Summer Entrepreneurial Experiences

Author Archive

EncepHeal Therapeutic’s Science Meeting Example

Sunday, August 27, 2017 7:04 pm

My most recent post illustrated an example of one of our weekly business meetings. This post will shed light on what might be covered in one of our weekly scientific meetings. These meetings are centered around presentations on a scientific paper that’s based on some particular topic that we cover over a few meetings. For example, since our compounds are analogues of Provigil (modafinil), we would like to know what clinical trials have been carried out for indications other than sleep disorders and cocaine addiction. A presentation might be on a clinical trial that uses Modafinil for the treatment of cognitive deficits associated with depression. This broadens our knowledge on potential target populations when we expand the market for our drug.

These presentations on alternate indications of our drug have served to be extremely useful, given our most recent task in having to develop a commercial development plan. This plan serves to inform about the current stage occurring in the drug development phase, as well as what is to follow. The current stage 1 involves the screening of compounds based on the company’s primary focus, which is for the treatment of cocaine addiction. The plan also briefly describes what future IND-enabling work will be conducted, which is necessary prior to moving the compound(s) onto clinical trials. Also included in this document are alternative indications for the lead compound. The chief science officer, chief research officer, and myself worked on this document for the past week. We had to compose convincing arguments for why we believe our lead compound can be used to target alternative indications, such as depression, cognition, and ADHD. The information we used to base our arguments off of was extracted from the presentations we’ve had over the past couple of months. Using ADHD as one example: we need to be able to judge which animal model for ADHD is the best and most feasible one to use, why we think our compound would show positive results, and how this might compare and contrast with current approved medications.

I meant to submit this post earlier, but due to the delay I’m pleased to announce that our commercial development plan has recently been approved by the NIH (National Institute of Heath)! This means that the experiments we proposed for future work will (most likely) be sufficient enough to support the indications we believe our compounds can be used for. This is very exciting for future investors because if our lead compound shows promising initial non-clinical results, then we can move forward with strong evidence for expanding the market for our drug. Very exciting!

Although I only have one more post to share, this is not the end of my experience. I’m fortunate to have been asked to continue interning for the company throughout the spring of 2018. This is a very exciting time because the company is growing at a much more rapid pace than when I had initially started working. I’ll be able to take on different projects that will help progress the next stage of drug developement. Stay tuned!

EncepHeal Therapeutic’s Business Meeting Example: Critical Decisions

Saturday, August 12, 2017 10:21 am

As I mentioned in my previous post, one of the factors that contributes to the efficiency of the Chorus Model is the teams ability to decide early on the likelihood of success for a particular drug compound. They use what’s called a critical success factor (CSF), which basically is criteria for determining whether a compound reaches the threshold for certain qualities, or whether the compound should be modified/discontinued. In this way, the company doesn’t waste resources, such as time and money, on compounds that are more than likely to be unsuccessful at the later, more costly stages of drug development.

Our recent business meeting was also centered around developing a critical decisions plan, but with a slightly different approach. We do already have a model to determine what qualifies for a compound to move forward, so the next step was to assess various realistic scenarios and what decisions should be made, in the likelihood of a scenario taking place.

We split up the scenarios into categories of research & development, funding, personnel, government & policy, and license & patent. They were then categorized based on whether it was a best, average, or worst scenario. So for example, our lead compound, under the best scenario in research & development, would take a minimum amount of time (<2 years) using the current development plan, and we would be able to screen for not only cocaine but also for methamphetamine and other indications. An average case scenario for personnel, for example, would be that the company has to be run under multiple operational locations. Potential tasks to be taken in result of this situation may include doing board meetings in person, determining the function of each location, and meeting guidelines for certain venture funds that are location-specific.

By anticipating and addressing possible scenarios across a range of factors that play a role in drug development, we will be prepared to respond with utmost diligence. If there is imminent change to a certain policy issue, we will be able to modify our research & development plan to accommodate this scenario. This critical decisions task has given me insight into what the experts in both the science and business sectors of the company are thinking, when it comes to the success of the company. Based on my own background in drug development and from what I’ve learned so far in this internship, I have been able to contribute to this decisions meeting with the proposition of additional likely scenarios.

Stay tuned for an example of what goes on in our science meetings!

EncepHeal Therapeutic’s Drug Development Model: Part 2

Monday, August 7, 2017 10:17 am

As part of our weekly business meetings, I present to the team information about some topic that the other intern and I have been assigned. One example of this was looking into the developmental model that EncepHeal Therapeutics partly mirrors. The Chorus Model, an internal branch of Eli Lilly, takes the “quick-win, fast-fail” approach to drug development, shown in Figure 1, vs. the traditional model. The purpose of presenting on this model was to share the aspects of Chorus that serve to expedite the pipeline of drug development, in addition to the ways EncepHeal Therapeutics can capitalize and expand on these strategies.

Traditional vs. Chorus Model

Figure 1: Traditional vs. Chorus Model

The Chorus model differs from the traditional model in that instead of obtaining their proof-of-concept (POC) at the end of phase II, which typically costs about $40 million, they get POC at an earlier point. They don’t invest in the later, more expensive and larger clinical trials until they have data providing some proof that their compound(s) are likely to be successful in a larger population of patients. This is called their “lean-2-proof-of-concept,” with the premise of getting as many early-stage compounds to POC as cost effectively as possible. They don’t invest in any manufacturing and commercialization of the product until they have a validated mechanism of action for their drug candidate. This higher probability of technical success saves them a lot of money if, let’s, say, that drug candidate would have otherwise failed at a later stage for a reason that wasn’t elucidated at an earlier point. EncepHeal Therapeutics is looking to follow this approach. They have several closely related compounds that are going through pre-clinical testing and will be refined into newer generation compounds if there isn’t sound proof of concept, such as a safety profile that will likely translate well into humans.

By presenting this model to the the CEO, CSO, and a couple of business and science advisors, EncepHeal members can identify areas where they would like to differ from the Chorus Model, to be even more efficient along their drug development pipeline. For example, one alternative strategy that was discussed was the possibility of testing the lead compound in a very small sample of non-human primates (NHP), shortly following rodent testing. For a drug to become FDA-approved, various toxicology and safety studies need to be conducted, using two different animals. NHPs are typically the higher-organism chosen, due to the high likelihood of results being translatable to humans. However, this testing is very costly. The idea of testing a promising compound in a smaller-than-normal sample would allow a quicker premature confirmation that the lead compound is likely to be successful at later stages.

The opportunity to research ways in which EncepHeal is similar and different than other companies gives me a keen perspective into what makes biotechnology companies succeed and fail. There are plenty of biotechnology companies that start out okay, but then fail and crumble. To ensure that EncepHeal is not only successful but also efficient in it’s drug development strategy, it’s crucial to understand how other similar companies are run. At our weekly meetings we can discuss how we are and should model some of these strengths. For example, the operational efficiency within the Chorus Model partly lies with them defining what their critical success factor (CSF) is from the start, so that if a compound falls short of certain thresholds, it’s discontinued.

Stay tuned to learn how EncepHeal Therapeutics is modelling various strengths characteristic of the Chorus Model, such as determining the minimum essential criteria needed for drug compounds to move forward.


EncepHeal Therapeutic’s Drug Development Model

Sunday, August 6, 2017 1:35 pm

Traditional drug development models describe the process of taking a drug from the drug discovery phase to FDA approval in 8-15 years (Figure 1). In addition, it costs about $1 billion for the entire process. This daunting pipeline is partly due to the fact that pharmaceutical companies oversee the entire process, which requires the need for in-house chemists to develop the compounds, to clinical research teams that carry out the early- and late-phase clinical trials.

Drug Development Gap

Figure 1. Drug Development Gap

To lessen the cost and time, larger companies are now moving towards developing at the later stages of research, by conducting clinical trials. In this way, they can bypass the early stages that require laboratories to do the pre-clinical animal research, as well as all of the personnel required for those tasks. The approach of EncepHeal Therapeutics is to bridge the gap, as shown in Figure 2, between early research discovery and commercialization/mitigating risk. One of my tasks has been to look into the drug development model that other pharmaceutical companies follow and compare/contrast with the model of EncepHeal. Understanding what works with these new and upcoming alternative models will provide greater insight into how EncepHeal can modify and expand on their own model and be even more efficient.

By in-licensing modafinil analogues from NIDA, EncepHeal can skip straight to carrying out the pre-clinical assays and early clinical trials. Once proof of concept has been established, they can out-source their lead compound(s) to a larger pharmaceutical company that’s specialized in the later clinical phase stages. In this way, EncepHeal Therapeutics can use their scientific team that has expertise in those particular experiments, and leave the other tasks to better equipped external experts.

Bridging the Drug Development Gap

Figure 2. Bridging the Drug Development Gap

Stay tuned to learn more about EncepHeal Therapeutic’s drug development model, which can potentially cut the time and cost associated with the typical 8-15 year drug development pipeline, by half.

EncepHeal Therapeutic’s Financial Pipeline

Saturday, August 5, 2017 3:01 pm

It all began a couple of years ago in 2015, at the Neuro Startup Challenge, a competition hosted by the Center for Advancing Innovation. With the winning innovative idea to use modafinil anaologues for treating stimulant addiction, EncepHeal Therapeutics was given the opportunity to in-license these analogues, synthesized by a chemist from NIDA (National Institute of Drug Abuse). With the company now off the ground, next began the search for accelerators and grants to fund the initial seed stage of their business plan.

Accelerators are funded programs offered to startup business teams as a chance to win seed funding and gain mentorship to “accelerate” the initial stage of business development. EncepHeal Therapeutics was a finalist among 8 teams in the 2016 New Ventures Challenge, run by Flywheel in Winston-Salem. The 12-week rigorous program consisted of business professionals providing their expertise in product development, sales, marketing, and funding strategies. In addition to this came an average $50,000 per startup team.

With EncepHeal Therapeutics looking to start their pre-clinical studies in 2017, greater funds were warranted. The Small Business Innovation Research (SBIR) program is a government-funded program that helps small businesses with their research and development (R&D). The program is divided into three phases, with the first phase aimed at funding feasibility and proof of concept, phase II aimed at funding research and development, and the third phase for commercialization. At the end of April 2017, EncepHeal Therapeutics was awarded a Phase I SBIR grant worth $300,000 to begin its pre-clinical screening assays, which has recently commenced. To help expedite this pipeline to Phase II, EncepHeal will use the $65,000 awarded by the NC Small Business Program in May, 2017.

I began my internship with EncepHeal Therapeutics at about the time when their drug screening assays were initiated. This has given me a neat perspective at seeing how and what sorts of funding is sought out for the initial stage of their drug development model, as well as for the prospective milestones. Funding for the future stages will come from venture capital funds, investors, grants, and possible non-traditional funding sources. Stay tuned to learn more about dilute and non-dilutive funding!



Teamwork: The Backbone of EncepHeal Therapeutic’s Initial Success

Thursday, June 22, 2017 10:32 pm

I, along with an NC State undergraduate student, are the first two interns at EncepHeal Therapeutics. Despite their small and young team, this company has already made great progress since they pitched their business idea just a couple of years ago. Their smooth and seemingly effortless progression is largely due to the Wake Forest University-affiliated science and business advisors who serve as mentors to the Chief Executive Officer (CEO) and Chief Science Officer (CSO), both who are under the age of 35. Some may think it to be a disadvantage to work for such a small company, but I would argue against this. Being an intern for an organization with a team of less than 20 members brings exciting responsibility with involvement in a variety of tasks. There is also a lot of visibility and the opportunity to closely collaborate with the other employees who are experts in their respective field.

On a weekly basis we have both business and science meetings that we are required to attend. More or less for everything else that the company is involved in, we are just encouraged to be a part of those activities and events. I think that both us interns are just so excited to be a part of this opportunity that we don’t even think twice about whether we’re going to attend something. We want to be familiar with every angle of how the company operates. It’s fairly easy to desire to be involved in all operations when we work under the leadership of such an amazing management team. The CEO and CSO delegate and oversee all of our tasks, but everyone is always in communication through email, phone-in meetings, and Google Drive. I think the communication between members of the management team is a huge strength that has been prevalent since the first day I started this internship. What helps drive this communication is that all of the work is transparent, with everyone having access to information surrounding the business and science aspect of the business. It’s easy to notice how passionate everyone is about the potential of this company. This is partly reflected by the constant welcoming of opinions on every matter discussed, without having only one person domineering a discussion.

EncepHeal Therapeutics is very team-oriented. As I mentioned before, there are weekly business and science meetings. The CEO and CSO are always present at both of these, so that they’re familiar first-hand with every decision made. Since this is a relatively young company, the management team consists of business advisors with extensive experience in the entrepreneurship realm, as well as a Chief Research Officer who has over 30+ years of experience in biochemical neuropharmacology. They give their expertise advice and knowledge in the meetings, but first listen to what the CEO and CSO have to say so that they too can learn to be independent leaders. Shortly after the meetings take place, the respective officer will email the team with a follow-up of what was discussed and what needs to be done moving forward. Google Drive is a very effective means to keeping everyone up-to-date with past, current, and future work. On the Drive are presentations that were given in meetings, financially-related documents like which venture funds would be best to contact first and why, organizational documents such as prioritization of tasks for the next week, etc.

Every task seems to be done in a timely manner, and this is partly due to the fact that there is no set 9am-5pm work day. For example, the other week the CEO and CSO were waiting on a response from a Program Loan they wanted to apply to. They were contacted two days before the application due date, and the CEO was away on vacation at this time. The application was already started at this point, but the additional information necessary for submission required the CEO to spend his vacation time finishing it up. At a professional level where everyone is busy handling so many jobs, it can’t be expected that everyone is going to be very reliable. To be a successful leader in a company, especially at a young age, you really have to know how to prioritize and sacrifice!

Stay tuned for how EncepHeal Therapeutics got funding to start the company and what the process looks like to continually support the pipeline of biotechnology organizations.


EncepHeal Therapeutics-Week 1

Monday, June 12, 2017 8:06 pm

It is estimated that 2.2 million Americans regularly use cocaine. It would not be surprising if you knew someone, either directly or indirectly, who has or is struggling with cocaine dependency. However, despite the high prevalence of cocaine abuse, there is no effective FDA-approved therapeutic treatment. Surprising, right?!

Let me try to break down as easily as possible how cocaine works in the brain…

Normally when we consume or engage in something pleasurable (e.g. eating an oreo!), we get a release of the neurotransmitter dopamine from neurons, our brain cells. We have a transporter (DAT) that will take back this dopamine into the cell and normalize levels. Cocaine acts by binding to this transporter and blocking its function, leaving elevated levels of dopamine swimming around in our brain, which results in a heightened and lasting feeling of pleasure. With consistent use, the chemistry of our brain changes and what used to give us pleasure is now dampened, thus requiring the intake of cocaine just to feel “normal.” Cocaine abusers will get an insurmountable craving to obtain the drug. Think of someone you may know, maybe during college, who used Adderall (also a psychostimulant). They were more talkative, focused, and energized when taking the drug, but then afterwards they “crash” and feel sluggish, inattentive, etc. In addition to the craving, deficits in executive function, attention, and working memory are also driving factors behind the drive to continue cocaine use.

Modafinil, commonly known as Provigil, is a wakefulness-promoting agent used to treat narcolepsy and sleep apnea. It has recently been investigated as a treatment for cocaine dependence because it binds to the same transporter (DAT) in the brain but is not a stimulant, is not addictive, and has few to no side effects. However, promising results from clinical trials are only modest. This leaves researchers wondering if maybe the chemistry of modafinil can be modified in such a way to enhance its effect in the brain, while still excluding any potential addictive properties or side effects.

This summer I will be working with EncepHeal Therapeutics, a start-up biotech company that will be testing modafinil analogues for the potential treatment of cocaine addiction. I will learn everything that relates to the drug development pipeline, from animal research experiments to the clinical trials phase. Some of my responsibilities will involve research on the market assessment, financials, and competition of EncepHeal’s core business practices, shadowing animal experiments, analysis of data collected, presenting pertinent scientific literature, and exploring ways to expand on the company’s mission to provide a comprehensive treatment for substance abuse. I hope to learn about the roles of each member in the company, the financial work required to start up and maintain a biotech company, and the steps involved in the drug development pipeline.

Potential cocaine abuse treatment coming your way! Stay tuned to learn what I learn.


Serving Humanity Through the Pursuit of Knowledge

Copyright © 2010 Wake Forest University ~ 1834 Wake Forest Road, Winston-Salem, NC ~ 336.758.5000