Accelerating Medical Product Development with Networked Resources

The mission of the regional AMPD^NR Initiative is to ignite and foster collaborative healthcare innovation and commercialization in southeast Wisconsin, leveraging regional resources, to improve human health through clinical use of innovative biomedical research and discoveries.

The regional AMPD^NR Initiative:

• Leverages ideas, talent and capital in Southeast Wisconsin – assists regional innovators seeking to develop clinical delivery processes, databases, diagnostics, devices, software or therapeutics.
• Provides unique AMPD^NR resources to healthcare innovators and startups, including grants, seed funds, classes and bootcamps, and consultation with legal, regulatory and venture capital experts.
• Identifies and connects the Network of Resources and experts within SE-Wisconsin’s healthcare innovation ecosystem with investigators from the CTSI partner institutions.
• Helps academic institutions increase their involvement and effectiveness in healthcare innovation and commercialization via public/private partnerships

AMPD^NR Executive Council

• Daniel Sem (Concordia University Wisconsin)
• Kevin Boggs (MCW)
• John Mabry (Blood Research Institute; Versiti)
• Brian Thompson and Jessica Silvaggi (UWM)
• Kalpa Vithalani (Marquette University)
• Wujie Zhang (MSOE)

AMPD^NR Funders

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AMPD^NR Courses and Online Training for Healthcare and HealthTech Startups

• Startup Entrepreneur Course ($200; free for AMPD^NR Members; contact us for mini grant-reimbursement)
  • The Startup Entrepreneur is a bootcamp series comprised of four modules, designed to assist the entrepreneur in transforming an idea to a funded company. Subject matter experts teach this as a master class. The four modules are:
    (a) Idea to business model
    (b) Building the business plan, doing financial projections, and starting your company
    (c) Legal and regulatory issues, and
    (d) Raising seeds funds and venture capital.
• Intellectual Property, SBIR/STTR Grant & Commercialization Training Modules
  • Have you discovered something? Do you understand the patenting process, or need help with this? Inventions can have tremendous commercial value if appropriately evaluated, nurtured, and supported. However, most scientists and physicians do not always have the knowledge necessary to take an idea from original discovery through the licensing and commercialization process.
  • To accelerate the pace at which discoveries move from the laboratory into the clinic and community, the CTSI’s Regional Intellectual Property and Commercialization Initiative has developed a series of web-based video learning modules designed to introduce researchers to the technology transfer process.
  • Are you looking to secure federal grant funding for the commercial development of your medical product? If so, consider applying for SBIR/STTR grants.

AMPD^NR Consultants and Advisors - Free Access for AMPD^NR Members

Whether you are an existing early-stage company, or a healthcare/HealthTech innovator considering starting a company, you will need expert advice in key areas, especially: Legal, Regulatory and Venture Capital. AMPD^NR provides limited monthly access to these advisors, by appointment. Contact us for more information.

Regulatory Consulting and Advising

• Regulatory Expert and Entrepreneur in Residence (REIR): Concordia University’s REIR
• WHO: Ann Marie Finley worked in senior positions in the FDA and in regulatory positions in the biotech/pharmaceutical industy
• WHAT: Ann Marie will provide brief pro bono consulting on FDA regulatory considerations for drug, diagnostic and device development, as well as Orphan Drugs.
• WHEN: 10:00 a.m. – 12:00 p.m. on the second Monday of every month
• HOW: Sign up via Calendly https://calendly.com/regulatoryexpert-entrepreneur
• More information: https://blog.cuw.edu/entrepreneur-in-residence/

Venture Capital Expert Consulting and Advising

• Venture Capitalist in Residence (VCIR):
• WHO: Richelle Martin is Managing Director of the $10 M Winnow Fund
• WHAT: Richelle will provide pro bono consulting on what venture capitalists are looking for, as well as general startup advice,
• WHEN: 8:30 a.m. – 12:30 p.m. on the last Monday of every month (summer hours by apt. through AMPD)
• HOW: Sign up via Calendly https://calendly.com/winnowfund/concordia-vcir-meeting
• More information: https://blog.cuw.edu/venture-capitalist/

Legal Advice for Startups (pro bono)

• Startup Lawyer in Residence (SLIR):
• WHO: Collin Schaefer works with startup business owners at all stages of their business development.
• WHAT: Collin will provide initial pro bono consulting on topics of relevance to startups, such as corporate filings, securities, considerations when securing funding, licenses, contracts, trademark and other matters.
• WHEN: Collin will be available on the last Thursday of every month (by apt. through AMPD)
• HOW: Sign up via Calendly – link coming soon

AMPD^NR NETWORK OF RESOURCES

Are you interested in commercializing inventions arising from your research?

Would you like to move your ideas from bench to market to bedside?

AMPD^NR can help you find the resources you need to:

• Connect with the regional network of resources
• Connect with Prototyping, Product Development and Manufacturing Resources
• Form & grow a startup company
• Raise investor dollars
• Connect with legal, regulatory and venture capital experts
• Secure commercialization (SBIR/STTR) grants

Networking / Connecting / Startup Consulting

• Catalyst BioConsulting
• BioForward & HealthTech MKE

Manufacturing, Product Development and Prototyping

Resources to assist you in prototyping your medical product (e.g. optimized drug lead; medical device), as well as pursuit of initial manufacturing (e.g. process chemistry and scale-up).

• Preclinical IND-enabling studies e.g. PK-ADME
• Pharmaceutical manufacturing
• Pharmaceutical preclinical and clinical studies
• Prototyping of physical products (medical devices)

Regulatory, Legal and Venture Capital Consulting and Advising 

Access to expert advisors as you plan for forming or growing your new healthcare or healthtech startup. Initial help is at no cost, but referrals to paid consultants is also possible, sometimes with AMPD^NR grants to subsidize.

• Navigating the FDA regulatory approval process for drugs (IND) and devices (510(k))
• Legal questions for startups, from corporate filings, closing equity rounds, negotiating licenses and other agreements, to Trademark
• Preparing for and executing venture capital and angel pitches; business models and business plans; negotiating a fair term sheet

Building and Funding your Company

Resources to help you refine your business model and business plan by better defining product-market fit. Additional resources to then help you secure grant funding or equity-based funding from investors (angels or venture capitalists).

• Participation in the I-Corps program to do customer discovery and refine product-market fit
• Access and referral to regional angel and venture groups
• Access to seed funds from AMPD^NR, through its partnership with Bridge to Cures and WEDC
• Mentoring and support for securing SBIR/STTR grants
• Assistance in securing CEO and other executive talent for your new company
• Legal forms for startups
• Legal clinics for pro bono help
• Physical space for your startup