Prateek Kumar

Assessing Technical Expertise: Choosing the Right CDMO for Advanced Therapy Medicinal Products (ATMPs) Recently, reflecting on a panel discussion I participated in with industry experts Louis Garguilo, Praveen Prasanna, and Vibhav Patel, I've developed a comprehensive framework for evaluating a Contract Development and Manufacturing Organization's (CDMO) technical capabilities. https://lnkd.in/dFWSrtcg Selecting the Right CDMO: 10 Critical Evaluation Criteria 1.    On-Site Due Diligence Conduct comprehensive on-site visits to assess capabilities. Immerse yourself in process development, QC labs, and GMP manufacturing suites to gain direct insights into the team's expertise and culture. 2.    Talent Assessment Evaluate the organization's talent approach: ·      Retention of top-tier professionals ·      Team interaction and communication dynamics ·      Leadership's commitment to technical excellence ·      Evidence of continuous learning 3.    Project-Specific Expertise Verify the CDMO's ability to demonstrate: ·      Specific ATMP methodologies ·      GxP compliance ·      Successful technology transfer ·      Regulatory understanding 4.    Analytical Capabilities Scrutinize analytical expertise: ·      Safety and purity testing ·      Identity verification ·      Quantitative analysis ·      ATMP-specific potency testing 5.    Industry Reputation ·      Leverage professional network insights ·      Seek candid colleague feedback ·      Treat CDMO selection like a critical review 6.    Problem-Solving Skills Assess their approach to challenges: ·      Deviation handling ·      Root cause analysis ·      Innovative problem-solving 7.    Talent Pool Considerations ·      Local talent availability ·      Recruitment strategies ·      Ability to attract top talent 8.    Subject Matter Expert Access Ensure direct communication with: ·      Project-specific SMEs ·      Technical experts ·      Professionals with nuanced insights 9.    Regulatory Track Record Verify: ·      Post-approval inspection performance ·      Patient-ready product history ·      Comprehensive Drug Master File 10. Technological Infrastructure Evaluate: ·      State-of-the-art facilities ·      Cutting-edge equipment ·      Novel ATMP technology expertise Final Insight Selecting the right CDMO requires systematic assessment of these critical aspects to align with your ATMP development goals. #ATMP #Biotechnology #CDMOSelection #RegulatoryCompliance #IndustryInsights

28

4 Comments

Thoughtful and insightful podcast on H5N1 and related topics, Arnab Chatterjee. Thanks for taking the time to share your wisdom, especially the part about needing more and better antivirals. https://lnkd.in/eMB-mta8

14

Happy Varamahalaxmi LinkedIn fam 🙏🏻 ✨Just as the eight forms of Lakshmi embody different aspects of prosperity, biotech startups can draw valuable insights. 🧬From Adi Lakshmi's emphasis on foundational research to Vijaya Lakshmi's celebration of success, each form offers guidance. 🪙Like Dhana Lakshmi, financial sustainability is crucial. 🌾Dhanya Lakshmi reminds us of the industry's role in agriculture. 📈 Gaja Lakshmi emphasizes scaling operations. 🔬Santana Lakshmi inspires innovation and new beginnings. 🦸🏻‍♀️Veera Lakshmi instills the courage to overcome challenges. 📚 Vidya Lakshmi highlights the importance of continuous learning. 💫By embodying the spirit of Ashtalakshmi, biotech startups can navigate the complex landscape and achieve remarkable success. #Varamahalaxmi #Biotechnology #Startup #Ashtalakshmi #Innovation #Success #Growth

32

2 Comments

Out of the box capabilities of #LLMs are necessary but not sufficient to address some of the complex use cases in #biopharma R&D, clinical trials and medical affairs. Aganitha ARC™ framework brings together patterns and tools necessary to solve these complex use cases.

29

Hey LinkedIn Fam - Help out Narwhal Bio! As part of the BioTools Innovator competition, Narwhal has put out a 1 min video about what we're building. The video will be part of a number of factors the BTI team of of advisors will use to rank the companies. Please go to Youtube and "Like" the video as exposure counts! https://lnkd.in/gc6zFqGf Please also "Like" this post below to keep it at the top of people's feeds! Thanks everyone!

53

1 Comment

Thanks to BiotechTV for the opportunity to discuss Rectify Pharma approach to restore and enhance membrane protein function using small molecule Positive Functional Modulators (#PFM). @AASLD meeting we presented preclinical data with lead dual targeted ABCB4/BSEP PFM that supports treatment of PSC by improving bile composition and enhancing bile flow, thereby reducing both cholangitis and cholestasis that underlies the core pathophysiology of multiple hepatobiliary diseases.

64

1 Comment

It was enlightening to hear from Dr. Califf and Dr. Chatterjee about the exciting advancements and future of omics and precision science at the FDA's Omics Day 2024. The integration of precision practices across diagnostics, biologics, and drug development is poised to enhance health outcomes significantly. Precision medical science approaches, rather than adopting a one-size or single approach, remind us of the story of seven blind mice. #FDA #PrecisionScience #HealthOutcomes #OmicsDay2024 #AltaQ #LDT #IVD

10

Check out our recent talk, "The best end-to-end deep-learning practices" at statgen 2024 authored by Jake Gagnon, Hangyu Liu, Lira Pi, and Himanshu Pandya https://lnkd.in/e3_D7Esh #DeepLearning #MachineLearning

11

Please join us in the webinar next Monday to learn the latest update for our AAV manufacturing platforms, using transient transfection and stable producer cell lines, and advanced analytics in genome integrity that can support your path to IND and beyond. "Current AAV manufacturing often suffers from low productivity and scalability, high cost of raw materials, supply chain complexity, and high batch-to-batch variation. To overcome these limitations and industrialize AAV manufacturing, Lonza has developed two high-performing Xcite® AAV manufacturing platforms, using transient transfection and stable producer cell lines (PCL) technologies. Lonza’s AAV transient transfection platform consistently delivers industry leading AAV titers (E11 to E12 vg/mL), high full/empty capsid ratio and overall yield (20-40% recovery). Lonza’s proprietary suspension HEK293 cell line and plasmids, optimized manufacturing processes and innovative AAV analytics have been integrated to generate a robust and scalable platform (3L to 250L) with proven performance using multiple serotypes (AAV2, 5, 6, 8, 9 and novel capsids) and transgenes. The streamlined transient transfection platform de-risks your path to IND and reduces complexity and timeline for lengthy process and analytical development. Building upon the proprietary HEK293 cells, Lonza further developed a high-producing, helper virus-free AAV stable PCL technology. AAV production is tightly regulated and is chemically induced using doxycycline. Selected PCL clones have been identified with higher AAV titer (> 1E12 vg/mL) than transient transfection process with comparable full/empty capsid ratio (> 30% full capsids at harvest). These stable clonal cells maintain long-term stability (> 30 passages) for AAV productivity and packaging efficiency. Helper-virus free AAV PCL eliminates the need for costly plasmids, reduces supply chain and manufacturing complexities and can be easily scaled to 2000L+. Taken together, our Xcite® AAV platforms can enable high quantity and quality of commercial AAV manufacturing at a scale you need for your valuable therapies."

77

For AI/ML companies seeking high-quality, paired, curated, machine interpretable NGS data for antibody discovery, we are launching new NGS data products. Several pharma customers have purchased our libraries to generate NGS data for AI/ML models, an approach well-funded AI/ML companies with experimental facilities may wish to consider. However, most AI/ML companies cannot afford experimental facilities, which is why Specifica is now offering custom high-quality NGS datasets, developed in collaboration with you, for your AI/ML models. AI/ML models need good data. Most models incorporating antibody sequences are trained on OAS, a leading database established by Charlotte Deane and her group at Oxford in 2018*. OAS data is derived from naïve or immune B cells, and heavily biased towards VH sequences with extremely limited VH/VL pairing (of human sequences, 84.3% are VH, 15.6% are VL and 0.09% are paired). As data is all in vivo derived, target specificity cannot be associated with individual sequences, but the dataset as a whole. There's a growing understanding that public datasets are insufficient for tasks relevant to the development of therapeutics, and that to solve a specific AI problem, the best data is that which addresses the specific problem. What do I mean by that? If you’re interested in using AI to generate, or improve, an antibody against target X, you will be more successful if your dataset comprises sequences of antibodies that do, and don’t, bind X, rather than a dataset of random antibodies of unknown specificity. Even better if there is some discrimination in the affinities of the antibodies that bind X. Ideally, every antibody sequence would have an affinity associated with it, but failing that, sequences enriched at different target concentrations. So, where does an AI company get high quality data? Many seem to think it should be free. I’ve been approached by more than one such company, asking if we would give them NGS data gratis. However, even if we were willing to supply such data for free (we’re not), it would not be the best for AI. That’s another change in emphasis: good targeted data is now more appreciated as valuable, rather than something scraped from public datasets. The best AI companies are now investing heavily in experimental labs to provide that data (e.g. see job postings from Xaira Therapeutics, a billion-dollar AI startup), with the number of experimental scientists often matching or exceeding the number of AI/ML scientists. But building infrastructure to get high-quality experimental NGS data is expensive. Not only is significant capital investment required to build and equip labs, but antibody expertise must be hired to ensure NGS data is relevant and of sufficiently high quality to build and improve models. So, why build your own infrastructure if it’s faster and more cost-effective to outsource to good collaborators?

103

7 Comments

AI, CTMS and Clinical Trials... Who wants to understand the tools out there to help #biotech #pharma and #cro be successful? Join the #anjusoftware #OnTimeTrials and #barringtonjames Webinar April 25!

6

By leveraging AI with vast genetic databases, we are not only quickening the pace of identifying potential drug targets but also enhancing the accuracy of clinical diagnostics and predictive modeling. Recently, I had the privilege of discussing the profound impact AI is having on pharmaceutical R&D with Kim Branson, GSK's SVP Global Head of Artificial Intelligence and Machine Learning. Listen on Raising Health: https://lnkd.in/g6QUm2-A

41

5 Comments

Today, we’re announcing a major milestone at Recursion: REC-1245 – a potentially first-in-class RBM39 degrader – has received FDA IND clearance for a Phase 1/2 clinical trial for the treatment of biomarker-enriched solid tumors and lymphoma. This is our first program to reach clinical studies derived from our AI-enabled Maps of Biology. REC-1245 represents the incredible breakthroughs made possible by our Maps, which use machine learning to explore predicted biological and chemical relationships to identify new targets. We’ll be advancing REC-1245 for the treatment of biomarker enriched solid tumors and lymphoma, and estimate that the initially addressable population for this potential therapeutic will be >100,000 patients in the US and EU5.   How did we get to REC-1245? It all started with CDK12. CDK12 is a well-validated and promising cancer target but one that has long been considered difficult to drug due to its high structural similarity to CDK13 which, if antagonized, causes significant tox. This is where our unique AI-enabled phenotypic approach comes in. By comparing morphological signatures induced by individually knocking out every human gene, we uncovered that RNA Binding Protein 39 (RBM39) seemed to have the same biological function as CDK12. We also used our AI-enabled map to find starting point molecules that inhibited RBM39, allowing us to mimic CDK12 inhibition while mitigating the toxicities associated with pan-CDK inhibitors. The preclinical data supports that RBM39 degradation induces splicing defects which downregulate DNA Damage Response (DDR) networks and cell cycle checkpoints. By leveraging our proprietary dataset, models, compute, and industrialized workflows, we’re not only driving new discoveries, but rapidly increasing the pace of discovery. We progressed REC-1245 from hit to preclinical candidate in under 18 months, more than twice the speed of industry average, and we expect the Phase 1/2 trial to initiate in Q4 2024. Very proud of this team and excited for the many new medicines to come in our future! Learn more:  https://lnkd.in/gTifXatG #techbio #ai #ml #drugdiscovery #target #cancer #cdk12 #rbm39 #automation

414

7 Comments

💻Champions' presents: AACR 2024 Poster QuickTakes! 📅 Join us on June 4 for an insightful session with BanuPriya Sridharan, our Scientific Director of Ex Vivo Services. She'll be diving deep into the systematic analysis of gene mutations and quantifying the therapeutic efficacy of drug candidates using our advanced ex vivo hematological VitroScreen platform. Register today: https://hubs.li/Q02yxh6S0 Key Takeaways: ☑️Discover how Champions Oncology's Hematological VitroScreen platform offers a cost-effective solution for screening the performance of new FLT3 inhibitors and other anti-neoplastic test agents. ☑️Delve into the seamless integration of our Lumin platform for enhanced model selection and data interpretation. Don't miss this opportunity to explore pivotal research and innovative platforms shaping the landscape of cancer treatment! #AcuteMyeloidLeukemia #FLT3 #ExVivo #Multiomics #Bioinformatics #cancertherapy #cancerresearch #oncology #drugscreening #bloodcancer #AACR2024 #Leukemia

14

Ten Companies to Watch in AI Drug Discovery https://lnkd.in/gCWtSdiZ In AI-based drug discovery—a field benefiting from a cumulative investment of $60 billion—the leaders are making real progress toward approved therapies. The post Ten Companies to Watch in AI Drug Discovery appeared first on GEN [...] #LosAngeles #OrangeCountyCA #Biotech #Lifescience #News

1

Many thanks to Genetic Engineering & Biotechnology News for organizing the exceptional 'State of AI in Drug Discovery 2024' Virtual Summit on October 30th! This event illuminated the transformative role of AI across drug design, translational research, and therapeutic discovery. Sessions featured included: 1. Keynote Speakers of the Summit- #Nobel Laureate David Baker (University of Washington/Howard Hughes Medical Institute (HHMI)), who illuminated the multitude of applications of de novo protein design and Najat Khan, PhD (Recursion), on scaling AI's industry impact. 2. Fascinating discussions led by trailblazers like Ava Amini (Microsoft Research), Gevorg Grigoryan (Generate:Biomedicines), and Karen Akinsanya (Schrödinger), exploring AI’s role in optimizing protein structures, enhancing design accuracy, and overcoming therapeutic challenges. 3. Dynamic breakout sessions led by the sponsors of this summit- Revvity Signals, Microsoft Research, and Anima Biotech, showcasing AI-driven therapeutic solutions. 4. Deep dives into foundational models that enable us to “read and write” the intricate language of biology from Ali Madani (Profluent), Brian Hie (Arc Institute), Alex Rives (EvolutionaryScale), and Elizabeth Wood (JURA Bio, Inc.). 5. Enlightening perspectives on AI-enhanced small molecule discovery from experts at 1910 Genetics, Terray Therapeutics, insitro, and Insilico Medicine. 6. Insights on AI’s role in shaping business dynamics with Simon Barnett (Dimension Inx), Sabrina Yang (Empress Therapeutics/Flagship Pioneering), and Colin Hill (Aitia Bio). This experience was both insightful and inspiring, even if occasionally overwhelming. I gained a wealth of knowledge and felt privileged to have attended this prestigious event and be among such distinguished experts. It further affirmed my belief that interdisciplinary scientific collaboration is the way forward. #AIDrugDiscovery #ProteinDesign #TranslationalResearch #HealthcareAI #Innovation #NextGenTherapeutics #LifeSciences #BiotechnologyRevolution #DrugDevelopment #MachineLearning #ClinicalTrials

17

Wuxi's exit from the US CDMO space will leave a gap. Currently, Indian CDMOs look like the most likely candidates to fill it. A key feature of Indian CDMOs' strategy has been to remain independent from Chinese suppliers, mitigating the risk of disruption. As other CDMOs scramble to find new suppliers, India will emerge as a key replacement for companies like Wuxi. However, there will still be opportunities for European organisations if they act fast. Bolstering our self-reliance will put us in a strong position to compete for entry into the US industry. #BiosecureAct #Biotech #CDMOs #Biopharma

140

4 Comments