Events
Regulatory Basics for Medical Startups
This month, we’re excited to welcome Natalie Vollrath, Senior Regulatory Consultant at MEDIcept, as our guest speaker. Natalie will lead a 45-minute workshop on "Regulatory Basics for Medical Startups."
In this session, Natalie, a regulatory expert with over 30 years of experience in the medical device industry, will provide an overview of the critical regulatory frameworks startups must navigate. Attendees will gain insights into FDA classifications, ISO standards, and compliance requirements for medical devices, diagnostics, and software. Natalie will guide participants through the essential steps for preparing regulatory submissions, meeting product registration requirements, and ensuring compliance in both U.S. and international markets.
Having led ISO and FDA compliance efforts and contributed to successful product introductions, Natalie will share her expert advice on determining regulatory pathways, preparing documentation, and avoiding common regulatory pitfalls. Whether your startup is just beginning or already developing products, this workshop will equip you with the knowledge to meet regulatory standards and advance with confidence.
Date: January 15, 2024
Time: 6 pm - 8 pm
Cost: $5
Register: Startup Grind
About Natalie Vollrath
Natalie Vollrath brings over 30 years of experience as a quality and regulatory professional in the medical device industry. She has broad experience across multiple product categories and device classes, preparing regulatory submissions and obtaining product registrations for U.S and international markets. Natalie has led ISO and FDA regulatory and compliance efforts throughout the product lifecycle and played a key role in new product introductions.
As a Sr. Regulatory Consultant at MEDIcept, Natalie assists clients with their regulatory needs, including determination of the regulatory pathways for US, EU, and other international markets, developing and preparing submissions, technical files, Pre-Submission meeting requests, non-filing justifications, and other regulatory documentation and activities.
Before joining MEDIcept, she held roles including Quality Assurance/Regulatory Affairs Manager at various companies in the medical device industry, working with a diverse range of products that included Software as a Medical Device (SaMD) and Software as a Service (SaaS).
Natalie holds a B.A degree from the University of California, San Diego as well as certificates in Systems Engineering and Biostatistics. She is Regulatory Affairs Certified through the Regulatory Affairs Professionals Society (RAPS). Natalie also holds several additional certifications through ASQ, including Certified Medical Device Auditor, Certified Quality Engineer, and Certified Software Quality Engineer.
The Art of Storytelling
What you do is not necessarily unique. But your story and the impact you're making is.
In a world where the things you do, the products and services you provide, are things that dozens of others are doing, how do you make yourself stand out? You share your story. People connect to PEOPLE, not products and services. And in a world where our thoughts divide, our feelings will unite. Jamie will help you switch the gears in your marketing minds to stray you away from the traditional self-promo type videos that most people use to create video content that ultimately gets overlooked. Jamie will show you the difference in creating content that focuses on your WHAT and instead help you focus on your WHY.
This workshop is aimed to help organizations find and share their stories so that people care about WHO you are, not WHAT you do. Jamie will guide you through finding your focus when creating a video, bringing out the most important, emotive parts and weaving it together to create a story that will receive good attention online and help promote your business and call to action.
Video is incredibly important in today's world. It's how everyone consumes information. After this webinar, you'll walk away with a better understanding of how to tell your own story and how it could make a tremendous difference in making YOU stand out.
Date: February 12, 2025
Time: 6 pm
Cost: $5
Location: ReadyStart CleanRooms by ThermoGenesis, 2890 Kilgore Road, Rancho Cordova, 95670
Registration: Startup Grind
About Jamie Perez
Jamie Perez is the owner and chief storyteller at Beyond Words Productions – a videography + storytelling company that focuses on creating heartfelt and emotive videos for businesses and nonprofits. Before Jamie became an entrepreneur, she was a TV news reporter for six years. Her career as a broadcast journalist moved her across the country from California to Iowa and eventually Wisconsin, where she covered tragedy, triumphs, politics, community events, and burdened our blizzards and severe weather on live TV. As a reporter, Jamie did everything as a one-woman band from finding her own stories to setting up interviews, filming everything, editing everything, presenting it in front of the camera, writing up the web story and doing it all over again day after day. Jamie said doing it all prepared her to be able to run her videography and storytelling business as a solopreneur. She is driven by emotional storytelling and has a passion for creating empathy through videos. Jamie's videos have helped organizations fundraise, hire staff, promote events, generate leads, and brand and market themselves in new ways that make other people care about them. Jamie’s business motto is: “If a picture says a thousand words, my videos will leave people Beyond Words.”
Startup Holiday Party!
Celebrate the holiday season with Sacramento's entrepreneurial community! Join us for an evening of connection, celebration, and camaraderie at the Startup Holiday Party—a collaborative event hosted by StartupSac, CleanStart, The Carlsen Center, Startup Folsom, MedStart, Startup Grind, 1 Million Cups and AgStart.
Why Attend?
Whether you're a founder, aspiring entrepreneur, or a supporter of the startup ecosystem, this is the perfect opportunity to network, unwind, and celebrate with fellow innovators. Enjoy an evening of good cheer with other local startups, venture supporters, and entrepreneurial advocates who make our region vibrant and forward-thinking.
Event Highlights:
Mix and mingle with a diverse network of entrepreneurs and community leaders
Raise a glass to the year’s successes and toast to new opportunities in 2025
Experience the unique ambiance of Lucid Winery, located in the heart of Sacramento’s R Street Corridor
Date: December 11, 2024
Time: 5:30 pm
Cost: $10
Location: Lucid Winery & Event Venue, 1015 R Street, Sacramento, 95811
Registration: Eventbrite
Process Optimization for Efficient Cell and Gene Therapy Manufacturing
The Sacramento Region is home to a vibrant medical startup ecosystem. To support its growth, MedStart, is a program dedicated to fostering innovation in medical and life sciences.
This month, Mary Ann F. Santos, Thermo Fisher Scientific Senior Manager, Strategic Collaborations and Sarah Daoudi and Kevin Pridham, Field Applications Scientists for Cell and Gene Therapy and Genome Engineering will be discussing process optimization for efficient cell and gene therapy manufacturing.
Cell and gene therapy is transforming the treatment of diseases by providing a targeted approach that has led to prolonged success for many patients. With a growing number of therapies in development, manufacturers are seeking ways to enhance and scale up the manufacturing process to meet regulatory standards and reduce costs.
For cell therapies, one strategy to overcome current manufacturing challenges is utilizing automated, closed systems with integrated software controls. The same can apply for streamlining gene therapies and utilizing optimized systems that allow for seamless scale-up of viral production. For the manufacture of cell therapies requiring gene modification, access to GMP-grade nucleases & reagents that can meet your clinical needs and required regulatory standards is also critical.
These systems offer advantages over traditional open systems, such as standardized processes, cost savings, consistent production results, and reduced contamination risks. This presentation will highlight some of the current challenges in cell and gene therapy manufacturing, highlighting the benefits of new closed, automated, and modular technologies in facilitating both end-to-end viral and non-viral processes. Additionally, we will explore the development of a High Fidelity GMP Cas9 protein that can be implemented within these closed, automated, and modular cell manufacturing systems.
MedStart is supported by ReadyStart Cleanroom, Carlsen Center for Innovation and Entrepreneurship, the 50 Economic Alliance, and Startup Folsom.
Please note that this event is in-person at the ReadyStart CleanRooms
Date: November 13, 2024
Time: 6 pm - 8 pm
Cost: Free
Register: Eventbrite
About Mary Ann Santos
Mary Ann Santos is a Global Cell and Gene Therapy Senior Manager, Cell, Gene and Advanced Therapies Strategic Collaborations at
Thermo Fisher Scientific. She has over 27 years of experience in the biotechnology industry with expertise in Cell Biology and Life Sciences. This
includes working with biotechnology, bioindustrial and biopharmaceutical companies in addition to academic institutions in North America and across the globe. She has also led research project teams with a focus in next generation cancer therapeutics as well as experience in Process Development prior to joining Thermo Fisher Scientific.
About
Sarah Daoudi
Sarah Daoudi is a Field Application Scientist that provides solutions and consultation for Thermo Fisher Scientific’s cell and gene therapy workflows and Gibco Cell Therapy Systems (CTS) brand of products. Sarah has expertise in cell therapy workflows including CAR-T workflows, manufacturing, viral vector production (lentivirus and adeno-associated viruses), and drug development. Formerly a R&D scientist at Thermo Fisher Scientific, she helped launch the CTS Rotea System by producing application data, writing and developing new protocols, as well as extensive troubleshooting and customer support. In her previous role as Process Development Research Associate at City of Hope (Duarte, California), Sarah oversaw and worked on improving, troubleshooting, and development of Phase I CAR-T cell therapeutic drugs and workflows for over ten different IRBs. Sarah received her master’s degree in Cell and Molecular Biology from California State University, Fullerton (California).
About Kevin Pridham
Kevin Pridham is a Field Applications Scientist at Thermo Fisher Scientific supporting the Gene Modulation & Editing and Advanced Cancer Cell models portfolios, consisting of CRISPR/Cas, RNAi, disease modeling, delivery, and cancer tumoroid culture across North America. Kevin has been with the company since 2022. Prior to joining Thermo Fisher Scientific, Kevin obtained his PhD from Virginia Tech in Translational Biology, Medicine, & Health. He has over 15 years of research experience in cancer biology, drug development, drug delivery, and neurobiology.
Insurance Reimbursement Essentials for Healthcare Startups
The Sacramento Region is home to a vibrant medical startup ecosystem. To support its growth, we are reintroducing MedStart, a program dedicated to fostering innovation in medical and life sciences.
This month, we are hosting Thom Schildmeyer who will share his expertise on healthcare insurance reimbursement, its importance to your business, and ways you can optimize the reimbursement process to ensure your success. Specifically, he’ll provide insights into each of the reimbursement stakeholders (provider, payer, and patient) and what you should consider when launching a product or service into the healthcare arena.
Thom will share real-world examples highlighting the opportunities and challenges with insurance reimbursement and how businesses of all sizes can benefit. In addition to understanding the needs and interests of the various stakeholders, you’ll leave with a strong knowledge of how money flows between the players and the different approaches you can take to maximize insurance reimbursement specific to your enterprise.
MedStart is supported by ReadyStart Cleanroom, Carlsen Center for Innovation and Entrepreneurship, the 50 Economic Alliance, and Startup Folsom.
Please note that this event is in-person at the ReadyStart CleanRooms.
Date: October 16, 2024
Time: 6 pm - 8 pm
Cost: Free
Register: Startup Grind
About Thom Schildmeyer
Thom is an accomplished executive and entrepreneur with nearly 30 years of experience in the healthcare industry. A trusted healthcare business consultant, coach, and advisor, he has a proven track record of delivering impactful results, with a focus on strategy and growth for businesses and their leaders.
Complementing his deep knowledge of business leadership, strategy, and growth, Thom has spent the majority of his career in the areas of healthcare technology, services, and programs, including revenue cycle management and insurance reimbursement. With an emphasis on the healthcare ecosystem and its various stakeholders (provider, payer, and patient).
In addition to his corporate healthcare leadership experience (Allergan, Inc., Vision Services Plan), Thom founded and successfully sold his own healthcare business, Aesyntix Health (now part of Modernizing Medicine), and has since launched TLS Strategy Solutions to help other entrepreneurs and leaders develop their businesses.
Digital Marketing Basics for Startups
Digital Marketing Basics for Startups
The Sacramento Region is home to a vibrant medical startup ecosystem. To support its growth, we are reintroducing MedStart, a program dedicated to fostering innovation in medical and life sciences.
This month, Rich Foreman will cover digital marketing basics which include website design, SEO, digital marketing, content marketing, social media, and influencer marketing. Rich's standard advice is that every startup needs to have a proficiency in digital marketing and in this workshop, he will outline what you need to know and provide actionable advice.
MedStart is supported by ReadyStart Cleanroom, Carlsen Center for Innovation and Entrepreneurship, the 50 Economic Alliance, and Startup Folsom.
Please note that this event is in-person at the ReadyStart CleanRooms. Food and beverages will be provided.
Date: September 26, 2024
Time: 6 pm - 8 pm
Cost: Free
Register: StartupGrind
BrainScanology Overview
The Sacramento Region is home to a vibrant medical startup ecosystem. To support its growth, we are reintroducing MedStart, a program dedicated to fostering innovation in medical and life sciences.
This month, we are hosting Dr. Dr. David Nguyen who will be discussing his startup BrainScanology which enhances the precision of radiologists, pathologists, and cell biologists by 1,000X.
MedStart is supported by ReadyStart Cleanroom, Carlsen Center for Innovation and Entrepreneurship, the 50 Economic Alliance, and Startup Folsom.
Please note that this event is in-person at the ReadyStart CleanRooms.
Date: August 14, 2024
Time: 6 pm - 8 pm
Cost: Free
Register: Eventbrite
About Dr. David Nguyen
David H. Nguyen, PhD. Dr. Nguyen is a computational biologist who invented the LCPC Transform, an algorithm that measures shape in ways not possible with area, volume, and signal intensity. He obtained his B.A. (Molecular & Cellular Biology) and Ph.D. (Endocrinology) from University of California, Berkeley. Following this, he was an Affiliate Scientist in the Division of Molecular Biophysics and Integrated Bioimaging at Lawrence Berkeley National Lab, and then a Visiting Scholar in the Department of Radiology at Stanford University.
MedStart Event featuring Elevai Labs Co-Founder Dr. Jordan Plews
The Sacramento Region is home to a vibrant medical startup ecosystem. To support its growth, we are reintroducing MedStart, a program dedicated to fostering innovation in medical and life sciences.
This month, we are hosting Dr. Jordan Plews will discuss the process, challenges, and benefits of taking Elevai Labs public.
MedStart is supported by ReadyStart Cleanroom, Carlsen Center for Innovation and Entrepreneurship, the 50 Economic Alliance, and Startup Folsom.
Please note that this event is in-person at the ReadyStart CleanRooms.
Date: July 17, 2024
Location: ReadyStart CleanRooms, 2890 Kilgore Road, Rancho Cordova, 95670
Cost: Free
Register: Eventbrite
About Dr. Jordan Plews
With over 15 years of experience spanning stem cell research, biochemical engineering, and the commercialization of biotechnological innovations, Dr. Jordan Plews has made significant contributions to both the academic and business worlds. Educated in the UK and further honed at Stanford University, his work has been published in premier journals, leading to groundbreaking developments in stem cell-based therapies and skincare products. Dr. Plews' expertise in product management, team leadership, and development of healthcare solutions showcases his unique ability to bridge the gap between cutting-edge science and impactful business ventures. His upcoming presentation is set to provide valuable insights into the advancements in regenerative medicine and the critical role of innovation in driving the future of biotechnology.
MedStart NIH Grant Workshop Featuring Advocacy Chiefs Founder Benjamin Cadranel
The Sacramento Region is home to a vibrant medical startup ecosystem. To support its growth, we are reintroducing MedStart, a program dedicated to fostering innovation in medical and life sciences.
This month, we are hosting an NIH Grant Workshop led by Benjamin Cadranel, founder of Advocacy Chiefs. The Small Business Innovation Research (SBIR) program, a federal grant initiative, invested over $4.3 billion in small business research and development in 2023. It represents the pinnacle of federal investment for early-stage startups, with 11 agencies, including the National Science Foundation and the National Institutes of Health, providing up to $2 million to small businesses without taking equity.
Advocacy Chiefs raises awareness, provides education, and offers direct grant writing support to local small businesses for this unique grant program. Recently, with the backing of the City of Sacramento’s Office of Innovation and Economic Development, Advocacy Chiefs launched a new program. This initiative is also supported by the Sacramento Entrepreneurial Growth Alliance, designated as an Accelerate CA Hub and funded by the California Office of the Small Business Advocate.
The goal of the program is to assist up to 10 local small business entrepreneurs in applying for the SBIR grant. Participants will receive vital resources such as direct grant writing support and technical and agency-like reviews prior to submission.
The workshop will cover the NIH’s solicitation process, including required registrations, timelines, and topics. It will also provide insights on SBIR readiness and strategies to increase success rates for the next round of SBIR grants.
MedStart is supported by ReadyStart Cleanroom, Carlsen Center for Innovation and Entrepreneurship, the 50 Economic Alliance, and Startup Folsom.
Please note that this event is in-person at the ReadyStart CleanRooms.
Date: June 19, 2024
Location: ReadyStart CleanRooms, 2890 Kilgore Road, Rancho Cordova, 95670
Cost: Free
Register: Eventbrite
About Benjamin Cadranel
Ben Cadranel is a corporate attorney and fundraiser who builds comprehensive collaborations and public-private partnerships by leveraging his extensive network and instincts as a master connector. He founded Advocacy Chiefs LLC, a grants and government development firm that positions clients to capture market share through strategic public-private partnerships funded through grants and other non-dilutive instruments.
Benjamin is an expert in building equitable, inclusive, and Future-Ready workforce development programs that serve historically underserved and underrepresented populations. Ben’s past experiences include being Director of Resource Development at Woodland Community College and the Associate Director of Development for the University of California-wide California Summer School for Math and Sciences (COSMOS). Ben’s portfolio includes working with the following companies and agencies: the Pacific Gateway (City of Long Beach), the Los Angeles Regional Consortium, Gladeo, Pockets Change, and DKS Associates.
MedStart CEO Forum
Startup Folsom, in partnership with the Carlsen Center for Innovation and Entrepreneurship and MedStart's original organizer Robert Groth, is launching the MedStart CEO Forum. This event aims to cultivate a supportive network among leaders in the medical startup community.
Our inaugural event will feature Jessie Becker Alexander who was the Founding CEO of Alydia Health which was acquired by Organon for $240 M. She is also the Program Director at FourthWave and the the Entrepreneur in Residence for the Sacramento State Carlsen Center for Innovation & Entrepreneurship. (Please note that Dr. Jordan Plews was originally scheduled but had to cancel due to a conflict. We will reschedule him for a future event).
Spaces are complimentary but limited to ensure meaningful interactions. Secure your spot at this in-person event by registering today. Don't miss out on shaping the next wave of medical innovation in the Sacramento Region.
Date: May 23, 2024
Location: Undisclosed. Location will be sent in an invite after you’ve been approved.
Cost: Free
Register: Google Form
About Jessie Becker Alexander
is an accomplished Entrepreneur in Residence at Sacramento State's Carlsen Center for Innovation and Entrepreneurship, dedicated to fostering the vibrancy and growth of the entrepreneurial community in the Sacramento region. With a diverse range of responsibilities, Jessie excels in managing the student pre-accelerator, known as the Hivemind, overseeing the FourthWave Accelerator, and co-facilitating The Lean Innovator cohort.
Previously, Jessie made a profound impact as the founding CEO of Alydia Health, a groundbreaking medical device company focused on revolutionizing the treatment for postpartum hemorrhage (PPH), the leading cause of maternal death worldwide. Her exceptional leadership led to Alydia Health's acquisition by Organon in June of 2021, valued at an impressive $240M. Recognizing her remarkable achievements, Forbes honored Jessie by including her in their esteemed 30 Under 30 list in Healthcare in 2015.
Prior to her pioneering work at Alydia Health, Jessie played a pivotal role in igniting the entrepreneurial movement at Cal Poly. As one of the founding members of the Cal Poly Entrepreneurship Club and an integral part of the initial team at the Cal Poly Center for Innovation and Entrepreneurship (CIE), she spearheaded the creation and implementation of various programs to empower student entrepreneurs.
With an unwavering commitment to innovation and an impressive track record of success, Jessie Becker Alexander continues to make a significant impact in the entrepreneurial landscape, driving positive change and inspiring future generations of innovators.