No Password Required: From Heavy Metal to the Front Lines of Cyber Innovation
AI Agents in Action: How Digital Colleagues Are Changing the Way We Work - On Record PR
Innovation in Compliance: Mastering Communication: Insights from Dr. Dennis Cummins on Speaking and Selling without Selling
Fox on Podcasting: PodPage and Beyond: Elevating Listener Experience with Dave Jackson
Innovation in Compliance: The Future of Compliance Training: AI, Adaptive, Learning, and Cultural
Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
The Rise of OTAs in Defense Contracting: Opportunities, Risks, and What Contractors Need to Know
Future-Ready – Equipping MBD Teams to Navigate and Leverage Emerging Technologies
AI in eDiscovery Today: An Open Conversation
Innovation in Compliance: Allison Lagosh on Proactive Compliance Planning for Regulatory Changes
Innovation in Compliance: Maximizing LinkedIn for Personal and Professional Branding with Carol Kaemmerer
Innovation in Compliance: The Critical Importance of Mobile Application Security: Insights from Subho Halder
Meet Phil Leslie, Cornerstone Research's New Chief Technology and Innovation Officer
Innovation in Compliance: Integrating AI in Compliance and Risk Management with Jana Brost
The Future of Supply Chains: Chris Andrassy on Using AI to Predict & Prevent Disruptions
Innovation in Compliance: Break the Five Lies - A Conversation with John Kormanik
Compliance Tip of the Day: Using Supply Chain to Innovate in Compliance
Innovation in Compliance: Innovative Approaches to Compliance and Training with Catherine Choe
Innovation in Compliance: Exploring the Fractional COO Model with La Tonya Roberts
Innovation in Compliance: Design-Centric Compliance Training with Karen Oddo
The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
Following consultation starting in 2022, on November 29, 2024, Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) were registered. These Regulations amend the Food and Drug...more
Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Matthew welcome Ed Hernandez, who oversees drug product manufacturing at Eli Lilly, an international pharmaceutical company. Ed discusses how Eli Lilly...more
This episode, Matthew and Heather chat with Paul Testa, an Executive Vice President of Kyowa Kirin, a pharma group that develops innovative specialty drugs to raise the health and well being of people across the globe. Paul...more
On February 6, 2024, the Federal Trade Commission (“FTC”) commented in support of what would be a historic expansion of government march-in rights under the Bayh-Dole Act in response to the release of the National Institute...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more
This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....more
Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more
On April 23, 2021, President Biden signed into law two bipartisan bills aimed at reducing prescription drug prices by supporting generic and biosimilar alternatives to branded drugs. The Ensuring Innovation Act supports...more
2020 Filings While there was a more than 20 percent decline in the number of securities class actions filed in 2020 (approximately 330 cases) as compared to 2019 (approximately 430 cases), the percentage of cases filed...more
Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more
Cancer is a horribly painful and debilitating illness, but would you ever call it “diabolical”? What about “conniving”? You might after you hear about the latest research out of Vanderbilt University showing that cancer cells...more
On October 17, the National People’s Congress (NPC) formally adopted a revised patent law, which will take effect on June 1, 2021. The new law includes significant changes in the intellectual property legal framework with...more
Innovative technologies are being deployed to address the Western world’s major killer: cancer. Traditionally, cancer treatment has included surgery, chemotherapy, and radiation, but recently, the development of targeted...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
For anyone concerned with the quality and safety of prescription medications, this may be an especially displeasing commentary from a pharmaceutical expert about drugs raced to approval now: “Some of them are really great,”...more
The Big Cost; Cancer is the Answer; and SDOH Evolves - The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a...more
The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For...more
For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more
In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research...more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more
A confluence of factors is increasing and accelerating the digitization of large amounts of real world data (RWD) generated on individuals and patients. Originally published in Update magazine - August/September 2018....more