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Courses
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Stanford Graduate School of Business, Strategy (2021)
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The Aspen Institute, Aspen Seminar (2011)
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Univ. of Chicago Booth School of Business, Finance for Executives (2000)
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Honors & Awards
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EY Entrepreneur of the Year
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Languages
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English
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French
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World Pharmaceutical Frontiers
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Kendalle Burlin O'Connell, Esq.
We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S
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Genezen
BIG NEWS! Genezen has signed an agreement to acquire uniQure’s commercial gene therapy manufacturing operations in Lexington, Massachusetts. This strategic acquisition will enable Genezen to deliver late-phase and commercial gene therapy development and manufacturing services to customers around the world. Steve Favaloro, President and Chief Executive Officer of Genezen, commented, “...This acquisition significantly enhances Genezen’s scale and differentiated capabilities, directly aligned with our mission to advance cell and gene therapies by providing top-tier, science-driven development and manufacturing solutions. We are honored to deliver these services to our current customers and the patients they serve, and are well positioned to immediately extend our support to even more customers in Lexington.” #cdmo #viralvectors #cellandgenetherapy #celltherapy #genetherapy #precisionmedicine #mergersandacquisitions #investment #finance #pharma #biotech CSL Ampersand Capital Partners https://lnkd.in/eqDDc_cf
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Laurent Boer
We’re honored that Alcami and our CEO William Humphries were included in Investment Reports' new publication, 'The New Era of Life Sciences 2024'. Don’t miss this comprehensive and inspiring exploration of the advancements shaping healthcare and beyond. Download it here: https://gag.gl/mLwcJY #Alcami #CEO #InvestmentReports #LifeSciences
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Exothera
Discover Patrick Thiaville's, CTO at Exothera, insights on GMP compliance and regulatory adherence in nucleic acid therapeutics manufacturing. 💬"Nucleic acid therapeutics have emerged as a promising frontier. These innovative treatments have the potential to address a wide range of diseases, from rare and infectious diseases to cancers, and offer hope for many patients worldwide. However, the journey from concept to clinic is fraught with challenges, particularly in the areas of manufacturing, regulatory compliance, and technological innovation." #rnamanufacturing #rnavaccine #biotherapeutics #gmp #nucleicacids
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BioAegis Therapeutics, Inc.
#BioAegis is identified as one of the "nine biotech companies to put on your radar." Thank you Labiotech.eu for acknowledging our progress and efforts to disrupt the way inflammatory diseases are treated. Our product, recombinant human plasma gelsolin (rhu-pGSN) is a non-antibiotic, host-directed, nonimmunosuppressive treatment for inflammation due to both infectious and non-infectious causes. BioAegis will be conducting a global phase 2 trial of #gelsolin for the treatment of Acute Respiratory Distress Syndrome. This will be the largest trial ever conducted for #ARDS. BioNJ #njbiotech #njstrong #bionj #savinglives #clinicaltrials #immunotherapy #biotechinvesting #NLR3Pinflammasome #lungdamage
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GemPharmatech
Yesterday, Gordon Haner, MBA, LATG, ILAM was onsite at EMD Serono, Inc. for a Biotech Vendor Services, Inc. vendor show! Thank you to all those who came to talk to Gordon about GemPharmatech's mouse models and preclinical services. If you are in the #bostonbiotech community make sure to reach our to Gordon if you do preclinical research with mouse models. Also a thank you to Matthew Potter and BVS! See you again soon, new EMD and MilliporeSigma friends! #preclinicalresearch #oncology #autoimmune #vendorshow #bvs #bvsvendorshow
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Kendalle Burlin O'Connell, Esq.
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Generate:Biomedicines
Our CEO Michael Nally spoke at MassBio's State of Possible Conference with Barry Greene of Sage Therapeutics, Sharon Cunningham of Shorla Oncology, and Daphne Zohar of Seaport Therapeutics, moderated by Douglas Banks of Boston Business Journal. The panel explored Massachusetts' success in the life science industry—a story of innovation and resilience. These leaders discussed how they have survived and thrived through significant challenges. In a blog entry for MassBio, Mike notes: "By spearheading the transition from trial-and-error to programable, precision-based drug development, Massachusetts is reshaping the future of healthcare to better serve patients, the ecosystem, and the economy." Learn more about the panel, including a replay: https://lnkd.in/eHanbnQF #GenerativeAI I #ProteinEngineering
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Alethium Health Systems
Day 2 Highlight at World Orphan Drug Congress in Boston 🌐 Industry insights on partnering in the rare disease space struck a chord with us. Panelists discussed the advantages of partnerships between large and small biopharma and pharma companies. While established organizations can bring more resources to the development of medical treatments, smaller companies often have a deeper understanding of rare diseases and innovative approaches to problem-solving. 💡 Our agile team at Alethium Health has designed our clinical trial platform to anticipate nuanced needs and challenges before they happen. We’ve optimized trials by adjusting for patient or caregiver struggles, such as incorporating televisits and providing additional translations, to make clinical trials globally accessible at exceptional speed, reduced costs, and minimal risk. 🚀 #ClinicalTrials #OrphanDrugCongressUSA #DigitalClinicalTrials #RareDisease
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BioPharma Nexus Conference
🎉 Get ready to unlock the keys to success in the small biopharma sector with Jerry W., Associate Director at Ascentage Pharma, LIVE at the 20th Biopharma Clinical Trials Nexus Conference! 🌟 Join Jerry as he delves into the dynamic world of "Effectively Steering Your Clinical Trials for Success in the Small Biopharma Sector." 🚀🔬 Dive deep into actionable strategies, insider tips, and real-world case studies tailored specifically for small biopharma innovators. 💡 Don't miss this exclusive opportunity to learn from one of the industry's brightest minds and gain the competitive edge you need to drive your clinical trials to success. 🎤 #BiopharmaClinicalTrials #Innovation #SuccessSecrets #SanDiegoConference
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Lachman Consultant Services
RECAP: April 2024 FDA SBIA Generic Drug Forum – A Flair for the PLAIR https://lnkd.in/e_HhMBkG "The Forum offered a diverse array of presentations applicable to the generic industry at large. In this blog, I will focus on one presentation related to PLAIRs (Pre-Launch Activities Importation Requests)." Click to Read More! #ANDA #Compliance #Generics #RegulatoryAffairs #FDA #SBIA #CDER
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We are thrilled to announce that iRegene has received US FDA IND approval for NouvNeu001, our innovative therapy targeting Parkinson's disease. This is a significant milestone in our mission to develop groundbreaking treatments for neurodegenerative disorders. At iRegene, we are dedicated to advancing neurodegenerative disease research and are excited about the potential impact of NouvNeu001 on the lives of those affected by Parkinson's. This approval brings us one step closer to providing a novel therapeutic option for patients in need. We extend our heartfelt gratitude to our partners, researchers, and supporters who have contributed to this achievement. #iRegene #ParkinsonsDisease #NouvNeu001 #FDAApproval #ClinicalTrials #NeurodegenerativeResearch #InnovationInHealthcare #Biotechnology
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Akron Bio
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Association of Strategic Alliance Professionals
LAST CHANCE to submit your topics and presentations for the 2024 ASAP BioPharma Conference! The conference will be held in Boston from November 4-6, 2024. We need your expertise and thought-leadership to ensure the most valuable and current topics regarding partnering, collaboration, and alliance management in the biopharma and life sciences industries are addressed. Don't miss this opportunity to contribute your knowledge! Submit your topics before the deadline on Friday, May 3, 2024 at https://lnkd.in/ehXhGm7U. #alliancemanagement #alliances #strategicalliances #alliancemanagers #collaboration #strategicpartnerships #pharmaceutical #pharmaceuticalindustry #biopharma #biotech #biotechnology #biotechindustry
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Market Access Today
Hormone Replacement Therapy Delay: FDA Extends Ascendis Pharma's TransCon PTH Review by Three Months Ascendis Pharma's quest for FDA approval of its hormone replacement therapy, TransCon PTH, has faced another delay, with the review period extended by three months to August 14, 2024, due to a major amendment to their application. This prolongs the approval process for treating hypoparathyroidism, a condition affecting about 70,000 people in the U.S. The announcement caused a 6% drop in Ascendis Pharma's share price. Despite this, the therapy has shown promising results in clinical trials and received marketing authorization in Europe and the UK. Ascendis Pharma CEO Jan Møller Mikkelsen affirmed their commitment to working with the FDA and maintaining access for patients in ongoing trials and expanded access programs. This follows an earlier setback in April 2023, where the FDA cited manufacturing concerns. For more details please click the link! https://lnkd.in/dYvsQNB5 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical
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Anthony Carita
I recently had an interesting conversation with a friend over lunch, delving into the distinct disparities between Clinical Finance and Financial Planning & Analysis (FP&A) and their unique roles within organizations. It's unfortunate that these nuanced differences often go overlooked by many organizations, yet they hold significant implications for managing clinical studies and related expenditures, particularly when the appropriate resources are not allocated or when reliance on service providers for critical performance data occurs. The following hopefully sheds some light on the differences between Clinical Finance and FP&A and the need for BioPharma organizations to engage Clinical Finance professionals: Clinical Finance - Clinical Finance primarily centers around both the financial management within specific clinical trials and its impact on operational performance at Clinical Research Organizations (CROs) and associated service providers. To execute their responsibilities, it necessitates a deep understanding not only of how clinical studies are conducted but also the intricate interactions between various functional components. - This understanding allows Clinical Finance professionals to be able to forecast the impact of expenditures (or lack thereof) on actual study performance, identifying negative or positive trends that may influence outcomes. - It involves tasks such as budgeting, financial planning, revenue cycle management, cost analysis, and financial reporting, all customized to support clinical operations, services, and research initiatives at the study level. - Close collaboration with internal functional staff, service providers, and finance teams ensures efficient resource allocation and optimization of financial performance while upholding high-quality study conduct. FP&A (Financial Planning & Analysis) - FP&A often spans a broader range of financial activities across all facets of an organization. It typically focuses on strategic financial planning, forecasting, budgeting, and performance analysis at the corporate level to support decision-making and foster business growth. - Professionals in this domain often collaborate with senior management and department heads to develop financial plans, analyze financial data, monitor performance against targets, and offer insights to optimize business operations and financial outcomes. - While FP&A functions are applicable across industries, they do not specialize in understanding or meeting the unique needs of clinical operations or research activities. In essence, Clinical Finance is tailored for planning and executing clinical studies, while FP&A has a wider application, concentrating on strategic financial planning and analysis to advance overall business objectives.
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