Newsletter June 2022

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IN THIS NEWSLETTER

SPOTLIGHT

LOCAL EVENTS

WEBINARS & VIRTUAL EVENTS

INDUSTRY RESOURCES

FUNDING OPPORTUNITIES

CAREER CORNER

VOLUNTEER OPPORTUNITIES

TEXAS LIFE SCIENCE ORGANIZATIONS

SPOTLIGHT

For over 25 years, CAI has been passionate about helping development-stage companies get their product to market faster. Any misstep on the path to commercialization drains capital, impacts valuation, and delays time to revenue. Most importantly, delays can impact patient access to novel, life-saving therapies. Our industry experts work with you to characterize your product and process, and to apply the principles of quality by design, quality risk management and industry best practices to help you reach each milestone on the path to commercialization in the most efficient manner. Our integrated project delivery model enables you to accelerate process validation, tech transfer, manufacturing scale-up, vendor selection, quality system implementation and regulatory affairs from early clinical trials through scale-up to commercial manufacturing.

CAI serves clients in the following business areas:

  • Commissioning & Qualification
  • Building Commissioning
  • Asset Management & Reliability
  • Quality, Regulatory, & Compliance
  • Human Performance
  • Process & Manufacturing Technology
  • Owner’s Project Management
  • Automation & Information Technology

For more information, please visit www.cagents.com or contact [email protected]

UPCOMING EVENTS

Local Events

June 7
3pm

Lightning Pitches & Enlightening Talks: Remote Patient Monitoring

Join AHC and TEXGHS to discuss how home-based health care (remote patient monitoring) increases pandemic resiliency in communities. This June, we are focused on remote patient monitoring. We’re bringing together Austin’s health leadership and regional entrepreneurs in health innovation for an enlightening talk and panel conversation about a health security topic of interest followed by lightning pitches from three promising later stage startups. 

June 8
4 – 5PM

The Biotech Moonshots & Startup Lift off from Lab to Launch

Karl Handelsman is the Founder and General Partner of Codon Capital, established in 2013 to invest in early-stage biotech teams uniquely qualified to build breakthrough technical solutions in therapeutics and synthetic biology. Karl has been working with extraordinary teams that have a track record of success for over 20 years. Codon supports teams in advance of the Series A to discover the highest value product for their technology. Codon also helps teams establish a capital efficient development plan with the goal of demonstrating value within 18 months of the Series A financing. During this seminar, Karl will walk you through the journey of becoming a founder and entrepreneur.

July 12
9 – 11AM

Regulatory 101

It is important to understand the role that regulatory affairs plays and how it could can help your business / start-up flourish and avoid unnecessary obstacles. At this event, Bobbi Drais from Drais Regulatory Consulting, LLC will introduce you to the regulatory function and provide a history of the FDA and its oversight of the biotech and life sciences industry.

Sept 21
8AM

Institute for Biomedical Entrepreneurship (IBE)

The IBE is a non-profit celebrating 5 years of helping entrepreneurs accelerate the flow of ideas to the marketplace. The IBE program is a 5 day experiential program that includes a mix of classroom work and hands on project work. Advisors work with participants over the 5 day program to develop and refine their pitch and present to an investor panel on the final day. Since its inception, the IBE has helped over 40 companies launch and over 50 corporate projects see success in the marketplace.

Sept 22, 7:30AM-6:30PM
Sept 23, 8AM-2PM

2022 iC3 Life Science Summit

The BioNTX iC³ Life Science Summit serves as the forum where leaders come together to discuss strategy, exhibit the broad spectrum of North Texas bioscience research, and where the latest innovation, products and services can be seen. Attendees range from the startup community through large multinationals representing industry sectors such as biotech, pharmaceuticals, healthcare companies, academic research institutions, innovators, and leaders. Also attending will be business development executives, vendor partners, investors, and talent seeking new opportunities.

Webinars & Virtual Events

June 2
12PM

How to Survive an FDA Inspection

A big challenge with all medical device manufacturers is to be compliant with any regulations applicable with their product. In the case of the United States it will include 21 CFR Part 820 which is a set of regulations from the FDA that outlines the current good manufacturing practice (CGMP) requirements that manufacturers must follow with regards to their quality system. Register for this free webinar where Anne Holland, CEO of QA Consulting with 20+ years experience advising medical device companies on regulatory and quality needs, will share some preventative actions that your medical device company can take to minimize the possibility of receiving a 483 which in some cases could result in a product seizure.

June 14-15
All Day

NAMSA Training Series: Biological Safety – Course A

NAMSA’s Biological Safety Training Series is geared toward medical device professionals who require a working knowledge of biological safety and biocompatibility.

June 28-29
All Day

NAMSA Training Series: Biological Safety – Course B

This two-day training course is designed for those who have received certification in the NAMSA Training Series Biocompatibility of Medical Devices – Two-Day Certification (Course A).

INDUSTRY RESOURCES

GGA-LP

Greenlight Guru Academy

Level up your medical device skills and grow your career! From quick, practical lessons to comprehensive certifications, you’ll learn everything you need to know about keeping up with the medical device industry.

Texas Health Catalyst Application

Apply to Texas Health Catalyst @Dell Medical School for commercialization support for your product idea/invention:

Apply to Texas Health Catalyst for an opportunity to receive consulting and commercialization support for your health product idea or discovery. Eligibility: Austin entrepreneurs, startups & UT faculty/researchers/students. Areas of interest: Therapeutics, Devices, Diagnostics/Research Tools, Digital Health/Software. Deadline: June 15th 2022. 

More information and application link > https://dellmed.utexas.edu/applythc.  

Austin Community College

Austin Community College biotechnology or computer science interns are available Email Kathryn Naughton for more information

BioNTX Job Board

Visit Bio North Texas job board for available job posting in the North Texas region.

Career Connections

We equip underserved jobseekers with 21st-century skills and connect them to Digital Marketing careers across the US. With a focus on underserved communities, we amplify the online presence of small businesses, while launching the careers of jobseekers.

The Global Medical Device Job Board

What if, there was a one-stop shop for candidates and companies looking for top medical device opportunities and talent, worldwide Increase your network with more than 150,000 medical device industry professionals to access exclusive top talent and list incredible jobs in the medical device industry. The job board will always be free to job seekers, and hiring companies will receive their first 90 days of unlimited job postings free.

Abbott

Multiple Positions
View positions

Aeglea Biotherapeutics

Multiple positions
View positions

ALKU

Multiple positions
View positions

AMDM IVD Job Board

https://www.amdm.org/jobs.html

Asuragen

Multiple Positions
View positions

Austin Technology Council (ATC) Jobs

https://www.austintechnologycouncil.org/jobs/

Babylon Health

Multiple Positions
View positions

Black Diamond Networks

Multiple Positions
www.blackdiamondnet.com

Commissioning Agents (CAI)

Multiple Positions
https://cagents.com/careers

FDA Quality and Regulatory Consultants (FDAQRC)

Join the FDAQRC CAREER NETWORK

Luminex

Multiple Positions
View positions 

Molecular Templates

Multiple positions
View positions

Nuclein

Multiple Positions
www.nuclein.com/careers/

Skills Alliance

Multiple positions
View positions

Syneos Health

Multiple positions
View positions

VOLUNTEER OPPORTUNITIES

Austin Community College Biotechnology

ACC Biotechnology program is looking to increase enrollment and retention in the program through partnerships with alumni. We are looking for ACC Biotech Alumni or Biotech Alumni from another 2-year biotech program to participate in virtual events like speed networking events. We are also looking to document different biotech career pathways to share with students. Contact Cassandra for more information.

Life Science Conferences, LLC

Attend the 3rd Annual Life Science Women’s Conference for free utilizing your talents. Help create an energetic, revitalizing environment for women in the Life Sciences while creating life-changing connections. We’re looking for volunteers to assist with event coverage, event management, logistics, set-up, and more depending on your availability. Contact Steve or Patti for information about volunteering

BioAustinCTX Seeking Grant Writing Volunteers

BioAustinCTX is seeking volunteers to assist with Grant Writing:
• Determines grant proposal concept by identifying and clarifying opportunities and needs, studying requests for grant proposals (RFPs), and attending strategy meetings.
• Prepares grant proposals by determining concept, gathering and formatting information, writing drafts, and finalizing.
• Supported by the BioAustinCTX Board

BioAustinCTX Seeking Volunteers

BioAustinCTX is seeking help with our PR/comms/marketing strategy as our content will increase in 2022. Please complete our volunteer form and indicate what areas you are interested in volunteering in.

UT needs your help

The IC2 Institute is exploring the impact of Dell Medical School (DMS) across Central Texas. We ask members of BioAustinCTX, especially C-level executives, to reach out to Dr. Gregory Pogue if you are willing to participate in a brief focus group and/or provide feedback on your experience with DMS and the impacts it has created. We would like to host the focus group in early December – please let us know your availability and interest. Thank you!

Austin Chamber Talent Ambassador program 

We partner with nearby businesses who offer learning opportunities (guest speakers, internships, apprenticeships, etc.), and connect them to local schools, post-secondary institutions, and those facing barriers to employment.

BioAustinCTX

We are seeking volunteers to help collect and compile data to map the healthcare landscape in Austin. If interested, please fill our volunteer form.

TEXAS LIFE SCIENCE ORGANIZATIONS

THANKS TO OUR TMDA SPONSORS

With warm regards,
Cathy Diehl, Gretchen Upton, Hector Torres, Joe Skraba, Kristen Whitson, Lance Anderson, Ryan Baird, Scott Collins, and Tim Sullivan, on behalf of BioAustinCTX and Texas Medical Device Alliance (TMDA).