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Interviews

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A selection of in-depth interviews and profiles of policymakers and industry executives.

US FDA Not Ready For Sponsors Citing Others’ Platforms Yet, Marks Says

Many platform designation requests have been from sponsors eager to cite other sponsors’ products, but CBER Director Peter Marks said in an interview with the Pink Sheet his office likely is years away from accepting those applications.

Platform Technologies Review Pathway

Parexel Execs On Regulatory Harmonization, AI Impact, RWE Challenges

From the US FDA’s ISTAND Program to EU’s Melloddy Initiative, and from the global challenges of real-world data to the opportunities in India, Parexel’s EVP for Clinical Data and Digital Services, chief strategy officer and India head speak on a range of topics in this interview with the Pink Sheet.

Research & Development Clinical Trials

Latest EU Pharma Reform Proposals Risk Stifling Innovation And Competitiveness

EU policymakers have the chance to adopt legislation that establishes a strong and predictable framework of incentives for R&D into new medicines, particularly those that require riskier investments, says CSL Behring’s Lutz Bonacker.

Europe EU Legislative Reform

PALADIN Consortium Aims To Speed Drugs To Market

Pink Sheet spoke with leaders of a new consortium that hopes to make drug company-patient advocacy group partnerships more efficient and effective.

Clinical Trials Research & Development

AI Assurance Lab Concept Leaves Potential Regulatory Gap

In an interview with the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.

Artificial Intelligence Research & Development

BIO Elevates State Policy, Patient Advocacy In Reorganization

BIO CEO John Crowley sat down with Pink Sheet at the industry’s annual convention to discuss his vision for a newly restructured BIO, his thoughts on the upcoming US elections and whether he’d ever lead another biotech. 

BIO Lobbying

How Accumulus’s ‘Dossier In The Cloud’ Platform Is Modernizing ‘Inefficient’ Drug Regulation

Global non-profit Accumulus Synergy wants to remove “unnecessary complexities and inefficiencies” in the regulatory process with its cloud-based communication platform, the corporation’s CEO and chief regulatory innovation officer tell the Pink Sheet.

BioPharmaceutical Europe

C3TI's Mission: Leverage FDA Trial Innovation Expertise, Educate Inspectors

The Center for Clinical Trial Innovation was created to be CDER’s hub for expertise and information on innovative clinical trial approaches. C3TI lead Kevin Bugin talks to the Pink Sheet about the program's genesis and what it hopes to accomplish.

Clinical Trials Real-World Evidence

NGGT Progresses First US Gene Therapy Trials For Rare Conditions

Next Generation Gene Therapeutics is fast-tracking clinical trials in the US for its gene therapy candidates for Bietti's crystalline dystrophy and classic phenylketonuria, supported by China data, the Chinese venture's CEO says in an interview.

China Clinical Trials

‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches

The current regulations were written when clinical trials involved far fewer entities, and a certain amount of ‘contortion’ is necessary when sponsors are trying to introduce decentralized, community-based and other modern elements, the FDA’s Kevin Bugin says in an interview with the Pink Sheet.

Clinical Trials Diversity & Inclusion

Relyvrio’s Failure Sparks NeuroSense ALS Development Changes

NeuroSense plans to adjust its upcoming clinical trial to avoid the fate of Amylyx’s ALS candidate, which was recently withdrawn from the market due to a lack of efficacy.

Neurology Clinical Trials

‘Do It Or We’re Not Going To Approve Your Drug:’ Industry Reps Ask FDA For Trial Diversity Sticks

FDA leadership has generally seemed apprehensive of going too hard on companies that don’t meet clinical trial diversity goals, but some industry insiders say a stronger FDA is needed to spark real change. Delayed guidance could indicate if the agency will change course.

Clinical Trials Diversity & Inclusion

BIO Seeks ‘Substantial Runway’ To Shift Away From China As Momentum For Manfacturing Bill Grows

Association CEO John Crowley tells the Pink Sheet that a survey which found decoupling from China could be disruptive underscores the need to do so because having the supply chain ‘tied up with a global adversary is profoundly worrying to all of us.’

Manufacturing Lobbying

What’s The Key To Successful R&D With Artificial Intelligence? ‘Bilingual’ Scientists

Before J&J’s former chief data scientist Najat Khan moved to Recursion, she talked to the Pink Sheet about how AI is transforming trials and driving collaboration between industry and regulators.

Artificial Intelligence Clinical Trials

ICER Debuts Clinical Trial Diversity Assessment Framework

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

Diversity & Inclusion Clinical Trials

EMA Pilots Partnering With Companies To Gain Efficiencies In Preparing Drug Assessment Reports

The European Medicines Agency is looking to increase the review efficiency and consistency of its assessors by experimenting with a US FDA-style approach in which companies can voluntarily submit certain information in advance to facilitate the product’s review.

Europe Regulation
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