As the global footprint continues to expand at Medpace, the strategic hiring and careful planning has allowed us to grow with our Sponsor partners - without sacrificing essential quality.
Friday, April 22, 2011
Medpace strengthens its clinical management operations in Europe
Medpace continues to focus growth strategy on a global scale. In addition to hiring key staff in Asia-Pac and Latin America over past several years, Medpace recently announced the addition of Dr. Dieter Seitz-Tutter to lead its European headquarters.
Dr. Seitz-Tutter adds to Medpace's continued development in the European region over the past several years. In addition to opening locations in the UK and Poland, Medpace has expanded its Czech Republic office, its Munich operations, Switzerland and Russia - in addition to several other expansions worldwide.
As the global footprint continues to expand at Medpace, the strategic hiring and careful planning has allowed us to grow with our Sponsor partners - without sacrificing essential quality.
As the global footprint continues to expand at Medpace, the strategic hiring and careful planning has allowed us to grow with our Sponsor partners - without sacrificing essential quality.
Monday, March 28, 2011
Deeper expertise in infectious disease
Brian S. Murphy, MD, MPH has joined Medpace as Medical Director with responsibility for leading clinical drug development for infectious disease and pediatric specific agents. The addition of Dr. Murphy, along with existing clinical and medical teams, allows Medpace to provide deeper expertise in emerging therapeutic areas to bring innovative anti-infective and pediatric drugs to market in partnership with our sponsors.
"Dr. Murphy’s reputation as an academic leader, combined with his years of experience in clinical development makes him a perfect fit for Medpace," said Jonathan Isaacsohn, MD, FACC, Executive Vice President, Medpace. "He will contribute to Medpace’s entry into one of the major therapeutic areas that poses challenges for emerging markets, that of infectious disease and the need for new and effective vaccines."
Dr. Brian Murphy brings to the Medpace medical management team over ten years of work at the University of Kentucky where he most recently served as Assistant Professor in the Division of Infectious Disease, the Department of Pediatrics, and the Department of Microbiology, Immunology, and Molecular Genetics. He has worked with multi-disciplinary translational/clinical research teams as the principal investigator and consultant on multiple funded projects investigating the pathogenesis and management of HIV, pulmonary infections, infections affecting immunocompromised patients and patients with chronic lung diseases i.e., cystic fibrosis and chronic obstructive pulmonary disease, fungal diseases, vaccine development, bioterrorism, and immunotherapeutics.
Dr. Murphy received his Doctor of Medicine degree from the University of Louisville and his undergraduate diploma in biology from the University of Louisville. Dr Murphy also received his Master of Public Heath in Epidemiology from the University of Kentucky.
"Dr. Murphy’s reputation as an academic leader, combined with his years of experience in clinical development makes him a perfect fit for Medpace," said Jonathan Isaacsohn, MD, FACC, Executive Vice President, Medpace. "He will contribute to Medpace’s entry into one of the major therapeutic areas that poses challenges for emerging markets, that of infectious disease and the need for new and effective vaccines."
Dr. Brian Murphy brings to the Medpace medical management team over ten years of work at the University of Kentucky where he most recently served as Assistant Professor in the Division of Infectious Disease, the Department of Pediatrics, and the Department of Microbiology, Immunology, and Molecular Genetics. He has worked with multi-disciplinary translational/clinical research teams as the principal investigator and consultant on multiple funded projects investigating the pathogenesis and management of HIV, pulmonary infections, infections affecting immunocompromised patients and patients with chronic lung diseases i.e., cystic fibrosis and chronic obstructive pulmonary disease, fungal diseases, vaccine development, bioterrorism, and immunotherapeutics.
Dr. Murphy received his Doctor of Medicine degree from the University of Louisville and his undergraduate diploma in biology from the University of Louisville. Dr Murphy also received his Master of Public Heath in Epidemiology from the University of Kentucky.
Friday, March 11, 2011
Medpace Expands Global Reach Capabilities
In an industry such as clinical and drug development, having a CRO partner with strong global capabilities is essential. Thats why Medpace has expanded their global reach with addition of Dr Dan Weng:
Medpace, Inc. today announced the addition of Dan Weng, MD, PhD, MA as Vice President, Rest of World (ROW) with responsibility for Asia, Pacific Rim, Latin America, and South Africa. Dr. Weng, an experienced clinical development professional, will be charged with driving global growth for Medpace in emerging markets. Emerging markets represent the fastest growing segment for drug development and clinical trials. The addition of Dr.Weng, along with existing Medpace clinical teams, will allow Medpace to provide deeper expertise in global development services for sponsors needing on-the-ground services in global markets.
"We are very pleased to have Dr. Weng join us. Dr. Weng enhances Medpace’s expertise in managing multi-national clinical trials in various therapeutic areas," said August Troendle, MD, President and CEO, Medpace. "His skill in managing global teams such as data services, regulatory, medical and safety, in addition to clinical operations adds to the overall capabilities of the Medpace group."
"I am very happy to join the Medpace team. Medpace has a reputation for great scientific process, clinical expertise, quality focus, and global capacity with local excellence in the markets they serve," said Dr. Weng. "I am confident that Medpace emerging markets will continue to develop local staffs to offer our sponsors new services on a global platform over the next few years."
Dr. Dan Weng brings to the Medpace management team over twenty five years of clinical experience, with seventeen years from executive positions with various clinical research organizations. Dr Weng’s extensive work in Asia, Pacific Rim, Latin America, and South Africa add to the global reach of the Medpace group. Dr Weng has held positions of increasing responsibility, including Executive Vice President, Emerging Markets over Rest of World. He has also served as a research fellow at Harvard Medical School and the University of California working on cardiovascular clinical trial protocol design, implementation, and review.
Dr. Weng received his Doctor of Medicine degree from Tongji Medical University in China and his undergraduate diploma in human psychology from the Psychology Institute of Sino-Academy of Sciences. Dr Weng also received his Master of Arts in Healthy Planning, Policy, and Management from Leeds University in the United Kingdom in addition to being a PhD candidate in bioengineering from Strathclyde University in Glasgow, United Kingdom.
Medpace, Inc. today announced the addition of Dan Weng, MD, PhD, MA as Vice President, Rest of World (ROW) with responsibility for Asia, Pacific Rim, Latin America, and South Africa. Dr. Weng, an experienced clinical development professional, will be charged with driving global growth for Medpace in emerging markets. Emerging markets represent the fastest growing segment for drug development and clinical trials. The addition of Dr.Weng, along with existing Medpace clinical teams, will allow Medpace to provide deeper expertise in global development services for sponsors needing on-the-ground services in global markets.
"We are very pleased to have Dr. Weng join us. Dr. Weng enhances Medpace’s expertise in managing multi-national clinical trials in various therapeutic areas," said August Troendle, MD, President and CEO, Medpace. "His skill in managing global teams such as data services, regulatory, medical and safety, in addition to clinical operations adds to the overall capabilities of the Medpace group."
"I am very happy to join the Medpace team. Medpace has a reputation for great scientific process, clinical expertise, quality focus, and global capacity with local excellence in the markets they serve," said Dr. Weng. "I am confident that Medpace emerging markets will continue to develop local staffs to offer our sponsors new services on a global platform over the next few years."
Dr. Dan Weng brings to the Medpace management team over twenty five years of clinical experience, with seventeen years from executive positions with various clinical research organizations. Dr Weng’s extensive work in Asia, Pacific Rim, Latin America, and South Africa add to the global reach of the Medpace group. Dr Weng has held positions of increasing responsibility, including Executive Vice President, Emerging Markets over Rest of World. He has also served as a research fellow at Harvard Medical School and the University of California working on cardiovascular clinical trial protocol design, implementation, and review.
Dr. Weng received his Doctor of Medicine degree from Tongji Medical University in China and his undergraduate diploma in human psychology from the Psychology Institute of Sino-Academy of Sciences. Dr Weng also received his Master of Arts in Healthy Planning, Policy, and Management from Leeds University in the United Kingdom in addition to being a PhD candidate in bioengineering from Strathclyde University in Glasgow, United Kingdom.
Friday, January 14, 2011
Medpace Penetrates Infectious Diseases Therapeutic Area
Medpace, Inc. announced the addition of Jon Bruss, MD, MSPH, MBA, FAAP, FIDSA as a Medical Director with therapeutic expertise in guiding global clinical trials in infectious disease. Dr. Bruss will combine therapeutic experience with existing Medpace clinical trial teams excellence to bring innovative anti-infective drugs to market in partnership with our sponsors.
―Dr. Jon Bruss strengthens the Medpace position supporting our sponsors who are advancing new drugs for infectious disease and vaccines, one of the largest pharmaceutical pipelines for development by biopharmaceutical sponsors,‖ said Jonathan Isaacsohn, MD, FACC, Executive Vice President, Medpace. ―Dr. Bruss’s experience and industry knowledge will allow us to provide strategic consultation to our sponsors in designing innovative clinical trial methods for many of our customers engaged in bringing new drugs to market in this challenging therapeutic area.‖
Dr. Jon Bruss has spent 20 years in drug development with global, clinical and regulatory expertise, managing clinical trials in the area of infectious diseases, including leading drug development in the US, Europe, and Asia. His clinical development experience includes the first in novel classes of compounds, involving adults, the elderly, children, and neonates. Dr. Bruss has held positions of increasing responsibility, including Chief Medical Officer, in both large and small pharmaceutical companies. He has also served as a consultant to numerous small biotechnology and large pharmaceutical companies. In addition, his clinical and academic research experience has included infectious disease research, vaccine research, public health management and tuberculosis control.
Dr. Bruss received his Doctor of Medicine degree from the University of New Mexico, School of Medicine and his undergraduate degree in Biology from the University of Utah. He completed his Internship and Residency in pediatrics at the Children’s Hospital of New Mexico and Clinical and Research Fellowships in Infectious Diseases at Harvard Medical School. In addition, he earned a Master of Business Administration at Northwestern University – Kellogg School of Management and a Master of Science in Public Health from Tulane University.
―Dr. Jon Bruss strengthens the Medpace position supporting our sponsors who are advancing new drugs for infectious disease and vaccines, one of the largest pharmaceutical pipelines for development by biopharmaceutical sponsors,‖ said Jonathan Isaacsohn, MD, FACC, Executive Vice President, Medpace. ―Dr. Bruss’s experience and industry knowledge will allow us to provide strategic consultation to our sponsors in designing innovative clinical trial methods for many of our customers engaged in bringing new drugs to market in this challenging therapeutic area.‖
Dr. Jon Bruss has spent 20 years in drug development with global, clinical and regulatory expertise, managing clinical trials in the area of infectious diseases, including leading drug development in the US, Europe, and Asia. His clinical development experience includes the first in novel classes of compounds, involving adults, the elderly, children, and neonates. Dr. Bruss has held positions of increasing responsibility, including Chief Medical Officer, in both large and small pharmaceutical companies. He has also served as a consultant to numerous small biotechnology and large pharmaceutical companies. In addition, his clinical and academic research experience has included infectious disease research, vaccine research, public health management and tuberculosis control.
Dr. Bruss received his Doctor of Medicine degree from the University of New Mexico, School of Medicine and his undergraduate degree in Biology from the University of Utah. He completed his Internship and Residency in pediatrics at the Children’s Hospital of New Mexico and Clinical and Research Fellowships in Infectious Diseases at Harvard Medical School. In addition, he earned a Master of Business Administration at Northwestern University – Kellogg School of Management and a Master of Science in Public Health from Tulane University.
Thursday, August 19, 2010
Medpace Lessons Learned: Global Trials
When a clinical trial goes global, a different mentality and philosophy must be applied in cross-functional working groups in your organization. From the clinical work at multi-national sites to data collection, read, and analysis, and even regulatory timelines, your trial must be designed in such a detailed and meticulous fashion to avoid change-in-scopes and other obstacles.
Medpace, your trusted and strategic partner for drug, biologic, and device development, has extensive experience with a global reach that can accelerate, expedite, and increase efficiency of your clinical development program. A few lessons learned from our experience and advantages that Medpace provides:
1) Think Globally; Act Locally – A broad vision is best, but having full time clinical and regulatory staff in the local countries is essential
2) Regulatory Headaches usually payoff – Some countries, such as Brazil, may scare sponsors due to the length and intensity of regulatory approvals and importation licenses. However, their “mega city” structure coupled with their patient populations provide a great location for a clinical trial.
3) It’s not about cost – Do not make decisions on countries due to cost. Perform a strong feasibility and go after countries where your desired populations are. It’s worth it.
We’re Medpace…and it’s a global thing.
Medpace, your trusted and strategic partner for drug, biologic, and device development, has extensive experience with a global reach that can accelerate, expedite, and increase efficiency of your clinical development program. A few lessons learned from our experience and advantages that Medpace provides:
1) Think Globally; Act Locally – A broad vision is best, but having full time clinical and regulatory staff in the local countries is essential
2) Regulatory Headaches usually payoff – Some countries, such as Brazil, may scare sponsors due to the length and intensity of regulatory approvals and importation licenses. However, their “mega city” structure coupled with their patient populations provide a great location for a clinical trial.
3) It’s not about cost – Do not make decisions on countries due to cost. Perform a strong feasibility and go after countries where your desired populations are. It’s worth it.
We’re Medpace…and it’s a global thing.
Tuesday, July 27, 2010
Thursday, July 22, 2010
Q: What is your experience in managing Intellectual Property protection?
A.Lyubchenko – This is probably the toughest part. India is best. They have added protection laws in 2005 which launched the pharmaceutical industry in India. They also have Intellectual Property laws, which is good. Russia does not have such a such law; and I do not believe Brazil does either. Russia and China are taking steps. We try not to provide any additional information and only provide it to those who need it.
Q: How is Budget Management and Negotiation facilitated in BRIC Countries:
J. Zimmerman – Have a local attorney in that country, who is someone you can trust, negotiate for you.
L. Koelle – For negotiations, having someone local is the only way to do it right. There are other things to consider to include in the budget. For example, the sponsor is expected to pay for some things In Brazil, that is not written out, but understood by the ethics committee. Another example and “hot topic” is providing at no cost, the study drug post-trial. All these things need to be included in the budget and local people have that knowledge.
It’s the additional costs, especially in oncology trials, that the sponsor needs to be aware of.
Q: Are sponsors walking away from Brazil and using Brazil as a last resort?
L. Koelle – We had a huge increase in clinical research in Brazil for the past 5 years, and I think we are reaching a plateau. As people understand what is going on, the new regulations are not making sponsors leave, it’s a matter of them becoming comfortable with them and understanding the risks involved, and then they bring their trials to Brazil.
A.Lyubchenko – This is probably the toughest part. India is best. They have added protection laws in 2005 which launched the pharmaceutical industry in India. They also have Intellectual Property laws, which is good. Russia does not have such a such law; and I do not believe Brazil does either. Russia and China are taking steps. We try not to provide any additional information and only provide it to those who need it.
Q: How is Budget Management and Negotiation facilitated in BRIC Countries:
J. Zimmerman – Have a local attorney in that country, who is someone you can trust, negotiate for you.
L. Koelle – For negotiations, having someone local is the only way to do it right. There are other things to consider to include in the budget. For example, the sponsor is expected to pay for some things In Brazil, that is not written out, but understood by the ethics committee. Another example and “hot topic” is providing at no cost, the study drug post-trial. All these things need to be included in the budget and local people have that knowledge.
It’s the additional costs, especially in oncology trials, that the sponsor needs to be aware of.
Q: Are sponsors walking away from Brazil and using Brazil as a last resort?
L. Koelle – We had a huge increase in clinical research in Brazil for the past 5 years, and I think we are reaching a plateau. As people understand what is going on, the new regulations are not making sponsors leave, it’s a matter of them becoming comfortable with them and understanding the risks involved, and then they bring their trials to Brazil.
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