Being within GPM and close to a TA gives me great opportunities to learn about the science behind our medicines in various seminars from biopharma and in Late CVRM but actually also within GPPM. But being on a GPT of course gives a chance to go deeper, and I have been on three GPTs/FTs the last year:
- Est Brands – Biweekly lunches, GPT meetings
- zibo/dapa – setting up 1:1
- dapa combos team – a pure learning experience
- Talk to the doctors, learn at meetings
- AI offers a great potential to check things up with very directed questions
Applying for both my previous and this job. Using my network to find someone to tell me more about what it is like being in CMC.
Moving around, keeping the contacts I have within AZ. In my current role, I have made sure to connect with everyone from at least initial 1:1 and, as appropriate, regular ones, building relationships.
- I have been working in many different areas and had the ambition to be long enough in the different areas to have a reasonable depth to continue to contribute. Keep the contacts. Some key areas – (PAT, Lab IT, Process technology) Lean. In particular my old managers since they have their network. Try to stay on by getting involved and not just meeting for a fika. For example I am still part of the Lean network, recently had a chance to use contacts for implementing a tool.
- Oncology Est Brands: Building and addressing issues. Pro-actively building and setting up a network. Not only for myself, but for our team. Identifying the potential together with my GPT from an ad-hoc meeting and then giving it a structure. Difficult challenge: bringing in new ideas to a team to become more innovative, although a clear remit. E.g. getting out sustainability thinking in another direction. Having new areas to explore, like supply chain.
- Japan food effect study + rel BA. Bring decisions forward as a team.
o Raised by reg as JP requirement on the final formulation
o Collecting information from different functions, mainly CMC, Clin Pharm and reg, but also the GPL. Investigating what other projects have done.
o Pre-meeting with key GPT members to set the requirement: clinical, reg and clin pharm to sort out options, narrowing it down. Not including CMC
o Larger workshop including CMC, also CMC reg + Biopharma from outside GPT – options + feasible and reasonable
o New round of off-line
o Brought back to GPT – for decision
o Outcome: Happy JP team!
I have not been so much of an innovator in my latest roles. I remember this question from previous interviews back a scientist where I had a great example of using modelling from the pulp and paper industry to our processes. Maybe I could think of innovative ways of improving ways of working. Whether unrelated or not, I had some great experienced from PT&D in using Lean, and in particular lean leadership philosophy: Improving meetings continuously. Huge impact to have better and better meetings. Several colleagues asked about it.
For me it is similar to how I work with understanding the science. Being on within GPM and close to a TA gives me great opportunities to learn about the science behind our medicines in various seminars from biopharma and in Late CVRM but actually also within GPPM. But being on a GPT of course gives a chance to go deeper, and I have been on three GPTs the last year:
- Est Brands – Biweekly lunches
- zibo/dapa – 1:1, keep discussions going
- Dapa combos FT
- Talk to the doctors, learn at meetings
But now on my projects I also have regular meetings 1:1 with Payer function, Commercial, FT head
Re-referencing of Onglyza
- US wanted to withdraw – no business with the inflation act
- In particular China, which is a reasonably large market
- Partly reg driven
- Sorted out options to solve it in US. Cross functional – I took the lead, it would not have been led by anyone if I wasn’t the one
- Participated and gave support in reg meetings, even opted to take notes
- New commercial discussions appeared with the Swiss marketing company
- Now in place
Alternative: Extended access – connecting and sorting. Keeping track going forward, having it on the risk log. Picking up the cross-functional aspects.
Re-referencing of Onglyza
- US wanted to withdraw – no business with the inflation act
- In particular China, which is a reasonably large market
- Partly reg driven
- Sorted out options to solve it in US. Cross functional – I took the lead, it would not have been led by anyone if I wasn’t the one
- Participated and gave support in reg meetings, even opted to take notes
- New commercial discussions appeared with the Swiss marketing company
- Now in place
Alternative: Extended access – connecting and sorting. Keeping track going forward, having it on the risk log. Picking up the cross-functional aspects.
Onboarding of Brilinta
- Didn’t know exactly when
- Preparing, having everything in place
o Communication early, meeting with Bangalore people
o Meeting structure
o On top of goals and risks
o Most important, a way to catch people who were worried – thinking about the extended team
o Securing key resources, e.g. medical
o Outcome so smooth transition.
When forming my Process Engineering team
Situation: Went on secondment as TM from my APS. Needed to recruit replacement for myself and actually found someone with a much better fit to the current needs. Possibly I could have argued for some more junior person to make myself look better. Outcome – good delivery and the given candidate for the permanent position when I made myself permanent. However, the surprise was that we recruited someone else. Probably shocking but … Learning – not having the best people is a larger threat for me than having the best people.
1. Innovation workshop with Health Works
2. PPS for CRO selection
1. Ph3 ID during summer 2023 + Ph2b in parallel, the acceleration
- Enabling resources in the plan
- Planning key, hence GPM key person
- Slim protocol had been discussed with FDA
- Read-out -> Interim to set dose when being sure enough (1-2 months ahead)
- Getting vendor contract in place – just waiting to press the button
- During the summer -> Being there myself, making the Ph3ID deck ready
2. The nine deviations
Dapa combos Franchise. Give up both my comfort and to some extent my ability to excel.
Solace contract: $1m missing because of setting a wrong date.
Solace contract: $1m missing because of setting a wrong date.
Sustainability: Not wanting new ideas. Raised in the LT. Searched for support offline with our Chief of Staff.
DDI lessons learned
Not often, we have robust systems in place and a great culture
Supported in the Philip Morris Vectura discussion.
SOLACE – supply issues
Health Works
GMP Blister machine
China PK study
Relying on CN to sort out and make a plan. Came up with a plan that was good but impossible. Pretty confused GPT meeting that was challenged back from the CMC organization.
- Good understanding from SC
- Meeting with CN
- Mapping out plan in detail
Quiz for goals