Services | Blomira Oy

SERVICES

Medical consulting services on pharmaceutical development and medical affairs for companies in Europe

R&D strategy tailored for your assets

Having worked with several therapy areas (e.g. neurology, oncology, women's health), I bring cross-therapy area insights to the planning. This enables simplified and creative approaches. While keeping always the regulatory and ethical integrity in the core, knowing the limitations and having experience on both success and failure in clinical studies allows innovative and solution oriented thinking. Continuous interactions with the regulatory authorities is a key, and I can help also in those.

Understanding the R&D entity when working hands on with details allows me to effectively write, review and help in finding the optimal path

Currently favored innovative approaches and risk-based thinking during clinical development allow straight forward plans keeping the ultimate goal in mind

The medical and patient insight, understanding the data and competitive landscape are essential for effective decision making.

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Serving as your interim CMO or medical lead

I have long-term experience as a head of various organizations including e.g. scientific leadership, regulatory and clinical operations, and Medical Affairs. and I have also worked as a Chief Medical Officer. Thus, I could serve as your interim expert or head to build a team, an organization or in finding and training colleagues for you. We could develop your processes together. As an interim CMO, I could be responsible for your asset or pipeline development, clinical research and medical affairs for an agreed period. I would effectively manage also your CROs to ensure the right things are done in an effective way.

Perhaps you have found it difficult to recruit a medic inhouse to take care for your assets with your team - or you do not know what is needed and wish to establish the team. I could help you with my connections, leadership and insights.

I would coordinate my own induction with your people as long as I know who in the company is responsible for what.

I'm happy to integrate into your team as a part-time member. I would work mostly remotely, but ready to travel as needed. We can find a flexible and effortless retainer cost-model for this purpose.

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Document and file evaluations

Medical, clinical, and R&D development insights are crucial when evaluating product related documentation e.g. in Due Diligences, during IND and NDA/MAA preparations, clinical trial applications, or when considering investing to a product. It is important that the commenting is done in a timely manner, and the comments are helpful. During the review period, it is equally important to make effectively the decisions between discrepancies and different wordings. During my 30 years I have seen it all, and you can trust my insights also on how the authorities should be approached - what works and what does not.

I will induct myself to the topic your documents are about -but there are a lot of similarities related to clinical development between therapy areas, and my past experiences are readily in use in the review.

My way of commenting is that I suggest alternative wordings - you will not get comments just requesting to rewrite. And I can help you writing the crucial parts if needed.

If you find it hard to decide which alternative from different comments is optimal, I can help to speed up the review process while ensuring that there is enough knowledge to make the right choices.

Let's discuss