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Viewpoints_Dr. Todd D. Cohen
VIEWPOINTS

PharmaShots Interview: Myriad Genetics’ Dr. Todd D. Cohen Shares Insight on Prolaris Test’s Ability to Guide Prostate Cancer Treatment

In an interview with PharmaShots, Dr. Todd D. Cohen, M.D., VP Medical Affairs and Medical Director of Urology at Myriad Genetics shared his views on the ability of a biomarker test to predict which men with aggressive prostate cancer will benefit from advanced hormonal therapy and which men with lower-risk prostate cancer can safely avoid such treatments.…
March 25, 2021

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Viewpoints_John Valliant
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PharmaShots Interview: Fusion Pharma’s John Valliant Shares Insight on its Collaboration with AstraZeneca

In an interview with PharmaShots, John Valliant, CEO at Fusion Pharma shared his views on the company's agreement with AstraZeneca, signed in Nov 2020. He also shared in-depth information about the company's TATs platform & Fast-Clear linker technology and provide a glance at Fusion's portfolio. Shots:  Fusion to receive $5M up front and $40M as milestones & other payments. The…
March 24, 2021

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In an interview with PharmaShots, Lawrence Ganti, President & Chief Business Officer at SiO2 Materials Science shared his views on the efforts to scale up the manufacturing of vials to combat COVID-19. Additionally, he also shared the benefits of using SiO2's smart vials and shed light on barrier technology. Shots: SiO2 received a $143M investment from the US government to scale the domestic manufacturing of their vaccine vials which are made from a new material that they spent the past 10+ years and $500M developing SiO2 have delivered the government enough vials to support 100M COVID-19 vaccine doses SiO2's Alabama facility went from manufacturing 10M vials per year to over 10M vials per month and their local workforce grew from 100 employees to over 500. Each vial manufactured by SiO2 is multi-dose and can hold anywhere from 8-10 doses of vaccine Tuba: Shed some light on SiO2 efforts in scaling up the manufacturing of vials to combat COVID-19. How do you feel being a part of Operation Warp Speed? Lawrence: It's been an honor to be part of this concept. The idea to help rebuild the critical medical infrastructure in the united states is great. The company is excited to help lead these efforts. We have added more than 500 new jobs, build new sophisticated manufacturing plants, and invented new technology. All of this is homegrown in the United States. Tuba: Discuss the funding received by the company from the US Government? How did this funding help in scaling up the manufacturing of their vaccine vials? Lawrence: We have received an investment from the US Government for $143 million. This is to help scale-out technology and manufacturing in support of the current and future pandemics. We have used this to build capacity to support more than 1 billion doses of vaccine. Tuba: How are SiO2's smart vials different from the traditional vials? Can we have a glance on the material used in the vials? Lawrence: https://www.youtube.com/watch?v=B_zBSS_XVCE Source: SiO2 Tuba: Can we have a glance on SiO2's patented barrier technology? Lawrence: The interior of the vial is covered with the barrier system coating, using plasma-enhanced chemical vapor deposition. A partially ionized gas mixture deposits a crystal-clear and ultra-thin barrier system that is covalently bonded to the polymer. The bond is so strong that the barrier system is rendered unremovable irrespective of chemical, thermal, or mechanical stress. The most interior protective layer is in direct contact with the vial's contents and is made of an organosilica material that is a mixture of silicon, oxygen, carbon, and hydrogen atoms. This patented composition was designed to resist dissolving in extremely high pH formulations, unlike ordinary glass. It also eliminates metal ions leaching into the drug formulation at extremely low pH formulations. The glass-like barrier layer is composed of pure silicon dioxide. This layer is extremely dense, which is an important characteristic of a barrier to oxygen, moisture, and other chemical compounds. And the final layer is composed of organosilica that creates a strong chemical bond to the plastic exterior and to the adjacent barrier layer. Tuba: What are the benefits of using SiO2's smart vials? Lawrence: SiO2 Materials Science's ready-to-use vial is the first of its kind, utilizing advanced materials optimized for biological drugs. Using our patented process, engineering, and materials science technologies, we've created a hybrid material that fuses all the benefits of glass with all the benefits of plastic, while eliminating the drawbacks of both. The material is a medical-grade polymer fused with a three-layer barrier system that protects contents from oxygen, moisture, leachables, and any compounds that can originate from the environment, the polymer, and label adhesives. Metal ions, leachables, and particles are seen commonly in conventional glass vials are virtually eliminated. The unique, patented vial provides an inert container for drugs and eliminates important problems facing biologic drug development. It eliminates contaminants associated with an immunogenic response such as subvisible particles and metal ions Ensures an oxygen and moisture barrier of glass with thermal stability down to -196 degrees centigrade Exhibits no leachable or extractable Exhibits no glass delamination .And is unbreakable even at cryogenic temperatures. All of these attributes make the SiO2 vials ideal for bioengineered vaccines, cell & gene therapies, and antibody-drug conjugates. Tuba: Apart from Moderna, who else are you working with that you can publicly mention? Lawrence: We can publicly only mention Moderna for Covid. We are working with a number of other covid vaccine and therapeutic manufacturers. They are testing our vials in their clinical trials. Beyond Covid, we have been working with Novartis and many other leading pharma companies. Tuba: Can you share other insights with our readers about the SiO2's growth? Lawrence: We have grown from 100 employees to over 500 employees. We have grown from 1 factory to 4 factories. All this was done in the last 6 months of 2020. Our growth continues as we support not only Covid but many other companies developing advanced biological drugs and therapies. Main Image Source: The Conversation About Author: Mr. Ganti looks after the day-to-day operations of SiO2 Materials Science. He brings more than 25 years of building commercial organizations, leading billion-dollar P&Ls, creating award-winning marketing campaigns, and driving growth initiatives in the Pharmaceutical, Consumer Products, and Data Analytics space. Related Post: ViewPoints Interview: Biogen's Wildon R. Farwell Shares Insight on Phase 4 RESPOND Study of Spinraza
VIEWPOINTS

PharmaShots Interview: SiO2’s Lawrence Ganti Shares Insight on the Efforts to Scale Up the Manufacturing of Vials for COVID-19 Vaccines

In an interview with PharmaShots, Lawrence Ganti, President & Chief Business Officer at SiO2 Materials Science shared his views on the efforts to scale up the manufacturing of vials to combat COVID-19. Additionally, he also shared the benefits of using SiO2's smart vials and shed light on barrier technology. Shots: SiO2 received a $143M investment from the US government to scale the domestic…
March 22, 2021

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Viewpoints_Wildon R. Farwell
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PharmaShots Interview: Biogen’s Wildon R. Farwell Shares Insight on Phase 4 RESPOND Study of Spinraza

In an interview with PharmaShots, Wildon R. Farwell, M.D., MPH, Global Medical Head of Neuromuscular Diseases at Biogen shared his views on the P-IV RESPOND study that assesses the benefits of Spinraza in patients treated with Zolgensma. Shots: RESPOND is a two-year, open-label study to evaluate the efficacy and safety of Spinraza (nusinersen) in infants and children with spinal muscular…
March 19, 2021

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Viewpoints_Allen Burton
VIEWPOINTS

PharmaShots Interview: Abbott’s Allen Burton Shares Insight on NeuroSphere myPath App

In an interview with PharmaShots, Allen Burton, M.D., Medical Director at Abbott Neuromodulation shared his views on the NeuroSphere myPath App which is designed to track and report pain relief in chronic pain patients. Shot: The app will record pain relief during the device trial period with SCS or DRG therapy, simplifying reporting outcomes & connect patients to…
March 15, 2021

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Viewpoints_Daniel A. de Boer
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PharmaShots Interview: ProQR’s Daniel A. de Boer Shares Insight on Sepofarsen, the First Treatment for Leber Congenital Amaurosis 10 (LCA10)

In an interview with PharmaShots, Daniel A. de Boer of ProQR shared his views on P-II/III pivotal trial of Sepofarsen to treat the root cause of a rare eye disease, Leber congenital amaurosis 10 (LCA10) Shots: The Illuminate P-II/III trial of sepofarsen is a double-masked, randomized, controlled, multiple-dose study to evaluate if sepofarsen is effective at improving vision and is…
March 8, 2021

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Viewpoints_Mark Gurney
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PharmaShots Interview: Tetra Therapeutics’ Mark Gurney Shares Insight on Topline Results of BPN14770 for Fragile X Syndrome

In an interview with PharmaShots, Mark Gurney, CEO at Tetra Therapeutics shared his views on the results of the P-II exploratory study of BPN14770 in adult patients with Fragile X Syndrome. Shots: The P-II study is a two-way crossover study assessing BPN14770 (25mg, bid) vs PBO in 30 adult male patients aged 18-45yrs. with FXS due to >200 CGG…
March 1, 2021

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Viewpoints_Ying Huang
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PharmaShots Interview: Legend’s Ying Huang Shares Insight on ASH 2020 Data and Initiation of BLA Rolling Submission for Cilta-cel

In an interview with PharmaShots, Ying Huang, Ph.D., CEO and CFO of Legend Biotech shed light on the clinical data following the rolling submission of BLA for Cilta-cel. He also shared insight on Legends' collaboration with Janssen. Shots: The submission of BLA was based on results from the P-Ib/II CARTITUDE-1 study of cilta-cel, which were recently presented at the 62nd ASH Meeting The…
February 25, 2021

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Viewpoints_Dr. Sophia Randolph
VIEWPOINTS

PharmaShots Interview: ALX Oncology’s Dr. Sophia Randolph Shares Insight on the Clinical Collaboration with Zymework

In an interview with PharmaShot, Dr. Sophia Randolph, Chief Medical Officer of ALX Oncology shared her views on the ALX Oncology's collaboration with Zymework for evaluating the combination with ALX148 and zanidatamab for patients with advanced HER2-expressing breast cancer and other HER2-expressing solid tumors. Shots: Zymeworks will conduct a P-Ib study to assess the safety and efficacy of the combination…
February 22, 2021

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