Optimize Your Medical Affairs Team s Influence in a Start-up Organization

Transcription

1 Optimize Your Medical Affairs Team s Influence in a Start-up Organization Rachel Couchenour, PharmD, MBA Sr. Director, Medical Affairs Mateon Therapeutics

2 Objectives Discover the unique challenges faced in small start-up biopharmaceutical companies Understand your bandwidth and prioritize limited resources for optimal organizational outcomes Expand your department s effectiveness by aligning with other functions to support corporate goals

3 What is Medical Affairs? No entry on Medical Affairs (MA), however there is an entry on MSLs Independent certifying organization that has developed standards for the field of MA Department within a pharmaceutical or device company that interacts with physician and other healthcare professional who utilize or are involved with research related to the companies products

4 Medical Affairs Functional Areas Public Affairs Medical Research Health Economics/ Outcomes Independent Medical Education Corporate Rebranding Initiative NDA Support Data Management / Biostatistics Medical Affairs Independent Medical Education Patient Advocacy Corporate Communications (e.g., PR, Social Media) Medical Communications Medical Science Liaisons Medical Information Phase 2 Study Steering Committee

5 Medical Affairs Experience employees 2-12 MA including CMO 17 Employees 2 MA present 2001: ~2,000 US employees 2010: ~ 17,000 US employees ~750 US employees

6 Chelsea Therapeutics December 2011 June 2014

7 Chelsea Therapeutics: Background Developmental stage (Phase 3) biopharmaceutical company Developing an orphan product for a non-motor symptom of Parkinson s Disease CMO with no pharma experience Board of Directors became highly involved with daily activities

8 Prioritize Department Needs Infrastructure Launch Preparedness

9 What Specifically Has to be Prioritized? Department infrastructure needs Medical Affairs Plan Strategic Imperatives Publication strategy Budget Hiring plan SOPs, policies, guidance documents, etc. Resources Virtual library Launch preparedness MSL organization Hiring profile / recruitment MSL training MSL resources / slide sets TL mapping Medical Information Vendor selection Training / SRLs / FAQs Managed Markets support Dossier Presentations

10 July 2012 Chelsea received a complete response letter

11 New Medical Affairs Activities Public Affairs initiative Patient advocacy NDA resubmission preparation Re-initiate publication plan Targeted TL outreach

12 Post 2 nd NDA Filing Lead preparation for open public hearing during Advisory Board Re-initiate vendor / partner discussions Medical Information PV Update MA plan Present plan to Board of Director Ultimately, company was acquired

13 Mateon Therapeutics July 2015 present

14 Mateon Therapeutics Early stage development biopharmaceutical company Developing vascular targeted therapies for orphan oncology indications No CMO First medical affairs hire

15 Prioritize Corporate vs. Traditional MA Activities Corporate Medical Affairs Role

16 Mateon MA Accountabilities Develop & execute MA Plan Scientific Communications TL engagement plan Clinical operations support Educational materials for clinical study site Develop and run study Steering Committee Develop accrual enhancement strategy and lead activities Corporate communications (including social media) Corporate rebranding project

17 Mateon MA Accountabilities Develop & execute MA Plan Scientific Communications TL engagement plan Clinical operations support Educational materials for clinical study site Develop and run study Steering Committee Develop accrual enhancement strategy and lead activities Patient advocacy engagement Corporate communications (including social media) Corporate rebranding project

18 Clinical Operations Support Traditional MA engagement with clinical operations: Site education: MOA, AEs of special interest, protocol Site identification At Mateon, future success of company reliant on ongoing clinical trials So I volunteered to do whatever was needed

19 Clinical Operations Support Committee Charter Regular meetings Steering Committee

20 Clinical Operations Support Committee Charter Regular meetings Logo creation Steering Committee Study Branding

21 Clinical Operations Support Committee Charter Regular meetings Logo creation Steering Committee Study Branding Study Website Secure domain name Content Development

22 Clinical Operations Support Committee Charter Regular meetings Logo creation Steering Committee Study Branding Accrual Support Study Website Digital advertising Study brochure Clinical Science Liaison Secure domain name Content Development

23 Clinical Operations Support has Led to: Hiring of 1 st field based employee MA running bi-weekly accrual update meetings Understanding & support to run an advisory board Output was tool for research sites

24 Corporate Communications Press Releases Medical accuracy review but also messaging input Lexicon project Scientific platform development Social Media Engagement Avenue to reach more stakeholders with both corporate and scientific messages

25 Patient Advocacy Engagement Focused goal of advocacy engagement Partnership Organize our community outreach

26 Corporate Rebranding Project

27 Corporate Rebranding Project Steps: ID marketing firm Approved creative brief Color exploration Name selection (company contest) Logo selection Website overhaul Internal preparedness Date for change PR surrounding launch / vendor notification External stakeholder

28 Prioritize Corporate vs. Traditional MA Activities Corporate Medical Affairs Role

29 Summary

30 Lessons Learned If you need rigid lanes then start-ups likely aren t for you May have to fill in the gaps to support corporate objectives Comfort zone No tall grass Individual contributions are noticed

31 Thank you! Rachel Couchenour, PharmD, MBA