Spotlight Q&A: A Deep Dive Into Generics and ANDA Filings With Cardinal Health Regulatory Sciences

OVERVIEW: Yin Lai, PhD, MSc, RAC is Director of Chemistry, Manufacturing and Controls at Cardinal Health Regulatory Sciences. Andy Trammel, PhD is Principal Scientist, Chemistry, Manufacturing and Controls at Cardinal Health Regulatory Sciences. These two experts will discuss generics, how they differ from innovator drugs, and the requirements necessary for regulatory approval in the United States. […]

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Driving Drug Discovery: The Innovation Podcasts

A recent survey revealed that over 99% of therapeutic development professionals believe innovation is critical to drug discovery. In these Charles River podcasts, produced in collaboration with Big4Bio and hosted by Daniel Levine, we talk to experts about how innovation is driving drug discovery, novel technologies, and the impact of advancing in vitro research techniques on […]

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Spotlight Q&A: A Deep Dive Into BLAs With Cardinal Health Regulatory Sciences

OVERVIEW: Mamadou Diallo, PharmD, MS is a Director of Chemistry, Manufacturing and Controls at Cardinal Health Regulatory Sciences, and Ana Barata is a Supervisor of Submissions Operations – Publishing at Cardinal Health Regulatory Sciences. These two experts will discuss the Biologics License Applications (BLA) – a necessary regulatory license request for biologic products in the […]

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Spotlight: Leveraging Technology to Avoid Costly Clinical Trial Delays

Drug developers face great pressures to complete clinical trials on time and on budget, but challenges like patient recruitment, patient retention, and site selection can cause unexpected delays with significant economic consequences. This is particularly true in the area of rare disease drug development where patient populations are small and geographically dispersed. Arthur D. Little […]

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Spotlight: Navigating JPM Week 2024 Webinar

We’ve heard your concerns loud and clear, and our pre-JPM Week/BioWeekSF online webinar, sponsored by BIO (Biotechnology Innovation Organization), is here to provide solutions and insights that will transform your JPM2024 experience. Our panelists are industry experts who understand your pain points and provided actionable solutions: – Dawn Bell, PharmD, Founder/Director, Myracle Therapeutics – Kimberly […]

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Podcast: Finding Investors and Partners at Life Science Events

Life Science Nation, which has created a global partnering platform that includes an investor and licensing partner database as well as an entrepreneurial education curriculum, helps startups prepare for their global roadshows. Each year, it holds five Redefining Early Stage Investments or RESI conferences to connect start-ups with early-stage investors and strategic channel partners. RESI […]

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Podcast: Envisioning the Future of Healthcare

The emergence of genetic medicines, the convergence of information technology and biotechnology, and the growing ubiquity of artificial intelligence represents some of the transformative forces reshaping healthcare in the years ahead. The BioFuture conference, which will be held in New York City October 4 through 6, brings together innovators and investors to exchange ideas, discuss […]

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Event Recap: The 2023 @Philly Cell and Gene Therapy Annual Conference Shines a Bright Light on the Vibrant Biotech Ecosystem in Greater Philadelphia

Anchored with a major ivy league University that literally gave birth to the Cell, Gene, and RNA therapies, Greater Philadelphia has been for decades not only a world leader in research and education of life science and medicine, but also a place with an abundance of available high quality biotech infrastructure, ample service providers, and […]

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Big4Bio Expansion Podcasts

BigBio Communications is proud to announce the upcoming expansion and brand repositioning of Big4Bio, the life science industry’s leading daily aggregator of news and developments of the top bioscience clusters in the world. The “Big 4” of Big4Bio has been rebranded to represent the company’s focus areas: drugs, devices, diagnostics, and digital (also known as […]

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Spotlight: RESI Boston Ends on High Note

by Marie Daghlian RESI (Redefining Early Stage Investments) capped a busy first week of June in Boston with more than 800 attendees who participated in more than 1500 meetings. “RESI June Boston showcased an amazing array of international technology assets and startup entrepreneurs,” noted Dennis Ford, CEO of Life Science Nation (LSN), the creator of […]

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Spotlight: Silicon Valley Bank Failure Rocks the Life Sciences

What it means to Big4Bio companies as well as ongoing media coverage On Wednesday, March 8, SVB Financial announced plans to raise $1.75 billion through the sale of shares to cover $1.8 billion in losses from securities sold by Silicon Valley Bank (SVB), located in Santa Clara, CA. Shares plummeted 60 percent the next day, […]

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Perfect Combination: The Sikich Life Sciences Practice Partners With Coupa to Help Clients Streamline and Control Business Spend

Sikich LLP is a business and technology consultancy who’s close to 1,500 team members provide advisory, consulting, and technology services to clients in life sciences, manufacturing, professional services, and other industries. The company’s life sciences practice spans the industry and supports more than 200 life sciences clients, including biotechnology and biopharmaceutical companies, CROs, and lab […]

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Event Recap: The Inaugural @Philly Cell and Gene Therapy Annual Conference Sparks Excitement Among Greater Philadelphia’s Biotech Innovators

The Greater Philadelphia area has long been a vibrant hub of biotech and pharmaceutical industry. Over the last three decades, scientists and entrepreneurs in the Greater Philadelphia region have held the global leadership in the discovery and development of Cell and Gene therapies. Four FDA-approved therapies have originated here, including the first cell therapy (Kymriah®) […]

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Spotlight: Start-up Stadium Coverage at BIO 2022

by Cassie Arnold Forty-four early and seed stage companies are presenting at this year’s Start-up Stadium held during the BIO 2022 Conference in San Diego. These companies were selected to present live during the conference from among the more than 150 companies that submitted applications including their pitch decks in April. The applications were reviewed […]

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