June 2020

#patientrecruitment, #multicenterstudies

Three Steps of Expansion

The proDERM Network for Multi-center Studies

The department Clinical Operations, responsible for GCP studies with medicinal products and medical devices, has developed a three-step plan to expand our network of external study centers to up to 80 units. Today we would like to report on the current status of the expansion.

Figure 1: Overview of study site pool, pre-qualified and qualified testing centers in Germany

proDERM Prüfzentren

In addition to single-center studies conducted at our own facility, we offer multi-center studies in cooperation with a network of qualified testing centers when the specifications of the study or the objective make this necessary.

Recruiting the proper patients is considered an essential aspect and rightly so: Sponsors are faced with the challenge of finding partners who can act flexibly and reliably to the greatest extent possible when providing patients for their studies. By expanding the proDERM network of external testing centers, we are in an even stronger position than before when it comes to attracting such partners. Expansion of the network is a three-phase process:

  • Step 1: Identification of potential testing centers in Germany from an existing study site pool
  • Step 2: Inclusion in the extended network by signing a general confidential disclosure agreement (CDA)
  • Step 3: Qualification and consequent final integration into the existing network

Figure 2: Extension of the proDERM Network of Study Sites

January 2020

15 qualified study sites
appr. 70 potential new study sites

June 2020

15 qualified study sites
26 pre-qualified study sites
appr. 46 potential new study sites

proDERM study sites

Decembre 2020

15 qualified study sites
appr. 70 pre-qualified study sites

We recently completed the first phase by identifying over 70 centers in Germany with whom we would like to form a cooperation or with whom we would like to work together. We are currently engaged in a dialog with the centers, having preliminary conversations and – if it has not already occurred – advancing them to the second phase and the respective qualification process.

Since January 2020: 26 New Sites in the Partner Network

So far we have been able to advance over 30% of the selected centers to the pre-qualification phase. This requires signing a CDA, which formally signals the intent to work together and enables and accelerates feasibility studies on the practicality of clinical studies. In many cases we have already signed preliminary agreements. This will avoid delays during the initial phase of your study. The qualification process for the testing centers in the extended network can take place either over the course of a study or independently of current projects.

In addition to the proDERM facilities in Schenefeld and Elmshorn (both near Hamburg, Germany), our network of external, qualified and pre-qualified study centers currently includes 41 sites throughout Germany. The testing centers in the network have so far conducted over 1000 clinical studies of pharmaceuticals and medical products. We are already firmly positioned in the fields of dermatology, gynecology and general medicine with this pool. The following table offers an overview of the extended network:

Table 1: The proDERM Network - 41 Study Sites in Germany

Therapeutic FocusNumber of qualified study sitesNumber of prequalified study sites
Dermatology1 university clinic and 4 doctor’s offices3 university clinics, 1 hospital, 3 SMOs, 6 doctor’s offices
General medicine4 doctor’s offices13 doctor’s offices
Gynecology1 university clinic und 2 doctor’s offices-
Ophthalmology2 doctor’s offices-
Pediatrics1 doctor’s office-

Our goal is to complete the network expansion described here as well as pre-qualification by the end of 2020. We will let you know about the pool of patients available as well as the qualification status when the time comes.

Mitarbeiter proDERM

If you have any questions about the expansion of our network, please ask Bernd Brormann, Director of Clinical Operations. Contact him via EMail.

#ramanspectroscopy, #skinbarrier

Quantifying Total Lipids

New Raman Parameter for Quick Claim Support

The barrier lipids in human skin can be quantified in vivo with confocal Raman spectroscopy. We can differentiate between cholesterol, free fatty acids and total ceramides, but for claim support it is often sufficient to quantify the total lipids. The determination of the lipid to protein ratio is a quick, precise and inexpensive way to do this. We have recently added this Raman parameter to our range of services.

The efficacy of care products promising an improved skin barrier is examined with various classical methods. The transepidermal water loss (TEWL) of the skin is the most commonly applied method. But like determining skin moisture with the capacitive process, this parameter is indirect and does not say anything about how the treatment actually improves the barrier. If however an increase in the lipids in the corneal layer is measured, the classically but indirectly measured improvement in the barrier can be easily explained. Another advantage is that the same measurement graphs can be applied to determine the moisture content and distribution in the corneal layer. So the measurement leads to two complementary and important parameters that can provide valuable information on how the barrier responds to a product.

The following illustration is an example taken from trade literature, showing how the parameter can be displayed. The graph shows the lipid/protein ratio as a profile of the corneal layer and parts of the living epidermis for patients with atopic eczema and for those with healthy skin. The authors were able to demonstrate the lower lipid contents of those with excema with only 15 test persons. And our own studies indicate clear effects for cosmetic products to enhance the barrier when used on dry skin.

Figure 1: Example Image of a Lipid-Protein-Ratio in Patients with Atopic Eczema

Lipid Protein

According to [Janssens, M., van Smeden, J., Puppels, G. J., Lavrijsen, A. P. M., Caspers, P. J., & Bouwstra, J. A. (2014). Lipid to protein ratio plays an important role in the skin barrier function in patients with atopic eczema. British Journal of Dermatology, 170(6), 1248-1255.]

Mitarbeiter proDERM

For any questions you may have, please do not hesitate to get in touch with Stephan Bielfeldt, Vice President & Director Science and Innovation, via EMail.

#crisismanagement, #covid19

Always Reliable, Even During a Crisis

How proDERM remains true to it values, even during the pandemic

Now that some of the restrictions imposed on our lives are being eased, we dare to look back at the weeks behind us. Despite the great challenges we have faced, we were able to successfully complete numerous projects. In cases where this was not possible due to the mandated hygiene measures and social distancing, we were able to find alternative solutions acceptable to both us and our clients. We are proud of these achievements and see them as an indication of our problem-solving skills and reliability even in these particularly challenging circumstances. Our entire team has clearly demonstrated that our slogan “Research to rely on,” to which we pledge allegiance in our mission statement, applies also and especially in crisis situations. I would like to illuminate a few aspects of our successful crisis management.

Crisis management

We formed a crisis management team way back in early March. Because of the constantly changing situation, one of the team’s tasks was to issue a daily assessment of the implications of Covid-19 for our business. Hygiene measures, the business community, working from home, prioritizing projects and short-time work were just some of the topics that were constantly being reassessed and adapted to what was needed. Which studies can or should we continue and what do we have to do to make this even possible? Which projects should be suspended and then resumed or re-started at a later time? Looking back, the fact that we made the right decisions at the time can be attributed to this team as well as to the understanding and cooperation of our clients. The projects that we and our clients considered worth continuing have since been successfully completed. The projects suspended in March and April to ensure safety are currently starting again.

Flexibility

At a time like this, when new challenges arise almost daily, it is essential to be flexible. For example, our IT department quickly adapted the existing infrastructure to the new needs, enabling all of the impacted employees to work from home. The employees who remained in the office practiced the required social distancing and spread out to the many offices that were now empty. Some of the teams split their time in the office into two shifts. This precaution meant that, if anyone were to come down with Sars-Cov2, the chain of infection could be broken. We used digital applications such as chat programs, video conferencing and podcasts to adapt internal and external communication to the new situation.

Willingness and hands-on mentality

Extraordinary circumstances demand extraordinary measures. Our staff was overwhelmingly willing and ready to cope with the crisis. Some of our employees sewed hundred of masks for the common good. Some applied their pharmaceutical training to developing proDERM’s own disinfectant (Read our Update on LinkedIn). And in no time at all, others erected Plexiglas panes, installed soap dispensers and posted signs informing employees and test persons of the new hygiene regulations.

Staff spirit

Social distancing and working from home while home schooling children can be grueling. A recent survey by the social network LinkedIn revealed that a third of participants were tense, irritable and anxious when working from home long-term. However, our employees managed to keep their positive attitudes the whole time. This can be attributed on the one hand to a high degree of self-discipline and personal responsibility. And on the other hand new offers were provided and utilized. One example is the newly created forum on “I feel good.” This platform allows users to share information on the online offerings intended solely to serve the best interests of participants. They include e.g. physical fitness seminars, back exercises, board games, fantasy trips and tips on how to structure your day. Then there is a proDERM cyber café and the initiative “Send a Smile,” a newsletter that allows you to send someone a smile. And a virtual gratitude tree was created as a worthy place to show appreciation in these times. All of these things had a positive impact on the morale and performance of the team.

We firmly believe that the reliability of a partner – whether in times of crisis or not – is invaluable. We are committed to this “reliability” and express it best in the slogan developed along with our employees: “Research to rely on.” Covid-19 has tested us and our reliability like nothing else ever has, and we are proud to have successfully mastered the challenge.

Yours Prof. Klaus-P. Wilhelm

#onboarding, #covid19

Challenges Faced by Human Resources

Onboarding in Times of Covid-19

The corona pandemic poses great challenges for Human Resources managers: In addition to new labor law issues, the managers are having to deal with adapting proven processes, working with communication methods attuned to the situation and handling technical, organizational and particularly human aspects of the crisis. Our HR manager Franziska Laboch explains the current challenges and illuminates the onboarding process in this article.

A while back we created a recruiting and onboarding process intended to make it as pleasant as possible for potential and new employees to be introduced to working at proDERM. We generally allow candidates to meet their future team members relatively early in the application process. We normally welcome new co-workers with a card and flowers at their new desk. And we normally take the new employee on an extensive tour of our facility, introducing her or him briefly to everyone. By the end of the tour, he or she has seen all the faces and forgotten most of the names (after all, we have over 100 employees).

Generally, normally, … That is no longer possible in the era of Covid-19. Instead, whenever possible we conduct all activities related to the recruiting and onboarding processes virtually and in compliance with our safety and hygiene measures. Interviews take place online. If they are done in person, we keep the circle as small as possible. Training is currently done preferably with digital tools, and the tour through the company is reduced to a minimum. However, it is still important to us that all new employees see their new workspace and meet their counterparts at least briefly.

Our new colleagues in the Study Conducting department are going through this very different introduction to proDERM right now. I would like to take this opportunity to introduce and welcome them: Katja Seedorf, Jessica Pickhard and Lisa Glöggler. They have readily met the challenge so far! I am already looking forward to showing them around proDERM when everything is back to normal: no empty rooms, only offices filled with lively teams working on site. The cheerful atmosphere is definitely a defining feature of proDERM.

But modifying recruiting and onboarding processes is not all there is to managing the crisis from an HR standpoint. Especially at the beginning of the pandemic, it was about positioning ourselves on fundamental issues and creating reasonable conditions for our employees. For example, the crisis team and senior management had to – and were able to – find a way to fulfill our obligation to protect the welfare of our employees while still remaining a reliable partner for clinical studies and thus meeting our obligations to our sponsors. At the same time it was essential during this difficult phase to convey a sense of security to our employees through proactive and clear communication, despite the lack of scientific findings and the increasingly dire impact on the economy. We did this with brief video messages, personal conversations and the newly added chat channels. And of course we had to quickly make sure that the employees were given the flexibility needed to cope with working from home while home schooling their children.

In summary, it is safe to say that during my seven years at the company, there has never been a time as challenging as the weeks and months since the pandemic broke out. But at the same time I am very proud that, despite the difficult circumstances, our staff has reacted positively and proactively. It sends a strong signal that although orders are declining, we are able to maintain our growth strategy and continue hiring. We are laying the foundation for revving up again when everything is back to normal … I am really looking forward to that!

#remotestudies

Digital Studies

Ready to conduct Remote Trials

Thanks to a new collaboration with a platform for video consultation, we are now able to conduct certain types of studies remotely, meaning that the test persons do not have to come to the study center. They can participate virtually through a terminal device. We would like to briefly inform you about the technology used.

The Covid-19 pandemic has changed the conditions governing clinical studies. In addition to the many safety and hygiene measures (link), so-called “remote studies” are becoming increasingly prominent. They appear to be a promising alternative to conventional studies. Because we are able to provide reliable results, we can now offer remote studies. We work with a platform designed for video consultations in a doctor-patient environment. The platform meets these criteria:

  • Easy to use
    Access via web browser without any downloads or apps that have to be installed.
  • Technical reliability
    All you need for online meetings is a stable Internet connection. It does not even have to be high-speed.
  • Compatibility
    Any Internet-ready device should be able to access the platform with common browsers such as Mozilla Firefox, Google Chrome or Safari.
  • Security
    Data transmission applies the highest security standards with SSL/peer-to-peer encryption.
  • Compliance with German data protection laws
    All of the information collected in the course of the online appointment is processed in compliance with German data protection laws.

We would be happy to answer your questions about our remote studies. Please contact our Business Development team at BD@proDERM.de.

#webinar, #antiage

How to substantiate Anti-Aging Claims?

Signs of aging and ways to measure product efficacy

On September 24, 2020 we will host the webinar “How to substantiate Anti-Aging Claims? – Signs of aging and ways to measure product efficacy”. In her lecture Dr. Gunja Springmann will discuss the following topics:

  • Intrinsic (inevitable genetically process) and extrinsic aging (lifestyle and environmental triggered)
  • Modern clinical parameters
  • Testing methodologies for the in-vivo investigations explained
  • Example Results

The webinar will take approximately 60 minutes and will end with a Q&A session.

#webinar, #haircaretesting

Biophysical measurements to investigate the efficacy of hair care products

The webinar aimed at providing a general overview of available methods

On October 1, 2020, we will host the webinar ‘Biophysical measurements to investigate the efficacy of hair care products’ at 3:00 p.m. CET. In this lecture Dr. Iryna Kruse and Dr. Lorena Bechthold present standard biophysical measurement methods for examining products in the areas of hair care, hair styling and hair color. Their lecture will answer the following questions:

  • What standard measurement methods are available?
  • Which method is suitable for which claim?
  • How do the respective methods work?
  • What do typical results look like?

The aim of this webinar is to provide the participants with a brief overview of the biophysical measurement options. It is primarily aimed at those who have little experience in this area or who want to refresh their knowledge.

The webinar will take approximately 60 minutes and will end with a Q&A session.

#webinar, #medicaldevice

Substance-based medical devices before and after May 26, 2021

The proDERM webinar on the effects of the medical device regulation

On October 29, 2020, at 3 p.m. CET, we will host the webinar ‘Substance-based medical devices before and after May 26, 2021’. Bernd Brormann, Director Clinical Operations at proDERM, will discuss aspects of the Medical Device Regulation that will come into force on May 26th, 2021 and in particular the implications for the category of ‘Substance-based medical devices’. The following topics will be presented:

  • Background and objective of the new medical device regulation
  • Definition of ‘material medical devices’ – the classification rule 21
  • Risk classes of material medical devices according to old and new regulation
  • Requirements for market approval – clinical trial or proof of equivalence?
  • Regulatory environment
  • Differentiation from medicinal products
  • Active pharmaceutical ingredients in medical devices

The webinar will take approximately 60 minutes and will end with a Q&A session.

#webinar, #dermalsafety

Dermal Safety of Medicinal Products and Medical Devices

Phase-1-Studies to Evaluate the Local Tolerability of Topical Products

On November 19, 2020 at 3 pm cet we will present the webinar ‘Dermal Safety of Medicinal Products and Medical Devices’. In this presentation we will provide an overview of required local tolerance studies. This includes methodological details as well as regulatory requirements.

While the local tolerance should be a prime concern for developing topical products successfully, this aspect is often neglected or addressed (too) late in the drug/medical device development. This webinar will provide a concise yet complete overview about required dermal safety studies and the respective protocol outlines, to evaluate cumulative irritation, contact sensitization, phototoxicity and photoallergy.