Speaker Spotlight: Anthony Costello, COO Mytrus

Anthony Costello

Mytrus is testing the boundaries of traditional clinical trial research, with the first all-electronic, home-based clinical trial to gain U.S. Food and Drug Administration approval. As co-founder and chief operating officer of San Francisco-based Mytrus, Costello is leading the charge. Costello is a leader in the areas of technology innovation and clinical operations. After beginning his research career at Genentech, Costello went on to co-found several technology start-up companies including Nextrials, a clinical research firm where he worked for 10 years as the vice president of product development. He is a frequent presenter on topics related to the efficient use of technology and clinical research.

Q: What brought you into the clinical research industry?

A: I got into the clinical research industry in the ’90s when I started working at Genentech. At the time, I was in data management and spent pretty much my whole career at Genentech in data management. I ended up overseeing the data management group for their oncology center and working mostly on the Herceptin trials and the early trials for what is now Avastin.

Back in those days, everybody was doing clinical research on paper. We did all of the international Phase 3 trials for Herceptin on three-part no-carbon-required paper, mailing it around the world and then data entering everything. Although I loved Genentech and it has certainly launched my career, I wanted to develop a technology that was faster and more effective. I left Genentech in 1999 to co-found a company that makes electronic data capture systems for clinical trials, called Nextrials.

Q: What happened next?

A: I left Nextrials in 2008, after almost 10 years there, and I met Dr. Steve Cummings (Mytrus CEO and chairman) and got excited by his idea of building more of a consumer-focused clinical trial that would allow patients to participate from home. I joined an advisory board that Steve was putting together to sort of vet out this idea, and we ended up deciding to form Mytrus around that. I joined as a co-founder and as the vice president of product development and commercialization and I now serve as chief operating officer.

Q: Mytrus is hoping to validate a new kind of study model. If this kind of remote results monitoring works, what might the future look like for pharmaceutical companies and their trials?

A: We hope that it’s going to make a big difference. Our hypothesis that is staring to play out is that there are some kinds of trials – we estimate about 15 percent to 20 percent – conducted in the United States annually that can be done using this method. They do not require specialized equipment at a site. They do not require specialized training, and, if a patient is willing and able to correspond via the web and provide their own updates about what is happening to them during the study, then those trials are suitable to use this method. It really changes once you free your mind, as Steve likes to say, from the idea that you have to have a bricks-and-mortar site for trials.

You do not have to have as much monitoring because the patients are the direct source for data and you do not have data being transcribed from the patient to a chart and then from a chart to an electronic data capture system and then from an EDC system to an alpha system. All those data transcription events are the reason monitoring was effective — to make sure nothing got missed or skipped or inadvertently entered. So, you could get rid of a lot of that. You don’t have to go through the contracting and start-up and hierarchy approval with hundreds of clinics around the country.

Q: What are the technology requirements for participation?

A: If you do not have an Internet connection, you cannot do it. In fact, depending on the trial, there are some studies where it is really going to be critical to have an Internet connection in the home. There are other studies where it would be perfectly suitable to have a smart phone or an iPad or even a shared Internet connection in some sort of public place if the patient is comfortable using that and it is private enough that someone can enter their own data. Patients are much more apt these days to use the Internet for their own medical research and they are much more comfortable communicating with doctors over email or over the Internet.

Q: What are you looking forward to hearing about at the CHI mobile health event “Take this Pill and Tweet Me in the Morning?”

A: There is just a lot more focus on health 2.0 technologies these days and so we’re excited about being involved. It seems like the lineup of speakers are people on that leading edge of moving trials or studies or health in a new direction so it is a perfect kind of conference for us.


Hear more from Anthony Costello at “Take This Pill and Tweet Me in the Morning,” happening Aug. 4 at the Salk Institute in San Diego.



CHI-Advancing California biomedical research and innovation

Executive Spotlight: David Shuey, The Willis Group

David Shuey

David Shuey, executive vice president and North America practice leader for The Willis Group’s life sciences practice, thinks “startups now realize they can’t be one-trick ponies – they have to have multiple product candidates in the pipeline.” With 19 years of hands-on experience serving the life sciences industry, he should know. His clients range from early-stage R&D companies to large pharmaceutical firms. Shuey has expertise in therapeutics, medical device, generics, nutraceuticals, consumer products, contract research organizations, laboratories and contract manufacturing. His focus is on casualty lines, particularly product liability and international human clinical trials. Read below to find out how Willis Group’s unique technology platform has helped companies of all sizes remain competitive in the global economy.


Q: Within Willis, how big is the life sciences practice?
A: We are a $3.5 billion revenue public company. Within Willis, life sciences is a large practice and a focus. I think management sees it is a growing area. We’re going to need new medical devices and therapeutics no matter what happens.


Q: Tell me a little about your focus at The Willis Group.
A: I have been with Willis for 22 years with 19 of those focused in life sciences. I started off in medical practice liability for doctor groups and integrated health systems. At the time, I was working in the Baltimore area, around D.C. and the northern Virginia area, and a lot of VC money was coming into the area. They were hiring scientists out of the NIH with a molecule and an idea for a company. So, I started working with a lot of those nascent companies as they were getting started and developed the expertise in life sciences and spent the rest of my career with life sciences companies.


Q: What do you notice are the major differences between biomedical startups today and back then?
A: From a risk perspective, things have definitely changed. I think it was easier to raise money back then. The concept of failing early with molecules and accelerating the discovery process using rational drug design techniques wasn’t available back then and is now – so that would be a change. Back then, the focus was on gene therapy, and, while still popular, I think regenerative medicine has taken over. A lot of med device companies that were developing things for labs are now moving into the clinical setting with personalized medicine a purpose.


Q: Can you give me an example of how The Willis Group came to the aid of a biomedical company or academic research institution in recent times?
A: One of my favorite stories involves a large client that was making an acquisition and it was an orthopedic implant, a Class 3 medical device. During due diligence, our client learned that the company they were acquiring had received an FDA non-approvable letter because their sales and medical reps were recommending an alteration to the implantable orthopedic device during surgery. Our client thought that might be a problem, so asked for a large contingency hold-back in the buy-and-sell agreement. So, we stepped in and wrote a three-year risk or loss mitigation program with a per person coverage limit and a three-year policy aggregate for them. The program had a provision that, if no claims came after three years, our client could commute the policy and get their money back. The insurance company would keep the risk charge and the unused premium at the end of the policy would be returned to the client. The fact that we could transfer that risk from the balance sheet to a risk policy allowed the deal to go through.


Q: With clinical trials management moving overseas for many in the industry, what implications does this have for business moving forward?
A: Even the smallest R&D therapeutics company will take their trials oversees, so small companies become international companies very quickly. That’s a change we’ve identified. We are particularly adept at managing global foreign trials clinical programs. We have something called CTTrack which is a dashboard that allows clients to see where they are in relation to a deadline to meet with insurance and certificate requirements around the world. We maintain a matrix of all the requirements around the world. It is kept real-time on our clients’ desktop so that when they conduct a trial in Israel they can flip on the matrix and go to Israel and find out what the requirements are and what kind of lead time they need to conduct the clinical trials.


Q: What other new offerings does Willis Group provide its clients?
A: We’ve put together a unique program called Diagnostics 2.0. We come in and conduct a mini enterprise risk-management analysis. We conduct an in-depth interview that is designed to uncover the organizational risk. At the end of the process, we’ve done a diagnostic of the risk, so now we can deliver a customized risk/review report. Then, we can go in and look at the insurance programs structure, the pricing, the coverage and match it up with the risk diagnostic. It really peals the onion on risk exposure and it is unique to Willis.


CHI-Advancing California biomedical research and innovation

The Evolving Business Model for Biomarkers

Biomarkers will be one of the major drivers of biotech research, drug and diagnostics development in 21^st century medicine. Dr. Jogarao Gobburu (Division of Pharmacometrics, FDA), Stephen Little (Qiagen), Mark Erwin (Prometheus Laboratories), Dr. Bryan Dechairo, (Medco Research Institute) and Dr. Christoph Huls (Merck Serono), explored the evolving business model for biomarkers and personalized medicine during a panel discussion at the 2011 BIO International Convention in Washington D.C. Mark Erwin summarized the common theme throughout the discussion: “Personalized medicine holds the promise for not only greatly improving healthcare for patients all over the world, but to generate cost savings and increase efficiencies in the healthcare system. All of us as healthcare stakeholders need to do what we can to incentivize this innovation.” Watch the video.

CHI-Advancing California biomedical research and innovation

How Biotech Companies are Shaping the Future in Rare Diseases

Biotech companies are navigating new trends in addressing rare diseases, conditions effecting 200,000 or fewer Americans. Jeremy Springhorn (Alexion Pharmaceuticals), Andrew Curtis (Pfizer), Marc Beer, (Aegerion Pharmaceuticals) and Susan Kahn (National Tay-Sachs & Allied Disease Association), shared their perspectives on the future of new treatments for rare diseases during a panel discussion at the International BIO Convention in Washington D.C. Alexion Pharmaceuticals invented Soliris, the first and only therapy for treating Paroxysmal Nocturnal Hemoglobinuria (PNH), a rare, progressive and life-threatening disease defined by hemolysis, the destruction of red blood cells. Pfizer created a new research unit in 2010 with the goal of leveraging existing scientific experience in rare diseases, such as hemophilia, to discover novel, life-saving medicines for patients with large unmet medical need. Aegerion Pharmaceuticals is developing a new drug to treat Homozygous Familial Hypercholeterolemia (HoFH), a rare genetic lipid disorder resulting in an accumulation of low density lipoprotein (LDL-C) often referred to as bad cholesterol in the blood. The National Tay-Sachs & Allied Disease Association is directly funding research to treat and cure Tay-Sachs, Canavan and related genetic disease and supporting affected families and individuals. Tay-Sachs disease is a rare progressive neurological genetic disorder that is caused by the absence or insufficient level of a vital enzyme called Hexosaminidase (Hex-A). All children with classic Tay-Sachs disease die early in childhood, usually by the age of 5, and today there is no cure or effective treatment. Jeremy Springhorn summed up the sentiments of the panelists: “To commit to putting the resources it takes to developing treatments for rare diseases, our focus is and will always remain on the patient.”

MedTech Innovators Highlight Need for U.S.-Korea Free Trade Agreement

CHI was joined by the U.S.-Korea Business Council, the Silicon Valley U.S. Export Assistance Center, Sunnyvale Mayor Melinda Hamilton and other key stakeholders at a medical technology industry roundtable held June 24 with Jong hyun Choi, Minister of Economic Affairs, Embassy of South Korea at Accuray in Sunnyvale, Calif. The meeting focused on the support of the California medical technology community for the U.S.-Korea Free Trade Agreement (FTA), the first FTA to include an entire chapter with commitments to openness and transparency in medical technology regulation and payment policies. CHI members Mark Deem, partner of the medical technology incubator, The Foundry, and Tom Loarie, executive chairman of Mercator MedSystems, shared their experiences bringing medical technology innovations to market and highlighted the need for open markets and fair regulatory and payment schemes worldwide to support development of technologies that can improve the lives of patients. Fred Kinder, a former CyberKnife patient, spoke of the need for access to medical technologies for all patients. Korea is one of the world’s largest and fastest growing markets for medical technology, with expected growth of 10-15 percent per year over the next several years. Following the meeting Accuray CEO Euan Thomson, Ph.D., gave a demonstration of the CyberKnife System to highlight how the technology is used to treat tumors in patients with cancer. Watch NBC News coverage of the event.

BIO Kicks Off With Run for Partnership for a Healthier America

Attendees at the Annual International BIO Convention kicked off the meeting Monday morning with a healthy 5K run hosted by the Diabetes Advocacy Alliance at Bluemark Park just outside the nation’s Capitol. I was joined by CHI member Sarah Nordstrom from Novo Nordisk and other biotech runners who came out to support the Partnership for a Healthier America, a partner to First Lady Michelle Obama’s Let’s Move initiative to combat childhood obesity. I was still on California time (4:00 a.m.!), so it was early to get up and run, but well worth the effort to raise awareness for a great cause! Watch the video.

Community Spotlight: CHI Participates in Rolling Readers Program

This month marked the end of an exciting journey I began this year into the world of volunteer reading and 1st grade learning.

As a volunteer for the Rolling Readers program, I began each Wednesday morning at Ocean Beach Elementary School, a community-oriented school that values education and learning through traditional and creative means. CHI allowed me the opportunity to bring my love of reading to the school each week, where I spent time on the colored floor mat of Ms. Tanner’s classroom – a lively bunch of students eager to read and quick with questions.

Rolling Readers connects volunteers to underprivileged classrooms, where we delve into classic tales (Curious George and Shel Silverstein books) and modern fantasies (John Lithgow’s I’m a Manatee).

The organization’s mission is a simple one: to inspire children to love reading. Children who love reading are more likely to become lifelong learners, so the saying goes.

I found inspiration through these staggering Rolling Readers statistics:

• In low income neighborhoods, the ratio of books to children is 1:300—which means that, on average, there is one book for every 300 children.

• By age four, children who live in poor families will have heard 32 million fewer words than children living in professional families.

Since every child deserves a book of their own, I was especially excited to participate in the annual Rolling Readers book drive. Each student in the classroom received a special edition of the popular Dr. Seuss book The Cat in the Hat (appropriately written in La Jolla).

The students erupted with joy when they saw the book. It is satisfying to know that they will be taking the book home to share, which may encourage reading among their friends and family.

Theodor Seuss Geisel, himself an advocate for elementary literacy, once said: "The more that you read, the more things you will know. The more that you learn, the more places you'll go.”


CHI-Advancing California biomedical research and innovation

Rep. Kevin McCarthy, Biomedical Industry Leaders Focus on FDA, NIH, at CHI Roundtable

The House Majority Whip, California Congressman Kevin McCarthy met with California biomedical innovators at a CHI-California Healthcare Institute roundtable at Gilead Sciences in Foster City, Calif. on June 7. In addition to Gilead, among the prestigious research institutions and companies represented were The J. David Gladstone Institutes, Amgen, Thallo Bioscience, Proteus Biomedical, and Abbott Vascular. CHI President & CEO David Gollaher introduced Congressman McCarthy, who was honored with CHI’s Leadership Award earlier in the year, and thanked him for his support for California biomedical research, investment and innovation. Rep. McCarthy was eager to hear about the latest research, treatments and new medical technologies from participants. They shared news of breakthrough research demonstrating that the use of HIV medication reduced the risk of HIV infection in uninfected people, a discovery that topped Time Magazine’s list of medical breakthroughs of 2010, the development of embedded computers and sensors inside proven drugs and devices to monitor real-time patient compliance and response, and less invasive heart valve replacement surgeries.

Rep. McCarthy was interested in the group’s perspective on what policies are stifling innovation and U.S. competitiveness. The U.S. Food and Drug Administration (FDA) is not keeping pace with U.S. biomedical innovation. The Agency-industry partnership is strained by unexplained regulatory delays, by a lack of clear standards for what clinical data are necessary for product approval, and by a bureaucracy whose communications are neither consistent nor predictable. In this regulatory environment, companies are launching products first abroad forcing jobs and investment offshore. NIH funding must also be preserved to ensure a healthy pipeline of new research for product development. Rep. McCarthy is optimistic on American ingenuity and innovation and wants to make better government to advance it: “We have the framework to turn it around, but do we have the willpower?”

CHI-Advancing California biomedical research and innovation