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05.20.21 -- Making Sense Of Antibody Epitope Claims


05.20.21 Making Sense Of Antibody Epitope Claims
 
 
A novel drug path to market is complex. Drug developers must navigate the journey, under growing pressure of regulation and competition while managing technical and financial risks. Challenges of gaining regulatory approval and transitioning production add to this complexity. Attend this webinar to understand the challenges when moving a bioconjugate candidate from clinic to market. Click here to learn more.
Featured Editorial
By Benjamin Pelletier, Haynes and Boone
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.  ....

United States , Scott Patterson , Sheri Gimigliano , Graham Clark , Nicolas Girard , Megan Kuikstra , Adam Christensen , Lee Stevens , Charles Ross , Christine Banaszek , Shaonly Saha , Debra Barnes , Adrian Mazzone , Steve Halpin , Jim Springer , Clean Technology Inc , Ropack Pharma Solutions , Nuaire Inc , Son Company , Application Note Silverson Machines Inc , Thermo Fisher , Robert Chew , Thermo Fisher Scientific , Silverson Machines , Anton Paar United , Mettler Toledo Product ,

Understanding Multinational Regulatory Filings New Chemical Entity


Understanding Multinational Regulatory Filings: New Chemical Entity
By Jim Springer, Steve Halpin, and Megan Kuikstra, Albemarle FCS
Finding the right long-term CDMO partner for development and commercial launch of a new chemical entity (NCE) presents sponsors with a uniquely challenging scenario. First, “right” must be defined in quantifiable metrics, then the search begins for a CDMO exhibiting those qualities. The challenge is magnified when a multinational launch is planned.
For many sponsors, the search for a CDMO partner begins in earnest during phase two of clinical trials:  the new chemical compound, chemical structure, or mechanism of action (MOA) is producing positive results, and the sponsor is actively evaluating the patient population and dose. They are trying to estimate volumes for launch and predict where growth might take the product in five or ten years. ....

Megan Kuikstra , Jim Springer , Steve Halpin , ஜிம் ஸ்பிரிங்கர் , ஸ்டீவ் ஹால்பின் ,

04.08.21 -- Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021


04.08.21 Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
 
On this episode of the
Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company s approach to process development and manufacturing. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Philip Chen, Kayleigh McGlynn, and Jenny Shmuel, Fish & Richardson P.C.
This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020, transition date, as well as the FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. ....

Niklas Sandler , Samsung Biologics , Satu Lakio , Oliver Stauffer , Josh Russell , Lee Allen , Fred Hines , Patrick Guertin , Megan Mason , Abdelaziz Toumi , Megan Kuikstra , Brad Larson , Lonza Biologics , Samuel Chia , Jim Springer , Steve Halpin , Jones Healthcare Group Packaging Services , Article Ajinomoto Bio Pharma Services , Automated Systems Of Tacoma Inc , Health Canada , Pharmaceutics International , Automated Systems , Professor Niklas Sandler , Richard Tree , Vlad Spehar , Jones Healthcare Group Packaging ,

Hall of Famers Coached by a Hall of Famer; 1950s Golden Era of Gustie Men's Hoops - Posted on January 11th, 2021 by CJ Siewert


Hall of Famers Coached by a Hall of Famer; 1950s Golden Era of Gustie Men’s Hoops
Posted on January 11th, 2021 by CJ Siewert
The 1950s truly was the golden era of Gustavus men’s basketball. Head Coach
Gus Young guided the Gusties to three consecutive runner-up finishes in the MIAC before dethroning Jon Hutton’s Hamline Pipers for conference championships in 1954, 1955, and 1956.
The makeup of those championship teams was extraordinary. The lineup for the 1956 squad that won a third-straight MIAC title and advanced to the quarterfinals of the NAIA tournament included four future Gustavus Athletics Hall of Famers under the direction of a Hall of Fame coach. 1956 graduates ....

United States , San Diego , North Dakota , Cliff Straka , John Patzwald , Jon Hutton Hamline , Jack Colvard , Angus Young , Shorty Patterson , Jim Springer , Bob Erdman , Dayton University , University Of Minnesota , Coach Gus Young , Jon Hutton , Hamline Pipers , Gustavus Athletics Hall , Western Kentucky , Jim Paxson , Minneapolis Lakers , Cincinnati Royals , North Dakota State , Myrum Memorial Fieldhouse , Eastern Tennessee State , Black Cloud , San Diego State ,