RareMoon is in full preparation mode and enthusiastic about planning for a successful three days in San Francisco for the industry’s biggest events of the year.
Why do we attend?
Considering what we’ve seen in the past few years, we are anticipating a lot of buzz around rare diseases, orphan drugs and novel therapies at the JP Morgan Healthcare Conference this upcoming January. For RareMoon, we consider JPM a time to tap into investors, bankers, and biotech companies investing both research efforts and time into the rare disease arena.
We know investors and partners want to see two things: proof of concept and agency “buy in.” The latter is where we step in to shepherd companies in the right direction.
Agency LOVE comes from both frequent and early communication between agencies and drug developers through interactions as well as through the various incentives offered by the FDA and EMA. These expedited development tools promote innovative R&D and are there to ensure safe and effective trial design and continued agency support including (but not limited to) Orphan Drug Designations (FDA and EMA), FDA’s Fast Track or Breakthrough Therapy Designations or EMA’s PRIME scheme.
Early and effective communication during the drug development and approval process along with taking advantage of all available incentives, plays a leading role in both the alignment of investors and the success of your program.
Why meet with us?
We are a virtual regulatory team. Whether you are needing assistance with agency communication and interactions, a risk assessment, or someone to execute and expedite the application process for you, we support you.
By offering our time, and our comprehensive and strategic expertise in orphan regulatory affairs, we work with you to ensure your objectives and milestones are achieved.
Success to you might be reaching milestones, connecting with the agencies, or getting investors interested and wanting more. In any case, we can make it happen.
