Partnership between CROs and Drug companies
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There is a new trend in the working relationships between CROs and Drug companies. The relationships evolve from the traditional transactional model to a partnership in the recent years. The partnership in the pharmaceutical industry is a new adventure to both CROs and Drug companies, and it also impacts programmers. The partnerships will bring the new challenges and opportunities to programmers. We will work with not only our colleagues, but also employees from other vendors and clients. The partnership working environments will require the new set of rules and behaviors. The paper will discuss what kind of challenges and opportunities we will encounter and how we will resolve and succeed in the partnership working environments. The paper will specifically discuss the role of a project leader in CRO who are working directly with the clients and other vendors in the partnership environments. It will emphasize how important the culture is in the partnership environments and how the project leader helps to build the right cultures in the partnership environments.
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Partnership between CROs and Drug companies
- 1. Accenture Accelerated R&D A New Trend in the industry – Partnerships between CROs and Pharma. Do we know how to work in this new relationship? Kevin Lee Clinical Data Strategies, Senior Consultant PharmaSUG June 4nd, 2014 We help our Clients deliver better outcomes, so they can improve the quality of people’s lives.
- 2. Disclaimer Any views or opinions presented in this presentation are solely those of the author and do not necessarily represent those of the company. 2© 2014 Accenture All Rights Reserved.
- 3. What is the partnership? 3© 2014 Accenture All Rights Reserved. An arrangement in which parties agree to cooperate to advance their mutual interests
- 4. 2012 Avoca Report - % of Partnerships between drug companies and CROs 4© 2014 Accenture All Rights Reserved. About 50% of Drug Companies About 70% of CROs
- 5. Types of Service Agreements between Drug companies and CROs. 5© 2014 Accenture All Rights Reserved. Transactional Model Functional Service Provider Model Strategic Partnership Model
- 6. Transactional Model 6© 2014 Accenture All Rights Reserved. • One or more projects at a time • Short-Termed • CROs usually work in their own infrastructure. • Drug companies provide “thinking” and CROs provide “doing”. • Cost-based agreement
- 7. Functional Service Provider (FSP) Model 7© 2014 Accenture All Rights Reserved. • Drug companies outsource functions to CROs. • Drug companies will work with many different vendors which provide the different functions. • Cost- or Value- focused agreement • Short-Termed or Long-Termed Proje ct Data Manage ment (CRO 1) STAT (CRO 2) Medical Writing (CRO 4) Clinical Operatio n (CRO 3)
- 8. Strategic Partnership Model 8© 2014 Accenture All Rights Reserved. • Long-Termed • Drug companies outsource projects for the agreed-duration. • CROs provide “doing” as well as “thinking”. • Strategy-focused agreement ( e.g., value, expertise, flexibility in resources, finance and location) • Drug companies and CROs work in the same infrastructure. (e.g., in the same SAS® working environment rather than in their own SAS working environment)
- 9. Why Strategic Partnerships? 9© 2014 Accenture All Rights Reserved.
- 10. Challenges in Partnerships 10© 2014 Accenture All Rights Reserved. • Are all parties in the same page about the partnerships? Partners? Some functions? • Changed roles and responsibilities (i.e., some programmers in sponsor need to manage service provides rather than programming)
- 11. Challenges in Partnerships 11© 2014 Accenture All Rights Reserved. • Different corporate cultures – could be a big challenge, but at the same time, a huge advantage if leaderships are able to take an advantage of them.
- 12. Challenges in Partnerships 12© 2014 Accenture All Rights Reserved. • Different Geographic locations – not much face time. • Different Time Zone – a limited communication time
- 13. Opportunities in Partnerships 13© 2014 Accenture All Rights Reserved. • More learning opportunities – The Sponsors and Service Providers will be able to learn from each other. • Different SAS programming techniques and process • Macros • Standards (e.g., CDISC) • Process flow • Software • Exposure to different corporate cultures (e.g., working cultures and geographic cultures ) • Chance to learn new ideas and different perspective
- 14. Opportunities in Partnerships 14© 2014 Accenture All Rights Reserved. • Chance to achieve excellence together • Exposure to more functions (e.g., Data Management, Statistics, Standard, and Regulatory)
- 15. How to achieve Successful Partnerships 15© 2014 Accenture All Rights Reserved. Strategy Culture Successful Partnership
- 16. Strategies for Successful Partnerships 16© 2014 Accenture All Rights Reserved. Joint Steering /Operation committee Communication Plan Who will talk to whom Escalation process Governance Structure (i.e. KPI) % of in-time project % of error rate Response Time Specified roles and responsibilities Clear Expectation
- 17. Cultures Eat Strategies for lunch 17© 2014 Accenture All Rights Reserved.
- 18. Cultures in Successful Partnerships 18© 2014 Accenture All Rights Reserved. Trust • In order to gain a trust from people, we need to show that we care of their well- being. If we don’t care for our partner’s well-being, we don’t get their trust. Win/Win cultures • It is not about who win or who lose. The partnership does not last forever unless both parties are winning. Focus • The focus is not on my company, not on drug companies or CROs, but on common goals like projects. Commit to excellence • All the participants need to understand why we build a partnership. The partnership is formed to provide a better product, so we should work toward better, faster, more efficient way to do a business.
- 19. Roles of Program Leads in Partnerships 19© 2014 Accenture All Rights Reserved. SAS programming skills CDISC knowledge Other Functions Understanding Statistical Analysis Regulatory Project Management
- 20. Roles of Program Leads in Partnerships 20© 2014 Accenture All Rights Reserved. Open minded and understanding Strong communication skills Building a relationship Building trust Crisis Management. Building a working culture for the team.
- 21. Home Improvement – working with contractors 21© 2014 Accenture All Rights Reserved. • Respect the contractors. • Keep the promise. • Try not to micromanage them. • Need to be open to his ideas. • Communicate frequently. • Monitor progress time to time.
- 22. Customer service or experience? 22© 2014 Accenture All Rights Reserved. • I’m sorry this has been such an upsetting experience for you. • I know I can’t change what happened, but how can I help you now? • Let’s work together to make sure things get better from this point. • Thank you for bringing this problem to our attention. • I will walk you through the problems.
- 23. Conclusion 23© 2014 Accenture All Rights Reserved. Working together is always better than working….alone.
- 24. Contact Information 24© 2014 Accenture All Rights Reserved. Email address : kevin.s.lee@accenture.com Linkedin Profile : www.linkedin.com/in/HelloKevinLee/ Tweet : @HelloKevinLee Blogs : HiKevinLee.tumbrl.com Slide share : http://www.slideshare.net/KevinLee56
- 25. Questions and Discussion 25 © 2014 Accenture All Rights Reserved.
Editor's Notes
- Thank you all for coming in this early morning. Personally, last two days were amazing. I learned a lot from others and got inspired and motivated. Before we start our talk today, I would like to take this time to thank PharmaSUG committees for giving me a opportunity to share my humble opinions. A special thanks to Jim and Kent for all the hard works to make management successful.
- 2014 is a special year for me and my wife. It is our 10 year anniversity. When we got married, we became a life time partners, but obvisouly, we did not know what we were getting into. Partnership not only exist in our personal life, but also in our professional life as well. So, what is the partnership in dictionary?
- So, let’s look at partnerships in Pharmaceutical industry. In 2012 Avoca Report, 50% of Drug companies are using partnerships and about 70% of CRO are using partnerships.
- I think that we remember what we try to do our first blind date? No, you forgot? Or you want to forget? What we try to do our first blind date?
- Strategic partnership is like a long term relationship, very close to a marriage. When you have children, both parents work together to raise the children.
- Knowledge Sharing: The providers and sponsors can benefit from each other. They can share their strengths and expertise to achieve a common goal. Cost Effeictive : Since strategic partnership is in longer duration, it is much more cost effective compared to transactional/FSP model. Increased Productivity: They can work together to improve the performance. The partnership last longer than FSP or Transactional model, so it has enough time to improve the performance. Improve Quality: They can improve quality. Cost Effective: They will have a time to build a trust, so the sponsor will be able to reduce the oversight cost.
- Joint Steering Committee (i.e., for leadership or management levels) get together to discuss the issues, to resolve the challenges, to plan for the future together. Joint Operation Committee (i.e., for functional or operation group levels) get together to resolve the current operation issues together. Communication Plan – who will communicate with whom and escalation process. Governance structure : Key Performance Index (KPI) should be both ways. % of in-time project deliverables % of error rate Duration of project (e.g., programming hours) Response time Specified roles and responsibilities for all the participants Clear expectation from each partner
- SAS programming skills CDISC knowledge Data Management Understanding Statistical Analysis Regulatory Medical Writing Project Management – workload, resource, budget, timeline and so on
- Open minded and understanding – the person who are working with today have more difficult times. Strong communication skills Listening (Inquiry, listen and confirm) Writing and Reading Building a relationship – There are many stake holders (e.g., clients and operation teams), so building a good working relationship is very critical for a successful partnership. Crisis Management. Trust (Who do you trust? You trust people who care about your well-being.) Contributing and/or executing a strategy for a successful partnership. Building a working culture for the team.
- When we bought the first house, we bought the house in a short sale. Basically, there are a lot of things that we need to fix on house, so we hired contractors. In order to get the most out of contractors, we realized that we need to something. When we oversight CROs, how do we handle or manage them?
- Let us think about the situation when you need to call cable or phone company to fix something. These are the sample scripts in customer service department. After the call, what do we feel? A great customer service is not really about resolving the problems, but understanding and emphatizing with the customers. It is about providing a great experience. CRO is a service provider, but what if we provide a great experience for sponsors? Aren’t our partner happy about? Is that a true partnership?
- My wife and I did not know what we were getting into when we got married, but we came along well with two beautiful children. We did not know what kind of partnership we are getting into the most time, but, building a strategy and a great working culture together, we not only survive, but succeed in the partnership environment.