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    "Roche Diagnostics is an important part of the foundation that modern healthcare builds upon. Our broad range of innovative diagnostic tests and systems play a pivotal role in the groundbreaking area of integrated healthcare solutions and cover the early detection, targeted screening, evaluation and monitoring of disease. Roche Diagnostics is active in all market segments, from scientific research and clinical laboratory syste...
    "Roche Diagnostics is an important part of the foundation that modern healthcare builds upon. Our broad range of innovative diagnostic tests and systems play a pivotal role in the groundbreaking area of integrated healthcare solutions and cover the early detection, targeted screening, evaluation and monitoring of disease. Roche Diagnostics is active in all market segments, from scientific research and clinical laboratory systems to patient self-monitoring. "

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    Roche Diagnostics GmbHGermany Flag
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    Sandhofer Strasse 116 P.O. Box 310120 Mannheim, 68305
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

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    16 Dec 2024
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    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    NEWS #PharmaBuzz

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    Roche Diagnostics and BioPorto expand collaboration
    Roche Diagnostics and BioPorto expand collaboration

    20 Feb 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com//news-release/2024/02/20/2831519/0/en/Roche-Diagnostics-and-BioPorto-expand-collaboration.html

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    20 Feb 2024
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    Health Canada Issues Recall of Roche Diagnostics' Elecsys® Troponin T Hs
    Health Canada Issues Recall of Roche Diagnostics' Elecsys® Troponin T Hs

    31 Jan 2023

    // HEALTH CANADA

    https://recalls-rappels.canada.ca/en/alert-recall/elecsysr-troponin-t-hs

    HEALTH CANADA
    31 Jan 2023
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    MorphoSys AG Reports Second Quarter and First Half 2022 Financial Results
    MorphoSys AG Reports Second Quarter and First Half 2022 Financial Results

    03 Aug 2022

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20220803005637/en

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    03 Aug 2022
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    Nordic Bioscience and Roche Diagnostics Collaborate for Chronic Diseases
    Nordic Bioscience and Roche Diagnostics Collaborate for Chronic Diseases

    16 Jun 2022

    // PRNEWSWIRE

    https://www.prnewswire.com/news-releases/nordic-bioscience-and-roche-diagnostics-strengthen-collaboration-for-development-of-biomarkers-for-chronic-diseases-301568907.html

    PRNEWSWIRE
    16 Jun 2022
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    Federal appeals court overturns $137M patent verdict against Roche
    Federal appeals court overturns $137M patent verdict against Roche

    11 Apr 2022

    // Nicole DeFeudis ENDPTS

    https://endpts.com/federal-appeals-court-overturns-137m-patent-verdict-against-roche-but-the-case-isnt-closed-just-yet/

    Nicole DeFeudis ENDPTS
    11 Apr 2022
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    Roche provides testing solutions to identify and differentiate Omicron variants
    Roche provides testing solutions to identify and differentiate Omicron variants

    16 Mar 2022

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2022/03/16/2404703/0/en/Roche-provides-molecular-testing-solutions-to-identify-and-differentiate-SARS-CoV-2-Omicron-variants-of-concern.html

    GLOBENEWSWIRE
    16 Mar 2022
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    Drugs in Development

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    Roche Announces Positive Data from Global Phase III Programme for Crovalimab In PNH, A Rare Life-Threatening Blood Condition

    Details:

    RG6107 (crovalimab) is an investigational, novel anti-C5 recycling monoclonal antibody designed to block the complement system which plays a vital part of the innate immune system that acts as the body’s first line of defence against infection.


    Lead Product(s): Crovalimab

    Therapeutic Area: Rare Diseases and Disorders Brand Name: RG6107

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 07, 2023

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    Lead Product(s) : Crovalimab

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Roche Announces Positive Data from Global Phase III Programme for Crovalimab In PNH, A Rare Life-T...

    Details : RG6107 (crovalimab) is an investigational, novel anti-C5 recycling monoclonal antibody designed to block the complement system which plays a vital part of the innate immune system that acts as the body’s first line of defence against infection.

    Brand Name : RG6107

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    February 07, 2023

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    Roche Receives FDA Approval For First Companion Diagnostic To Identify Patients With HER2 Low Metastatic Breast Cancer Eligible For ENHERTU

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    PATHWAY anti-HER2 test is only FDA approved companion diagnostic indicated as an aid in assessment of HER2 low status in metastatic breast cancer patients, who may consider ENHERTU (fam-trastuzumab deruxtecan-nxki) as a treatment option based on results of Phase 3 trial.


    Lead Product(s): Deruxtecan

    Therapeutic Area: Oncology Brand Name: Enhertu

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: AstraZeneca

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 04, 2022

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    Lead Product(s) : Deruxtecan

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : AstraZeneca

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Roche Receives FDA Approval For First Companion Diagnostic To Identify Patients With HER2 Low Meta...

    Details : PATHWAY anti-HER2 test is only FDA approved companion diagnostic indicated as an aid in assessment of HER2 low status in metastatic breast cancer patients, who may consider ENHERTU (fam-trastuzumab deruxtecan-nxki) as a treatment option based on results ...

    Brand Name : Enhertu

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    October 04, 2022

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    Roche's VENTANA PD-L1 (SP263) Assay Receives CE IVD Approval To Identify Patients With Locally Advanced And Metastatic Non-small Cell Lung Cancer Eligib...

    Details:

    The VENTANA PD-L1 (SP263) Assay as a companion diagnostic helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy based on the results of the Phase III EMPOWER-Lung 1 study.


    Lead Product(s): Cemiplimab

    Therapeutic Area: Oncology Brand Name: Libtayo

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Regeneron Pharmaceuticals

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 09, 2022

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    Lead Product(s) : Cemiplimab

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Regeneron Pharmaceuticals

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Roche's VENTANA PD-L1 (SP263) Assay Receives CE IVD Approval To Identify Patients With Locally Adv...

    Details : The VENTANA PD-L1 (SP263) Assay as a companion diagnostic helps determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy based on the results of the Phase III EMPOWER-Lung 1 study.

    Brand Name : Libtayo

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 09, 2022

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    Roche Receives FDA Approval for VENTANA MMR RxDx Panel to Identify dMMR Solid Tumour Patients and pMMR Endometrial Cancer Patients Eligible for KEYTRUDA

    Details:

    The VENTANA MMR RxDx Panel is the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and who may be eligible for KEYTRUDA® (pembrolizumab).


    Lead Product(s): Pembrolizumab,Lenvatinib

    Therapeutic Area: Oncology Brand Name: Keytruda

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Merck & Co

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 11, 2022

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    Lead Product(s) : Pembrolizumab,Lenvatinib

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Merck & Co

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Roche Receives FDA Approval for VENTANA MMR RxDx Panel to Identify dMMR Solid Tumour Patients and ...

    Details : The VENTANA MMR RxDx Panel is the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and who may be eligible for KEYTRUDA® (pembrolizumab).

    Brand Name : Keytruda

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    August 11, 2022

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    Inotrem Secures Strategic Licensing Agreement for a Companion Diagnostics Test in Septic Shock

    Details:

    Inotrem entered a worldwide licensing agreement with Roche Diagnostics for the commercialization of a mechanism-based companion diagnostic test using a soluble plasma protein.


    Lead Product(s): Nangibotide

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Peptide

    Recipient: Inotrem

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 21, 2020

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    Lead Product(s) : Nangibotide

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Phase II

    Recipient : Inotrem

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Inotrem Secures Strategic Licensing Agreement for a Companion Diagnostics Test in Septic Shock

    Details : Inotrem entered a worldwide licensing agreement with Roche Diagnostics for the commercialization of a mechanism-based companion diagnostic test using a soluble plasma protein.

    Brand Name : Undisclosed

    Molecule Type : Peptide

    Upfront Cash : Undisclosed

    January 21, 2020

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