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.
Thursday, August 19, 2010
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.
Going to BRIC Countries can be scary, especially if this is your first time. What are some factors or advice?
L. Koelle – Have local people with strong knowledge work with you. Whether it is an affiliate of your company or a CRO, having contacts at the agencies working with you is best. Having a partner, like a CRO from the very beginning, to obtain importation licenses and having a submission strategy is best.
For example, new regulations were reached in Argentina that contracts need to be signed before they reach the ethics committee. Having regional and country specific knowledge will best resolve the issues that arise.
J. Zimmerman – Fear of the unknown is the biggest factor from a clinical operational management perspective. Having a large multi-national CRO partner, especially for a small biotech company, is best. BUT, do not go where the CRO does not have staff.
A. Lyubchenko – Having a CRO with a local staff for regulatory connections will make it easiest for you. “Think Globally; Act Locally.” Big Pharma, like J&J, has local people in all BRIC countries, and they guide us through the process. They know the best.
L. Koelle – Have local people with strong knowledge work with you. Whether it is an affiliate of your company or a CRO, having contacts at the agencies working with you is best. Having a partner, like a CRO from the very beginning, to obtain importation licenses and having a submission strategy is best.
For example, new regulations were reached in Argentina that contracts need to be signed before they reach the ethics committee. Having regional and country specific knowledge will best resolve the issues that arise.
J. Zimmerman – Fear of the unknown is the biggest factor from a clinical operational management perspective. Having a large multi-national CRO partner, especially for a small biotech company, is best. BUT, do not go where the CRO does not have staff.
A. Lyubchenko – Having a CRO with a local staff for regulatory connections will make it easiest for you. “Think Globally; Act Locally.” Big Pharma, like J&J, has local people in all BRIC countries, and they guide us through the process. They know the best.
Panel: Differentiating the BRIC Countries
LIVE from Miami, FL!
Differentiating the BRIC Countries to Overcome Unique Difficulties within those Regions
Clinical Research in Emerging Countries
Panelists Include:
Ms Lais Koelle, Director, Clinical Operations, Latin America, Medpace
Mr Joe Zimmerman, Senior Director, Clinical Operations, Amylin
Ms Annie Lyubchenko, Manager, Global Regulatory Affairs Strategic Policy & Support, Johnson and Johnson
Moderator:
Mr William Chang, JD, Associate Director, Clinical Operations, Gilead Sciences
Opening Comments from panelists. BRIC Countries include: Brazil, Russia, India, and China.
L. Koelle –
Brazilian economy is growing ~5%/year, which makes it an important market for pharmaceutical products. 8th Pharma market globally. Clinical Research is an important piece to capitalize upon that growth. Primary challenges are the complex regulatory system and bureaucratic "ANVISA" to avoid further delays in trial approvals.
Advantages:
Quality of Data is top notch
Investigators are extremely motivated
Accelerated Patient Recruitment AND High Retention
Worth the challenges of the regulatory.
J. Zimmerman
Why are we interested in BRIC Countries?
Macroeconomic growth is exponentially greater in BRIC countries than the developed world. Data quality is good, recruitment time is less, and we are currently seeing success in a trial that is running in all four BRIC countries. However, cost is not the most compelling reason to go to a BRIC country…it’s access to patients
Lessons Learned:
1) Think Locally (Additional training for sites/CRAs; Translation Offerings)
2) Things Change (Governments, Internal Conflict, Foreign FDAs may later reconsider allowing to run your trial)
3) Don’t do it alone (Development and Services Organizations to partner with for importation and management)
A. Lyubchenko
Why do Pharma go to BRIC Countries? At J&J, our credo states to bring products to everyone in need. Regulatory Challenges: Brazil is tough and complex; Russia takes awhile to get approval but nothing too challenging; India is changing; China is long and extensive, similar to submitting the NDA in the USA.
Takeaways: Include China early in the process to stay on timelines.
Differentiating the BRIC Countries to Overcome Unique Difficulties within those Regions
Clinical Research in Emerging Countries
Panelists Include:
Ms Lais Koelle, Director, Clinical Operations, Latin America, Medpace
Mr Joe Zimmerman, Senior Director, Clinical Operations, Amylin
Ms Annie Lyubchenko, Manager, Global Regulatory Affairs Strategic Policy & Support, Johnson and Johnson
Moderator:
Mr William Chang, JD, Associate Director, Clinical Operations, Gilead Sciences
Opening Comments from panelists. BRIC Countries include: Brazil, Russia, India, and China.
L. Koelle –
Brazilian economy is growing ~5%/year, which makes it an important market for pharmaceutical products. 8th Pharma market globally. Clinical Research is an important piece to capitalize upon that growth. Primary challenges are the complex regulatory system and bureaucratic "ANVISA" to avoid further delays in trial approvals.
Advantages:
Quality of Data is top notch
Investigators are extremely motivated
Accelerated Patient Recruitment AND High Retention
Worth the challenges of the regulatory.
J. Zimmerman
Why are we interested in BRIC Countries?
Macroeconomic growth is exponentially greater in BRIC countries than the developed world. Data quality is good, recruitment time is less, and we are currently seeing success in a trial that is running in all four BRIC countries. However, cost is not the most compelling reason to go to a BRIC country…it’s access to patients
Lessons Learned:
1) Think Locally (Additional training for sites/CRAs; Translation Offerings)
2) Things Change (Governments, Internal Conflict, Foreign FDAs may later reconsider allowing to run your trial)
3) Don’t do it alone (Development and Services Organizations to partner with for importation and management)
A. Lyubchenko
Why do Pharma go to BRIC Countries? At J&J, our credo states to bring products to everyone in need. Regulatory Challenges: Brazil is tough and complex; Russia takes awhile to get approval but nothing too challenging; India is changing; China is long and extensive, similar to submitting the NDA in the USA.
Takeaways: Include China early in the process to stay on timelines.
Thursday, July 15, 2010
The Safety Apocalypse – Where Do We Go From Here?
It seems like you no longer have to look for drug safety gossip…it finds you! Any website you browse, newspaper you open, or evening news you tune into, there is talk about Avandia, diabetes safety, and cardiovascular risk. In a previous blog – Battle of the Brains - Orlando – we asked the question of what measures and steps the FDA would take to prevent this in other therapeutic areas. Well the increased reports of MI due to glucose lowering Avandia has finally found a mate in an anti-obesity drug, Qnexa.
Hitting the press yesterday, the FDA said “reviewers should take into account rates of depression, memory and concentration lapses, and heart-related issues, among others.” Ring the bells; we’ve got a match.
But besides the high pressures these pharmaceutical companies are facing by the regs, feds, and industry, what can be learned? Medpace knows adjudication is the answer. Better articulation of final reports, real time platforms for adjudicators, and easily customized, study specific portals allow the adjudication committee to reach a unanimous diagnosis for each case identified and presented.
Medpace’s ClinTrak® Adjudication Module is a component of our proprietary project management software program housing EDC and Adjudication capabilities. To learn more about Medpace, ClinTrak®, or our Adjudication excellence, check out http://bit.ly/aWVjkL.
Hitting the press yesterday, the FDA said “reviewers should take into account rates of depression, memory and concentration lapses, and heart-related issues, among others.” Ring the bells; we’ve got a match.
But besides the high pressures these pharmaceutical companies are facing by the regs, feds, and industry, what can be learned? Medpace knows adjudication is the answer. Better articulation of final reports, real time platforms for adjudicators, and easily customized, study specific portals allow the adjudication committee to reach a unanimous diagnosis for each case identified and presented.
Medpace’s ClinTrak® Adjudication Module is a component of our proprietary project management software program housing EDC and Adjudication capabilities. To learn more about Medpace, ClinTrak®, or our Adjudication excellence, check out http://bit.ly/aWVjkL.
Thursday, July 1, 2010
Battle of the Brains – Orlando
The weather wasn’t the only thing hot in Orlando. Take the Dr. David Orloff (Medpace Exec Director, Regulatory Affairs; Former FDA) and Dr. Steven Nissen (Chair, Cardiovascular , Cleveland Clinic) debate over the new FDA standards of novel diabetes drugs at the ADA’s 70th Scientific Session as an example.
2 opposite views with a common thread – increased safety and efficacy for diabetes drugs. But what is the best way to deliver better drugs and minimize the CV risk in doing so?
Nissen’s support of the one-size-fits-all stems from his meta-analysis of GSK’s Avandia (rosiglitazone) which showed 43% increase in relative risk for Myocardial Infarction. Nissen criticizes placebo-endpoint studies and calls the industry’s “glucosecentricity” for expediated approvals and paved the way for drugs like Avandia.
Orloff, however, takes a more nuanced approach citing Nassim Nicholas Taleb’s “Black Swan Theory” on the biases that ensues from a rare and uncertain event. Dr. Orloff expresses the need for customizable and agent specific review to curtail development time and save the patient money in the long run.
Orloff, an expert at crafting clinical development plans, has been the thought leader in the CV and diabetes spaces for years.
You can gain a better understanding of the new FDA guidelines here: http://www.medpace.com/AboutUs/NewsAndEvents/OnDemand/OrloffPodcast.aspx
OR can meet with Dr Orloff at the CBI Obesity and Diabetes Summit in Arlington, VA July 20-21.
Is this the first step by the regs towards standardization across CV related indications? Is obesity, cholesterol, and blood pressure next? We shall see…
2 opposite views with a common thread – increased safety and efficacy for diabetes drugs. But what is the best way to deliver better drugs and minimize the CV risk in doing so?
Nissen’s support of the one-size-fits-all stems from his meta-analysis of GSK’s Avandia (rosiglitazone) which showed 43% increase in relative risk for Myocardial Infarction. Nissen criticizes placebo-endpoint studies and calls the industry’s “glucosecentricity” for expediated approvals and paved the way for drugs like Avandia.
Orloff, however, takes a more nuanced approach citing Nassim Nicholas Taleb’s “Black Swan Theory” on the biases that ensues from a rare and uncertain event. Dr. Orloff expresses the need for customizable and agent specific review to curtail development time and save the patient money in the long run.
Orloff, an expert at crafting clinical development plans, has been the thought leader in the CV and diabetes spaces for years.
You can gain a better understanding of the new FDA guidelines here: http://www.medpace.com/AboutUs/NewsAndEvents/OnDemand/OrloffPodcast.aspx
OR can meet with Dr Orloff at the CBI Obesity and Diabetes Summit in Arlington, VA July 20-21.
Is this the first step by the regs towards standardization across CV related indications? Is obesity, cholesterol, and blood pressure next? We shall see…
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