Newsletter March 2021

BioAustin | Texas Medical Device Alliance | Austin Health Tech

NEWSLETTER
MARCH 2021

CONTENTS

LIFE SCIENCE INDUSTRY NEWS

INDUSTRY RESOURCES & FUNDING OPPORTUNITIES

WOMEN IN SCIENCE & WOMEN’S HEALTH

SPOTLIGHT

UPCOMING EVENTS

CAREER CORNER

VOLUNTEER OPPORTUNITIES

TEXAS LIFE SCIENCE ORGANIZATIONS

LIFE SCIENCE INDUSTRY NEWS

In Our Neck of The Woods….

TMDA Audio File – Medical Device Packaging & Validation – More To It Than You Think

The February 25 TMDA meeting audio file can be accessed: https://www.dropbox.com/sh/oq6lg8khd8f8477/AACqcuPRXGvuLMsEidsHjqhWa?dl=0

Reflections on a Record Year for Novel Device Innovation Despite COVID-19 Challenges

As we look ahead this year, it is important to pause and reflect on the important milestones the U.S. Food and Drug Administration reached in 2020 to help strengthen the public health. Among those milestones is the work the FDA’s Center for Devices and Radiological Health (CDRH) accomplished in response to the COVID-19 pandemic, while keeping up with the Center’s ongoing work and continuing to bring a growing portfolio of innovative devices to patients.

Quantum Materials Corp. to Accelerate Development of QMC HealthID™ and Quantum Dot Research Following Equity Investment from Pasaca Capital Inc.

Leading American nanomaterial and quantum dot producer and technology company, Quantum Materials Corp (OTCQB: QTMM) today announced an equity investment from California-based private equity firm, Pasaca Capital, Inc. of $15 million and under terms of the distribution agreement formed between the two companies, Quantum Materials Corp would receive cumulative gross royalties and/or gross sales, licensing or other revenues of no less than $15,000,000, over the period including 2020 and continuing until twelve months after the Company has completed development of a functioning product integrating the QMC HealthID intellectual property and Innova Medical Group’s products.

Across the Pond….

Namsa: How To Successfully Transition From IVDD To IVDR: A Roadmap Of Priorities And Compliance Strategies

The European Union’s In Vitro Diagnostic Regulation EU 2017/746 (IVDR) has been in place since 2017, and with it, has come new challenges for the IVD industry throughout Europe. Given the scale of the regulation’s proposed changes, a five-year transition period has been underway since its publication with the date of application (DOA) of 26 May 2022. Upon this obligatory conformity date, all IVD products must meet the new requirements, including non-application of CE marks under the superseded In Vitro Diagnostic Directive (IVDD).

INDUSTRY RESOURCES & FUNDING OPPORTUNITIES

$10 million Artificial Kidney Prize

Apply today for access to expert mentorship, a global peer network, $250k in deals & discounts, up to $1M in cash awards and prizes, and more – all equity free, no strings attached.

Ultimate Guide to Training Management for Medical Device Companies

Training is a regulatory requirement of FDA and international governing bodies. According to FDA CFR 820.25, medical device manufacturers are required to show proof that personnel have the “necessary education, background, training and experience” to ensure that they can correctly perform their jobs.

MedTech Slack Channel

Project Medtech invites you to join the new Slack channel dedicated to connecting the people and organizations within the Medtech Industry. In this space, we are committed to improving the speed of delivery and success of innovative technology for patients. Join the group today and begin connecting with industry leaders!”

3 Ways to Transform your Change Process from Reactive to Predictive

You’ll learn about 3 powerful ways to transform your change management process through predictive quality that leverages AI/ML technologies that will allow you to make data-driven, proactive decisions and have full visibility into your entire change process.

THBI: We Need Your Help in Identifying Workforce Needs in the Life Science Industry

THBI is collaborating with TEConomy, with the support and participation of InnovATEBIO, to produce the 2021 national and state/regional workforce reports.

This real-time data is extremely valuable for Texas as we work with legislators, academic institutions, and other stakeholders to make certain we are developing the right talent to address our industry’s critical workforce needs. We are seeking companies to complete this brief (~20-minute) survey by no later than March 1. Your individual responses will be confidential and only reported in aggregate with responses from other bioscience companies. We would only like to include your company name in a list of responding companies in the report. This data will be included in a 2020 BioTexas Life Science Brief and as part of a national report of the Coalition of State Bioscience Institutes (CSBI), both of which will be released at BIO Digital this June. You will receive copies of both reports.

If you are interested in participating in this important project, please contact Julia Perkins at [email protected] for the link to submit your response.

WOMEN IN LIFE SCIENCE & WOMEN’S HEALTH

AWIS Scholarship

The Distinguished Doctoral Research Scholarship ($10,000) will be awarded to an AWIS member whose dissertation research project is judged likely to make important and original contributions to her field.

AWIS Opportunity Scholarships for Career Re-entry ($2500 each) will enable up to four women to return to a STEM career after being out of the workforce for more than two years.

Deadline: Wednesday, March 10, 2021 at 11:59 p.m. PT. Scholarships will be awarded in May. Learn more and apply online at https://www.awis.org/scholarships/

WIB Virtual Events Offer the Chance to Connect Virtually

Women In Bio welcomes you to attend any of the fantastic virtual events our dedicated chapters are holding — even if you don’t live near those chapters. We offer a variety of networking and learning opportunities that will engage, educate, and empower. View the full list of virtual events.

Scientist refuses to let people with TB get left behind

As a child in Bujumbura, Burundi, Mireille Kamariza didn’t know any scientists, and as an adult she didn’t achieve her childhood dream of becoming an astronaut, but her invention of a one-step, portable, inexpensive tuberculosis test has made her a star, and she’s just getting started. Kamariza co-founded OliLux Biosciences and was invited to join Harvard’s Society of Fellows in 2018, making her the society’s first Black female biologist, and she continues to focus on TB research as many of her colleague’s pivot to COVID-19 research.

Startup pits viruses against cancer

Theolytics is among the startups developing oncolytic viruses, or viruses that target cancerous tumors, and hopes to get its lead candidate — an intravenous treatment for ovarian cancer — into clinical trials within three years, says CEO Charlotte Casebourne. The company was co-founded by Casebourne, Margaret Duffy, Kerry Fisher and Len Seymour and uses a phenotypic screening platform to identify virus variants with potential to attack specific tumor types, Casebourne said.

Gilead, Gritstone partner to kick, kill HIV

Gilead Sciences and Gritstone Oncology are developing a therapeutic vaccine for HIV that employs one compound to “kick” infected but dormant cells into producing HIV particles and another that stimulates the immune system to kill those cells, says Diana Brainard, Gilead’s viral therapeutics group leader. Gritstone’s artificial intelligence platform identifies neoepitopes on the surface of infected T cells and packages the information in an adenovirus that contains the genetic sequence of the neoepitope and the genetic instructions for self-amplifying RNA, says Karin Jooss, Gritstone’s chief scientific officer.

8 women leading the fight against COVID-19

Women have been instrumental not only in developing effective vaccines for COVID-19, but also in efforts to contain the pandemic. Influential women include vaccinologists, epidemiologists, genomicists, political leaders and the 90-year-old woman who volunteered to get the first COVID-19 vaccine outside of a clinical trial.

SPOTLIGHT

Texas Global Health Security Innovation Consortium (TEXGHS) is organizing the inaugural TEXGHS @ SXSW Health Security Demo Day as an official event of the virtual South by Southwest (SXSW) 2021 conference. The event will highlight market ready technologies that are impacting our ability to prevent, predict, detect, and respond to pandemic infectious disease threats. Companies will also highlight innovations focused on community resiliency and recovery from COVID-19 and future health security challenges.

A series of 60-minute demo sessions organized around specific health security challenges. Each session will include an opening panel followed by six-minute pre-recorded video presentations by companies describing their innovation or startup. A group of expert coaches will be available prior to the event to support participants in crafting their presentations. 30-minute interactive sessions between presenters and participants will follow each session. The event is free to attend and a SXSW badge is not required. Organizing partners include the Consulate General of Norway in Houston, the Consulate General of Denmark in Houston, the Australian Trade and Investment Commission (Austrade), and the European American Enterprise Council. Sponsorship opportunities are available. For more information visit www.TEXGHS.org

Register now: https://www.eventbrite.com/e/texghs-sxsw-2021-global-health-security-demo-day- tickets-141484488915

For Sponsorship contact: Lisa McDonald

UPCOMING EVENTS

Austin Technology Council Calendar of Events

https://tinyurl.com/y9zzr6jv

Texas States Small Business Development Center Network Calendar of Events

https://tinyurl.com/ybf68aom

Women in Business Virtual Calendar of Events

View the full list of virtual events.

Temple Health & BioScience District’s (THBD’s) E-Learning Series Webinars Library

https://www.templebioscience.org/elearning/

NAMSA’s Podcasts Calendar of Events

https://namsa.com/resources/podcasts/biocompchatibility-podcast/

Qosina Video Library – BIOMEDigital 2020 | MD&M West 2020

https://tinyurl.com/y6sjrxaa

MedTech Innovator Live Weekly Webinar Series

https://www.youtube.com/channel/UCza4pwHPN-GQYTbi6FuE4rw

March 2-4 | Online Conference

Covance Scope: These four standout sessions can help transform your clinical trials by reducing cost, time and complexity while ensuring patient safety.

March 15-19 | Online Summit

EU MDR and IVDR True Quality Summit Series

March 22-23 | Online Summit

Medical Device Manufacturing & R&D Summit

March 24 | Online Webinar

Drug development for start-ups and emerging pharma

March 25 | Online Webinar

Intranasal Immunization: Promises and Challenges

15 April 2-3:30pm central | Virtual (free)

Texas Medical Device Alliance (TMDA)

Save the Date – Hiring the right people & setting the right culture for a small company/start up –

Remote Team Building, Social Media Culture, Remote Employee Effectiveness.

April 16, 22 and 23 | Online Summit

AMDM Annual IVD Regulatory Meeting and FDA Submissions Workshop

FDA IVD Submissions Workshop – Thursday April 22^nd

AMDM IVD Regulatory Meeting – Friday April 16^th & Friday April 23^rd

15 July 2-4pm central | Tentative In-person Meeting (free)

Texas Medical Device Alliance (TMDA)

Save the Date – FDA Medical Device Regulations – Quick Pace Changes in the light of Emergency Use Authorization (EUA)

21 October 2-4pm central | Tentative In-person Meeting (free)

Texas Medical Device Alliance (TMDA)

Save the Date – Supplier/Sponsor Summit or Medical Device Marketing (TBD)

VOLUNTEER OPPORTUNITIES

Become a Talent Ambassador

Through the Talent Ambassador program, the Austin Chamber partners with nearby businesses who offer learning opportunities (guest speakers, internships, apprenticeships, etc.), and connects them to local schools, post-secondary institutions, and those facing barriers to employment.

Contact Kwee Lan Teo at [email protected] for questions or more information.

Call for Mentors – UT Austin Women’s STEM Program

The Association for Women In STEM at UT (AWIS at UT) is recruiting mentors for their 2021 mentorship program which pairs undergraduate students, grad students, and postdocs at UT with women in STEM careers for 1 year of meetups (starting Jan. 2021) scheduled at the pair’s convenience and guided by supporting materials. Sign Up at https://utexas.qualtrics.com/jfe/form/SV_b9NPyRLozuJtirX

BioAustin/TMDA/AHT/CCI/TX Health Catalyst/Capital Factory/ Health Tech Austin

We are mapping the Austin’s landscape in healthcare/life sciences/biotech/MedTech. Anyone interested in volunteering to collect/compile this information as a team? If you are, please contact Scott Collins at [email protected].

ATX Women in MedTech

Looking for volunteers to support community outreach, event management, PR, sponsorship and more. Email [email protected] for details.

BioAustin

We are seeking volunteers. If interested, please reach out to Scott Collins

TEXAS LIFE SCIENCE ORGANIZATIONS

BioHouston

http://biohouston.org/

Temple Health & Bioscience District (THBD)

http://www.templebioscience.com/

Texas Healthcare and Bioscience Institute (THBI)

https://www.thbi.com/

Texas Biomedical Research Institute, San Antonio

https://www.txbiomed.org/

Texas Health Catalyst

https://dellmed.utexas.edu/thc

Texas Medical Device Alliance (TMDA)

https://texmda.org/

Texas Medical Device Alliance (TMDA) LinkedIn Group

https://www.linkedin.com/groups/6952028

The Health Cell, San Antonio

http://thehealthcell.org

TMCX/TMCX+, Houston

http://www.tmc.edu/innovation/innovation- programs/tmcx-plus/

Top Austin-Area Medical Device Companies

https://tinyurl.com/ya9v2s5u

Velocity Texas, San Antonio

https://velocitytx.org/

Women in Bio-Texas (WIB-TX, Austin & Houston)

https://www.womeninbio.org/page/t

THANKS TO OUR TMDA SPONSORS

With warm regards,

Amy Shepherd, Christine Scheve, Dana Abramovitz, Elisa Maldonado-Holmertz, Gretchen Upton, Joe Skraba, Lance Anderson, Ryan Baird, Sandie Roth, Scott Collins, and Tim Sullivan, on behalf of BioAustin, Texas Medical Device Alliance (TMDA), and Austin Health Technology (AHT)