<span fr-original-style="font-size: 14px; font-family: Arial; font-weight: 700; font-style: italic; color: rgb(0, 0, 0);" style="font-size:14px;font-family:Arial;font-weight:700;font-style:italic;color:rgb(0, 0, 0);box-sizing:inherit">Join Haystack Project and Dr. Woodcock in engaging researchers, developers and patient organizations as they highlight case studies that demonstrate the need to update the current regulatory framework for rare diseases. <div style="width:100%;line-height:1.5;box-sizing:inherit">The path to approval for rare diseases is so difficult that, for some treatment candidates, it is simply not feasible. The current regulatory framework considers that only a controlled (usually, concurrently controlled) trial can constitute an “adequate and well-controlled” study and that a statistical analysis yielding a “p value” of less than 0.05 must be the criterion of success or failure.                               </div><div style="width:100%;line-height:1.5;box-sizing:inherit">                                                Building on Congressional precedent, it is imperative to codify another modification of the meaning of “adequate and well- controlled clinical investigations,” allowing scientific rigor and specific rare disease expertise to lead us to feasible and convincing development programs in rare diseases when randomization may not get us there. The time is now to match our advances in science and technology with evaluation frameworks that are fit-for- purpose.                         </div><div style="width:100%;line-height:1.5;box-sizing:inherit"> </div>*The Scientific Workshop will be held on February 12th, 2025 from 1 pm - 4 pm EST*

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Join Haystack Project and Dr. Woodcock in engaging researchers, developers and patient organizations as they highlight case studies that demonstrate the need to update the current regulatory framework for rare diseases. <div>The path to approval for rare diseases is so difficult that, for some treatment candidates, it is simply not feasible. The current regulatory framework considers that only a controlled (usually, concurrently controlled) trial can constitute an “adequate and well-controlled” study and that a statistical analysis yielding a “p value” of less than 0.05 must be the criterion of success or failure.                               </div><div>                                                Building on Congressional precedent, it is imperative to codify another modification of the meaning of “adequate and well- controlled clinical investigations,” allowing scientific rigor and specific rare disease expertise to lead us to feasible and convincing development programs in rare diseases when randomization may not get us there. The time is now to match our advances in science and technology with evaluation frameworks that are fit-for- purpose.                         </div><div> </div>*The Scientific Workshop will be held on February 12th, 2025 from 1 pm - 4 pm EST*

Haystack Project Inc

Haystack Project Scientific Workshop with Dr. Janet Woodcock

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