Christian Schenk

Episode 2 - The Market Access @ HEOR Podcast is released with Andrew Xia and the excellent Marcus Metcalfe! Full episode see the link below or go to my profile page. I placed Andrew at Mundipharma about 8 years ago and we've stayed in touch. One of the bits i remember is he had a more complex business setup with interests in China and the US - so for him working as an HEOR/Access Interim made perfect sense. In this short taster we touch on the perception of Interims from a Client perspective - they kind of operate in this unclear/middle space space between an FTE and a fixed project consultant. Which is exactly why it can work very well, because there is a lot to get done in between! I hope you enjoy the podcast, it's been great fun. I'm looking to include some truly global perspectives, so get in touch if you'd like to have a chat? Putting yourself out there on camera is daunting, but what's the worst that can happen.. https://lnkd.in/esrTJ3f3

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IPO ALERT 🚨 (Rapport Therapeutics & Telix Pharmaceuticals Limited) Johnson & Johnson backed Rapport Therapeutics have decided to file for an Initial Public Offering last week to raise funds for its CNS system-targeting small molecule clinical trials, while radiopharmaceuticals developer Telix Pharmaceuticals Limited also informed the U.S. Securities and Exchange Commission of its plans to go public on the Nasdaq.🎯 Rapport Therapeutics will be the third neuroscience-focused biotech to go public in 2024. Contineum Therapeutics raised $110 Million with its IPO in April & Alto Neuroscience's initial offering brought in $129 Million in February. 🧠 Telix Pharmaceuticals Limited, the Australia-based radiopharma company filed for its IPO, leaving the dollar amount details blank for now. It already has a product on the market. Telix’s prostate cancer PET scan agent Illuccix targets the PSMA protein on cancer cells throughout the body, potentially detecting tumors more accurately. 👏 #Elixir #Nasdaq #IPO #CNS #Oncology #Cancer #TelixPharma #Neurology #Biotech #DrugDevelopment #InitialPublicOffering

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Our recent industry meeting inspired me to share my experience with the clinical trials budget and contract process. As always I try to provide some recommendations on how we can improve the process. At the end of the day our patients will be the winners if we can set up clinical trials much quicker. It is always good to have that in mind! #clinicaltrials #budget #contract #UK

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Want to know the path to the CEO position of a large pharma company? Internal succession is the most prevalent route. Following Robert Michael's appointment as Abbvie's new CEO on July 1st, I analysed the pharma sector. It seems succession plans are delivering. Below is a sample from the top 10 pharma (by R&D). Invite your comments about succession effectiveness and relative performance. Merck & Co.: Robert M. Davis became CEO in July 2021. He joined Merck in 2014, previously serving as President, EVP Global Services, and CFO. His appointment indicates internal succession​​. Roche: Thomas Schinecker took over as CEO in March 2023. He has been with Roche since 2003, serving in successive leadership roles within the diagnostics business before becoming CEO. His appointment clearly signifies internal succession​​. Johnson & Johnson: Joaquin Duato became CEO in January 2022, succeeding Alex Gorsky. He has been with J&J since 1989, serving in many roles and with different business units. Duato is another case of internal succession​​. Novartis: Vasant Narasimhan has been CEO since February 2018. He joined Novartis in 2005, serving previously as Global Head of Drug Development and Chief Medical Officer before his CEO appointment, indicating internal succession​​. AstraZeneca: Pascal Soriot has been CEO since October 2012, after joining the company in 2012 from Roche. Pascal Soriot can be considered external appointment since he had not worked at AstraZeneca prior to his appointment​​. Pfizer: Albert Bourla became CEO in January 2019. He joined Pfizer in 1993, serving the company for more than 30 years in multiple roles, most recently as Chief Operating Officer before becoming CEO. Bourla’s appointment is considered as internal succession​​. Eli Lilly: David A. Ricks has been CEO since January 2017. Prior to his appointment to the CEO post, he served as President of Lilly Bio-Medicines. He joined Eli Lilly in 1996, representing an internal succession appointment​​. Bristol-Myers Squibb: Chris Boerner became CEO in December 2023, succeeding Giovanni Caforio. He joined the company in 2015, most recently serving as EVP and COO, but previously as EVP and CCO. Boerner’s appointment is considered an internal success appointment. AbbVie: Robert Michael, Abbvie’s recently appointed CEO – July 1st 2024. He was previously appointed vice chairman and president in 2022, vice chairman, finance and commercial operations in 2021 and chief financial officer in 2018. He succeeds Richard Gonzalez who has been CEO since AbbVie’s inception in 2013, having worked at Abbott Laboratories (from which AbbVie was spun off) since 1977, suggesting internal succession within the broader organisation.​ ​ Sanofi: Paul Hudson became CEO in September 2019, having joined Sanofi in 2019 from Novartis, where he served as CEO of Novartis Pharmaceuticals from 2016 to 2019. This represents an external appointment​​. #pharmaceutical #CEO #succession

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Hemogenyx Pharmaceuticals PLC (LSE:HEMO, OTC:HOPHF), the UK-based biotechnology firm, has secured £340,000 through a placing of 100,000 new shares at 340p each. The investment round was underwritten by a single institutional investor, who also received 50,000 warrants exercisable at 500p per share, valid for 12 months from March 1. The company stated that proceeds from the placing will be directed towards advancing clinical trials of its lead therapy, HG-CT-1, which targets relapsed or refractory acute myeloid leukaemia (AML) in adults. Hemogenyx noted that recruitment for the trial is underway, with the first patient undergoing eligibility screening. https://lnkd.in/e2UbdKVm

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Allogeneic CAR-T therapy drives autoimmune diseases into remission: Early reports suggest that chimeric antigen receptor (CAR)-T therapy has remarkable potential for treating autoimmune disease. Current approaches rely on autologous CAR-T cells, creating a bottleneck to the broad deployment of this therapy.  A recent publication in Cell reports the first use of allogeneic CAR-T cells in three patients with systemic autoimmune disease. This off-the-shelf cell product (TyU19) was manufactured by isolating T cells from a healthy donor’s peripheral blood mononuclear cells, transducing the T cells with a second-generation CD19 CAR, and then using CRISPR-Cas9 to target TRAC, HLA-A, HLA-B, CIITA, and PD-1 to reduce the risk of immune rejection and graft-versus-host disease (GvHD). These cells were then banked and infused into one patient with immune-mediated necrotizing myopathy and two patients with diffuse cutaneous systemic sclerosis. In all three patients, CAR-T cells engrafted and expanded, coinciding with a complete depletion of circulating B cells for at least 2 months. Impressively, all three patients showed significant clinical improvement via respective clinical indexes, molecular markers, and radiographic measures. Remarkably, fibrosis in the lungs and hearts of some patients showed improvement. Although follow-up has only been extended to 6 months, these patients have remained in remission. This scientific discovery holds great potential for future treatment of autoimmune diseases. Original publication: https://lnkd.in/ejPsikBa Further reading: https://lnkd.in/e9DssDqa https://lnkd.in/e2zB33zN https://lnkd.in/eH2aY-XG https://lnkd.in/egSa6gCH https://lnkd.in/eKKdWAWg https://lnkd.in/eFA4mcpN

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Here’s an interesting publication detailing how trial efficiency can reshape early-stage development in #biotech... In Phase I studies, every decision affects the development pathway, making trial design and timing critical. By introducing flexibility into these early phases, clinical teams can meet complex study demands without compromising on speed or quality—a balance essential in today’s fast-paced therapeutic field. With streamlined processes, from recruitment through data collection, biotech R&D professionals can better allocate resources, achieve reliable results, and move confidently toward later stages of development. #BiotechR&D #BioTech #BioPharm #EarlyStageDevelopment #ClinicalTrials #TrialEfficiency #DrugDevelopment

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So... Lots going on re EMR analysis / AI for patient recruitment, but we still know that building relationships with potentially eligible patients / onboarding the right way is so important (shout out to the great study coordinators and PIs out there!). Is EMR analysis the main game? Is better patient onboarding the main game? Please check out (and like/promote) my latest column in Applied Clinical Trials that focuses on challenges / debates in clinical trial recruitment. Special thanks to Brett Kleger and Elisa Cascade for their contributions!

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Tech and Drugs - Podcast Episode 1 is in the bag - Thanks Filippo Abbondanza and Mark Davies for a great conversation! Now I am working on the edit, and we should get the episode out before Xmas 🎅 ... But that's not it, this morning I am already recording Episode 2 ... not it isn't "Attack of the Clones" ... it's even more exciting than your latest StarWars movie: today i am meeting with Benjamin Szilagyi who will share with us how you start and execute (successful) large scale (and very ambitious) digital transformation programs?

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The latest news from ACURX Pharma on New to the Street: https://lnkd.in/e4iXg3hD Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). #acurxpharma #acxp #nasdaq 

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We all like to talk what companies should do to have their product on the market but in this episode I would like to focus on what the regulatory agencies need to know about small pharma and biotech companies and how they can support them. Developing new pharmaceuticals is a collaborative project between the companies, the investors, the regulators, the physicians and the patients. It is time to change the way we see drug development as a responsibility to the pharma and biotech companies only. #drugdevelopment #startups #pharmaceuticals

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Boost in UK biotech investment signals growth opportunities! The industry recorded its strongest quarter post-pandemic, raising £1.98 billion in Q1 & Q2 2024, as per UK BioIndustry Association (BIA) data. This uptrend aligns with the surge in demand for senior talent within start-ups and SME's setting the stage for a fiercely competitive talent market in Q1 & Q2 2025. Conversations with clients reveal proactive talent strategies being devised to stay ahead and attract top talent early on. Are you gearing up for 2025? It's time to strategize and secure your talent pipeline for the future! Looking to know more about the current market and how to attract and retain the best talent? Contact me to discuss, lissa@kazienlifesciences.com #UKBiotech #TalentStrategy #BusinessGrowth #BiotechInvestment #UKBIA #IndustryInsights #kaizenlifesciences

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🧬 Weekly Biotech Roundup: Key R&D Developments! This week brought significant advancements in biotech, particularly for early-stage companies making strides in innovative therapies. 🚀 CAR-T Cell Therapy Trials Update The FDA has lifted clinical holds on three CAR-T cell therapy trials. This decision allows early-stage biotechs to resume critical research. These trials are pivotal for companies aiming to expand their CAR-T options for various cancers. Notably, collaborations in this space could enhance treatment accessibility and efficacy. 👁️ Wet AMD Gene Therapy Approved An investigational new drug application for a gene therapy targeting wet age-related macular degeneration has received FDA clearance. This therapy, developed by a smaller biotech, highlights the potential of gene editing in treating eye diseases. As early-stage companies continue to innovate, partnerships with larger organizations could accelerate development timelines and bring novel treatments to patients faster. 🧬 CRISPR RNA Editing Breakthrough The FDA has approved a CRISPR-based RNA editing therapy developed with AI technology. This marks a significant milestone, as it showcases the power of integrating artificial intelligence in biotech research. Small firms focused on CRISPR technology are well-positioned to collaborate with tech companies, potentially reshaping therapeutic approaches for genetic disorders. 🔍 Insights and Opportunities The common thread among these developments is the collaboration between smaller biotechs and larger entities. This synergy is vital for driving innovation and improving patient outcomes. As a biotech staffing specialist, I am excited to support these early-stage companies and the talent that fuels their growth. Stay tuned for more updates as these companies continue to advance their groundbreaking work!

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🚀 Weekly Biotech R&D Roundup This week brings exciting developments in the biotech space, particularly from early-stage companies making impactful strides. 🧬 2025 Drug Approvals As we look ahead, 2025 is set to be a landmark year for drug approvals. Notably, smaller biotechs are at the forefront, pushing innovative therapies through the pipeline. Companies like Astellas and their partnership with Adaptimmune are notable, focusing on cell therapies that address unmet medical needs. 🧠 Neurology Advancements In neurology, Sangamo Therapeutics is making headlines with its hemophilia gene therapy, developed in collaboration with Pfizer. This partnership aims to deliver a one-time treatment that could significantly improve patient outcomes. Such collaborations showcase how established firms are investing in the promising technologies of smaller players. 🌟 Spotlight on Early-Stage Biotechs Smaller biotechs like Cerevel Therapeutics and their advancements in neurological disorders are crucial. Their innovative approaches could redefine treatment paradigms, demonstrating the potential of fresh ideas in addressing complex health challenges. 🔍 Insights and Trends Common themes this week highlight the importance of collaboration in biotech. Partnerships between established and early-stage companies are essential for accelerating development timelines and bringing novel treatments to market. As we witness these dynamics, it’s clear that the synergy between innovation and experience is vital. Let's keep an eye on these developments. The future of biotech is bright, especially with the contributions of our emerging leaders!

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Found this article quite interesting - describing the quest of getting a gene therapy for an ultra rare disease approved in the UK market - not by a pharmaceutical company, but by a hospital! #GeneTherapy #UltraRareDisease #UK #Innovation

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The biotech IPO market remains open, but a backlog of "IPO ready" biotech companies remains. Key stats: - 9 biotechs went public in Q1 2024 raising $1.3B - This is up from $375M in Q1 2023 and roughly matching pre-pandemic Q1 2020 levels - Still way below the $4.6B raised by 31 companies going public in Q1 2021 - 6/9 IPOs were >$100M - CG Oncology ($380M) and Kyverna Therapeutics ($319M) had the largest respective raises - Companies with more mature pipelines and led by industry veterans are raising the most cash - Preclinical biotech Metagenomi's IPO shows that the IPO market is open for the right early stage biotechs - Only 3/9 of the Q1 public market debutants are trading about their IPO price (CG, Kyverna and Telomir Pharmaceuticals, Inc.) - There are still 25 outstanding applications for biotechs who have indicated plans to go public but have not yet made it out Let's hope for continued momentum throughout 2024 as potential rate cuts move closer 🚀 https://lnkd.in/gj-z2n7x

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🔊 Stay ahead with latest updates on ADC in Oncology 🚀 📅 Daiichi Sankyo US and AstraZeneca refiled their BLA for datopotamab deruxtecan (TROP2 ADC) targeting EGFR-mutated NSCLC based on updated TROPION-Lung05 data. 📅 Mersana Therapeutics advances XMT-1660 (B7-H4 ADC) in Phase 1 trials while XMT-2056 (HER2 ADC) shows promise in preclinical studies. 📅 Pyxis Oncology to present preliminary Phase 1 data for PYX-201 (EDB+FN ADC) in solid tumors on November 20, 2024. 🤝 Alphamab Oncology joins Shanghai’s pilot program for a 30-day phase 1/2 review of JSKN033 (HER2 ADC) in advanced tumors. 🎯 Innate Pharma to launch a Phase 1 trial of IPH4502 (Nectin-4 ADC) in Nectin-4 positive solid tumors by Q1 2025. 📅 GSK’s DREAMM-7 trial demonstrates improved survival for RRMM patients with Blenrep (ADC) + BorDex, with full results at ASH 2024. 🎯 ArriVent Biopharma and Aarvik Therapeutics Inc Therapeutics progress their ARR-002 ADC program for solid tumors, with IND studies slated for early 2025. 🎯 Mabwell’s 9MW2821 (Nectin-4 ADC) received IND approval in China for urothelial carcinoma and solid tumors. 🤝 Chime Biologics and Waterstone Pharmaceuticals partner to enhance ADCs, combining production and linker-payload expertise. 🧪 Lonza expands its bioconjugation facility by 2,000m² to meet rising ADC demand and future product approvals. 🤝 GlycoNex Inc. partners with Sterling for clinical trial production of GNX102 (NaPi2b ADC). 💰 Alentis Therapeutics raised $181.4M in Series D funding to advance ALE.P02 and ALE.P03 ADCs for CLDN1+ cancers and organ fibrosis. Fast track designation granted to ALE.P02. 💰 IPA (ImmunoPrecise Antibodies) targets next-gen ADCs for a $20B oncology market with high-impact antibody innovation. 🤝 Entero Therapeutics (Nasdaq: ENTO) merges with @Journey Therapeutics, advancing the NIC ADC cancer platform with 99% equity to Journey shareholders. 🤝 BioNTech SE acquires Biotheus Inc., gaining its bis ADC pipeline and proprietary technology for cancer and inflammatory diseases. 🤝 Telix Pharmaceuticals Limited partners with Eckert & Ziegler SE to enhance alpha therapy production, supporting TLX252 (CAIX radio ADC). 🤝 Akari Therapeutics, Plc and Peak Bio Inc. merge, securing $3.2M in PIPE financing and a $50M equity line for ADC advancements. 🎯 IDEAYA Biosciences selects IDE034 (B7H3/PTK7 Bs ADC) as a development candidate under an exclusive Biocytogen license. 🎯 Araris Biotech AG Biotech unveils new peptide linker technology, enabling more precise and versatile ADC creation.

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First in our series of mini explainers on European HTA describing the shift toward Joint Clinical Assessment (JCA) and what it means relative to what we do today. We’re working to support companies in thinking through and preparing for the implementation of JCA from predicting the PICOs (www.picopredict.com) through to our unique readiness assessment tool to aid organisational development. #teamdecisive #hta #jca #picopredict #jcalab #heor

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