Prepare Your Team to Collaborate in the Industry’s

New Business Models

Tuesday, November 15

Bart HENSCareer Zone Classroom

Please don’t forget to complete the satisfaction

survey!• AAPS 2016 Annual Meeting App

Pharmaceutical Industry

MANAGEMENT SCIENCE

Collaborative Negotations

Closed versus Open business models

Transparency, globilization, data sharing,...

INNOVATIONproduct success rate of more than 50% and an increase of research & development (R&D) efficiency with more than 60%

Kaitin KI, DiMasi JA. 2011. Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009. Clin. Pharmacol. Ther. 89:183–188.

Learning Objectives• Network with the right people that will contribute

positively to your project: Who are the right people to select to make this project a success?

• Create a logical, manageable workplan to make sure you will have a successful project from the start.

• Identify the key components of a truly collaborative environment that you should look for: What is the expertise of each company and how can they contribute to the project?

• Know and avoid the pitfalls of poorly structured collaborative environments.

Whenever keeping these objectives in mind, the chances to obtain project approval, funded by external sources, will increase!

Case Study with OrBiTo and PEARRL project

How to go for an open business model?

“To predict the in vivo performance of oral drug products across all stages of drug development”

“Safe and effective new medicines faster”

OrBiTo PEARRL

€ 24 million € 3,9 million

5 year period 3 year period

13 pharmaceutical companies 6 pharmaceutical companies+4 regulatory affair partners

14 academic partners 6 academic partners

Project Main Objective: OrBiTo"Oral Bioavailability Tools"• Optimizing in vitro and in silico biopharmaceutical

tools to empower their predictions towards the in vivo outcome of the drug.

Project Main Objective: PEARRL

PEARRL will drive innovation, economic growth and create job opportunities for highly qualified researchers with its emphasis on

excellent science, industrial leadership and tackling societal challenges.

1. Network with the right people:

Multidisciplinary Approach

Project

Industrial partners

Academic

partnersSME’s

EDAN conference: European Drug Absorption Network initiated negotations among different partners to start OrBiTo:• Combining different expertises of each company• + combining different expertises of each academic institution

IMI OrBiTo project – innovative tools for oral biopharmaceutics

• OrBiTo consortium comprises 13 EFPIA companies with 14 academic centres and SME companies• Managing entity: Uppsala Univ (Hans Lennernäs/Krister Halldin).• Scientific coordinators:Astrazeneca (Bertil Abrahamsson) & Pfizer (Mark McAllister)

2. Create a workplan

3. Identify the key components of a truly collaborative environment

In-house neutral compounds In-house basic compounds

Stomach Duodenum

pH p

robe

pH p

robe

Different expertises lead to different models to test and to cross-validate during the project

3. Identify the key components of a truly collaborative environment

4. Avoid pitfalls

• What about shared data after the project?• Policies/agreements?

• Dissemination of data before it can be shared with the entire scientific world

Make sure to define rights and duties prior to the start of the project!

4. Avoid pitfalls• Ethical Concerns:

• What about medical issues that will occur during the project?

• Example: healthy volunteer of your clinical study seemed to have HIV-1 after analysis of his blood. Who will and is responsible to communicate this issue?

5. Schedule meetings to stay up-to-date• Monthly conference calls among work packages• Annual F2F meetings to have a general overview of

the project and to discuss future perspectives, challenges and opportunities

Annual OrBiTo Meeting 2015 Paris, France

6. Training of young scientists“The youth of today are the leaders of tomorrow”

• Local training activities versus networking • Webinars, poster sessions, work shops, internships,...• The power of Social Media

7. Success will lead to more success

2.0 2.0

Design your own project

Developing an interactive collaboration among industry and academic partners to find a cure for

HIV-1.

4) Discussion data and next steps?

3) Overview of the project?

5) Training of young scientist?

6) Pitfalls?

7) How will the project stimulate next collaborations?

2) How to recruit?

1) Kind of people?

Road to Success/Innovation

Questions

Bart Hens – bart.hens@kuleuven.beDrug Delivery & DispositionHerestraat 49, Box 9213000 Leuven

: bart hens

: @HensBart

: Bart Hens

: Bart Hens

Please don’t forget to complete the satisfaction

survey!• AAPS 2016 Annual Meeting App

Acknowledgments

the Innovative Medicines Initiative Joint Undertaking under Grant Agreement No. 115369, resources of which are composed of financial contribution from the European Union’s Seventh Framework Program and EFPIA companies’ in kind contribution.

https://www.orbitoproject.eu

This project has received funding from the European Union’s Horizon 2020 Research and Innovation program under agreement number no 674909

https://www.pearrl.eu

Young Orbito is a community of young scientists, represented by PhD students & postdocs, who intensively contribute to the IMI and EFPIA funded project Orbito.

https://www.youtube.com/watch?v=xt3zESkbm7g

References• S. Wu-Pong, J. Gobburu, S. O’Barr, K. Shah, J. Huber, and D. Weiner, “The

Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group,” Am. J. Pharm. Educ., vol. 77, no. 4, May 2013.

• J. Hunter and S. Stephens, “Is open innovation the way forward for big pharma?,” Nat. Rev. Drug Discov., vol. 9, no. 2, pp. 87–88, Feb. 2010.

• Kaitin KI, DiMasi JA. 2011. Pharmaceutical innovation in the 21st century: new drug approvals in the first decade, 2000-2009. Clin. Pharmacol. Ther. 89:183–188.