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| May 13, 2026 | Modicus Prime Secures $8 Million to Revolutionize Pharma AI Compliance | Modicus Prime secured $8 million total funding, with a fresh $4.5 million infusion. This investment fuels its mission to provide robust AI compliance infrastructure for the pharmaceutical industry. The company's Trustworthy AI Compliance So... |
| May 8, 2026 | Modicus Prime: $8 Million Raised To Expand AI Compliance Infrastructure For Pharma | Modicus Prime announced it raised a total of $8 million in funding following an additional $4.5 million investment led by Frist Cressey Ventures, with participation from Silverton Partners and Oncology Ventures.
The company said the financi... |
| Sep 4, 2025 | AI Governance as Competitive Capability: The Pioneering Work of Sumesh Nair in Biopharma | Created by Carl Williams
Published: Sep 04 2025, 00:41 AM EDT
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| Aug 6, 2025 | Quantifying the ROI of Compliance: Sumesh Nair on Architecting Risk-Based AI Validation for Modern Clinical Trials | Share
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For any new therapy to reach the patients who need it, it must first navigate a formidable and complex global regulatory landscape. In the life sciences industry, this landscape is built upon a foundational set... |
| Apr 3, 2025 | 23andMe's Rocky Road: A Genetic Gamble in Bankruptcy | The story of 23andMe is a tale of ambition, innovation, and now, a desperate scramble for survival. Once a beacon of hope in the consumer genetics landscape, the company has hit a wall. It filed for Chapter 11 bankruptcy protection, a move ... |
| Apr 2, 2025 | 2025 ISPE Europe Annual Conference Debuts New Workshops and Announces Keynote Speakers | The 2025 ISPE Europe Annual Conference plans to have strong regulatory participation from European health authorities.
The 2025 ISPE Europe Annual Conference will take place 12 – 14 May in London, United Kingdom (UK), and virtually.
NORTH B... |
| Mar 26, 2025 | 2025 ISPE Biotechnology Conference Announces Keynote Speakers | The 2025 ISPE Biotechnology Conference will feature speakers from throughout the biotech ecosystem.
The 2025 ISPE Biotechnology Conference will take place 2 – 3 June in Boston, Massachusetts, USA, and virtually.
NORTH BETHESDA, Md., March 2... |
| Sep 19, 2024 | 2024 ISPE Pharma 4.0™ and Annex 1 Conference Featured Speakers Are Announced | The 2024 ISPE Pharma 4.0™ and Annex 1 Conference will take place on 10-11 December in Rome, Italy, and virtually.
The 2024 ISPE Pharma 4.0™ and Annex 1 Conference will take place on 10-11 December in Rome, Italy, and virtually.
NORTH BETHES... |
| Aug 27, 2024 | Currax Pharmaceuticals: CONTRAVE®/MYSIMBA® Demonstrates Positive Cardiovascular Safety in a Large, Real-World Evidence Study | BRENTWOOD, Tenn., Aug. 27, 2024 /PRNewswire/ -- Currax Pharmaceuticals LLC ("Currax") today announced the results of a Cardiovascular Health Outcomes Analysis (HOA). The results showed there is no evidence of excess cardiovascular... |
| Jul 9, 2024 | 2024 ISPE Annual Meeting & Expo Focuses on the Workforce of the Future, with AstraZeneca's David Churchward as Executive Chair | The 2024 ISPE Annual Meeting and Expo, which will take place from 13 to 16 October in Orlando, Florida, USA, will bring together thousands to foster innovation and collaboration between regulators, pharmaceutical industry professionals, rec... |
| Apr 30, 2024 | INCOG BioPharma Services Continues Positive Momentum | Achieves FDA Approval for Sterile Injectable Drug Product Manufacturing
FISHERS, Ind, April 30, 2024 /PRNewswire/ -- INCOG BioPharma Services proudly announces that its sterile injectable manufacturing facility has received approval from th... |
| Aug 11, 2023 | ISPE Announces Leaders from Health Canada, AltruBio, AstraZeneca, Gilead, Lonza, Lyndra, and More to Speak at the 2023 ISPE Annual Meeting & Expo | Pam Cheng
NORTH BETHESDA, Md. (PRWEB) August 11, 2023
The International Society for Pharmaceutical Engineering (ISPE) announced eight keynote speakers for the 2023 ISPE Annual Meeting & Expo, occurring 15-18 October in Las Vegas, NV, an... |
| Jul 12, 2023 | Gilead Sciences to Support ISPE Foundation’s Student Grant Program to Further Promote Diversity, Equity, and Inclusion in Pharmaceutical Engineering | Antonio Moreira, PhD, Chair of the ISPE Foundation Board Through this program, we are not only investing in the future of the students but also cultivating a more vibrant and diverse community of pharmaceutical industry professionals.
NORTH... |
| Jun 22, 2023 | ISPE Names Gilead Sciences' Joydeep Ganguly Executive Chair of the 2023 ISPE Annual Meeting & Expo | The conference agenda has been curated to provide exclusive insights on emerging trends to position yourself at the forefront of the pharmaceutical landscape, while creating the space to forge invaluable partnerships.
NORTH BETHESDA, Md. (P... |
| Jun 6, 2023 | ISPE Releases Report on its Work Supporting the Establishment of the European Health Emergency Preparedness and Response Authority (HERA) | “ISPE put together a multidisciplinary team that included experts from Roche, Novartis, Merck, Merck Darmstadt, Gilead, and others, to take on the project,” said Tom Hartman, ISPE President and CEO.
NORTH BETHESDA, Md. (PRWEB) June 06, 2023... |
| May 23, 2023 | ISPE Just Released Its New Drug Shortages Prevention Model | ISPE Drug Shortages Prevention Model The ISPE Drug Shortages Prevention Model serves as a guide to help prevent drug shortages by providing quality, regulatory, and technical recommendations for the pharmaceutical manufacturing industry.
NO... |
| May 9, 2023 | 2023 ISPE Facility of the Year Awards (FOYA) Category Winners Announced | "We are thrilled to be recognizing this year’s FOYA category winners for their outstanding work in the pharmaceutical industry,” said Tom Hartman, ISPE’s President and CEO, “These exceptional facilities demonstrate a strong commitment ... |
| Mar 14, 2023 | Strongest ever glass-fiber Nylon and PK 3D printing filaments launched by Fortis3D | Canadian start-up Fortis3D is launching two new 3D printing materials for a range of industrial applications. Accompanying the launch of PA-GF20, and PK-GF20, Fortis3D has provided a detailed analysis of each filament’s material characteris... |
| Mar 6, 2023 | 2023 ISPE Facility of the Year Awards Finalists Announced | For the first time in the history of the ISPE Facility of the Year Awards (FOYA) program, the International Society for Pharmaceutical Engineering today announced the twelve 2023 FOYA Submission Finalists.
NORTH BETHESDA, Md. (PRWEB) March ... |
| Mar 6, 2023 | 2023 ISPE Facility of the Year Awards Finalists Announced | NORTH BETHESDA, Md. (PRWEB) March 06, 2023
For the first time in the history of the ISPE Facility of the Year Awards (FOYA) program, the International Society for Pharmaceutical Engineering today announced the 2023 FOYA Submission Finalists... |
| Jan 19, 2023 | ISPE Announces Leaders from the White House, FDA, Merck, Catalent, & More at Facilities of the Future Conference | NORTH BETHESDA, Md. (PRWEB) January 19, 2023
The International Society for Pharmaceutical Engineering (ISPE) announced keynote speakers for the 2023 ISPE Facilities of the Future Conference, taking place 31 January–1 February 2023 in North ... |
| Nov 1, 2022 | ISPE Names Takeda the 2022 Facility of the Year Awards Overall Winner | NORTH BETHESDA, Md. (PRWEB) November 01, 2022
The International Society for Pharmaceutical Engineering (ISPE) has announced Takeda Pharmaceuticals International AG as the 2022 Facility of the Year Awards (FOYA) Overall Winner for their proj... |
| Oct 19, 2022 | Pharmaceutical Engineering® Announces 2021 Article of the Year | Roger F. Sherwood Article of the Year “The article contributes a lot to clarify the complexity of medical devices in combination products use,” said Ferdinando Aspesi, Senior Partner, Bridge Associates International, and Chair of the Pharma... |
| Oct 17, 2022 | ISPE Provides Guidance on Improving and Advancing Process Performance and Product Quality Monitoring Systems | ISPE APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS)
NORTH BETHESDA, Md. (PRWEB) October 17, 2022
The International Society for Pharmaceutical Engineering (ISPE) announced the release of the ISPE APQ Guide: P... |
| Oct 10, 2022 | ISPE Announces Leaders from FDA, Pfizer, Takeda, Cognizant, and Gilead to Speak at Annual Meeting & Expo | NORTH BETHESDA, Md. (PRWEB) October 10, 2022
The International Society for Pharmaceutical Engineering (ISPE) announced seven keynote speakers for the 2022 ISPE Annual Meeting & Expo, taking place 30 October–2 November 2022 in Orlando, F... |
| Aug 31, 2022 | ISPE Announces 2022-2023 International Board of Directors Election Results | NORTH BETHESDA, Md. (PRWEB) August 31, 2022
The International Society of Pharmaceutical Engineering (ISPE) is pleased to announce the results of its 2022–2023 International Board of Directors election. The election was run by an independent... |
| Aug 18, 2022 | Global Pharma Experts to Spotlight Digital Transformation at the 2022 ISPE Annual Meeting & Expo | “Digital adoption plays a strategic role across companies at all levels to prevent repeated missteps, guiding product development and fast decision-making,” said Robert Perks, Regional Manager, Cognizant, and Chair of the 2022 ISPE Annual M... |
| Jul 28, 2022 | ISPE Pharmaceutical Engineering® Article “AI’s Promise for ATMPs” Honored with 2022 APEX Award | 2022 APEX Awards “We are delighted to see Pharmaceutical Engineering® content and authors recognized for this article, which addresses a major area of development and achievement for the pharmaceutical industry,” said Susan Sandler, Senior ... |
| Jun 10, 2022 | ISPE Provides New Guidance on Membrane-Based Water for Injection Systems | ISPE Good Practice Guide: Membrane-Based WFI Systems “Membrane-based WFI is a method that should be used whenever possible,” said Guide Co-lead Fritz Roeder, Senior QA Manager, Merck Healthcare KGaA. “This Guide will be useful to engineers,... |
| May 11, 2022 | Moderna Senior Executive to Speak at the 2022 ISPE Biotechnology Conference | Juan Andres
NORTH BETHESDA, Md. (PRWEB) May 11, 2022
The International Society for Pharmaceutical Engineering (ISPE) announced Juan Andres, Chief Technical Operations and Quality Officer of Moderna, Inc., as the confirmed closing keynote sp... |
| May 5, 2022 | Iovance Biotherapeutics Reports First Quarter 2022 Financial Results and Corporate Updates | SAN CARLOS, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor infiltrating lymphocyte, TIL, and peripheral-b... |
| May 3, 2022 | ISPE Provides New Guidance on Continuous Manufacturing of Oral Solid Dosage Forms | Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms “This Guide serves as a reference for continuous manufacturing of oral solid dosage forms, providing guidance for companies, regulators, engineering firms, and vendors... |
| Apr 26, 2022 | 2022 ISPE Facility of the Year Category Award Winners Announced | “The pharmaceutical industry is being shaped every day by innovative companies worldwide. The 2022 FOYA Category Winners have a commitment to excellence and set the bar for quality in the design and social impact consideration of their faci... |
| Mar 30, 2022 | ISPE Provides New Guidance on Change Management Systems | ISPE APQ Guide: Change Management (CM) System “This Guide explains how to optimize the system a company has, provides tools for improvement, and offers guidance on how to improve and develop a Change Management System that is appropriate to... |
| Mar 24, 2022 | ISPE Announces Leaders from FDA, EMA, WHO, and AEMPS at Annual European Conference | NORTH BETHESDA, Md. (PRWEB) March 24, 2022
The International Society for Pharmaceutical Engineering (ISPE) announced six regulatory speakers for the 2022 ISPE Europe Annual Conference, taking place 25–27 April 2022 in Madrid, Spain and virt... |
| Feb 23, 2022 | ISPE Announces Leaders from FDA, PIC/S, and Johnson & Johnson as Keynote Speakers for Global Aseptic Event | NORTH BETHESDA, Md. (PRWEB) February 23, 2022
The International Society for Pharmaceutical Engineering (ISPE) announced three keynote presenters for the 2022 ISPE Aseptic Conference, taking place 14–15 March 2022 in North Bethesda, Maryland... |
| Jan 27, 2022 | U.S. Office of Science and Technology Senior Advisor to Deliver Keynote Address at the 2022 ISPE Facilities of the Future Conference | Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy (OSTP), Executive Office of the President
NORTH BETHESDA, Md. (PRWEB) January 27, 2022
The International Society for Phar... |
| Jan 18, 2022 | New ISPE Guide Includes Updated Guidance for Controlled Temperature Chambers | Good Practice Guide: Controlled Temperature Chambers 2nd Edition "This Guide provides the information of how successful practices are being used today to safely store samples and to meet compliance objectives with regulatory agencies,”... |
| Jan 11, 2022 | ISPE Global Forum Explores What's Next for Pharmaceutical Manufacturing Facilities of the Future | “This global forum brings together industry leaders, experts, and peers to share how they collaborated during a global crisis—something uncommon prior to the COVID era,” said Jeffrey Biskup, PE, CEO and Chairman of the Board, CRB, and Chair... |
| Dec 9, 2021 | ISPE Publishes First-of-Its-Kind Guide for Advanced Therapy Medicinal Products (ATMPs) | ISPE Guide: ATMPs - Autologous Cell Therapy The growing number of autologous products that are entering the pipeline is evidence to the growth potential of this therapeutic approach. Science has promised this for years; it is now delivering... |
| Dec 7, 2021 | Aspen Technology : The FDA's Advanced Manufacturing Initiative Is What We Do | Have you ever been frustrated or had a sinking feeling when you need a product but can't find it in stock anywhere? The pharmaceutical industry is not immune from this challenge, especially given the disruptive impacts of the pandemic. One ... |
| Nov 22, 2021 | ISPE Publishes ISPE Good Practice Guide: Good Engineering Practice (Second Edition) | ISPE Good Practice Guide: Good Engineering Practice (Second Edition) “This Guide considers the entire range of pharmaceutical engineering activity and identifies key attributes of GEP within it, including how GEP relates to and interfaces w... |
| Nov 2, 2021 | ISPE Names Janssen Sciences Ireland the 2021 Facility of the Year Awards Overall Winner | NORTH BETHESDA, Md. (PRWEB) November 02, 2021
The International Society for Pharmaceutical Engineering (ISPE) has announced Janssen Sciences Ireland as the 2021 Facility of the Year Awards (FOYA) Overall Winner at the 2021 FOYA Banquet duri... |
| Nov 1, 2021 | AspenTech PAT Solution Recognized as a Pharma Manufacturing 2021 Innovation Award Winner | In recent years, the pharmaceutical industry has been grappling with the tension between the growing demand for increasingly diverse pharmaceutical products and the escalating challenges of ensuring supply. The weight of this challenge beco... |
| Oct 21, 2021 | AspenTech at ISPE 2021: Agility, Collaboration and Innovation | The International Society of Pharmaceutical Engineering (ISPE) is a revered, global organization focused on the advancement of scientific and technical best practices, as well as regulatory insights across the pharmaceutical lifecycle. Aspe... |
| Oct 6, 2021 | ISPE Publishes ISPE GAMP® Good Practice Guide: Enabling Innovation | “This Guide supports best practices in software engineering, data management, and ‘as a Service’ offerings, including supporting tools and automation, facilitating resources, and the application of up-to-date and proportionate approaches,” ... |
| Sep 29, 2021 | ThermoGenesis BioArchive System: The Best Smart Storage Solution for the Cell Therapy Manufacturing Process | A key element of all cell and gene therapies (CGTs) is cryopreservation, the controlled freezing of cell samples. In cell therapy manufacturing, cell samples are collected and stored for future use, often for decades, so the proper collecti... |
| Sep 9, 2021 | ISPE Publishes ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices | ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices “This Guide is the first collection of best practices in Reverse Logistics,” said Guide Team Member Cat Hall, Vice Pre... |
| Aug 25, 2021 | ISPE Announces 2021-2022 Board of Directors Election Results | NORTH BETHESDA, Md. (PRWEB) August 25, 2021
The International Society for Pharmaceutical Engineering (ISPE) announced the results of its 2021–2022 International Board of Directors election, revealing a slate of strategic leaders who represe... |
| Jul 29, 2021 | ISPE Publishes ISPE APQ Guide: Management Responsibilities and Management Review | ISPE publishes ISPE APQ Guide: Management Responsibilities and Management Review “This guide is a tool for organizations that want to strengthen their leadership systems to support their pursuit of cultural excellence and ultimately create ... |
| Jul 15, 2021 | Top Biotech Experts to Speak at the 2021 ISPE Biotechnology Virtual Conference & Workshops | The impact of the evolving regulatory environment and the need to ensure continued innovation and continuity in the supply chain in light of this crisis and assuring preparedness for future crises will be integrated throughout the conferenc... |
| Jul 8, 2021 | Moderna Vice President of US Manufacturing to Deliver Keynote Address at the 2021 ISPE Facilities of the Future Conference | NORTH BETHESDA, Md. (PRWEB) July 08, 2021
The International Society for Pharmaceutical Engineering (ISPE) announced Scott Nickerson, Senior Vice President, US Manufacturing, Moderna, Inc., as a newly confirmed keynote for the hybrid 2021 IS... |
| Jun 29, 2021 | ThermoGenesis : Cell Storage Solutions for Cellular Manufacturing of Clinical Products | Cell and gene therapies have become increasingly popular in the last few decades, especially with the recent FDA approval of CAR T-cell therapies such as Kymriah and Yescarta. These life-changing therapies are the latest in scientific and t... |
| Jun 7, 2021 | JACOBS ENGINEERING GROUP INC.
Sustainable, Safe and State-of-the-Art: Biocon Biologics' New Bangalore Facility Receives Recognition | The Biocon Biologics Manufacturing Plant (B3), the newest addition to the biopharmaceutical company's 100-acre Biocon Park in Bengaluru, India, is no small achievement.
Stretching 340,000 square feet and costing $120 million (USD), it is no... |
| May 20, 2021 | ISPE Publishes ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry | Employing Knowledge Management methods and tools enables organizations to better manage their knowledge as a key asset, in turn improving the effectiveness of the pharmaceutical quality system, providing operational benefits and more.
NORTH... |
| May 6, 2021 | ISPE Convenes Regulators and Industry to Discuss Challenges & Solutions for Quality Risk Management | These events require a visionary approach in assessing the challenges facing pharmaceutical operations on a global basis specifically for those that are critical to the supply of essential medicines such as in the Asia Pacific region, amid ... |
| Apr 27, 2021 | 2021 ISPE Facility of the Year Awards Winners Announced | COVID-19 has certainly presented significant challenges to the pharmaceutical industry, and the innovations of these dedicated companies has a direct impact in shaping global expectations for the manufacture of effective and safe medicines.... |
| Apr 13, 2021 | ISPE Gathers Global Health Authorities to Discuss Remote/Distant Assessments, Audits, and Regulatory Guidance | This event is another means for ISPE to provide a platform to enable these transparent conversations in the industry that includes representatives and perspectives from worldwide regulatory authorities.
NORTH BETHESDA, Md. (PRWEB) April 13,... |
| Feb 11, 2021 | ISPE Publishes ISPE Good Practice Guide: Maintenance, 2nd Edition | In the second edition, we seek to provide guidance on the latest trends in maintenance programs, recommend flexible, standard practices that can be applied globally, and offer suggestions to control the escalation of non-value generating re... |
| Jan 28, 2021 | ISPE Gathers Global Aseptic Leaders to Discuss Trends, Innovations, and COVID-19 Impact | Sterile dosage forms will overtake all other dosage forms in the next few years in terms of value, and the conversations that take place during the ISPE Aseptic Conference are really where the shape of the pharmaceutical industry forms.
BET... |
| Jan 21, 2021 | ISPE Publishes ISPE Good Practice Guide: Equipment Reliability | As innovation extends to and transforms the supply chain, equipment lifecycle costs and availability become ever more relevant to maintaining a competitive advantage.
NORTH BETHESDA, Md. (PRWEB) January 21, 2021
The International Society fo... |
| Jan 20, 2021 | Drug price hikes without new evidence upped spending by $1.2B, ICER says | “These are not cherry-picked niche drugs, or some sort of outlier situation,” ICER spokesman David Whitrap said in a phone interview. “These are the costliest price increases for our country and of those ten, seven of them have no evidence ... |
| Dec 17, 2020 | ISPE Invited to Participate in DAF ACT Initiative to Support Domestic Manufacturing of Active Pharmaceutical Ingredients | This partnership aligns with ISPE’s mission to support the international pharmaceutical industry and multiple programs we actively lead, including the Drug Shortages Initiative, Advancing Pharmaceutical Quality (APQ), Continuous Manufacturi... |
| Dec 15, 2020 | ISPE Publishes ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System | The APQ Program recognizes that the ability to advance the maturity of quality management lies within the industry itself, and a key driver for this program is to provide a range of sustainable and practical quality management improvement s... |
| Dec 8, 2020 | ISPE Foundation Partners with Gilead Sciences on Internship Program to Diversify the Pharma Industry’s Workforce | The ISPE Foundation Diversity Internship Program interns will be immersed in creative and innovative projects, they will be connected with role models and senior leaders at Gilead, and they will be encouraged to let their imagination go to ... |
| Mar 19, 2019 | Drug shortages jeopardize the lives of children with cancer | Alice, a preteen with newly diagnosed leukemia, and her parents were understandably distraught when she was diagnosed with cancer. As I sat down to discuss treatment options with Alice’s parents, I was glad I had something positive to share... |
| Jul 26, 2016 | Gates Foundation leads $14M funding round for Just Biotherapeutics to battle infectious diseases | Just Biotherapeutics CEO and Founding Partner Jim Thomas
Seattle-based Just Biotherapeutics said Monday it closed a $14 million funding round led by the Bill & Melinda Gates Foundation.
A group of former Amgen scientists founded Just in... |
| Drug price hikes without new evidence upped spending by $1.2B, ICER says | BMS
The Institute for Clinical and Economic Review (ICER) published its second-ever report on Unsupported Price Increases (UPI) last week, compiled from data supplied by SSR Health, which is part of the investment research firm SSR.
While t... |
