GreenField Chemical

In our latest blog, we’re discussing the critical role communication plays in getting a drug to market. The often overlooked step between drug developers and the patients who receive their life-changing drugs is the communication between regulatory agencies. Regulatory agencies play the role of a gatekeeper between developers and consumers. It is their duty to ensure that products that come to market are safe and effective. Tension between the hopeful innovation of developers and these bodies' steadfast protocols can make walking the line between the two feel like a tightrope. So how does one make it safely across the otherside? Knowing how to strike the correct balance between innovation and familiarity. When appealing to one of the major agencies like The Food and Drug Administration (FDA) or The European Medicines Agency (EMA), one is expected to communicate in two steps: prepare a written submission and attend application meetings. The written submission includes formal documents such as Investigational New Drug (IND) applications and New Drug Applications (NDAs). Through the written submission and subsequent meeting, it is the drug developers' chance to support their drugs potential, efficacy and safety through extensive data. Meetings that occur pre-IND as well as formal application meetings are a chance to meet face-to-face and clarify any questions and/or concerns. This ensures all protocols are followed and the application is airtight before the formal submission. This is where that balance comes in, by being familiar with regulatory agencies' guidelines (for example, the FDA’s Good Clinical Practice guidelines) it can mean the difference between an approval and a rejection. Playing by the rules of the game, you make regulatory bodies your teammate on the field vs. your adversary. By understanding their rulebook and strategy you are better able to think collaboratively and ensure the process to get approval is seamless. What other questions do you have about these regulatory bodies or the submission process? Read the entire blog here: https://lnkd.in/g3NkPMeB #blog #DrugDevelopment

There is growing concern over fungal infections due to an increasing number of drug-resistant fungi. The Microbial Cell ‘s epidemiological data shows that severe fungal infections have risen to 150 million cases annually with 1.7 million deaths occurring worldwide. Vulnerable populations, including those with compromised or weakened immune systems, are most at risk for severe fungal complications. The WHO has recognized this threat. One company addressing this threat is the U.K.-based biotech, F2G. After being rejected by the FDA, they have since raised $100 million to finish Phase 3 testing for a new antifungal treatment. The drug, “olorofim,” targets invasive aspergillosis. The drug works by disrupting a key enzyme in the fungus, killing it. In 2019, it was designated as a Breakthrough Therapy by the FDA. Later, utilizing data from the first 100 patients of the Phase 2b study, F2G submitted for regulatory approval. However, it was rejected, citing the need for additional data. F2G aims to collect such data through its current Phase 3 test and reapply. The CFO Ralf Schmid is confident that the guidance provided by the FDA as well as the investor’s capital will advance olorofim to market. Read the article here: https://lnkd.in/gNeGc6Ck Do you think that anti-fungal treatments will continue to be a point of interest in the drug development space? #PharmaNews #article #innovation

The US is considering legislation that would have a major impact on the pharmaceutical industry. It is called the Biosecure Act. This Act is a direct response to the United States current reliance on Chinese contract drug manufacturers and research organizations. If it were to pass, other players, primarily in India, may see an exponential increase in business. Potential recipients of the contracts previously held in China may include these notable Indian companies: Divi'sLab, Suven, Aarti Pharma & Syngene. The Act has not been passed yet, and there is no indication on how fast these contracts would be diverted from China to other countries. Experts in India both laude the decision for its potential tremendous economic impact on the county and expressed some concern over the country’s lack of experience as well as lesser access to more advanced technologies. Time will tell if India will be able to challenge China’s current domineering 8% share of the global Contract Development and Manufacturing Organization (CDMO) market (India currently holds 2.7%). Do you think this Act will positively impact the pharmaceutical industry? Watch the video here: https://lnkd.in/gRDRFXag #PharmaNews #USAPharma

Teamwork is paramount in the success of a pharmaceutical company. A highlight from our recent blog highlights the relationship between innovation and teamwork. When pharmaceutical developments are portrayed in the media, it is often the image of a solitary brilliant scientist. We know this archetype well: the genius holed up in the lab scrutinizing a whiteboard covered in formulas crossed out and re-worked four times over. Suddenly, the camera zooms in as they unlock the missing element ushering in their perfect “Eureka!” moment. But that’s just Hollywood. In reality, innovation thrives when a collective of intelligent thinkers with diverse perspectives gather together. In the pharmaceutical industry, these minds include scientists, clinicians, engineers, and business experts. Each of them have niche expertise that allow them to tackle challenges from their own unique perspective. Problem solving from multiple angles allows for the most innovative solutions to be discovered. Teamwork demands curiosity. A mutual desire to learn and contribute to the knowledge of others is how we in the industry are able to stay dynamic and ahead of industry standards and the competition. When questions are seen as gateways to new heights and challenges as opportunities to achieve something greater, that is teamwork at work. What do you think is the most important benefit of teamwork? Read the entire blog here and share your thoughts: https://lnkd.in/gkCWZJMr #pharma #blog

How can you protect your pharmaceutical IP (intellectual property)? Due to the competitive nature of the industry, all innovation must be fiercely protected. There are many to protect your IP, today we’ll break down the difference of Trademarks vs. Copyrights. Trademarks help pharmaceutical companies build, establish, and maintain a cohesive brand. Trademarks ensure that no competing entities can infringe or imitate key branding elements like a logo or name. This protects companies from competitors who may dilute their brand image and confuse consumers who have built trust and loyalty with a specific brand. Registering trademarks with national and international offices offers an additional layer of legal protection and expands options to enforce its protection. Copyrights are less common when it comes to protecting pharmaceutical IP. Oftentimes, copyrights do not pertain directly to the actual product. However, copyrights can help protect vital aspects of the pharmaceutical process. Things like research, development, as well as any creative work that is produced or distributed that contribute to the product’s success. “Creative works” refers to packaging design, software, website copy, product literature as well as marketing materials. A copyright grants the creator sole ownership of the work. With that comes exclusive rights to reproduce, distribute, display and modify it. Copyrights add an extra layer of protection as explicit permission must be granted for any other company to utilize these third-party copyrighted materials. Do you use one of these methods or a combination in regards to your IP? #pharmaceutical #PharmaNews #drugdeveloper

What can an investment in SCaaS providers do for your company? Our latest blog discusses how SCaaS providers can help streamline companies' operational procedures by reducing costs and enhancing efficiency. This allows them to deliver high-quality products in a precise and timely manner. SCaaS providers are revolutionizing the pharmaceutical industry landscape by allowing them to focus on their core competencies. When a company outsources all their supply chain functions, they are able to concentrate on the niche operations that bring them the most success and profit such as R&D and innovation. Accelerating drug discovery as well as development can help a company breakthrough this highly competitive industry and carve out their place within it. By allocating large amounts of resources to these critical aspects of the business, they will become more lucrative and esteemed within the industry as a whole. A jack of all trades will be successful, however, that success has limitations. Their attention is more thinly spread and divided. A company that outsources some of these demands is able to specialize in the most important areas of focus and surpass standard success benchmarks. Working with a SCaaS provider that specializes in supply chain management will also ensure that operations are not delayed or disrupted by compliance issues. This gives the company the freedom to innovate with the solid assurance that all operations are carried out with the most scrupulous and up-to-date regulatory standards. This sets their pace ahead of regulatory bodies and their competition. This also ensures that their products maintain the highest levels of quality. Have you considered working with an SCaaS provider? Why or why not? Read the full version of the blog here: https://lnkd.in/gDsRYAGM #pharma #blog #SCaaS

Major legislation is affecting the pharmaceutical industry. For the first time ever, the United States government will be able to directly negotiate prices set on certain drugs within Medicare. The Inflation Reduction Act is a direct response to many voters' concerns about rising drug costs. The newly negotiated rates for the 10 drugs, according to the CMS, will be 38% to 79% lower than drugmakers list price. If honored, in 2026 alone, the new prices have the potential to save Medicare patients $1.5 billion in out-of-pocket costs. While this is tremendous news for Medicare enrollees, the Act is not without controversy. Many in the pharmaceutical industry staunchly opposed it, calling it “unconstitutional.” They argue that it is more accurate to call it “price setting” vs. negotiating as those who opt out face serious financial penalties. However, any legal challenges brought forth by both drugmarkers and trade groups have not succeeded in court. Critics also argue that such strident price negotiations will stifle innovation and drug discovery by limiting potential profit margins. However, this is a big step towards making medicine more equitable. Life changing drugs will be available to a larger population that may not have had access to them before. Ultimately, it should be the aim of the industry to treat as many patients as possible. What do you think about the Inflation Reduction Act? Do you think the positive impact on consumers will balance the concerns of a potential reduction in both drug innovation and profit? Read the entire article here and decide for yourself: https://lnkd.in/gyF_jJhj #Pharma #News

Have you read our newest blog yet? The whole version is available now: https://lnkd.in/gDsRYAGM #blog #pharma

Take a look at some of the most intriguing and innovative clinical trials happening in the second half of 2024. One particular drug “comeback” story piqued our interest. NewAmsterdam Pharma is revisiting a specific CETP inhibitor to treat a genetic disorder affecting cholesterol levels as well as atherosclerotic cardiovascular disease. It was believed that increasing high-density lipoprotein, or HDL would be more effective than reducing the levels of “bad” cholesterol most commonly associated with heart problems. Thus CETP inhibitors were developed. CETP inhibitors were once lauded to be a potential breakthrough in cardiovascular medicine, but since their debut they have been largely dismissed due to serious side effects and multiple failures in clinical candidates. Companies including Pfizer, Roche and Eli Lill have all discontinued their research after these results. However, NewAmsterdam is focusing on one specific CETP inhibitor. It is called, “obicetrapib.” They have licensed this drug from Amegen in 2020, restarting testing it claiming the molecule may be safer and more effective then its predecessors. It has the potential to rewrite the previously checkered CETP narrative and treat serious heart and cholesterol problems. Early and mid-stages of the studies have demonstrated that obicetrapib is able to raise HDL levels as well as lower “bad” cholesterol levels while avoiding the safety issues that had been observed in past tests. However, more conclusive data will be available after three ongoing Phase 3 trials conclude. Do you think that this drug has the potential to generate billions for the company or is the reputation of CETP drugs combined with competition from already available cholesterol lowering medicines going to prove too insurmountable to make it a success? Read the article here: https://lnkd.in/eTw8aJ69 #pharma #ClinicalTrials

The dynamic pharmaceutical industry faces an increasing onslaught of new challenges. One such challenge concerns intellectual property. Due to the highly competitive nature of pharma, securing and protecting intellectual property remains critical to a company’s success and competitive edge. So how does the industry respond? To prevent the loss or encroachment on a company's IP (intellectual property) there are several safeguards to protect it. One of those is regulatory exclusivity. Regulatory Exclusivity is handled by the US FDA. It allows those in the pharmaceutical industry to refer to specific delays and/or bans on approving competitor drugs, on the legal precedent contingent to the approval of a drug and/or supplements. These terms are shorter than patents, another form of IP protection. We’ll break down pharmaceutical patents in the future. Regulatory Exclusivity length can vary. For example, New Clinical Investigation Exclusivity is three years, while New Chemical Entity Exclusivity (NCE) is five years long. The FDA claims that while exclusivity protects IP, it still encourages innovation. That’s because the terms and lengths protected by the exclusivity incentivize discovery while allowing public access to generic drugs once the period ends. What other IP protections are you interested in learning more about? #pharma #IntellectualProperty