• Pages
  • Editions
01 Cover
02 Welcome Letter / Sections
03 Section 1: Introduction
04 Introduction to USA Life Sciences Industry
05 Janssen Interview
06 Etihad Cargo Interview
07 UPS Healthcare Interview
08 The Investment Climate
09 MPM | BioImpact Capital Interview
10 Industry Insights: Promising Forecasts for Consolidation and M&As
11 The Regulatory Landscape
12 Porzio Life Sciences Interview
13 PBOA Interview
14 EY USA Interview
15 LaVoieHealthScience Interview
16 Section 2: Established and Emerging Hubs
17 Map of US-based life sciences companies interviewed
18 The East and the West
19 BioNJ Interview
20 MassBio Interview
21 Biocom California Interview
22 PABC Interview
23 Growing Life Sciences Hubs
24 JLL Interview
25 Industry Insights: From Ivory Towers to Incubators
26 Section 3: Drug Discovery and Development
27 Drug Discovery and Development
28 Sangamo Therapeutics Interview
29 PsychoGenics Interview
30 Aphios Corporation Interview
31 Industry Insights: Biotechs Fairing in 2023
32 Ymmunobio Interview
33 Section 4: Contract Manufacturing, Services and Chemicals
34 The Industry's Growing Reliance on CDMOs
35 Pfizer CentreOne Interview
36 CordenPharma International Interview
37 AMPAC Fine Chemicals Interview
38 Adare Pharma Solutions Interview
39 Aenova Group Interview
40 Dipharma Francis Interview
41 Kindeva Drug Delivery Interview
42 Prince Sterilization Services Interview
43 Interbiome Interview
44 Adopting a Proactive Stance
45 Lonza Interview
46 Aragen Life Sciences Interview
47 Industry Insights: Contractors, Manufacturers, and Lab Services
48 Nivagen Pharmaceuticals Interview
49 Chemicals and Service Providers
50 Evonik Health Care Interview
51 Section 5: New Technologies
52 Leveraging AI for Drug Discovery
53 Apprentice.io Interview
54 Technology for Patient Centricity
55 Illumina Interview
56 Section 6: Company Profiles
57 Porzio Life Sciences Company Profile
58 Adare Pharma Solutions Company Profile
59 SK pharmteco Company Profile
60 Article & Interview Directory
61 Credits

Gil Roth President

PHARMA & BIOPHARMA OUTSOURCING ASSOCIATION (PBOA)

"When it comes to 'onshoring', we help explain that 'everyone has a shore', and that a robust supply chain is better than a geographically constrained one."

The Generic Drug User Fee Amendments were a key focus for PBOA in 2022. What has your progress looked like, and what else kept you busy last year?

A core focus of ours in 2022 was helping shepherd the GDUFA 5-year reauthorization along. It was a little bumpy for a variety of reasons not tied to our negotiations, so the user fees — Generic, Prescription, Biosimilars and Medical Device — got approved later than they usually do in the fiscal year. Because of that delay, some FDA-related riders intended for the UFA legislation “fell out”, but some were included in the year-end Appropriations Omnibus bill. One of these was a pilot program for FDA to review advanced manufacturing platforms and technologies in a way that’s not tied to specific drug applications, making them “application-agnostic”. We believe that will help free up resources on the FDA side over time as CDMOs’ platforms are better understood by the agency, helping those technologies proliferate. In addition, there is also legislation to create Centers of Excellence in Advanced and Continuous Manufacturing that got passed in the Appropriation Bill that will help with new technologies in the US.

What have been your Supply Chain Task Force’s main achievements?

That PBOA subgroup has connected with several agencies to discuss supply chain issues. We help when the HHS and other groups want to discuss how to ensure that supply chains are ready for the next pandemic. For some areas, there is plenty of capacity in the US, and we help explain why investments and incentives need to be targeted; it is about getting sources of discrete doses and finding that balance. When it comes to “onshoring”, we help explain that “everyone has a shore”, and that a robust supply chain is better than a geographically constrained one. We talk about some of the international dynamics; for example, Europe wants to increase its domestic manufacturing base, while Canada realized it had no vaccine manufacturing capacity and ended up buying Covid-19 vaccines from CEPI at one point.

To what extent do you expect a reshoring of the supply chain, and how does one close the manufacturing loop in the US?

It would take decades and add a huge cost to drugs to “reshore” the supply chain. In 2020, the previous administration put out an Essential Medicines List, the idea being to make sure these medicines have a secure supply chain. The new administration looks more towards “friend-shoring”, while still pushing for more domestic manufacturing. But friends are not immune to natural disasters. As far as onshoring goes, we have explained that within the dosage form space, there is plenty of manufacturing capacity and room for expansion in the US. With APIs, it is a different story, because of a variety of factors, but reshoring a lot of commodity APIs manufactured in China would involve a significant cost.

How is the current geopolitical uncertainty impacting the life sciences industry?

The Ukraine crisis highlighted how Europe needs to look at its energy supply and how it will make sure it has secure supply chains. Part of that has involved the US more closely. With China, it is cloudy. Geopolitics will have a more significant impact going forward.

What are some of the key drivers of the CDMO market?

The growth in biologics, vaccines and cell and gene space are huge drivers. Also, more companies became more conformable with some type of outsourcing. J&J manufactured its bulk Covid-19 vaccine but outsourced drug products to several of our members. They were comfortable with not owning that huge project, and never said, “We’ll work with these CDMOs until we can build our fill-finish capacity.” Smaller biotechs were getting more funding, which feeds into the CDMO sector, although that has dipped in the current interest landscape. The healthier the bio-startup world is, the healthier the CDMO market will be.

What will be PBOA’s main priorities heading into 2023?

Keeping an eye on where the onshoring conversations go. With the new Congress in place, there may be tensions in terms of pandemic preparedness and how much the government is willing to spend to sustain manufacturing capacity. On the regulatory front, the FDA continues working on its Quality Management Maturity Initiative, and there are challenges regarding the data they want to collect and how they plan to use it.

Next:

Interview: EY USA