20 Nov Challenges of Marrying a Drug with Diagnostics: PMWC Interview with Dan Snyder, President and CEO of MolecularMD – Speaker at PMWC 2018 Silicon Valley
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[et_pb_accordion_item title=”Q: You are the CEO of MolecularMD. Can you tell us what need MolecularMD is addressing with their specific offering in precision medicine?”]
A: 75% of targeted and immuno oncology investigational therapies in development depend upon diagnostics to support their clinical end points and demonstrate response. The intent of deploying a diagnostic in an oncology drug development is to reduce risk in development, and if not planned and implemented properly, a companion diagnostic can instead add significant risk to regulatory approval of novel oncology agents. MolecularMD is an organization that is entirely focused on supporting drug approvals with advanced diagnostics. Significant risks and gaps in the drug – diagnostic codevelopment process can occur among the commonly adopted partnership models. Risks include misalignment of clinical strategy, business incentives, and development timelines. MolecularMD’s organizational structure, quality systems, and experience is designed to help mitigate the risk profile of drug – diagnostic co development and ensure that all clinical, technical, regulatory, and commercial requirements for the drug development program are met in the face of uncertainty.
[/et_pb_accordion_item][et_pb_accordion_item title=”Q: The current drug development and commercialization process is highly volatile and competitive. What are some of the biggest issues of the current process? “]
A: Oncology Drug development programs are challenged with filling their patient cohorts with rare, low prevalence genomic alterations under highly compressed timelines. When this process is adopted by the traditional pharma organizational structures and regulatory processes, this places significant risk on timelines and cloud key decision points impacting eventual approval of therapy.
[/et_pb_accordion_item][et_pb_accordion_item title=”Q: What are some of the challenges when it comes to incorporating a strategy for companion diagnostics? How can we overcome these challenges?”]
A: Timing – Drug sponsors struggle with how and when to integrate their codevelopment activities which could potentially lead to a companion diagnostic. Each organization has their own set of experiences and assumptions that go into their decision making and strategic planning for companion diagnostics. The typical result is that programs defer decision making because of the uncertainty and lack of proper funding in translational phases. The key to over coming this challenge is taking a staged diagnostic strategy and setting up partnership that can adapt and execute around key decision point in clinical development and have a partner that can drive such an approach. The Drug sponsor need to actively manage the strategic and tactical objectives of the diagnostic, which can change drastically. The diagnostic can often become disconnected with major regulatory and clinical decision points and this can significantly increase risk downstream. A fit for purpose companion diagnostic strategy that is not solely dependent on one diagnostic path and can adjust quickly with change in therapeutic clinical and regulatory strategy is key to success.
[/et_pb_accordion_item][et_pb_accordion_item title=”Q: What challenges are there when it comes to defining the commercialization strategy for when marrying a drug with diagnostics?”]
A: Key questions when defining a commercialization strategy for a drug associated diagnostic:
- What is the role of the diagnostic with respect to supporting the indication and administration of the therapy? The objective is to commercialize the drug, not the diagnostic, so how must the diagnostic be implemented in order to meet the objectives of the drug commercial strategy and market access?
- What are the analytical performance and lab reporting requirements necessary to support HCP decision making?
- What is the state of existing testing (LDT’s) with respect to availability, quality and cost?
- Given small markets and challenging reimbursements often tied to molecular diagnostics, what is the viability of the business model around the diagnostic and how does the drug commercial plan help to ensure that the test economics support drug commercialization objectives.
- The commercialization strategy can change all the way up to final indication and regulatory approval of the therapy. The indication for the drug may eventually not require a companion diagnostic at all. What is best approach to manage the Dx commercial plan and agreement given the nature of this uncertainty?
[/et_pb_accordion_item][et_pb_accordion_item title=”Q: How can we change the field of drug discovery and development to improve the communication and collaboration between diagnostics and pharma companies?”]
A: The collaboration between diagnostic and pharma companies is highly dependent upon the differences in economic incentives and psychology of the two organizations. The diagnostic leaders must understand how drug development teams are structured and how those teams are managed and incentivized. One of biggest challenges which is often faced is the lack of visibility that diagnostic companies have into the drug development planning and decision making processes. This is the consequence of the fragmented nature of biopharma organizational structures which can create issues with continuity. The establishment and management of a Joint Development Team is a key factor for success to ensuring a good, robust collaboration. All major functions including regulatory, development, IT, quality, commercialization, and clinical must be included in the JPT. Given the focus of the JPT on the development of the diagnostic, the diagnostic partner must take the lead and full accountability on the functioning and organizational culture of this joint team.
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