ARTICLES BY LOUIS

• Pharma's Lack Of Leadership On Coronavirus Origins

  6/2/2021

  Pharma has a China problem. In at least one regard, it uncomfortably mirrors that of the media. But the media has (tentatively) begun a mea culpa of sorts. Should Pharma? An editorial on how Pharma has handled the (lack of a) Wuhan Coronavirus Lab investigation.

• What Orphan Drug Developers And CDMOs Expect From Each Other

  6/1/2021

  Although broad in target and modality – FDA lists ~6,000 designations – the orphan drug “industry” presents specific challenges for outsourcing development and manufacturing. CDMOs must respond to both the common and unique needs of these specialized drug developers.

• What Happens When IP is Redistributed? CDMOs Without Borders

  5/24/2021

  Would any respectable contract development or manufacturing organization agree to utilize intellectual property “waived” by the WTO or other body from a reputable innovator? We say no, and for valid reasons.

• The Best Consultants Burst Biopharma Bubbles

  5/24/2021

  "The sooner we instill commercial thinking into a clinical-stage company, the better,” says Evelyn Kelly, founder of Orphan Drug Consultants, Ltd. “I have to get the virtual biotech to always think thoughts such as: ‘How will we get this drug to the populations most in need of it?’

• Did You Vote To Give Your IP Away?

  5/19/2021

  Unfortunately, the turmoil of the China-borne coronavirus, and the U.S. presidential election of 2020, continue to find new ways to impact us. A biopharma-industry patent lawyer walks us through some implications.

• Ensysce Biosciences CEO Talks SPAC

  5/18/2021

  Ensysce Biosciences CEO Lynn Kirkpatrick knows every organization is different, but believes any CEO of a biotech today might consider going the special purpose acquisition company (SPAC) route to financially fuel the organization. Here’s how and why she and Ensysce decided to move forward.

• The Right Words For Optimal Outsourcing

  5/13/2021

  We can tend to get "sloppy" with how we use acronyms such as ATMP or CGT. This is important for all emerging biotech: You’ll need to talk to groups from different backgrounds, perspectives, and countries. Particularly, correct language use with CDMOs can save you time and money.

• SPACs, Opioids, and COVID: Ensysce Biosciences Making “Virtual” History

  5/10/2021

  If Ensysce Biosciences were a ball of yarn, we’d be unwinding it for hundreds of miles from its location in La Jolla, California. We’d unravel solid oral dose programs – new opioids and a COVID treatment, an all-outsourced model, and now one of the first biotechs to go public via a SPAC (special purpose acquisition company).

• Do You Speak ATMP-CGT-RMAT? Better Watch Your Language

  5/6/2021

  Editors and scientists should care about the words they use. That’s why it’s curious to hear U.S. biopharma pitching the European acronym "ATMP." Is this simply an acrimonious acronym argument between regulatory regions? Turns out there’s real danger lurking in our usage of these terms. 

• Standards For New Technologies: Easy Listening For Outsourcing

  4/29/2021

  We’re comforted by our music standards, those go-to playlists we can always rely on. In drug development and manufacturing, standards are also music to our ears. Now, says Ronald Piervincenzi, USP’s CEO, advanced technology needs new standards to guide the next generation of U.S.-based production of medicines.