White Papers

White papers represent the synthesis of ClearView's perspective on key areas of interest within the broader biopharmaceutical industry.

The Challenges of Gene Therapy

Establishing Trust

For any emerging biotech company with a novel platform technology, establishing trust in that platform is essential to building momentum and long-term success. Trust must be established with multiple stakeholders, including potential licensing partners, investors, regulators, clinicians and, foremost, with patients. In the gene therapy and genome editing space, these concerns are heightened by the unprecedented manipulation of the body’s basic building blocks, where failures of past programs effectively delayed progress for decades. Building a meticulous plan to establish evidence of safety and of clinical utility in a stepwise manner is thus of heightened concern for companies advancing technologies into this arena.

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Opportunity Assessment Through the In-Licensor's Lens

For an emerging biotech, a traditional commercial opportunity assessment is an essential part of the partnering process for a development-stage asset. This assessment provides an in-depth market understanding to support investment toward commercialization, and as such provides the ideal information for conversations with potential partners. However, there are additional, critical considerations that can ensure a well-rounded conversation.

This white paper is the third in our “Growing Up Biotech” series. The two previous papers (“Taking the Long View: Translating Science and Technology into Commercial Opportunity” and “To Partner or Not to Partner: Determining Your Commercialization Plan”) discussed the technical and transactional assessments required to identify the right type of partnership for a biotech’s asset or platform and overall business needs. 

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To Partner or Not to Partner
To Partner or Not to Partner: Determining Your Commercialization Plan

 

Deciding whether to partner an important late-stage asset or commercialize it independently is a biotech dilemma as old as the industry itself. An emerging company aims to maintain as large a share of equity in its lead asset as it can. At the same time, a biotech needs to assess whether tapping the resources of a larger and/or more experienced organization would maximize the product’s commercial success. Making the best decision on whether to partner and with whom will depend on many factors. This second installment of our “Growing Up Biotech" series identifies the key factors around a pivotal question posed when launching your product: to partner or not to partner?

 

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Translating Science and Technology into Commercial Opportunity

 

Translating Science and Technology into Commercial Opportunity 

Written by:
Philip Kenner, Principal

In the first white paper in our series “Growing Up Biotech”, we discuss the importance of communicating a compelling product story early in a biotech's development. It may seem early for a company 10 years or more from gaining approval of its first product to begin positioning, however it’s important to implement strategies early and take a long-term view while doing so. The value story should translate scientific promise into its commercial opportunity for a biotech company’s diverse set of audiences, including partners, payers, regulators, patient advocates, and investors.

 

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Engaging Patient Advocacy Groups
 
Engaging Patient Advocacy Groups: A Key Piece of the Puzzle 
 
Written by:
Pooja Doshi, Engagement Manager
Laney Monsey, Head of Expert Research Solutions
Chris Von Seggern, Partner
 
Patient advocacy groups play an increasingly important role in the drug development and regulatory process. Biopharmaceutical companies that truly want to be patient-centered should engage these groups early, often, and enthusiastically.
 
Patient advocates are becoming savvier navigators, instigators, and research engines, and in the process making themselves indispensable partners for the biopharmaceutical industry. The question is not whether to engage with patient advocacy, it’s how.
 
Download this paper to learn how engaging with Patient Advocacy Groups can help:
  • Support and guide R&D
  • Inform and refine patient support services
  • Identify and educate patients
  • Influence regulation and policy

 

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IO's Impact on Strategic Decision-Making In The Broader Oncology Landscape

Dramatic growth in the immuno-oncology field suggests a paradigm shift across oncology in the coming years.  This evolution will impact decision-making for all novel oncology assets, and in particular for non-IO therapies.  To compete in this future environment and ensure success within the future standard of care, cancer drug developers must think strategically regarding enduring white space opportunities and how to best position novel agents to capture these opportunities.

In this article published in In Vivo, we review key strategic considerations across clinical development, market access, and post-launch commercialization that will be important for current and future oncology drug development.

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Orphan Diseases
Key Trade-offs for Drug Developers

Orphan drug development is attractive to drug developers for many compelling reasons: tax advantages, extended market exclusivity, accelerated approval timelines, historical­ly favorable access at premium prices, potential for lower cost clinical trials, and recent commercial success stories such as Soliris and Kalydeco. However, orphan diseases do not necessarily offer an easy win. Manufacturers must be prepared for the unique chal­lenges associated with orphan disease drug discovery, clinical trials, and market devel­opment, as well as the eventual likelihood that U.S. payers will actively manage pricing and market access for orphan products. Ultimately, considerable opportunity remains for drug developers in orphan diseases, but success will require companies to develop an orphan disease mindset for strategic decision-making and invest in capabilities com­mensurate with the anticipated nuances and challenges.

In our new white paper, we lay out the clear areas of opportunity and the unique challenges associated with orphan disease drug development to help companies be best prepared to succeed in this exciting, but nuanced, space. 

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Companion Diagnostics
Strategies to Optimize Performance in the Era of Precision Medicine

Informed drug development in an era of “precision medicine” requires a clear understanding of the risks and benefits that accompany the pursuit of companion diagnostics, a difficult objective given the complexity and rapid evolution of the field. While business cases for companion approaches typically focus on pricing and volume considerations, there is also a need for careful analysis of the strategy associated with managing clinical development, securing access and reimbursement, and generating product demand among target physicians. Without a full accounting of and appreciation for these factors, it is challenging, if not impossible, to direct an efficient, forward-looking drug-diagnostic program capable of maximizing commercial potential.

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The Breakthrough Therapy Designation
Implications and Strategic Business Considerations

The breakthrough therapy designation has generated substantial interest since its creation one year ago, as this new pathway represents the most comprehensive set of clinical development benefits available for a pipeline agent. However, the breakthrough therapy pathway may also lead to potential commercial downsides and regulatory risk. Most notably, the limited dataset from the breakthrough clinical program may be insufficient to garner favorable pricing and reimbursement, particularly in Europe. In addition, the abridged clinical trials may not be considered satisfactory for regulatory approval in ex-U.S. markets. Taken together with several other commercial considerations, it is critical for manufacturers to develop a comprehensive understanding of these advantages and disadvantages prior to pursuing the breakthrough therapy pathway.

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