MedTech

BIOTECHNOLOGY INNOVATION ORGANIZATION

January 4, 2022

BIOTECHNOLOGY INNOVATION
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in
the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of
1974: Request for Public Comment and Announcement of Public Hearing.

Spotlight

Argos Therapeutics, Inc. (NASDAQ: ARGS)

Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos'​ most advanced product candidate, rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, rocapuldencel-T is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for renal cell carcinoma (RCC) and for the treatment of non-small cell lung cancer (NSCLC).

OTHER WHITEPAPERS
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Synthetic Biology Biotechnology & AgTech

whitePaper | June 8, 2022

For nearly two decades, the Future Today Institute has meticulously researched macro forces of change and the emerging trends that result. Our focus: understanding how these forces and trends will shape our futures.

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The biopharmaceutical industry is leading the way in developing vaccines and treatments for COVID-19

whitePaper | April 8, 2020

The rapid spread of the novel coronavirus across the globe is a major public health threat for all, with profound health, social and economic impacts around the world. As a science-driven industry that aims to address some of the world’s biggest healthcare challenges, the research-based biopharmaceutical industry is uniquely positioned to respond rapidly to COVID-19. It has deep scientific knowledge gained from decades of experience working on developing solutions for combatting a range of infectious diseases such as MERS, SARS, Ebola and influenza.

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Gene, Cell, & RNA Therapy Landscape

whitePaper | January 24, 2022

The American Society of Gene & Cell Therapy (ASGCT) is the primary professional membership organization.

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The EU Clinical Trials Regulation − What You Need to Know

whitePaper | March 22, 2022

The Clinical Trials Regulation has retained some definitions and refined others. For example the definition of “clinical study”: “Any investigation in relation to humans intended: (a) to discover or verify the clinical, pharmacological or other pharmacodynamic.

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Early engagement and regulatory considerations for biotech

whitePaper | March 24, 2023

Biotechnology companies are at the epicenter of innovative drug development, with discoveries spanning from small molecules, large molecules, and biologics to genomic medicines and first-inclass immunotherapies.

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Leveraging innovations in plasmid manufacturing to bring advanced therapies to market

whitePaper | December 13, 2022

The global demand for plasmid DNA has increased dramatically in recent years, fueled by a surge in the clinical development of next-generation cell and gene therapy products and more recently by the success of COVID-19 vaccines.

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Spotlight

Argos Therapeutics, Inc. (NASDAQ: ARGS)

Argos Therapeutics is an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis® technology platform. Argos'​ most advanced product candidate, rocapuldencel-T, is being evaluated in the pivotal ADAPT Phase 3 clinical trial for the treatment of metastatic renal cell carcinoma (mRCC). In addition, rocapuldencel-T is being studied in Phase 2 investigator-initiated clinical trials as neoadjuvant therapy for renal cell carcinoma (RCC) and for the treatment of non-small cell lung cancer (NSCLC).

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