Contact

Harm Hermsen

+

Harm Hermsen
PhD – Principal Consultant

Harm Hermsen holds a Ph.D. in Biochemistry. Harm has worked for the office for Genetically Modified Organisms (GMO office) at the Dutch National Institute for Public Health and the Environment (RIVM). For a few years he was acting secretary of the Committee for Genetic Modification (COGEM) which is an advisory committee on environmental risks of genetic modification. He was involved in environmental risk assessment and legislation of gene and cell therapy applications submitted to the GMO office and has been coordinating the Dutch Gene Therapy Office. Harm has several years of experience working as senior pharmaceutical assessor of biological medicines. He was involved in assessments and scientific as well as regulatory advices for cell and gene therapy products. He has been a member of the European Medicines Agency (EMA) Gene Therapy Working Party, The Gene Therapy Working Group of EDQM and the Gene Therapy Group of ICH. As a member of these groups he was participating in the design of several regulatory guidance documents particularly related to gene and cell therapy products. In the Netherlands Harm participated in the CBG-MEB advanced therapy group as well as the Health Inspectorate team that was responsible for the implementation of the Hospital Exemption procedure for advanced therapy products in the Netherlands.

At Xendo Harm is currently managing a team of experienced RA consultants. Also within Xendo his activities in the field of biotech and ATMPs are continued. His ambition is to contribute to product development by translating experience and knowledge of the regulatory framework into the product lifecycle.

-

Xendo offers industry seasoned CMC project managers and over 100 pharma and biotech professionals in biological sciences, biotech and small molecule development. We cover the areas of manufacturing, analytics, quality assurance, engineering and regulatory affairs. Xendo has experience with the development of MAbs, recombinant proteins, vaccines, gene and cell therapy products, and small molecules. We can provide you with a product development roadmap and successfully guide your product development to Clinical Proof-of Concept and to the market.

Also for your medical device product we can manage the design process and apply the required design controls, thereby creating a solid Design History File / Medical Device File and paving the road for a successful regulatory submission.

CMC / Program & Project Management

A broad but significant part of every drug development program to ensure your product to be delivered within the desired timeframe. Our CMC management team consists of senior experts who are experienced in balancing the various areas of development as to optimize the quality of the delivered product and the process by which it is delivered. In project management we aim to implement the Lean Six Sigma principles and have in-house specialists ranging from Yellow to Black Belts, to do so.

Clinical Development & Investigational Medicinal Product Management 

It’s defined that in the European Union a pharmaceutical form of an active substance (or placebo) used in Clinical Trials is subject to a broad spectrum of regulatory Requirements including differing issues regarding distribution, labelling, packaging, and release by a Qualified person, for instance.

Acceleration of swift proceedings through the different phases of clinical trials can have a significant impact on the eventual Return on Investment of your product development, making it worthwhile to look into this aspect carefully.

The last decade we've also seen an increased digitisation of clinical trials with technologies that can streamline trial processes, increase trial quality, efficiency and flexibility, reduce costs and improve patient compliance. However, the quality and integrity of a trial stands or falls by the reliability of the systems, often provided by different (third) parties, and the interfaces between those systems. Health Authorities are also aware of challenges regarding this digitisation of clinical trials and data integrity has their attention which is why Xendo also has a strong focus on GCP and Quality Assurance in Computerised Systems.

Up- & Downstream process development

We offer a broad range of expertise in upstream and downstream bioprocessing within the different Chemistry Manufacturing Control (CMC) development stages from early to late phase clinical programs. Products supported include (recombinant) proteins, monoclonal antibodies, biosimilars, antibody drug conjugates (ADC), but also ATMPs including cell therapy and gene therapy.

Our expertise and support includes cell line development, further up- and downstream process development, definition of analytical requirements, upscaling and improvement of manufacturing processes, technology transfer, single-use /disposable technologies, continuous chromatography and simulated moving bed. Besides this we strive to provide solutions for facility modifications and improvement of plant output by applying principles from Lean Six sigma and Quality by Design. Our team of experts guarantees a multidisciplinary approach for any issue in the development and production of biopharmaceuticals that you might encounter.

Upstream - Downstream

Scientific Writing

We assist in writing documents such as protocols or data summaries at an increased pace with an eye on compliance to requirements of the Common Technical document, ensuring your development is not delayed due to hurdles in submission to regulatory agencies.

Formulation development

A swift and effective formulation program has the ability to accelerate your early development, but achieving it requires a broad portfolio of knowledge and scientific skills of the people involved in the project. Aspects you will be confronted with at a product level include selection of the proper dosage form, excipient compatibility studies, solubility evaluation, dissolution behavior and stability evaluation, each of these areas being subdivided into more specialized areas.

Having worked many years in the pharmaceutical and biotechnology industry, our consultants are properly educated to offer their assistance to you.

Analytical Development

Assurance of successful development relies significantly on analytical methods which allow accurate characterization, stability assurance of your product, reduces risk throughout the developed and applied methods. Every aspect of producing in a GMP environment, as recorded into the many different guidelines and directives, should be taken into account and application of these analytical methods is essential.

Most of our consultants are registered pharmacists, they have been working according to GMP quality standards their whole careers and are assured to design techniques which are robust and reproducible.

Product release (QP)

To assure a smooth transition from manufacturing a product in a GMP environment and its shipment to a clinical trial site, Xendo offers Qualified Persons who excel in communication with various partners and / or external vendors. They are all experienced industry professionals and continuously trained to comply with applicable QP requirements in the European Union.

Medical device design and development

Design and development of medical devices, including In Vitro Diagnostics (IVDs), are facing increased regulatory requirements. For both the FDA Quality System Regulations (QSR as defined in 21CFR Part820) and the new Medical Device Regulation in the European Union (MDR), as well as its counterpart the IVDR, Xendo offers expert advice and project management. This will result in optimal review times, FDA approval / clearance and Notified Body CE Certification. Our expertise spans the entire range, from planning, to verification, clinical validation and transfer to manufacturing.