SBIR Innovation Lab National Cancer Institute

In the second episode on writing a good specific aims page, Enzyme by Design Co-Founder and COO Amanda Schalk and JBS Science Co-Founder Ying-Hsiu Su provide insights into their experiences with reviewers’ first impression on an SBIR/STTR application, the specific aims page.
 
Listen to this podcast to hear: •               Ways to address a competitive landscape
•               Considerations for reapplying
•               Application features for digital health and device startups
•               Differences between an SBIR grant and traditional academic grants
•               How to describe quantitative milestones
 
Podcast Guest Speakers:  
Name
Bios

William Bozza, PhD
Program Director
SBIR Development Center
National Cancer Institute
William Bozza, PhD serves as a Program Director, managing a portfolio of oncology startups (SBIR & STTR awardees) to facilitate small businesses in technology commercialization for cancer diagnosis and treatment.  Dr. Bozza is currently leading the Center’s efforts on the Small Business Concept Award for early-stage high risk/high reward technologies that are targeting rare and pediatric cancers.  He is also taking the lead on the Program’s Peer Learning and Networking Webinar Series to help SBIR companies learn from peers and facilitate collaboration.

Amanda Schalk, PhD
co-founder and COO
Enzyme by Design
Amanda Schalk, PhD is the co-founder and COO of Enzyme by Design. Amanda earned her undergrad degree in biochemistry on a full-ride scholarship from Eastern Michigan University and went abroad to Goettingen, Germany to earn her Master's and PhD degrees in Molecular Biology from the prestigious International Max Planck Research School for Molecular Biology and the Max Planck Institute for Biophysical Chemistry.  She spent 5 years as a postdoc in the lab of Dr. Lavie at the University of Illinois at Chicago characterizing the structures and enzymatic activities of L-asparaginases, resulting in multiple first author peer-reviewed publications.  She also has experience as the operations manager at a startup where she also has gained experience as a virtual lab manager.

 
Ying-Hsiu Su PhD
Cofounder,
JBS Science
Ying-Hsiu Su PhD is a co-founder of JBS Science Inc. and a member of the Board of Directors. Dr Su is a Professor of Translational Medical Sciences at The Baruch S. Blumberg Institute. She is one of few pioneers in the field of transrenal DNA for cancer detection. Dr. Su’s research team has developed the technology to preferentially isolate this circulation-derived urine DNA for detection of colon and liver cancers. In addition, a Standard Operating Protocol (SOP) for collection and storage of urine samples for biomarker studies in the EDRN of the NCI has been established by her group. Dr. Su has collaborated with JBS scientists in developing various approaches to bring the transrenal DNA technology to clinical applications in the fields of cancer detection and personalized cancer management. Dr. Su’s office and lab are located in The Baruch S Blumberg Institute. Dr. Su contributes her expertise in urine DNA technology. She serves as a member of the scientific advisory board.
Programs referenced in this episode:  ·       PLAN series: specific aim page - - https://sbir.cancer.gov/commercialization/workshops-webinars/peer-learning/specific-aims
·       NCI SBIR/STTR Grants - https://sbir.cancer.gov/small-business-funding/grants
·       Phase IIB Bridge Award - https://sbir.cancer.gov/small-business-funding/grants/bridge-award
 
Transcript:        [music]
 
             BILLY BOZZA:  Hello and welcome to Innovation Lab, your go to resource for all things biote

In this episode, you will get advice from two NCI SBIR-funded startups on how to write a good specific aims page on your application. Senior Vice President of Radiant Digital Jeffery McLaughlin and Co-Founder and CEO of DoseOptics William Ware will share how they successfully put together this key application component.
Listen to this podcast to hear: ·       Highlighting significance and clinical impact in your specific aims page
·       How to provide sufficient detail and quantitative milestones
·       Specific features for devices and digital health
·       Considerations for Fast-Track and Phase II SBIR/STTR applications
 
Podcast Guest Speakers:   
Name
Bios

William Bozza, PhD
Program Director
SBIR Development Center
National Cancer Institute
William Bozza, PhD serves as a Program Director, managing a portfolio of oncology startups (SBIR & STTR awardees) to facilitate small businesses in technology commercialization for cancer diagnosis and treatment.  Dr. Bozza is currently leading the Center’s efforts on the Small Business Concept Award for early-stage high risk/high reward technologies that are targeting rare and pediatric cancers.  He is also taking the lead on the Program’s Peer Learning and Networking Webinar Series to help SBIR companies learn from peers and facilitate collaboration.
 

 
Jeffrey McLaughlin
Senior Vice President
Radiant Digital
Jeffery McLaughlin is a highly accomplished professional with over 25 years of experience encompassing organizational leadership, customer and user experience, digital media, human-centered design, and software development.
 
Mr. McLaughlin is recognized for his ability to drive innovation through human-centered design thinking, customer discovery, and rigorous engineering. His research endeavors have yielded impactful projects in domains such as worker safety, trauma recovery, cancer survivorship, medication adherence, chronic disease management and more. These endeavors reflect his commitment to improving the lives of individuals through outcome-focused technology solutions.
 
In his role as Senior Vice President of Services and Solutions at Radiant Digital, Mr. McLaughlin provides strategic leadership across every facet of the company’s business, including service line definition, technology development, delivery, and business growth. Under his guidance, Radiant Digital has consistently produced award-winning digital experience initiatives for Federal, State, and commercial clients.
 

 
William Ware,MS
co-founder and CEO
DoseOptics
William Ware is the co-founder and CEO of DoseOptics, LLC. The company is developing an imaging technology that will allow, for the first time, radiation therapy to be visualized. Treatments will be easily and routinely verifiable directly on patients thereby minimizing delivery errors and improving outcomes. William graduated with a Master of Science in Chemical Engineering from Darthmouth Thayer School of Engineering, from where he spun out the company’s technology based on the work of President and Co-founder Prof. Brian Pogue.
Transcript:               [music]
 
             BILLY BOZZA:  Hello and welcome to Innovation Lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute’s Small Business Innovation Research, SBIR Development Center.
 
             Our podcast hosts interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting edge cancer solutions from lab to market.
 
             I'm Billy Bozza, a program director at NCI SBIR and today's host.
 
             In the last episode, you heard from an SBIR-funded

NCI SBIR Team Leaders Monique Pond and Jonathan Franca-Koh cover the basics of registering a small business for an SBIR/STTR application and the anticipated timeline to expect from submitting an application to receiving an award.
Listen to this podcast to hear: •               Guidance on the four registrations that should be completed before applying for SBIR/STTR funding
•               Managing eRA Commons accounts
•               Addressing registration errors and warnings
•               Reviewing the SBIR/STTR grants application summary statement
•               Typical timeline from applying to receiving an award
Podcast Guest Speakers: Name
Bios

Monique Pond, PhD
Program Director and Team Leader
SBIR Development Center
National Cancer Institute
Monique Pond, PhD is a Program Director in the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI). She manages a portfolio of grants and contracts to small businesses developing novel cancer therapies, digital health technologies, and therapeutic devices. Pond leads the CARE program, Connecting Awardees with Regulatory Experts, and other collaborative initiatives with FDA to assist small businesses in navigating the regulatory pathway for their technology. She initially joined the NCI SBIR Development Center in 2018 as a Science & Technology Policy Fellow with the American Association for the Advancement of Science.
 
 

 
Jonathan Franca-Koh, PhD, MBA
Program Director & Team Leader
SBIR Development Center
National Cancer Institute
Dr. Jonathan Franca-Koh is a Program Director at the National Cancer Institute's Small Business Innovation Research (SBIR) Development Center. Jonathan manages SBIR & STTR grants and contracts with a focus on cancer therapeutics and novel tools for research and drug discovery. He provides oversight throughout the award period and mentors applicants and awardees in developing their technology goals and commercialization strategy. Additionally, he plays an active role in several center initiatives, including recent investor forums, workshops, targeted funding opportunities, and represents the NCI on the trans-NIH REACH program. Prior to joining the SBIR Development Center, Jonathan was a Program Director at the NCI Division of Cancer Biology and Center for Strategic Scientific Initiatives, overseeing the Physical Sciences-Oncology Centers (PS-OC) program, a network of interdisciplinary centers that brought together physical scientists and cancer biologists. Jonathan received his PhD in Cell and Molecular Biology from the University of London’s Institute of Cancer Research in 2003, and completed post-doctoral research at Johns Hopkins University and the J. Craig Venter Institute. In 2014 he completed his MBA from Johns Hopkins University, focusing on finance and health care innovation.
 
 
Programs referenced in this episode:  SAM (System for Award Management) - https://sam.gov/content/home eRA Commons - https://www.era.nih.gov/register-accounts/register-in-era-commons.htm Grants.gov - https://www.grants.gov/applicants/applicant-registration SBA (Small Business Administration) - https://www.sbir.gov/registration NIH SEED Small Business Funding - https://seed.nih.gov/small-business-funding/how-to-apply/before-you-apply Transcript:  MONIQUE POND:    Hello everyone and welcome to Innovation Lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute’s Small Business Innovation Research or SBIR Development Center.
 
             Our podcast hosts interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting edge cancer solutions from lab to market. I'm Dr. Monique Pond, a Program Director and team lead here at NCI SBIR and I'll b

Podcast Summary NCI SBIR Team Leaders Monique Pond and Jonathan Franca-Koh break down the importance of speaking with a program director before applying and share advice on how to go about doing so.
Listen to this podcast to hear: •               When to reach out to program directors
•               Tips for matching with the right program director
•               The type of guidance program directors offer (grants, programs, steps based on innovation or company stage, SBIR/STTR application)
•               Steps to take if your technology fits under multiple NIH institutes
•               Actions to take after you receive your application summary statement
 
Podcast Guest Speakers:  
Name
Bios

Monique Pond, PhD
Program Director and Team Leader
SBIR Development Center
National Cancer Institute
Monique Pond, PhD is a Program Director in the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI). She manages a portfolio of grants and contracts to small businesses developing novel cancer therapies, digital health technologies, and therapeutic devices. Pond leads the CARE program, Connecting Awardees with Regulatory Experts, and other collaborative initiatives with FDA to assist small businesses in navigating the regulatory pathway for their technology. She initially joined the NCI SBIR Development Center in 2018 as a Science & Technology Policy Fellow with the American Association for the Advancement of Science.
 
 

 
Jonathan Franca-Koh, PhD, MBA
Program Director & Team Leader
SBIR Development Center
National Cancer Institute
Dr. Jonathan Franca-Koh is a Program Director at the National Cancer Institute's Small Business Innovation Research (SBIR) Development Center. Jonathan manages SBIR & STTR grants and contracts with a focus on cancer therapeutics and novel tools for research and drug discovery. He provides oversight throughout the award period and mentors applicants and awardees in developing their technology goals and commercialization strategy. Additionally, he plays an active role in several center initiatives, including recent investor forums, workshops, targeted funding opportunities, and represents the NCI on the trans-NIH REACH program. Prior to joining the SBIR Development Center, Jonathan was a Program Director at the NCI Division of Cancer Biology and Center for Strategic Scientific Initiatives, overseeing the Physical Sciences-Oncology Centers (PS-OC) program, a network of interdisciplinary centers that brought together physical scientists and cancer biologists. Jonathan received his PhD in Cell and Molecular Biology from the University of London’s Institute of Cancer Research in 2003, and completed post-doctoral research at Johns Hopkins University and the J. Craig Venter Institute. In 2014 he completed his MBA from Johns Hopkins University, focusing on finance and health care innovation.
 
 
Programs referenced in this episode:  Program director contacts - https://sbir.cancer.gov/about/contact-staff SF424 SBIR/STTR Application Guide - https://sbir.cancer.gov/commercialization/business/icorps/sf424-sbirsttr-application-guide.pdf PLAN series: first steps to a business - https://sbir.cancer.gov/commercialization/workshops-webinars/peer-learning/first-steps-starting-small-business PLAN series: specific aim page - https://sbir.cancer.gov/commercialization/workshops-webinars/peer-learning/specific-aims Transcript:               [music intro]
 
             MONIQUE POND: Hello and welcome to Innovation Lab, your go to resource for all things biotech startups, brought to you by the National Cancer Institute’s Small Business Innovation Research, SBIR Development Center.
 
             Our podcast hosts interviews with successful entrepreneurs and provides reso

NCI SBIR Director Michael Weingarten and Rukiyah Van Dross-Anderson, Founder and CEO of SBIR-funded Claradele Pharmaceuticals discuss the journey from postdoc to biotech startup and how women and underrepresented entrepreneurs with innovative cancer solutions can also leverage SBIR support to move their ideas forward. Listen to this podcast to hear: •               Stages of product development (fundraising rounds, company collaborations, team culture development, and more)
•               Lessons Learned when transitioning from academia to the early stages of product commercialization
•               Benefits of contacting program directors when applying for SBIR/STTR opportunities
•               Coaching received through the Applicant Assistance Program
•               Utilizing state biotech professional organizations
•               Programs early-stage businesses can use
 
Podcast Guest Speakers: Name
Bios

Michael Weingarten, MA
Director
SBIR Development Center
National Cancer Institute
 
In this role, Michael Weingarten leads a team of nine Program Directors who manage all aspects of the NCI SBIR & STTR Programs including a portfolio of $182M in grants and contracts annually. The SBIR & STTR programs are NCI's engine of innovation for developing and commercializing novel technologies and products to prevent, diagnose, and treat cancer. Weingarten has implemented a set of key initiatives for optimizing the performance of the NCI SBIR Program at the NIH. These include the establishment of a new model at the NCI for managing the program - the SBIR Development Center. 
 
 

Rukiyah Van Dross-Anderson, PhD
Founder and CEO
Claradele Pharmaceuticals
 
Rukiyah T. Van Dross-Anderson, PhD is the CEO and founder of NCI SBIR-funded therapeutics company, Claradele Pharmaceuticals. Her work began at East Carolina University, where she is an associate professor and the director of Graduate Programs, Pharmacology & Toxicology Concentration. Dr. Van Dross-Anderson is working to develop an effective and non-toxic drug as an alternative therapeutic regimen for melanoma patients who aren’t responsive to traditional treatments.  To attract third-party investors that would help get her innovation to get to the patients that need them, Dr. Van Dross-Anderson is working through proof-of-concept studies to demonstrate her innovation’s commercial viability. Through her participation in the NCI SBIR program, she used funding to scale up production and received entrepreneurial mentorship to navigate the complex business world. Dr. Van Dross-Anderson graduated from Rutgers University, UMDNJ-RWJMS with a doctoral degree in Molecular and Cellular Pharmacology.
 
Programs referenced in this episode: •               Minority Biomedical Research Symposium (MBRS) program - http://mbrs.newark.rutgers.edu/
•               Minority Access to Research Careers - https://www.nigms.nih.gov/training/MARC/Pages/USTARAwards.aspx
•               Applicant Assistance Program - https://sbir.cancer.gov/small-business-funding/application-process/applicant-assistance
•               I-Corps at NIH program - https://sbir.cancer.gov/commercialization/business/icorps
•               NCI SBIR Women’s Innovation Network
•               Office of technology transfer (offered at most school)
•               NCI SBIR Investor Initiative - https://sbir.cancer.gov/commercialization/business/investor-initiatives
•               Small Business Transition Grant - https://sbir.cancer.gov/small-business-funding/grants/small-business-transition
Transcript:           

To conclude the three-part series on starting a small business, NCI SBIR Program Director William Bozza convenes the four panelists from the previous episodes to answer questions about their biotech entrepreneurship journeys.
TRANSCRIPT
[music]
 
BILLY: Hello and welcome to Innovation lab, your go to resource for all things biotech startups brought to you by the National Cancer Institutes Small Business Innovation Research, or SBIR Development Center. Our podcast hosts interviews with successful entrepreneurs and provides resources for small businesses looking to take their cutting edge cancer solutions from lab to market.
 
BILLY: I'm Billy Bozza, a program director at NCI SBIR and today's host. In the last two episodes, you heard from four of our companies about how they went about kick-starting their small businesses. Today, we are bringing the speakers together to answer some questions from researchers and to be entrepreneurs.
 
[music]
 
BILLY: OK, so I don't want to take any more time. These are our panel speakers. I'm going to let each of you introduce yourselves, moving from left to right. If you could just mention your name, your company, role in the company, kind of, you know, quickly summarize how the company got started, and then I thought it would be fun to do like an icebreaker, talking about company culture and if you could each take about, you know, 2 to 3 minutes in time, so we have sufficient time for questions that'd be great.
 
MARGARET: Hi. I'm Dr. Margaret Jackson. I'm the founder and CEO of a company called Biomass. We are a preclinical stage company focused on the TGF beta super-family, developing therapeutics for cancer induced anorexic-cachexia. We have been successful in achieving a SBIR phase one and a phase one federal contract grant, which really helped get Biomass off its feet to generate proof of concept data to be able to seek further investment from investors.
 
So as per the icebreaker culture, you know, I have lived the world through academia. I have also had a fabulous 15 year career in large pharma for developing drugs and now I’m working in the smaller business biotech world. So the cultures are very, very different and being able to set up Biomass, we were able to set up our own culture.
 
In large pharma, while it's great to develop therapeutics, you're working with fabulous talent, a lot of resources and finance to move projects along. It's quite periodic, it also is slow in decision making. So in a smaller company, you're able to have a flatter structure, less bureaucracy. And you're able to make decision-making much more quicker and be more nimble.
 
And we're able to set up our own core values, which is on our web page, which is really to focus on scientific excellence, innovation, and people. And we also hold everyone accountable to get things done and at higher integrity. So thank you.
 
BILLY: Thanks, Margaret. Eric?
 
ERIC: Yeah. Hi, I'm Eric Broyles. I'm the CEO and founder of Nanocan Therapeutics Corporation. And Nanocan is a preclinical biotechnology company that is working to commercialize a patented immunotherapy delivery technology developed at Harvard's Dana Farber Cancer Institute. We’re the nanocancer global exclusive licensee for the technology.
 
As far as company culture, so I'm actually a lawyer by training, I practiced corporate law for 10 years before becoming an entrepreneur, and I've done healthcare deals for the past decade or so, and so definitely a big difference in culture from being a lawyer to being an entrepreneur and certainly being an entrepreneur in the healthcare and biotech space.
 
I would say our culture as a company is obviously innovation is very important to us and sort of patient centric. We always keep in mind who is the person that will benefit from our innovation? And that's the thing that drives us, each of us, every day as we roll out our technology.
 
BILLY: Great, Craig?
 
CRAIG: Hi, eve