Albert Bourla

As the healthcare industry continues to evolve, one of the most promising areas of innovation is the development of GLP-1-based therapies. These treatments, crucial for addressing conditions such as obesity, type 2 diabetes, and high cholesterol, are currently experiencing a rapid expansion in clinical trials, indicating a robust future pipeline. A standout in this space is Real Chemistry and its Iris platform, which illuminates the significant progress being made across more than 110 active GLP-1 agonist clinical trials. With 53 of these trials in advanced phases, the potential for new therapeutic options is immense, covering over 60 disease states. This progress underscores the need for strong commercial readiness as companies prepare to bring these innovative solutions to market. At Rockland Immunochemicals, Inc. Immunochemicals, and through our brand antibodies-online.com, we are committed to supporting this exciting field. Our teams are actively expanding antibodies and assays that are integral for studying GLP-1 pathways and designing more effective treatments. These tools are not only pivotal for understanding the basic physiology of GLP-1 and its receptors but are also essential in our race to enhance efficacy and minimize side effects. I am enthusiastic about the potential of our GLP-1 antibodies to contribute to improved patient outcomes and am keen to explore how we can leverage these innovations to support the healthcare community further. Discover more about our GLP-1 research tools here:  https://lnkd.in/eUHwvxuU #GLP1 #DiabetesTreatment #ObesityManagement #HealthcareInnovation #ClinicalTrials #RocklandImmunochemicals #AntibodiesOnline

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This content is intended for U.S. audiences only. The countdown to Chicago is on, as we gear up for #ASCO24 in less than two weeks! For the first time, @AstraZeneca will headline not one, but TWO back-to-back plenary sessions in LUNG as well as a late-breaking study in BREAST. Our team is focused on treating cancers at earlier stages and across subtypes while advancing medicines and combination therapies that attack the disease from all angles, evidenced by our strong, diverse research to be presented in Chicago. Behind every data point is a patient, who deserves a personalised therapy that will give them a longer and healthier life. For each one, we’re pushing the boundaries of science, and I can’t wait to highlight our research advances in the coming weeks. Stay tuned! 🔬 For a more detailed preview of our #ASCO24 data presentations, please see our press release https://lnkd.in/ehH7tqFc #CancerResearch #oncology #MedicalAdvancements

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Great post Brian Reid. With respect to changing how we pay for innovative medicines, we have a global transition to value-based healthcare yet we are not applying the same payment approach to the most utilized benefit in all of healthcare - pharmacy! Whether under the pharmacy benefit or the medical benefit, we have the tools to correlate drug use with clinical outcome which in turn allows us to better define value. #valuebasedcontracts #COEBRA

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Over the past few weeks amidst discussions post American Society of Clinical Oncology (ASCO) and Biotechnology Innovation Organization, I had the privilege to dive into the latest advancements in BioPharma, deals and portfolio strategies. From groundbreaking presentations to inspiring conversations, and most importantly connecting with new members of the ecosystem and ex-colleagues in person 🤝 Here are some key takeaways from the past few weeks, adding some insights into how the industry is trending and how new disease areas and modalities are transforming the landscape of oncology and healthcare as a whole. This quarter saw a rise in Immunology, Ophthalmology, and Neurology deals. In Oncology specifically, a rich pipeline of multi-specific antibodies is crossing stage gates across cold and hot tumors. 🚀 Let's continue the dialogue and drive innovation together!

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ONO PHARMACEUTICAL CO., LTD. is set to make its largest acquisition yet, purchasing Deciphera Pharmaceuticals, an American cancer drug maker, for $2.4 billion. 💼 The move comes as Ono seeks to fuel #growth with new drug candidates, especially as key patents on its Opdivo #cancer immunotherapy are set to expire in 2028. 🌱 Established in 2003, Deciphera is the maker of the Qinlock cancer drug available in the U.S. and Europe. 🩺 Qinlock boasts a unique mechanism that inhibits enzymes critical for cancer cell proliferation. 🛑 Additionally, Deciphera holds promising new drug candidates. 🌟 One such candidate, a treatment for benign tumors in joints, is in the final stages of clinical trials in #Europe and the #US, with approval slated for 2024. 💉 Deciphera is also developing a drug to address complications in blood cancer treatment. 🩸 #Japan #Pharma #Pharmaceutical https://lnkd.in/dppfbjsy

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Business Development leaders in mid-cap and large-cap BioPharma organizations follow peculiar career pathways.   Interestingly, the vast majority do not make a lateral move to a peer BioPharma organization. The most common next step is transitioning into a CEO, GM or VC role.   Most leaders are internal promotes who have held a more junior BD role within the organization. External hires often come from the Financial Services world.   Understanding typical C-Suite career pathways can help CEOs and People Officers optimize their succession plans and hiring strategies.

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Nearly all OECD countries are facing the great demographic reversal, coupled with increased life expectancy, which places tremendous financial and psychological burdens. A pharmaceutical agent which delays the disease progression by even a few years brings hope with dignity to patients and their caregivers, and true impact to the entire humanity. Recomended reading: The Great Demographic Reversal by Goodhart & Pradhan https://lnkd.in/g6WKerEP

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A new report from the Nuffield Trust, “The future for health after Brexit” (https://lnkd.in/eFK9vjYv), really caught my eye last week. The merits and otherwise of Brexit have been debated endlessly, and I’m not going to go into them here. But what I would like to point out is the significant attention that the issue of medicines shortages within the report. The report has called medicine shortage a “new normal” – a terrifying prospect for people who rely on these medicines to manage all manner of different conditions. It's a complex issue, and not one I’m going to suggest I have an easy fix for. In global markets, with global supply chains and increasing uncertainty, there are lots of factors to consider. But what I do find interesting about this is that it’s an example of applied policy; where policy created in the corridors of Whitehall, meets real world conditions over which it is trying to influence. For example, the company that I lead here in the UK, Teva, is the largest single supplier of medicines to the NHS. And yet, we’re not included in the government’s life sciences advisory council, nor were we consulted over the application of post-Brexit regulations. I understand that this sounds like I'm making a narrow point about my own company, but I’m trying to draw attention to a much wider one – for governments to make smart policy decisions that benefit people, not hinder them, it is vital that they consult far and wide with the different parties who both impact, and are impacted, by them; and that when they do, they listen to what we say. Our industry trade body British Generic Manufacturers Association (BGMA) has been warning of the risks of medicines shortages for years. The reasons behind these shortages are many and varied, but one cause that’s picked up specifically by Nuffield is that of capacity of the UK to approve medicines quickly enough. In a nutshell, the MHRA is under enormous pressure, with more work and fewer resources. In short, the delays are contributing to shortages. Another factor has been downward pressure on prices (again, something that the medicines industry has warned about). If the prices of medicines are pushed too low, manufacturers will drop out of the market, reducing supply and crucially, robustness of supply, making it more susceptible to global shocks. The ultimate irony is that, according to the report, this downward pricing pressure has ended up costing the NHS £220million in excess costs, required to secure increasingly scarce medicines. The medicines ecosystem is complex, and I think the best way to overcome such complexity is to work together, to co-create solutions. That doesn’t mean that my company or the wider industry should get everything it ever asks for, but it does mean that the expertise and experience within the sector is respected and listened to, for all of our benefit, not least the patients.

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Transatlantic Talk About Obesity: From ECO2024 to ENDO2024 The main conversation continues to revolve around novel anti-obesity agents, particularly incretin mimetics or nutrient-stimulated hormone-based therapies. Various combinations of GLP-1, GIP, and glucagon agonists or antagonists are currently under clinical development, including weekly or monthly injectable and oral formulations. While presentations of novel AOMs often start with their weight reduction effects, which may be a prominent as almost quarter of body weight loss within a year (in TRIUMPH-2 study Retatrutide in highest dose demonstrated weight reduction of 24.6% within 48 weeks)—additional focus has been placed on other direct and indirect beneficial effects, such as reducing cardiovascular risks, MASH scores, knee pain associated with osteoarthritis. The principle of health gain alongside weight loss seems less theoretical and is supported by strong data from multiple clinical trials and post-hoc analyses of the STEP and SURMOUNT programs. With data from phase 2 and 3 studies of dual and triple incretin mimetics, it seems that the more gut-brain nutrient-sensing signals are combined in one chemical entity, the better the results: higher weight reduction with better tolerability. This is due to a familiar principle of targeting several receptors with lower “doses” of each component, which may explain the better tolerability and more potent cumulative effect. An interesting combination of incretin mimetics with sex hormones is being developed in the labs. If successful, it may address the specifics of obesity in postmeno/andropause. However, all clinical data support the definition of obesity as a chronic disease requiring lifelong therapy. In the extension phases of clinical trials across all programs (STEP, SURMOUNT, TRIUMPH, ATTAIN, and other), discontinuation of the study drug was associated with weight regain. This has stimulated the search for novel OAMs with a “legacy effect,” allowing a longer “holiday period” once optimal weight is achieved. A potential candidate is MariTide, a monthly injectable GLP-1 agonist/GIP antagonist. In a phase 1 study, it demonstrated promising results (body weight reduction by 14.5% at 85 days). However, it’s too early to comment on its potential for long-term weight maintenance. It’s intriguing that GIP antagonism is returning to clinical research, which may help us better understand the pathophysiological components of obesity. The well-known challenge of supplying injectable approved AOMs creates a favorable background for developing OAMs in oral formulations. Orforglipron and danuglipron stand out in this context as a non-peptide-based incretin mimetics that do not require special storage and can be taken independently of meals, unlike oral semaglutide Rubelsys. It has demonstrated good results in phase 2 trials: the mean change ranged from −9.4% to −14.7% at week 36, making it highly competitive with peptide-based OAMs.

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A change in lupus care is on the horizon. Clinical recommendations now advocate for earlier intervention, and remission is highlighted as a key care goal to pursue. With these revised guidelines, we can work towards reducing dependence on oral corticosteroids and build a future where remission could become a reality for more patients living with lupus. This World Lupus Day, learn more about the work we’re doing to ensure those living with lupus have access to the quality care they deserve: https://bit.ly/3Wt2QkT #WorldLupusDay #MakeLupusVisible

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The #PHSSR 3rd Summit was a significant event held during Abu Dhabi Global Healthcare Week, bringing together health system policymakers, experts, and stakeholders worldwide to discuss and enhance global health systems. Key highlights include: 1 - Opening addresses by @AstraZeneca's Chair Michel Demaré and prominent health leaders from Abu Dhabi, Egypt, and Greece. 2 - Launch of the Abu Dhabi PHSSR report with essential policy recommendations on non-communicable diseases and the climate-health nexus. Check out the wrap-up video to learn more about our collective efforts to build resilient health systems. #ADGHW #HealthSystems #GlobalHealth

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Honestly how many more stories like this are we going to hear before real change starts occurring? How many companies have to drop their ultra-rare disease programs before our federal government understands that the capital markets aren’t going to solve the public health crisis that is rare disease drug development? And that continuing to let the NIH dole billions of dollars to academic researchers isn’t helping? We need funding directly to patient advocacy groups + partnerships with CRO’s + better FDA pathways and understanding of clinical endpoints in rare neurological conditions.

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Another sizable licensing deal East-West. Interestingly, the licensor is not a big pharma. Showing that significant value creation could be captured by small/mid-size Western players. But also how crowded the space could become. #biotech #innovation

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FDA’s Endorsement: The Marvel of MRD Minimal Residual Disease (MRD) “Elevating MRD to the Forefront” and Revolutionizing Cancer Treatment Approaches The FDA’s Oncologic Drugs Advisory Committee’s recent meeting in April 2024 has cast a spotlight on Minimal Residual Disease (MRD), underscoring its critical role in the advancement of cancer therapies. Here’s how the FDA’s recognition is reshaping the future: 1. Multiple Myeloma: The FDA’s committee has officially recognized MRD as a valid endpoint for accelerated drug approvals. This pivotal decision by the FDA is a testament to MRD’s potential in changing the treatment paradigm for multiple myeloma. 2. Acute Lymphocytic Leukemia (ALL): MRD serves as a vital prognostic indicator, and the FDA’s stance influences treatment choices and regulatory approvals of new medications. It’s a significant step forward, with the FDA’s backing enhancing the credibility of MRD in clinical settings. 3. Chronic Lymphocytic Leukemia (CLL): The MRD status is integral to treatment planning, and the FDA’s consideration is crucial during the approval process of new treatments. The FDA’s involvement ensures that MRD remains a key factor in CLL therapy strategies. 4. Acute Myeloid Leukemia (AML): MRD is being considered by the FDA as a potential surrogate endpoint in trials, which could expedite the approval of innovative AML therapies. The FDA’s support could pave the way for quicker access to new treatments. These examples underscore the vital role of MRD as a clinical endpoint across various cancer types. It’s not just a measure; it’s a movement towards enhancing patient care and fast-tracking the introduction of innovative treatments. The FDA’s Oncologic Drugs Advisory Committee’s discussions and decisions highlight the indispensable role of MRD, now backed by the FDA’s authoritative support. It’s a monumental stride in enhancing patient care and introducing cutting-edge treatments more swiftly, all through the FDA’s visionary lens. For more details, please contact, sales@oliveridleyadvisory.com #oncology #oncolotrials #clinicaltrials #pharma #drugapproval #FDA #minimalresidualdisease #cancer #approval #aacr #esmo #ash Dr. Simone SeiterMoussa Ahmed AmerMou ChatterjeeAnshu Mittal Roy PhD (She/Her)Reena KhuranaKarnik RampalKriti ArnejaMolekule Consulting LLCDavid AldermanAmaninder Singh DhillonVikas SarangalRicha S.Nidhi DhingraYogesh VadepalliBruno LarvolAmit GuptaDr.Hamid Hasan Faridi, MD MBAMichele SpinettaRobert F. Siegmund, PhD MBASabih BeckDr. Timos PapagatsiasSalvador CarlucciDIWAKAR JHA, M.PHARM, M.B.A

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Presenting #HEOR reseach about the cost of managing adverse events associated with systemic therapies for previously treated metastatic colorectal cancer #mCRC at #AMCP2024 in New Orleans. Join me Wednesday April 17 at 11:30 to dive into the results of this study and the latest #evidence that can help shaping #ManagedCare and healthcare decision making. AMCP 2024 is gathering 4,000+ managed care decision-makers from health plans, PBMs, biopharmaceutical companies, consultants, and other leaders in managed care! #Takeda #TakedaOncology

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Thoughtful commentary from my former Lumanity (Cello BioConsulting, Defined Health) colleague Joel Sandler, Ph.D. It will be very interesting to see how all this plays out in terms of therapeutic index, ease of use, manufacturing, and value (clinical benefit versus price) between CAR-T, cell engagers, cancer vaccines, next gen IO antibodies and maybe oncolytic viruses. #immunooncology #immunotherapy #cancer #oncology

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