AUTM Workshop

AUTM Business Development Course – Diagnostics

Commercialization for Medical Diagnostics Technologies

Medical diagnostics have become one of the leading disruptive areas for innovation in healthcare industry. New tools rapidly enter medical laboratories and physicians’ offices, appear on the shelves of convenience stores creating a new paradigm in healthcare.

Next-generation sequencing, wearable sensors, liquid biopsies, new point-of-care and companion diagnostics had a profound impact on healthcare delivery. As the medical diagnostics field develops the commercialization path for novel diagnostic technologies becomes progressively more sophisticated and complex.

**Any individual registered for Life Sciences Future is applicable to attend the AUTM Business Development Course  Diagnostics.  Please RSVP to the course during registration.

This Course will:

  • Provide an overview of the commercialization process for medical diagnostics
  • Share real-life examples, and detail requirements and hurdles for developing such technologies from product conception through market launch
  • Address current trends and needs of the sector
  • Share updates on IP protection environment within and outside of the U.S.
  • Provide insights on regulatory considerations and pathways
  • Discuss reimbursement hurdles and trends
  • Review issues around managing and protecting patient data
  • Discuss deal structures for licensing and partnering of stand-alone biomarkers, companion diagnostics, point-of-case diagnostics, and diagnostic platform technologies
  • Touch upon issues and practices to be considered during negotiations

 

Invited speakers include representatives from large diagnostic companies and diagnostic startups, university licensing specialists, intellectual property attorneys, and reimbursement and regulatory experts. Attendees will come away better equipped to address the challenges of commercialization in the diagnostics marketplace.

 

Register Now!

AUTM Course Speakers:

Ai_ Erkang

Erkang Ai

Associate
Hogan Lovells
Charles Caldwell-2

Charles “Bill” Caldwell, M.D., Ph.D.

President and
Chief Scientific Officer
GenomicPathways
Deehr_ Manya

Manya Deehr

Partner
Cooley LLP
Doyle_ Kathryn

Kathryn Doyle

Patent Attorney
Saul Ewing Arnstein
& Lehr
Joe01-2

Joseph V. Ferrara

CEO
Boston Healthcare Associates
Gilly_ Richard

Richard Gilly

Partner
Archer & Greiner
Kandel_ Ben

Ben Kandel

Senior Data Scientist
HVH Patient Precision Analytics
King_ Russ

Russ King

President
MethodSense, Inc.
Martin_ Viviane

Viviane Martin

Director
Perelman School of Medicine
Penn Center for Innovation
University of Pennsylvania
Debbie Parrish Headshot-2

Debbie Parrish

Partner
Parrish Law Offices
Rappaport_ David

David Rappaport

SVP, Business Development
OraSure
Sheflin_ Tim

Tim Sheflin

Executive Director
Boston Healthcare Associates
Shukla_ Oodaye

Oodaye Shukla

Chief Data Scientist
HVH Precision Analytics
Silva_ Domingos - photo

Domingos Silva

Patent Attorney
Saul Ewing Arnstein
& Lehr

AUTM Course Moderators:

Axanova_ Linara

Linara Axanova

Associate Director
Penn Center for Innovation
University of Pennsylvania
Goswami_ Joy

Joy Goswami, MS, MBA, RTTP

Assistant Director, Technology Transfer
& Corporate Partnerships
University of Delaware

 First Day – October 29:

Session 1. 9:00 – 10:00 AM – The State of the Diagnostics Field and Current Trends  

This session will explore the evolution of the rapidly developing diagnostic field as well as current trends touching on advancement of companion diagnostics, point-of-care diagnostics, novel genetic and epigenetic analyses, liquid biopsy diagnostics and others.

Speakers:

Charles “Bill” Caldwell, President and Chief Scientific Officer, GenomicPathways
Tim Sheflin, Executive Director, Boston Healthcare Associates

Session 2. 1:00 – 2:30 PM –  Intellectual Property Protection for Diagnostics

Patent eligibility of diagnostic technologies in the United States has become much more limited over the last several year. This session will help to navigate most recent USPTO Guidelines on patent eligible subject matter and provide a better understanding of patent eligibility requirements in the United States as well as other jurisdictions. We will look at the types of claims that are being allowed in and outside of the U.S, and discuss the value of method claims and kit claims.

Speakers:

Kathryn Doyle, Patent Attorney, Saul Ewing Arnstein & Lehr
Domingos Silva, Patent Attorney, Saul Ewing Arnstein & Lehr

Session 3. 3:00 – 4:30 PM – Deal Structures – Licensing Diagnostics Technologies

Type of a diagnostic to be licensed, its path to the market, required approvals, and who will pay for it are important factors when structuring a licensing deal for a diagnostic technology. This session will cover various structures of licensing deals and value of patent rights, know-how and data within those deals. We will discuss how recent changes to the U.S. patent law have effected licensing structure and financial terms. We will cover most common heavily negotiated terms, especially when it comes to licensing university-based technologies, and issues that arise when negotiating with well-established companies as well as new ventures. Session will include representatives from university technology transfer offices, diagnostic companies, and contract attorneys.

Speakers:

Richard Gilly, Partner, Archer & Greiner
Viviane Martin, Director, Perelman School of Medicine, Penn Center for Innovation, University of Pennsylvania
David Rappaport, SVP, Business Development, OraSure

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Second Day – October 30: 

Session 4. 10:30 – 11:40 AM – Regulatory Considerations and Pathways 

Human diagnostics in the US can be regulated either by the Food and Drug Administration (FDA) or by Centers for Medicare & Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). This session will discuss the regulatory pathways for various types of diagnostic such as Laboratory Developed Tests (LDTs), In-Vitro Diagnostic kits (IVD), and companion diagnostics which are considered medical devices. Experts as well as FDA representatives will discuss important factors and give recommendations on how to work effectively with the regulatory authorities.

Speakers:

Russ King, President, MethodSense, Inc.
Erkang Ai, Associate, Hogan Lovells

Session 5. 12:00 – 1:00 PM – Managing Big Data and Patient Data

The last decade has seen huge advances in the amount of data we generate within healthcare industry including patient data, genetic data, data collected from wearable devices etc. This session will discuss regulations and important considerations for licensing, using, or managing patient data and large sets of research data.

Speakers:

Oodaye Shukla, Chief Data Scientist, HVH Precision Analytics
Ben Kandel, Senior Data Scientist, HVH Patient Precision Analytics
Manya Deehr, Partner, Cooley LLP

Session 6. 2:25 – 3:40 PM – Reimbursement Consideration

Companies developing novel diagnostic technologies face multiple hurdles related to cost reimbursement. It becomes imperative to coordinate the efforts related to clinical adoption, market adoption, and reimbursement strategies very early in the commercialization and development process. During this session we will discuss the basics of analysis, development, and implementation of coding, coverage, and payment strategies for novel diagnostic technologies.

Speakers:

Joe Ferrara, CEO, Boston Healthcare Associates
Debbie Parrish, Partner, Parrish Law Offices