MY AREAS OF FOCUS
WHATEVER YOU NEED. AND MORE.
I am ready to take responsibility for your development project and organization. From idea to launch, as an internal or external project leader. Or by supporting you with both, extra resources or by offering an experienced, external perspective.
You can expect attentive, superior support of any aspect of your pharmaceutical drug product development. In close collaboration with my partners you will receive complete operative drug product development. This includes all CMC activities from API development, regulatory, clinical trials, quality management, project leadership and IP management.
If you are looking to improve your R&D management, let me assist you in setting up, implementing and continuously improving your systems, processes, organization, administration – Together we can build your R&D culture and develop your individual innovation management system.
DRUG PRODUCT DEVELOPMENT
Conception and project strategy compilation, API search or development, the execution of technical feasibility and product development, process optimization, scale up and tech transfer, process validation:
A successful drug product development project is a marathon, not a sprint. Let me help you reaching the finish breathing easy.
To support your decision-making, I will organize any necessary technical feasibility studies and begin working with your teams or external service providers to set up a target oriented development strategy.
I may also assist your formulation development experts dealing with challenging projects and technologies. How? My long experience with “deadlocked” cases has demonstrated to me the advantages of integrating new people and their perspectives on seemingly unsolvable problems. With my long technical hands on experience I will bring in a new perspective to potentially hopeless cases.
How much help would you like? In cooperation with my partners I can support your complete drug product development project in whatever ways are needed, including all regulatory, clinical and IP work packages. You might need assistance finding the best partners for your project. In such a case I will compile a development strategy, the required RfP documentation incl. conclusions from all available information and a risk assessment, organize the project set up, support the contracting procedures and carry out the necessary monitoring during later execution of the projects.
For me, QbD is no rocket science but a mindset of working and a good tool, which makes a lot of sense and will improve the efficiency and quality of your drug product development projects. It’s Good Scientific Practice, nothing else.
WHAT’S IN IT FOR YOU? Reliability. Networking. Expertise.
They’re all there for you.
I have been responsible for many technical transfers of products from one site to another or to a CMO – as the responsible technical lead of the receiving or the sending site. Everybody who has executed tech transfers knows, that key success factors are an extremely detailed preparation, a science-based risk and gap assessment and the definition of adequate measures to minimize risks and to deviate an adequate control strategy. In addition to that, working in or leading of complex teams on both sides and excellent, open communication are must haves in technical transfer projects. The technical, scientific expertise in both organizations as well as good communication to Regulatory and Quality organizations should be on high level in order to execute a scientific based, efficient and successful technical transfer of your product. All this you will get as the core of my mindset.
Make it grow.
TECHNICAL DUE DILIGENCE
Are you planning to license a product or to acquire another R&D or production site ?
I will be your partner in assessing the technical quality of the dossier/ product or the site you are evaluating. I am offering my long experience in Pharma product development and tech transfers to identify potential weaknesses, gaps and strengths of products or sites and organisations.
I am offering my long experience in Pharma product development and tech transfers.
R&D is where your company’s growth potential lies. Just asking some key questions – and answering them honestly – can be a catalyst for positive change. How good are your processes? How well does your organization’s R&D department cooperate with administration, business development or production? Have you found the right balance between innovation and creativity and a process/quality oriented mind set? How is your multiproject management organized and how is your resource management executed ?
How often do you ask questions like these? Let me support your business from a bird’s eye view.
Working together, we will identify the weak spots in your organization or structures and come up with ways to improve the situation. We will leave no stone unturned to ensure that you are reaching your full potential and I will help foster and nourish new ways of thinking that will lead to new ways of doing.
In short: I urge you to choose inspiration, active leadership and living the right culture. After all, this is what R&D is all about. Trying to transfer process/ quality oriented and “operational excellence” mindset to R&D organisations will fail –
key is to find and lead the right balance of a convergent thinking process/ quality oriented organisation with the divergent thinking and the hopefully open minded, flexible and creative mindset in your R&D organisation.
Improving your R&D. The best is yet to come.
Let me manage your organisation on interim basis for a limited time. I will be ready to efficiently and successfully lead your teams in R&D, Product Development, Tech Transfer, Production or in Project and Innovation Management.
Do you talk about innovation? Or do you innovate?
I have made the experience with several service providers around the world that customer orientation in many cases had a very low priority. Unfortunately, many service providers still don’t understand that a strong commitment to serve the customer and to implement an absolute service mindset should become an essential part of the company culture. Together with the strong customer orientation, service providers should target to become a high level consultant and reliable partner for the customers in order to realize a long term relationship. Become the preferred partner of your customers !
This also means that you as a high level service provider you are able to work with your clients on equal level regarding scientific approaches, quality systems, project management, communication and general professionalism. You know exactly your customer’s needs, expectations, background, strategy, targets and way of working. Based on that you are able to support and provide advices on highest level. As a high-level service provider you know that each customer needs a different level and approach of collaboration, as an expert in your field you are flexible enough to adjust the services and way of collaboration for each of your customers individually. The clients recognize you as highly reliable professional experts they can entrust their important strategic projects. Absolute customer orientation does not mean to always accept everything, but also means that your customer will consider your recommendations as a reliable expert.
Let me support your organisation to become a service provider on highest level !
I will challenge your organisation, culture, mindset and working processes with all my experience in that field, working as a service provider for more than 13 years but also on behalf of my clients in the roll as a customer with many service providers in different markets and regions.
An evolution from idea to launch.
Since 2005 I have been registered as a Qualified Person (EU QP) for clinical trial supplies in different R&D organizations as well as for routine production. Based on this experience, I can take over interim and/ or external responsibility as QP for your organization.
Allow me to assist you in making your R&D and CTS Quality Management an efficient and effective part of your internal or external services.
At your service – with pleasure!
OPERATIVE INNOVATION MANAGEMENT
Let me support you in defining, implementing, continuously developing, living and actively leading your innovation management in a way that is appropriate to your markets, products and organization. I believe that Innovation Management is an actively managed, holistic approach made up of many essential components.
- innovation strategy
- innovation culture
- innovation process
- idea generation and management
- measuring & monitoring/ controlling
- excellence in technology and market intelligence