Cytovia, A Specialty Immuno-Oncology Pharmaceutical Company: From Vision Toward Implementation

| April 17, 2017

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Many IMNP shareholders have been asking about our vision and implementation plan for Cytovia. We now have a clear strategic business plan, validated by a leading consulting firm and by industry experts, to create a global specialty immuno-oncology pharmaceutical company around our core asset Ceplene. As the plan is implemented, Cytovia would focus on commercialization and late stage development of immuno-oncology drugs while Immune would focus on clinical proof of concept development for immuno-inflammation and immuno-dermatology drugs.

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Creativ-Ceutical

Creativ-Ceutical provides strategic pricing, market access and health economics consulting in life sciences. We provide both the strategic advice and the technical services to deliver results that meet your expectations. We have broad experience in the areas of central nervous system (CNS), oncology, vaccines, metabolic/cardiovascular diseases, and rare diseases. These are complex and developing fields, where treatment paradigms are in constant evolution and where clinical and economic issues require rigorous analysis to determine the best therapeutic choices. This experience allows us to address the most complex challenges and to anticipate pricing and market access issues that will arise in other therapeutic domains.

OTHER ARTICLES

3 Big Pharma Stocks Plunging the Most During the Coronavirus Stock Market Crash: Are They Buys?

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Big pharma stocks have been clobbered during the coronavirus-caused stock market crash. You can count the number of drugmakers with market caps of $25 billion or more whose shares haven't dropped by double-digit percentages on one hand -- and have several fingers left over. Three big pharma stocks have plunged the most: AbbVie (NYSE:ABBV), Bristol Myers Squibb (NYSE:BMY), and Pfizer (NYSE:PFE). But are these stocks smart picks to buy right now?

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How pharma can continue engaging HCPs in a world gripped by COVID-19

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How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

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Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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VIEWS AND ANALYSIS

New Dimensions of Clinical Trial Optimization

Article | March 26, 2020

For much of the past three decades, even as methodologies for clinical trial design have advanced and refined, the idea of the optimized clinical trial has centered on optimal patient samples, target enrollment rates, and generally the most efficient uses of scarce resources in the form of patients. Yet anyone who has had to design and optimize a clinical trial, knows that trial optimization occurs within an ecosystem of choices; a series of choices that stretch from the time it takes to implement a clinical trial and submit clinical data for analysis, to general concerns about the cost and power of a clinical trial. A true clinical trial optimization process would try to unify a number of these choices into a single framework for trial optimization. The complexity of clinical trial optimization comes from the need to align priorities on the one hand, and to understand opportunities on the other. We know that at a very general level, clinical operations specialists benefit from simplicity in clinical trial design, and that commercial teams prefer shorter clinical trials to longer ones. We also know that the statistical design of a clinical trial can influence both simplicity and duration. Yet how many sponsors have their clinical operations and commercial teams, sit with their R&D teams to review various statistically nuanced design options? For many sponsors, the reason this process does not occur as often as it should, is because the nuanced statistical parameters of a clinical trial design are very difficult to communicate to non-statisticians. Yet a trial optimization tool like Solara, equipped with data visualizations and the ability to see tradeoffs intuitively, can overcome this challenge. The real challenge is often convincing the non-statistician that they have a stake in clinical trial design. Cytel recently had a client that thought it needed a sample size re-estimation design, because it had a very strict limit on the number of patients it could enroll. After a few hours of working with Solara, though, a statistician discovered that a much simpler Group Sequential Design would deliver comparable power using about the same number of patients. The gains from the more complex design were minimal from the optimization perspective, when understood as the eco-system of choices. Similarly, most commercial teams pressure their clinical trial designers to have the most accelerated clinical trial imaginable, but as we all know, the longer the clinical trial the more likely there will be a higher number of events that demonstrate the effectiveness of a new medicine. So commercialization teams have a stake in longer clinical trials, even when their rule of thumb is to shorten them. Therefore, it is absolutely essential to communicate the benefits of various statistical designs to multiple stakeholders in a way that makes tradeoffs clear. Aligning on priorities early during the clinical trial design process is essential to selecting the optimal clinical trial. Yet for this statisticians need to be equipped for both a strategic and communicative role in the R&D process.

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Spotlight

Creativ-Ceutical

Creativ-Ceutical provides strategic pricing, market access and health economics consulting in life sciences. We provide both the strategic advice and the technical services to deliver results that meet your expectations. We have broad experience in the areas of central nervous system (CNS), oncology, vaccines, metabolic/cardiovascular diseases, and rare diseases. These are complex and developing fields, where treatment paradigms are in constant evolution and where clinical and economic issues require rigorous analysis to determine the best therapeutic choices. This experience allows us to address the most complex challenges and to anticipate pricing and market access issues that will arise in other therapeutic domains.

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