Dannielle Appelhans

The CDMO business model is changing. As it moves away from contracts and towards strategic partnerships, it's clear that leaders will need to change with it. A recent report from WittKieffer has highlighted some key skills. Digital transformation, AI, and ESG skills will all help leadership teams better navigate the changing landscape and adapt to new technology. However, soft skills will be just as valuable. The shift to partnerships will require leaders to hone their interpersonal and collaboration skills if they want to see success. #LeadershipSkills #Leadership #CDMOs #Partnerships

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November marks Alzheimer Disease Awareness Month, a time to reflect on the urgent need for innovative solutions to this devastating disease. Today, over 6.9 million Americans live with Alzheimer disease and this number is projected to double by 2060. The past year has seen significant progress with several #cellandgenetherapies emerging as a viable treatment to address this complex disease and rising prevalence. Advancements in several novel #genetherapies targeting genetic risk factors and promising #celltherapies have the potential to address key mechanisms or slow progression of the disease. The work is far from over, but with these advanced therapies moving through the clinical pipeline, there is a new hope for patients and families battling this devastating disease. 

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Our upcoming "office hours" session on August 20th is a great, informal way to have your questions on DILIsym and RENAsym (liver and kidney safety prediction platforms) addressed! Please join us by registering and submitting insightful questions! #SimulationsPlus #DILIsym #QSP

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Looking for ideas to accelerate your business? I can definitely help. Our integrated approach includes: Connect with industry leaders through exclusive Strategy Meetings Showcase your expertise with our Innovation Spotlight events Expand your market reach through Business Development Outsourcing Forge valuable partnerships at our Strategy Dinners Let's talk. #ProventaConsulting #LifeSciences #Growth #Innovation #Networking #BusinessDevelopment #Asia

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There are so many advantages of the co-located lab and clinic that we offer in Lincoln. From the scientific advantage such as PBMC prep, Flow Cytometry and rapid sample analysis to the cost and risk savings of eliminating sample shipment to the improved ease of business by having a one stop shop for your Phase 1 and other Clin Pharm studies with one contract, one site to visit and a single point of contact who can get EVERYONE running a study in the same room. This just can’t happen anywhere else. The analysis is literally one staircase away from the clinic processing lab. Not only that, for your bioanalytical needs we will conduct all of your assays in the same building: safety labs, PK LCMS/LBS, Flow cytometry, biomarkers or qPCR. Give us a call for your next study! #celerion #celerionbioanalysis

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We are excited about the extensions to our enhanced test menu and global reach. Drop me a line if you want to hear more, and we can explore how we can help you with your next clinical trial project. #ClinicalTrials #Partnership #MPLN #Biotech #Pharma #MedicalResearch #ScientificDiscovery

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Demonstrating the technical leadership of SK pharmteco! 🧬 Catch up with our team at ASGCT to discuss how SKPT can support your #cellandgene development!

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2024 Best Places to Work in Biopharma - BioSpace BioSpace's annual Best Places to Work list demonstrates a company’s desirability in the recruitment marketplace. Each organization’s merits are considered with particular emphasis on culture, career growth and development opportunities, leadership and innovation. The list includes 60 employers with U.S. operations based on the votes and ratings of thousands of life science community members, with 30 ranked in large and small employer categories respectively. Don't miss our interview with our top large and small company winners on what they do that makes them a great place to work. Here are the top rated companies to work for, both large and small, across the U.S. https://lnkd.in/eq9x5fxm

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OPCU - Partner Week: Biotech's developing large molecule drugs should attend, finding the right outsourcing partner is critical to drug development strategy! At OPCU events, get your questions answered and find out what you need to know within your selection process of working with CDMO partners, timing , capabilities and cultural fit can all be assessed at the Outsourced Pharma Capacity Update. Just Ask for a follow up meeting after the presentation!

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In the latest episode of the #ParexelBiotech podcast series, "De-Risking Drug Development," we focus on the pre-approval phase of drug development, where commercial launch planning should be started 2 - 3 years before marketing authorization. Learn why it's critical to start early and approaches biotechs should be implementing, especially those with a first-time launch. Our experts provide practical examples of how to build and embed launch excellence, focusing on actionable insights to mitigate risk at this stage in the product lifecycle. Create success by planning for it. Listen now: https://lnkd.in/ghpWGEms #DrugDevelopment #Biotech #LaunchExcellence #ClinicalDevelopment

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Yesterday, I had an experience with my direct reports that made me pause and "rethink everything" – a core value at Alto Neuroscience. During a routine discussion, I raised a few technical issues that I believed warranted retraining. My intention was to encourage the team to always seek better, more efficient ways to do things, embracing innovation and continuous improvement. However, the message I intended to convey was not the one that was received. One of my team members ended the call with a statement that shook me to my core: "So, is there anything that we are doing correctly?" That made me pause—more than just a few seconds. I felt heartbroken, realizing that what I had communicated was not what I had meant. My goal had never been to imply that they weren’t doing a good job. Rather, I wanted to inspire them to rethink and refine their processes for better efficiency. In that moment, I realized I, too, needed to “rethink everything.” As leaders, we often focus on optimizing workflows or implementing new strategies. However, in doing so, we sometimes forget how our words and actions can be interpreted. My goal was to foster collaboration and brainstorming, not to make anyone feel inadequate or unappreciated. I thought to myself: "How did my feedback land as criticism? As if they weren’t doing a good job or that I wasn’t happy with their performance, which couldn’t have been further from the truth." I knew then that I must reconsider my approach moving forward. How, you may ask? 1) Start with positivity – Before introducing areas for improvement, acknowledge the hard work that has already been done. Recognize specific contributions, & emphasize that any suggested changes are meant to build upon the solid foundation they’ve already established. 2) Frame feedback as growth – rethinking doesn’t mean something is wrong. It’s about sharpening our skills, exploring new perspectives, & staying adaptable in a constantly changing environment - state that this is opportunity for growth, not criticism. 3) Communicate intent clearly – be transparent but involve them with the approach! I failed in telling them versus asking them how to improve efficiency! Use language that invites collaboration, such as "How can we improve on..." 4) Create dialogue – encourage the team to voice their feelings if they perceive feedback negatively. Reinforce a culture of open communication. Had I led with these recommendations, I believe the conversation would have taken a different tone, one that inspired confidence rather than self-doubt. It’s a reminder to all of us—leaders and team members alike—that retraining is not about what’s wrong but about making what’s right even better. Always begin with positivity & clarity. Uplift before you retrain. And remember, how you frame the conversation often determines how it’s received. I’ll leave you with this thought: "In the pursuit of improvement, we often forget that the first step is recognizing what’s already great."

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Thank you for all who voted and shared! I've to say I am not surprised with the results. Results were close as finding the right provider, who collects samples respecting all ethics and legal considerations certainly has an impact on the quality of the biospecimens. Finding the right provider for human biospecimens can be a challenging task. With thousands of biospecimen providers (academic and commercial biobanks, hospitals, clinical sites, brokers, etc) around the world, and new ones continually launching, companies face a daunting task to locate a provider that can provide the right high-quality sample needed for research. Ensuring the quality and authenticity of the specimens is paramount, requiring providers to maintain stringent ethical and regulatory standards. The variability in sample types, donor demographics, and the specific requirements of different research projects further complicates the selection process. Additionally, logistical issues such as timely delivery, proper storage conditions, and transparent communication with the provider can significantly impact the research outcomes. These challenges necessitate a careful and thorough vetting process to identify a reliable and reputable biospecimen provider. Are you having difficulties finding the right biospecimen provider? Let’s talk.

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The NC pharmaceutical industry #growth and #innovation has been nothing but astonishing since I moved here. While this is not a comprehensive list, I wanted to highlight some of the major expansions and builds in just the last few years for my friends who may have missed them (Note: Some information in this post may be out of date - information sourced from Fierce Pharma and respective company websites). Novo Nordisk: $𝟐𝐁 investment to build an Active Pharmaceutical Ingredient (API) facility. This facility aimed to increase production capacity for diabetes treatments. + Novo Nordisk: Additional $𝟒.𝟏𝐁 investment to build a second fill-finish manufacturing plant, doubling the combined footprint of Novo Nordisk's existing facilities in the state (~3,500 𝑗𝑜𝑏𝑠 𝑖𝑛 𝑁𝐶 𝑡𝑜𝑡𝑎𝑙). Eli Lilly and Company: over $𝟏𝐁 investment in a new injectable product and device manufacturing facility in Concord, North Carolina. (~600 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). + Eli Lilly and Company: $𝟒𝟓𝟎𝐌 investment in its manufacturing site in Research Triangle Park (~100 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). FUJIFILM Diosynth Biotechnologies: $𝟏.𝟐𝐁 in expansion of its end-to-end biomanufacturing facility in Holly Springs. This brought the total investment in the plant to more than $𝟑.𝟐𝐁 (~680 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). Amgen: $𝟓𝟓𝟎𝐌 investment in a greenfield manufacturing facility in Holly Springs for biologics and other medicine production. Resilience: $𝟐𝟐𝟓𝐌 aimed at scaling up production capacity. SCHOTT Pharma: $𝟑𝟕𝟏𝐌 in a new prefilled syringe manufacturing facility in Wilson, North Carolina (~400 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). Fresenius Kabi: $𝟏𝟎𝟎𝐌 expansion of its pharmaceutical manufacturing facility in Wilson, increasing production capacity for generic drugs in prefilled syringes (~450 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). Pfizer: $𝟔𝟎𝟎𝐌 investment in expanding its gene therapy manufacturing facility at its Sanford campus to improve clinical and commercial-scale manufacturing capabilities. Kyowa Kirin International plc. Kirin: $𝟓𝟑𝟎𝐌 to establish a biologics manufacturing facility in Sanford (~100 𝑛𝑒𝑤 𝑗𝑜𝑏𝑠). These significant investments in North Carolina foreshadow its growing role as a hub for biotech manufacturing and innovation. I'm glad I get to be a part of it, and I'm equally excited to see what comes next! #NC #Biotech #PharmaceuticalManufacturing

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Robert Battista has some great insights on the unique #transportvalidation challenges for pre-filled syringes. Check it out at Modality Solutions today!

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Our lead asset, AU-007, is leveraging IL-2 differently. Hear what makes our #AI -backed approach different on #BusinessofBiotech with Matthew Pillar. https://bit.ly/3YxaZpp #BioTech #Oncology Bioprocess Online

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Just finished the course “Nano Tips to Foster a Growth Mindset and Mental Agility with Shadé Zahrai” by Shadé Zahrai! Check it out: https://lnkd.in/gC_hgGR8 #criticalthinking #personaldevelopment.

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GMP-manufactured CRISPR/Cas9 technology as an advantageous tool to support cancer immunotherapy The latest advancements in GMP procedures are allowing an efficient improviement of personalized medicine. In particular immunotherapy is strongly taking advantage of clinical manufacturing platforms to cure patients who are refractory to previous therapy or who relapse upon a first period of remission. CRISPR/Cas9 technology has become the most widely used gene-editing tool in cancer immunotherapy favoring differentiation and persistence of genetically modified T-cells. The discovery of cancer-selected markers remains one of the principle obstacles while the use of allogenic CRISPR/Cas9-modified CAR T-cells is overcoming the difficulties to treat relapsing cancer cells showing an antigen different from that expressed at the onset of the disease. CAR T-cells generated against multiple tumor targets are preventing relapsing events. The manufacturing processes still comprised procedures performed manually even if supported by semi-automated manner, which result in product variability and very high cost. The development of a more controlled and cost-effective manufacturing process remains the pivotal aim to ensure CAR T-cells therapy for all patients. https://lnkd.in/eWkEGiNq

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