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Asembia 2025 

Topic

Sales and Marketing

1rem

Authors

Dr. Chitra Lele is Chief Scientific Officer, Sciformix Corporation.

Stakeholders around the world can benefit from RWD as it can improve patient outcomes and speed at which products come to market.

The Growing Importance of Real World Data

The need for proactive pharmacovigilance is being increasingly acknowledged by all companies, regardless of their size and product mix, writes Dr. Chitra Lele.

The Power of Proactive Pharmacovigilance

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

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiation therapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and potential side effects. Ongoing research continues to refine these strategies, aiming for improved survival and quality of life.

This whitepaper presents a structured analysis of prior authorization outcomes for RA treatments requiring medical benefit coverage. It examines real-world access barriers from the perspective of payer decision patterns, documentation requirements, site of care, and plan type. Unlike claims-based studies or survey-based research, this analysis draws from actual prior authorization cases, providing a direct window into the real-world challenges faced by prescribers and patients alike.

New Data Reveals What’s Behind Delays and Denials in RA Care 

The management of lung cancer brain metastases has seen significant advancements, with a focus on personalized treatment strategies. The integration of targeted therapies and immunotherapies has improved patient outcomes, offering more effective and less invasive options compared to traditional methods. Stereotactic radiosurgery and whole-brain radiotherapy remain crucial, but their roles are evolving with the advent of novel systemic therapies. Multidisciplinary approaches are essential for optimizing treatment plans, considering factors such as genetic mutations, patient performance status, and potential side effects. Ongoing research continues to refine these strategies, aiming for improved survival and quality of life.

Case study on how one mature/late stage biopharmaceutical brand leveraged SamaCare’s insights and intervention platform to decrease administrative related discontinuations of their drug and maintain market share during a biosimilar release. 

How One Brand Protected Market Share Amid Biosimilar Pressure

Case study on how a neuro biologic brand leveraged SamaCare’s insights and interventions platform to decrease patient access friction and improve patient starts. 

How One Neuro Brand Cut Through Prior Auth Barriers

Reverse Merger Offers Vyome Cost Effective Route to Go Public

, Shiladitya Sengupta, founder of Vyome Therapeutics, discussed the company’s strategic decision to go public through a reverse merger with Reshape Life Sciences, its approach to engaging US investors despite its strong Indian biotech roots, and its focus on developing innovative therapies for immuno-inflammatory diseases. Sengupta detailed how the company is leveraging deep networks in India, repositioning existing drugs to address unmet medical needs, and advancing a robust pipeline of treatments aimed at transforming patient care, while also exploring broader opportunities in med tech and AI.

Pharmaceutical Executive: What led Vyome to pursue a reverse merger with ReShape Lifesciences rather than a traditional IPO?

We wanted to go public, and we felt this was a more efficient and cost-effective way to do so. It required finding a clean shell with no baggage, which took some time. ReShape ultimately fit that requirement. Yes, we had to build up the Vyome brand afterward, but in my mind, it was a simpler and more efficient route.

We also had investors ready to come on board, so there was no pressure to follow the traditional IPO path. That’s the main reason we chose a reverse merger.

The company opted for a reverse merger with Reshape Life Sciences rather than a traditional IPO as a more efficient, cost-effective way to go public. The availability of a clean shell without any liabilities made the process attractive, allowing the company to focus on building its brand, Biome, while leveraging a ready pool of investors without the pressure of a conventional IPO route.

Communicating to U.S. investors about the company’s Indian biotech connections will emphasize its status as a U.S.-registered company with an Indian subsidiary. The leadership brings deep local knowledge, regulatory experience, and extensive networks across biotech, pharmaceutical, med tech, AI, and healthcare sectors in India. This includes co-founders with government and industry leadership roles and access to patient populations and medical data, which the company plans to leverage gradually to capture untapped opportunities. The approach is long-term, focused on steady growth rather than short-term gains.

The company’s lead programs focus on immuno-inflammatory diseases. Its primary asset is nearing the completion of a Phase II trial for malignant fungating wounds, a severe condition affecting 10% of advanced cancer patients with no currently approved therapies in the U.S. The development strategy emphasizes repositioning drugs with proven mechanisms in other indications to reduce risk and cost while targeting unmet medical needs. A preclinical program for uveitis is underway, developing a topical eye-drop formulation to replace systemic immunosuppressive therapy, reducing side effects and improving patient outcomes.

Over the next 12–18 months, milestones include initiating pivotal trials for malignant fungating wounds, pursuing geographic development of a Phase III-ready acne asset in Asia, and filing an IND for additional pipeline programs. The company also aims to expand strategically into med tech and AI through partnerships, reflecting its broader vision of leveraging its Indian network and technology access to build a multi-faceted, high-value healthcare platform.

Shiladitya Sengupta, founder, Vyome Therapeutics, explains how the company leveraged a reverse merger with ReShape Lifesciences to streamline its path to going public while minimizing costs and complexity.

In a turbulent era for the life sciences, leadership demands clarity, resilience, and adaptability. In this candid podcast conversation with 

, Ken Banta, founder and CEO of The Vanguard Network, shares high-level insights on what CEOs can do to thrive amid the disruption—from regulatory agility to cultural resilience. The corporate strategy expert and author of the new book 

 explains why the best leaders are the best learners—and how prioritization, honesty, and boldness will separate those who merely survive from those who shape the industry’s future.

Navigating a “new maze” at the FDA and its personality-driven complexities

R&D bets shifting toward proven winners, leaving long-shot breakthroughs behind

Building trust and culture through transparency in uncertain times

The call for leaders to embrace continuous learning—from AI startups to lab bench innovators

 Click below to listen. View/download the transcript 

Ken Banta, founder and CEO of The Vanguard Network, reveals the mindsets and moves biopharma leaders need to not just endure—but rise above—the current age of industry disruption.

Chitra Lele, PhD

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