Partnerships in Clinical Trials

These 10 Reasons Partnerships is the One Event you Must Attend This Year

noreply@blogger.com (Jennifer) — Wed, 06 Jan 2010 15:44:00 +0000

We recognize how hard it can be to obtain approval to attend industry conferences right now. Yet we also know how important attending Partnerships in Clinical Trials is to the future of your organization. Partnerships is not just any conference, it is the industry event of the year and it is the one place “Where business gets done.” To make it easier for you this year, we’ve pulled together all the information you’ll need to make the case for your company’s investment.

1. It’s the most respected industry event that brings together the Who’s Who in senior clinical development and outsourcing leadership in an interactive and engaging environment to share strategies and inspire innovation – Get a glimpse into what the future of Pharma R&D will look like and determine how well your company is prepared

2. Over 1800 senior pharma, biotech and CROs executives from over 40 countries attend each year with whom you’ll be able to connect and exchange ideas around sourcing to low cost regions, regulatory, quality and drug safety, M&A and co-development deals and much more

3. The event offers rich content researched with industry leaders and the Partnerships Advisory Board, recognized for providing an unparalleled level of educational sessions and networking opportunities, and has an extensive history of delivering the highest-quality content and out-of-the-box Keynote Speakers not seen at any other event of its kind.

4. Partnerships’ extensive program agenda features over 150 speakers, 50 educational sessions, 8 in-depth workshops, and 8 custom tracks to spark new ideas for transforming our industry with more robust future business models such as risk/reward and virtual drug development.

5. New and innovative interactive learning and networking formats including roundtable sessions, workshops, speed networking, hall tours and a charity run to benefit cancer research.

6. With over 200 of the top clinical trial providers exhibiting at the event, you can spend time reviewing all of the products and services your company is planning on using (such as patient recruitment, central labs, e-technology) on the spot without having to schedule multiple office visits with suppliers.

7. Face-to-face time with your existing partners is critical to the success of our ongoing relationships which you can accomplish through formal pre-set meetings to optimize your time out of the office plus timely discuss ions on maximizing the true value of a strategic partnership with a CRO and understanding the drivers for sourcing for small, medium and large size sponsors

8. With the majority of your competitors attending this event, it is essential that your company is represented and is there to pick up on new industry information, trends and competitive intelligence on strategies in early clinical development, meeting post-marketing research obligations, approaches to RFPs and oversight, process efficiencies and cost containment, site management and more

9. The timely inclusion of topics related to our changing healthcare environment is paramount as we partner to manage uncertainties within our industry with one of the country’s foremost authorities, former Senator Tom Daschle, headlining these discussions

10. High-level discussions and new perspectives around value creation, strategic sourcing and partnerships, investigator sites, alliance

management, cost and contract management, global regulatory requirements and pharmacovigilance, and leading virtual teams among many other hot topics confirms that this conference is the one to attend in 2010

We hope to see you there!

Central Labs Spotlight: Peter Colbourne, ConcentRx Consulting

noreply@blogger.com (Jennifer) — Mon, 04 Jan 2010 15:03:00 +0000

With Central Labs coming up in February, we've started an interview series with some of the speakers we're looking forward to in February.

Our third podcast is with Central Labs Conference Chair Peter Colbourne. During this podcast, he answers the following questions:
-A look at Logistics standardization
-A preview of the Logistics Taskforce
-Some Logistics advice

Download Peter Colbourne's podcast here.
Download a transcript of Peter Colbourne's podcast here.

Centra l Labs West will be taking place February 3-5, 2010, and before then, we're going to highlight some of the speakers who will be joining us. We invite you to join our Central Labs LinkedIn group to network and communicate with others before and during the event!

Complimentary Web Seminar: Offshoring to Emerging Countries: Navigating Uncertain Waters

noreply@blogger.com (Jennifer) — Sat, 26 Dec 2009 14:00:00 +0000

Offshoring to Emerging Countries: Navigating Uncertain Waters
Thursday, January 21, 2010
2:00 PM - 3:00 PM EST

About the webinar:
As the biotech and pharma industries come out of the current downturn, sponsors will increasingly look for lower coast, high quality cost solutions to their clinical data needs. Combine this with the ever decreasing availability and high cost of clinical trial patients in the US, and we find we must look to the emerging markets for our patients. Setting up studies in far flung places presents significant challenges to the sponsor and can put him in unfamiliar waters. This webinar will discuss ways in which sponsors might safely explore these markets to generate the clinical data they need efficiently and ethically.

What you will learn:
• Understanding the nuances of the changing regulatory environments in offshore clinical trials to better manage trial risks
• Know your environment: an up-to-date picture of standards in India and China and other regions
• Matching trials to the right country: evaluating trial requirements with different regulatory and environmental factors
• Choosing CRO’s that have credible and substantiated experience in trials with key groups

Presented by:
Jacquie Mardell
Sr Director Clinical Operations
Metabolex

Register here.

Presented by:

Happy Holidays from Partnerships in Clinical Trials

noreply@blogger.com (Melissa) — Fri, 25 Dec 2009 11:00:00 +0000

We're taking some much needed time off from our coverage of Clinical Trials to celebrate the season with our loved ones. We want to sincerely thank you for your readership, your comments and your participation.

Here are our top posts from 2009:

We'll be back in January with more coverage.

We wish you Happy Holidays!

Complimentary Web Seminar: Offshoring to Emerging Countries: Navigating Uncertain Waters

noreply@blogger.com (Jennifer) — Wed, 23 Dec 2009 15:00:00 +0000

About the webinar:
As the biotech and pharma industries come out of the current downturn, sponsors will increasingly look for lower coast, high quality cost solutions to their clinical data needs. Combine this with the ever decreasing availability and high cost of clinical trial patients in the US, and we find we must look to the emerging markets for our patients. Setting up studies in far flung places presents significant challenges to the sponsor and can put him in unfamiliar waters. This webinar will discuss ways in which sponsors might safely explore these markets to generate the clinical data they need efficiently and ethically.

What you will learn:
• Understanding the nuances of the changing regulatory environments in offshore clinical trials to better manage trial risks
• Know your environment: an up-to-date picture of standards in India and China and other regions
• Matching trials to the right country: evaluating trial requirements with different regulatory and environmental factors
• Choosing CRO’s that have credible and substantiated experience in trials with key groups

Presented by:
Jacquie Mardell
Sr Director Clinical Operations
Metabolex

Title: Offshoring to Emerging Countries: Navigating Uncertain Waters
Date: Thursday, January 21, 2010
Time: 2:00 PM - 3:00 PM EST

Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/188567057

Central Labs Spotlight: Craig Lipset , Pfizer

noreply@blogger.com (Jennifer) — Tue, 22 Dec 2009 16:33:00 +0000

With Central Labs coming up in February, we've started an interview series with some of the speakers we're looking forward to in February.

Our second podcast is with Craig Lipset, Central Labs West conference chair. During this podcast, they answer the following questions:

-What are Craig's passion points?
-Why does the Central Labs West conference resonate with him?
-He discusses how industry continues to explore novel imaging techniques in the context of their early phase development programs.
-He discusses some of the standardization taking place in the industry.
-Lipset looks at what he sees coming in the future for this industry.

Download Craig Lipset's podcast here.
Download a transcript of Craig Lipset's podcast here.

Centra l Labs West will be taking place February 3-5, 2010, and before then, we're going to highlight some of the speakers who will be joining us. We invite you to join our Central Labs LinkedIn group to network and communicate with others before and during the event!

Attend Central Labs on us!

noreply@blogger.com (Jennifer) — Mon, 21 Dec 2009 22:01:00 +0000

That’s right, we’re offering a few exclusive all-access complimentary passes to Central Labs West – February 3-5, 2010 in San Francisco, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in the safe and efficient completion of clinical trial research to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Celtic Pharma, Bristol Myers Squibb, Pfizer, Novartis and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, January 20, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us in San Francisco.

For more on the Central Labs West event, visit the website:
http://bit.ly/65Qx2G

Partnerships keynote speaker Ethan Zohn's cancer is in remission

noreply@blogger.com (Jennifer) — Mon, 21 Dec 2009 16:23:00 +0000

For the 19th Annual Partnerships in Clinical Trials, Ethan Zohn will be joining us for the keynote speech on Monday, April 12. He's be addressing the personal perspective how the pharmaceutical industry has changed his life.

Last week, he found out that his cancer was in remission. Watch the video here.

Attend Partnerships in Clinical Trials as a Guest Blogger

noreply@blogger.com (Melissa) — Thu, 17 Dec 2009 15:34:00 +0000

That’s right, we’re offering a few exclusive all-access complimentary passes to Partnerships in Clinical Trials– April 12-14, 2010 in Orlando, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in clinical operations and development to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Shire Pharmaceuticals, Icon Development Solutions, Fierce Biotech, Kendle and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, March 24, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us in April in Orlando.

For more information about the event, please follow the links below:

For more on the Partnerships in Clinical Trials event, visit the website: http://bit.ly/7qIMWd

Download the Brochure: http://bit.ly/8yx3GT

Central Labs Spotlight: Guy Mascaro and Linda Sullivan , Metrics Champion Consortium

noreply@blogger.com (Jennifer) — Wed, 16 Dec 2009 17:21:00 +0000

With Central Labs coming up in February, we've started an interview series with some of the speakers we're looking forward to in February.

Our first podcast is with Guy Mascaro, the President of the Metrics Champion Consortium (MCC) and Linda Sullivan, Vice President of Operations at the MCC. During this podcast, they answer the following questions:

• A look at the history of the MCC and current initiatives at the Metric Champion Consortium
• Where they think companies go wrong in trying to measure vendors
• They look at the speed of growth at MCC and how it's become a pivotal player in the industry.
• A look at the panel discussion on MCC Metrics adoption implementation and updates at the Labs West program, tell us how you get companies to change their processes and adopt a new way of doing things.
• How can quantifying Labs deliverables make companies more profitable?
• Other thoughts.

Download Guy Mascaro's podcast here.

Centra l Labs West will be taking place February 3-5, 2010, and before then, we're going to highlight some of the speakers who will be joining us. We invite you to join our Central Labs LinkedIn group to network and communicate with others before and during the event!

Covance expanding in Asia-Pacific

noreply@blogger.com (Jennifer) — Tue, 15 Dec 2009 20:50:00 +0000

According to NJ.com, Covance will continue expansion in the Asia-Pacific region in order to accommodate the current growth taking place in clinical trials in the Asia Pacific region. They'll be expanding their Tokyo and Hong Kong offices, along with opening offices in South Korea and India. They also have offices in Australia and Singapore.

Nick Wright, vice president and general manager, clinical development services, Asia-Pacific, stated:
“Our new Asia-Pacific offices support our global expansion strategy, which targets the most qualified investigators and appropriate patient populations in a region that is increasingly important to clinical trials.’’

How open innovation could reinvigorate the pharmaceutical industry with fresh R&D opportunities

noreply@blogger.com (Jennifer) — Thu, 10 Dec 2009 15:27:00 +0000

Partnerships in Clinical Trial 2010 speaker Thomas Senderovitz recently wrote an editorial entitled "How open innovation could reinvigorate the pharmaceutical industry with fresh R&D opportunities." Read the article here.

He brings up several interesting observations about the current state of innovation in the Pharmaceutical market:
-Pharma innovation is often divided into therapeutic innovation and pharmacological innovation
-The cost of bringing new medicines to patients has increased dramatically over recent decades, while productivity has declined
-The pharmaceutical industry has done little to innovate their business model

The article also states:
The best innovative activity occurs when everyone - researchers, companies, government and nongovernment organizations - work together to ensure that new ideas reach public, but are appropriately regulated and efficiently delivered to those who need them.

What are your comments on this? Does the Pharma industry need to change their model? Should more players than just the Pharma companies and CROs work together to create new ideas and bring them to the public?

See Mr. Senderovitz give the keynote speech "Thinking Small in Big Pharma: What Will Future Pharma R&D Look Like?" Tuesday, April 14, 2010 in Orlando at The 19th Annual Partnerships in Clinical Trails Conference. For more on sessions at the conference, visit the Agenda at a Glance here or download the brochure here.

Would you like to guest blog from Partnerships in Clinical Trials 2010?

noreply@blogger.com (Thiago) — Wed, 09 Dec 2009 16:14:00 +0000

That’s right, we’re offering a few exclusive all-access complimentary passes to 19th Annual Partnerships in Clinical Trials– April 12-14, 2010 in Orlando, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in clinical outsourcing and development to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Shire Pharmaceuticals, Icon Development Solutions, Fierce Biotech, Kendle and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, March 24, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us in April in Orlando.

For more information about the event, please follow the links below:

For more on the Partnerships in Clinical Trials event, visit the website:
http://bit.ly/7qIMWd

Download the 19th Annual Partnerships in Clinical Trials Brochure:
http://bit.ly/8DRnHv

Rules-Based Medicine and Psynova Neurotech Announce Companion Diagnostic Collaboration with Roche

noreply@blogger.com (Melissa) — Tue, 08 Dec 2009 16:55:00 +0000

Applied Clinical Trials Online reported on December 3rd that Rules-Based Medicine, Inc. announced that Psynova Neurotech Limited, a majority-owned subsidiary of RBM, has executed an exclusive research and licensing agreement with Roche to collaborate on the discovery, development, validation and commercialization of diagnostic immunoassays to aid the clinical development and commercial differentiation of novel treatments for schizophrenia.

Learn more: Rules-Based Medicine and Psynova Neurotech Announce Companion Diagnostic Collaboration with Roche

Thank you from Partnerships in Clinical Trials Asia Pacific!

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 08:22:00 +0000

Partnerships in Clinical Trials Asia Pacific has concluded! Thank you for following our live coverage!

Goodbye from Singapore!

Partnerships in Clinical Trials Asia Pacific: Focus on China

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 08:08:00 +0000

Deng Ya-Zhong, Vice President, CONTRACT RESEARCH ORGANIZATION UNION, China

What is the current situation in China for clinical trials? There is a current shortage in staff, trend for regulatory approval times to further decrease, uncertainty time around approval times is reducing, and local knowledge and liaison with regulator is essential.

What is the strategy for China clinical trials?
-Synchronize China development and launch timelines with global development.

For site overviews, clinical trial needs to be conducted in SFDA certified hospitals. SFDA certified sites are rapidly increasing, from 125 in 2001 to 335 in 2009. There is a big imbalance in the talent location and the patient population. FDA inspections suggest a maturing quality outlook in China.

What is the challenge? There is an increasing competition for money for clinical trial sites. There is not much reward for conducting a clinical trial in China. The investigator may not have enough access to the hospital resource. There is also insufficient training for investigators.

In China, with all of the sponsors, there is a record shortage of qualified staff. Staff turnover is also very high.

Positives to conducting clinical trials with China:
-Personal Connection
-English communication
-Communication between CROs and MNCs
-Communication with HQ

Government initiation of supporting innovation – Government is focusing on developing new drugs. They are inviting all CROs to the country together to promote collaboration in the industry.

Key outsourcing partner requirements include:
-Clear understanding of China & foreign regulations
-Experience on the therapy area
-A highly trained, skilled, responsive and creative team
-A performance driven culture
-Frequent and consistent communication
-Flexibility to work under multiple types of requirements

Partnerships in Clinical Trials Asia Pacific: Focus on Vietnam

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 07:56:00 +0000

Dr. Nguyen Ngo Quang, Expert of the Science and Training Department, Secretary of ERB, MINISTRY OF HEALTH, Vietnam
Vietnam is the new country for clinical trials. There is a population of over 80 million. The biggest city in Vietnam is HoChiMinh in the south.

Introduction to Vietnam: Relations among principal Investigator, health authority and sponsors in the proposal, research and development of new medicines, vaccines and medical equipments. They have focused on the standardization of clinical research and application of GCP in Vietnam. Harmonization and international integration are key to the GCP system.

The necessities for GCP system development in Vietnam:
-Great and urgent needs for medicines and medial equipment both domestically and internationally
-Legal bases for the safe and effective exposure to new products
-Improving scientist doctors roles in using clinical study
-Requirements for integration, acceptance and respect international reuse on clinical trials

Supervision and inspection of clinical trials in Vietnam:
-They all follow the GCP standard
-Set up GCP inspection team under guidance of MoH
-Data management and SAE report system/DST-MoH

Approval procedure in Vietnam:
Sponsor and protocol lead to health authority’s approval in 30 days, EC 30 day approval and Minister approval in 15 days which lead to Implementation.

Partnerships in Clinical Trials Asia Pacific: Focus on India

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 06:50:00 +0000

Y.K. Gupta; Head, Dept. of Pharmacology, All India Institute of Medical Sciences & Coordinator; ZONAL PHARMACOVIGILANCE CENTRE, India

India is fast becoming a preferred partner for clinical research. There are 1.14 billion people in India. The health care is 6% of the GDP. There are 650,000 physicians. India also has 4 extreme seasons. The geographical location offers unique options for patient population.

Fundamental strengths for Indian Clinical Research: speed, lower cost, vast pool of treatment native patients, English speaking investigators and regulatory facilitation of parallel phase studies.

Twenty years ago, India was considered to be a hub for diseases. Now, the primary diseases in India are CNS, CVS, Cancers and Diabetes. One out of ten citizens have diabetes today in India. India becomes a comprehensive clinical source. There are more than 50,000 pharmacies and 30,000 technicians. There are over 200 PhDs to do the research in clinical analysis. There are 289 medical colleges and 282 dental colleges, as well as strong English speaking physicians.

General Issues faced by ECs
-Registration of ECV
-SOPs
-Accountability & Legal implications
-User fee
-Monitoring body for EC
-Record keeping
-Compensation guidelines
-Audits of ECs
-Disagreement between ECs in mulitcentre trials
-Training of EC members in GXP

The quality of the data in India is very high, making it a prime region to conduct clinical trials.

Partnerships in Clinical Trials Asia Pacific: Tailoring Outsourcing Strategies for the Asia-Pacific Region – Functional Insourcing

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 06:05:00 +0000

Chee Hwee Lim, Director of Clinical Operations, Asia Pacific Region, COVANCE

Three stages of Outsourcing evolution
1980s/1990s – Tactical outsourcing by big Pharma
2000-2005 – Biotech/specialty Pharma use outsource strategically
2005 – Partnerships models emerge between Pharma/CRO – Why? Cost benefit analysis.

What’s the current marketplace in the Pharma/Biotech industry?
Pharma:
-75% of global research comes from global Pharma
-It’s mostly done inhouse.

Biotech:
-25% of development spending
-50% of molecules in development
-Limited internal capacity, use of outsourcing is prevalent

Partnership Models:
Limited Competitivge Pool of Two CRO Models
Partnership in Growth
Sole Source Relationship
Functional Service Provider
Integrated Service Alliance

What is a critical success factor?
-Cultural fit
-Aligned Corporate Goals
-Maintain positive public employee perceptions
-Develop a solution with mutually beneficial economic characteristics
-Maintains continually in current workflow

What are the drivers for outsourcing?
-Product pipeline streamlining
-Opportunity to focus on core competence or activities
-Cost savings
Notice where the costs are coming from. Realize the longterm benefit of saving costs.
-Reducing the time to market: We can have a bigger focus of getting drugs to market faster.
-Expertise and specialization: Someone else could have more knowledge about a subject, and they may be able to better to the project with you

Integrated drug development services:
-Central labs, ECG, Clinical, etc are all one combined service. It’s from Phase I to Phase IV.
Full/Partial Clinical Services
-They have all or most of the clinical service components, including feasibility ans site selection, project management, clinical monitoring, and can be from Phase I to Phase IV.

What is best in Asia Pacific?
The Standalone and in sourcing will allow you to exert some control.

How do you successfully outsource? Fear is one of the things hold companies back from successful outsourcing. How do you choose your outsourcing strategy?
--Prior to making the decision to outsource, you must make an internal assessment.
--In Asia Pacific, what are the reasons to shift outsourcing to more tactical than strategic?

What's your opinion?

Partnerships in Clinical Trials Asia Pacific: The Sponsor-Site Relationship: Optimizing the CRO Partnership

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 04:18:00 +0000

CRO Perspective: Umakanta Sahoo, MBA, PhD, Executive Director-Asia Pacific, CHILTERN, India
Site Perspective: Deng Ya-Zhong, Vice President, CONTRACT RESEARCH ORGANIZATION UNION, China
Sponsor Perspective: Tina Kwan, Country Representative Operations, ALLERGAN, USA

Question: Are sponsors equally interested in maintaining a relationship when they outsource to a CRO?
Kwan, a Sponsor: The relationship from site to site should be good, as they can put priority on the studies, and the sponsor is looking for a longer term relationship. They’re looking for future, scientific and marketing relationships. As a sponsor, they want to retain the relationship as long as possible.
Sahoo, a CRO: They have sponsor and other side is the site and the investigator. They have to meet the expectations of both. For the sponsor, they have to have visibility, site selection, etc. They had to take a commitment from the site and give it to the sponsor. They have to meet expectations that are realistic from the sponsor and from experience from the site. Another link is or regulatory submissions, he has to make a timeline based on feedback from the site. It has to be complete and meet the expectations of the sponsor. Due diligence is key day to day. The quality of data is also important. Cost effectiveness is a key factor to success. Once the budget is agreed on, the CRO has to work with both the site and the sponsor so that the sponsor remains happy.
Dr. Ya-Zhong: Investigator side. As a CRO, they work with the investigators and manage over 14 hospitals. They’re developing a CRC network for hospital reliance. From the Site/Sponsor relationship, yes, every sponsor is interested in developing a relationship. However, some sponsors aren’t really aware of how to maintain or develop a relationship with site. Do they have enough resources to develop the site relationships? From the sponsor side, they look at quality and recruitment time line. The issue in the early stages is the investment. How do they care about the external costs, investigation costs, and in early stage they need to consider those things, so early investment is key.

Why are you working on long-term relationship with the site:
Sahoo: Site relationship is key, because multiple CROs can use the same site. It’s important for the CRO to have the relationships, and they have to look at: the motivations to do the trial and the costs. The investigator then has the challenge to keep up the long term plan. It’s his job to meet the expectations of data quality, so the CRO must maintain both relationships.
Ya-Zhong: A partnership is called MOU, for both Pharma and MNC. On the hospital side, they are more interested in efficiency and efficacy. The partnership with the CRO, they are looking for the CRO to be professional with efficiency and communication. Can they really work in the long term?

In summary: CROs sites and sponsors can work together to promote the relationships with the sites and investigators.

Audience Question: As a sponsor, we usually talk to investigator sites. They get requests for CRAs from the Sponsors instead of the CRO. What’s a reason for this?
Sponsor view: The site prefers to have sponsors CIA because they are closer to the knowledge of the compounds. The sites feel they can connect to the site sponsor more closely? To remedy this, they communicate the study design up front. As a company, they decided to outsource.
Site: In good communication practice, if there is a CRO involved, it is better to bring the CRO into “the know” and communicate directly to the site. If the CRO has given responsibility, they defiantly ask for the problem and confusion for. For the CRO respective, they look to be in touch with the site, and the site welcomes and accepts the sponsor site.
Investigator: Investigator wants to know the knowledge and the scientific initiatives of the protocol. The CROs have less knowledge on the scientific background. The site investigator wants immediate support. The facility might need equipment, if they’re talking to the sponsor; it’s easy for direct communication to the sponsor.

The goal of maintaining longer relationships with the sites are different between the CRO and the Sponsor. How can they maintain the relationship? Two keys: site recognition and staff training. Open communication for Sponsor visits between the CRO/CRA and Site investigation. What do you think about these points?

Partnerships in Clinical Trials Asia Pacific: How partnering with Japan CROs Can Benefit the Global & Asian Drug Development

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 02:49:00 +0000

Keiko Oishi, Senior Managing Director, CMIC Co, LTD, Japan
Umakanta Sahoo, MBA, PhD, Executive Director – Asia Pacific Region, CHILTERN, India

Ms. Oishi:
Major contenders in the Japanese CROs Market today are IRBD is declining, but CMIC and EPS are the largest domestic CROs. In 1994, the Japan CROs corporation was form. The Japanese did not allow clinical trials before then. The JCRO corporation has 37-40 members. The growth has been very dramatic.

Why are Japanese clinical studies contenders now? Japan has faced serious drug lag, they’re usually 4 years behind the US and European drug market. These drug makers can’t make any profits in Japan over these years they can’t participate.

Policy: 5-Year Clinical Trial Vitalization Plan in April 2007. The purpose of was to reduce drug lag to a total of 2.5 years by 2011. They’ve begun collaborating with Asia by joining research programs on important diseases and conditions.

MHLW’s Basic Principles on Clinical Trials:
Main Purposes – TO synchronize drug development timings in Japan with those of other countries and to eliminate Drug lag.

Outsourcing schemes to cover Japan in global studies
1. Global CRO which has monitoring operation in Japan
2. Global CRO and its allied Japan local CRO
3. Global Pharma’s Japan affiliate and Japan local CRO
4. Global HQ’s Assignment of local CRO as in-Country Clinical Caretaker (ICCC)

Japan CROs are accoustomed in SMO Management and Collaboration which is very essential in conducting clinical studies in Japan.

What is SMO’s function?
In order to support clinical investigational sites, Site Management Associate (SMA) and Clinical Research Coordinator (CRC) of SMO will function at the sites.

Dr. Sahoo:
Chiltern is a full service global CRO. It’s in 20 countries currently. Japan is a tremendous opportunity, and very high in market potential. The history of drug development, prior to 1998, there were no multinational Japanese studies.

Challenges for Asian Drug Development:
-Regulation and systems in each country are different
-Regulatory time lines vary
-Style of working varies – cultural understanding is essential – expectation mismatch
-A great challenge to handle logistics – import/export – local distribution
-Communication – language barrier – fluency in English
-EDC – Infrastructure, language, training, connectivity, preference for a specific EDC Platform

Partnerships in Clinical Trials Asia Pacific: Regional Regulatory Briefings – What It Takes to Get Your Regional Clinical Trial Going

noreply@blogger.com (Jennifer) — Thu, 03 Dec 2009 02:00:00 +0000

Regional Regulatory Briefings – What It Takes to Get Your Regional Clinical Trial Up and Running from a Regulatory Perspective
Deng Ya-Zhong, Vice President, CONTRACT RESEARCH ORGANIZATION UNION, China
Narendra Maharaj, General Manager, Global Clinical Operations, Glenmark Research Centre, GLENMARK PHARMACEUTICALS, India

Ya-Zhong: We need to understand the requirements behind the data requirements and the time line. In 1998, SFDA was introduced in China. It was a huge workload for the review. They had a shortage of staff. There were only 150 for review. In China, the government wanted to take the patients for safety concerns. They’re not allowed in Phase I study. All of the previous history data had to be reviewed by SFDA.

The industry should take some responsibility for the long time line. Long time lines could be a result of poorly written protocol. The submission process, from the local staff, doesn’t understand the communication for dosage requirements. Insufficient communication between the sponsors and the local MNC can cause problems as well.

Improvements after the DRR: IND review time – reduced 120 to 90 days, further reduced to 80 days.

New Module: Pre-meeting, special application; Sample testing: No need for sample testing and verification value

Special approval process:
-Early intervention
-Priority review
-Multi-channel communication
-Dynamic data supplement

What is expected from the SFDA:
-Shorter CTA approval time line for “innovative products”
-Removal of predefined patient allocation targets
-Increased opportunity for development consultation
-Increased acceptance of a common east Asia ethnicity assessments
-more technical requirements, but more guidance to follow
-Review and approval process control strictly by computer system, more detail but more transparent
-Regulatory requirements

What can the industry do? Understand SFDA’s direction, build up a local scientific capacity and capability regulatory affair, build up the communication channel with e SFDA, submit a high quality complete application earlier involvement in chin development in Asia studies.

Narendra Maharaj
There have been many positive changes in regulatory protocol in India over the last few years. These are Maharaj’s personal views.

Timelines for approvals are decreasing. If it’s biological, the review time is longer. They do align with authorities in other countries.
New developments:
Registration on trials – effective June 15, 2009
http://www.ctri.in/Clinicaltrials/index.jsp

-CRO Registration
-Inspectors
-Accreditation of site
-Registration of Ethics committees

Good links for clinical trial information in India:
http://cdsco.nic.in/ (DDSCO)
http://icmr.nic.in/ (ICMR)
http://nppaindia.nic.in/index1.html (Pricing)
http://chemicals.nic.in/npp_circulation_latest.pdf (Pricing)

Partnerships in Clinical Trials Asia Pacific: A Day in Photos

noreply@blogger.com (Jennifer) — Wed, 02 Dec 2009 10:44:00 +0000

Here are the Photos captured from Day 1 at Partnerships in Clinical Trials Asia Pacific!

Partnerships in Clinical Trials Asia Pacific: Accelerating Patient Recruitment and Retention in Clinical Trials

noreply@blogger.com (Jennifer) — Wed, 02 Dec 2009 08:13:00 +0000

Deven Parmar, MD, Vice President - Clinical Research, WOCKHART, India

Training and experience of clinical investigators globally – should there be training programs on the ethics of clinical trials globally?
-Genomic information in drug development – Extend FDA programs
-India has developed a review of all of the ethics committees.
-Payment compliance – Increase costs results in delays for payments

How can you attack and understand key issues in patient recruitment?
Examine:
- Study design challenge
- Site selection challenge
- Recruitment challenge

How do sponsors select the best countries for their studies?
-How do the patients feel about the existence of the disease?
-Are patients open to finding new cures for it?

How has technology helped with patient recruitment?

Computer and internet use has exploded. There are 31% of patients join trials because they found them on the internet. SMSs are very useful in encouraging clinical trail patients to continue participation in clinical trials.

Innovation ways for patient recruitment
-Use media, convey the right message to your patient.

Patient centric approach has work well for all parties. Patients become better educated and treated, sites see more success from motivated, compliant patient and drug companies.

Partnerships in Clinical Trials Asia Pacific: Strategies for Successful Site Evaluation

noreply@blogger.com (Jennifer) — Wed, 02 Dec 2009 08:07:00 +0000

Dr. Narendera Maharaj, General Manger, Global Clinical Operations, Glenmark Research Center, India

Why is it important to have the right site selected?
Site selection: Key elements to look at
-Speed
-Quality
-Cost

At the end of the day, it’s critical the both the sponsor and the CRO agree to what they select.

It is not important to have a database of investigators, what they need to know is that they have sites that they are comfortable with in terms of speed and quality. They need to have sites that they’ve had good experiences working with them. Look at a comprehensive of all of the sites you’ve selected, and find out what works best with you. You must plan, a CRA must do all of the homework before going to the site. It can all be done in house.

What does someone do as part of the site selection visit? One needs to prepare, do things at site, and have post visit follow up.

At the site visit, you must allow investigators to ask the right questions. They could be both general and study specific questions. For example, it could be about your patient recruitment and your safety requirements. At the end of the day one of the real questions is if the conductor has the interest to do the investigation properly.

There are now software analysis that will help you predict a site’s performance. It could be very helpful in selecting the right sites. Benchmark for your sites according to your own experience are critical for beneficial benchmarks.

After having a round of site evaluation experiences, do a benchmark on the information from the sites. Come up with a way to rank the sites.