PRD 2013

LAS VEGAS – Corticosteroids remain the initial treatment of choice for myositis and myositis-associated interstitial lung disease, but immunosuppressive agents, intravenous immunoglobulin, and biologics can also play a role in the treatment of one or both of these conditions, according to Dr. Chester V. Oddis.

For myositis in general, Dr. Oddis, professor of medicine and associate director of the rheumatology fellowship training program at the University of Pittsburgh, recommends an initial divided dose of 30 mg of prednisone twice daily, continued until serum creatine kinase (CK) levels fall to normal. At that time, the total daily prednisone dose can be consolidated into a single morning dose, he said at Perspectives in Rheumatic Diseases 2013.

The prednisone can then be tapered by 25% every 3-4 weeks down to a 5- to 10-mg daily maintenance dose that is continued until active disease is suppressed for 12 months. This is a general guideline that helps prevent disease flares, he noted.

Keep in mind that improvement in strength generally lags behind improvement in CK levels, he added.

Nonsteroidal immunosuppressives

Not all patients will need an additional immunosuppressive agent, but for those who do, methotrexate is a good option, Dr. Oddis said, noting that methotrexate is the drug he is most comfortable using in those cases.

The literature also supports the combined use of methotrexate and azathioprine, which when given together have been shown to be effective in treatment-resistant myositis and in those who failed either of the drugs alone.

"So that’s a regimen you might want to think about," he said.

Another immunosuppressive option is mycophenolate mofetil (MMF), which has been shown in several small studies and case series to be of benefit. In one study, 6 of 10 patients with dermatomyositis successfully tapered corticosteroids with MMF, and 10 of 12 in another study experienced improvement in cutaneous features of the disease.

The use of intravenous immunoglobulin (IVIg) as add-on therapy with MMF was effective in severe refractory patients, including four with polymyositis and three with dermatomyositis. In a retrospective review of 50 patients with juvenile dermatomyositis, MMF for 12 months was well tolerated, improved skin and muscle, and proved to be steroid-sparing, Dr. Oddis said.

Cyclosporine, tacrolimus, and cyclophosphamide are other immunosuppressive options.

While cyclophosphamide is more often used for myositis-associated interstitial lung disease (ILD), it can be of benefit for refractory skin disease, and can be useful in non-ILD myositis cases that involve severe skin disease.

The only available controlled data for IVIg alone are from a study published more than 20 years ago, but that randomized, double-blind, placebo-controlled study showed that treatment was safe, effective, and steroid sparing in 15 patients with dermatomyositis, he said.

Biologics

As for biologics, anti–tumor necrosis factor–alpha (anti-TNF-alpha) therapy and B-cell therapy have both been considered. Anti-TNF-alpha therapy makes sense because TNF-alpha and other proinflammatory cytokines are increased in muscle tissue of myositis patients; TNF-alpha is toxic to myofibers and prevents their regeneration; and TNF-alpha enhances other inflammatory cytokines in both dermatomyositis and polymyositis, but data are lacking on whether targeting TNF-alpha is worthwhile.

B cell therapy, on the other hand, is showing promise. In one open-label pilot study, rituximab was effective in seven patients with refractory dermatomyositis, and in others it was effective in anti-synthetase syndrome. Rituximab also was effective in two studies for refractory myositis and dermatomyositis rash, and it induced longstanding remission in some of the patients. In another study, however, rituximab was not effective for dermatomyositis rash.

The multicenter Rituximab in Myositis (RIM) study, the largest ever done in myositis, evaluated rituximab for the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis patients.

Although the primary and secondary endpoints of the RIM study were not achieved, 83% of refractory adult and juvenile myositis patients met the definition of improvement, there was a significant corticosteroid sparing effect between the baseline dose and the dose at study conclusion, and treatment was generally well tolerated, he said.

Other targets that are being explored include interleukin-6 and type 1 IFN genes. Findings suggest that coordinated dysregulation of type 1 IFN signaling and IL-6 production are contributors to dermatomyositis pathogenesis, he explained.

Treating myositis patients with ILD

The treatment approach to these patients is somewhat similar to those without ILD, with corticosteroids as initial treatment, Dr. Oddis said.

Cyclophosphamide and azathioprine have been used early on, and also in corticosteroid resistant cases, but with variable results. Cyclophosphamide can be given orally or by IV for 3-6 months.

MMF has been used with success in connective tissue disease–associated ILD, and based on small studies it appears to be effective in myositis-associated ILD as well.

Cyclosporine and tacrolimus have been used in both adult and pediatric patients with promising, steroid-sparing results, he said, noting that the use of anti-T-cell therapy in myositis-associated ILD makes sense, because findings from multiple studies have implicated activated CD8-positive T-cells in myositis-associated ILD.

"It’s an exciting time for therapeutic interventions in myositis, but even though we have all these therapeutic options, we have to temper our enthusiasm with what they do long term," he said.

Dr. Oddis has served on an advisory board for Questcor.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Corticosteroids remain the initial treatment of choice for myositis and myositis-associated interstitial lung disease, but immunosuppressive agents, intravenous immunoglobulin, and biologics can also play a role in the treatment of one or both of these conditions, according to Dr. Chester V. Oddis.

For myositis in general, Dr. Oddis, professor of medicine and associate director of the rheumatology fellowship training program at the University of Pittsburgh, recommends an initial divided dose of 30 mg of prednisone twice daily, continued until serum creatine kinase (CK) levels fall to normal. At that time, the total daily prednisone dose can be consolidated into a single morning dose, he said at Perspectives in Rheumatic Diseases 2013.

The prednisone can then be tapered by 25% every 3-4 weeks down to a 5- to 10-mg daily maintenance dose that is continued until active disease is suppressed for 12 months. This is a general guideline that helps prevent disease flares, he noted.

Keep in mind that improvement in strength generally lags behind improvement in CK levels, he added.

Nonsteroidal immunosuppressives

Not all patients will need an additional immunosuppressive agent, but for those who do, methotrexate is a good option, Dr. Oddis said, noting that methotrexate is the drug he is most comfortable using in those cases.

The literature also supports the combined use of methotrexate and azathioprine, which when given together have been shown to be effective in treatment-resistant myositis and in those who failed either of the drugs alone.

"So that’s a regimen you might want to think about," he said.

Another immunosuppressive option is mycophenolate mofetil (MMF), which has been shown in several small studies and case series to be of benefit. In one study, 6 of 10 patients with dermatomyositis successfully tapered corticosteroids with MMF, and 10 of 12 in another study experienced improvement in cutaneous features of the disease.

The use of intravenous immunoglobulin (IVIg) as add-on therapy with MMF was effective in severe refractory patients, including four with polymyositis and three with dermatomyositis. In a retrospective review of 50 patients with juvenile dermatomyositis, MMF for 12 months was well tolerated, improved skin and muscle, and proved to be steroid-sparing, Dr. Oddis said.

Cyclosporine, tacrolimus, and cyclophosphamide are other immunosuppressive options.

While cyclophosphamide is more often used for myositis-associated interstitial lung disease (ILD), it can be of benefit for refractory skin disease, and can be useful in non-ILD myositis cases that involve severe skin disease.

The only available controlled data for IVIg alone are from a study published more than 20 years ago, but that randomized, double-blind, placebo-controlled study showed that treatment was safe, effective, and steroid sparing in 15 patients with dermatomyositis, he said.

Biologics

As for biologics, anti–tumor necrosis factor–alpha (anti-TNF-alpha) therapy and B-cell therapy have both been considered. Anti-TNF-alpha therapy makes sense because TNF-alpha and other proinflammatory cytokines are increased in muscle tissue of myositis patients; TNF-alpha is toxic to myofibers and prevents their regeneration; and TNF-alpha enhances other inflammatory cytokines in both dermatomyositis and polymyositis, but data are lacking on whether targeting TNF-alpha is worthwhile.

B cell therapy, on the other hand, is showing promise. In one open-label pilot study, rituximab was effective in seven patients with refractory dermatomyositis, and in others it was effective in anti-synthetase syndrome. Rituximab also was effective in two studies for refractory myositis and dermatomyositis rash, and it induced longstanding remission in some of the patients. In another study, however, rituximab was not effective for dermatomyositis rash.

The multicenter Rituximab in Myositis (RIM) study, the largest ever done in myositis, evaluated rituximab for the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis patients.

Although the primary and secondary endpoints of the RIM study were not achieved, 83% of refractory adult and juvenile myositis patients met the definition of improvement, there was a significant corticosteroid sparing effect between the baseline dose and the dose at study conclusion, and treatment was generally well tolerated, he said.

Other targets that are being explored include interleukin-6 and type 1 IFN genes. Findings suggest that coordinated dysregulation of type 1 IFN signaling and IL-6 production are contributors to dermatomyositis pathogenesis, he explained.

Treating myositis patients with ILD

The treatment approach to these patients is somewhat similar to those without ILD, with corticosteroids as initial treatment, Dr. Oddis said.

Cyclophosphamide and azathioprine have been used early on, and also in corticosteroid resistant cases, but with variable results. Cyclophosphamide can be given orally or by IV for 3-6 months.

MMF has been used with success in connective tissue disease–associated ILD, and based on small studies it appears to be effective in myositis-associated ILD as well.

Cyclosporine and tacrolimus have been used in both adult and pediatric patients with promising, steroid-sparing results, he said, noting that the use of anti-T-cell therapy in myositis-associated ILD makes sense, because findings from multiple studies have implicated activated CD8-positive T-cells in myositis-associated ILD.

"It’s an exciting time for therapeutic interventions in myositis, but even though we have all these therapeutic options, we have to temper our enthusiasm with what they do long term," he said.

Dr. Oddis has served on an advisory board for Questcor.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Corticosteroids remain the initial treatment of choice for myositis and myositis-associated interstitial lung disease, but immunosuppressive agents, intravenous immunoglobulin, and biologics can also play a role in the treatment of one or both of these conditions, according to Dr. Chester V. Oddis.

For myositis in general, Dr. Oddis, professor of medicine and associate director of the rheumatology fellowship training program at the University of Pittsburgh, recommends an initial divided dose of 30 mg of prednisone twice daily, continued until serum creatine kinase (CK) levels fall to normal. At that time, the total daily prednisone dose can be consolidated into a single morning dose, he said at Perspectives in Rheumatic Diseases 2013.

The prednisone can then be tapered by 25% every 3-4 weeks down to a 5- to 10-mg daily maintenance dose that is continued until active disease is suppressed for 12 months. This is a general guideline that helps prevent disease flares, he noted.

Keep in mind that improvement in strength generally lags behind improvement in CK levels, he added.

Nonsteroidal immunosuppressives

Not all patients will need an additional immunosuppressive agent, but for those who do, methotrexate is a good option, Dr. Oddis said, noting that methotrexate is the drug he is most comfortable using in those cases.

The literature also supports the combined use of methotrexate and azathioprine, which when given together have been shown to be effective in treatment-resistant myositis and in those who failed either of the drugs alone.

"So that’s a regimen you might want to think about," he said.

Another immunosuppressive option is mycophenolate mofetil (MMF), which has been shown in several small studies and case series to be of benefit. In one study, 6 of 10 patients with dermatomyositis successfully tapered corticosteroids with MMF, and 10 of 12 in another study experienced improvement in cutaneous features of the disease.

The use of intravenous immunoglobulin (IVIg) as add-on therapy with MMF was effective in severe refractory patients, including four with polymyositis and three with dermatomyositis. In a retrospective review of 50 patients with juvenile dermatomyositis, MMF for 12 months was well tolerated, improved skin and muscle, and proved to be steroid-sparing, Dr. Oddis said.

Cyclosporine, tacrolimus, and cyclophosphamide are other immunosuppressive options.

While cyclophosphamide is more often used for myositis-associated interstitial lung disease (ILD), it can be of benefit for refractory skin disease, and can be useful in non-ILD myositis cases that involve severe skin disease.

The only available controlled data for IVIg alone are from a study published more than 20 years ago, but that randomized, double-blind, placebo-controlled study showed that treatment was safe, effective, and steroid sparing in 15 patients with dermatomyositis, he said.

Biologics

As for biologics, anti–tumor necrosis factor–alpha (anti-TNF-alpha) therapy and B-cell therapy have both been considered. Anti-TNF-alpha therapy makes sense because TNF-alpha and other proinflammatory cytokines are increased in muscle tissue of myositis patients; TNF-alpha is toxic to myofibers and prevents their regeneration; and TNF-alpha enhances other inflammatory cytokines in both dermatomyositis and polymyositis, but data are lacking on whether targeting TNF-alpha is worthwhile.

B cell therapy, on the other hand, is showing promise. In one open-label pilot study, rituximab was effective in seven patients with refractory dermatomyositis, and in others it was effective in anti-synthetase syndrome. Rituximab also was effective in two studies for refractory myositis and dermatomyositis rash, and it induced longstanding remission in some of the patients. In another study, however, rituximab was not effective for dermatomyositis rash.

The multicenter Rituximab in Myositis (RIM) study, the largest ever done in myositis, evaluated rituximab for the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis patients.

Although the primary and secondary endpoints of the RIM study were not achieved, 83% of refractory adult and juvenile myositis patients met the definition of improvement, there was a significant corticosteroid sparing effect between the baseline dose and the dose at study conclusion, and treatment was generally well tolerated, he said.

Other targets that are being explored include interleukin-6 and type 1 IFN genes. Findings suggest that coordinated dysregulation of type 1 IFN signaling and IL-6 production are contributors to dermatomyositis pathogenesis, he explained.

Treating myositis patients with ILD

The treatment approach to these patients is somewhat similar to those without ILD, with corticosteroids as initial treatment, Dr. Oddis said.

Cyclophosphamide and azathioprine have been used early on, and also in corticosteroid resistant cases, but with variable results. Cyclophosphamide can be given orally or by IV for 3-6 months.

MMF has been used with success in connective tissue disease–associated ILD, and based on small studies it appears to be effective in myositis-associated ILD as well.

Cyclosporine and tacrolimus have been used in both adult and pediatric patients with promising, steroid-sparing results, he said, noting that the use of anti-T-cell therapy in myositis-associated ILD makes sense, because findings from multiple studies have implicated activated CD8-positive T-cells in myositis-associated ILD.

"It’s an exciting time for therapeutic interventions in myositis, but even though we have all these therapeutic options, we have to temper our enthusiasm with what they do long term," he said.

Dr. Oddis has served on an advisory board for Questcor.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Three rheumatologists shared three different career routes that fellows may choose to embark on over the course of their careers.

Dr. Michael Schweitz, who has been in practice for over 30 years, presented insights into the world of private practice, as well as tips for interviewing and contract negotiation. Dr. Orrin Troum discussed taking the clinical research track, and Dr. James S. Louie explored the option of working for a pharmaceutical company. They shared their perspectives during Rheumatology Fellows Day at Perspectives in Rheumatic Diseases 2013.

Amy Pfeiffer/IMNG Medical Media

PRIVATE PRACTICE

According to Dr. Schweitz, there are pros and cons of going into private practice that must be weighed. Having a private practice or being a partner in a group practice may bring more financial gain, but with that comes more responsibility, management, and liability, noted Dr. Schweitz, who has a private practice in West Palm Beach, Fla. Some physicians prefer to join a group practice as an employee.

Interviewing. When interviewing at practices, he recommended that physicians meet with all of the partners in the group to get a sense of what they are like, as well as a sense of the culture of the practice. He recommended that fellows spend a day at a practice before accepting a position, and watch how physicians interact with the staff and patients.

One of the interview tips that he offered is to make the prime focus of the interview about the practice, not about salary, vacation, or how long it takes to become partner. "Ask operational questions. Financials will work themselves out over time," he explained.

After a position has been offered, it is important to have a lawyer look at the contract. Try to find a medical business attorney, he said.

Building a practice. The best way to build a practice is by doing a good job so that patients will recommend the practice. "Your biggest source of referrals will be your patients. They will fill your schedule," he said.

When referrals come in from other physicians, call the referring physician and let him or her know that the patient was seen and what course of action was decided upon. Stress the "we," he said, so the referring physician does not feel left out of the treatment process.

Another way to build a practice is to get involved with the community. For example, give lectures at community centers, churches, and health fairs. But starting a private practice is hard, he stressed, and may not even be feasible with the current plethora of medical regulations. In an audience poll of the fellows at his lecture, no one said that they planned to start their own practice.

CLINICAL RESEARCH

Dr. Troum said that he believes that one of the most rewarding parts of doing clinical research is providing patients with medication that they would not otherwise be able to obtain. He said that it has also expanded his expertise and enriched his experience as a rheumatologist.

There are no cures for most rheumatic diseases, and some of the most common conditions among Medicare populations are arthritis (57%) and osteoporosis (16%), said Dr. Troum, clinical professor of medicine at the University of Southern California, Los Angeles. Most rheumatologists are already performing assessments required by studies every day when they are seeing patients, so participating in clinical trials should not be that difficult, he said.

However, he would never ask his patients to participate in a study that he wouldn’t participate in himself, and chooses not to participate in phase I studies, he added.

Undertaking a trial. When deciding to embark on a clinical trial, there are many regulations that need to be followed. First and foremost, patients must be advised that the drugs they are being treated with are for investigational purposes and that all requirements regarding informed consent are met, he explained. Patients must be informed of the potential dangers of the therapy, as well as the benefits. There are also reporting requirements to the sponsor (adverse events, serious adverse events, and unexpected problems).

It has to be also be ensured that all associates, colleagues, and employees assisting the study are informed and trained. Be sure to understand the investigator’s brochure and consider the risks and side effects. Good clinical practice is a requirement, and includes study design, conduct, performance monitoring, auditing, recording, analysis, and reporting to ensure a credible and accurate report.

A support staff and the proper infrastructure are key. There has to be a principal investigator, a study coordinator, and possibly a subinvestigator, a regulatory specialist, a patient recruiter, and an RN or pharmacist for studies involving intravenous drugs, Dr. Troum said.

Acquiring a study. To begin acquiring studies, new investigators can ask their medical science liaisons from pharmaceutical companies, attend industry meetings, go to seminars, ask colleagues for referrals, be introduced to company scientists, and subscribe to periodicals that publish research opportunities.

Negotiating a contract. Routinely, the sponsor of the trial will propose a lower budget than is needed to cover costs, so negotiation is important, Dr. Troum said. Never begin a study without a signed contract, he warned.

Clinical trials should be considered a separate business entity. There are overhead and costs, he said, as well as hidden costs such as purchasing dry ice and having to store documents for many years. A payment schedule should be agreed upon prior to the study. If a sponsor refuses to negotiate fair value, the study should be refused, he said.

Performing a stellar study. The best method to obtain further studies is to conduct stellar studies, Dr. Troum said. Accrue the promised number of patients, accurately and efficiently collect data, and demonstrate excellent execution of the study. All assessments and procedures should be documented.

"Successful completion of a clinical trial should be a rewarding experience for the subject and investigators," he said. Enroll patients who are willing to participate through advertising, doctor-to-doctor letters, and community outreach.

"If done properly, clinical investigation may be both intellectually and financially rewarding," he concluded.

BIOTECHNOLOGY

"Careers in biomedical industry are increasingly attractive career options," said Dr. Louie, who was the medical director for Amgen for 5 years. They are also rewarding, he said, because you have a hand in creating the most effective therapies for patients, while keeping up with the latest advances in medicine.

It is a very exciting time in rheumatology because the therapeutic landscape is changing and there are powerful new research technologies, he said. "We are progressing toward personalized medicine."

To prepare for a career in the biotechnology industry as a student or fellow, participate in the recruitment, data collection, and interpretation of clinical trials and translational research, advised Dr. Louie, professor emeritus in rheumatology at the University of California, Los Angeles. Also, investigative experience and an advanced degree should be considered (MBA, MPH, PhD).

Before accepting a position in the pharmaceutical industry, ask yourself three questions:

• How will you negotiate for your contract?

• What do you want to learn from the experience?

• What will be your exit strategy as you move to other areas of interest?

There are fundamental financial considerations in pharmaceutical/biotechnology companies, so negotiate carefully with advice from your colleagues and lawyers.

There is money in industry, so negotiate carefully, he said. And if this is the route that a fellow chooses to take, he or she should continue to attend at a teaching institute to stay current in patient treatment.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

apfeiffer@frontlinemedcom.com

LAS VEGAS – Three rheumatologists shared three different career routes that fellows may choose to embark on over the course of their careers.

Dr. Michael Schweitz, who has been in practice for over 30 years, presented insights into the world of private practice, as well as tips for interviewing and contract negotiation. Dr. Orrin Troum discussed taking the clinical research track, and Dr. James S. Louie explored the option of working for a pharmaceutical company. They shared their perspectives during Rheumatology Fellows Day at Perspectives in Rheumatic Diseases 2013.

Amy Pfeiffer/IMNG Medical Media

PRIVATE PRACTICE

According to Dr. Schweitz, there are pros and cons of going into private practice that must be weighed. Having a private practice or being a partner in a group practice may bring more financial gain, but with that comes more responsibility, management, and liability, noted Dr. Schweitz, who has a private practice in West Palm Beach, Fla. Some physicians prefer to join a group practice as an employee.

Interviewing. When interviewing at practices, he recommended that physicians meet with all of the partners in the group to get a sense of what they are like, as well as a sense of the culture of the practice. He recommended that fellows spend a day at a practice before accepting a position, and watch how physicians interact with the staff and patients.

One of the interview tips that he offered is to make the prime focus of the interview about the practice, not about salary, vacation, or how long it takes to become partner. "Ask operational questions. Financials will work themselves out over time," he explained.

After a position has been offered, it is important to have a lawyer look at the contract. Try to find a medical business attorney, he said.

Building a practice. The best way to build a practice is by doing a good job so that patients will recommend the practice. "Your biggest source of referrals will be your patients. They will fill your schedule," he said.

When referrals come in from other physicians, call the referring physician and let him or her know that the patient was seen and what course of action was decided upon. Stress the "we," he said, so the referring physician does not feel left out of the treatment process.

Another way to build a practice is to get involved with the community. For example, give lectures at community centers, churches, and health fairs. But starting a private practice is hard, he stressed, and may not even be feasible with the current plethora of medical regulations. In an audience poll of the fellows at his lecture, no one said that they planned to start their own practice.

CLINICAL RESEARCH

Dr. Troum said that he believes that one of the most rewarding parts of doing clinical research is providing patients with medication that they would not otherwise be able to obtain. He said that it has also expanded his expertise and enriched his experience as a rheumatologist.

There are no cures for most rheumatic diseases, and some of the most common conditions among Medicare populations are arthritis (57%) and osteoporosis (16%), said Dr. Troum, clinical professor of medicine at the University of Southern California, Los Angeles. Most rheumatologists are already performing assessments required by studies every day when they are seeing patients, so participating in clinical trials should not be that difficult, he said.

However, he would never ask his patients to participate in a study that he wouldn’t participate in himself, and chooses not to participate in phase I studies, he added.

Undertaking a trial. When deciding to embark on a clinical trial, there are many regulations that need to be followed. First and foremost, patients must be advised that the drugs they are being treated with are for investigational purposes and that all requirements regarding informed consent are met, he explained. Patients must be informed of the potential dangers of the therapy, as well as the benefits. There are also reporting requirements to the sponsor (adverse events, serious adverse events, and unexpected problems).

It has to be also be ensured that all associates, colleagues, and employees assisting the study are informed and trained. Be sure to understand the investigator’s brochure and consider the risks and side effects. Good clinical practice is a requirement, and includes study design, conduct, performance monitoring, auditing, recording, analysis, and reporting to ensure a credible and accurate report.

A support staff and the proper infrastructure are key. There has to be a principal investigator, a study coordinator, and possibly a subinvestigator, a regulatory specialist, a patient recruiter, and an RN or pharmacist for studies involving intravenous drugs, Dr. Troum said.

Acquiring a study. To begin acquiring studies, new investigators can ask their medical science liaisons from pharmaceutical companies, attend industry meetings, go to seminars, ask colleagues for referrals, be introduced to company scientists, and subscribe to periodicals that publish research opportunities.

Negotiating a contract. Routinely, the sponsor of the trial will propose a lower budget than is needed to cover costs, so negotiation is important, Dr. Troum said. Never begin a study without a signed contract, he warned.

Clinical trials should be considered a separate business entity. There are overhead and costs, he said, as well as hidden costs such as purchasing dry ice and having to store documents for many years. A payment schedule should be agreed upon prior to the study. If a sponsor refuses to negotiate fair value, the study should be refused, he said.

Performing a stellar study. The best method to obtain further studies is to conduct stellar studies, Dr. Troum said. Accrue the promised number of patients, accurately and efficiently collect data, and demonstrate excellent execution of the study. All assessments and procedures should be documented.

"Successful completion of a clinical trial should be a rewarding experience for the subject and investigators," he said. Enroll patients who are willing to participate through advertising, doctor-to-doctor letters, and community outreach.

"If done properly, clinical investigation may be both intellectually and financially rewarding," he concluded.

BIOTECHNOLOGY

"Careers in biomedical industry are increasingly attractive career options," said Dr. Louie, who was the medical director for Amgen for 5 years. They are also rewarding, he said, because you have a hand in creating the most effective therapies for patients, while keeping up with the latest advances in medicine.

It is a very exciting time in rheumatology because the therapeutic landscape is changing and there are powerful new research technologies, he said. "We are progressing toward personalized medicine."

To prepare for a career in the biotechnology industry as a student or fellow, participate in the recruitment, data collection, and interpretation of clinical trials and translational research, advised Dr. Louie, professor emeritus in rheumatology at the University of California, Los Angeles. Also, investigative experience and an advanced degree should be considered (MBA, MPH, PhD).

Before accepting a position in the pharmaceutical industry, ask yourself three questions:

• How will you negotiate for your contract?

• What do you want to learn from the experience?

• What will be your exit strategy as you move to other areas of interest?

There are fundamental financial considerations in pharmaceutical/biotechnology companies, so negotiate carefully with advice from your colleagues and lawyers.

There is money in industry, so negotiate carefully, he said. And if this is the route that a fellow chooses to take, he or she should continue to attend at a teaching institute to stay current in patient treatment.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

apfeiffer@frontlinemedcom.com

LAS VEGAS – Three rheumatologists shared three different career routes that fellows may choose to embark on over the course of their careers.

Dr. Michael Schweitz, who has been in practice for over 30 years, presented insights into the world of private practice, as well as tips for interviewing and contract negotiation. Dr. Orrin Troum discussed taking the clinical research track, and Dr. James S. Louie explored the option of working for a pharmaceutical company. They shared their perspectives during Rheumatology Fellows Day at Perspectives in Rheumatic Diseases 2013.

Amy Pfeiffer/IMNG Medical Media

PRIVATE PRACTICE

According to Dr. Schweitz, there are pros and cons of going into private practice that must be weighed. Having a private practice or being a partner in a group practice may bring more financial gain, but with that comes more responsibility, management, and liability, noted Dr. Schweitz, who has a private practice in West Palm Beach, Fla. Some physicians prefer to join a group practice as an employee.

Interviewing. When interviewing at practices, he recommended that physicians meet with all of the partners in the group to get a sense of what they are like, as well as a sense of the culture of the practice. He recommended that fellows spend a day at a practice before accepting a position, and watch how physicians interact with the staff and patients.

One of the interview tips that he offered is to make the prime focus of the interview about the practice, not about salary, vacation, or how long it takes to become partner. "Ask operational questions. Financials will work themselves out over time," he explained.

After a position has been offered, it is important to have a lawyer look at the contract. Try to find a medical business attorney, he said.

Building a practice. The best way to build a practice is by doing a good job so that patients will recommend the practice. "Your biggest source of referrals will be your patients. They will fill your schedule," he said.

When referrals come in from other physicians, call the referring physician and let him or her know that the patient was seen and what course of action was decided upon. Stress the "we," he said, so the referring physician does not feel left out of the treatment process.

Another way to build a practice is to get involved with the community. For example, give lectures at community centers, churches, and health fairs. But starting a private practice is hard, he stressed, and may not even be feasible with the current plethora of medical regulations. In an audience poll of the fellows at his lecture, no one said that they planned to start their own practice.

CLINICAL RESEARCH

Dr. Troum said that he believes that one of the most rewarding parts of doing clinical research is providing patients with medication that they would not otherwise be able to obtain. He said that it has also expanded his expertise and enriched his experience as a rheumatologist.

There are no cures for most rheumatic diseases, and some of the most common conditions among Medicare populations are arthritis (57%) and osteoporosis (16%), said Dr. Troum, clinical professor of medicine at the University of Southern California, Los Angeles. Most rheumatologists are already performing assessments required by studies every day when they are seeing patients, so participating in clinical trials should not be that difficult, he said.

However, he would never ask his patients to participate in a study that he wouldn’t participate in himself, and chooses not to participate in phase I studies, he added.

Undertaking a trial. When deciding to embark on a clinical trial, there are many regulations that need to be followed. First and foremost, patients must be advised that the drugs they are being treated with are for investigational purposes and that all requirements regarding informed consent are met, he explained. Patients must be informed of the potential dangers of the therapy, as well as the benefits. There are also reporting requirements to the sponsor (adverse events, serious adverse events, and unexpected problems).

It has to be also be ensured that all associates, colleagues, and employees assisting the study are informed and trained. Be sure to understand the investigator’s brochure and consider the risks and side effects. Good clinical practice is a requirement, and includes study design, conduct, performance monitoring, auditing, recording, analysis, and reporting to ensure a credible and accurate report.

A support staff and the proper infrastructure are key. There has to be a principal investigator, a study coordinator, and possibly a subinvestigator, a regulatory specialist, a patient recruiter, and an RN or pharmacist for studies involving intravenous drugs, Dr. Troum said.

Acquiring a study. To begin acquiring studies, new investigators can ask their medical science liaisons from pharmaceutical companies, attend industry meetings, go to seminars, ask colleagues for referrals, be introduced to company scientists, and subscribe to periodicals that publish research opportunities.

Negotiating a contract. Routinely, the sponsor of the trial will propose a lower budget than is needed to cover costs, so negotiation is important, Dr. Troum said. Never begin a study without a signed contract, he warned.

Clinical trials should be considered a separate business entity. There are overhead and costs, he said, as well as hidden costs such as purchasing dry ice and having to store documents for many years. A payment schedule should be agreed upon prior to the study. If a sponsor refuses to negotiate fair value, the study should be refused, he said.

Performing a stellar study. The best method to obtain further studies is to conduct stellar studies, Dr. Troum said. Accrue the promised number of patients, accurately and efficiently collect data, and demonstrate excellent execution of the study. All assessments and procedures should be documented.

"Successful completion of a clinical trial should be a rewarding experience for the subject and investigators," he said. Enroll patients who are willing to participate through advertising, doctor-to-doctor letters, and community outreach.

"If done properly, clinical investigation may be both intellectually and financially rewarding," he concluded.

BIOTECHNOLOGY

"Careers in biomedical industry are increasingly attractive career options," said Dr. Louie, who was the medical director for Amgen for 5 years. They are also rewarding, he said, because you have a hand in creating the most effective therapies for patients, while keeping up with the latest advances in medicine.

It is a very exciting time in rheumatology because the therapeutic landscape is changing and there are powerful new research technologies, he said. "We are progressing toward personalized medicine."

To prepare for a career in the biotechnology industry as a student or fellow, participate in the recruitment, data collection, and interpretation of clinical trials and translational research, advised Dr. Louie, professor emeritus in rheumatology at the University of California, Los Angeles. Also, investigative experience and an advanced degree should be considered (MBA, MPH, PhD).

Before accepting a position in the pharmaceutical industry, ask yourself three questions:

• How will you negotiate for your contract?

• What do you want to learn from the experience?

• What will be your exit strategy as you move to other areas of interest?

There are fundamental financial considerations in pharmaceutical/biotechnology companies, so negotiate carefully with advice from your colleagues and lawyers.

There is money in industry, so negotiate carefully, he said. And if this is the route that a fellow chooses to take, he or she should continue to attend at a teaching institute to stay current in patient treatment.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

apfeiffer@frontlinemedcom.com