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Lana Sinichkina is Partner, Kateryna Oliinyk is Counsel, andYevgeniya Ocheretko is Associate, all at Arzinger, Ukraine.

Lana Sinichkina, Kateryna Oliinyk and Yevgeniya Ocheretko discuss how the recent settlement between Gilead and Ukraine's Ministry of Health could promote earlier market access in the country.

Ukraine: Protecting Investments through Entry Agreements Between Pharma and Government

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

Twenty years ago, pharmaceutical product launches were dominated by primary care drugs. These launches were focused on achieving the largest share of voice and were led primarily by sales representatives. Since then, the market has advanced to the specialty era, which includes a more complex patient journey and numerous physician specialties—sometimes as many as seven. Engagement has become more multichannel, and payers are demanding more integrated evidence with increased requirements. These increasingly complex product launches can benefit from the many advantages of generative artificial intelligence (AI), and yet the debate about its usefulness and ethics continues.

To further compound these issues, we see the trajectories of post-pandemic launches underperform and decline. For example, median cumulative sales of post-pandemic drug launches were 28% lower than they were pre-pandemic. This was seen in an analysis of innovative launches during the first six months and across the top eight markets. As we know, the first six months is a pivotal time when determining a drug’s long-term success, as only 20% or fewer struggling launches are able to significantly change their trajectory.

WHY GENERATIVE AI SHOULD BE YOUR LAUNCH ASSISTANT

Getting the right information and insights quickly is imperative for a drug launch. For those launches that are more complex, which involve updating and generating hundreds of documents and have multiple teams searching for information, this is especially true. Using large language models to perform a multitude of language processing tasks allows generative AI to assist marketing teams by optimizing the search and retrieval of information. For example, a generative AI assistant that is trained using online data and documents can understand the semantic context of each query and provide results that are specific to what the user is seeking. This enables users to have an easier time finding what they need quickly and accurately without having to sort through irrelevant content.

A generative AI assistant can also compile a response that connects information from a variety of sources. As a result, responses can be tailored to different personas and be based on preferences that determine the information that is necessary. These assistants can also be used to generate cognitive responses, much like the way individuals process, interpret, and respond to information. Additionally, the assistant can provide the logic behind its produced answers, which can help instill the user’s confidence in the results.

Medical, legal, and regulatory (MLR) reviews of marketing content are another area in which generative AI can help and even accelerate the process. Sample promotional messages that received MLR approval can be used to train a generative AI model. In this way, the model can emulate language flow and produce messages that have a high probability of getting through the review process. Market access teams can also use this model to adapt to global values.

Need insights on the drivers of launch success? Generative AI models can help here, too, and account for variations and the impact of numerous factors unique to specific countries and markets. These models can evaluate timelines and ascertain physician perceptions six months post-launch versus one year. They can also be used to inform tactics by comparing the channel mixes of successful launches versus those that were not effective and determine the optimal channel mix.

Success from using generative AI assistants has been evident. For example, one customer completed a targeted literature search in just two weeks. This was significantly faster than the previous six-week norm. Others using generative AI saw a 50% gain in productivity in creating value dossiers. Value dossiers are the information that manufacturers submit to payers to determine whether the effectiveness of a product justifies its proposed price. Additionally, using a conversational AI model on top of anonymous real-world data enabled customers to conduct the analysis 70% faster. The team didn’t need to know programming, the right international classification of diseases, or other codes to quantify the segment size. This helped expand the use of real-world data.

ENHANCE CUSTOMER ENGAGEMENT WITH GENERATIVE AI

Generative AI can enhance the understanding of various healthcare professional (HCP) segments and allow for more tailored engagements. As AI assistants are used among payers, HCPs, and physicians to help inform prescribing and treatment decisions, pharma may need to start viewing these assistants as another type of stakeholder segment.

As we see other industries using AI-powered chatbots for salesforce training, it may also be advantageous for pharma to create a field force assistant for a launch. A generative AI field force assistant can be invaluable when launching in a new therapeutic area or a new indication, especially when the understanding of key stakeholders isn’t clear. The use of “digital twins” personas can mimic how HCPs communicate and increase the overall familiarity with different personas before sales reps go into the field. This can enhance conversations on specific topics and facilitate responding to difficult questions with new data and insights, as well as promote which answers best resonate with a particular persona.

INNOVATIONS ARE NEEDED TO ENSURE LAUNCH SUCCESS

Launch planning and execution can benefit greatly from generative AI and the game-changing opportunities it provides. The ability to analyze and learn from terabytes of structured and unstructured data is a key advantage of using generative AI. Its ability to generate new content via text, images, or code, and learn to become more intuitive and conversational, are other advantages that can help overcome the hurdle of adoption. Generative AI can also increase productivity in launch planning and execution by providing real-time, personalized, and smarter insights to generate content. Predicting uptake curves and the outcomes of health technology assessments are other benefits, and they can be used to create capability models to predict the future events in the product lifecycle.

DRIVING LAUNCH PRODUCTIVITY AND VALUE FORWARD

By assisting, augmenting, and automating insights, generative AI models can provide enhanced clarity and focus for evidence-based decision-making. Better access to insights encourages and empowers cross-functional collaboration. These insights can facilitate operational agility and allow teams to respond more quickly and with certainty to changing internal and external environments.

The future of pharma is now, which is why incorporating generative AI into product launches should be a serious launch team consideration. Generative AI offers numerous advantages in addition to enhancing launch speed and efficiency. These assistants can also improve the effectiveness of different work streams by enabling quicker processing of reams of data and insights for faster decision-making. Their ability to personalize customer engagement messages and get these messages through the MLR-approval process more quickly provides further support.

Generative AI can mitigate launch challenges and drive productivity, enhance decision-making, and elevate customer engagement to achieve launch excellence. Those who incorporate generative AI into their launch plans are sure to see its incredible value realized. Will your launch team be among them?

Natalie Harb is Vice President, Offering Development, Global Commercial Solutions, IQVIA

1. Launch Excellence VIII. IQVIA. July 12, 2023. 

https://www.iqvia.com/library/white-papers/launch-excellence-viii

How drugmakers can reap value from using generative AI in their market-entry strategies and decision-making, including mitigating launch challenges and enhancing the customer conversation.

The Future of Launch Excellence is Generative AI

Spinal cord injuries (SCI) can be devastating. Victims can often be left with permanent disabilities and debilitating pain. Mike Kelly, president and CEO of 

, spoke with Pharmaceutical Executive about the company’s unique approach to actually repairing these injuries. The company’s primary drug, NVG-291, has shown the ability to activate the body’s ability to heal itself.

Pharmaceutical Executive: How did you become involved with NervGen?


 I’ve been in pharma for about 30 years, starting off on the commercial side of the business. For my last several jobs, I was at the executive level at different companies. At my last job, I was involved in launching the Narcan nasal spray. I joined NervGen after a friend of mine introduced me to the company and said I should look at the technology. I got in touch with the company’s founder Dr. Jerry Silver and had a fantastic conversation. We booked a half-hour and an hour-and-a-half later, Jerry realized he had to leave because he had another call to get to.

Jerry is a great inventor, but he’s also a fantastic teacher. Since I’m not a scientist, he’s been able to take complex science and break it down so he can educate a non-scientist like me about his technology and the series of discoveries he made that led to NVG-291.

Then I met the company’s founder, Dr. Harold Punnett. He started the company after his daughter-in-law fell and became paralyzed. Harold had been a dentist and had a science background, so he began searching the world for spinal cord injury treatments. This is when he discovered Jerry’s research. Ultimately, he convinced Jerry to out license the technology, got a group of investors together, launched an IPO, and started the company.

It's not your typical path for a biotech.

After I met with Jerry, I met the board and core management team. With each conversation, I became more excited that I could actually help the company. The skillset that I brought to the table would get the company to next level.

PE: How significantly can SCI impact a patient’s quality of life?


 There are 18,000 new cases a year, and there’s over 300,000 people living with these injuries, which can range from a minor motor-incomplete injury to a severe, full-paralysis injury. When people think of SCI, they think of someone like Christopher Reeve who was in a wheelchair and needed a ventilator. However, there are folks that had a small accident or sports injury. One of our board members was an avid bike rider. One day, he got run off the road by a truck and got a lot of different injuries. However, one small tweak of his spine left him in a wheelchair for the rest of his life.

The average age for people with SCI is 43. These are people whose lives changed in an instant. It’s pretty devasting to go from being fully functional to having a permanent condition. Some folks have minor injuries that leave them unable to grasp things. Other people are left with more severe injuries and are unable to walk or lose the use of an arm. They must very quickly figure out how to get through life impaired.

It’s not like a disease that has a slow onset. Something happens and these people very suddenly found themselves in a hospital being told that this is how things will be for the rest of their lives.

PE: How does NVG-291 differ from traditional SCI treatment?


 Traditional treatment is just rehab. There’s a lot of cutting-edge things that are starting to happen, but there is no pharmaceutical treatment. Our product works in a simple way. When you cut your hand or break a bone, your body repairs itself. If you damage your spinal cord, however, your body protects itself, and that inhibits repair.

One of the molecules involved in this protection process is CSPG, and this is where Jerry’s research came into play. He had discovered that these molecules could inhibit the repair process, so he started to look into how to turn these molecules off. Through a collaboration with Harvard, a receptor was discovered where these molecules were attaching to cells. He then began developing drugs that could disrupt that process, which is where NVG-291 was discovered.

We’re still trying to determine the specific molecular mechanism of action, but the action we’ve seen is that when the drug is introduced into a rodent model, it turns off those molecules and the body is able to regenerate. We’re not propagating anything; we’re just shutting off the inhibitor and allowing the body to the work on its own.

Kelly discusses how the company takes a different approach to spinal cord injuries.

Repairing the Spine: Q&A with Mike Kelly, CEO of NervGen

Ushering in a first-in-class therapeutic approach in oncology, the FDA, in November 2023, approved AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) for treating adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN).

HR-positive breast cancer is currently the most common subtype of breast cancer, as approximately 65% of breast cancer tumors have been given this classification. Additionally, mutations in PIK3CA and AKT1 and alterations in PTEN have affected around half of patients with advanced HR-positive breast cancer. Considered a limited distribution drug and specialty medication, Truqap was launched in the commercial market earlier this year and reportedly generated $92 million in sales in the second quarter.

 spoke with Ashley Gaines, VP, head of breast cancer franchise, US oncology business unit, AstraZeneca, to discuss the approval of Truqap and its significance as a novel treatment for HR-positive HER2-negative locally advanced or metastatic breast cancer.

“Within this form of breast cancer, there’s a significant need for new treatment options after they progress on therapy for metastatic disease, and that’s where Truqap comes in,” said Gaines. “Truqap in combination with fulvestrant is now approved for patients who have progressed on initial therapy from biomarkers PIK3CA, AKT1, or PTEN. What’s exciting here is that this combination brings a new mechanism of action to the second-line setting, which is addressing a critical unmet need in this space. It brings a medicine that offers both compelling efficacy and a compelling benefit risk profile.”

Prior to Truqap, AZ has had many breast cancer medicines approved - Enhertu in HER2+ and HER2-low breast cancer, Lynparza in early and metastatic breast cancer as well as older breast cancer medicines such as Faslodex and Zoladex.

“Our ambition at AstraZeneca is to eliminate breast cancer as a cause of death one day. As part of that ambition, we hope to bring medicines to the market that will increase survival,” Gaines told 

 “With Truqap, we saw in the [Phase III] CAPItello-291 study a 50% disease reduction or death, which is really exciting. Our overall data at the time of the data readout was immature but encouraging.”

In June of this year, Truqap also received approval in Europe for adult patients with estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.

The approval momentum for Truqap was tempered some with news in June surrounding efforts to expand the drug’s indication. In results released from the Phase III CAPItello-290 trial evaluating Truqap in combination with paclitaxel as a treatment for patients with metastatic triple-negative breast cancer, the trial failed to meet its primary efficacy endpoints of improving overall survival compared to paclitaxel with a placebo. Amid the setback, Susan Galbraith, AstraZeneca’s executive vice president of oncology R&D, reaffirmed the company’s commitment to advancing science for particularly difficult-to-treat heterogeneous subtypes of breast cancer, such as triple-negative.

“While we are disappointed in the CAPItello-290 outcome, these results will further our understanding of the role of the PI3K/AKT pathway in breast cancer as we continue our clinical research across the Truqap clinical development program and across our pipeline,” she said in a press release.

, Gaines discussed the CapItello program as a whole, which is investigating Truqap’s utility in several other indications and tumor types.

“We’re also further studying it in hormone receptive-positive breast cancer,” she said. “We have a study underway where we’re looking at a combination of capivasertib CDK46-inhibitors and fulvestrant. We also have two studies underway in prostate cancer and we’re excited to see what the treatment can do as we expand into other tumor types as well.”

A breakthrough for biomarker-altered breast cancer—but broader challenges remain.

'Marked’ for Stardom?: Truqap

New technologies, such as artificial intelligence (AI), machine learning (ML), and large language models (LLM), have long been expected to transform the pharmaceutical and healthcare industries. While some promises are yet to materialize, others are already making their way into drug development, disease screening, and diagnosis and treatment. In many areas, Asia stands at the forefront of these emerging technologies.

For one thing, the Hong Kong stock market (HKEX) saw the first listing of an AI drug discovery company in June. According to its prospectus, XtalPi combines quantum physics-based first-principle calculations, AI, high-performance cloud computing, and scalable robotic automation for drug discovery services. Its clients include pharma giants such as Johnson & Johnson and Pfizer, as well as Asian biotech companies and research institutions.

There could be more AI drug discovery companies on the way. Insilico Medicine, for example, recently published a paper in 

 on its AI-generated drug candidate for idiopathic pulmonary fibrosis. The drug candidate took 18 months to develop, cost 90% less than a conventional program, and has completed a Phase I clinical trial with a validated safety and pharmacokinetics profile. While most AI-powered drug candidates are still years away from crossing the finish line, the changes new technologies are bringing to the industry are unmistakable.

AI has also become instrumental in disease screening and diagnosis. An AI tool for eye imaging, SELENA+, was first introduced in Singapore for early detection of diabetic retinopathy. Since then, it has received regulatory approvals in several Southeast Asian markets, as well as Australia, Brazil, and South Africa. Through partnerships and collaborations with medical institutions, health ministries, and optometry clinics, it has started to generate revenue from Asia and beyond.

Another innovative tool combining 3D visualization and AI analytics, Cliniface has been adopted to identify unusual facial phenotypes associated with rare diseases using Human Phenotype Ontology standards. First developed by Australia’s Curtin University, Cliniface has received endorsements from SingHealth, a Singapore healthcare cluster, and pharma giant Takeda for the screening and diagnosis of hereditary angioedema. This ensures patients receive timely interventions to prevent potentially fatal progression.

LLMs have also proven to be powerful in disease detection and diagnosis. Children’s Hospital of Soochow University has developed an LLM-based clinical decision support system for Gaucher disease, a rare condition known for its high misdiagnosis rate and delayed triage. By processing the extensive information already stored in electronic medical records, the system can identify patients with high-risk factors and help doctors provide more efficient diagnosis, treatment, and ongoing monitoring.

When it comes to surgeries, augmented reality (AR) and virtual reality tools have found their way into operating rooms. Hainan Medical University hospital recently performed an Anterior Lumbar Interbody Fusion procedure with AR-guided imaging, and 3D AR glasses were used for the first time to examine anatomic structure, locate lesion site, and minimize damages to surrounding tissue and organs. The procedure was a great success, as it was completed 50% faster than conventional surgery with 100% accuracy.

Brain-computer interface (BCI) has been in the limelight globally, with China, Japan, Korea, and India among the leaders for research and publications, together with the US and Germany. BCI provides direct communication between brain and external devices, such as computers and robotic limbs, by linking the brain’s electrical activity and the external environment through the new interface. Some Asian companies are making great progress in helping patients communicate and interact with the outside world, while others are working to restore lost sensory or motor functions in neurodegenerative patients. Besides invasive brain implants, many are focusing on minimally invasive and non-invasive BCI as the next frontier, as these would enable easier adoption for a broad range of applications across ALS, Parkinson’s disease, epilepsies, and spinal cord injuries.

For many of the emerging tools to fully deliver on their promises, more collaborations across sectors and borders are needed, toward developing common ethics standards and safety protocols, sharing the latest data and progress, and benefiting all patients in need. After all, disease knows no borders, and neither should the solution.

- Justinian Liu in Simon-Kucher’s China Life Sciences division contributed to this article.

Bruce Liu is Partner at Simon-Kucher & Partners, leading its life sciences division in greater China

The region is moving to the forefront in integrating therapeutic innovation. 

Asia Embracing New Technologies for Better Healthcare

AstraZeneca Oncology Agents

PE: Are there any other promising oncology agents in AstraZeneca’s pipeline that you wish to highlight?

So, we are dedicating today into two different types of drugs to attack cancer: the ones that attack cancer directly, by targeting a mutation like EGFR mutations, like directing with ADCs or radioligands to a specific marker in the cell -- so attacking the tumor cell itself. We have a lot of success stories there, like TAGRISSO, LYNPARZA, CALQUENCE, and we have ENHERTU and Dato-DXd coming to the market soon, directing to the cancer cell itself.

Then, the other part of our strategy, which is the part that will be growing more and more in the next few years, is how can we enhance the immune system in controlling the growth of the cancer. Now we were not the first there, this all started with PD-L1 and PD-1 inhibitors. We were not the first ones to enter that but I’m very proud to say today that we now probably have the biggest portfolio in that regard. That includes not only PD-1 and PD-L1 inhibitors, but bispecifics. We also have T-cell engagers in both in solids and in heme, and we also have a big portfolio of cellular therapies coming both in hematological cancers, solid tumors, and even in immunology that we’re starting trials across the world. Well, [we’ve already started trials] in hematology right now; in solid tumors we already started, and in immunology [trials are starting] very very soon So, there's tons of things that will come your way and plenty of opportunities for us to meet again and talk about the ten years or the first year or the five years anniversaries of all the molecules. All in all, what we are expecting in the next 24 months, is something like 20 to 26 read outs if everything goes right.

In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business Unit, AstraZeneca, discusses a number of oncology targets in the works at AstraZeneca. 

Lana Sinichkina, Kateryna Oliinyk, Yevgeniya Ocheretko

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