Next Phase Newsletter

By James Huang, Research Analyst, LSN

The CFDA released a set of proposals on May 11th regarding major reforms in the Chinese regulatory and approval system. The series of proposals is designed to accomplish four major goals:

From the many proposals presented, two key points stand out as potentially having a major impact on life science startups outside of China:

• NHFPC will issue a rare diseases list and drugs/medical devices targeting these diseases will be eligible for a clinical trial waver and accelerated review. Drugs with orphan approval overseas will initially receive conditional approvals in China and only need minimal additional trials for full approval by the CFDA. Additionally, if investigational therapeutics or devices in the rare disease space show early clinical efficacy and predictable therapeutic benefit, they may receive conditional approval.
• Applicants who submit CTA/INDs may proceed with clinical trials if the Chinese Centre for Drug Evaluation (CDE) does not send comments or a rejection notice within 60 working days.

The first proposal regards approval and use of orphan medications in China. The CFDA is currently proposing to establish an orphan and rare disease list and, additionally, therapeutics and devices that treat life-threatening conditions on this list can receive conditional approval if early or mid-stage data can predict clinical benefit for these therapeutics and devices. Furthermore, the CFDA also proposed that conditional approval be given to orphan therapeutics and devices that have already received approval in foreign countries, even if they have no clinical trial data in China. Instead, these therapeutics and devices would have to conduct confirmatory trials as directed by the CFDA to keep the conditional approval. Fierce Biotech delves a bit more into the implications of these changes here.

The implications of these changes for both investigational and marketed therapeutics and devices in the orphan space are huge since, if approved in their present form, these proposals would make it easier to access the Chinese market, a process which has been both time consuming and financially prohibitive historically.

The second proposal focuses on the review process.  A key highlight is the proposed change to allow Phase I clinical trials in China to begin if no comments or rejection has been received from the CFDA review committee 60 working days after the application has been submitted. This change combined with the orphan therapeutics change mentioned above means that orphan therapeutics can be sure to get on a fast track to testing and on the market very quickly.

However, whether all these proposals will be approved in their current state remains to be seen. Keep your eyes peeled for the CFDA’s announcement coming in June.

By Dennis Ford, Founder & CEO, Life Science Nation; Creator of RESI Conference Series

As LSN heads into its fifth year, we have seen what works and what doesn’t in the fundraising process. LSN has developed a fundraising platform consisting of an early stage life science investor database (the LSN Investor Platform), and the RESI conference series, which takes place every two and a half months at venues through out North America. These two vehicles allow fundraising executives the ability to be very efficient in finding investors and partners that are a fit for their stage of development and their product offering.

Providing an efficient vehicle for identifying and understanding global investors that are a fit for your company is very helpful, but quite frankly is just the ante into the game. The devil is in the details and this is where we see many scientist entrepreneurs fall short on their capital raising efforts. I have proclaimed time and time again that raising money is a numbers game, and that theme is ever present in the basic process of getting in front of investors. Not surprisingly, it’s all about the frontend, making that introductory calls and the backend, doing the all-important follow-up calls. These two pieces of the process always prove to be the most daunting because of the tedious and repetitive nature of this simple activity.

I have advised many of my fundraising clients that it is essential to find someone in their organization who enjoys scheduling meetings and following up regarding meetings. It sounds easy but is far from it. Everybody is busy and everybody is trying to prioritize their schedule around their to-do lists of important tasks. Therefore it takes someone who is genetically coded to handle the setting up and follow up, someone who doesn’t interpret a “no” just because they haven’t received an answer back. Someone who has a “can do” attitude of going after a meeting until they get it booked or get an emphatic, no thanks, and it’s off the table. It can take 3, 5, 10, or 20 attempts to book or follow up on a meeting so having the right personality for this mission is critical. I routinely suggest if no one in-house is available or capable of performing these tasks then hire an intern or recent college grad who is looking to get some exposure and training on the business side of the house. Having a CEO or a business development executive trying to arrange meetings is too time intensive and doesn’t work (there I said it).

In summary, if you have a current accurate database of global investors and an ongoing conference series to attend, the crucial next step is doing the hard work to get you and your story in front of the right investors. Don’t underestimate the tenacity needed to participate in the numbers game called fundraising.

By Cole Bunn, Senior Research Analyst, LSN

Life Science Nation’s investor platform and Pitchbook both offer various data on early-stage investors which get used by a variety of different stakeholders in the industry. Although there is some overlap in the data tracked by these platforms, there lies stark differences in how the data is sourced, updated, and the industry specific nature of the data. These core differences result in two different types of platforms that serve different purposes. Pitchbook’s utility lies mostly in providing a high-level overview of different markets/sectors whereas the value in the LSN platform is providing actionable, industry-specific data.

The LSN investor platform is focused solely on the early-stage life science space

While Pitchbook and other data providers focus on the overall private market’s landscape, LSN investor platform is specifically focused on seed and venture-stage (series A, B) companies in the life science space which we define as therapeutics, medical devices, diagnostics, research tools and healthcare IT. LSN’s highly-specific focus has allowed for the development of a platform that captures the most critical data points for entrepreneurs seeking compatible investors. In addition, LSN’s expertise has led to a highly efficient search ontology capable of searching the space on a more specific level. LSN’s investor profiles are tagged in terms of Sector, Subsector, Indication, Product Phase-of-Development, Geographical exposure, investment size and several other variables that are of importance to a fundraising entrepreneur.

LSN captures more than data

Pitchbook obtains their information through web-crawlers and surveys. These methods have two main problems 1) primarily historical data 2) no reliable method for keeping data up-to-date. While this does provide their database with a great volume of data, it falls behind LSN’s platform in terms of depth. The LSN platform achieves great depth by supplementing the publicly available information with interviews performed by a dedicated team of research analysts that identify new capital sources allocating to early-stage life science companies, to parse out investment preferences. In addition to the depth of data this allows LSN’s team to gather, maintaining a personal relationship through an ongoing dialogue and involvement in the RESI conference series provides a direct benefit to LSN’s fundraising clients. This personal connection between the LSN research team and an investment firm/group allows LSN to capture and utilize a unique flow of information and provides an unmatched tool for fundraising CEOs to understand the players in their space, their nuanced preferences/strategies and a way to begin a dialogue with them.

LSN team is a value add

Pitchbook data is a tool that provides its users a way to take the pulse of a certain industry. Along with a way for entrepreneurs to quickly survey the investment landscape and identify relevant groups, a subscription to the LSN investor platform grants licensees a comprehensive onboarding meeting with the LSN team that covers best practices for using the platform, light marketing/messaging consultation, as well as some assistance in finding a few highly-targeted leads. These meetings also inform the LSN research team of exactly what our clients are working on, allowing them to tailor their surveys to better understand the investors’ interest level in current clients. Finally, all investor accounts are tagged with both a date and the analyst responsible for the account. Any entrepreneurs with questions or concerns around the profile or firm are encouraged to contact the analyst on the profile.

LSN Platform + the RESI Conference

The biggest differentiator among the LSN investor platform, Pitchbook and other similar data providers, and the biggest value driver, is the intertwined relationship between the LSN and the RESI conference series. The RESI conference is an early-stage investment/partnering event that allows entrepreneurs to meet face-to-face with up to 16 relevant investors in one day, and is powered by the LSN investor platform and LSN’s relationships with these groups. All data on an investment firm’s preferences are used to populate the investor’s profile in the RESI partnering system, allowing for a more effective match-making process. Using the LSN platform and RESI conference in parallel allows fundraising CEOs to identify a variety of capital sources in their space, begin a dialogue with these groups and continue to strengthen these relationships through in-person meetings at RESI conferences.