A drug crisis has been quietly growing that many people may not be aware of—the abuse of stimulant medications prescribed to teens and young adults with attention deficit hyperactivity disorder (ADHD). In addition to the problem of teens and young adults selling and sharing their ADHD meds, many are crushing the prescription pills and then snorting or injecting the substance to achieve a greater “high.”
Vallon Pharmaceuticals Inc., co-founded by David Baker in 2018, is working on a way to reduce this dangerous practice. As CEO, Mr. Baker is leading the company as it prepares to submit a new drug application to the Food and Drug Administration for its lead investigational product candidate called ADAIR, which stands for Abuse Deterrent Amphetamine Immediate Release.
ADAIR uses a novel, patented formulation to deliver the active ingredient, dextroamphetamine, while deterring attempts to crush the pills in order to take the medication non-orally. In an interview with Ashton Tweed, Mr. Baker discusses Vallon’s specific niche and how he tries to stay on top of every aspect of the development process:
Yes, it’s surprising to many people. Most people have an awareness that prescription stimulants like Adderall are abused and people have an impression of kids using them to study for the SATs or college kids using them to cram for exams.
People are really shocked when they hear how often kids are crushing and snorting pills, either to get them to work faster or to get high or to party longer or for other reasons. Over 5 million people abuse these medications every year, and the statistics from multiple studies show that about 40 percent of people who misuse or abuse stimulants do so by crushing or snorting them to produce an even greater “high.”
I’ve spent the past 15 years in the psychiatry and neurology fields and I’ve been involved with the development and commercialization of some of the most successful products for ADHD. We noticed that, while there have been a lot of great products developed to treat ADHD, the misuse and abuse of the stimulant medications continues to exist. In fact, it’s grown over time. So, we saw an unmet clinical need, as well as a commercial opportunity, that just wasn’t being addressed in the field and we set out to design products to address that need.
For everything we hear about the opioid crisis, among teenagers and young adults there’s actually a greater rate of abuse of prescription stimulants like Adderall and Ritalin. So, we’re basically trying to develop forms of Adderall and Ritalin that kids will have a hard time crushing and snorting.
Development of ADAIR began in 2015 when I was working at another company as a means of building out our ADHD pipeline. When that company completed a merger, we had the opportunity to acquire ADAIR with the backing of some very insightful investors. The idea was to build Vallon around ADAIR so that we could continue its development and continue to develop other abuse-deterrent products.
Since we formed Vallon two years ago, we’ve managed to deliver on all of the objectives we set out to achieve when we started the company. We’ve taken ADAIR from a preclinical compound to the final phases of clinical development.
On one hand, yes, because it was something new for me. But on the other hand, I think my career has prepared me with a progression from Merck, a Big Pharma company, to Shire, a mid-sized company, and then Alcobra, which was a small startup when I joined. So, while it was somewhat daunting, it seemed like a natural next step and a challenge I was up for.
For many small life science companies, raising capital is always a major challenge. The key is raising money in advance of when you really need it. When I was at Shire, I developed a track record of making money for the company and indirectly for the investors, but now I have to show investors that I can make money for them directly.
Another challenge, which is somewhat related to the first, is working really hard to be efficient and smart about spending the financial resources investors give us. The good news is that the more you do it, the better you get at it.
I would say learn as much as you can from disciplines that are outside your core area of expertise and responsibilities. For many years, I was a marketer and I didn’t really think much beyond that role.
But, I found is that if you push yourself to learn as much as you can about things outside your discipline, it will pay off in the long run—especially if you want to have a role as a CEO, where you really have to be a generalist.
In addition, as the CEO of a small company, you have to learn to be both highly strategic and highly tactical at the same time. You have to know everything that’s going on in the company. For example, I didn’t have real expertise in manufacturing, or even the details of what goes into running a clinical trial. I knew about clinical trials and I knew how to use the results as a marketer, but I didn’t know about all the nitty gritty details that go into effectively starting up a study and recruiting subjects for the study. If I think back to early in my career, I never thought I’d be involved with things like looking into where to store our clinical trial supplies or store the blood samples that are drawn in a clinical trial.
For me, a big part of it has been on-the-job experience, but I also looked for opportunities to get involved. I’ll give you an example. When I was with Alcobra, I was the Chief Commercial Officer. Marketing and commercialization was my expertise, but we wanted to run a clinical trial for an orphan condition. When you deal with orphan conditions and a small number of patients, recruiting for your studies can be a real challenge.
I basically threw myself in and used my skills as a marketer to help the clinical operations team recruit subjects. We developed a social media campaign and developed a website—not to promote a product, but to promote a study.
The smaller the organization, the more you’re going to have the chance to learn what’s going on across the company. One of the things that I do as a CEO is to get everyone on the phone as a team once a week to discuss everything that’s going on operationally. So, if you’re the regulatory person, you know what’s happening in terms of preclinical work, or if you’re the manufacturing person, you know what’s happening with business development transactions. At a small company, it’s important that everyone understands what’s going on and doesn’t just live within their own domain.
So, the next year is really big for us. We’re planning to run our last major clinical trial before seeking FDA approval for ADAIR. We’re also going to be completing our final preclinical work and scaling up our manufacturing process. So a lot to get done, but all putting us on the path to get our first drug approved.
Ashton Tweed would like to thank David Baker for this interview. If your company needs help from members of the Ashton Tweed Life Sciences Executive Talent Bank, we can supply that assistance either on an interim or a permanent basis. Additionally, if you are among the many life sciences professionals affected by the changes in the industry, Ashton Tweed can help you find the right placement opportunity — from product discovery through commercialization at leading life sciences companies — including interim executive positions and full-time placements. In either case, please email Ashton Tweed or call us at 610-725-0290. Ashton Tweed is pleased to continue to present insightful articles of interest to the industry.