Cell and Gene Commercialization
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On The Exosome/Extracellular Vesicle Frontier, Choose Your Own Adventure
9/29/2023
Gain insight into the importance of scalability for future clinical products made from extracellular vesicles, the quality of peer-reviewed extracellular vesicle/exosome science, and more.
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Cell & Gene Therapy Solutions
9/29/2023
Your therapy can make all the difference. Together, we’ll unlock its potential.
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The Evolution Of The Cell And Gene Therapy Field
9/29/2023
Lung-I Cheng, Vice President, Cell and Gene Therapy, AmerisourceBergen, discusses emerging trends in the CGT market and details the value of leveraging the expertise of knowledgeable partners and stakeholders.
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Commercial Readiness With Orca Bio's Dan Kirby
9/17/2023
Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing.
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Commercial Readiness with Orca Bio's Dan Kirby
9/14/2023
Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing.
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Operationalize Cell & Gene Therapies
9/1/2023
As you aim to bring your advanced therapies to patients in need, partnering to overcome the associated regulatory, manufacturing, and logistical complexities is essential to avoid unnecessary costs and delays.
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How To Navigate The EU’s New Interim PSA Program
9/1/2023
In the EU, national health technology assessment bodies generally aren't so well equipped to address novel and complex medicinal products. That makes the EMA's interim parallel scientific advice program especially useful for biologic drug developers completing market authorization activities in EU member states.
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4 Ways Academic Medical Centers Can Capture Greater Value In The Cell & Gene Therapy Industry
8/22/2023
Academic medical centers (AMCs) are unique in the way academic functions and healthcare delivery services are co-located. With strong research capabilities, access to leading scientists, access to patients, and more, AMCs are uniquely positioned to conduct research and clinical trials, enable process development and manufacturing, and more.
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FDA To Sarepta’s Gene Therapy: “Express Yourself…Maybe?”
8/21/2023
Though we cling to — and simultaneously despair over — the fact that regulatory experiences are product-specific, the hurdles/debates Sarepta faced remind us of the scientific and clinical complexities our future CGT products will no doubt be faced with during their own BLA reviews.
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Essential Steps For Successful Commercialization Of CGTs
8/21/2023
Review the CGT commercialization checklist to ensure that your therapy can advance to market with both a reduced risk of delays and additional costs as well as broad patient access.