PharmaLex GmbH

Mannheim, Germany

PharmaLex GmbH

Mannheim, Germany
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News Article | May 10, 2017
Site: www.prnewswire.com

"We are delighted to be joining the PharmaLex Group," said Safis Solutions founder Ping Poulsen. "Not only can we expand our breadth and depth of expertise by being part of a global multinational company but a more mature infrastructure will allow us to offer our clients a more comprehensive service portfolio." PharmaLex, headquartered in Frankfurt, Germany, provides solutions for drug development, regulatory affairs, and pharmacovigilance. The company features a multidisciplinary team from more than 40 nationalities with knowledge that spans the whole spectrum of life sciences, including biology, biochemistry, pharmacology, engineering, food chemistry, medicine, nutritional science, pharmacy science, toxicology and veterinary medicine. "The acquisition enables PharmaLex to complement its existing E.U. medical device expertise with high quality and established U.S. medical device capabilities," said Dr. Thomas Dobmeyer, PharmaLex CEO. "It will help establish us as a key provider in the U.S." Generational Equity Managing Director Douglas Smith and Vice President Ryan Johnson led the deal to a successful close. "It was very important to Ping Poulsen that Safis Solutions be acquired by a company best able to leverage Safis' expertise and maintain its reputation in major medical and pharmaceutical markets for exceptional ethical and work standards," said lead dealmaker Johnson. "PharmaLex was the perfect fit and offers an exciting opportunity for Safis' employees to be part of a larger multinational company." Generational Equity, part of the Generational Group headquartered in Dallas with over 200 professionals located throughout North America, helps business owners release the wealth of their business by providing merger, acquisition and strategic growth advisory services. Their four-step approach features exit planning education, business valuation, value enhancement strategies, and M&A transactional services. The M&A Advisor recently named the company its 2016 Investment Banking Firm of the Year. For more, visit http://www.generational.com or the Generational Equity press room. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/generational-equity-announces-sale-of-safis-solutions-to-pharmalex-group-300451964.html


Cartilage lesions in the knee of juvenile patients require an effective repair to regain life-long functional activity of the joint. Autologous chondrocyte implantation (ACI) is discussed to be advantageous over other methods for cartilage repair regarding long-term outcome. ACI has successfully been applied in juvenile patients, although currently recommended for patients ≥18 years of age. Only few controlled clinical trials present evidence of efficacy and safety of ACI in adolescent patients. ACI products have to undergo the process of a marketing authorisation application, including the submission of a paediatric investigation plan (PIP). Data from prospective clinical studies or retrospective collection of long-term data in paediatric patients should be submitted for risk-benefit evaluation by the Paediatric Committee (PDCO). © 2013 Elsevier Ltd. All rights reserved.


Bendadani C.,German Institute of Human Nutrition | Meinl W.,German Institute of Human Nutrition | Monien B.H.,German Institute of Human Nutrition | Dobbernack G.,German Institute of Human Nutrition | And 2 more authors.
Archives of Toxicology | Year: 2014

The common polycyclic aromatic hydrocarbon 1-methylpyrene is hepatocarcinogenic in the newborn mouse assay. In vitro studies showed that it is metabolically activated via benzylic hydroxylation and sulphation to a reactive ester, which forms benzylic DNA adducts, N 2-(1- methylpyrenyl)-2′-deoxyguanosine (MPdG) and N 6-(1- methylpyrenyl)-2′-deoxyadenosine (MPdA). Formation of these adducts was also observed in animals treated with the metabolites, 1-hydroxymethylpyrene and 1-sulphooxymethylpyrene (1-SMP), whereas corresponding data are missing for 1-methylpyrene. In the present study, we treated mice with 1-methylpyrene and subsequently analysed blood serum for the presence of the reactive metabolite 1-SMP and tissue DNA for the presence of MPdG and MPdA adducts. We used wild-type mice and a mouse line transgenic for human sulphotransferases (SULT) 1A1 and 1A2, males and females. All analyses were conducted using ultra-performance liquid chromatography coupled with tandem mass spectrometry, for the adducts with isotope-labelled internal standards. 1-SMP was detected in all treated animals. Its serum level was higher in transgenic mice than in the wild-type (p < 0.001). Likewise, both adducts were detected in liver, kidney and lung DNA of all exposed animals. The transgene significantly enhanced the level of each adduct in each tissue of both sexes (p < 0.01-0.001). Adduct levels were highest in the liver, the target tissue of carcinogenesis, in each animal model used. MPdG and MPdA adducts were also observed in rats treated with 1-methylpyrene. Our findings corroborate the hypothesis that 1-SMP is indeed the ultimate carcinogen of 1-methylpyrene and that human SULT are able to mediate the terminal activation in vivo. © 2013 Springer-Verlag Berlin Heidelberg.


On 30 December 2008, the Regulation (EC) 1394/2007 on advanced therapy medicinal products (ATMPs) entered into force. Herewith the first EU-wide regulatory framework for ATMPs was established. It requires a central marketing authorisation application to the EMA (European Medicinal Agency). This new framework especially changes the code of regulatory practice for tissue engineered products (TEPs), as no registration procedure had been previously required for autologous TEPs. This also meant that no clinical proof of efficacy achieved by a pivotal clinical trial was necessary. Difficulties and their background as well as the vast requirements for product development that have to be addressed by small companies within a very short time frame are presented. Hereby, it is obvious that regulatory experience which is required to identify and implement the resulting implications was not in place yet and still had to be established. The lack of regulatory experience also resulted in difficulties with scientific advice preparation, expectations toward regulatory agencies, consultants, and transformation of regulatory requirements. Addressing the regulatory requirements within the transition period is even more difficult for entrepreneurs with products which are assigned for indications resulting in complex challenges to the trial design. Due to the enormous time pressure to generate data and due to the implied financial pressure, different adaptation strategies are evolving. In Germany the "hospital exemption" according to §4b AMG (German Medicinal Products Law) is of major importance. A reorientation toward acellular products and a slow down in development of new ATMP products is expected. © 2011 Springer Medizin Verlag.


Olliaro P.,World Health Organization | Olliaro P.,University of Oxford | Delgado-Romero P.,PharmaLex GmbH | Keiser J.,Swiss Tropical and Public Health Institute | Keiser J.,University of Basel
Journal of Antimicrobial Chemotherapy | Year: 2014

Praziquantel has been the mainstay of schistosomiasis control since 1984 and widely distributed since 2006 through 'preventive chemotherapy' programmes to school-aged children or at-risk populations. In addition, preschool-aged children are now recognized as a vulnerable population and a group for targeted treatment, but they may be difficult to dose correctly with the available product-a racemate, based on the biologically active enantiomer (R-praziquantel) and the inactive distomer (S-praziquantel), which contributes the bitter taste and doubles the size of the tablets. Hence, a paediatric formulation is required, possibly enantiomerically pure. Developing such a product and extending its use to younger children should be pharmacologically guided, but limited data exist on pharmacokinetics and pharmacokinetic/pharmacodynamic correlations for praziquantel. This article presents available data on the chemistry, pharmacokinetics and pharmacodynamics of praziquantel, as well as R-praziquantel, and points to gaps in our knowledge. © The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved.


Rao P.R.,University of California at San Francisco | Lin L.,University of California at San Francisco | Lin L.,PharmaLex GmbH | Huang H.,University of California at San Francisco | And 6 more authors.
eLife | Year: 2015

The Drosophila tracheal system is a branched tubular network that forms in the embryo by a post-mitotic program of morphogenesis. In third instar larvae (L3), cells constituting the second tracheal metamere (Tr2) reenter the cell cycle. Clonal analysis of L3 Tr2 revealed that dividing cells in the dorsal trunk, dorsal branch and transverse connective branches respect lineage restriction boundaries near branch junctions. These boundaries corresponded to domains of gene expression, for example where cells expressing Spalt, Delta and Serrate in the dorsal trunk meet vein–expressing cells in the dorsal branch or transverse connective. Notch signaling was activated to one side of these borders and was required for the identity, specializations and segregation of border cells. These findings suggest that Tr2 is comprised of developmental compartments and that developmental compartments are an organizational feature relevant to branched tubular networks. © Rao et al.


Dobbernack G.,German Institute of Human Nutrition | Dobbernack G.,PharmaLex GmbH | Meinl W.,German Institute of Human Nutrition | Schade N.,German Institute of Human Nutrition | And 10 more authors.
Carcinogenesis | Year: 2011

Soluble sulfotransferases (SULTs) generate electrophilically reactive metabolites from numerous food-borne compounds, environmental contaminants and drugs, often resulting in mutagenicity and carcinogenicity. Substrate specificity, regulation and tissue distribution of SULTs show large interspecies differences. In humans, therefore, SULTs may be involved in the induction of cancer in different tissues than in standard animal models. To construct a rodent model taking some species differences into account, we transferred a 68.5 kb human (h) genomic sequence that comprised the transcribed and long flanking regions of SULT1A1 and 1A2 into murine oocytes. This approach resulted in several mouse lines expressing these human genes in a copy number-dependent manner with a tissue distribution similar to that in humans. In previous in vitro studies, we had demonstrated that human SULT1A1 and 1A2 efficiently catalyze the terminal activation of 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine (PhIP) to a mutagen. The transgenic mice were used to study the hSULT1A1/1A2-mediated activation. Tissue distribution and levels of DNA adducts were determined in hSULT1A1/1A2 transgenic and wild-type mice after an oral dosage of PhIP. Transgenic mice exhibited significantly elevated PhIP-DNA adduct levels compared with the wild-type in liver (13-fold), lung (3.8-fold), colon (2-fold), kidney (1.6-fold) and cecum (1.5-fold). Moreover, among the eight tissues examined, liver was the one with the lowest and highest adduct levels in wild-type and transgenic mice, respectively. Hence, expression of hSULT1A1/1A2 not only enhanced the genotoxicity but also substantially changed the organotropism of PhIP. © The Author 2011. Published by Oxford University Press. All rights reserved.


Fickert S.,University of Mannheim | Gerwien P.,University of Mannheim | Helmert B.,University of Mannheim | Schattenberg T.,University of Mannheim | And 3 more authors.
Cartilage | Year: 2012

Background: The 3-dimensional autologous chondrocyte transplantation (ACT3D) comprises isolation of chondrocytes from cartilage biopsies, cultivation to spheroids, and transplantation into the cartilage defect. Objectives: To evaluate the patients' general health and functionality and to assess the defect repair after ACT3D with spheroids by MRI and MOCART scoring. Methods: Thirty-seven patients with isolated chondral lesions of the knee underwent ACT3D with spheroids through medial arthrotomy. Patient-administered scores were assessed at baseline (day before transplantation), at 6 weeks, and at 3, 6, and 12 months. MRI and MOCART scoring were performed at 3 and 12 months after ACT3D. Results: Patients were diagnosed with full-thickness patellofemoral (n = 16), femoral condylar (n = 18), or both defect types (n = 3), International Cartilage Repair Society (ICRS) grade 3 or 4, with defect sizes between 1.0 and 12.0 cm2. On average, 59.5 spheroids/cm2 in defect size were transplanted. An overall statistically significant improvement from baseline to 12 months was observed for all assessment scores (Lysholm, International Knee Documentation Committee [IKDC], SF-36, Tegner) combined with a significant reduction in the visual analog scale (VAS) for pain and an advanced defect filling. Subgroup analyses revealed a positive clinical outcome independent on defect size, defect locations, spheroid dosage, age, duration of symptoms, and severity of complaints at baseline. Seven patients experienced in total 8 adverse events, of which knee joint effusion and blocking were assessed as possibly or probably related to ACT3D. Conclusions: The patient-administered assessment scores along with the fast defect filling with ACT3D using spheroids demonstrated an increase in activity level and quality of life after a 1-year follow-up. © SAGE Publications 2012.


PubMed | PharmaLex GmbH
Type: Journal Article | Journal: Drug discovery today | Year: 2013

Cartilage lesions in the knee of juvenile patients require an effective repair to regain life-long functional activity of the joint. Autologous chondrocyte implantation (ACI) is discussed to be advantageous over other methods for cartilage repair regarding long-term outcome. ACI has successfully been applied in juvenile patients, although currently recommended for patients 18 years of age. Only few controlled clinical trials present evidence of efficacy and safety of ACI in adolescent patients. ACI products have to undergo the process of a marketing authorisation application, including the submission of a paediatric investigation plan (PIP). Data from prospective clinical studies or retrospective collection of long-term data in paediatric patients should be submitted for risk-benefit evaluation by the Paediatric Committee (PDCO).


PubMed | Ludwig Maximilians University of Munich, University of Mannheim and PharmaLex GmbH
Type: Journal Article | Journal: Cartilage | Year: 2015

The 3-dimensional autologous chondrocyte transplantation (ACT3D) comprises isolation of chondrocytes from cartilage biopsies, cultivation to spheroids, and transplantation into the cartilage defect.To evaluate the patients general health and functionality and to assess the defect repair after ACT3D with spheroids by MRI and MOCART scoring.Thirty-seven patients with isolated chondral lesions of the knee underwent ACT3D with spheroids through medial arthrotomy. Patient-administered scores were assessed at baseline (day before transplantation), at 6 weeks, and at 3, 6, and 12 months. MRI and MOCART scoring were performed at 3 and 12 months after ACT3D.Patients were diagnosed with full-thickness patellofemoral (n = 16), femoral condylar (n = 18), or both defect types (n = 3), International Cartilage Repair Society (ICRS) grade 3 or 4, with defect sizes between 1.0 and 12.0 cm(2). On average, 59.5 spheroids/cm(2) in defect size were transplanted. An overall statistically significant improvement from baseline to 12 months was observed for all assessment scores (Lysholm, International Knee Documentation Committee [IKDC], SF-36, Tegner) combined with a significant reduction in the visual analog scale (VAS) for pain and an advanced defect filling. Subgroup analyses revealed a positive clinical outcome independent on defect size, defect locations, spheroid dosage, age, duration of symptoms, and severity of complaints at baseline. Seven patients experienced in total 8 adverse events, of which knee joint effusion and blocking were assessed as possibly or probably related to ACT3D.The patient-administered assessment scores along with the fast defect filling with ACT3D using spheroids demonstrated an increase in activity level and quality of life after a 1-year follow-up.

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