the role of a chief medical officer › uploads › assets › ...• role in product development...
TRANSCRIPT
![Page 1: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/1.jpg)
www.bioindustry.org
The role of a Chief Medical Officer
Professor Glen ClackUniversity of Sheffield
Dr Hamish CameronSV Health Investors
Dr David JefferysEisai
Dr Penny WardKarus Therapeutics
![Page 2: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/2.jpg)
www.bioindustry.org
View from Investors – what they want from a CMO
Dr Hamish CameronSV Health Investors
![Page 3: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/3.jpg)
View from Investors – what they want from a CMO
Dr Hamish Cameron, Operating Partner, SV Health InvestorsCMO Summit, March 5th 2018
![Page 4: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/4.jpg)
The CMO as part of the investment thesis
• People – science – plan – investment
• Context of a private VC backed biotech
• CMOs as part of a founding team – full/part-time
• Discovery interface
• Level of experience, knowledge, skills and track record of achievement
• Medical lead – gateway to the challenges of translation and the interactions with KOLs, clinical Ad Boards – developing the very best medical thinking
• Likely to be “new” science and “early” stage development
• Absence of infrastructure - responsible for all the medical research/medical affairs functions although many components outsourced or delivered by consultants
• A broader context – across discovery/regulatory/clinical/commercial/business/market access leading to an “exit”
![Page 5: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/5.jpg)
Special challenges for the biotech CMO
• Communication and influencing
• Effective regulatory interactions
• New science and treatment modalities
• Working across different indications
• Interacting with CEOs and CSOs
• Rare diseases – interactions with parents, patients, associations, media…..
• Creating ideas for risk mitigation and developing options
• Fundraising input – CMO a key focus for new investors joining a syndicate
• Business development – “selling” the story
• Working as a full member of the biotech company C-suite team
![Page 6: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/6.jpg)
www.bioindustry.org
View from a regulatory perspective –what they need from a CMO
Dr David JefferysEisai
![Page 7: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/7.jpg)
A view on the current and future role of the
Chief Medical Officer from the Regulatory
/Regulators Perspective
Dr David Jefferys
Senior Vice President Global Regulatory and Patient Safety Eisai
Board Member of the FPM
5th March 2018
![Page 8: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/8.jpg)
Short survey
• Do all companies have a CMO?
• SMEs vs mid/large Pharma
• Global vs Regional vs National
• Relationship with the CSO (Chief Scientific Officer) and
Rand D Departments.
• Role in product development
• Role in patient safety pre and post marketing:
Relationship with EU QPPV
• Role in medical information and market access
• Role in patient access, named patient use patient access
programmes
• Role in ethical issues, data transparency.
• Trusted spokesperson/role in crisis management
• Contact person with stakeholders/key opinion leaders
8
Current role
![Page 9: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/9.jpg)
• Statutory role:
EU level, Member State level
• Expert reports
• Expert signatory
• MD and IVD Regulations 2017/745 and
2017/746:
Concept and role of the "Regulatory
Expert "
9
![Page 10: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/10.jpg)
• patient focussed and patient centred drug
development
• Increased role in market access
/accelerated pathway submissions
• Combined regulatory /HTA evaluations
(EU proposal for 2020)
• Expansion of the role of the regulatory
/compliance expert
• Brexit implications?
10
The future
![Page 11: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/11.jpg)
Concluding remarks
![Page 12: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/12.jpg)
www.bioindustry.org
View from the coalface – what is expected
Dr Penny WardKarus Therapeutics
![Page 13: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/13.jpg)
View from the CoalfaceDr Penelope Ward MBBS FFPM
CMO, Karus Therapeutics (Achilles Therapeutics, Blue Earth Diagnostics, Topivert Pharma, Glenmark, Novimmune)
![Page 14: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/14.jpg)
How it’s been for me…..
Reasons to be grateful:
• Past experience• CD (PI-III) in multiple TAs, med affairs,
consumer health, PV and med info, multiple geography regulatory interactions, crisis management
• Lifelines• Consult the expert• Call a friend• Ask the audience
• Interminable optimism
What I wish for:
• Financial literacy (as opposed to budget management experience)
• Better understanding of business development
• Better tools• costing software (site and CRO),
‘e’feasibility for trial designs, ‘e’ protocols, patient data – genetic, outcomes, pooled datasets (retrospective control trials)
• The ability to remember that ‘better’ is the enemy of ‘good’
![Page 15: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/15.jpg)
View from the CoalfaceDr Penelope Ward MBBS FFPM
CMO, Karus Therapeutics (Achilles Therapeutics, Blue Earth Diagnostics, Topivert Pharma, Glenmark, Novimmune)
![Page 16: The role of a Chief Medical Officer › uploads › assets › ...• Role in product development • Role in patient safety pre and post marketing: Relationship with EU QPPV • Role](https://reader033.vdocument.in/reader033/viewer/2022060506/5f1ee4b87600d84a8d33cc13/html5/thumbnails/16.jpg)
www.bioindustry.org
Discussion
Professor Glen ClackUniversity of Sheffield
Dr Hamish CameronSV Health Investors
Dr David JefferysEisai
Dr Penny WardKarus Therapeutics