Special Feature: Pharma Leaders of Innovation
Taking a different path
Med Ad News’ first Pharma Leaders of Innovation showcases two CEOs focusing outside the big pharma box and an agency tech leader.
Pharma is an industry about innovation, but that word can descend into meaningless buzzword status in company annual reports. When Med Ad News looked for innovative leaders, we wanted to find individuals who chose a different road than those who have traveled down a more traditional career path, with a perspective and work that could make a real difference in pharma sales and marketing.
What we found was a CEO of an epilepsy-focused generics company that was established to fund a foundation focusing on epilepsy treatment in “rest of world” countries; an agency tech leader who is launching a data “cloud” system that could revolutionize the way companies are keeping track of and interacting with physician customers; and a CEO of a company taking on the scourge of opioid addiction with an implantable drug, using her experience in big pharma to fulfill the promise of small specialty pharma.
CEO, OWP Pharmaceuticals
Founder, ROW Foundation
Founding a company that sells branded generic epilepsy drugs is not the typical way to “retire” from big pharma. And establishing a charitable foundation that actually partially owns the company as well of part of its profits is also not a typical way to go about business. But for Scott Boyer, founder and CEO of OWP Pharmaceuticals, making a profit and doing good are not mutually exclusive things, and he has found a rather creative way of combining the two.
“Our unique vision and mission is to build a company that will use the United States epilepsy market as our financial engine to drive growth and to drive sales and provide a profit,” he says. “And our not for profit foundation, ROW Foundation, will reach out and provide support with education, diagnosis, and treatment of epilepsy around the world.”
Boyer grew up in Iowa, in a family that owned a business, so it’s not completely surprising that he would eventually found his own company. “I have something for a taste for small family businesses, that stayed pretty much with me for my whole career,” he says.
At about the age of 25, he was hired by Abbott Laboratories, spending 11 years with the company on the sales and marketing side. After that, he moved on to Bristol-Myers Squibb for about 16 years, spending most of that time as regional or national sales director, with a lot of projects in the home office.
Boyer says doing these sales projects is how he became familiar with the global pharmaceutical market, and provided the spark that drove him to start OWP Pharmaceuticals. “Most of the time and energy of big pharma – and I’m not saying this in a negative way, it’s reality – is spent in 20 or so, no more than 25 countries, the wealthy countries and their healthcare systems,” Boyer tells Med Ad News. “And that’s where I started to think about how unfortunate it is, if you have a disorder or disease that’s relatively straightforward to diagnose and treat, in most countries you won’t have an opportunity to get those medications.”
Boyer truly admires what the pharmaceutical industry does. “They create magic bullets that save people’s lives and change people’s lives,” he says.
But when companies come out with a new drug, their focus is only on 20 to 25 countries. “The rest of the countries are kind of left on the sidelines,” he says. “That’s the thing that kind of broke my heart and drove me to do this. As I looked at data from different countries, and specific products, whether it was a future drug or a current drug, as you started to compile those 20 or so countries, you saw that was the majority of sales.
“But then there would always be this other small bar in the bar graph called ROW. And you’d sit there and you’d realize, ‘Oh my god, there are more people in ROW than all the rest of these countries combined,’ but they only result in 1 or 2 percent or a very small percentage of sales.”
Now imagine, Boyer says, having epilepsy and being in someplace such as Kenya. Even though there are effective drugs for this condition around the world, and some of them even generic, “you can’t get them for your child or for yourself because of where you live.
“And that’s what really drove us to create this model to try and impact those people around the world who could be easily diagnosed and very effectively treated 70 percent of the time. That’s what’s driving us to do what we’re doing.
After Boyer left Bristol-Myers Squibb he spent two years with inVentiv Health, still living in Chicago but commuting to inVentiv’s location in Somerset, N.J.
While at inVentiv, he began working on the model for OWP Pharmaceuticals. “You need to make money, you need to be profitable, but this company isn’t just about the profit,” he says.
And he did not start up OWP for possible future sale. “I can literally say every single startup firm I’ve worked with was for sale, for the right price,” Boyer says. “Their intent was not to be long term in any regards. Their focus was either on getting their product approved by the FDA or getting sales up to a certain level, and as soon as they got the right number, they were gone. That is not our intent. In fact, we’ve built the model in such a way that it would be very difficult for us to be sold.”
Because of this model, OWP Pharmaceuticals will not be sold to one of the epilepsy giants such as UCB.
“Our goal is really to build out this model into epilepsy and to help under-resourced people, without the wherewithal and resources that we have in the wealthy countries,” Boyer says.
Before starting OWP Pharma, Boyer and his team did research in the epilepsy field.
“That was one of the things, we had to create a value proposition, a clinical value proposition, that people would buy into and therefore we’d have a place in the marketplace,” he told Med Ad News.
The neurologists surveyed told Boyer that there were no branded generic choices of drugs to prescribe for epilepsy, unlike other disease states. For example, endocrinologists have alternatives to Synthroid and physicians have generic versions of warfarin, instead of Coumadin. “It was one of these things that we had to create a viable way to build a market, get a percentage of the market and be profitable long term,” he says. “The evidence was overwhelming, and our market research supported that epilepsy would work.”
OWP Pharmaceuticals has one drug on the market right now, a branded generic version of levetiracetam called Roweepra. “We were able to get it through an ANDA process which means it’s not as costly,” Boyer says. “And when we looked at the brands in epilepsy, like Lamictal and Keppra, it was very apparent that there’s a big brand loyalty – because the consequence of seizures is so great that people don’t want to use the generics as often. A lot of people stay with the brands even though they’re very expensive.”
Neurologists in the market research studies told Boyer that they would prescribe a branded generic if the quality was assured. “I’m a business guy, and there is a business model that I believe will work in epilepsy, and we did a lot of market research with a lot of neurologists who told us, ‘You know what, if you come out with this brand, where we know we’re getting the same drug, from the same manufacturer, every single time, just like Keppra, and you price it affordably, we would write that drug,’” he says.
Roweepra will not be the only drug the company markets. A second drug, a once-daily version of Roweepra called Roweepra XR, was approved and will be launched in fourth-quarter 2016. Additionally, “We’re in the process of negotiating for our third drug right now,” Boyer says.
Boyer is aiming for OWP to have five or six epilepsy brands in the marketplace in the next few years.
The philanthropic aim of the company was also established from the very beginning. Although epilepsy is relatively straightforward to diagnose and treat, people in underresourced areas often cannot get the treatment that they need.
“We know that when we diagnose people with epilepsy, currently available generic medications, like levetiracetam, like lamotrigine, will treat about 70 percent of those patients and they’ll either have no seizures or so few seizures they’ll live a relatively normal life,” Boyer says. “They’ll go from a totally disrupted life to a high quality of life with hope for the future, that they can basically build their future.”
Even though three out of 10 patients with epilepsy may not be easily diagnosed and treated, those patients in underresourced areas face an even tougher time. The ROW Foundation can help, Boyer says. “We knew when we got to these underresourced areas around the world, those who have really been left on the sidelines when it comes to treatment, we’ll really be able to have a huge impact with those people,” he says.
According to Paul Regan, president of the ROW Foundation, the foundation is funding a project through the Christian Medical and Dental Associations (CMDA) to place mobile EEG units in two rural hospitals in Kenya and train technicians to use them. The scans will be sent to neurologists in the United States who will prescribe treatment plans that can be implemented by physicians in Kenya caring for the patients.
According to Regan, The ROW Foundation is looking to this project as a “proof of concept” for what can be done with mobile EEGs around the globe. “We will follow up by exploring how anti-epileptic drugs can be provided in a sustainable way to patients in Kenya. This project will run in September 2016, with follow-up visits, every six months or so through 2017 and onward,” Regan comments.
All of ROW’s administrative costs are covered by OWP. “ROW Foundation is basically an equity owner in OWP,” Boyer says. “This model has been used in other places, but what it does is basically create a self-sustained foundation.”
Because ROW is an equity owner of OWP, it is earning money through the company’s dividends and profits. “That’s what we believe will keep this sustainable long term, they are not just relying on donations,” Boyer says. “They own part of OWP and therefore they will get a steady stream of dividends with which that they can fulfill their vision and mission of serving the underresourced areas with epilepsy around the world.”
ROW’s ownership of OWP is “critically important, otherwise you’re at the whim of wealthy people who make donations,” Boyer says. “That’s just a tough row to hoe. Not that we wouldn’t accept some donations, and we do get some, but long term, that is not the primary funder of ROW’s good work.”
Boyer is definitely not looking to get rich, he says. His wife, who is also from Iowa, still works as a surgical nurse in a Chicago-area hospital. Though pharma has treated him well, OWP and ROW “is a way for us to set up a company that will give back and will help other people that are underresourced,” Boyer says.
In addition to the Kenya project, the ROW Foundation has awarded a grant of EEG equipment to Arabkir Pediatric Hospital in Yerevan, Armenia.
The foundation has also researched and vetted equipment needs in several other places, Regan says, and hopes to make equipment grants once the funds become available. These locations are in The Republic of Georgia, Swaziland, Ghana, India, and Guatemala.
Chief Digital Officer
It’s easy enough to find Ritesh Patel, the chief digital officer of Ogilvy CommonHealth Worldwide. Just Google his name, and he can be seen on a number of social media platforms, including Twitter, Instagram, and LinkedIn. And he also owns a restaurant – Brick Lane Curry House in Montclair, N.J.
Why a restaurant? “I was tired of crappy Indian food, in Montclair, so we opened a restaurant,” he jokes. “I was going down to [Little India in] Edison quite a lot, and I was like, ‘Why am I going so far? I need somewhere I can walk to!”
And just like becoming a restaurateur, the creator of the OCHWW Marketing Cloud – a first of its kind, data-driven offering launched in April to help marketers better understand, reach, and engage with physicians on an individual level – has not had a conventional path to pharma agency life.
According to Patel, “I’m a bit of a square peg in a round hole.” He grew up doing programming and building data warehouses, with a background of technology for marketing.
“I started years ago at Citibank, doing data warehouses for storing models and algorithms, for marketing to our Visa/MasterCard database,” he says, “I had my own business for awhile where I was literally grabbing data from point of sale systems at Intercontinental Hotels, from individual hotels and then creating marketing reports for the marketing director of the hotel to let them know who their best customers were.
“My background is truly in technology, I’ve been in IT, I’ve run IT functions, I was a CIO globally, for Havas for awhile. So helpdesks, e-mail, LAN/WAN networks, all of that stuff. And applying that technology, starting in ’98, I moved away from IT and moved into digital marketing, and I went to work for a company called Agency.com.”
After leaving Agency.com, he says he “did the whole dotcom boom, had a couple of startups, went back into IT. And then in 2009, I got a call from inVentiv.”
The call came from someone he knew at Chandler Chicco, inVentiv’s PR agency. “She said, ‘Hey we need a person who knows digital.’ And I said, ‘Julie, I know nothing about healthcare, and I know nothing about public relations.’
“And she said, ‘We’ve got 400 people who know about healthcare and PR, we have nobody who knows digital. You’ve got to come over here.’ So I joined Chandler Chicco, and I spent five years there, moving from Chandler Chicco to inVentiv.” Eventually Patel became the global head of digital and innovation for inVentiv Health.
According to Patel, Ogilvy came calling two years ago. “So that’s how I ended up where I am,” he says.
Patel notes that his time in healthcare has taught him to be more inventive, “simply because of the regulatory and medical environment that we live in.
“Most of the work I did was Ralph Lauren.com, Gucci.com, Texaco.com. Here [in healthcare], if something goes wrong, you’re messing around with people’s lives. People could die. But if you do it right, you’re saving many lives. You’re helping people live with their disease. It’s a different world and different way of thinking, which makes you become more inventive and ingenious in your process and how you think. You have to think outside the box a lot more and frame it so your clients can do things that you’re proposing you can do for them.”
What drove him to want to create the OCHWW Marketing Cloud? Patel says it was because he found out how little his pharma clients really knew about their customers, compared with the customer knowledge of previous clients in other industries.
“Right now we have pockets of knowledge of our customer, the doctor,” Patel says. “I am not talking about the patient – the patient is the end customer – but for a manufacturer, the people we work with, the customer is the person who is prescribing their drug.”
Pharma manufacturers currently “are on a kick on” the concept of patient centricity. “However, they don’t have the datacast for knowing their current customer,” the physicians, Patel says.
“Here’s how they know their customers today: they either know them through the sales people in the territories and their account lists that they have, or they know them by the specialty or the facility that they’re in, whether they’re an IDN or not; and they’re completely siloed,” Patel comments. “Let’s say an oncology franchise of a major manufacturer with a number of brands, would all think individually that each brand has its own customer, and they firmly believe that they know that customer well. But if you were to take all those siloed, penned databases together and put them into one, you’d find the overlap is dramatic, because there aren’t that many oncologists in the first place. But the brand manager doesn’t think that way, nor does the franchise.”
The OCHWW Marketing Cloud partnered with Medikly, a provider of physician engagement solutions.
Patel had looked into Medikly’s platform while he was still at inVentiv. “We took the system apart and we found that it would be a really good place to start creating profiles for our clinical trial business, our CRO,” he says. “So we did a partnership with them where the CRO would use their backbone as a way to collect information around our clinical trial participants.”
After coming to OCHWW, he realized Medikly’s platform could be extremely useful to the agency’s pharma marketing clients. In fact, some clients were not using a CRM system at all. “Initially I met one, very large manufacturer whose entire client list was an Excel spreadsheet,” Patel says.
Contrast that with the CRM system Patel created between 2005 and 2009 for the commercial real estate company Cushman and Wakefield. “The goal was that the company would know who their top 100 customers were, all the buildings we managed for them, all the deals we’ve done for them, and all the brokers who were working on those deals,” Patel says. “And at a touch of a button I could get a report that says it took us four years to build it and roll it out to 10,000 brokers.
“And then I come into this mad industry where a major manufacturer is managing their client list on a spreadsheet.”
Patel says the goal of the Marketing Cloud is to create a universal HCP profile for customers. Through the Cloud, “They would know everything about this doctor – who they are, where they worked, what their referrals are, where their prescriptions are, who are the sales people who are calling on them, what their claims list looked like, what their social media presence is, and what are they reacting to from a sales and marketing perspective,” he told Med Ad News. “Are they clicking on banners? Are they opening e-mails? Are they consuming CME content? Do they react to videos better than pamphlets? So that’s where we started around a year and a half ago.”
Though version 1.0 of the Marketing Cloud was launched in April, an updated version will be launching during the first week of September. “We’ve got three clients now who will put on that version, and then I suspect we’ll start eventually rolling it out [to everyone],” Patel says.
“There will be three ways clients will be able to consume this. One will be, give us your spreadsheet, and we’ll give you a database, a proper one, all de-duped, and you will have profiles for each of your customers individually,” he states. “The second way is as part of a campaign that we do because that will make us more intelligent and we’ll have better information about the customer.
“Most companies do [campaigns] based on a survey, they’ll survey 300 doctors and based on that survey, they’ll say, ‘We believe all oncologists behave this way, so this is the campaign we’re going to do.’ But we’ll have all oncologists, and we’ll have actual behavior, not what they tell us they do.”
The Marketing Cloud is not a dashboard, Patel stresses. “Dashboards are front-end tools to the data, but if the data is crap, your dashboards are not that great to begin with,” he says.
Some of the larger pharma companies have built their own databases, “at the cost of millions of dollars and corporate IT manages it for them at the cost of millions of dollars a year,” Patel says.
“What we’ve done is for the bulk of those guys who think they have a database, but what they actually have is siloed lists of customers that may have been created over time, that may not have been de-duped in any way, nor overlaid with any of the information we have around things like the social footprint of the doctor, the kinds of things they are prescribing over and above the drug that they have, as well as any other content data.”
If all the database a client has is just the called-on list of clients and the dashboard is built on that, “that’s OK, but it’s not going to give me the referral patterns of that doctor, or that they’re now in an IDN, so the message patterns I have to give them are different, or worse yet, they are the do not calls, I can’t do anything with them from a sales perspective, and now I have to figure out a different way of educating them about my product,” Patel says.
And yes, Patel realizes that the OCHWW Marketing Cloud will be competing with IMS Health and Veeva Systems. But he maintains the OCHWW Marketing Cloud will hold certain advantages over the other two. “IMS approaches it very much from a claims perspective, their base is claims,” he says. “Veeva places it specifically from a called-on perspective, because Veeva Vault is sitting on top of Salesforce. So the back-end underlying database is really Salesforce, which is one single view of the customer. I’ve deployed nine Salesforce deployments in my life, large and small. What we’re doing is combining the two together, and then adding a third layer to it. I’ve thought it through really well.”
But he realizes IMS Health and Veeva are here to stay. “Pharma doesn’t change very fast,” he says. “Sometimes it takes years.
“I don’t think we will ever get rid of Veeva and IMS, they will always be there because there are constituents within the pharma companies that firmly believe those things are very valuable. What we will do though is help our marketer clients and our brand manager clients with a new way of looking at their customer over and above what they have in the traditional IMS and Veeva world, new ways of segmenting their customer, new ways of thinking about the behavior of their customer as they look at campaigns.”
President and CEO
Behshad Sheldon, the CEO of specialty company Braeburn Pharmaceuticals, may seem like a big pharma insider with long stints at SmithKline Beecham, Bristol-Myers Squibb, and Otsuka Pharmaceuticals under her belt and command of some big brands, including the schizophrenia drug Abilify.
But Sheldon also has valuable “outsider” perspective, stemming from her childhood in Tehran and her immigration to the United States, and her position as one of the few women CEOs in pharma.
“People always laugh when I tell people that English is not my mother tongue,” Sheldon says. Though she was born in the United States, when she was 3 years old and her father, a cardiologist, had completed his residency, the family moved back to Tehran.
“My dad went back because he wanted to do his duty to his country, and so I was there from 3 to 14,” Sheldon says.
When the family returned to the United States so her father could do his fellowship, the Iranian revolution occurred and the Shah was deposed. “So we stayed and the rest is history,” she says.
And at Braeburn, Sheldon has helped make history by leading the team bring to market Probuphine, the first implantable form of buprenorphine for treating opioid addiction.
Sheldon had a neuroscience undergrad degree when she joined SmithKline Beecham. “Even back then, I was a data dweeb and science person,” she says.
Her father, who practices in Rochester, N.Y., was “apparently one of the few welcoming cardiologists in New York to sales reps,” Sheldon told Med Ad News. “And from his perspective, this was a really great job, he said they went around and talked to doctors and educated them. So he said why don’t you look into this? I interviewed and got the job.”
Her first sales territory comprised Syracuse, N.Y., and an area all the way to the Canadian border.
“God’s country, they called it,” she says. “It was a four-hour drive from end to end, I would go up and stay up in Ogdensburg and Canton and all of those places. I would make a call, go for a drive, make a call, go for a drive … And I found out that not everyone was quite as welcoming as my dad, other doctors offices, it was actually really hard work! This was a long time ago, so I am sure it’s even more difficult now.”
But she was encouraged by one of her first district managers, who told her that she had “a nose for where they business is.
“I don’t know if he was right, but the combo of some of those things and my data dweeb-ness led me to continue on and going to the home office,” Sheldon says.
After rising through the ranks, she became the manager for the topical antibiotic Bactroban. “I managed everything to do with this product as a pretty young, relatively new to industry person,” she says. “I had full P&L responsibility for it, I managed trials, there was a recall, complications in manufacturing, so it was a really fantastic and lucky experience. I had two sales forces for it, managed care, the whole bit. I learned marketing from some of the best, SmithKline was a great training ground for key executives in the industry now.”
Then Sheldon was recruited by Bristol-Myers Squibb, she found herself doing the company’s first direct to consumer advertising campaign, for the diabetes drug Glucophage. “Back then it wasn’t television, we did all different kinds of magazines and newspapers and outdoor signage,” Sheldon says. “It had a big impact on the strategy of Glucophage in being used in combination with other things and now it has become the foundation and that was our intent, that Glucophage would become the foundation [of treatment] that other things were added to. That’s exactly how diabetes is approached now.”
And it was at BMS that she began to learn about how patients can be stigmatized for the diseases that they have.
“In diabetes, I thought, ‘OK, this is not fair,’ but there’s a whole angle of, well if you just lost weight, if you just exercised, if you just got a hold of yourself, you would not need any medicine and you’d just be fine,” Sheldon says. “Clearly, that’s simply not the case. Most doctors, and most patients who have diabetes, know that it’s a struggle and it’s a struggle even for people who are not overweight, as they age. Even back then, it was one in 10 over 80 that have diabetes. It just happens, your pancreas peter out and you’re not handling the same amount of sugar the same way. It was also a great education, because I was delved for the first time into direct to consumer advertising, which was the only thing I hadn’t done with Bactroban.”
Sheldon was next put on the blood thinner Plavix. “We were able in that case to do direct to consumer advertising on television but also drive new indications and drive a combination with aspirin indication,” she says. “Plavix became a hugely successful product.”
Sheldon was able to get back to her neuroscience roots when she was transferred to the schizophrenia drug Abilify in 2002.
Working on Abilify was another lesson on how patients with certain diseases are stigmatized.
“Abilify was yet another sort of shock to the system, of how to treat people who have severe mental health disorders in this country,” Sheldon says. “Mental health parity was just starting to be talked about. I don’t know, I guess we’ve made a little progress since then, but for the most part what I noticed back then is still true, people with serious mental health disorders end up in the street, they end up in prison.”
Being able to launch Abilify and see the difference it made in patients’ lives has been rewarding, Sheldon says. “We would get letters from family members and from patients themselves who would say, ‘I have my life back,’ or ‘I have my child back,’” she says. “They went back to school, they got their degree.”
In expanding the indications for Abilify, Sheldon opened Otsuka’s Princeton, N.J., office with Dr. William Carson (now president and CEO of Otsuka Pharmaceutical Development & Commercialization) and Dr. Taro Iwamoto, who eventually became head of Otsuka’s pharmaceutical business in Japan.
“The three of us started the Otsuka Princeton office, in the first three weeks we actually hung out in my backyard because we didn’t have an office,” she says, “And then we had an office that had no fax machine [or receptionists], we would answer the phones and say, ‘Yes, please hold for Behshad Sheldon! Hi, this is Behshad!’”
The three worked closely with BMS to grow the internal team, “but we were there to look out for Abilify. That was our main mandate at that moment when we first started, and pretty much drove every decision that was ever made commercially or clinically about Abilify’s expansion into other indications, bipolar, major depressive disorder, autism,” Sheldon says.
And Sheldon realizes that spending 10 years on a brand is somewhat unusual for most pharma marketers. “There’s sort of a revolving door,” she says. “People come and they are on a brand for a couple of years and they go, and they’re on another brand for a year and they go. Abilify was quite different for me in that before it was launched in 2002 until I left Otsuka in 2012, there was not ever a decision that was made about Abilify that I wasn’t involved with.
“It was a different model and a different situation because at Otsuka I was running commercial that involved more than Abilify, obviously, all the alliance products and all the internal products and all the early products.”
She credits her time at Otsuka for giving her the breadth of experience she possesses now, experience that allowed her to step up to Braeburn. “At Otsuka I got to spread my wings beyond commercial,” Sheldon says. “The Japanese have a different point of view and especially Otsuka had a very different perspective, which was there are no boxes, there are no cages; you bring it and you can do whatever you can do. Ultimately I ended up on the board of the development organization, and I was involved in lots of clinical and regulatory strategies, operationalizing, discussions, in multiple therapeutic areas, which was really great training for Braeburn.”
While at Otsuka, she had seen Probuphine being shopped around by Titan Pharmaceuticals, the company that invented the ProNeura delivery system for the drug. After leaving Otsuka, she was directly recruited as CEO of Braeburn by Rosemary A. Crane, whom she had known at Bristol-Myers Squibb and is on the board of Appletree Partners, the investment firm backing Braeburn.
“She said, “Oh, we’re looking at this asset, and if we are successful in getting the deal, we would like you to come and launch it.” I asked what is it, and she told me, and I was like, “I saw this at Otsuka and I really liked it!” It was really the promise that I saw in Probuphine as a medicine that could improve people’s lives in their therapeutic area. I didn’t know quite how much it needed innovation at that moment, but I could say from all the experience over the years that I had that this was going to be an innovative and game-changing product.”
And in moving on to Braeburn, Sheldon came to understand how much worse people with opioid addictions are stigmatized, and how difficult it is for them to get and stay clean.
“The most dangerous place to be as an addict is being clean and not being on medicine, because this is a relapsing-remitting disease, and you never know when a mistake might happen,” Sheldon says. “And it’s such an unforgiving disease, that one mistake will kill you.
In the surveys of patients done by Braeburn, Sheldon found a pattern of patients going into rehab and getting clean, relapsing, and having to be revived by Narcan when they overdosed. “I’m hearing about this revolving door, where people are getting Narcan every week!” Sheldon says, “Once a week they overdose, they go to the ER, they get revived with Narcan, and out they get sent again, with their unprotected neuroreceptors, having lost their tolerance, they’re completely wiped clean, and they use the same amount that they could barely get high on and it would kill them! Or they would go back to the hospital again to be revived.”
Probuphine is the first implantable form of buprenorphine, which was previously available only as a pill or as a film placed under the tongue or inside the cheek. Probuphine provides a new treatment option for people in recovery compared to other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication on a daily basis.
The road to the drug’s marketing approval in May was not smooth. After the first FDA advisory committee meeting, the company received a complete response letter.
“And so I had to switch and become clinical and regulatory,” Sheldon says. “I was personally involved with negotiating with the FDA on the design of the new study, the double-blind, double-dummy, path forward and getting it done. For most of the time conducting that study, there were four of us here working on the study. And then we had an office manager and a finance manager. So there were six people in the company for most of the time after the CRL, that led to the completion of the study and then as we got new data that showed positive results, we started to get more people on board and prepare to change what truly was not a very hopeful state of affairs in opioid use and opioid addiction.”
After Probuphine was approved, Braeburn has been “going at a fast and furious pace,” Sheldon says, with the drug being shipped within three weeks of approval.
“And we’ve been working with reimbursement with payers, so far we’ve had really great reception,” Sheldon notes. “There are medical benefits so we have to write coverage policies and that doesn’t happen overnight. But we haven’t had any denial yet, and from pretty big national payers, we’ve talked with over 20 now, have said that they are going to cover it. And even some small regional ones who usually tend to be more persnickety have said they are going to cover it.”
Sheldon has relished the experience she has had at Braeburn, and to her it wasn’t a “shock to the system” to go into small pharma. “The Otsuka Princeton office experience actually prepared me and drove a lot of what I believe in and bring to work every day,” she says. “We had just three of us in the Otsuka Princeton office and I think there’s something like 600 now. Before I left it was one of those where I’d get on the elevator with a bunch of people and think I don’t know any of these people, they must be going to a different floor, but they would all get off on the same floor as me. So it had become big pharma but it had started out very, very small.”
According to Sheldon, innovation in pharma derives from diversity of thinking. “If you do that same thing that everybody else has done in the same way that it’s been done,” she says. “We have written in really big letters which is question everything. There will be no innovation or people will start to confuse small incremental changes for innovation. And for us, innovation has to be for the game changing. If you’re not going to fundamentally change how something is done, how people are being treated and how care is being delivered, it’s not innovation.”
And she believes the success she had at Otsuka partly derived from her own diverse background. “I was perceived as different than typical Americans at Otsuka, because I had a different, Asian mentality about certain things and understood that there’s a different perspective,” she says. “And it definitely has helped me in my career, relating to when I’ve done alliances with people from other countries. It does help when you’ve had experience being exposed to different points of view.
And she wants Braeburn to keep being an innovator in long-acting drugs in critical therapeutic areas. “Our goals are to bring as many long-acting implantables and injectables to neuroscience-based disease spaces,” Sheldon says. “In neuroscience, in schizophrenia, in opioid addiction, in pain, the consequences of taking your medicine wrong or not taking it at the right time or forgetting or blowing it off are just too significant. And guaranteed compliance is not just a nice to have in neuroscience, it’s essential.”
Besides Probuphine, Braeburn is developing a weekly and a monthly long-acting injection of buprenorphine. “We’re going to explore the same products for pain, because buprenorphine is a great molecule to treat pain,” Sheldon says.
Also in clinical trials are a six-month risperidone implant for schizophrenia and a new antipsychotic medicine that is being developed into a long-acting implant or injection. “We’re going to keep going, we have a few more things up our sleeve,” Sheldon says. “I envision in five to 10 years, we have a number of clinically and commercially successful products that are based on these principles of implantables and injectables to guarantee adherence in diseases where it makes a huge difference.”
Sheldon is aware that she belongs to a very small club of female pharma CEOs. She has straightforward advice to other women in the industry aiming at the C-suite. “I would just say be fearless and do your job and don’t be drawn into playing anybody’s game, male or female,” she says. “If you have a set of principles and you go by them and you are good at what you do, it is absolutely possible to get there.
“And I’m still amazed myself, I go to JP Morgan and I see a sea of men in black suits. It isn’t just that they’re men, it’s that they all kind of look alike!”
Sheldon believes that Braeburn is the antithesis of what is typically perceived about pharma. “This goes back to why we think diversity is at the core of innovation,” she says. “The only way you can become unconventional is by testing new ideas and going against what might even seem like common sense to do something that’s going to make a difference.”
Braeburn has a significant social justice component to its mission as well. “We helped start an organization that is female leaders in addiction medicine, it’s called FORCE, Female Opioid-addiction Research and Clinical Experts,” she told Med Ad News. “Some of my guys complained they couldn’t be in it. And my reaction was, ‘Look around! There are plenty of places for guys to be!’”
Sheldon says it was Otsuka that provided the example of gender diversity in pharma, with Dr. Iwamoto and former Chairman Akihiko Otsuka being “quite visionary” when it came to recognizing and promoting talented women.
“People ask me, ‘What’s the big deal? Why women? Why African Americans? Why people of different backgrounds?’ Sheldon says. “It’s all about the fact that different experiences mold us into who we are. If your only experience has been without too many difficulties, because you’re an American born and bred and you’ve always worked here, a white male without any major difficulties in your life, you’re going to have a certain point of view that maybe isn’t going to lend itself to doing things a different way, because you’ve done OK doing things your own way.”