The Partnerships in Clinical Trials Blog focuses optimization intelligence, regulatory trends and globalization strategies for both as sponsors and CROs.It is an extension of the Partnerships in Clinical Trials Conference.
As a reader of the Partnerships in Clinical Trials blog, mention code XP1700BLOG when registering to join us in Orlando to receive a discount of 15% off the standard rate!
Would you like to guest blog on our site? Or send us feedback? Send an email to jpereira@iirusa.com.
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
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.
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
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.
Central 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!
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 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.
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
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.
Central 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!
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.’’
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.
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
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.
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
Dr. Nguyen NgoQuang, 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.
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.
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?
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?
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
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
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.
Dr. NarenderaMaharaj, 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.
Joan Shen, MD, PhD, Director, CNS, Clinical Research and Development, WYETH RESEARCH, USA
Major objectives: -Define trail needs -Generate a global protocol
Identify the site, contact sites personally instead of using the corporation staff. They visited the site and wanted to explore the capacity of the sites. Upon visiting the sites, they share the protocol in the hospitals. They make sure they have a patient resource.
They have been working with regulators, it’s helpful or big Pharma to come together with international standards. They’ve now reached a common consensus on how trials should be run internationally. This is just one effort to harmonize. They’ve had the FDA join as well.
How do you define trial needs? They’re not able to choose the vendor. They were forced to work with multiple vendors, as the CROs choose who they will work with. They looked at statistics, but also data management, regional staff, and statistics. They can choose which CROs can provide all services. The Central CRO will help with rectory submission, monitor sites in multiple countries and help with meeting planning.
In this specific example, they wanted a CRO to cover all the regions. They needed a vendor who could do everything: experiences and reputation, key team members, pricing advantages and full services versus partial service. As a team, they have the flexibility to choose the CROs who have better quality.
How do you collaborate with a CRO? One vital aspect is to ensure you set up everything you need to make the trial happen successfully. Set up communication channels. Make sure everyone can communicate with others. For both sides, language communications is very important.
Keys to successful collaboration: -Communications Channels -Data management and integration -Site selection, set up and monitoring -Investigator meeting preparation
How do you ensure quality when working with CROs? -Site monitor training -Consistent message to the sites -Protocol implementation -Frequent monitoring visits at site to verify source documents and to monitor progress -Frequent and timely review of the individual subject data by sponsor medical team
Simon Britton, Vice President, Clinical Development, PPD, USA
PPD discusses what a smaller CRO brings to the table. What are the advantages? In terms of basic numbers, North America and Western Europe are slow growing market. North America is decreasing in terms of trials. There is a greater growth in Asia.
Compared to other regions, Asia is a small number. With the population size and the Pharma markets, the market is clearly growing in this region. The numbers of trials coming to Asia that are registered provide a steady growth. By country, China and Korea and Thailand are growing rapidly. The market growth is similar. The populations are large and becoming more wealthy. They’re more likely to spend money on health with their disposable income.
Difficulties in Asian Market: -Regulation and adherence to GCP vary among countries in Asia Pacific -Increased competition for GCP-trained investigators -Importing drug samples and clinical supplies -Infrastructure for EDC varies by country -Additional treatment costs -Insurance and indemnification language -Low literacy rates complicated obtaining Informed Consent
Now, generally in clinical trials, CROs are looked at as resources. They global CROs have to look at and be educated by the local companies in the language and the culture of the region. From a global perspective, it’s difficult to understand cross-culture.
Why did PPD buy Excel? As the region becomes more important, they need to have a ground team to understand the region and the culture. Building a team may take too long and there may be some special techniques lost throughout the process. Local providers can provide pivotal insight.
From Excel’s point of view, they’re looking at how local and global CROs differ, what the key issues and challenges are, and how local companies ensure quality in trials. In each country, there are a few small CROs that operate better than the global CROs.
Differences: Global CROs provide: -capital -infrastructure -global expertise
Local CROs provide: -knowledge of local markets -scale of operations in local markets -investigator/hospital knowledge -lower pricing
The growth of the aging population leads to companies placing their trials in Asia. Every multinational company is using their resources to drive the growth faster for site selection. How are you going to drive this? Are you going to look to place your strengths in Indianapolis or Shanghai? Who is more likely to win the business? The market states that the local CROs are winning the business.
A key differentiator for small CROs is the ability to throw resources at a trial quickly. Most global players can’t do this with their resources. Turnover is high in Asia. Who is better at managing turnover? The local CRO will be better than the office in the US. The costs are increasing across all regions. Local players are better at containing the costs. In Japan, the local CROs are not in Tokyo. They’re moving to the smaller areas. Cost centers are being moved to more affordable places. The landscape in China is changing as well. The population has more world experience. The doctors and hospitals are experiencing private hospitals and rural insurance.
Lack of local knowledge is a roadblock for global CROs.
Key factors for local CROs to compete with large CROS: -Continuous training -Answering site concerns rapidly -Dedicated teams -Turn-over planning -Site knowledge
Albert G.S. Liou, Corporate Vice President and General Manager, Asia-Pacific Region, PAREXEL INTERNATIONAL, Taiwan
Melvin Toh, Vice President, Pharmaceutical Development, CK LIFE SCIENCES, Hong Kong
Fidela Ll. Moreno, MD, Vice President, Global Development Operations, Clinical Site Management and Monitoring, ALLERGAN, USA
The trend has been moving towards the leadership of global trials to be lead in Asia. The innovation trends for drugs in Asia are expanding beyond generics. Moving forward, there is the opportunity to develop more drugs.
From a partnership perspective, what is it a biotech is looking for? Background for Mr. Toh, he has seen many biotech companies are setting up in Asia and Singapore. A biotech sponsor is different from a Pharma sponsor. They look for different things in CROs. They are resource restrained, they don’t have the manpower, and they’re looking for someone to fill in the gaps. Everything they do is outsourced. About 40% of drug development programs are done by biotech companies. Focus should be how they interact with biotech companies versus Pharma companies.
Ms. Moreno states that big Pharma is looking for knowledge base an expertise. More and more companies are really looking for new places to go. For the past year, small to midsized companies have entered Asia Pacific. They’re just now building their clinical trial models. Singapore is their hub, and other countries are their spokes in the Allergan model. They all report into Singapore. The hub and spoke model gives them flexibility and in setting up operations in APAC, they tend to begin small. They rely more and more on the CRO partners to help them bridge the gap of the work volume in Asia Pacific.
As for operations, what are the challenges? Turnover is a reality. CROs have great human resource planning; however, sponsors have the approach the staff. It’s key to look at their replacement agreement due to turnover in this competitive market. This needs to be established in the contract. What else are CROs looking for? What is the partner’s ability to be flexibility with the resources?
Co-monitoring visits are significant. One must know that the CRO turnover rates are high. They’re bad in Asia, USA, and Canada. The sponsor involvement creates a familiar face to build the relationship with the trial. It’s key to touch base with them first before outsourcing to CROS.
Ms. Moreno states that when CROs, they integrated the contract into their Allergen piece. By integrating the two, investigator sites can’t tell who is a CRO and who is the Sponsor.
Is using the Internet for communication for site services. Is this something we are ready for or are Asia trials not ready? Asian companies are ready, there is a lot of data entry that can be done in Asia. Back in the late 90s, sites were already downloading reports from the internet. An increasing number of biotech companies are being set up in Asia. The funding increases as they hit specific milestones. More milestones equal more money. When they go to the CROs, they’re looking for someone who can deliver on time and in a proper manner.
Japanese-based clients have headquarters out of Japan. In Asia, we’re looking towards Japan, and running trials out of Japan. Japanese sponsors are now getting closer. There’s direct management control over the trails across the world. With Japan taking more and more leadership opportunities, is this a great opportunity for the CRO industry to provide growth and promotional opportunities?
In Asia Pacific, there is as much talent in Asia as overseas. The true question is for headquarters. Are headquarters prepared to let Asia Pacific lead clinical trials? Moreno has seen both options, it’s very company and management specific. What would be the advantages of having the global leadership in Asia? From a time perspective, the population is where the sites are. Even though the study is being conducted, the management leadership is coming up from Asia. Would you consider the prevalence of the disease from project leadership? Someone should be on the ground with medical expertise. An obvious solution to this is to have project leaders where the projects are taking place. The expertise is sitting there and is able to speak with them while operating in the same time zone. Many companies are based in Asia; it’s a hub to run global trials.
Sven Ohlman, Regional Director Clinical Study Operations Asia, ASTRAZENECA, Singapore Ruiping Dong, MD, PhD, Vice President, Global Development & Medical Affairs, Asia-Pacific & Emerging Markets, BRISTOL-MYERS SQUIBB, Japan Larry Fiori, Associate Director, Clinical Trial Outsourcing & Compliance, Compliance & Quality Management, BOEHRINGER INGELHEIM PHARMACEUTICALS, USA
There is a change most of the companies do their clinical trials in Asia. This challenge is not only for the global market but also the local market. There is a significant pharmaceutical market, and globally the market will be be #3 in 2011 and #2 in 2020. There is an increase in regulation requirements in clinical trials. It’s a regional opportunity. It’s significant to make the Pharma companies come out and pay attention.
Focus on Strategy and opportunity Asia-Pacific is a very diverse region. There’s an uneven spread of the world’s population, about 50%. There’s also a broad range of growth rates. Many of the countries are westernized, many are not
The one strategy in Asia Pacific is really to focus on development. There are three phases, it will take a long time and cost you more to operate in the country. The strategy has changed, it is now: full development, bridging strategy, and global/regional development.
The best example for clinical activity in China and India really grew in 2005. This was affected by the increase in IP protection which lead companies realized the market and value.
The local companies were forced to recognize the the regulations. Many western Pharma companies created minimal activity for the registration purposes. More and more regional studies will take place in Asia pacific.
Keys for rationale for Asia Clinical Trial Development -Scientific rationale – similar genetic and disease patterns -Regulation rationale – responding to change environment -Operational rationale – improve efficiency/productivity -For patients – let patient access innovative drugs early
Focus on operational challenge Seven deadly challenges 1. Getting the global development strategy right for Asia Regulatory expectations we need to meet and address. There are seven markets that required studies approved by PMDA: China, Korea, Japan. This leads to a significant number of studies approved in the region. 2. Clinical trial cost level in Japan It’s the highest level in the world when combining internal and external costs. One should include Japan development in the core global program to include the country in Clinical Trials when beginning a clinical trail there. 3. Clinical trial application approval times There are long approval times in some Asian territories. This is an important issue in China. Large late stage studies with fairly long recruitment are allowing China to catch up. Recent trends, however, are showing faster approval times. 4. Maturity of investigator sites Invest in GCP and other training for investigators and site staff. Consider your geographic footprint. Is anyone else there? 5. Maturity of CRO industry in Asia CRO footprint and capabilities often vary in different in Asia. This presents some challenges, which could lead sponsors to go to other countries for the delivery model. Make your own through assessment of external provides in the region based on objective data and track records 6. Internal project/study management capabilities Historically projects have been managed by western sites. However, Asia‘s role increasing studies this is becoming inefficient, so western management may hinder efficiency. 7. Global perception of Asia The global perception makes it a challenge. How can they improve this perception? A key is to get quality right. CROs should focus on the training of their people and focusing on leadership talents.
Focus on measurement What measures can we put in place as a team? The CROs, the sites, the patients and the sponsor should all be responsible for this. Some important areas to focus on : contracts and expectations,
SOPs need to be defined. The CRO needs to be able to use their SOPs, because this is what their staff is trained for.
Co-monitoring should be built into management plans for sponsors and site. Training is critical. The relative shortage and lack of experience of field monitors is a constant problem in Asia. They should be specified who is responsible for what.
Report Cards given to trial sites can improve this. A timely review and feedback for continuous improvement and quality can help the productivity of the sites. On site teams were able to identify sites where there were issues with the trials being conducted. They were able to work with the sites to fix simple technique issues that were causing the problems.
Fidela Ll. Moreno, MD, Vice President, Global Development Operations, Clinical Site Management and Monitoring, ALLERGAN, USA
Dr. Moreno welcomes us to the first Asia Pacific Partnerships conference. The annual Partnerships in the US brings together solution providers and Pharma. They share best practices, project management, and successful strategies when introducing new drugs into the market. It’s a very anticipated event in the United States where partnerships are formed and industry information sharing is a reality. Now Partnerships is making it’s introduction in Asia Pacific. Asia is making up 57% of the world’s global population, companies are focusing on this region. Strong strategic partnership can be formed here. We need to find solutions to our current economic climates, and that can be done at this event.
Central 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!
James Dewey Watson was born and raised in Chicago, Illinois. He was a precocious student, and entered the University of Chicago when he was only 15. He received his Bachelor of Science degree in Zoology four years later, and went on to earn a Ph.D. in the same subject at Indiana University. He was engaged in research at the University of Copenhagen in Denmark when he first learned of the biomolecular research underway at the Cavendish Laboratory of Cambridge University in England. Watson joined Francis Crick in this work at Cambridge in 1951.
Together, Watson and Crick attempted to determine the chemical structure of living matter. When their initial research failed to produce results, the directors of the laboratory ordered them to end their investigation, but they continued their work in secret and, on February 28, 1953, they made a momentous discovery.
The two scientists had determined the structure of the molecule deoxyribonucleic acid (DNA), of which all living matter is made. In June they published their findings in the British science journal Nature. The article created a sensation. The DNA molecule, Watson and Crick had found, is shaped like a double helix, or "gently twisted ladder." The two chains of the helix unlink "like a zipper," and reproduce their missing halves. In this way, each molecule of DNA is able to create two identical copies of itself.
The initials DNA and the elegant model of the double helix, became known around the world. So did Watson and Crick. Their discovery revolutionized the study of biology and genetics, making possible the recombinant DNA techniques used by today's biotechnology industry.
James Watson became a Senior Research Fellow in Biology at the California Institute of Technology, before returning to Cambridge in 1955. The following year he moved to Harvard University, where he became Professor of Biology, a post he held until 1976.
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