Index of Chapters · Academic Entrepreneurship for Medical and Health Scientists

by Natalie Oppenheimer and Flaura Winston

Introduction: What Is Academic Entrepreneurship?

Definition of Academic Entrepreneurship through domains of academia, ideation, IP/regulation, finance and people

Academia

by Alexandra Marquez and Flaura Winston

The Promotion Process: Academic Entrepreneurship Career Tracks

by Swapnil V. Shewale and Flaura Winston

Careers in Academia and Industry: Transitions and Challenges

by Amanda Ackermann and Flaura Winston

Intrapreneurship: Strategic Approaches for Managing Disruptive Innovation in Clinical and Research Projects

by Anupam Kumar and Nalaka Gooneratne

Resources at Academic Entrepreneurship Centers

by Barbara Coons and Nalaka Gooneratne

Clinical and Translational Science Awards

Ideation

by Diane Dao and Jake Brenner

Identifying Unmet Needs: Problems That Need Solutions

by Helge Hartung and Sarah Rottenberg

Human-Centered Design: Understanding Customers’ Needs Through Discovery and Interviewing

by Michael Sosnowski

Conducting Insightful Market Research

by Olivia Jew and Roy Rosin

Rapid Prototyping Strategies

by Annette Krysiewicz and Tomás Isakowitz

I-Corps as a Training Tool for New Technology Development

by Brian Jenssen

Social Entrepreneurship in Healthcare

Intellectual Property and Regulations

by Cynthia Dahl

Intellectual Property: Ownership and Protection in a University Setting

by Cynthia Dahl

Intellectual Property: Commercializing in a University Setting

by Ryan Fauzan and Nalaka Gooneratne

Working with the University Technology Transfer Office

by Toshitha Kannan, Elliot Stein, and D. Mark Maloney

Does My Invention Already Exist? Conducting a Patent/Prior Art Search

by Megan Brewster and Pallab Singh

Intellectual Property Protection for Biologics

by Tai-Yun Kuo and Scott Manaker

Reimbursement Strategies and CPT Codes for Device Development

by Deepthi Alapati, Patrick Egan, and Janet Holcombe

Understanding Conflict of Interest for Academic Entrepreneurs

by Ramesh Iyer and Jeremy Solomon

Laws and Ethics in relation to Medical Entrepreneurship

by Sunghee E. Park and Thomas P. Schaer

Preclinical Animal Models

by Alexander H. Morrison, Nicola J. Mason, and Yvonne Paterson

Developmental Strategies for Animal Medical Therapeutics

by Anupam Kumar and Nalaka Gooneratne

Overview of Device Development

by Jason Van Batavia and Seth Goldenberg

FDA Device Regulation: 510(k), PMA

by Nicolette Driscoll, Mohit Prajapati, and Ari Brooks

Surgical Device Development

by Claire Phoumyvong and Matthew Maltese

Pediatric Medical Device Development Pathways

by Nalaka Gooneratne

Overview of Drug Development

by E. Bike Su Oner, Sergio R. Labra, and Shelly Fehr

FDA Drug Regulation: Investigational New Drug Applications

by Gauri Srivastava and Ashley Winslow

Orphan Drugs: Understanding the FDA Approval Process

by Ryne Didier and David Mankoff

Development of Radiographic Contrast Agents for Diagnostic Imaging

by Ping Wang

Developing In Vitro Diagnostics for Commercialization and Clinical Implementation

by Mauricio Novelo, Nalaka Gooneratne, and James Weimer

Digital Health: Software as a Medical Device

Finance

by Jenny Cai and Ben Doranz

Startup Company Formation and Management

Connections

Supplements (1):

Company Formation Checklist/Operating Partnership Agreement Questionnaire

by Fabiana Zappala and Moe Rinkunas

Accelerators and Incubators

by Elliot Stein and Brett Topche

Seeking Venture Capital Investment

by Maire Conrad, Vanessa Chan, and Linda Miller

Writing Business Plans for a Life Science Startup or Clinical Program

by Neil N. Patel and Adam Dakin

Equity Allocation in Startups: How to Cut a Pie When There Is Only a Crust

by Abhinay Ramachandran

Angel Investors

by David Lee, Elliot Stein, and Nalaka Gooneratne

SBIR/STTR Grants: Introduction and Overview

by Elliot Stein, David Lee, and Nalaka Gooneratne

SBIR/STTR Grants: Application Guidance

by Erin Esparza

Nonprofit- and Foundation-Sponsored Research: Developing New Models of Collaboration for Research and Development

by Jason Van Batavia and Seth J. Goldenberg

Strategic Planning and Costs of FDA Regulation

by Julia Kelly and Richard Sensenig

Department of Defense: SBIR/STTR Grants and Other Contracts

People

by Maura Weber and Zev Sunleaf

Building a Successful Startup Team

by Anthony R. Martín and Eric Max, Esq.

Negotiation Strategies

by Neil Patel and Nalaka Gooneratne

Marketing in an Academic Institution

by Joy Sun and Flaura Winston

Forming and Maintaining Meaningful Partnerships Between Academic Scientists and Corporations

by Linda Fleisher and Alexandra Marquez

A Seat at the Table: Special Considerations for Women and Underrepresented Groups in Academic Entrepreneurship

by Prima Pisuttisarun and Nalaka Gooneratne

Handling Disruptive Innovation in Clinical and Research Settings

by Elana Meer

Innate Biases

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