Alert: The Plaza Building will remain closed through Jan. 1, 2025.
Faculty and staff may retrieve items and use copy machines in preparation for finals week with Campus ID badges through the door on the Southwest side across from King Center. Additionally, the Auraria Health Center (link: https://healthcenter1.com) is continuing to operate at a reduced capacity.
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SPARK Previous Events
Pre-Recorded Webinars
For your information
Previously recorded sessions below are an additional resource for those who want to learn more about bringing new technologies to commercialization. A variety of impressive professionals below provide valuable insights on their areas of expertise.
Educational Program Launch 2024 with Stan Lapidus
Join us to welcome the new cohort of SPARK awardees. The session will kick off with a keynote from Stan Lapidus, who will talk about his own and other successful companies. He'll provide suggestions for the audience on how to better estimate budgets and timelines as they pursue their own adventures. We will also walk through the process of IP protection and commercializing technologies in CU Anschutz, and the expectations of the SPARK program.
CU Anschutz IND/IDE Program: A New Central Resource with Heike Newman, MS, EMBA, CCRP
(recorded January 31, 2024)
The IND/IDE Program at CU Anschutz was established in 2023, and is open to business to clinical researchers as of July 1st. The program consists of teams within the IND/IDE Office (Vice Chancellor for Research) and the Cancer Center (School of Medicine). This presentation will provide information on the structure of the program, the support that is being provided through this new resource, and a description of projects and submissions that can currently be supported through the program.
Clinical Development: From the Lab to the Market
(recorded March 27, 2024)
Gilad Gordan, MD, MBA will focus this lecture on clinical development of drugs and vaccines. He will cover the types of studies needed to get drugs out of the lab and into the clinic, the four phases of clinical trials, and the NDA process, and use case studies to illustrate effective strategies for drug development.
Educational Program Launch 2023 with Rhonda Wallen
This education session launched the 2023 SPARK|REACH educational program. The Keynote speaker will be Rhonda Wallen MS, MBA, who is an Independent Board Director and Advisor to life science companies, leveraging her 25 years of experience to help founders and CEOs develop strategy, complete financings and plan for execution and growth. The second half of the session will be an amuse-bouche of topics necessary for innovators to understand to move products forward, including protecting intellectual property, and developing a target product profile. Jumpstart your knowledge on commercializing healthcare products by attending this informative session!
Entrepreneurs Bootcamp: Startup Legal, Tax and Fundraising Considerations
(recorded October 25, 2023)
This session will focus on forming, launching and financing your startup. Matt Dubofsky, Dave Strong and Cassie Wetzel, attorneys in Wilson Sonsini’s Boulder office, and Matt Meyer, Wilson Sonsini’s Chief Business Advisor, will lead the session and cover various topics, including entity selection, startup formation documents, startup tax considerations and early-stage fundraising strategies.
Patenting 101 with USPTO's David Le
(recorded March 22, 2023)
This session will discuss practical and essential insights on patent fundamentals, updates at the USPTO, including numerous recent pilot programs, domestic initiatives and legislation, and the process for securing intellectual property rights domestically (US) and internationally.
SPARK|REACH & Catalent Seminar: Strategic Considerations in Biologics CMC Development
(recorded September 22, 2023)
Developing new biologics from early research is a complex endeavor. Failing to prepare for process development and manufacturing activities to meet the need of the clinical trials can cause delays and bears the risk of clinical trial failure. Therefore, companies need clarity around essential elements of the manufacturing process, quality control and assessment, and CMC activities to guide the development and manufacturing work for early clinical trials.
The Twists and Turns of Intellectual Property, Licensing and Partnerships with Gali Baler, PhD and Mary Tapolsky, PhD
(recorded January 25, 2023)
This education session will begin by providing the audience with an overview of intellectual property. After this brief introduction, the session will cover the intricacies of licensing and partnerships for the academic inventor. Cases and decision trees will be employed to convey the complexities and ultimate strategies inventors may want to consider when moving their inventions forward.
Straight Talk About My Winding Path Through Business: Sharing My 25 Years of Commercial Experiences to Improve Your Chance at Success with Raymond Tarr
(recorded June 28, 2023)
The 4 critical actions a founder needs to take to ensure their business remains their business: protect your position as an owner, don’t be blinded by the love of an idea, know your market, and drive your business or there will be consequences.
Introduction to Candidate Lead Optimization: Turning a Molecule into a Drug with Edwin Garner, PhD
(recorded May 24, 2023)
Bridging the gap between drug discovery and development requires a focus on optimizing lead molecules for drug like properties. Ed Garner, PhD will describe early IND enabling studies and gives examples of successful and not so successful candidates for development with emphasis on pharmacokinetics.
Walking Through the Valley of Death: Adventures in SBIR/STTR Grant Applications with Stephanie Fertig
(recorded October 26, 2022)
This session will cover an overview of federal funding for small businesses, with a description of the nuances of SBIR/STTR, types of SBIR and STTR grants, and registrations needed. We will also learn from successful SBIR/STTR awardees.
Getting the Information you Need: Customer Discovery with Cathy Bodine, PhD
(recorded July 13, 2022)
Customer discovery is challenging. This session will focus on creating good questions for use during a customer discovery session. We will review the I-Corps@NCATS training program, discuss Business Canvas and Innovation Within tools and will focus on developing your question database.
Effective Boards: Forming and Managing Your Best Board with Barbara Bauer
(recorded June 22, 2022)
The Executive Director of Boardbound by the Women’s Leadership Foundation describes the challenges and opportunities of forming and managing a board for a start up or growth company, and the need for diversity on the board to achieve results.
Biocompatibility Considerations for Medical Devices with Audrey Turley of Nelson Labs
(recorded June 15, 2022)
Audrey Turley, BS, RM (NRCM), CBA (ASQ), Senior Biocompatibility Expert at Nelson Labs presents. Biocompatibility of medical devices is an evaluation of the manufacturing materials and processes to ensure safety for the patient/end user. While this may easy at first glance, there are several initial considerations to employ for success when final designs are determined and submission to market is on the horizon. We will discuss these considerations to aide in future successful medical device innovations. Key take aways will include: 1) Basic understanding of biocompatibility. 2) Important factors to consider early in the design phase. 3) How to properly evaluate devices based on contact type and duration.
GXPs for Early Stage Drug Development with Nikolas Burlew
(recorded May 25, 2022)
Nik Burlew, Head of Quality Assurance, Clovis Oncology covers the basics of Good Manufacturing Practices (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) as it relates to early stage development of drugs and biologics.
Shining a Light on the FDA Black Box: A Nonclinical Perspective with Melanie Hartsough
(recorded April 27, 2022)
This talk will describe the types of early communications with the FDA and the high-level requirements for nonclinical programs supporting clinical development of 4 product types: small molecules, protein therapeutics, prophylactic vaccines and cell and gene therapies. Case studies will be provided.
MedTech Commercialization: A Roadmap for Regulated Industry with Michael L. Mestek, PhD
(recorded April 20, 2022)
We will explore healthcare technology pathways from design through the commercial phases with an emphasis on how to resolve common barriers to adoption.
Formulation, Frogs and Baseball with Tom Anchordoquy
(recorded April 13, 2022)
The talk will cover some basic ideas about how to think about a formulation problem. However, most projects quickly go “off the script” and involve trying some creative, and often fruitless, approaches. In this context, I will review some of my formulation adventures and the non-scientific experiences that I encountered when working with colleagues and starting companies.
Building a Value Portfolio Throughout the Life Cycle of Innovation with Brett McQueen, PhD
(recorded March 23, 2022)
So you’ve developed a unique intervention/ technology and it’s likely to be approved by regulators, now what? How do I get my product covered/reimbursed? What evidence do I need? Learn how to estimate the value and sustainability of your health care intervention; Understand the evidence needed for various pharmacoeconomic applications (e.g., cost-effectiveness, return on investment); and learn about the role of pharmacoeconomics in coverage and reimbursement decision-making with emphasis on recent developments in the United States private and public insurance markets.
Is it Safe? Toxicology in Therapeutic Development with Kenneth J. Olivier Jr., PhD
(recorded April 6, 2022)
Toxicology is a borrowing science, using what is known about the physicochemical properties of a test article (e.g., potential therapeutic) and biology of the intended target (e.g., receptor) hypothesized to modulate the disease of interest. Prior to entering first in human clinical trials, rigorous in silico, in vitro and in vivo testing must produce tolerability data supporting safe use of the test article for its intended use (i.e., drug label). Topics covering early and required toxicology testing will be covered.
Academia to Global Entrepreneur: A Vision to Impact Sub-Saharan Africa with Dhiren Thakker, PhD
(recorded January 19, 2022)
Dr. Thakker is the Founding President and CEO of Med Aditus International, a nonprofit corporation that he launched in 2019 to improve availability of affordable and quality medicines to underserved populations in sub-Saharan Africa. Med Aditus seeks to revolutionize access to medicine in Sub-Saharan Africa, from product development and manufacturing to secure supply chains and patient delivery.
Analytical and Method Validation with Laura Bechtel, PhD, DABCC
(recorded January 12, 2022)
Laura Bechtel, PhD, DABCC is Program Director of Chemistry & Toxicology with Kaiser Permanente, CO and CLIA director at two laboratories performing both FDA-approved and LDT testing. In this session she discusses what is involved in analytical and method validation.