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The legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer's drug development, leading to securities litigation over allegedly misleading statements about trial results and commercialization efforts.

Securities Litigation Arising from Alzheimer's Drug Treatments

AbbVie Pedro Valencia ADCs

PE: How is AbbVie using novel cancer biomarkers to develop potential first-in-class ADCs for the treatment of advanced solid tumors?

We're constantly looking for biomarkers that can help us to do two key things. The first is to tackle cancer cells. and spare normal cells. We’re looking for specific antigens that are over-expressing tumor cells, and you see limited expression in normal cells. We want to make sure that target that’s over-expressed is critical for the survival of the cancer cell. Once you block it, you can actually drive a cancer cell death. That’s what we're looking for. In that perspective, c-Met is one of those biomarkers that is over expressing multiple tumor types such as lung, colorectal, gastric, and other GA tumors. We as an industry have tried to tackle c-Met in the past but have been unsuccessful. It would actually be successful to tackle what we call met, which is a gene inside the cell.

There’s this thing called met amplification, where the cancer cell produces multiple copies of the gene, and around 30% of patients have it. We can actually tackle that with small molecules. But once the gene becomes a protein and gets over-expressed in the cell, that over-expression is something we haven’t been able to target. For example, we know that on lung cancer, c-Met over-expression is about 25% to 50% in colorectal cancer, and it could be anywhere from 30% to 70% depending how you measure it, so it’s quite prevalent.

With ADCs, we’re trying to tackle c-Met over-expression on the surface of cancer cells. That was novel, and we can do it through ADCs. 706 has a target called SEZ6, and it’s a target that is over expressed in neuroendocrine cells or neuroendocrine neoplasms. When you think about it, multiple tumor types kind of have a subset of cells that are neuroendocrine driven. Small cell lung cancer is one of the few that has everything driven by neuroendocrine cells. The beauty of SEZ6 is over-expressing those cells and limited expression in normal cells. So, we can tackle it with an ADC and drive the results that we're seeing today.

PE: ADCs have redefined the treatment of cancer in recent years. Can you please discuss the promise of this emerging class and what the future may hold?

At the end of the day, ADCs work like a trojan horse. You have a good antibody that cancer cells are happy to receive, but once you hook into the cancer cell receptor, you deliver the payload, which is pretty much chemotherapy. It’s actually a highly potent version of the regular chemotherapy cancer patients are given on a regular basis. So, from that perspective, our goal is to replace chemotherapy. Our grand goal with ADCs is to replace good old, decades old chemotherapy that is really toxic for some patients. That’s how we see the redefinition of cancer treatment in the future with ADCs. So, what do we see in the future? Well, if you think about it, chemotherapy is being given in combination with other agents. In the future, we see ADCs being given in combination with chemotherapy. There will be one with other agents such as immuno-oncology agents. So, if you combine the ADC and the PD1s, you can start seeing that synergy come together and kind of start really dreaming about cures for the patients. All in all, we're super excited about ADCs replacing chemotherapy. 

In an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer. 

Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors

With any new year, comes change, of course, and for 

, we have an exciting one for our readers. As you may have noticed, our 

It’s been a few years since the publication’s last redesign, but our latest one, we are confident to convey, is much more than simply a refresh. Our goal was to marry the brand’s authoritative content and analysis that you’ve long relied upon with an upgraded presentation to match. After all, the industry we cover is constantly evolving and innovating—so why shouldn’t we?

The result was the creation of a more modern, sophisticated, and sleeker look to the magazine, with a nod to some of those trusted business titles you may still page through at the doctor’s office or on the plane. Ease of navigation was also very important to us. You’ll notice in 

 February issue a smoother and, we hope, a bit more inviting flow of text and visuals. Let’s face it, print today is up against an ultra-fast-paced, attention-packed, digital world. Sprucing up overall eye appeal is one thing, but we know it’s the cohesion of the ingredients inside that will be what differentiates and enhances your content experience the most.

We hope you enjoy the new design. A special thanks to our talented creative team, where Ariana Mexquititla, associate art director, spearheaded the project, in collaboration with editorial. We’re still in tweak mode, so we invite your feedback, good or bad, and suggestions and thoughts on ways we can improve further!

Mike Hennessy Jr. is President and CEO of MJH Life Sciences

Welcome to a bold new look for Pharmaceutical Executive's print and digital magazine.

At First Glance 

Gene Mack became CEO of Gain Therapeutics in January 2025 after previously serving as interim CEO and chief financial officer for the company. Mack brings 25-plus years of experience to the leadership role for the clinical stage biotechnology company, having previously worked in areas such as clinical research, financing, investing, corporate strategy, and business development.

 Mack discussed his transition as the company’s new CEO, its use of physics-based artificial intelligence (AI) for drug discovery, the progress and financing of its lead drug candidate GT-02287 for the treatment of Parkinson’s disease, and strategic decisions regarding clinical development, partnerships, and future growth.

PE: You’re fairly new as the CEO of Gain Therapeutics. Can you speak more about different aspects of the company, such as its physics-based AI, how it could be applied to this new AI paradigm, and speak more about your lead candidate?

I joined the company about a year ago as its chief financial officer. I had a connection to the board. The scientific founder is a CEO I covered as a cell side analyst, and we developed a relationship that continued for the next decade. Last year, he gave me a call since his CFO went off to do something in Europe, and he felt that the current management didn’t have a lot of experience with capital markets. So, they asked me if I would take a look. I have a neuro background, and since it was for Parkinson’s disease, it was natural for me to take the role of CFO.

The CEO and the board parted ways over business development and types of transactions that the company should be pursuing. In June, they agreed to disagree and I became the interim CEO, which was made permanent in January. Small biotech companies live through chronic periods of existential threats, with brief periods of enormous success if they’re good. But for the most part, there are a lot of existential threats out there. In a small company, a CEO has to be available at all times. So, that’s a challenge, but it’s very rewarding and I’m happy to be there.

We have enough capital to complete an interim analysis from our Phase IB trial (of GT-02287), which we think will be a sufficient enough signal finding exercise to design Phase II. At that point, we’re going to share the interim results with our potential partners as well as the market. From there, we either raise additional capital on our own, with partners, or some combination of the two that allows us to maintain significant ownership of the compound.

PE: Are you putting forward additional candidates or are you waiting to see the results of the readout?

We have a backup portfolio of compounds that also target glucocerebrosidase (GCase), which is the target of GT-02287. The interesting aspect is that it’s structurally distinct. In a nutshell, the Magellan platform was initially good at taking known compounds and figuring out the binding kinetics and could do some things intuitively. What we do now is bind kinetics for fragmented molecules that don’t necessarily exist yet but could potentially be formulated based on the structure that the platform builds. Then you see structures flickering in and out of view, you start to see things stick and not come off, because there’s a threshold. As that structure is built, that is a theoretical threshold.

I think the next thing that we need to improve upon is having it spit back more accurately and be something that can stabilize quickly. It takes a tremendous amount of data. Right now, AI is a shiny object, but there’s a million people working in the background to make sure that objects stay shiny. This includes constant data integration. If you don’t do it correctly, it won’t work properly.

PE: What can you tell us about the timeline for clinical data milestones?

In December, we received approval in Australia to start our Phase I study in patients with Parkinson’s disease. In the third quarter of last year, we reported safety and tolerability results from a health volunteer study. The first step in a Parkinson’s disease study is to conduct a health volunteer study for 14 days in order to make sure the drug is well tolerated. We saw the safety and tolerability profile that we wanted as well as target engagement. In health volunteers, we were able to increase Gcase activity, which was an important finding. That’s the target of GT-02287. You shouldn’t see that in healthy volunteers. People in homeostasis work on feedback loops. When something shifts into an imbalance, the body works well at reacting quickly to compensatory mechanisms in order to nail it back down. Based on the snapshot that we took, we were able to see that the enzymes received 53% activation. To me, that’s the reason to believe that we’re on target going forward.

Now we have to demonstrate in another pilot study that it’s safe and tolerable. In our first study, we saw some grade 2 nausea, and we want to make sure that doesn’t turn into something worse, but there’s no reason to believe that it will. Nonetheless, we still need to do the three-month dosing study. We expect to see Gcase activity there as well, but we’re not sure if we’ll see a functional response after three months. Some of these patients have had toxic substrate building up in their brains for four years. Something working into that mechanism is going to take much longer to show functional employment, because you’re basically trying to stop the damage. You’re not repairing or masking anything. But if we can stop it in severe patients, we continue to move that treatment paradigm earlier as long as the therapeutic index remains appropriate.

PE: What are the next steps in the Phase IB study?

We’re going to enroll 15 to 20 patients, and we’re expected to start any day now. The open-label study will dose these patients for three months. We’ll watch enrollment from now through March. By the end of March, I expect to be able to tell the market what will be included in an internal analysis from the Phase I study.

There are a number of decisions that need to be made on the back of the Phase IB interim analysis. We’ll start incorporating and thinking about a Phase II design, but we might keep that protocol open and extend the dosing to 12 months. By the time the Phase IB data reads out, we will be able to incorporate that into the protocol amendment and extend the dosing. As a result, we’ll be able to get an answer much sooner than if we stopped the trial towards the end of this year. The Phase II readout won’t occur until some point in 2027. If I can start dosing patients for 12 months, beginning in the third quarter of this year, I’ll have that data a full year earlier. That’s important for the field, investors, and for patent life.

The next two big milestones coming are an enrollment update at the end of March with guidance on what the interim analysis would say.

PE: Tell us more about the financing of the company up to this point

It’s been very difficult. The private financing went smoothly but the public financing, that became a bit problematic. When the company went public towards the tail end of 2021, the market was starting to cool off. I would guess that Gain Therapeutics was one of the last companies to go public that year before the financing window went away completely. At the time, the company had about two years’ worth of cash. We went back to the market in 2023 and conducted a very difficult financing at around $2.75. We then did another financing round in June at $1.35.

All the while, the fundamentals of GT-02287 have improved. It’s been elaborated through the data. So, the financing tracker has been inversed to the success of the company, and there’s a couple of reasons for that. I think early on, expectations were that this company would get acquired by a strategic partner quickly. With preclinical data, I think that was a bit naïve. The expectation crept out into the market, but there weren’t enough discussions about the clinical development decisions that needed to be made.

People felt that there was no conviction. Meanwhile, the strategic partners are at the gate. We could make a deal tomorrow. Most companies act favorably, but they didn’t consider whether the data will look as good three years from now as it does today. We don’t want to be unfair, but we also don’t want to leave a tremendous amount of money on the table. The early work we’ve done will significantly reduce that risk.

We’ve had some pressure to partner before our Phase IB trial, and we’ve been resistant to that because for little capital, we can deliver a Phase IB result, and then see if we’re still the right company to move forward with, and I think we are.

There’s a lot of debate on the board on what the company’s growth is going to look like in the next year. Is it going to be a partnership, a solo venture, or is it going to have another name on it? That’s something that will be determined by the data. But having activated Gcase in health volunteers, I am content to wait and see how this plays out.

PE: Would you envision that all eyes are on getting GT-02287 to move forward?

Yes, the eyes were initially on Magellan and tweaking it in a way that it can be monetized. When I joined the company, I thought that was all wrong. We have a drug in clinical that will validate the platform rather than keep pumping out molecules that may or may not work. If they fail, it reflects poorly on Magellan. Let’s prove that those end products can make it into the clinic. Since coming in as CEO, I’ve converted us over a little more towards clinical operations and a little bit less towards bench research. It’s not less of an emphasis on bench research but right now, the growth area is in clinical operations.

The people running Magellan, and our early-stage pre-clinical research are awe-inspiring, because we have a pipeline that’s difficult to validate at low levels because of the productivity. We’re trying to consolidate some of that work and build the clinical operations team so that we can make good strategic decisions, which is where the company should have been headed as soon as GT-02287 entered clinical development.

Gene Mack, Gain Therapeutics CEO, provides a look into the future of the company and the use of physics-based artificial intelligence in the drug discovery process. 

Q&A: Gain Therapeutics CEO Discusses AI-Driven Drug Discovery, Strategic Growth Plans

is planning two events to be held next month. First, is our very first virtual conference and expo, Reaching the Healthcare Provider After 

COVID-19, on Aug. 13. Next up is the second of what looks like it could become a popular series, Pharmaceutical CEO Leadership closed virtual roundtables, to be held on Aug. 20. The Pharmaceutical CEO Leadership During the Pandemic roundtable appeared 

. You can also view the video excerpts from the roundtable 

. The next one in the planning stages will be spearheaded by Senior Editor Elaine Quilici and will feature key insights from Rob Jekielek, managing director at Harris Interactive. This should prove interesting as we get insights from the CEOs around “Pharma Image: 2021.”

	There’s a lot that can be said about Image. It’s not just reputation, or public perception, or one topic. It’s the whole of what an organization does internally and externally to offer an overall picture of who they are and what they represent. In this 

 from Quilici in June, as well as my editor’s letter from last month, we referenced reputation as a positive that pharma could achieve during COVID-19 and after. 

	Those sentiments were based on interviews we conducted, presentations we watched, as well as comments from the first roundtable and highlighted by Regeneron CEO Leonard S. Schleifer, MD, PhD, who said, “This is an existential moment for the industry. I think we will rise to the occasion. I am excited about the number of different companies trying incredibly novel approaches for vaccines, the number of companies who are trying different therapeutics. We have to do it scientifically, and we have to do it in an affordable, successful way. If we do, we’ll change industry and, frankly, we’ll change society for a long time.”

	As the pandemic raged on past the May 20 roundtable, the broader public continued learning more about scientific innovation, and the basic workings of clinical trials. But soon, lockdowns ended, people grew tired or forgot about distancing and masking, and now we are in another point of our public relationship with the pandemic. 

	On June 29, CNBC’s Meg Tirrell interviewed Gilead Sciences CEO Daniel O’Day on 

 about the company’s announcement of its pricing of remdesivir (watch video 

). The price was set at $2,340 for a five-day course; however, US insurers, in addition to Medicare and Medicaid, would pay $3,120. Remdesivir received emergency use authorization from the FDA to treat hospitalized COVID-19 patients on supplemental oxygen.

	Tirrell, of course, hit all the right questions, even, maybe, hopefully referencing our own magazine in her opening question: “This is a very important moment both for Gilead and the drug industry as a whole. You know, one industry publication writing this is a moment that could define the conversation around the pharmaceutical industry’s reputation for years to come. You set this price, basically in line I think with what a lot of people expected. You said it’s well below the value the drug brings, but it’s 30% higher to US insurers than to government insures around the world, in developed countries. Tell us about how you set this price.” 

	O’Day went on to inform about the differences in prices and how the therapy would influence reductions in hospital stay and healthcare spend. Tirrell pressed on the role of the middleman in the pricing, as well as the question of supply for America vs. rest-of-world. And O’Day dutifully explained those also.

	But at the end of the day, the headlines were mixed for Gilead. While some thought the announcement would lead to further erosion of pharma’s reputation, others referenced estimates from the Institute for Clinical and Economic Review (ICER) in Boston that remdesivir priced at $2,800 would be “reasonable” given its overall positive effect on those healthcare costs. Still, others voiced concern that the price doesn’t account for US taxpayer money. The same money that helped fund the NIH clinical trial of remdesivir for COVID-19.

	Clearly, this was the first pricing move out of the COVID gate, and it isn’t a vaccine or a “cure.” However, it is a reminder that the next steps are not without image risk. Continuing the dialogue that therapies and medications are important to the whole healthcare spend and quality of life for people, that the middlemen are also not absolved of responsibility, and that there is need for a more transparent patient pricing system would be a major benefit toward a more holistic image makeover. 

Gilead's pricing of COVID drug remdesivir is a reminder of pharma's tenuous path forward as it seeks a more holistic image makeover.

Will the Industry Rise to the Occasion?

	While scientists around the world are striving to discover, produce and distribute safe and effective vaccines to halt the coronovirus outbreak, cadres of anti-vacciners are revving up misinformation campaigns to undermine public confidence in such preventives. Despite the clear danger of COVID-19 to global health, vaccine opponents have gained ground, as fearful populations lose faith in the capabilities of industry and government to protect public health. 

	The latest tactic of anti-vaccine forces is to align with protests against government lock-down policies and restrictions on business and daily life. The “Reopen America” campaign has attracted groups fighting state vaccine requirements for school-age children. Despite strong childhood vaccination rates (over 90%) in the U.S., notable pockets of resistance dot the nation, as anti-vacciners show considerable savvy in communicating their message through social media to fuel more widespread “vaccine hesitancy.” A recent poll by the Associated Press and NORC at the University of Chicago found that while 49% of respondents plan to get vaccinated against COVID-19, 20% say they will not and 31% are not sure. Hesitant responders cite fear of side effects, of getting infected from the vaccine, belief that the new vaccines don’t work well, and 

 – issues that need to be addressed clearly by manufacturers and health authorities. 

	Ironically, the high-profile U.S. campaign to develop and produce vaccines against COVID-19 quickly, as promoted by the Trump administration’s Operation Warp Speed initiative, may fuel such objections. Instead of undergoing five or ten years of pre-clinical and clinical testing involving tens of thousands of individuals, current experimental COVID-19 vaccines are moving quickly through the development and approval process. Although such accelerated discovery is widely applauded, it also opens the door to fears that resulting preventives may be inadequately tested and less safe. 

	Related to this is the rise in novel technologies being explored to expedite vaccine development and production. Among some 150 COVID-19 vaccines in development, early front-runners utilize mRNA, DNA, new gene therapies and additional adenovirus vectors to trigger an immune response. Anti-vacciners describe these approaches as “synthetic” and “unnatural” and likely to generate adverse events more lethal than the virus itself. 

	Suspicions in vaccines also stem from charges that biopharma companies and international organizations are foisting risky treatments on the world just to make huge profits. Anti-vaccine crusaders have levelled conspiracy charges for years, particularly at the Bill and Melinda Gates Foundation and the World Health Organization for seeking to control the global health system in ways to track individuals’ activities. Such accusations have undermined international efforts to expand vaccine access to developing nations and to vulnerable populations. 

	Pharma critics also oppose industry patents on pandemic treatments, particularly those discovered and tested with significant financial support from government and public agencies. Although manufacturers of early experimental therapies have provided some treatments at no cost, and analysts have calculated fairly high values for vaccines that save lives and help restore the world economy, the debate over cost and access will continue. 

	Policy makers face further disagreement over the extent that anti-COVID-19 vaccination will be required for individuals to engage in activities involving greater personal interaction. With clear evidence that COVID-19 is highly contagious and dangerous, local and state governments may move beyond requiring certain vaccinations for children to attend school to mandating or recommending vaccination for those in certain jobs, to attend public events, and to utilize public facilities. Employers and service firms may impose similar requirements on staff, while the federal government could require vaccination for travel in and out of the country. Medical authorities estimate that 60-70 percent of the population would need to be vaccinated or found immune to achieve “herd immunity,” a high number that will require millions of vaccine doses fairly quickly. 

	The Centers for Disease Control and Prevention (CDC) has launched a “vaccinate with confidence” campaign to address concerns of those hesitant about vaccination, as opposed to the relatively few vocal vaccine opponents, explained Nancy Messionnier, director of CDC’s National Center for Immunization & Respiratory Diseases, in a recent virtual meeting on tackling vaccine access and hesitancy issues organized by the Forum on Microbial Threats at the National Academies of Sciences, Engineering and Medicine (NASEM). The group will further examine the impact of declining vaccine confidence at a 

	CDC also is concerned that scheduled vaccinations for young children have declined in recent months, largely because parents have delayed routine doctors’ appointments for fear of infection at medical facilities. While vaccination rates are expected to return to normal, the current drop raises fears of measles and meningitis and other outbreaks in coming months. Health authorities already are pressing for widespread seasonal influenza vaccination in the fall to reduce health risks from a second COVID-19 outbreak when cold weather returns. 

	Transparency and full disclosure of vaccine benefits and risks are important for overcoming public fears of new preventives. Manufacturers and regulators need to clearly communicate potential adverse events, while moving away from the long lists of possible side effects that confuse and scare the public. Clear assurance of product quality and safety also will be critical, especially for any vaccine produced overseas. 

While scientists are striving to discover and produce safe and effective vaccines to halt the coronovirus outbreak, anti-vacciners are revving up misinformation campaigns.

Vaccine “Hesitancy” Threatens COVID Immunization Efforts

 Emerging Pharma Leaders recognition reemerges in this issue. The Class of 2020 features 11 leaders who span large pharma to emerging biotech, as well as roles that lead the various complex and innovative areas across their respective companies. We started the Emerging 

Pharma Leaders (EPLs) nomination and voting process well before the pandemic and conducted interviews on the cusp of the initial lockdowns. Therefore, we

 didn’t discuss COVID-specific questions. However, we can clearly see how leadership determines the path biopharma companies navigate through not only a very complex and regulated industry, but how leaders can steer through public and global crises.

	One of the criteria the judges used to evaluate our EPLs is the actions that nominees took to ensure their path in the C-suite. That determination speaks not only to the desire to lead, but the qualities needed to guide biopharma through difficult times.

 is extremely excited to debut the EPLs milestone with another, the 

, one which was a true collaboration between many departments and our external Editorial Advisory Board. You may have noticed that we also changed the tagline of 

 to “Master the Science of Success.” Though we have had a few taglines in the brand’s existence, this one speaks eloquently to you, the audience, and reiterates what we provide you from reading our articles in print or on the web, or engaging with our other media platforms such as enewsletters or webcasts, eBooks or videos, podcasts or virtual events. We are dedicated to providing you with the information and tools you need to lead and succeed in this industry.

	We’ve reimagined the design of the publication to better reflect our audience, as well as the pacing of the articles, so that you know where to find your favorite columns, or easily page to the Executive Profiles or in-depth features. Thank you to our exceptional design staff, Jeff Brown, Ray Pelesko, Marie Maresco, and Maya Hariharan for their talent in transforming our thoughts into a tangible vision.

	To our regular columnists who have provided exceptional coverage of the FDA and EU regulatory and government landscapes, we’ve added four more regular staples. The Financial column is authored by Barbara Ryan, an EAB member and founder of Barbara Ryan Advisors, a capital markets and communications firm she started in 2012 following more than 30 years on Wall Street as a sell-side research analyst covering the US Large Cap Pharmaceutical Industry. Her opinions and expertise are widely sought; she is frequently quoted in the press and appears on CNBC; and she is well-positioned to provide our readers with with the insights and current financial outlook for biopharma.

	Sandor Schoichet is well-placed to pen our new Biopharma Sustainability column. In his capacity as Director & Independent Advisor, Meridian Management Consultants, he co-founded the Biopharma Sustainability Roundtable, an annual invitation-only Roundtable and Investor Day. Topics have included sustainability strategy, program management, and enterprise process improvement. Sandor has worked with several life science, IT, and technology development organizations in executive and consulting roles.

	Our Technology column is helmed by Julian Upton, P

’s European and Online Editor. Often writing on the topic already, our go-to tech expert will continue to provide the right balance of know-how with ways companies evaluate success.

	Elaine Quilici, our Senior Editor, will contribute a monthly column on Leadership. In the past year, Elaine has taken charge of the PharmExec podcast, as well as writing features and executive profiles. Leadership takes many forms, so this column will be diverse, and it will address, again, the success strategies you can consider for you and your organization.

	As we move forward with our new design and our new “Master the Science of Success” as our compass, we will continue to bring you the content you’ve grown to rely on. COVID-19 has impacted many biopharma companies in the short-term, and will continue into the long-term. Our articles will continue to weave lessons learned from the biopharma community as we move onto the next stages of the pandemic. June’s annual Pharma 50 issue will also include an article on how large pharma responded to the crisis. Moving into September, the annual Brand Launch issue will tackle how brands were affected overall by the pandemic, whether sales, marketing pivots, or patient access. With Science part of the Success equation, our November Pipeline issue will offer a COVID therapy development section, at which time the landscape will have hopefully dramatically changed.

	Please enjoy our new design and branding, and please share your opinions with us.

. She can be reached at lhenderson@mjhlifesciences.com. Follow Lisa on Twitter: @trialsonline

Welcome to the new look and branding of Pharmaceutical Executive-reimagined to better reflect you, our audience, and expand on the content you've long trusted us to deliver.   

Robin Wechkin, Sara B. Brody, Sarah Hemmendinger

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