
Show Notes
This week Dr. Evan Loh, Paratek CEO, returns to Off the Shelf to share the latest in the biopharmaceutical company’s partnership with the Biomedical Advanced Research and Development Authority’s (BARDA’s) Project BioShield. Paratek’s antibiotic, NUZYRA (omadacycline) has been designated “an essential” medicine by the FDA, and Loh provides an update on the progress made in onshoring of manufacturing of NUZYRA, from the production of API through finished drug product for both IV and oral formulations. Loh shares the journey to domestic manufacturing, highlighting the critical role Paratek’s public-private partnership with BARDA played in developing manufacturing capability. Antimicrobial resistance (AMR) along with biological threat actors are continuing and growing threat and Loh discusses the current environment and the key policy considerations in combatting these and other healthcare threats. Finally, Loh talks about the potential that the results from the successful development of treatments through public-partnerships have the potential to be leveraged to support/protect the warfighter. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
More from Off the Shelf
Jason Workmaster, member at Miller & Chevalier, joins Off the Shelf for procurement potpourri, highlighting some of the current developments in federal procurement policy, law, and operations. Workmaster gives his assessment of the Revolutionary Federal Acquisition Regulation (FAR) Overhaul (the RFO), ad shares his thoughts on whether the RFO, specifically the FAR Part 15 rewrite, will reduce the risk of protest. He also provides his insights regarding a series of policy and contracting issues surrounding GSA’s Multiple Award Schedule (MAS) program, including the potential outcome surrounding GSA’s RFI targeting resellers. The discussion turns to the so-called “MAS Blogger’s” recent post regarding the use of e-Commerce platforms to fill MAS orders. Other topics include the role of bid protests involving Other Transactions Authority (OTAs) and Commercial Solutions Openings (CSOs). Finally, Workmaster covers a recent decision addressing the constitutionality of the role of relators under the Civil False Claims Act. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Ken Dodds, executive vice president and general counsel at The Coalition for Common Sense in Government Procurement, joins Off the Shelf for a timely and in-depth discussion of the Small Business Administration’s (SBA’s) proposed rule amending the size standards. The proposed rule makes significant changes to the size standards. For example, the size standard for IT services goes from $34 million to $531 million and the size standard for consulting services goes from $24.5 million to $295 million. Dodds discusses the implications of the proposed changes, including the impact on competition across the federal market as well as the potential impact on current small, medium, and large businesses. He also provides a tutorial on the basics of the non-manufacturer rule, including what happens when the rule is waived for a procurement. Finally, Dodds shares his thoughts on GSA’s proposed AI clause versus commercial practice. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
Michael Gruden, partner at Steptoe LLP, joins Off the Shelf for the latest on cybersecurity and government contracts compliance. The conversation focuses on “CMMC to Be or Not to Be” where Gruden provides his insights and assessment of the CMMC journey to date and in the future. He outlines the considerations playing into the CMMC pause and what he expects moving forward. Gruden also shares some best practices for cyber compliance across the federal contracting landscape, and he give his thoughts regarding the Revolutionary FAR Overhaul (RFO) and the new Controlled Unclassified Information (CUI) guidance in FAR Part 40. Finally, Michael talks about Cyber Incident Reporting for Critical Infrastructure Act (CIRCIA) rule making and what can be expected.
Brian Friel, owner of BD Squared, joins host Roger Waldron on this week's Off the Shelf for a wide-ranging and in-depth discussion of the current state of interagency contracting. The discussion kicks off with some historical context regarding interagency contracting, the creation of the IT GWACs, and the evolving role (mandatory versus non-mandatory) of the Multiple Award Schedules (MAS). Friel gives an update on POLARIS, Alliant 3, OASIS+, and shares his thoughts on the impact of the wind down of NIH’s interagency contracting vehicles and program. Turning to NASA SEWP VI, Friel provides his insights, analysis, and outlook for the recently awarded contract vehicle, and touches on interesting policy changes impacting multiple award IDIQs. Finally, Friel discusses the current status of the Army’s MAPS procurement. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
This week on Off the Shelf, Soraya Correa, president and chief executive officer of the National Industries for the Blind (NIB), shares the AbilityOne story, discussing its origin, history, and mission to the present day. Correa then turns to NIB, sharing its mission of providing opportunities for people who are blind or visually impaired. She outlines NIB’s organizational structure, employee profile and the products and services it provides to the government, and highlights the contributions NIB makes to local economies across America, including its focus on delivering domestic products. Finally, Correa gives her take on the Revolutionary FAR Overhaul (RFO) and the role of the acquisition workforce in leveraging the new, streamlined framework. See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.