Steven J. Skates, Ph.D.
Associate Professor of Medicine
Massachusetts General Hospital Cancer Center

Khusru Asadullah
Vice President, Head of Global Biomarker
Bayer HealthCare

Jeffrey Spaeder, M.D., Chief Medical and Scientific Officer, Quintiles

The biopharmaceutical industry is increasingly finding it difficult to demonstrate that new therapies provide clinically relevant enhanced efficacy over existing standard of care. At the same time regulatory agencies have given heightened attention to the safety of new therapies and payers are questioning the clinical and economic value of new therapies, which will only be exacerbated by demographic trends and macroeconomic factors in the future. In response to declining revenues, the Industry has undertaken a series of cost-cutting initiatives; however, cutting alone will not yield new innovations.

Biomarkers that are not only correlated to, but are directly linked to the pathogenesis or progression of disease can be used to identify populations with unmet needs and stratify patients that are most likely to derive benefit from therapies, which allows clinical studies to be conducted more efficiently and allows for the development of more compelling value propositions for payers and policy makers.

The development of a molecular-based drug development strategy requires multiple components, some of which require modification of existing drug development capabilities, but some of which will need to be developed. Additionally, these functional components must be able to interact regularly.

While there have been successful biomarker-driven clinical development programs in the recent past, they will need to become routine in the future. This will require an integrated approach from the biopharmaceutical industry, clinical research organizations, healthcare providers, regulators and payers.

Key takeaways:

• Significant structural challenges are fundamentally changing the biopharma industry
• The difference between a biomarker correlated to outcome vs. a cellular biomarker that is involved with the pathophysiology of disease
• The value of a drug development program that incorporates biomarkers
• The necessary components of a biomarker development program

Scott Siegel, Ph.D., Vice President Business Development, Ezose Sciences

Eric Furman, Ph.D., Partner, Knobbe Martens Olson & Bear

Intellectual property is the foundation of companies in the biotechnology sector. Strong intellectual property provides leverage for collaboration and the basis for investment. This session will explore how the recently enacted America Invents Act (AIA) will change how companies approach patent protection, partnering, and collaboration. Recent patent reform legislation has now been signed into law and will make radical changes to practice at the U.S. Patent Office. Some changes will weaken IP, while others will bring strength. This session will bring you up to speed on those changes that matter most to deal-makers, and teach you what pitfalls to avoid, and what new options are now available for you to exploit. In addition, you will learn what is happening in the field of intellectual property in the field of biomarkers in the U.S. and abroad, and give you tips and strategies for maximizing the value of patents in your deals and partnerships.

• America Invents Act (AIA) changes U.S. patent law from a first to invent to a first to file system.
-This shift will change the approach to partnering and collaboration.
• America Invents Act (AIA) provides new post-grant opportunities to challenge issued patents.
-This shift forces companies to be diligent in monitoring and pursuing competitors.

David A. Lewin, Ph.D., Associate Director of Licensing, Strategic Direction for Biomarker Partnering, Office of Cooperative Research, Yale University

A university’s mission is to create, preserve, and disseminate knowledge. Its technology transfer office (TTO) helps disseminate this knowledge through partnerships that translate academic research findings into tangible products and services to benefit society. These partnerships benefit companies through access to cutting-edge technology that might not otherwise be available while furthering the academic mission, enhancing the reputation of the university, and generating revenue that can be reinvested to support the mission.

Successful discovery and translational partnerships must value the commercial perspective and skill of companies and recognize the risks associated with the commercialization of early-stage technology. The relationship must also recognize and materially appreciate the value of the opportunities generated by universities through the unique technological expertise and inventive contribution that enables commercialization.

This presentation focuses on the roles of a TTO in biomarker/diagnostic discovery, development, and commercialization. Topics include: opportunities for strategic partnership, academic resources that support such partnerships, university licensing practices, and pragmatic contractual solutions to mitigate a partner’s risk in developing early-stage biomarkers/diagnostics in accordance with the academic mission.

Benefits:
• Review how TTO’s partner with investigators to develop a credible value propositions that are around actionable information; and
• Summarize what TTO’s understand to be the risks taken by licensees to advance early stage technologies and the concerns universities have about commercialization of essential technologies; and
• Describe pragmatic contractual solutions that recognize and mitigate the risks taken to develop a product originating from basic research in light of such concerns.

[Oral Presentations from Exemplary Submitted Abstracts]

To be considered for an oral presentation, please submit an abstract here

Vern Norviel, Partner, Wilson Sonsini Goodrich & Rosati

The presentation will outline intellectual property strategies and challenges associated with biomarkers. In addition, the presentation will provide potential unique approaches to the combination of biomarkers with drugs that could be of potentially far greater value than the value of biomarker IP alone.

Particularly, the presentation will address the following topics:
• The various “flavors” of biomarker patents
• The potential impact of two court decisions on biomarker patents, specifically:
- Myriad
- Prometheus
• The potential for linkage of drug patents with biomarker patents for high value/impact extension of the patent lifetime for drugs
• The presentation will allow for creative thinking around the strategies for patenting around biomarkers, and conversely, allow you to avoid creating low value patents. Drug/diagnostic linkage strategies may provide for drastically increased value of a companion diagnostic product.

With the recent approvals of immunotherapies for metastatic castrate resistant prostate cancer and non-resectable metastatic melanoma, a shift in the development paradigm of cancer immunotherapies has occurred, and at the heart of this shift is the understanding that immunotherapies result in novel patterns of antitumor response ,which are delayed compared to other conventional treatments. Therefore it is evident that measurable and reproducible biomarkers must be identified for use as either prognostic or predictive tools, thus allowing investigation of its relationship with clinical outcomes. OncoSec Medical Inc. is attempting to decipher these biomarkers early in clinical development using novel profiling assays, for its electroporation-mediated delivery of the immunotherapeutic agent Interleukin-12 (IL-12).

OncoSec Medical Inc. is pioneering the development of electroporation-mediated delivery of immunotherapies using its proprietary OncoSec Medical System (OMS), and developing the Company’s OMS ElectroOncology therapies for treatment of rare and deadly skin cancers such as melanoma, Merkel cell carcinoma and cutaneous T-cell lymphoma.

Much attention is being focused on developing Biomarkers to assist Drug development and delivery in many ways. Whether to accelerate drug development, foreshorten and save costs due to identifying toxicity earlier or provide more sensitive markers to help with proof of mechanism, safety or efficacy to name a few! More recently, the area of companion diagnostics seems to be attracting more of this attention with view to being more effective in getting the right drugs to the right patients.

Achieving a successful solution to these challenges is a complex issue

• What is the role that the contract laboratory services can play in partnering with organizations wishing to develop Biomarkers for various purposes?
• What is special about companion diagnostics?
• How do different technology platforms fit into the Biomarker development paradigm – which is best or most suitable?
• What are the scientific requirements of the analytical methods from a development, validation and technology transfer perspective?

All of these issues require careful consideration when entering into agreements in the Biomarker development process. This talk will present information from actual experience in this arena and cover the topic from research to accredited diagnostics.