Thursday, April 25, 2013

#PCTUS 2013: Partnerships and Outsourcing

To conclude our Partnerships experience, we learned about some of the challenges to be aware of when outsourcing to China and more about the Partnerships Award Winning partnership between PAREXEL, Pfizer and ICON.

In the presentation Overcoming Challenges in the Asia-Pacific Region: Roadblock and Opportuniites, Christina Bodurow of Eli Lilly; Warren Myers of Takeda Pharma; Patrice Hugo of Lab Corb and Stephen Porter of Dragon Bio-Consultants.

Porter believes that patient access in India and China have infinite access to patients. China has traditionally been less than the region. The market opportunity is growing at 25% a year. In terms of regulatory approval, it may be 12+ months. Guidelines on strategies to identify and mitigate risks for first-in human clinical trials. There are only 300 approved hospitals to do clinical trials in China.  China is not likely to follow any contracts. The standard of care in China is different, so it’s difficult to bring a western protocol in to the country. Start in China with the concept of international registration, success will follow with faster enrollment.

What is the clinical strategy/business model and does it vary country to country? Meyers comments that his company has recently begun registering products in Asia. For legacy assets, they’re seeking local access. They also have a large number of partners who are working within the country and then they work with local providers. He is quick to point out that the local Asian market isn’t consistent. There are regulatory and quality risks. He advises developing a local expert who also knows the global supplier.

LabCorp points out that 99% of their efforts are done in China to maintain GCP. They decided to have every important role in China based in the country  To expand their reach, they have opened a lab in Singapore and announced a strategic relationship with a Japanese company to harmonize their processes and have them cover the Japan only trials.

Porter also points out that different stages function differently in China, for example, life stage studies are great in China, but they’re lacking behind in the first-to-human testing. The cold chain and logistics are also a problem. On an incredibly innovative front, the country has just announced that they’re going to do a gene-screen on every new born. This will lead to tremendous opportunities when it comes to personalized medicine.

Problems can be solved from the beginning when it comes to moving some of your clinical trials into China?  An internal staff needs to be built within the country with individuals who know the ins and outs of clinical outsourcing.  Then, let locals learn from those individuals. Big Pharma needs to set standards and use the small team concept, sharing the knowledge and skill sets. Panelists encourage all going into the the Asian region to help and guide the sites, the sponsors and train the staff members. Also experience the work in their shoes - go into the field – visit the hospitals, sites, regulators – get to know who you’re working with.

We then transitioned into a panel that showed the true power of partnerships in clinical trials - the Pfizer/ICON/PAREXEL Partnership.  Panelists included Coleen Glessner of Pfizer; Chris Hilton of Pfizer; Dana Poff of Icon Clinical Research; Conal Burgess of Parexel International; and John Oidtman of Pfizer.

Pfizer was promoted to realign their partnerships structure after prompted by the FDA.  They started off by questioning how they could make their operations more efficient.  The original model of outsourcing Pfizer ran had 17+ functional service providers. This prompted them to eliminate the transactional bidding process.  This prompted them to go with a CRO vetting model, they needed the CROs to have the same willingness and approach to get to the same goal Pfizer was looking for – specifically why quality was going to be embedded in their work. In the model, they needed transparency into the resourcing, monitoring plans, visit schedules. The information isn’t always shared but needed it to be.  They then chose a system that would focus on 12 things that would get to the essence of what they needed to do which led to these seven metrics: Control of investigator fees, control of resourcing, quality performance, investigator satisfaction survey, key milestones on critical path studies, process improvement or innovation and noncompetitive or insufficient capabilities.

What were some of the learnings from this partnership?  It’s important to build trust and work with everyone involved – there is no such thing as overcommunicaiton. Coleen of Pfizer was the most surprised by commitment to quality in combination with the CRO’s implement of quality has been amazing. The infrastructure must be solid to commit to that in the long run. They had to focus on the cultures within the different sectors of the business – Pharma/CROs. These three teams had to start thinking like partners.

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