Latest news with #CRO
Associated Press
14 hours ago
- Business
- Associated Press
Marin Biologic Laboratories Releases FDA-Ready Bioanalytical Cell-Based Assays White Paper
New Publication Sets Standard for Phase-Appropriate Assay Qualification, Offering Clear Path from IND to Commercialization 'Whether you're preparing for your first IND or scaling up for commercial release, assay integrity is non-negotiable. This white paper reflects our commitment to excellence.'— Tania Weiss, Ph.D., CEO, Marin Biologic Laboratories NOVATO, CA, UNITED STATES, June 27, 2025 / / -- Marin Biologic Laboratories Inc. (MarinBio), a leading bioanalytical testing and regulatory compliance contract research organization (CRO) based in Northern California, announces the release of a new white paper, 'Selecting Bioanalytical Assays for FDA Approved Clinical Trials and Commercialization.' company/selecting-bioanalytical-assays-fda-clinical-trials-commercialization/ This in-depth publication offers the biopharmaceutical industry a clear, scientifically grounded roadmap for selecting regulatory-ready assays that meet FDA requirements. The white paper walks readers through the full continuum of assay development—from early-stage, fit-for-purpose qualified assays to fully validated, GMP-compliant platforms ready for BLA and NDA submission, and commercialization. 'Whether you're preparing for your first IND or scaling up for commercial release, assay integrity is non-negotiable,' said Tania Weiss, Ph.D., CEO of Marin Biologic Laboratories. 'This white paper reflects our commitment to excellence—scientific, operational, and regulatory—and our desire to enable clients to meet FDA expectations without unnecessary delays or cost overruns. Our goal has always been to act as a true scientific partner to our clients, including those pioneering the next generation of therapeutics. This white paper is a natural extension of that mission. We are codifying three decades of experience to provide the entire industry with a clear, actionable framework for navigating the immense complexities of modern drug development. We believe that sharing our expertise in regulatory strategy and advanced bioanalysis will help accelerate innovation across the board.' The white paper content leverages MarinBio's 30 years of scientific leadership and impeccable regulatory track record to enable companies on their journey from preclinical projects to commercialization. The publication draws upon MarinBio's deep expertise in GMP/GLP-compliant assay development and its recent successes in passing both FDA, with no 483s, and EU regulatory audits. Key insights from the white paper include: - Phase 1: Research-Level Assay Development – Streamlined approaches for initial technology transfer or de novo assay design that deliver reliable, fit-for-purpose data for preclinical and early clinical studies. - Phase 2: Assay Qualification – Criteria for building a qualified assay for Phase 2 FDA submissions including intermediate precision, accuracy, linearity, and specificity to support IND-enabling studies with confidence. - Phase 3 & Commercial: GMP Assay Validation – A guideline for validating, and documenting robust assays in full compliance with GLP/GMP and FDA standards—ready for commercial deployment. The white paper also offers real-world advice for biotech and pharma clients navigating pre-IND/IND readiness and BLA/NDA submissions and commercialization phase —making it an essential read for development teams, regulatory leads, and scientific executives. About Marin Biologic Laboratories Inc. Marin Biologic Laboratories (MarinBio) is a woman-owned contract research organization (CRO) with over 30 years of experience supporting the pharmaceutical and biotech sectors. Specializing in custom cell-based assays, GMP/GLP compliance, and regulatory strategy, MarinBio partners with clients to advance therapeutics from discovery to commercialization. With a team of senior PhD scientists and a flawless regulatory audit history, MarinBio provides the scientific expertise and quality systems necessary to meet global compliance standards. Marin Biologic Laboratories is recognized for its scientific agility, rigorous quality systems, and deep understanding of FDA regulatory expectations. The company is known for working collaboratively with clients, ensuring each assay is customized to meet specific regulatory, technical, and commercial goals. Operating from a GMP-compliant facility in Novato, CA, MarinBio supports US and international clients ranging from venture-backed startups to top-tier global biopharma firms. The company's service portfolio includes: - Potency Assays for Lot Release - Stability Testing - PK/PD & Immunogenicity Studies (ADA) - ELISA, Flow Cytometry - Cell-Based Assays ( ) - Molecular Biology - qPCR - GMP / GLP Compliant Validation and Regulatory Reporting For the complete white paper or to discuss your bioanalytical assay development needs, please visit the MarinBio website at Tania L. Weiss, Ph.D. Marin Biologic Laboratories, Inc. +1 4158838000x100 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content 'as is' without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
Forbes
19 hours ago
- Business
- Forbes
What Nearly Blowing My Promotion Taught Me About Leadership
Toyna Chin is the Global Director of Marketing at Novotech, a global biotech CRO. A few years ago, I stepped into a new role through an internal promotion. I'd been with the company for a while, understood the people and had a strong pulse on the business. Naturally, I thought I was ready to hit the ground running. Spoiler alert: I wasn't. Almost immediately, I found myself creating tension. Not because I had bad ideas, but because I was too eager to act without fully understanding my new reality. I later picked up What Got You Here Won't Get You There by Marshall Goldsmith, and the title alone felt like it was written for me. It helped me reflect on why my instincts (which had served me well until that point) were suddenly working against me. Here's what I wish I had done differently and what I eventually figured out the hard way. In my prior role, I was valued for being proactive, decisive and solution-focused. When I moved up, I leaned on those same traits—but now they were landing differently. Instead of being seen as helpful, I came off as pushy. I was unintentionally steamrolling people who had more context than I did. I remember diving into a team meeting and immediately suggesting changes to a process I thought was outdated. What I didn't realize was that this 'outdated' process had been carefully developed to meet very real constraints I hadn't yet uncovered. That was my first big leadership lesson: Leading from the middle is very different from leading from above. Execution and influence are not the same thing. My job was no longer to drive every solution but to enable the team to solve the right problems. One trap I fell into was assuming that my tenure gave me all the insight I needed. I'd been involved in cross-functional projects, sat in on leadership meetings and even contributed to some strategic planning. But I didn't realize how much nuance I was missing until I started asking more questions. Eventually, I slowed down and started meeting with key stakeholders—not to tell them my vision, but to ask for theirs. I asked questions like: • 'What's working well that you'd want to protect?' • 'Where do you think I can be most helpful?' • 'What do you want me to understand before I try to change anything?' Those conversations gave me insight that no dashboard or report ever could. I realized I had a few puzzle pieces—but not the whole picture. I came into the role with good intentions, but my early attempts to make improvements were met with hesitation. It wasn't until I stepped back and focused on building trust that things began to shift. I started by owning what I didn't know. I became more transparent about my learning curve and started showing more appreciation for the team's existing efforts. I stopped assuming and started listening with patience. And something powerful happened: the resistance faded. People became more open, more engaged and, ironically, more receptive to change. They felt respected and included in the process. There was a process I was certain we needed to sunset. In my mind, it was inefficient and outdated. But when I spoke to the team that created it, I heard the backstory. That process wasn't built in a vacuum; it was born from constraints, limited resources and a lot of trial and error. Instead of scrapping it immediately, I invited the team to revisit it with me. We explored what still served us and what we'd outgrown. Together, we built something better. That collaboration turned what could've been seen as a teardown into a shared success. It taught me something critical: Honoring past work isn't about clinging to the old. It's about showing people that their efforts matter—and that progress is something we create together. I had a new title, new responsibilities and formal decision-making power. But the moment I tried to rely on that power alone, I hit walls. Influence, I realized, comes from alignment, not hierarchy. So I brought people into the conversation early. I started socializing ideas instead of announcing them. I gave space for feedback, even when it was hard to hear. Over time, something shifted: the team stopped seeing change as my agenda and started treating it as our direction. Looking Back: Growth Requires A Gear Shift That promotion was a turning point for me not just professionally, but personally. It challenged my assumptions, exposed some blind spots and ultimately reshaped how I lead today. Goldsmith's premise still rings true: The skills that get you promoted won't necessarily make you successful in your new role. Transitioning into leadership requires letting go of old habits, embracing new ones and remembering that people don't follow titles—they follow trust. If you've recently stepped into a new role or have one on the horizon, here's my advice: don't rush to prove yourself. Start by listening, aligning and showing people that you respect the journey they've been on. Because when people trust that you see them, they'll walk with you even when the path changes. Forbes Communications Council is an invitation-only community for executives in successful public relations, media strategy, creative and advertising agencies. Do I qualify?
Miami Herald
4 days ago
- Business
- Miami Herald
Patrick McNamara Named Chief Commercial Officer at Yunu, Driving Growth in Trial Imaging for Pharma
CARY, NC / ACCESS Newswire / June 24, 2025 / Yunu, the creator and leader in cloud-native imaging workflows for clinical trials, proudly announces Patrick McNamara as its new Chief Commercial Officer. With over two decades of experience in clinical research and business development, McNamara has played a pivotal role in Yunu's rapid expansion across the pharmaceutical, biotech, and contract research organization (CRO) sectors. McNamara's appointment reinforces Yunu's commitment to advancing transformative clinical trial imaging solutions at scale. His deep industry knowledge is built upon years of hands-on leadership as the prior VP of Business Development for the clinical endpoint division of a major CRO as well as key oversight of commercial and operational teams. His extensive experience and strategic vision accelerate Yunu's ability to deeply engage with sponsors and CROs in Yunu's industry-wide effort to transform trialimaging workflows, accelerate new therapies, and improve data quality. "We are thrilled to appoint Patrick McNamara as our Chief Commercial Officer," said Jeff Sorenson, CEO & Co-founder of Yunu. "Patrick's unique perspective allows Yunu to orient our teams around the specific needs and processes of pharma while also fine-tuning our go-to-market as we continue to deliver game-changing trial acceleration and transparency." Yunu recently unveiled a groundbreaking software release that empowers pharma sponsors to rapidly configure new studies, connect to readers, and ensure real time access to their imaging data within their primary data systems. This advancement underscores Yunu's role as an innovator and leader in harmonizing multi-site trials, reducing complexity, and accelerating trial imaging timelines. Yunu is also managing all imaging endpoints delivered to sponsors at more than 25% of NCI-designated Comprehensive Cancer Centers. The platform's impact will be discussed during a special session with City of Hope leadership in addition to showcasing these latest advancements during the 17th Annual AACI CRI Meeting in Chicago from Monday, June 23rd, to Wednesday, June 25th. ABOUT YUNUYunu enables life sciences organizations to streamline imaging workflows, improve accuracy, and accelerate timelines. Yunu's platform supports clinical trials across various therapeutic areas, offering scalability and flexibility for organizations of all sizes. For more information, visit and follow us on LinkedIn or X @Yunu_Inc.
Irish Independent
13-06-2025
- Business
- Irish Independent
Enterprise Ireland chairman Michael Carey resigns
In a statement Mr Carey confirmed he's stepping down from role he's held since September 2023. He is also resigning as chairman of the Housing Agency. 'With regret I am announcing my resignation from two voluntary unpaid/un-expensed state board positions: as chairman of Enterprise Ireland and of The Housing Agency,' he said. "Recent media reports have highlighted late account filings with the CRO for our business East Coast Bakehouse, where I'm a major shareholder and executive chairman. This has occurred due to management administrative errors. "The delay has been exacerbated by an unanticipated need for a decision by our board to change our auditors. There is no suggestion of any financial issues at the company; the accounts for these periods are completed and the fully audited accounts are expected to be filed in the CRO by early July.' Mr Carey added: "The widespread issue of late filings of accounts with the CRO has been highlighted in recent months, with over 15,000 firms in a similar position each year. This issue of this late filing at East Coast Bakehouse has received particular media attention due to my role as chairman of these state agencies. "I accept personal responsibility for the failure of the business to comply with this corporate governance requirement and the heightened requirement to fully comply, as chairman of a number of state boards. A late filing fee will be paid as appropriate and actions have been taken to avoid any future reoccurrence. "In order to avoid embarrassment to the ministers and any distraction from the crucially important jobs undertaken by these two agencies, I will step aside from these roles with immediate effect. I will work with the board and CEOs of these agencies as/if required to facilitate a smooth transition.' East Coast Bakehouse company is now more than 18 months late filing accounts for its 2023 financial year. The company is also late filing accounts for the 2024 financial year. Despite the resulting potential legal consequences, the Department of Enterprise, Trade and Employment, which oversees Enterprise Ireland, had continued to back Mr Carey's position as chairman of a state agency that helps Irish companies to grow and expand internationally. East Coast Bakehouse, which was founded by Mr Carey in 2015, is based in Drogheda, Co Louth. Enterprise Ireland is a significant backer of the venture, having ploughed about €2.4m into the business. ADVERTISEMENT Learn more The major delay in filing the accounts continues to leave Mr Carey and other directors of biscuit maker East Coast Bakehouse, including his wife, Alison Cowzer, open to potential prosecution for offences under the Companies Act. Earlier today, Mr Carey had told the Irish Independents that the accounts for the firm's 2023 and 2024 financial years would be filed by next month. In the middle of April, he said East Coast Bakehouse would file all up-to-date accounts in coming weeks. He said at the time the company expected to soon close a €5m equity fundraising and line up €5m in debt finance. On April 30, the Department of Enterprise told the Irish Independent that Mr Carey had informed it that the accounts for the company's 2023 financial year had been finalised. 'They have received a commitment that they will be filed with the CRO in the coming weeks and that steps have been taken to avoid this occurring again in future,' said the Department at the time. On June 4, Mr Carey told the Irish Independent that the funding process that had been underway was complete, and that the accounts for East Coast Bakehouse would be filed that week or the following Monday. Today he said it would now be July before the accounts are filed, with both 2023 and 2024 prepared. 'A number of issues outside of our control have delayed the process,' he said. 'Work continues on the audit of these accounts, aiming to file fully up-to-date with the Companies Registration Office in early July.' 'We acknowledge that filing of these accounts are late due to administrative errors and an unforeseen need to decide to change our auditors,' he added. 'A late filing fee will be paid as required in such circumstances.' Mr Carey added: 'Steps have been taken by the business to ensure this error is not repeated in future years.'
Indian Express
11-06-2025
- Climate
- Indian Express
Delhi among eight Indian cities facing double heatwave threat by 2030: Report
Delhi is one of eight Indian cities projected to experience a two-fold increase in the number of heatwave days by 2030, according to a latest research report. Mumbai, Chennai, Surat, Thane, Hyderabad, Patna, and Bhubaneswar are the seven other cities that are at a similar risk. Titled 'Weathering the Storm: Managing Monsoons in a Warming Climate', the report was released jointly by Esri India, a geographic information systems (GIS) solutions provider, and IPE Global, an international development consultancy group, on Monday. It is co-authored by climate experts Abinash Mohanty and Krishna Kumar Vsav. 'Extended heat wave conditions are likely to trigger more frequent, incessant, and erratic rainfall events. Eight out of ten districts in India are going to experience multiple instances of incessant and erratic rainfall by 2030,' the report stated. Delhi, which has already seen a heatwave this month, is projected to face heightened climate risks as summer conditions now increasingly spill over into the monsoon season. 'These extreme temperature events are not just limited to the peak summer months — they now increasingly overlap with the monsoon season, creating a dual threat of oppressive heat and extreme rainfall,' underlined a statement by Esri India. The report highlights a disturbing trend of intensifying heatwaves and prolonged summer-like conditions that extend well into the monsoon. It has warned of a 2.5-fold increase in the number of heatwave days by 2030 and a 43% rise in the intensity of extreme rainfall events across India, both driven by accelerating climate change. According to the analysis, India has seen a 15-fold increase in extreme heatwave days from March to May and June to September over the past three decades (1993–2024). The last decade alone recorded a 19-fold increase in such events, underscoring the growing urgency for climate adaptation, as per the findings. In the context of Delhi, this means that extreme heat will no longer be confined to the peak summer months but may coincide with heavy monsoon rains, posing a compound risk to the city's residents. In the report, it was further highlighted that about 72% of Tier-I and Tier-II cities are likely to face increased occurrences of both heat stress and extreme rainfall, often accompanied by storm surges, lightning, and hailstorms. Districts across diverse geographies — including Maharashtra, Tamil Nadu, Gujarat, Uttar Pradesh, Himachal Pradesh, and Odisha — have been flagged as vulnerable hotspots, indicating the pan-India nature of climate change risks. Among the states in the country, Gujarat, Rajasthan, Uttar Pradesh, Uttarakhand, and Himachal Pradesh are expected to face the greatest stress, with over 75% of their districts likely to endure this 'double whammy' of persistent heat and erratic rains by the end of the decade. In terms of the way forward, the note recommended the establishment of a Climate Risk Observatory (CRO) to provide real-time risk assessments at the national level. This system would facilitate hyper-granular risk mapping and enhance early warning systems. Another key recommendation is the development of risk financing instruments to offset the socio-economic impacts of extreme weather.
