Regulatory Compliance. It Is Required.

Entrepreneurs are the hardy sorts who leverage their innovative thinking, resourcefulness, persistence and determined focus, to launch new companies, and to create new markets for anything from brilliant consumer products to live saving medicines. It is hard, demanding, often humbling work and, more often than not, results in failure (which, as one of life’s most profound teachers, is not a bad thing).

Life sciences entrepreneurs, especially those creating products or services that will ultimately involve the treatment or diagnosis of patients, have a significant additional hurdle along the way. For good and sound reasons, virtually every country has formal regulatory requirements in place to ensure that such products and services are safe and effective. Everything from manufacturing controls to clinical validation is required for regulatory approval prior to market launch.

Sounds complicated, and it is. Join us to hear from experts steeped in regulatory compliance to learn what is needed to be compliant and effective strategies for setting your life sciences company on the path to success.

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, Meeting Organizer

Roger Frechette, Life Science Business Executive / Entrepreneur / Mentor

My daily purpose is to exercise an innate drive to transform ideas and projects into life-changing commercial assets. In the life science business, this is the long game, requiring boundless energy and creativity, coupled with knowledge, experience, and patience. Consulting services include advisory and fractional executive engagements in operations, strategic planning and business development.

In my work, I leverage an extensive global network and insights derived from >20 years of experience in business development, calibrated with an extensive science background. My career has encompassed success as a business executive, project/alliance manager and entrepreneur, and also as a scientist, including leadership of discovery/preclinical development teams resulting in a new drug candidate – NDAs for omadacycline submitted by Paratek in early 2018.

https://www.linkedin.com/in/rogerfrechette/