On the 20th of March 2020, EMA published a new guidance addressing the impact of the COVID-19 pandemic on the conduct and initiation of clinical trials in the EU/EAA. Considering the urgency, no public consultation was launched on this guideline.
Various restrictions are being implemented in order to minimize the COVID-19 transmission together with an increased workload and potential shortage of hospital staff will impact the conduct and initiation of clinical trials.
The new guidance identifies affected areas, potential challenges and proposes measures to mitigate the risk for patients and the study/data validity:
- Travel restrictions and confinement/quarantine of patients and study staff (e.g. access to laboratory testing critical for the trial, limiting avoidable patient visits to sites, trial monitoring, limiting on-site visits, transfer of participants, trial staff availability etc.). Where possible contact via phone, video, e-mail (adherence to personal data protection laws).
- Communication with authorities (limited capacity of assessors) - New CT applications for prevention/treatment of COVID-19 and substantial amendment applications to ongoing CTs (due to COVID-19 pandemic) to be prioritized.
- Communication to sites – the changes to be communicated clearly (e.g. via documents with track changes) and agreements appropriately documented.
- Difficulties in obtaining informed consent (e.g. isolation of patient, patients in critical condition incapable of giving informed consent).
- Challenges in the distribution process of Investigational Medicinal Products (IMPs) (alternative shipping procedures, storage arrangements, management of urgent IMP shortages, use of direct delivery from sponsor to participant where possible, ensuring that blinding is not affected).
- Protocol deviations – an increase in protocol deviations is expected, deviations to be assessed and reported in study report in line with existing ICH guidelines. Protocol deviations due to COVID-19 vs.GCP § 5.20.
- Documentation and reimbursement of exceptional expenses.
It is essential to adhere to the study protocol, GCP, regulatory requirements etc. The sponsors and investigators should keep track of specific national regulations and guidelines that might be already in place or will be developed soon.
When a deviation cannot be avoided as a result of current extraordinary circumstances, such deviation must be properly justified and documented in clinical trial files, to support validity of studies. Before an amendment to clinical study conduct is implemented a thorough benefit-risk assessment is necessary, at all times priority must be given to rights and wellbeing of clinical trial participants.
Additional draft guidance by CHMP Biostats has been developed and published on 25th of March 2020. The guidance discusses the COVID-19 impact on methodological aspects of ongoing trials. A 4-week public consultation was launched for this draft guideline. As noted by BSWP it is impossible to provide a general advice how to handle ongoing trials and a careful case-by-case assessment is necessary. The sponsors should ensure that the study data and deviations (together with justifications) are captured in a way that will allow identification of the affected data. The sponsors are encouraged to make use of Data Monitoring Committee to assess the impact on data integrity and interpretability and to plan appropriate follow-up actions. Scientific Advice on these matters can be requested as well.
Further updates to both guidance documents are likely in order to cover the rapidly evolving situation.
For details please refer to:
At 3D-PharmXchange, we understand the challenges faced by many biotech and pharmaceutical companies to innovate and develop (bio-)pharmaceutical compounds that are safe and effective for patients. Especially in the current situation, where companies, hospitals, governments and patients need to deal with the COVID-19 pandemic. We are a Dutch consultancy firm and our consultants are experts in CMC, non-clinical, clinical and regulatory aspects needed to speed up your development programs and bring the product to market.
Our highly trained clinical development and regulatory affairs consultants are here to discuss and provide the needed support in your drug development during the COVID-19 pandemic. Please send us an email to firstname.lastname@example.org and we will contact you shortly.
w www.3d-pxc.com t +31 1 353 482 72
Mark has taken on the role of consultant CMC biologicals as of the 1st of September 2019.
Mark has over 17 years’ experience characterizing and formulating proteins, initially in academia and subsequently in industry in the UK, the US and the Netherlands. He has formulated antibodies and ADCs, Fc-constructs, blood clotting factors and other proteins as well as adeno vaccines for SC and IV dosing. He has represented drug product on CMC teams for Phase I and II programs and led an early stage CMC team. He engaged with CMC teams to set up and execute stability, shelf-life, specification, compatibility and comparability strategies. Through this work he also gained experience with Quality and Regulatory strategy, writing INDs/IMPDs and answering regulatory questions. He obtained managerial experience setting up and leading groups in Discovery as well as in Formulation Development.
Mark obtained a BSc in Chemistry from Imperial College, London, and a D.Phil. from the University of Oxford.
Charles Simons is a pragmatic, goal-oriented problem solver using buy-in to get things done. Charles has over 16 years of experience in the pharmaceutical field, with a focus on manufacturing and project management in orphan drug development area. The products he worked on range from; small molecules in the Coenzyme A metabolic disease field to mid-size molecules (oligonucleotides) against Duchenne disease and Myotonic Dystrophy disease to biotech products in the Hereditary Angioedema and Hemophilia A disease flied. During his career in the pharmaceutical industry he worked on projects ranging from early R&D, to (pre-) clinical up to and including a submission of the Drisapersen NDA to the regulatory agencies and amendments to the Ruconest BLA. Charles holds a BSc in biotechnology / biochemistry and an MBA from the University of The Hague.MoreLess
On Thursday April 18, Inez de Geef and Ronald van der Geest are both speakers at the Rare Disease Symposium, organized by HollandBIO. The second edition of the Rare Disease Symposium is about challenging the status quo and the development of orphan drugs.
Inez de Greef, CEO at Treeway and partner at 3D-PharmXchange, will talk about ‘right-to-try’; what does it mean for a patient-driven biotech company?
Ronald van der Geest is present as 3D-PharmXchange partner and will talk about a new exciting development in the way clinical trials are executed, called platform trials, in which multiple drug or diseases can be studied.
For more information or to register for the symposium, click on the following link: https://www.rarediseasepatient2030.comMoreLess
Tilburg, March 25th, 2019 - 3D-PharmXchange announced the appointment of André van de Sande, former CEO of Xendo, as member of the company’s Advisory Board.
“We are very pleased to have André join our Advisory board,” said Inez de Greef, managing partner at 3D-PharmXchange. “He knows both the Pharma and Biotech industry inside out and has wide ranging board experience.”
André is a Senior Executive with 30 years of Life Science experience and a proven track record in both mature and emerging markets all over the globe. He holds an MBA degree from Tilburg University, the Netherlands, and a MSc in Management from Purdue University, USA. His most recent experience as CEO of life science consultancy Xendo and earlier role as Managing Director at Schering Plough (now called MSD) and Organon, make him a very valuable addition to the 3D-PharmXchange team.
Next week (25 - 27 March) 3D-PharmXchange will be attending BIO Europe Spring in Vienna. Ronald van der Geest, Partner, will be present at the event and is looking forward to some very fruitful meetings.
If you are also attending the BIO Europe and would like to speak to us, feel free to send us an invite via the partnering tool.
Ronald van der Geest is a speaker at the Expert Class about Early Clinical Trials, organized by the LifeSciences@Work Accelerator on March 29, 2019 at the Pivot Park in Oss.
LifeSciences@Work Expert Classes are organized to support LifeSciences and Medical Technology start-ups. Ronald will kick off the meeting, sketching the bigger picture of early clinical trials, case studies based on personal experiences, tips and tricks, do's and don’ts etc. Ronald will also zoom in on new exciting developments in the clinical trial landscape in particular on platform trials. The LifeSciences@Work Accelerator is powered by Health-Holland, Topsector LifeSciences & Health.
Startups not (yet) part of the LS@W community but who are interested to join are welcome provided you match our community profile. Send an email to Ellen de Waal: email@example.comMoreLess
Co owner and founder Inez de Greef tells about the start of 3D-PharmXchange, her love for science and entrepreneurship and being CEO at Treeway.
Check out the link to read the interview: https://www.pivotpark.com/3404-2/MoreLess
On Thursday February 14th 3D-PharmXchange will attend the sixth edition of Innovation for Health in WTC Rotterdam. This event provides an opportunity to meet key players in Health and Life Sciences in order to exchange ideas, learn from best practices and gain new insights. You can meet Ronald van der Geest and Sytske Moolenaar at booth number 52.MoreLess
We would like to introduce you to our new colleague; Oskar Smals.
Oskar is an experienced regulatory professional with 20 years of product development experience. He has been involved in the development of a variety of drugs and biologics for many different indications, both hands-on and high-level strategic. He started his career at Organon in the Netherlands and in the US, after which he moved to Vancouver, Canada where he worked for various small biotech companies with increasing scope and responsibility. Oskar´s regulatory experience includes early and late stage products (covering CMC, preclinical and clinical), various indications (immunology, cardiovascular, metabolism and oncology) and both small molecules as well as advanced therapies (gene therapy).
Oskar obtained his MSc in Medical Biology from Utrecht University.
We are very happy to add Oskar to our team and look forward to working with him. Do you have a project that can benefit from Oskar's expertise? Feel free to contact us at firstname.lastname@example.org or on our phone number: +31 (0)13 53 482 72MoreLess
We are happy to announce that Ronald van der Geest will participate as an invited speaker in the rare disease panel discussion on ‘Successful drug development for rare diseases' in BioVaria conference from 23 - 24 April, 2018. As an expert mentor, he will also coach start-up companies in various topics including, but not limited to, IP, business plan, technology development, funding and manufacturing.
The BioVaria conference will bring together European research institutions across national borders in order to improve the transfer of their research results into application. Europe's most established technology transfer organizations will join to present their most promising projects from academia to decision makers from international industry.
Panel Discussion: ‘Successful drug development for rare diseases’
Moderator: Prof. Horst Domdey, BioM
Dr Paul Lasko, Scientific Director, Canadian Institutes of Health Research (CIHR) Institute of Genomics & former Chair (IRDiRC)
Dr Olaf Ritzeler, Director, Rare Diseases External Innovation, Global Business Development & Licensing, Sanofi
Dr. Ronald van der Geest, Founder and General Partner at 3DPharmXChange, & Chief Development Officer at Treeway
Check out the link for more details: https://lnkd.in/gZFkukmMoreLess
As of March 1st 2018, Susan will take on the role of Senior consultant regulatory afairs.
Susan brings with her 20 years of experience in regulatory affairs, both from the originator and the generic pharmaceutical industry. She spent a large part of her career at Organon/Schering-Plough/MSD in different roles, ranging from regulatory affairs scientist to Director, Regulatory Affairs International. Most recently she was part of the management team of the Regulatory Competence Centre Europe of Sandoz.
Susan has gained knowledge and experience in global regulatory requirements for the development and registration of new medicinal products as well as maintenance of approved drugs. This includes eperience in developing regulatory strategies, providing strategic regulatory input to global interdisciplinary teams, compilation and submission of registration files worldwide, interactions with health authorities worldwide, clinical trial applications, implementation of new legislation and due diligence activities. Susan obtained her PhD in Immunology from the University of Amsterdam.
We are very happy to add Susan to our team and look forward to working with her.MoreLess
Last week, Ronald van der Geest and Syeda Quader visited the BIO Europe in Berlin. This annual event is the largest partnering conference serving the global biotechnology industry.
This year's BIO event attracted over 4,000 attendees from over 60 companies, representing over 2,000 different companies.
Ronald and Syeda had great BIO meetings. "The BIO is a fabulous platform to meet and re-connect with life sciences companies looking to add value and advance their development programs. It is exciting to catch up with all the ongoing developments and how we can help them move forward."MoreLess
We are pleased to introduce our new colleague: Maarten Nieboer.
As of January 1st 2017, Maarten will take on a role as Senior consultant responsible for management of CMC (Chemistry, Manufacturing, Controls) development for Biologicals.
Prior to joining 3D-PharmXchange, Maarten spent the past 16 years of his career in different roles with increasing responsibility in Program management, Process Development and Manufacturing of Biologicals. He spent a significant part of his career with DSM Biologics (now part of Patheon) and more lately MSD (Merck) where his most recent role was Exec. Director, Biologics Manufacturing Sciences and Commercialization. Over the past years, Maarten has built a broad experience through many different Biological development programs (both early phase and late phase/commercial, including KEYTRUDA®). Maarten obtained his PhD in Biology from the Groningen University.
Exciting developments in the biotech sector are occurring in the relatively new fields of Gene Therapy and MicroRNA’s. Although the Netherlands and Belgium are frontrunners in the field, there are still some hurdles to overcome and companies are most likely struggling with the same or similar issues when developing this new challenging class of drug. With this in mind, 3D-PharmXchange and Mirabilis came up with the idea to have a free-flowing discussion on this topic during a Round Table Meeting. The meeting took place on the 17th of November in the Colour Kitchen in Utrecht. Dutch and Belgian companies working on microRNA’s and Genetherapy were invited. The goal of the meeting was to bring the field forward successfully and efficiently in a setting that is different from usual. The meeting was organized in cooperation with Health Holland and HollandBio.MoreLess
As of November 23, 2106 3D-PharmXchange has appointed François van Och as Chief Operating Officer (COO).
François has over 15 years of experience in the pharmaceutical industry, including extensive work in (non-)clinical project- and line management. Previously at 3D-PharmXchange, he acted as toxicology expert and project leader of multi-disciplinary development projects. Prior to joining 3D-PharmXchange, he was non-clinical project director at Merck Sharp & Dohme (MSD), where he was responsible for safety assessment of multiple compounds (NCE’s and biologicals) and acted as line manager of bioanalytical and biochemical laboratories.
In his new role, he will be responsible for leading and streamlining the daily operations, business development and strategic direction.
François received a MSc in life sciences from Utrecht University, The Netherlands followed by a PhD on Immunotoxicology at the faculty of Veterinary Medicine, Utrecht University in close collaboration with the National Institute for Public Health and the Environment (RIVM) in Bilthoven, The Netherlands.MoreLess
We are pleased to introduce our new colleague Philip Kwant. As of October 10th 2016, Philip will take on the role of Business Development Manager.
Prior to joining 3D-PharmXchange, he worked in the pharmaceutical industry for 20 years in various positions at Organon N.V., Schering-Plough and Merck. During this time he gained broad experience in the set up and execution of in-vivo toxicology studies (general en reproduction toxicology), was responsible for outsourcing preclinical safety studies/packages, DMPK, bionanalytical work and hiring consultants. His latest position at Merck was clinical trial specialist and clinical trial manager for two phase III clinical trials in the therapeutic area of Women's Health. In the past 2 years he was project manager and purchaser in the cosmetic industry.
The HBA (Healthcare Businesswomen’s Association) is organizing their 2016 HBA Europe Leadership Summit ‘The Future Is Now: Are You In It? The purpose of the HBA is to further the advancement and impact of women in the business of healthcare. At this summit, our partner Inez de Greef will give a lecture on “ALS –how the ice bucket challenge impacted awareness of rare diseases” and will discuss in more detail how to lead the patient-driven biotech company Treeway. The Summit will take place from 26-27 October at The Corpus Congress Centre, Leiden, The Netherlands. For more information on the event, click hereMoreLess
From a safety perspective, all companies with multifunctional pharmaceutical and chemical production facilities must be able to adequately determine cleaning limits and permitted daily exposures (PDEs) by characterizing the effects of possible cross-contamination in the non-intended patient population via calculation of health-based carry-over exposure limits (ICH Q3D, EMA). This may enforce renewed cleaning validation activities, test method detection and sampling, and potentially lower detection limits. So what are the greatest obstacles in setting the PDEs so far? We answer the four most commonly asked questions:
Q: What do you do when there is insufficient data on NOAELs, dose and toxicities?
A: Initiate a practical approach; include relevant internal IBs, CTD’s etc. and conduct a literature research to evaluate the data that is available from public libraries. Find the appropriate product characteristic or patient information and determine the therapeutic dosages and adverse effects. It’s a question of knowing where to look!
Q: Does human data not always supersede non-clinical data?
A: Human data is of course very valuable, but both studies should complement each other in the derivation of a sound PDE. For example, human data can be scarce if the product is relatively new, in which case non-clinical data could be more appropriate in setting your PDE. In addition, reproductive toxicity is mostly investigated non-clinically, thereby making it an essential asset in completing your toxicological evaluation.
Q: Do you need single dose studies (i.e. the MTD/LD50/etc.) for the PDE derivations?
A: Even though all data should be considered, the derivation of the PDEs should be reflective of your lowest limits at which adverse effects can occur. This implies that maximum tolerated dosages or non-clinical LD50 dosages might be less relevant in determining your critical PDE.
Q: There is more than one relevant PDE, what do I do?
A: Your PDE report can, and sometimes even should, provide more than one PDE as it can be derived from various clinical or non-clinical studies, different routes of dosing and/or multiple type of adverse effects. The most critical factors should be considered, i.e. incidence, severity and dose level, with which a critical PDE can be selected.
The deadline for the PDEs is to be employed as of June 2016. If you need any help in implementing this guideline, let us at 3D-PharmXchange help you integrate these type of questions into one clear scientific based evaluation with our peer-proofed PDE template, which can be readily implemented and ensures complete compliance with regulatory requirements and standards.MoreLess
We are proud to announce that our partner Inez de Greef is co-author of an article published by Clinical Pharmacology & Therapeutics on November 13, 2015. The objectives were 1) to develop an MCDA tool to compare drug effects in OAB quantitatively, 2) to establish transparency in the evaluation of the benefit-risk profile of various dose combinations, and 3) to quantify the added value of combination use compared to monotherapies. This case study underlines the benefit of using a quantitative approach in clinical drug development programs. For more information, click here.MoreLess
We are very proud of the achievements of our colleagues Jorgen, Ronald and Dirk and their contribution to research on ALS and cancer by cycling the Mont Ventoux and Alpe d'Huez.
On the 2nd of June, Jorgen joined the team of NTRC during Alpe d'HuZes and climbed this mountain 6(!) times to raise money for cancer research. Alpe d'HuZes was organized for the 11th time and over €10 million has been raised so far!
The next day, June 3th, Ronald and Dirk (team Treeway Riders) climbed the Mont Ventoux during Tour du ALS to raise money for research on ALS. The Tour du ALS 2016 was a great success, over 400 participants cycled to the top of the Mont Ventoux and raised over €730,000!
We would like to thank all of you for your donations to our colleagues, together we helped to increase awareness and to speed up research on ALS and cancer.MoreLess
3D-PharmXchange was well represented at the Health-Holland Pavilion during the Bio Europe Spring from 4 to 6 April in Stockholm, Sweden. At BIO-Europe Spring over 2,300 executives from 1,377 companies and 49 countries engaged in 12,452 one-to-one meetings to discuss licensing opportunities, deal potential and strategic collaborations. At the Health-Holland Pavilion, the Netherlands was represented as an attractive country for establishing a biotech company, as an innovative business partner, and a successful location for R&D. This edition for the first time, the pavilion featured a “Dutch Biotech in the Spotlight Corner” powered by 3D-PharmXchange and Pivot Park Screening Center. Giving Dutch companies the opportunity to present themselves and their unique offerings to the conference’s public.MoreLess
We are proud to announce that our colleague Ramon Mols is co-author in a publication in Current Therapeutic Research by Elsevier. This study was designed to demonstrate that alendronate (ALN)/vitamin D3 combination tablets (ALN/D5600) are bioequivalent to corresponding doses of ALN and vitamin D3 as individual tablets in healthy Taiwanese volunteers.
In this study the combination tablet was considered bioequivalent to coadministration based on ALN AUC0–∞ and unadjusted vitamin D3 parameters. Slight differences for ALN AUC0–last and Cmax (upper 90% CIs outside the bounds) were not considered clinically significant. The combination tablet was well tolerated. No serious adverse experiences were reported.MoreLess
This month we welcomed Selcan Yildiz (pronounced as Sel - djan) at 3D-PharmXchange. She studies at VU University in Amsterdam and is enrolled in the MSc program Science, Business and Innovation. This is a multidisciplinary study with courses from different academic backgrounds, focused on the life science industry. Prior to this graduate program, she gained practical experience within the academic world as a student-assistant at the Utrecht University and worked as an intern at different international pharmaceutical and health care oriented companies. These experiences have sparkled her interest in consultancy. At 3D-PharmXchange she will have the opportunity to explore this field. In addition, she will participate in different projects and focus on patient involvement within the drug development process for her graduate thesis.MoreLess
Successful dose and confirmatory study solid platform for phase II/III trial in ALS patients
Today Treeway announces the completion of two successful phase I trials with their lead compound TW001, a new more patient friendly oral formulation of the Japanese stroke and ALS therapy edaravone. Treeway, founded by two Dutch ALS patients, aims at speeding up ALS research in collaboration with academic and research centers around the globe.
TW001 was tested in both single and multiple dose phase l studies in healthy volunteers and in ALS patients. In the two Phase 1 clinical studies TW001 was shown to be safe and well tolerated and adequate exposure levels with the oral formulation were detected. Based on these trial data, the company is now aiming to start a pivotal phase 2/3 study in 2016. Earlier, Treeway obtained orphan drug designation for edaravone of ALS from both the FDA and EMA.MoreLess
Inez de Greef, CEO of Treeway comments on the trial outcome:
“The positive results of our Phase I program are an important milestone for the development of TW001 for ALS. This outcome is not only represents a significant achievement for our company, but first offers important new patient friendly aspects to the treatment of ALS”. We look forward to sustaining this momentum in the coming months, as preparations for the pivotal Phase II/III clinical study are now ongoing.’
TW001, Treeway’s lead compound, is an oral formulation of edaravone. Edaravone is a well-established free radical scavenger, which targets oxidative stress, a process that plays an important role in ALS. Intravenously administered edaravone has been shown to slow down disease progression in ALS patients in previous Japanese clinical trials.
Treeway has developed an oral formulation (TW001) to overcome the problems associated with intravenous administration. The reformulated drug allows for chronic daily use and its route of administration (oral) is patient friendly.
Currently, edaravone is marketed in Japan by Mitsubishi Tanabe as an intravenous formulation (Radicut®) for the indication stroke and ALS. The intravenous formulation of edaravone is administered to ALS patients via 1-hour infusions in a hospital setting. Drug holiday cycles are part of the treatment regimen (patients are treated 10 out of 28 days).
More information: www.treeway.nl
Walloon Government supports the development of iTeos proprietary pipeline to develop novel therapeutics targeting the immune tumor micro-environment
iTeos Therapeutics SA, the drug discovery company for immunomodulators, announced that it has received a €2.94 million non-dilutive funding from the Walloon Region of Belgium to expand its preclinical drug discovery pipeline targeting new immunotherapies for the tumor micro-environment.
“This grant will allow us to expand our proprietary pipeline by adding a program to develop small molecule inhibitors for a target involved in T cell anergy”. said Christophe Quéva Ph.D., chief scientific officer of iTeos. “It will complement our growing portfolio of small molecules and antibody approaches aimed at stimulating certain immune responses against cancers.”
"We are very pleased to continue to receive strong support for our preclinical research from the Walloon Region. In parallel to our strategic collaboration with Pfizer, which was announced in 2014, we are expanding the Company’s drug candidate pipeline where such grant support is pivotal for our research efforts to discover our own diversified and innovative set of drug candidate programs." said Michel Detheux Ph.D., chief executive officer of iTeos.
More information: www.iteostherapeutics.comMoreLess
Treeway is pleased to announce a collaboration with the Cedars-Sinai Board of Governors Regenerative Medicine Institute for the development of AAV5-GDNF (TW002) gene therapy for amyotrophic lateral sclerosis.
Treeway, a biotech company founded by two ALS patients, obtained an exclusive license agreement from uniQure for the use of AAV5-GDNF earlier this year. GDNF has a promising clinical potential in ALS, but optimization of delivery to the site of action is required. AAV5-GDNF is a gene therapy with a novel administration modality for clinical use and is Treeway’s second product in development (TW002).
To advance the development of AAV5-GDNF gene therapy, Treeway will work with a research team led by Clive Svendsen, PhD, director of the Cedars-Sinai Board of Governors Regenerative Medicine Institute in Los Angeles. Svendsen is an expert in human neural stem cell biology and has specifically focused on using neural stem cells, modified to release GDNF, to treat ALS.MoreLess
Treeway and Cedars-Sinai applied for a TREAT ALS™Drug Development Contract and received the $500,000 award. The Drug Development Contract, an initiative of The ALS association, was designed to rapidly bring promising potential therapeutics closer to clinical trials. The TREAT ALS™Drug Development grant will be used to start a preclinical study in which the safety and efficacy of TW002 in an ALS rat model will be assessed further. The preclinical studies are an important step in the development of TW002 for ALS.
Inez de Greef, CEO of Treeway, is pleased with the collaboration and says: “consistent with Treeway’s philosophy of ‘innovation by collaboration’ we believe that this research will help us to rapidly advance breakthrough science and further the goal of bringing new treatment approaches to ALS patients. We are grateful for the grant awarded by The ALS Association which enables us to jointly work on finding a cure for ALS.”
“The ALS Association is pleased to support funding for academic-industry partnerships to expedite therapy development for ALS”, commented Lucie Bruijn, Ph.D. MBA Chief Scientist from the ALS association.
More information: www.treeway.nl
Laura van Dijk has published and defended her PhD-thesis on “EGFR Imaging in Head and Neck Cancer” in July 2015, describing research focusing on a method for head and neck cancer patient selection for EGFR-targeted therapy in combination with radiotherapy. If patients in whom treatment will work can be identified, their care and disease control will be improved. In addition, other head and neck cancer patients will not be treated unnecessarily and will not experience the side effects.MoreLess
Within the six published articles, Dr. van Dijk shows that by radioactively labelling a F(ab’)2 protein fragment of cetuximab, the response of xenografted head and neck cancers to treatment can be imaged with PET and SPECT. The change in uptake was monitored before and during treatment and showed that a difference in uptake was evident early on, where and increase in tumor uptake signified non-responsiveness and a decrease in uptake pointed to successful treatment. Clinically, this could aid in early identification of cetuximab (non-)responsiveness in patients, allowing for patient selection and the necessary development of personalized healthcare.
We are pleased to introduce our new colleague Jorgen Willemsen. As of July 1st Jorgen will support our CMC Project Leader and is involved in the entire CMC development trajectory from early development until market introduction. Prior to joining 3D-PharmXchange, Jorgen worked at Corbion in Gorinchem. During this period, he obtained broad knowledge in designing continuous chemical processes for the production of chemicals derived from biorenewables. Jorgen obtained his PhD in Organic Chemistry at the Radboud University in Nijmegen. Welcome aboard, Jorgen!MoreLess
The 1st edition of the New Amsterdam City Swim was a great success. On June 21st over 400 participants jumped into the Hudson River in New York City to swim 1.5km. Through fundraising over $400.000,- was raised! We would like to thank all of you for your donations to team Treeway, together we helped to increase awareness and to speed up therapy development for ALS.
3D-PharmXchange welcomes Laura van Dijk who recently joined our non-clinical development team. Laura holds a Master degree in Medical Biology and is near to obtaining her PhD on Radiation Oncology & Nuclear Medicine at the Radboud University Medical Center Nijmegen. During her Master Medical Biology she gained research experience in Alzheimer’s Disease at the RadboudUMC and Bacteriological R&D at Nobilon/MSD Animal Health. We are confident that Laura will be of great value to the company and our clients.MoreLess
Treeway is pleased to announce that the US Food and Drug Administration (FDA) has granted orphan drug designation for TW001 for the treatment of ALS (Amyotrophic Lateral Sclerosis). ALS is a neurodegenerative disease causing death on average after 3 years of symptoms onset.
Treeway accelerates ALS therapy development by patients involvement and TW001 is the lead compound within Treeway’s pipeline. “Obtaining orphan designation for TW001 from the FDA is an important milestone for Treeway” said Ronald van der Geest, CDO of Treeway. "The orphan drug designation will help us further to align with FDA on the acceptability of a US clinical study program, and to profit from possible financial incentives related to the orphan designation status, such as reduction of clinical trial costs, a waiver of user fee (approx. $2.0 M) for the submission of a future registration file (NDA), and a 7-year Marketing Exclusivity following eventual NDA approval”.
More information: www.treeway.nlMoreLess
This year, 3D-PharmXchange celebrates its 5th anniversary. On February 1st 2010, 3D-PharmXchange started with three founders from an attic room.
“The vision we had from the start is becoming a reality today. It is great fun to watch how our partner and client companies grow with us. Together, we realize that there are new and better strategies through which drugs can be developed,” Ronald van der Geest, partner and co-founder at 3D-PharmXchange, said.MoreLess
Now, five years later, we have two offices: one located in Tilburg and one at Pivot Park in Oss. We work together with 14 in-house experts and a similar sized team of collaborative partners. As a result, our team covers the core disciplines needed to bring drug development programs forward. We have been and still are involved in multiple inspiring and innovative projects.
“In the short history of 3D-PharmXchange, significant achievements have been reached in collaboration with our clients. Apart from the expertise of our personnel, their commitment and motivation is key to our success. I am always pleased when our employees say that they feel like they are part of the client's team”, Inez van der Greef, partner and co-founder at 3D-PharmXchange, said.
Our client Treeway is looking for persons who have been diagnosed with ALS. With the help of ALS patients, scientists and the industry Treeway aims to develop a suitable therapy or drug to cure ALS. If you would like to apply for participation in the Clinical Study, please click here. The Clinical Study is executed by TRICALS. TRICALS is an independent platform founded by Prof. Dr Leonard van den Berg with the objective of generating more research into ALS. For more information, visit the TRICALS website or send an email to email@example.comMoreLess
On the 10th of February, Biocartis announced that it is in the testing phase of a Rapid Ebola Virus Triage Test that it is developing in association with Janssen Diagnostics and the Institute for Tropical Medicine in Antwerp (Belgium) for its Idylla™ system, a fully automated molecular diagnostic platform that is CE-IVD marked in Europe.MoreLess
The Rapid Ebola Virus Triage Test is designed to enable healthcare workers, even in challenging environments, to test blood samples and aims at providing accurate and fast diagnosis of Ebola. The test is designed to offer a unique combination of speed, sensitivity, accuracy and ease-of-use required for outbreaks where time is of the essence. Rudi Pauwels, Biocartis’ Chief Executive Officer commented: “This test aims not only to improve the diagnosis of the Ebola virus for hard-pressed healthcare professionals in the field, but to lay the foundations for a better and faster diagnostic infrastructure after the current outbreak has receded, both in this region and around the world. One of the lessons of the Ebola outbreak has been the urgent need for faster and more accurate diagnostics. Biocartis is pleased to be working, alongside prestigious partners, on what it believes could offer a viable solution for healthcare workers around the world to enable faster testing of infectious diseases in virtually any setting.” For full press release, click here.
Under the terms of the licensing and collaboration agreement, uniQure has granted our client Treeway an exclusive license in this field to uniQure’s relevant AAV5 viral vector and GDNF (Glial cell-derived neurotrophic factor) intellectual property. Treeway is responsible for the preclinical and clinical development of the ALS gene therapy treatment. uniQure will provide Treeway with its manufacturing capabilities and will further collaborate with Treeway on ALS gene therapy development. Treeway and uniQure will jointly commercialize any resulting ALS gene therapy with defined geographical rights for commercialization assigned to each company. For full press release click hereMoreLess
iTeos Therapeutics SA announced today a strategic collaboration with Pfizer Inc. pursuant to which iTeos will license to Pfizer rights to iTeos’ pre-clinical compounds targeting Indoleamine 2,3-dioxygenase (IDO1) and Tryptophan 2,3-dioxygenase (TDO2). Pfizer will be responsible for the development and commercialization of IDO1 and TDO2 drug candidates. Additionally, the parties will collaborate to discover and validate new targets that play key roles in the ability of tumors to evade immune responses. These new targets will be shared by iTeos and Pfizer for further independent or collaborative development.MoreLess
"This strategic collaboration is a transformative opportunity for iTeos,” said Michel Detheux, Ph.D., chief executive officer of iTeos. “The oncologic expertise of Pfizer will help enable the acceleration and expansion of the scope of iTeos’ IDO1 and TDO2 programs. Furthermore, by working with Pfizer, we aim to produce a series of new targets that have the potential to be further developed by iTeos or Pfizer. This expansion of our drug discovery programs is expected to provide additional, novel immunomodulators for future treatment of cancer patients. The successful integration of Ludwig Cancer Research science into iTeos’ preclinical discovery platform in just two years following inception of the company made this collaboration possible." For full press release click here
On December 1st, 2014, our client Treeway was pleased to announce that the European Medicines Agency (EMA) has granted orphan drug designation for TW001 for the treatment of ALS. ALS is a neurodegenerative disease causing death on average after 3 years of symptoms onset.MoreLess
Treeway accelerates ALS therapy development by patient involvement and TW001 is the lead compound within Treeway’s pipeline. “Obtaining orphan designation for TW001 in the European Union (EU) is an important milestone for Treeway”, said Ronald van der Geest, Chief Development Officer for Treeway and partner at 3D-PharmXchange. “This orphan drug designation comes right on time to support our entry into the clinical stage, with which we are now fully engaged”.
EMA’s Orphan Medicinal Product Designation is designed to promote the development of drugs that may provide significant benefits to patients suffering from rare, life-threatening diseases. With the orphan drug designation, Treeway will benefit from several incentives related to contacts with the EMA and market exclusivity. For full press release click here.
The 3rd edition of the Amsterdam City Swim was a great success. On September 7th over 2000 participants jumped into the canals of Amsterdam to swim 2km. Through fundraising a total amount of €2,160,492.- was raised! We would like to thank all of you for your donations to team Treeway, together we helped to increase awareness and to speed up therapy development for ALS.MoreLess
We are pleased to introduce our new colleagues Sytske Moolenaars and Ramon Mols. As of September 1st Sytske fulfils the role of Consultant CMC. Prior to joining 3D-PharmXchange, Sytske held different positions at MSD where she gained broad knowledge in formulation development and biopharmaceutics related topics. Ramon has over 10 years of experience in drug development, clinical pharmacokinetics, scientific writing and regulatory affair. Accordingly, he started as Consultant Regulatory Affairs. We are confident that both Sytske and Ramon will be of great value to the company and our clients.MoreLess
This edition of Folia Pharmaceutica features an in-depth interview with Ronald van der Geest. Ronald elaborates on the successes of 3D-PharmXchange, his specific career path and personal vision on the Pharmaceutical Industry. Folia Pharmaceutica is one of the oldest student magazines in the Netherlands and is distributed nationally. The theme of this edition is ‘failures and blockbusters’ and contains articles about successes, failures and problems in the Pharmaceutical Industry.
For the full article click image on the right or click here for the August edition of Folia Pharmaceutica (both in Dutch)MoreLess
We are proud to announce that our colleague Bert Haenen is co-author (chapter 3) of a new publication, The Role of the Study Director in Nonclinical Studies by Wiley. The book, launched this month, is a single-source reference with a broad and holistic overview of nonclinical studies. It offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives.MoreLess
Chapter 3, for which Bert Haenen is first author, provides direction to Study Directors in the vast regulatory landscape of safety testing of chemical products. It provides more thorough understanding of how nonclinical data will be used in the regulatory landscape and to help Study Directors to design and conduct studies in a manner that will facilitate global acceptance of test results, regardless of the end use of a chemical.
It describes how pharmaceuticals, pesticides, and chemicals are regulated with respect to toxicity testing in general terms. The chapter focuses on regulatory guidance and guidelines that are important in the conduct of toxicity studies. It reviews the similarities and differences in guidance provided by various regulatory bodies in the main industrial areas. The chapter highlights the pivotal role of organizations in toxicity testing, and discusses potential pitfalls in regulations. For more information click here
July 17, Financieel Dagblad presents an extensive 2-page article with interesting insights on outsourcing strategies of virtual biotech companies. Partner and co-founder of 3D-PharmXchange, Ronald van der Geest, contributes with our vision on drug development in the life science industry.MoreLess
Treeway and Amarna Therapeutics join forces and form a collaboration to identify new therapeutic targets for the treatment of ALS. The aim of the project is to screen for new targets which play a role in both the cause and progression of ALS using the patented viral gene delivery platform SVac. With this collaboration, Treeway and Amarna Therapeutics hope this may ultimately lead to a new therapy for patients with Lou Gehrig’s Disease or Amyotrophic Lateral Sclerosis (ALS). For full press release click here.MoreLess
3D-PharmXchange is pleased to welcome Mirjam Mol-Arts from the 1st of October as new CEO of Pivot Park in Oss. She was already involved with the establishment of Pivot Park and member of the Task Force Life Sciences Park Oss. In this new position she will focus on expanding the park, building a community and improving the infrastructure. We congratulate Mirjam with this new role.MoreLess
3D-PharmXchange is proud to announce that our partner Joris Schuurmans has been appointed as COO at Biocartis. In this role he is responsible for Biocartis' Manufacturing and Supply Chain Operations, Systems Engineering, Program Management and R&D.MoreLess
On 1 February 2014, Dirk Lok has started to work at the Development Section of the Regulatory Affairs Department of Astellas Pharma Europe R&D in Leiden. For a period of 7 months he will act as the Global Regulatory Lead for various urology projects, taking care of the responsibilities of one of the regulatory affairs managers during her maternity leave.MoreLess