Flying Sky High — Rajesh C. Shrotriya

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Kim Ribbink

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With enormous enthusiasm and a joie de vive, Dr. Rajesh Shrotriya, chairman and CEO of Spectrum Pharmaceuticals, is instilling his employees with the same gusto for development of new drugs. Propelled by a joy of work and a commitment to remaining focused on a task until it is accomplished, Rajesh C. Shrotriya, M.D., has a catalogue of successes to his name, including helping to develop therapies and invigorate companies. It’s this energy that Dr. Shrotriya believes inspires and gives confidence to his staff and board at Spectrum Pharmaceuticals Inc., the company he leads. “I believe people follow the leader not by the words he or she speaks but by his or her actions,” he says. “Employees, the board, and our investors know I’m available 24/7, and if people see the leader working passionately, they respond accordingly.” This dedication and commitment to getting the job done made him a good doctor, Dr. Shrotriya believes, because he was able to put the needs of his patients first, which ultimately led to his leadership position today. Dr. Shrotriya attributes his single-minded attitude to work to lessons he learned as a child. “My mother taught me not to procrastinate; if something has to be done tomorrow do it today, and if it needs to be done today, do it now,” he says. “I carry this with me still.” Never afraid of hard work or a challenge, Dr. Shrotriya has spent his career searching for ways to get the most out of any situation. And he has made a name for himself in the industry for his ability to turn failures into successes. At MGI Pharma, he came up with a business plan to improve sales of Salagen tablets, an approved treatment for chronic dry mouth symptoms associated with head and neck cancer patients treated with radiation. Within a month of working in the field, he understood where the obstacles were and developed a plan to overcome the barriers, despite working outside of his area of expertise. SuperGen, the company he joined immediately after MGI Pharma, is in a strong financial position, thanks in large part to the acquisition of Dacogen in 1997/1998, a purchase that Dr. Shrotriya organized. Dacogen is a treatment for patients with myelodysplastic syndromes, which occur when there is a defect in the blood-forming stem cells, resulting in too few and poorly functioning blood cells. “I acquired the drug for a small number of shares in the company, and today I’m pleased to say it is approved and marketed and SuperGen has profited by tens of millions of dollars thanks to that product,” he says. In 2004, MGI Pharma and SuperGen signed an agreement for Dacogen, granting MGI exclusive worldwide rights for the development, manufacture, commercialization, and distribution in exchange for an investment in SuperGen and milestone payments. Dr. Shrotriya’s achievements at Spectrum have been even more spectacular, turning the company, once called NeoTherapeutics, around. While awaiting the success of proprietary drugs in the portfolio to get near-term revenue, he built a generic portfolio by making strategic alliances and partnerships with a diverse group of pharmaceutical companies. Today, Spectrum is a $140 million market cap company with a diversified portfolio of oncology drug candidates in both early- and late-stage development. “In 2005, we were ranked as one of the best companies to work for in Orange County by Orange County Metro,” Dr. Shrotriya says. “We have a dedicated team of people who are all committed to the mission of developing drugs for patients who currently aren’t being helped.” Reasons and Seasons Family influence and an interest in the details of science and biology made the choice of medicine an easy one for the young Rajesh Shrotriya. Aside from having an older brother and uncle who were doctors, Dr. Shrotriya says his parents wanted him to go into medicine. “In India, the art of suggestion plays a big role so I’m sure my family had a lot to do with my pursuit of medicine,” he says. Moving to a new country might be considered a big adjustment, but Dr. Shrotriya maintains the move from India to America, from a medical career point of view, was fairly seamless. “There are more similarities than dissimilarities because as a physician you treat patients the same; in every language you say the same thing,” he says. “So for me it was fairly easy, and I quickly passed all the exams to practice medicine in the United States.” The differences, he says, lie more in issues surrounding the practice of medicine, such as patients see a nurse before being examined by the doctor in the United States as well as a propensity to conduct numerous tests, which Dr. Shrotriya maintains detracts from the more personal relationship between the patient and doctor that prevails in India. And he bemoans the litigious nature of medical practice in the United States, which forces doctors to spend copious hours documenting everything. But the vast majority of Dr. Shrotriya’s career has been spent in industry, and it is in this pursuit that he found he was able to put his medical skills to best use. “As a physician I felt I could only help one patient at a time, but if I was developing medicines it would be possible that, by discovering a new drug or bringing one drug to the market, I could help millions of patients; that’s what drives me and has become my mantra for success,” he says. That hope became reality a number of times, with Dr. Shrotriya playing a part in bringing a number of drugs to the market during his 18 years at Bristol-Myers Squibb. The years he spent at Bristol-Myers Squibb were significant for Dr. Shrotriya, and he looked forward to each day’s challenges. He was always pursuing a variety of responsibilities, including 10 years spent overseeing international clinical research, which took him to Japan and Europe several times a year. Above all, he held the highest regard for the people he worked with. “I was very fortunate to work with a group of people who were not only good mentors but above all they were good friends; they were also kind-hearted, generous, good leaders,” he says. In fact, he so enjoyed his job at Bristol-Myers Squibb that he says he would never have left had it not been for a headhunter who pestered him to go for an interview with a young Minneapolis company, MGI Pharma. “I agreed to meet the CEO and employees,” he says. “The whole day, I was convinced I was not going to work at MGI Pharma. But on my flight back to New York I reviewed how the day was spent and what the company was doing. I thought they’re wonderful people with so many things on their plate, and I decided they needed my help and that I could make a difference.” Dr. Shrotriya describes his decision to take the job at MGI Pharma as one of the most transforming events in his career. “Had I not gone to MGI Pharma at that time, today I would not be CEO and chairman of a company,” he says. “Not only was I the medical director of the company, I was involved in almost every decision — business development, marketing and sales, being on the road, raising money for the company, writing a five-year business plan — I was energized.” The job, however, had one serious drawback. As a Minnesota-based company, Dr. Shrotriya endured two bitter winters and when an opportunity at San Francisco-based SuperGen emerged, he jumped at it. In 2000, as a favor to an investment banker, Dr. Shrotriya agreed to conduct due diligence on a company called NeoTherapeutics. His call to the company was answered by the CEO, who knew of Dr. Shrotriya because SuperGen’s leader was a board member of NeoTherapeutics. “During the call he said he was looking for a president and was wondering if I would be interested,” Dr. Shrotriya recalls. “I flew to Orange County, met with the board members, and by the end of the day I’d accepted the post of president and chief operating officer.” Business Savvy In April 2002, when Dr. Shrotriya had been at NeoTherapeutics for less than two years, the ground collapsed beneath the company. NeoTherapeutics had one drug in Phase III development, Neotrofin, to treat Alzheimer’s disease. But just when the company was hoping its years of hard work would pay off, the outcome of a study showed there was no difference between the drug and placebo. “When that happened the company lost its entire market cap; the stock, which was once as high as high $20 a share fell to a low of 8 cents a share,” Dr. Shrotriya says. In August 2002, the company’s board approached Dr. Shrotriya, then president, and asked him to take over as CEO and chairman of the company; he agreed on one condition. “I told them since our technology had failed I would like to build a company based on the acquisition of drugs rather than the discovery of drugs,” Dr. Shrotriya says. The board agreed and on his first day in the job, Aug. 16, 2002, Dr. Shrotriya laid off all but about 10 staff members. In addition, he stopped taking his salary and deferred his compensation. Next, Dr. Shrotriya flew to Washington, D.C., to plead with the Nasdaq officials who had issued NeoTherapeutics a delisting notice and were threatening to delist the company from trading on the stock market unless it met certain conditions. “I told the officials I was the new CEO, I had stopped the bleeding, and I had a plan to raise money,” he says. “I pleaded with them to give me 90 days probation to turn the company around, which they did.” This was a turning point for the company, and the start of its journey back to profitability. Dr. Shrotriya had begun acquiring drugs from contacts he had in the industry, including Bristol-Myers Squibb and two companies in Europe, from which it got three anticancer agents. In addition, Dr. Shrotriya had negotiated a partnership deal with a German company to codevelop the anticancer drug satraplatin. He also was able to raise funds through friends and industry contacts. The NeoTherapeutics name was clearly no longer a good fit, and Dr. Shrotriya began the search for ideas. Originally, he had wanted to call the new company Phoenix Pharmaceuticals but since the name already existed, other ideas were sought. In the end, it was an employee who came up with the name Spectrum, to describe the broad spectrum of drugs the company was acquiring and developing. “Fast forward four years, and we’re a reasonably successful company with $140 million in market cap, with more than $50 million in cash as of the end of the third quarter 2006, with 10 drugs in development, and two drugs could be on the market in 2007, and we have two drugs going into Phase III trials next year,” he says. But being cash conscious and hands on didn’t start with moving to the smaller company; Dr. Shrotriya says even at Bristol-Myers Squibb he preferred to roll up his sleeves and get involved in projects, rather than giving orders. “Some people think that in a big company money grows on trees and if you have a $3 billion R&D budget you can spend what you like; I never believed that, I would question every expense,” he says. Not content to rest on his laurels, Dr. Shrotriya has ambitious goals for the company. As a physician, one of his primary objectives is to develop a pipeline of products that will meet critical health challenges for which there are currently few other treatment options. From a business perspective, his goal is to build Spectrum into a $1 billion company within five years, a target he believes is very achievable. “I want a company that is successful and profitable for our shareholders, who trusted this management and gave us the money we needed,” he says. To achieve these goals requires an ability to step back and take in the broader view, and Dr. Shrotriya finds a powerful analogy between his work and his favorite pastime, flying. “When I fly, I get a much wider view of the world than I do when I am walking; it’s about getting perspective and seeing the larger picture about what we are here for, what we are trying to achieve,” he says. “When I’m in the air I think about things, such as who would take over from me in the role of CEO and what should be his or her virtues, qualities, or merits. Is there someone in the company I can train? Should I be looking outside? I don’t want a clone of myself; I want someone with new ideas. Flying alone (or with his dog Max, a Shichon) helps me concentrate on these, and other issues, that are constantly on my mind.” The mark of A Leader Perhaps one of the characteristics that has assisted Dr. Shrotriya with success is a frankness, be that about the way a business is operating or even his own capabilities. Of his own skills as a CEO, he gamely admits to a financial ineptitude and says one responsibility that troubles him is the fact that the Sarbanes-Oxley rules put the onus on the CEO to state the company’s revenue and profits correctly and follow a particular format. “My background is not in that area, so I hired a head of finance with a 21-year track record as an auditor with Deloitte and Touche, who has a nose for sniffing out problems, and a lawyer from Latham & Watkins, a large law firm, who is an expert on SEC issues,” Dr. Shrotriya says, adding light-heartedly. “I make sure they work together and before they put any paper in front of me related to finances of the company I make sure they’ve signed it. I tell them if I go to jail, you’re coming with me.” But the opportunity to work in small pharma companies has taught the leader a lot about his own strengths — that not only is science a forte, but so too is sales and marketing. And one of the great pleasures Dr. Shrotriya gets out of working in the industry and in overseeing a broad range of people is the variety it affords. While working at Bristol-Myers Squibb, he thoroughly enjoyed the opportunity to travel to Europe and Asia and to learn new cultures and experience the different approaches to research. “Change is the spice of life,” he says. “Today at Spectrum I enjoy that I get to work with different people with different backgrounds — science, accounting, investment, marketing, sales, and regulatory. I’ve built a team of people I enjoy working with and from whom I learn something new every day.” No matter how capable a leader is, no company can thrive without a strong team of motivated, happy employees. Dr. Shrotriya strives to ensure his staff feels energized and to know that what they do makes a difference. “For the past three years we’ve held a leadership retreat that involves every person in the company,” he says. “We go to an off-site venue for two to three days, and we work with an external facilitator to encourage staff members to speak their minds. This is a great team-building exercise, and it’s a great way to generate buy in, because I ask every person to give me one idea to make the company a better place to work. And if there are 50 employees in the room, I get 50 ideas.” Moreover, it is vital that the staff feels valued. Each month at a staff meeting Dr. Shrotriya urges members to discuss their concerns and vent their frustrations. He begins the meeting by delivering his report card and asking his staff to judge him. He encourages them to challenge him if they don’t agree with an approach and to present alternative ideas, which he says he gladly considers. And each month during those staff meetings at least one employee is presented with a president’s award, based on the recommendations of their colleagues. “I have my executive committee help me pick the best performer for the month and the winners receive a crystal plaque with their name and a certificate and some financial award,” he says. “Those people qualify to become an employee of the year, where they will be given a large prize to recognize their contribution to the company. To me, it’s important to build incentives in addition to salary and stock options.” To keep the staff further motivated, Dr. Shrotriya regards his role as being one of cheerleader for the company. “My job is to make it easy for my staff to succeed; I give them the infrastructure, I give them opportunities, and then I support them,” he says. PharmaVOICE welcomes comments about this article. E-mail us at feedback@pharmavoice.com. Regardless of what he is doing — be it flying, running a company, doing research, or practicing medicine — Rajesh C. Shrotriya, M.D., has enormous enthusiasm and a joie de vive. And he’s instilling that gusto in his employees at Spectrum Pharmaceuticals. February 2007 PharmaVOICE By Kim Ribbink Focused Enthusiasm — Rajesh C. Shrotriya Covering the Spectrum of Possibilities Since its foundation in 2002, out of what was once NeoTherapeutics, Spectrum Pharmaceuticals has been focused on acquiring and advancing a diversified portfolio of oncology drugs. The company’s pipeline includes drug candidates in early- and late-stage research that seek to address the needs of seriously ill patients, such as at-home chemotherapy and new treatment regimens for refractory disease. For the company’s chairman, CEO, and president, Rajesh C. Shrotriya, M.D., the opportunity to bring to the market drugs that have been ignored or passed over is particularly thrilling. Among the candidates that most excite him are Spectrum’s lead drug, Satraplatin, a Phase III oral, anticancer drug for second-line chemotherapy for hormone-refractory prostate cancer, Ozarelix, for the treatment of prostate cancer and benign prostatic hypertrophy (BPH), and Eoquin for bladder cancer. “Satraplatin was being developed by Bristol-Myers Squibb and Johnson Matthey for many years, and after a 650 patient trial, Bristol-Myers Squibb abandoned it,” Dr. Shrotriya says. “I was very disappointed so we went and got the rights to it.” Satraplatin is a third-generation platinum compound. Its predecessors in the series, cisplatin and carboplatin, are given by injection, and patients either have to stay in the doctor’s office or in a hospital; furthermore cisplatin is nephrotoxic. “Satraplatin, however, was pretty safe; patients can take it at home, and it’s convenient,” he says. In late September 2006, Spectrum reported on a study of 950 patients with hormone-refractory cancer that showed that the results for progression-free survival (PFS) are highly statistically significant (p<0.00001) using the protocol-specified log-rank test. PFS is the primary endpoint for submission for accelerated approval in the United States and will serve as the primary basis for a Marketing Authorization Application (MAA) in Europe. “I’m so pleased with these data, because this drug could offer significant help to patients with second-line hormone refractory prostate cancer for whom currently there are no approved treatments,” he says. The research also indicated that the drug has a relatively benign safety profile, with mild-to-moderate adverse reactions consisting of myelosuppression and gastrointestinal events. Satraplatin currently is being developed through a licensing agreement between Spectrum Pharmaceuticals and a German biotech company. Spectrum hopes to receive approval for the drug by the middle of 2007. The second drug, Ozarelix, is currently being evaluated for its intended initial indications, hormone-dependent prostate cancer and BHP. The company also plans to evaluate this compound for the treatment of endometriosis. The most common symptoms of BPH include a weak and interrupted urine stream and frequent and urgent urination. In severe cases, BPH can cause urinary tract infections, incontinence, and kidney failure. Dr. Shrotriya says in the United States it is estimated there are at least 18 million men who have some symptoms of benign prostate enlargement. “Currently there are several drugs that are marketed — they have more than $4 billion a year in worldwide sales — by companies such as GSK, Pfizer, Merck, and Abbott,” he says. Current treatments for BPH require that patients take a tablet every day for the remainder of their lives. Ozarelix is a fourth-generation luteinizing hormone releasing hormone antagonist administered as an injection on day one and day 15 of treatment. He says clinical findings to date show the effect lasts for six months. He adds that in a trial of 144 patients, data indicated that the drug has about 300% better efficacy than any of the approved drugs compared with the data that are listed in package inserts of the marketed drugs. “If these results can be proven in a second trial, which we are now designing and plan to start early this year, we could be sitting on a gold mine in terms of having a better improved, convenient therapy for patients with BPH,” Dr. Shrotriya says. 10 drugs in development; 2 drugs potentially on the market in 2007; 2 drugs going into Phase III trials next year. My mother taught me not to procrastinate; that if something has to be done tomorrow do it today, and if it needs to be done today, do it now. I carry this with me today. Spectrum’s Pipeline Levofolinic Acid Osteogenic Sarcoma and Colorectal Cancer 2007 Satraplatin Hormone-Refratory Prostate Cancer 2007 Sumatriptan Inj. Migraine (ANDA filed with Par. IV) 2008 EOquin Superficial Bladder Cancer Ozarelix Hormone-Dependent Prostate Cancer Ozarelix Benign Prostatic Hypertrophy Ozarelix Endometriosis Elsamitrucin Refractory Non-Hodgkin’s Lymphoma Lucanthone Radiation Sensitizer in Brain Tumor and Brain Metastases SPI-1620 Adjunct to Chemotherapy RenaZorb Hyperphosphatemia in ESRD SPI-205 Chemo-Induced Neuropathy Phase I Phase II Phase III NDA/ANDA Expected Running the Gamut Rajesh c. shrotriya, M.D. — RESUME Aug. 2002 — Present. Chairman and CEO, Spectrum Pharmaceuticals Inc., Irvine, Calif. Sept. 2000 — Aug. 2002. President, Spectrum Pharmaceuticals Inc., (NeoTherapeutics) Irvine, Calif. Nov. 1996 — Aug. 2000. Executive VP and Chief Scientific Officer, Senior VP, SuperGen Inc., San Ramon, Calif. July 1995 — Oct. 1996. VP and Chief Medical Officer, MGI Pharma Inc., Minneapolis Aug. 1994 — June 1995. VP, Medical Affairs, MGI Pharma Inc., Minneapolis Aug. 1988 — Aug. 1994. Executive Director, Worldwide CNS Clinical Research, Bristol-Myers Squibb Co., Wallington, Conn. Sept. 1985 — Aug. 1988. Director, CNS Clinical Research, Bristol-Myers Squibb, Wallington, Conn. 1983 — 1985. Director, CNS Clinical Research, Bristol-Myers Squibb (Mead Johnson), Evansville, Ind. 1981 — 1984. Attending Physician and Member, Faculty — Department of Medicine, St. Joseph Hospital, Stamford, Conn. 1978 — 1982. Director, Clinical Research Internal Medicine, Bristol-Myers Company International Division, New York 1976 — 1977. Associate Director, Clinical Research Internal Medicine, Bristol-Myers Company International Division, New York 1973 — 1976. Marketing Director, Ethical Pharmaceuticals, Hoechst Pharmaceuticals, Bombay 1972 — 1976. Head, Clinical Pharmacology Unit, Hoechst Pharmaceuticals, Bombay 1972 — 1976. Honorary Lecturer, Clinical Pharmacology, Grant Medical College, Bombay 1971 — 1973. Medical Advisor and Director, Regulatory Affairs, Hoechst Pharmaceuticals, Bombay Education 1971 — 1974. M.D. (Doctor of Medicine), equivalent to Board Certification in U.S., Grant Medical College, Bombay 1970 — 1971. D.T.C.D. (Diploma in Chest Diseases), Delhi University, V.P. Chest Institute, Delhi 1967 — 1970. MBBS (Bachelor of Medicine and Bachelor of Surgery), equivalent to M.D. degree in U.S., Armed Forces Medical College, Poona, India 1960 — 1962. Bachelor of Science with Chemistry, Agra University, Aligarh, India Boards and Memberships 1988 — 2000. Member of the Governing Body and Executive Committee of the American Association of Physicians of Indian Origin (AAPI) 1990 — 1995. Founding Member, President-Elect, and President of the Connecticut Association of Physicians of Indian Origin 1991 — 1994. Cochairman, Membership Committee, AAPI 1990. Chairman, Liaison Committee, AAPI 1987 — 1992. Founding President of the Armed Forces Medical College Alumni 1986 — 1988. Member, Liaison Committee, the Canadian College of Neuropsychopharmacology As a physician I felt I could only help one patient at a time, but if I was developing medicines it would be possible that, by discovering a new drug or bringing one drug to the market, I could help millions of patients; that’s what drives me and has become my mantra for success. A Science Focus In an exclusive interview with PharmaVOICE, Rajesh C. Shrotriya, M.D., discusses his fears for the world and his passion for science. A scientist and doctor first and foremost, Rajesh C. Shrotriya, M.D., is a firm believer in the potential of discovery and invention as a way to unify the globe. The growing preoccupation with inflicting religious views on others, to the point of being willing to kill those who don’t hold the same views, deeply troubles the chairman, CEO, and president of Spectrum Pharmaceuticals Inc. “The world is growing so fast; we are not only going to the moon and Mars, we have sent small ships millions of miles away and brought them back,” he says. “To me it’s fascinating that on one hand we’re doing this research and on the other we are stopping stem-cell research because of the beliefs of some people.” He draws a parallel between the issues the world is facing today with religious opposition to science in the past, such as the Catholic Church’s condemnation of the work of Galileo Galilei. “I’m very concerned when religious beliefs interfere in the progress of science and when the issues of science are politicized,” he says. With a determination to spread the joy of science and to promote those who share his belief in scientific progress, Dr. Shrotriya devotes time outside of work to mentoring and to helping others in the industry. He is on the board of Antares Pharma, was a founder and president of Armed Forces Medical College alumni, and assisted the Democratic gubernatorial candidate for California in the November 2006 elections. In addition he has served on the executive committee of the American Association of Physicians of Indian Origin and was president of the Connecticut Association of Physicians of Indian Origin.

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