<a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new">We love to hear from our listeners. Send us a message. </a>On this week&apos;s episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes. Dr. Niazi offers a behind the scene look at the way FDA policy gets made, and unmade, and his own role in key regulatory changes, and legislation such as the Biologics Price Competition and Innovations Act (BPCIA), and the Inflation Reduction Act (IRA). We also discuss Dr. Niazi&apos;s current company, RNA Therapeutics, and his quest to make new drug modalities accessible to patients around the world.     This episode of the Business of Biotech is brought to you by Cytiva. Access this and hundreds of episodes of the Business of Biotech videocast under the <a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'>Business of Biotech</a> tab at lifescienceleader.com.  Subscribe to our monthly <a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'>Business of Biotech newsletter</a>. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com Find Ben Comer on LinkedIn: <a href='https://www.linkedin.com/in/bencomer/'>https://www.linkedin.com/in/bencomer/</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new"&gt;We love to hear from our listeners. Send us a message. &lt;/a&gt;&lt;/p&gt;&lt;p&gt;On this week&amp;apos;s episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes. Dr. Niazi offers a behind the scene look at the way FDA policy gets made, and unmade, and his own role in key regulatory changes, and legislation such as the Biologics Price Competition and Innovations Act (BPCIA), and the Inflation Reduction Act (IRA). We also discuss Dr. Niazi&amp;apos;s current company, RNA Therapeutics, and his quest to make new drug modalities accessible to patients around the world.     &lt;/p&gt;&lt;p&gt;This episode of the Business of Biotech is brought to you by Cytiva. &lt;/p&gt;&lt;p&gt;Access this and hundreds of episodes of the &lt;b&gt;Business of Biotech videocast&lt;/b&gt; under the &lt;a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'&gt;&lt;b&gt;Business of Biotech&lt;/b&gt;&lt;/a&gt; tab at lifescienceleader.com.  &lt;/p&gt;&lt;p&gt;Subscribe to our monthly &lt;a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'&gt;&lt;b&gt;Business of Biotech newsletter&lt;/b&gt;&lt;/a&gt;.&lt;br/&gt; &lt;br/&gt;Get in touch with &lt;b&gt;guest and topic suggestions&lt;/b&gt;: ben.comer@lifescienceleader.com&lt;br/&gt;&lt;br/&gt;Find &lt;b&gt;Ben Comer&lt;/b&gt; &lt;b&gt;on LinkedIn&lt;/b&gt;: &lt;a href='https://www.linkedin.com/in/bencomer/'&gt;https://www.linkedin.com/in/bencomer/&lt;/a&gt;&lt;br/&gt;&lt;br/&gt;&lt;br/&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message.  On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes. Dr. Niazi offers a behind the scene look at the way FDA policy gets made, and unmade, and his own role in key regulatory changes, and legislation such as the Biologics Price Competition and Innovations Act (BPCIA), a...

Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D.

<a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new">We love to hear from our listeners. Send us a message. </a>On this week&apos;s episode of the Business of Biotech, Thijs Spoor, CEO at Perspective Therapeutics,  a company developing Pb 212 (lead)-based therapeutics, talks about why radiopharmaceuticals are surging again and why biodistribution is the make-or-break variable when your payload is a radioactive isotope. Thijs discusses the reasons behind Perspective&apos;s investment in a proprietary generator for therapeutic production, manufacturing and delivery strategy, workforce constraints, and building a clinical strategy around receptor positivity across tumor types. Access this and hundreds of episodes of the Business of Biotech videocast under the <a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'>Business of Biotech</a> tab at lifescienceleader.com.  Subscribe to our monthly <a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'>Business of Biotech newsletter</a>. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com Find Ben Comer on LinkedIn: <a href='https://www.linkedin.com/in/bencomer/'>https://www.linkedin.com/in/bencomer/</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new"&gt;We love to hear from our listeners. Send us a message. &lt;/a&gt;&lt;/p&gt;&lt;p&gt;On this week&amp;apos;s episode of the Business of Biotech, Thijs Spoor, CEO at Perspective Therapeutics,  a company developing Pb 212 (lead)-based therapeutics, talks about why radiopharmaceuticals are surging again and why biodistribution is the make-or-break variable when your payload is a radioactive isotope. Thijs discusses the reasons behind Perspective&amp;apos;s investment in a proprietary generator for therapeutic production, manufacturing and delivery strategy, workforce constraints, and building a clinical strategy around receptor positivity across tumor types. &lt;/p&gt;&lt;p&gt;Access this and hundreds of episodes of the &lt;b&gt;Business of Biotech videocast&lt;/b&gt; under the &lt;a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'&gt;&lt;b&gt;Business of Biotech&lt;/b&gt;&lt;/a&gt; tab at lifescienceleader.com.  &lt;/p&gt;&lt;p&gt;Subscribe to our monthly &lt;a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'&gt;&lt;b&gt;Business of Biotech newsletter&lt;/b&gt;&lt;/a&gt;.&lt;br/&gt; &lt;br/&gt;Get in touch with &lt;b&gt;guest and topic suggestions&lt;/b&gt;: ben.comer@lifescienceleader.com&lt;br/&gt;&lt;br/&gt;Find &lt;b&gt;Ben Comer&lt;/b&gt; &lt;b&gt;on LinkedIn&lt;/b&gt;: &lt;a href='https://www.linkedin.com/in/bencomer/'&gt;https://www.linkedin.com/in/bencomer/&lt;/a&gt;&lt;br/&gt;&lt;br/&gt;&lt;br/&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message.  On this week's episode of the Business of Biotech, Thijs Spoor, CEO at Perspective Therapeutics,  a company developing Pb 212 (lead)-based therapeutics, talks about why radiopharmaceuticals are surging again and why biodistribution is the make-or-break variable when your payload is a radioactive isotope. Thijs discusses the reasons behind Perspective's investment in a proprietary generator for therapeutic production, manufacturing a...

Radiotherapeutics For Neuroendocrine Tumors With Perspective Therapeutics' Thijs Spoor

<a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new">We love to hear from our listeners. Send us a message. </a>On this week&apos;s episode of the Business of Biotech, Dan McHugh, head of the investment team at Yosemite, explains the San Francisco VC group&apos;s approach to investing in early-stage cancer therapeutics and funding academic research through unrestricted grants. Founded by Reed Jobs, son of Steve Jobs and Laurene Powell Jobs, Yosemite invests across drug modalities and supporting technologies in the oncology space. Dan talks about his path from bioengineering to biotech venture capital, meeting Reed Jobs on Stanford&apos;s fencing team, his CEO turn at Tune Therapeutics, and the current fundraising environment for innovative science.   Access this and hundreds of episodes of the Business of Biotech videocast under the <a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'>Business of Biotech</a> tab at lifescienceleader.com.  Subscribe to our monthly <a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'>Business of Biotech newsletter</a>. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com Find Ben Comer on LinkedIn: <a href='https://www.linkedin.com/in/bencomer/'>https://www.linkedin.com/in/bencomer/</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new"&gt;We love to hear from our listeners. Send us a message. &lt;/a&gt;&lt;/p&gt;&lt;p&gt;On this week&amp;apos;s episode of the Business of Biotech, Dan McHugh, head of the investment team at Yosemite, explains the San Francisco VC group&amp;apos;s approach to investing in early-stage cancer therapeutics and funding academic research through unrestricted grants. Founded by Reed Jobs, son of Steve Jobs and Laurene Powell Jobs, Yosemite invests across drug modalities and supporting technologies in the oncology space. Dan talks about his path from bioengineering to biotech venture capital, meeting Reed Jobs on Stanford&amp;apos;s fencing team, his CEO turn at Tune Therapeutics, and the current fundraising environment for innovative science.   &lt;/p&gt;&lt;p&gt;Access this and hundreds of episodes of the &lt;b&gt;Business of Biotech videocast&lt;/b&gt; under the &lt;a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'&gt;&lt;b&gt;Business of Biotech&lt;/b&gt;&lt;/a&gt; tab at lifescienceleader.com.  &lt;/p&gt;&lt;p&gt;Subscribe to our monthly &lt;a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'&gt;&lt;b&gt;Business of Biotech newsletter&lt;/b&gt;&lt;/a&gt;.&lt;br/&gt; &lt;br/&gt;Get in touch with &lt;b&gt;guest and topic suggestions&lt;/b&gt;: ben.comer@lifescienceleader.com&lt;br/&gt;&lt;br/&gt;Find &lt;b&gt;Ben Comer&lt;/b&gt; &lt;b&gt;on LinkedIn&lt;/b&gt;: &lt;a href='https://www.linkedin.com/in/bencomer/'&gt;https://www.linkedin.com/in/bencomer/&lt;/a&gt;&lt;br/&gt;&lt;br/&gt;&lt;br/&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message.  On this week's episode of the Business of Biotech, Dan McHugh, head of the investment team at Yosemite, explains the San Francisco VC group's approach to investing in early-stage cancer therapeutics and funding academic research through unrestricted grants. Founded by Reed Jobs, son of Steve Jobs and Laurene Powell Jobs, Yosemite invests across drug modalities and supporting technologies in the oncology space. Dan talks about his path fr...

Investing In Early-Stage Oncology With Yosemite's Dan McHugh

<a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new">We love to hear from our listeners. Send us a message. </a>On this week&apos;s episode of the Business of Biotech we&apos;re speaking with Alan Bash, President, Carvykti, at Legend Biotech, about how Carvykti became a blockbuster, category-leading CAR T therapy for multiple myeloma. Alan talks about manufacturing and delivering an autologous cell therapy at commercial scale, Legend Biotech&apos;s partnership with Johnson &amp; Johnson, lessons he learned at Bristol Myers Squibb, Checkmate Pharmaceuticals, and ZielBio, and his strategy for growing Carvykti&apos;s patient footprint and facing new competitors in the market.  Access this and hundreds of episodes of the Business of Biotech videocast under the <a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'>Business of Biotech</a> tab at lifescienceleader.com.  Subscribe to our monthly <a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'>Business of Biotech newsletter</a>. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com Find Ben Comer on LinkedIn: <a href='https://www.linkedin.com/in/bencomer/'>https://www.linkedin.com/in/bencomer/</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new"&gt;We love to hear from our listeners. Send us a message. &lt;/a&gt;&lt;/p&gt;&lt;p&gt;On this week&amp;apos;s episode of the Business of Biotech we&amp;apos;re speaking with Alan Bash, President, Carvykti, at Legend Biotech, about how Carvykti became a blockbuster, category-leading CAR T therapy for multiple myeloma. Alan talks about manufacturing and delivering an autologous cell therapy at commercial scale, Legend Biotech&amp;apos;s partnership with Johnson &amp;amp; Johnson, lessons he learned at Bristol Myers Squibb, Checkmate Pharmaceuticals, and ZielBio, and his strategy for growing Carvykti&amp;apos;s patient footprint and facing new competitors in the market.  &lt;/p&gt;&lt;p&gt;Access this and hundreds of episodes of the &lt;b&gt;Business of Biotech videocast&lt;/b&gt; under the &lt;a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'&gt;&lt;b&gt;Business of Biotech&lt;/b&gt;&lt;/a&gt; tab at lifescienceleader.com.  &lt;/p&gt;&lt;p&gt;Subscribe to our monthly &lt;a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'&gt;&lt;b&gt;Business of Biotech newsletter&lt;/b&gt;&lt;/a&gt;.&lt;br/&gt; &lt;br/&gt;Get in touch with &lt;b&gt;guest and topic suggestions&lt;/b&gt;: ben.comer@lifescienceleader.com&lt;br/&gt;&lt;br/&gt;Find &lt;b&gt;Ben Comer&lt;/b&gt; &lt;b&gt;on LinkedIn&lt;/b&gt;: &lt;a href='https://www.linkedin.com/in/bencomer/'&gt;https://www.linkedin.com/in/bencomer/&lt;/a&gt;&lt;br/&gt;&lt;br/&gt;&lt;br/&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message.  On this week's episode of the Business of Biotech we're speaking with Alan Bash, President, Carvykti, at Legend Biotech, about how Carvykti became a blockbuster, category-leading CAR T therapy for multiple myeloma. Alan talks about manufacturing and delivering an autologous cell therapy at commercial scale, Legend Biotech's partnership with Johnson &amp; Johnson, lessons he learned at Bristol Myers Squibb, Checkmate Pharmaceuticals, and ...

Commercializing CAR T Cell Therapy With Legend Biotech's Alan Bash

<a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new">We love to hear from our listeners. Send us a message. </a>On this week&apos;s episode of the Business of Biotech we speak with Dr. Marc Hedrick, M.D., President and CEO at Plus Therapeutics, about the company&apos;s pivot from cell therapy to radiotherapeutics for brain cancers, and what&apos;s behind the choice of Rhenium-186 as the radioisotope for its lead development candidate, Reyobiq. We&apos;ll talk about Plus Therapeutics&apos; diagnostic subsidiary, CNSide, and hear from Marc about recent FDA meetings and the agency&apos;s attitude toward novel radiotherapeutics.      Access this and hundreds of episodes of the Business of Biotech videocast under the <a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'>Business of Biotech</a> tab at lifescienceleader.com.  Subscribe to our monthly <a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'>Business of Biotech newsletter</a>. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.com Find Ben Comer on LinkedIn: <a href='https://www.linkedin.com/in/bencomer/'>https://www.linkedin.com/in/bencomer/</a>

<description>&lt;p&gt;&lt;a target="_blank" href="https://www.buzzsprout.com/1011661/fan_mail/new"&gt;We love to hear from our listeners. Send us a message. &lt;/a&gt;&lt;/p&gt;&lt;p&gt;On this week&amp;apos;s episode of the Business of Biotech we speak with Dr. Marc Hedrick, M.D., President and CEO at Plus Therapeutics, about the company&amp;apos;s pivot from cell therapy to radiotherapeutics for brain cancers, and what&amp;apos;s behind the choice of Rhenium-186 as the radioisotope for its lead development candidate, Reyobiq. We&amp;apos;ll talk about Plus Therapeutics&amp;apos; diagnostic subsidiary, CNSide, and hear from Marc about recent FDA meetings and the agency&amp;apos;s attitude toward novel radiotherapeutics.      &lt;/p&gt;&lt;p&gt;Access this and hundreds of episodes of the &lt;b&gt;Business of Biotech videocast&lt;/b&gt; under the &lt;a href='https://www.lifescienceleader.com/solution/the-business-of-biotech-podcast-lsl'&gt;&lt;b&gt;Business of Biotech&lt;/b&gt;&lt;/a&gt; tab at lifescienceleader.com.  &lt;/p&gt;&lt;p&gt;Subscribe to our monthly &lt;a href='https://www9.lifescienceleader.com/business-of-biotech-nl-sign-up/'&gt;&lt;b&gt;Business of Biotech newsletter&lt;/b&gt;&lt;/a&gt;.&lt;br/&gt; &lt;br/&gt;Get in touch with &lt;b&gt;guest and topic suggestions&lt;/b&gt;: ben.comer@lifescienceleader.com&lt;br/&gt;&lt;br/&gt;Find &lt;b&gt;Ben Comer&lt;/b&gt; &lt;b&gt;on LinkedIn&lt;/b&gt;: &lt;a href='https://www.linkedin.com/in/bencomer/'&gt;https://www.linkedin.com/in/bencomer/&lt;/a&gt;&lt;br/&gt;&lt;br/&gt;&lt;br/&gt;&lt;/p&gt;</description>

We love to hear from our listeners. Send us a message.  On this week's episode of the Business of Biotech we speak with Dr. Marc Hedrick, M.D., President and CEO at Plus Therapeutics, about the company's pivot from cell therapy to radiotherapeutics for brain cancers, and what's behind the choice of Rhenium-186 as the radioisotope for its lead development candidate, Reyobiq. We'll talk about Plus Therapeutics' diagnostic subsidiary, CNSide, and hear from Marc about recent FDA meetings and the ...

Radiotherapeutics For CNS Cancers With Plus Therapeutics' Marc Hedrick, M.D.

The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. SUBSCRIBE to our new newsletter at www.bioprocessonline.com/bob. We bring you insight into organizational, finance and funding, HR, clinical, manufacturing, regulatory, and commercial challenges you’ll face as you navigate your company from an idea to success in the clinic and beyond. Each episode features guest commentary and best practices from accomplished founders and biopharma industry luminaries. The Business of Biotech is produced by Life Science Connect.

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