Business and Finance

Cold Chain

Commercial Channels

Data and Technology

Legal and Regulatory

Manufacturing & Packaging

Market Access and Pricing

Opinion

Patient Support

Security

Supply Chain Logistics

Trade & Channel

News

Pharma Pulse

Publications

Brand Insights

Webcasts

Resources

Conferences

Conference Coverage

Conference Listing

Events

Videos

Podcasts

Editorial Podcasts

Subscribe

Business strategies and top news in the biotech / biopharma industry, including market access, supply chain distribution and more.

About Us

Advertise

Editorial

Contact Us

Do Not Sell My Personal Information

Privacy Policy

Terms and Conditions

Pharmaceutical Commerce

Instagram

Twitter

Facebook

LinkedIn

Threads

Soundcloud

Spotlight

Digital Editions

Topics

1rem

Authors

By working with the sales force, incentive plan design can boost a product launch

Include the sales force in incentive compensation

KeySource, a wholesale supplier of generic prescription medications, has unveiled that Ryan Sevek—the company’s CFO—will become its president.1 A graduate of the University of Cincinnati Carl H. Lindner College of Business, Sevek has expressed interest in how the generic pharma industry contributes to United States’ healthcare landscape, and is a contributor to various industry groups.

His new responsibilities will entail heading the organization’s purchasing and sales divisions, while continuing to lead the company’s IT, logistics, and finance divisions.

“I am extremely pleased that Ryan is taking on the key role of president of our company. Since joining KeySource, he has been an outstanding leader, within and outside our company," said Albert Paonessa, CEO. “He has helped drive new systems and distribution capacity essential to the company’s success in recent years.”

Sevek was originally hired in 2017 as the director of finance, a position in which he was able to boost the KeySource’s financial processes and efficiencies; he was promoted to CFO five years later.

“I look forward to the continued challenge to drive value through the pharmaceutical supply chain, build lasting relationships within the industry, and continue to foster a culture at KeySource that puts patient care and our customers first,” noted Sevek. “I want to express my sincere thanks to leader, Albert Paonessa, and the board of directors for the privilege of serving as our company’s president. I accept these new responsibilities, confident in the ability of our entire KeySource team to further drive growth for our company, while enhancing the position of trust given to KeySource and industry partners by pharmacy providers, health care professionals, patients and the public at large.”

1. KeySource Promotes Ryan Sevek to President from CFO. KeySource. August 20, 2024. Accessed August 22, 2024. Press release provided via email.

Ryan Sevek, the supplier’s CFO, will become president. 

KeySource Unveils Internal Promotion

FDA Inspections

PC: You recently hosted a session on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance.” What points did you dive into during your presentation?

We talked about a lot of in general, what the FDA is inspecting. My key for this was trying to go for people that had never seen the FDA before, such as some of these warehouses and 3PLs. They may not have seen an FDA inspector before. So, what is an FDA audit? What types of audits and inspections can happen? Some of the documentation you'll see behind it, some of the forms they might use, you can be prepared to know what to expect from them and be given by them, as well as some of the things you can do to prepare and get yourself ready for the inevitable inspection. So, things such as having a process and a procedure in place, and, more importantly, training and practicing that procedure. Processes are a dime a dozen. If you don't train on them, they're worthless.

PC: What exactly is the FDA looking for during these inspections?

So, at its core, the FDA is looking to protect public health, and when they come in for an inspection, they're looking to see, do you have processes and procedures in place to the applicable regulations that they've implemented, and then what's the evidence you have that you are compliant and using those procedures applicably to those regulations? That's the simplest answer you can get for what they're looking for.

PC: What other session/topics at the Traceability Seminar have caught your eye thus far, and which upcoming ones are you looking forward to?

I sat in earlier on the topic for sale-able returns and how those are going to be handled. I think that's going to be a big challenge once this is fully implemented. I think having those things in place and figured out by that time is going to be a real challenge.

In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance" breakout session at the 2024 HDA Traceability Seminar.

Latest Conference Coverage

HDA 2024 Traceability Seminar: What to Expect From FDA Inspections

The first day of HDA’s Traceability Seminar was certainly not lacking educational sessions. Another fascinating one that I attended revolved around “Filing WEEs: Lessons Learned HDA Perspectives on DSCSA Implementation and Readiness,” featuring Elizabeth A. Gallenagh, general counsel and SVP, supply chain integrity, HDA; Tish E. Pahl, principal, Olsson Frank Weeda Terman Matz PC; and Brian P. Waldman, partner, ArentFox Schiff LLP.

, a WEE, or Waiver, Exception, or Exemption (WEE) request, is evaluated by FDA on a case-by-case basis.

The panel started off the discussion by reminding the audience of the small dispenser exemption that the FDA recently made, which essentially exempts dispensers with 25 or few full-time licensed pharmacists and qualified pharmacy technicians from package-level 2023 requirements until Nov. 27, 2026.

It’s important to note that although the deadline for trading partners to submit requests was Aug. 1, 2024, requests can be made at any time, but the FDA is unable to guarantee that it was act or make a ruling prior to the Nov. 27, 2024 date.

The panel outlined that a WEE should explain:

What specific DSCSA requirements you need relief from

What you’ve done so far/progress that’s been made

Why this specific request won’t create an issue for downstream trading partners.

Waldman also noted that as WEE should be a narrow as possible, meaning that if one needs an additional six months to comply, one should request six months, as opposed to more time, but nothing is guaranteed—as Pahl advised, “be prepared for what happens if you don’t get what you want.”

On July 29, the National Association of Chain Drug Stores (NACDS) submitted a letter—which Gallenagh noted is fully supported by HDA, who themselves have recommended a phased approach three times—to the FDA in which they asked for a phased approach when it came to implementation. In NACDS’ opinion,manufacturers should need to comply by the existing Nov. 27, 2024, while wholesale distributors should achieve full compliance 6-8 months later. As for dispensers—larger ones who have not been previously exempt by FDA—should have until Feb. 27, 2026 to comply.

Some might be wondering what NACDS’ justification is on these suggestions. The association believes that pharmacies shouldn’t be penalized for suppliers’ lack of compliance. They are also concerned for lack of compliance to result in supply disruptions, including drug shortages.

As the panel also stated, it even raises additional WEE concerns that could hold implications down the road, such as additional clarity being needed where a downstream trading partner seeks exemption for supplier non-compliance; the suggestion that WEE should be at national drug code level or NDC, not lot level; that granted WEEs should be applicable to 

 trading partners; and FDA should post all NDCs that are subject to exemptions and waivers in order to keep the entire supply chain informed.

This raises a key question for the FDA: being that the agency has vowed to prioritize patient access to medications, how does it proceed? Does it choose to break the DSCSA law in order to stay true to that oath?

Gallenagh EA, Pahl TE, Waldman BP.Filing WEEs: Lessons Learned HDA Perspectives on DSCSA Implementation and Readiness. August 27, 2024. HDA 2024 Traceability Seminar. Washington, DC.

Session uncovers distributors’ experiences with the Waiver, Exception, or Exemption request process, and how these affect the overall supply chain. 

HDA 2024 Traceability Seminar: DSCSA Implementation and Readiness

Touchlight, a contract development and manufacturing organization (CDMO) that specializes in enzymatic DNA production, will be providing its branded dbDNA (doggybone DNA) to the University of Nottingham for research and development of a DNA vaccine that combats the Zika virus.

 The material used in the clinical study abides by good manufacturing practices (GMPs).

The plan is for University of Nottingham scientists to lead the charge in designing the vaccine, which is expected to have the capability to be produced within weeks. Specifically, the process will involve a synthetic manufacture of the vaccine as opposed to bacterial fermentation, which slices the development time from six months to six weeks.

This project will be spearheaded by Dr. James Dixon from the university’s School of Pharmacy, alongside Professor Janet Daly, director of the University of Nottingham’s Wolfson Center for Global Virus Research. The DNA vaccine will be administered via injection.

According to Touchlight, enzymatic dbDNA technology allows for a quick, scalable, and efficient way to develop vaccines by offering the capability to decrease dosage, while eliminating antibiotic resistance. DNA vaccines also don’t require the same type of cold chain storage that mRNA vaccines would demand.

“The Touchlight technology has enabled us to make rapid progress and will make it possible to produce large quantities of the DNA vaccine at [a] speed which is vital in pandemic prevention and our response to deployment of vaccines in the developing world and globally,” said Dr. James Dixon.

Touchlight executives are also excited for the endeavor.

“We are thrilled to support the University of Nottingham with our innovative dbDNA technology in the development of a Zika virus DNA vaccine,” noted Tommy Duncan, Touchlight’s COO. “We are committed to enabling developers of DNA vaccines by providing rapid, high purity DNA for vaccines against emerging pathogens.”

On the other hand, regarding mRNA, Touchlight recently signed a license agreement with GSK, which centers around using the CDMO’s enzymatic dbDNA technology for mRNA-based products.

“GSK is a global leader in vaccination, and we are delighted they have licensed our proprietary enzymatic dbDNA technology for the development and production of their mRNA-based products,” commented Jonny Ohlson, executive chair and founder of Touchlight. “The adoption of Touchlight’s enzymatic DNA is gathering pace and becoming an important part of the advanced therapy supply chain. Our technology delivers the speed, scalability and high-quality DNA products that are essential for the next generation of mRNA therapeutics.”

1. Touchlight to supply GMP dbDNA to support University of Nottingham’s clinical study for a next-generation vaccine for Zika virus. 

t. August 21, 2024. Accessed August 21, 2024. 

https://www.touchlight.com/news/touchlight-to-supply-gmp-dbdna-to-support-university-of-nottinghams-clinical-study-for-a-next-generation-vaccine-for-zika-virus/#:~:text=Touchlight%2C%20an%20innovation%2Ddriven%20contract,vaccine%20targeting%20the%20Zika%20virus

2. Touchlight and GSK sign license agreement for use of enzymatic dbDNA production technology for mRNA manufacturing. 

t. July 23, 2024. Accessed August 21, 2024. 

Although it still has to undergo the preclinical and clinical trial process, the DNA vaccine—which could be created in as little as six weeks—does not require the cold chain storage that mRNA jabs often demand.

Touchlight, University of Nottingham Collaborate on Development of Zika Vaccine

The Inflation Reduction Act provides Medicare with the right to directly negotiate with drug companies as a way to improve access to various brand name Part B and D drugs. Never before has the federal government been able to bargain with drugmakers over the costs of the drugs they produce.

Keeping that in mind, on Thursday, Medicare officials released results of the first round of prescription drug negotiations for individuals with Medicare Part D, which would go into effect by 2026.

 People enrolled in the program are also expected to save $1.5 billion in out-of-pocket costs once those new prices are enacted.

The first 10 drugs that will see lower prices go into effect include:

Eliquis (by BMS and Pfizer), a blood thinner for the prevention and treatment of blood clots, which will receive a 56% discount off of the 2023 list price

Jardiance (by Boehringer Ingelheim and Eli Lilly) diabetes, heart failure, and chronic kidney diseases, which will receive a 66% discount off of the 2023 list price

Xarelto (by Johnson & Johnson) a blood thinner for the prevention and treatment of blood clots, and reduction of risk for patients with coronary or peripheral artery disease, which will receive a 62% discount off of the 2023 list price

Januvia (by Merck) for the treatment of diabetes, which will receive a 79% discount off of the 2023 list price

Farxiga (by Merck) for the treatment of diabetes, heart failure, and chronic kidney disease, which will receive a 68% discount off of the 2023 list price

Entresto (by Novartis) for heart failure, which will receive a 53% discount off of the 2023 list price

Enbrel (by Amgen) for the treatment of rheumatoid arthritis, psoriasis, amd psoriatic arthritis, which will receive a 67% discount off of the 2023 list price

Imbruvica (by AbbVie and Johnson & Johnson) for the treatment of blood cancers, which will receive a 38% discount off of the 2023 list price

Stelara (by Johnson & Johnson) for the treatment of psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, which will receive a 66% discount off of the 2023 list price

Fiasp, NovoLog (by Novo Nordisk) for the treatment of diabetes, which will receive a 76% discount off of the 2023 list price

The selected drugs were among those with the highest total spending when it came to Medicare Part D. Had these negotiated prices gone into effect in 2023 as opposed to 2026, Medicare would have saved an estimated $6 billion.

As noted above, this only represents the first round of negotiations. As part of Medicare’s drug price negotiation program, additional drugs will be chosen annually. Come next year, Medicare will be selecting as many 15 other drugs to be covered under Part D for negotiation, up to an additional 15 Part B and D drugs in 2026, and as many as 20 drugs every year following.

1. FACT SHEET: Biden-⁠Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation to Lower Costs for Millions of Americans. 

. August 15, 2024. Accessed August 16, 2024. 

https://www.whitehouse.gov/briefing-room/statements-releases/2024/08/15/fact-sheet-biden-harris-administration-announces-new-lower-prices-for-first-ten-drugs-selected-for-medicare-price-negotiation-to-lower-costs-for-millions-of-americans/

2. Negotiating for Lower Drug Prices Works, Saves Billions. US Department of Health and Human Services. August 15, 2024. Accessed August 16, 2024. 

https://www.hhs.gov/about/news/2024/08/15/historic-first-biden-harris-administration-successfully-negotiates-medicare-drug-prices-delivers-promise-lower-prescription-drug-costs-american-seniors.html

By 2026, the first 10 drugs for individuals with Part D coverage—whose medications are mainly used to treat cancer, diabetes, and heart disease—will see discounts off of list prices ranging from 38-79%.

Medicare Unveils Results of First-Round Drug Price Negotiations

In the not-so-distant future, healthcare will no longer be a one-size-fits-all endeavor. The industry is undergoing a seismic shift toward patient-centric care, where treatments and care are tailored to the individual, considering their genetic makeup, lifestyle, and unique needs. Picture a cancer patient treated with a hyper-personalized chimeric antigen receptor (CAR) T-cell therapy,

which reengineers her own immune cells to combat cancer.

As compelling as the vision of patient-centric care is, it also poses a question: What will the supply chain for such patient-centric care look like? Unlike mass-produced drugs, many emerging therapies will be customized for the individual and require precise coordination and logistics. This process will often involve harvesting, modifying, and transporting unique human cells with extreme care to ensure they remain viable. Taking a patient-centric approach will require pharma companies to deeply rethink their supply chains, moving away from stockpiles and batch production to real-time patient orders.

Decentralized clinical trials and virtual trials can include patients from more demographic groups, which will mean better science and stronger participation and trust across all communities. This is great news for groups that have been underrepresented in clinical trials.

 However, this new model also requires direct-to-patient distribution of investigational products, supplies, and study materials. As more participants take part in these studies, the need for on-demand inventory increases.

Additionally, fast-developing individualized investigative medicines are growing in effectiveness and popularity. For example, CAR T-cell technology is a revolutionary cancer therapeutics. This treatment takes T-cells from a patient, re-engineers them in a lab, and reintroduces them back into the patient. The process requires a supply chain with no room for error: The cells must remain within strict condition parameters and be carefully tracked across their entire journey.

Partnerships with specialized manufacturing facilities must produce CAR-T products in a timely and quality-controlled manner. Pharma companies will need logistics capabilities to coordinate, plan, and schedule all players in the care journey to ensure patients receive CAR-T therapy promptly.

Wearable medical devices are also increasing. Drugmakers must coordinate the distribution from the manufacturing facility to distributors, wholesalers, or directly to healthcare providers, while providing key end-user post-sale support. Increasingly, this medical device supply chain will be enriched by data. For example, the internet of things data (IoT) from devices like pacemakers will not only measure battery health in real time but also feed that data back into the supply chain, leveraging predictive analytics to ensure batteries are available when needed, track their performance, and manage safe disposal.

All these developments in healthcare will cause a transition from a “push” to a “pull” supply chain. Advanced analytics and artificial intelligence (AI) can match need and supply by allowing companies to integrate data from various sources (sales, inventory, and demand forecasts).

Additionally, machine learning will help generate more accurate demand forecasts and perform near-real-time demand sensing. Again, this requires collaboration across supply chain industry partners to improve visibility into inventory levels and demand signals.

The main goal of redesigning pharmaceutical supply chains is to prevent interruptions in patient care, given the new reality of individualized therapies. When there are few options to treat a particular condition, the patient can’t simply select another treatment or wait for therapies to be on hand.

The supply chain must be fine-tuned to rapidly and effectively deliver precisely what each patient needs. The following five strategies can help the pharma industry redesign its existing supply chains to become more fully patient-centric.

Implement advanced analytics and forecasting techniques to match patient needs, optimize inventory levels, reduce waste, and ensure that medications and treatments are available exactly where and when needed. By accurately predicting demand, pharmaceutical companies can streamline operations and respond more effectively to patient requirements.

2. Implement real-time inventory management with smart devices.

AI-powered systems can continuously monitor inventory levels, expiration dates, and usage patterns. Incorporating IoT devices and smart package tracking monitors medication usage, temperature, and humidity during storage and transportation while providing real-time data on inventory levels. This helps prevent stockouts, reduce waste, and ensure the availability of medications when patients need them. In the future, an intelligent supply chain can also respond to population-level health events. For example, an AI-powered supply chain theoretically could track regional spikes in pneumonia infections and autonomously alter supply chains to move medication to areas of need.

Establish end-to-end visibility across the supply chain to ensure transparency and traceability. This includes tracking the movement of medications from manufacturing to distribution, and ultimately to the patient. Real-time data and analytics can help identify potential bottlenecks and enable proactive decision-making. Advanced analytics tools can analyze supply chain data, identify trends, and predict demand patterns. These tools optimize inventory levels, improve distribution routes, and reduce lead times, ultimately ensuring timely medication supply to patients.

AI can analyze medical devices and equipment data to predict maintenance needs and prevent breakdowns. These insights ensure critical equipment, such as refrigeration units for storing medications, function optimally, reducing the risk of medication spoilage and supply chain disruptions.

5. Detect fraud and prevent counterfeiting.

AI can analyze data patterns and identify anomalies to detect fraudulent activities or counterfeit medications in the supply chain. Implementing these technologies enhances the integrity and safety of the pharmaceutical supply chain, offering protection to both the drug manufacturer and patients.

The next-generation healthcare supply chain

Emerging trends require the pharma industry to shift supply chains from a “push” to a “pull” model. The existing one-size-fits-all model will not work in the next generation of healthcare. New emerging technologies such as AI can make this possible with better demand forecasting and inventory management to meet personalized care service needs.

When it comes to patient-centric care, timely and agile delivery is key. The pharma industry’s supply chain function will have a powerful role to play in the future of medicine by working with regulators, technology partners, and healthcare stakeholders. 

Srini Rajamani is the Business Unit Head of Wipro.

1. CAR T Cells: Engineering Patients’ Immune Cells to Treat Their Cancers. National Cancer Institute. March 10, 2022. 

https://www.cancer.gov/about-cancer/treatment/research/car-t-cells

2. Driving Diversity and Equity in Clinical Trials. Wipro. August 2021. 

https://www.wipro.com/blogs/srini-rajamani/driving-diversity-and-equity-in-clinical-trials/

A prediction of how this shift toward patient-centric care may look.

Kevin Frymire, Beghou Consulting

Articles

Latest Updated Articles