/device combination products, pharmacovigilance, compliance, and marketing applications across multiple therapeutic areas including dermatology, oncology, immune-oncology, endocrine, and allergy. She has prepared many types of submissions including IND, BLA, NDA, sNDA, 510(K), PMA, and Special Protocol Assessments. She has actively engaged and led FDA meetings including Pre-IND, EOP, Pre-NDA and Pre-BLA meetings. In addition, she has led multiple FDA drug and device inspections. She has extensive experience with labeling and advertising/promotion regulations and submissions.
Joanne has successfully led the development and post-marketing regulatory activities of drug/device combination products. She has established comprehensive compliance programs and has been responsible for all regulatory related activities including advertising and promotion, cGMP, and the Quality system.
https://www.linkedin.com/in/joanne-lavalle-mshs-rac-351985105/
Jeanne Bertonis, Chief Operating Officer, Azitra Inc.
Ms. Bertonis is a seasoned healthcare professional with experience in early stage start-up companies as well as established corporations.
She is currently Chief Operating Officer for Azitra, Inc,, a clinical-stage medical dermatology company that leverages extensive scientific knowledge about the skin microbiome to discover and develop novel products for the treatment of adverse skin conditions and diseases. For the past 15 years she has also been providing strategic and business consulting to pharmaceutical, medical device, biomaterial and diagnostic companies. Projects range from the creation of business, product and marketing strategies, to licensing, partnering, and mergers and acquisitions.
She is the past co-founder and CEO of Visgo Therapeutics, which focused on local drug therapies for joint diseases. She was President and CEO of BioSyntech, a public biomaterials company with an approved product for cartilage repair, from 2009 to 2010. From 2000-2006, she held the positions of Chief Business Officer and Vice President Corporate Development for Angiotech Pharmaceuticals, the company that developed the paclitaxel-coated stent. Ms. Bertonis has additional experience in business and research positions with Genzyme, Guidant, Eli Lilly and Biogen.
Ms. Bertonis has an MBA from the Kellogg School in Management, an MS from University of Massachusetts, and a BA from Vassar College. She has served as Director for both private and public biotech and device companies.
https://www.linkedin.com/in/jeanne-bertonis-554803a/
Geetha Rao, CEO and Founder, Springborne Life Sciences
Dr. Geetha Rao is the founder and CEO of Springborne Life Sciences, a firm based in Silicon Valley providing compliance and strategic advisory services on emerging medical technologies and healthcare innovation. Dr. Rao has worked at the forefront of emerging technologies for her entire career and for over 20 years in the life sciences industry. Her particular focus is on platform technologies with applications in digital health, connected medical systems, and health information and intelligence.
Dr. Rao has worked with numerous start-ups and larger companies. She serves as an advisor at the California Life Sciences Institute, Health Technology Forum, and several other healthcare innovation organizations. She has served as program faculty for the BioDesign Innovation Program at the Stanford University School of Medicine and as an advisor in several innovation programs the University of California, San Francisco. She has been elected to the Dean’s Advisory Council, Physical Sciences Division and Co-Chair of the Innovation Network at University of Chicago and is a member of Chicago Innovation Exchange. Dr. Rao was a contributor on the 2013 World Economic Forum research project on Sustainable Health Systems and a TEDMED scholar. She serves on standards committees for medical technology interoperability and security.
Dr. Rao holds a Ph.D. in Engineering from MIT and a Master’s in Business from Stanford University, Graduate School of Business.
https://www.linkedin.com/in/geetha-rao/
Moderator:
Roger Frechette, Ph.D., Founder and Principal, NEPAssociates
