Friday Coffee Meet Up Podcast

Kwame Ulmer’s talk will discuss what role regulations play in a healthcare startup’s life. He will provide a deep dive into regulatory strategy with an overview of 5 categories that healthcare startups should consider to be prepared for the road ahead.

Bio: Kwame Ulmer

Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. This experience allows him to help companies at all stages efficiently navigate global regulatory agencies. Kwame has particular expertise in all aspects of the USFDA, from premarket applications to postmarket compliance.

Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation (Fortune 150) operating company. He led efforts to shorten global registration timelines, improved product quality by process optimization and achieve best-in-class department engagement scores. Kwame has in depth knowledge of the cross-functional activities needed to take a medical device from concept to product launch in markets including North America, EU, EMEA, China and LATAM.

Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA) and personally evaluated over 1,000 medical technologies. He has successfully overseen products through all FDA application types (IDE, 510(k), PMA, 513(g)) and advised over 100 early-stage medtech companies on regulatory path.

Mr. Ulmer is a member of Tech Coast Angels (LA), the world’s largest angel investing network and a Venture Partner at Wavemaker Three-Sixty Health - the leading Southern-California based, early stage venture capital firm (Seed and Series A) focused on the healthcare industry. Kwame earned his B.S. in Physics from Lincoln University (Pennsylvania) and both an M.S. in Materials Engineering and M.B.A. from the University of Virginia.

Twitter handle @kwameulmer

Kwame Ulmer’s talk will discuss what role regulations play in a healthcare startup’s life. He will provide a deep dive into regulatory strategy with an overview of 5 categories that healthcare startups should consider to be prepared for the road ahead.

Bio: Kwame Ulmer

Kwame Ulmer brings nearly twenty years of experience evaluating medical technologies in the government and serving in senior operating roles at medical device companies. This experience allows him to help companies at all stages efficiently navigate global regulatory agencies. Kwame has particular expertise in all aspects of the USFDA, from premarket applications to postmarket compliance.

Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation (Fortune 150) operating company. He led efforts to shorten global registration timelines, improved product quality by process optimization and achieve best-in-class department engagement scores. Kwame has in depth knowledge of the cross-functional activities needed to take a medical device from concept to product launch in markets including North America, EU, EMEA, China and LATAM.

Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA) and personally evaluated over 1,000 medical technologies. He has successfully overseen products through all FDA application types (IDE, 510(k), PMA, 513(g)) and advised over 100 early-stage medtech companies on regulatory path.

Mr. Ulmer is a member of Tech Coast Angels (LA), the world’s largest angel investing network and a Venture Partner at Wavemaker Three-Sixty Health - the leading Southern-California based, early stage venture capital firm (Seed and Series A) focused on the healthcare industry. Kwame earned his B.S. in Physics from Lincoln University (Pennsylvania) and both an M.S. in Materials Engineering and M.B.A. from the University of Virginia.

Twitter handle @kwameulmer

It’s uncharted territory for many — having everyone who answers to you in a different location, checking in only by email, text and Zoom.

But management principles are the same no matter where your team is, with just a few extra steps needed when your workforce isn’t all under one roof.

This talk covers:

- Why the happiness of your employees should be your highest priority (hint: because their unhappiness costs you millions)

- How to root out and fix the problem of “Accidental Managers”

- Communication tools to keep everyone engaged and productive, and

- How AAA and AC/DC will save your bottom line

In times of uncertainty, most people strive to feel useful and productive. The best thing you can do is know how to lead them to give you their best.

BIO:

Valerie Alexander is a nationally-recognized speaker on the topics of happiness in the workplace, the advancement of women, and unconscious bias, and her TED Talk, “How to Outsmart Your Own Unconscious Bias” has been viewed more than 75,000 times. Valerie’s books include Happiness as a Second Language -- an Amazon #1 Seller, Success as a Second Language and How Women Can Succeed in the Workplace (Despite Having “Female Brains”), plus several more she’s published in her trademarked “...as a Second Language” series. Valerie started her career as an IPO lawyer, investment banker and Internet executive in the Silicon Valley, then transitioned to Hollywood, where she enjoyed success as a screenwriter and director. She is a graduate of Trinity University, U.C. Berkeley and Berkeley Law, and was Trinity’s 2016 Commencement Speaker. In addition to running two corporations and traveling the world as a keynote speaker, Valerie also writes Christmas movies for the Hallmark Channel, which she knows you secretly love, even though you’ll only admit to watching them with your mom.

https://www.speakhappiness.com/

It’s uncharted territory for many — having everyone who answers to you in a different location, checking in only by email, text and Zoom.

But management principles are the same no matter where your team is, with just a few extra steps needed when your workforce isn’t all under one roof.

This talk covers:

- Why the happiness of your employees should be your highest priority (hint: because their unhappiness costs you millions)

- How to root out and fix the problem of “Accidental Managers”

- Communication tools to keep everyone engaged and productive, and

- How AAA and AC/DC will save your bottom line

In times of uncertainty, most people strive to feel useful and productive. The best thing you can do is know how to lead them to give you their best.

BIO:

Valerie Alexander is a nationally-recognized speaker on the topics of happiness in the workplace, the advancement of women, and unconscious bias, and her TED Talk, “How to Outsmart Your Own Unconscious Bias” has been viewed more than 75,000 times. Valerie’s books include Happiness as a Second Language -- an Amazon #1 Seller, Success as a Second Language and How Women Can Succeed in the Workplace (Despite Having “Female Brains”), plus several more she’s published in her trademarked “...as a Second Language” series. Valerie started her career as an IPO lawyer, investment banker and Internet executive in the Silicon Valley, then transitioned to Hollywood, where she enjoyed success as a screenwriter and director. She is a graduate of Trinity University, U.C. Berkeley and Berkeley Law, and was Trinity’s 2016 Commencement Speaker. In addition to running two corporations and traveling the world as a keynote speaker, Valerie also writes Christmas movies for the Hallmark Channel, which she knows you secretly love, even though you’ll only admit to watching them with your mom.

https://www.speakhappiness.com/

It's been said time and again that persistence is key to success, but living that ideology through times of trial is another story. Hear first hand how these Entrepreneurs have navigated the many times their business should have failed, and how they adapted during these moments to become stronger and more successful.

Trey and Ashleigh Lockerbie Bio:

Trey and Ashleigh Lockerbie were internationally touring musicians, working with the likes of Rihanna, Lady Antebellum, Selena Gomez, and Lenka. The rigorous travel schedule was replete with late nights, early mornings, airplanes, and tour buses; They craved connectedness to a community and a healthier lifestyle.

When they met in 2011, Trey and Ashleigh began brewing kombucha at home in support of a family member who had recently been diagnosed with breast cancer. Kombucha was known for its potentially anti-cancerous properties, but not for tasting great.

Better Booch was founded in January, 2012 in an effort to make the healthy choice the obvious one. They have since grown from their first batch in a 1-gallon jar to producing over 20,000 gallons per month out of their DTLA brewery.

Twitter: @betterbooch

Instagram: @betterbooch

It's been said time and again that persistence is key to success, but living that ideology through times of trial is another story. Hear first hand how these Entrepreneurs have navigated the many times their business should have failed, and how they adapted during these moments to become stronger and more successful.

Trey and Ashleigh Lockerbie Bio:

Trey and Ashleigh Lockerbie were internationally touring musicians, working with the likes of Rihanna, Lady Antebellum, Selena Gomez, and Lenka. The rigorous travel schedule was replete with late nights, early mornings, airplanes, and tour buses; They craved connectedness to a community and a healthier lifestyle.

When they met in 2011, Trey and Ashleigh began brewing kombucha at home in support of a family member who had recently been diagnosed with breast cancer. Kombucha was known for its potentially anti-cancerous properties, but not for tasting great.

Better Booch was founded in January, 2012 in an effort to make the healthy choice the obvious one. They have since grown from their first batch in a 1-gallon jar to producing over 20,000 gallons per month out of their DTLA brewery.

Twitter: @betterbooch

Instagram: @betterbooch

During this rapidly developing pandemic, it is difficult to stay ahead of the information, much less the viral spread. Dr Kimberly Shriner's talk will focus on coronavirus origin, pathophysiology, clinical presentations and a short review of current proposed therapies. It will be directed for both medical and nonmedical audiences.

Bio: Kimberly A. Shriner, M.D., F.A.C.P.

A native of Pasadena, Dr. Shriner attended John Muir High School, Occidental College and Case Western School of Medicine. She completed her residency in internal medicine at Huntington Hospital and received her fellowship degree in Infectious Disease from UCLA/Olive View in 1992. Since that time, she has practiced infectious disease and tropical medicine at Huntington Hospital and in the Pasadena community.

Dr Shriner has been a faculty member and assistant director for the graduate medical education department at Huntington Hospital. She is the founder and director of The Phil Simon Clinic, a Huntington based outreach clinic for underserved clients with HIV. She is also the founder and President of the Board of The Phil Simon Clinic Tanzania Project, a Pasadena nonprofit organization that, for the last 20 years, has been providing multidisciplinary care for the underserved in Northern Tanzania.

Dr. Shriner is a fellow of the American College of Physicians, Infectious Disease Society of America, HIV/MA Association and the International Travel Medicine Society. She has published in peer reviewed journals and continues her research in HIV and aging, zoonotic diseases and global health.

During this rapidly developing pandemic, it is difficult to stay ahead of the information, much less the viral spread. Dr Kimberly Shriner's talk will focus on coronavirus origin, pathophysiology, clinical presentations and a short review of current proposed therapies. It will be directed for both medical and nonmedical audiences.

Bio: Kimberly A. Shriner, M.D., F.A.C.P.

A native of Pasadena, Dr. Shriner attended John Muir High School, Occidental College and Case Western School of Medicine. She completed her residency in internal medicine at Huntington Hospital and received her fellowship degree in Infectious Disease from UCLA/Olive View in 1992. Since that time, she has practiced infectious disease and tropical medicine at Huntington Hospital and in the Pasadena community.

Dr Shriner has been a faculty member and assistant director for the graduate medical education department at Huntington Hospital. She is the founder and director of The Phil Simon Clinic, a Huntington based outreach clinic for underserved clients with HIV. She is also the founder and President of the Board of The Phil Simon Clinic Tanzania Project, a Pasadena nonprofit organization that, for the last 20 years, has been providing multidisciplinary care for the underserved in Northern Tanzania.

Dr. Shriner is a fellow of the American College of Physicians, Infectious Disease Society of America, HIV/MA Association and the International Travel Medicine Society. She has published in peer reviewed journals and continues her research in HIV and aging, zoonotic diseases and global health.

Design consistently improves the most profitable companies and products but why do many startups fail to integrate design strategy as they grow. Learn ways to utilize design to build teams, streamline products, connect to users and acquire customers.

Bio:

Robbie Nock is the Director of Entrepreneurship and Professional Practice at ArtCenter. His background spans media production, new technology and venture development and he is driven to connect design, business and engineering partners to develop new synergies for early-stage innovation. Robbie produces academic programs and provides strategic services for a global community of entrepreneurs, educators, investors and philanthropist.

At ArtCenter, Robbie has initiated and grown: BOLD, ArtCenter’s entrepreneurship symposium; Launch Lab, a capstone accelerator for graduating students; RE/BOOTCAMP, a mid-career professional training program; and the Ethics and Emerging Technology Roundtables, an interdisciplinary thinktank to prepare designers for the future.

Robbie received an MA from the University of Edinburgh and MFA California Institute of the Arts. He is a practicing visual artist and surfs, skis and runs whenever possible.

http://www.artcenter.edu/academics/interdisciplinary-programs/professional-education.html

@robbienock, [email protected]

Design consistently improves the most profitable companies and products but why do many startups fail to integrate design strategy as they grow. Learn ways to utilize design to build teams, streamline products, connect to users and acquire customers.

Bio:

Robbie Nock is the Director of Entrepreneurship and Professional Practice at ArtCenter. His background spans media production, new technology and venture development and he is driven to connect design, business and engineering partners to develop new synergies for early-stage innovation. Robbie produces academic programs and provides strategic services for a global community of entrepreneurs, educators, investors and philanthropist.

At ArtCenter, Robbie has initiated and grown: BOLD, ArtCenter’s entrepreneurship symposium; Launch Lab, a capstone accelerator for graduating students; RE/BOOTCAMP, a mid-career professional training program; and the Ethics and Emerging Technology Roundtables, an interdisciplinary thinktank to prepare designers for the future.

Robbie received an MA from the University of Edinburgh and MFA California Institute of the Arts. He is a practicing visual artist and surfs, skis and runs whenever possible.

http://www.artcenter.edu/academics/interdisciplinary-programs/professional-education.html

@robbienock, [email protected]