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On this episode of the Business of Biotech, Leonard Mazur, co-founder, CEO, and chairman of Citius Pharmaceuticals, shares his rollercoaster ride to success in biotech, the founding story of Citius Pharmaceuticals, his engagement with the Department of Defense, and the effort to revive an antibiotic used on the frontlines.

Leonard takes us into the complexity of investor relationships, and his personal investment that influences his leadership style. He reveals his strategies for constructing a successful biotech pipeline, underscoring the importance of a unique mechanism of action and the hurdles of resurrecting a retired product. Get ready for an intimate look at Leonard's decision-making process, and his insights into managing the financial aspects of a bio-pharma company. 

As we wrap up, Leonard offers an honest look at the evolution of the biotech industry, the financial challenges faced, and his advice on navigating these turbulent waters. He brings his experience with auction processes and drug hunting to light, preparing us for unexpected hiccups in the biotech world. Leonard also credits mentorship in shaping his approach to constructing a clinical pipeline. Join us for this inspiring exploration of resilience, determination, and success in the biotech industry.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

In this weekend health news update, Fred Bodimer talks several significant developments. British scientists have successfully created a liver dialysis treatment that mimics the functions of the liver, offering hope for millions suffering from liver disease. Initial trials have shown promising results, with the device being able to reverse acute liver failure more effectively than existing treatments. If further clinical trials confirm its effectiveness, the treatment could become widely available within three years.

See omnystudio.com/listener for privacy information.

See omnystudio.com/listener for privacy information.

Serial inventor and entrepreneur Alex Blyth had long held interests in health and science, but losing his mom to pancreatic cancer was the inflection point that launched LIfT Biosciences in 2016. Now, the preclinical company is on a mission to develop the world's first 'off-the-shelf' cell therapy to destroy all solid tumors, irrespective of strain or mutation, beginning with pancreatic cancer. On this episode of the Business of Biotech, Blyth shares the company's scientific approach and progress, and we explore the shortcomings of legacy clinical protocols including the inherent problems and limitations of mouse models.  

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Immunome CEO Purnanand Sarma, Ph.D. joins the Business of Biotech for a discussion on precision antibodies and his company's discovery platform, which  identifies novel therapeutic antibodies and their antigen targets by leveraging highly educated memory B cells from patients who have learned to fight off their disease. It’s kind of like picking an all-star team of players who have been in the game, and who are well-trained to win. On today's episode we'll learn how they’re discovered, how they’re developed, and how they’re applied in cancer and coronavirus.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Ampio Pharmaceuticals is currently weaving the gauntlet of a clinical hold triggered by COVID's disruption to clinical studies of its lead candidate Ampion, and recently launched an independent investigation  into that trial and others. On this episode, Ampio Pharmaceuticals chairman and CEO Mike Martino joins the Business of Biotech for a candid discussion on the company, the candidate, the disruption, and the go-forward plan. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Join your host Matt Pillar and guest Allan Shaw for a no-hold-barred retrospective on the year's top stories and trends. From the frontlines of the COVID-19 pandemic to the questionable approval of Aduhelm to leadership instability at the FDA and more, Shaw dissects the year past and predicts how those stories will influence the biotech industry in 2022 and beyond.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Rik Mehta & Ed discuss the onslaught of vaccine mandates, and the sort of consequences it could have towards impacting essential personnel.

More about Rik:

Rik Mehta is running for Congress in New Jersey's competitive 7th Congressional District, and was previously the Republican nominee for US Senate in 2020. He is a biotech entrepreneur, innovator, healthcare policy expert, as well as a licensed attorney and pharmacist. Mehta owns and runs a consulting firm, R&R Strategies, and works as a partner at Licentiam, a healthcare licensing technology firm.

Visit Rik’s Campaign website at rikfornj.com on Facebook at @RikMehtaForNewJersey

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The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. On this episode of the Business of Biotech, friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Cartesian President & CEO Murat Kalayoglu, M.D., Ph.D.  has led three of his company's six autoimmune, oncology, and respiratory candidates through Phase I/II clinical trials and two more of them are on the cusp of entering Phase I this year.  With so many programs in and entering the clinic, he's a great choice for a conversation on GMP expectations for phase I first-in-human trials. Glean insight from Cartesian's experiences and learn about the company's novel approach to RNA-engineered cell therapies for oncology and beyond on this episode of The Business of Biotech. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Are you healthy and well? The focus of our show Saturday, May 1st is wellness with essential oils and health insurance. We are featuring Tracy Callow and Anita Carreno. Contact Anita Carreno at ANITA.CARRENO@USHAdvisors.com and Tracy Callow at essentialtracy@gmail.com. Talking about health insurance should include talking about the Patient Protection and Affordable Care Act also known as the Affordable Care Act, ACA or Obama Care. The ACA was passed March 23, 2010. The National Federation of Independent Business challenged the ACA in a 2012 lawsuit. In 2017, Congress amended the ACA to remove the tax penalty imposed for individuals who did not purchase health insurance. Most recently, attorney generals in Texas and other states filed suit. The lawsuit now known as California versus Texas was argued before the Supreme Court of the United States on November 10, 2020, but it has not yet been decided. The question is whether the ACA is constitutional without the tax penalty. A related legal topic that some attorneys overlook is the Health Insurance Portability and Accountability Act, which is known as HIPAA. Attorneys can prepare an authorization for physicians and healthcare providers to release protected medical information to designated individuals you choose. The benefit is that your family and friends won't be left in the dark if you suffer an unforeseen illness or injury. Contact an attorney to advise you about comprehensive and professional estate planning with last wills, living trusts, and taxes. Marquardt Law Firm, P.C. sponsors our show, and attorneys at Marquardt Law Firm, P.C. empower clients to tax efficiently protect and preserve assets, reduce family conflict, and maximize government benefits. www.MarquardtLawFirm.com

See omnystudio.com/listener for privacy information.

Scott Cleve brings an entire career dedicated to the mastery of global biopharma regulatory standards to his role as Vice President of Regulatory Operations and Compliance at bluebird bio. Join Cleve, host Matt Pillar, and Erin Harris, chief editor at Cell & Gene, for a candid discussion on the regulatory trends shaping the advance of bluebird's pipeline of gene therapies for the treatment of serious, life-altering diseases including Cerebral Adrenoleukodystrophy, Multiple Myeloma, Transfusion-Dependent β-Thalassemia, and Sickle Cell Disease.

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

Allan Shaw rejoins the Business of Biotech with candid and deep commentary on the unprecedented pace of biopharma innovation, and how the FDA is doing in its equally unprecedented effort to keep pace. In particular, Shaw shares his take on the advance of cell and gene therapies, his observation on the outsized approval rate for orphan disease and oncology therapies, and much, much more. *Editor's note: the review of Biogen's Aducanumab, referenced here as taking place in the March timeframe, was extended shortly after this episode was recorded. 

Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!

My American Friend Akshay, lives in Ohio. He is a Scientist, Engineer and BBQ aficionado.

We talk about Covid-19, the Vaccine race, Ice-cream and growing up in India. He generously gives me an insight into his work with Astrazeneca and what his life is like, during these most challenging of times.

Recorded September 29 2020 with supplemental content recorded December 11 2020.

Acknowledgements; Australian and American flag artwork designed by www.slon.pics

"American" font 'Marcelle' designed by Clement Nicolle. Donate here clementnicolle@gmail.com

Music by Lost Horizons. Purchase here www.premiumbeat.com/royalty-free-tracks/great-feelings

Co-Creator Vanessa Hart Miller