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1rem

 interview, Allen Jacques, a life sciences industry thought leader at Kinaxis, dives into:

What he sees as limitations of current government efforts when it comes to boosting domestic production of essential medicines, and why they aren’t sufficient

The challenges that generic drug manufacturers are facing today

Why more resilient and transparent supply chains are necessary in the pharmaceutical industry, and how these can help mitigate shortage issues

Allen Jacques explains the history behind medications’ lack of supply, while offering ways to help alleviate their impact. 

Mitigating Drug Shortages

 interview, Brandon Newman, Xevant’s CEO and founder, explores:

The implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system

The role that pharmacy benefit managers (PBMs) and other intermediaries' play when it comes to determining drug costs, and how spread pricing is involved

How Xevant helps improve drug cost transparency efforts

Strategies for affordability Newman would offer the pharma industry that can be implemented immediately

Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drug price transparency. 

A Further Examination of Pharmacy Benefit Managers

 interview, Rob Besse, Archbow Consulting’s VP of distribution services, shares:

A general overview of how the 3PL process works, using his 20-plus of pharma supply chain experience as added insight

The factors that manufacturers should consider when selecting a 3PL, along with the array of services that a quality 3PL should provide

Valuable lessons he believes 3PLs learned during the COVID-19 pandemic that have helped improve efficiencies

Trends affecting the pharma industry that 3PLs be on the lookout for the rest of the year

Podcast is available directly on SoundCloud.

Rob Besse offers a breakdown of the third-party logistics (3PL) process, including lessons that these providers have learned coming out of the pandemic.  

A First-Hand Account of 3PLs

The partnership revolves around augmenting regulatory compliance, along with drug sampling distribution and compliance.

Kenco, QPharma Collaborate on Improving Supply Chain Challenges

The CRO earned a Bronze rating for criteria based on environmental, social, and ethical performance.

 Sygnature Discovery Given Award for Sustainability

IATA data points to a fourth consecutive month of double-digit, year-on-year growth. 

Air Freight Demand Continues Its Climb in March

The CDMO’s boost in production will be centered around pharmaceutical products.

Berry Global Increases Manufacturing Capacity

There is no doubt that drug shortages are a detriment to the pharma supply chain, but how commonplace were they during the COVID era?

Examining Drug Shortages Before and During the COVID-19 Pandemic

Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem.

Using AI to Solve Drug Shortage Issues

What’s causing drug shortages right now?

So, the causes for drug shortage are several, one of them being high demand for a certain type of drug, which means that the manufacturing and the QA folks have to increase the production and it's often not that straightforward. The second is increase of generics. So, when a drug gets the pants is expiring, you get generics in the market, but which are much cheaper than the brand. But also, that means the incentives to manufacture generics is lacking. Because the margins profit margins on these generics is slim. So, it really comes down to only one or two manufacturing plants generating those generics. And one key example is in the cancer drugs. So unfortunately, given there's no commercial incentive to pharma to cream to generate a lot of generics, the patients suffer. And lastly, it's really the way the supply and demand work within the drug development cycle and what happens in the distribution of the drugs.

Is there a ‘light at the end of the tunnel’ to these shortages or will they continue?

Unfortunately, I don't think there's going to be a light at the end of the tunnel. And in fact, it's going to have more and more significant repercussions as we get more drugs off banned. There's more demand for certain types of drugs and having production challenges and quality control challenges to manufacture drugs. I just don't see that this issue is going to be resolved anytime soon.

How can AI/Machine Learning help solve drug shortage issues?

Definitely, I'm biased since we are an AI company. But I do believe that AI is not going to solve every problem in healthcare. But the challenges that are we seeing in drug shortage such as what do we do to create financial incentives for companies so that they help in manufacturing production, this is where AI can help improve the manufacturing efficiency. And there are several ways that certain companies are tackling this challenge. The other is the parent challenges, right, so each drug comes with the parent lifespan. So, if AI can help increase that lifespan, so for example, our technology helps improve the formulation or a change of route of administration. And those all elements can improve the patent extension, and that that can help resolve some of these drug shortages challenges. And the third is increasing the number of drugs coming to the market so that the pharma companies don't have to rely on one or two mega blockbusters, since you probably are aware of the R&D to create the drug to the market is very expensive and very long. So, if there's any way to cut down the time, and improve the odds of getting drugs, more drugs into the market, it's a win-win for everybody. That means when the generics come into the market, the companies are not feeling financially strapped to not do nothing about it. In fact, there are other drugs in the pipeline or in the market, that they can generate revenue. And the and also enable and help manufacturing plants and do up those, you know, increase the production of those generics. So, I think those are all the big places, AI can be very helpful.

AI isn’t the only component needed to solve this problem, so what else will it take from industry?

This is a pretty complicated question and a very, I will be giving a very complicated answer. The there's a lot of things need to change to really resolve drug shortage. One is specific reforms that need to happen in the drug development from how the incentives are tied to a drug to how what manufacturing plants need to generate or produce that number of drugs to getting aligned with the government agencies to enable How do we create a win-win solution. So, the economic reforms are needed to you know, be it could be specific funding from the government to enable production There's mass production of these generics or increasing the manufacturing plants and helping boost up production of drugs that are much needed by the patients. And lastly, I think having more drugs to the market is a big incentive to help reduce the shortage.

With drugs like Ozempic and Wegovy significantly increasing in popularity amongst patients just looking for that quick weight loss fix, instead of its intended use, how can the industry avoid shortages for therapies like these blockbuster drugs?

Yeah, this is a very important conversation in the society we need to have. I think it's not just for drugs like Ozempic, but also for mental health drugs, there's been an insane amount of abuse in a way to drugs because somebody comes and says, like, hey, you know, I have read game challenges. So, if they get prescribed drugs, psychosom piglet without knowing, I mean, they know the side effects. Every drug comes with the side effects, but they don't really know the implications of being on a drug for so long. And those are real challenges that as a society, first, we need to address that, do you really need? And how do you qualify for a drug like that, and then really, taking steps backwards, like type two diabetes, there's a lot of nutritional and weight gain challenges. So, the big four, first couple of things you need to do is really get on a regime of diet that works in favor of reducing the insulin resistance that your body is generating, versus getting a drug, which is sort of like a Band-Aid, to a larger problem. So, I think having that clarity and a clear checklist of what group of patients shouldn't be given a certain type of drug is a very much needed conversation. And unfortunately, you know, the incentives for pharma companies to do so it's really nothing because you know, if you have lots of patients on the drugs, it's a huge quarterly gain as you can see in the market. So, it is it is a tough problem, but I think it needs to start from the patients and the doctors to really have an open conversation whether or not you need drugs to come back for weight loss.

In this video interview with Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem.

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How AI Can Help Solve Drug Shortage Issues

Editor Nicholas Saraceno, Bill Roth, SVP, Managing Partner, Blue Fin Group, speaks on key takeaways from his "Fight for the Dollar" keynote speech. 

Access Insights 2023: Bill Roth Provides an Overview of his Keynote Speech, Fight for the Dollar

: The keynote was a culmination of a story that I've been working on all year long. We've always heard about the flow of the dollar. I'm getting quite tired of that one graphic that represents how brands flow. There's nine other flows. What became obvious to us over the last year and a half was this concept of the fight for the dollar. No one is really laying back and allowing the channels to basically use the manufacturers. Between 340B, the removal of the AmCap, and the addition of the IRA, price increases as we know it have been abolished. If you do it moving forward, you're going to wind up regretting the actions. The way that I open it up, I ask this question: If you put a dollar bill equidistant in a four way intersection and you put a payer pharmacy/distributor equal to that and a gun goes off, who gets to the dollar bill first and why? Traditionally, the answer has been not the manufacturer. The fight for who gets that money has created awkwardness and I think the ability to talk about that in front of a group like this is great because we're putting a problem on the table that we all need to solve. 

SVP and Managing Director for Blue Fin Group offers a synopsis of the conference opener. 

Latest Conference Coverage

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Jenifer Smith, Sr. Logistics Specialist, Direct Relief, talks more about her organization. 

: Direct Relief is a nonprofit. We're based out of Santa Barbara, Calif. and we ship prescription drugs and medical supplies to approximately 90 countries every year including all US states and territories. I'm on our transportation team and our team is the one that figures out how to get the product from our warehouses in the US and Europe to other countries all over the world. We receive product donations directly from manufacturers 

Direct Relief executive provides more information about the company. 

LogiPharma USA 2023: Jenifer Smith Talks About Direct Relief

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Jenifer Smith, Sr. Logistics Specialist, Direct Relief, speaks on her upcoming fireside chat. 

: I'm currently doing a case study on product in Ukraine. Direct relief has delivered countless shipments and there are a lot of challenges delivering into a conflict zone. I have been with Direct Relief for six years and the majority of the difficult shipments to the regions I've gone into are difficult because of natural disasters or lack of infrastructure. Ukraine is one of the first war zone areas that I've had to ship into. It's a whole different ballgame. During the war, hospitals are being targeted, clinics are being targeted. So, there's a whole level of risk that's inherent with moving temperature sensitive product into a war zone. 

Jenifer Smith talks about what to expect during breakout session. 

LogiPharma USA 2023: Jenifer Smith Discusses the Focus of Her Fireside Chat 'Establishing Goals for Active Conflict Zones'

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Jenifer Smith, Sr. Logistics Specialist, Direct Relief, offers her thoughts on what men and women can do to foster growth and development. 

: One of the things someone brought up in our initial discussion was the likability dilemma, which I hadn't really heard about. I was listening to readings on it last night and it's the idea that women who have leadership qualities, the same that men have, are viewed as less likable. A man doing those same things with those same qualities are viewed as likable. So, that's one of those things that you might not realize, why someone bothers you. You're in a meeting presenting ideas and it bothers you. What is it about this person that isn't sitting well with me and is it you don't imagine a person of that gender having those qualities? Another thing that I think is important is meeting room interruptions. We had a training at our work several months ago where there was a study women interrupt other women more in meetings than men interrupt women. We all need to make sure that everybody's voices are getting heard. What can we do to elevate the voice of somebody being interrupted?

Jenifer Smith provides suggestions on what can be done to continue growth and development. 

LogiPharma USA 2023: Jenifer Smith Discusses What Men and Women Can Do to Continue Fostering Growth and Development

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Jenifer Smith, Sr. Logistics Specialist, Direct Relief, discusses being a part of the 'Women Leaders in Supply Chain' breakout session. 

: It's really cool to be able to sit on a panel with so many people with different backgrounds and have been in the industry for a number of years. We had a call beforehand to discuss what we were going to talk about. We really want to bring some discussion points about how the industry has changed and how women in leadership has evolved in the past 20-30 years. Some of these people have been in the pharma industry. Also, I have some takeaway points for both men and women alike. What can you do in your position in your job today that can help elevate women in leadership and recognize your own internal biases? That's something that I am personally working on that doesn't get talked about as much. It's really exciting to be able to sit on a panel with important women at such an important event. 

Direct Relief executive offers her thoughts on breakout session. 

LogiPharma USA 2023: Jenifer Smith Discusses Her Thoughts on the 'Women Leaders in Supply Chain' Session

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US discusses examples for GS1 US DSCSA Implementation Guideline R1.3.

: You have the global standard, EPCIS, and your core business vocabulary, that's on the global. Then you have our implementation guidelines for DSCSA. It's essentially the standardized way to implement DSCSA. Then you have this addendum based on scenarios such as different supply chains. These guidelines are hundreds of pages long. It can be quite complicated and overwhelming  to go through these beginning to end. What we found was that if we can do an addendum that have these different supply chain scenarios, it might be easier for someone to say, "I'm a CMO, and this is my typical supply chain scenario," and just look to see what the business steps are. 

Sr. Director of Community Engagement for Pharmaceuticals at GS1 US explains what the implementation guidelines are meant to accomplish. 

LogiPharma USA 2023: Tracy Nasarenko Discusses the GS1 US Addendum Guidance and XML Examples for GS1 US DSCSA Implementation Guideline R1.3

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US provides steps to be taken by the pharmaceutical industry to quickly implement new DSCSA rules. 

It's really not stopping, pausing, or slowing down at all. You can't work on exceptions if you exchange data. You can't do onboarding downstream if your suppliers haven't already onboarded. There's this huge dependency on progressing to be able to do the next steps. If we really get into implement, troubleshoot, and mature, you need that exchange of data. You need to have it completely in place to really be able to realize what your errors are. What are going to be those issues that you didn't think of? Being able to use that year to work it out so that you're not impacting the patient or the consumer with drug shortages so you can still move that supply chain. 

GS1 US Executive provides insight on how pharma supply can speed up the process of complying with regulations. 

LogiPharma USA 2023: Tracy Nasarenko Discusses Steps Pharma Supply Should Take to Adapt to New DSCSA Laws

We talked about what DSCSA is. It's the Drug and Supply Chain Security Act. It went into law about 10 years ago essentially to protect the patient or consumer from counterfeit drugs. It has different milestones as it goes through, and the final milestone is actually in November of this year. It's for serialized unit traceability with an interoperable data exchange. We talked about different data elements of DSCSA beyond what it is such as the complexity of it, how you have to work and interact with your trading partners. Recently, there's been activity from FDA in establishing a stabilization period. Essentially, from November of this year to November of next year, there will be a one year period to help implement, troubleshoot, and mature so it's not deemed as a delay. It's really to help the industry set up and prepare for DSCSA. 

In an interview at LogiPharma USA 2023 with Pharma Commerce Editor Nicholas Saraceno, Tracy Nasarenko, Sr. Director of Community Engagement for Pharmaceuticals, GS1 US highlights her “DSCSA—Final Checks to Have Before Deadlines.”

LogiPharma USA 2023: Tracy Nasarenko Provides a Synopsis of “DSCSA—Final Checks to Have Before Deadlines.”

In an interview at the DIA Global Annual Meeting with Pharma Commerce Editor, Nicholas Saraceno, Venkatraman Balasubramanian discusses broader supply chain issues.

Supply Chain Logistics

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