Radiopharmaceutical Theranostics with Roseanne Satz, Advanced Innovative Partners

About the Interviewee (Sourced from AIP’s Official Website)

Roseanne “Rose” Satz, is the Chief Executive Officer (CEO) and Co-Founder of Advanced Innovative Partners (AIP), a company on the vanguard of tackling the toughest challenges in predictive and personalized healthcare practice.

Ms. Roseanne Satz is a seasoned businesswoman that has worked hard to make a difference in the world. Armed with degrees in both International Business and Marketing Management her credibility and aptitude for developing professional networks. She is a true entrepreneur engaged in multiple endeavors including serving as CEO and Co-Founder of Advanced Innovative Partners. She has served as a regulatory advisor and consultant for Johnson & Johnson as well as several foreign and domestic pharmaceutical manufacturers. Ms. Satz successfully built a network of scientific experts, research organizations, and manufacturing partners building a robust pipeline of diagnostics and therapeutics.

The Discussion

The Founding of Innovative Theranostics through AIP

[Dex Marco]: It’s such a pleasure to have you here with us today, Miss Roseanne. With over 20 years of proven track record in leadership in radiopharmaceuticals, management, regulatory affairs, and production that have resulted in multiple FDA approvals, what would you say drove you towards this field, and what brought you to eventually co-found Advanced Innovative Partners?

[Ms. Roseanne]: Thank you for the warm introduction. It’s a pleasure to be here today. The journey that led me to co-found Advanced Innovative Partners (AIP) in the field of radiopharmaceuticals has been quite interesting.

Initially, I had plans to pursue a career in medicine. However, things took a different turn after I completed my degrees in marketing management and international business. At that time, my father, who is also a co-founder, made the decision to start his own company.

When he shared his plans, I saw an opportunity to contribute to this new healthcare venture. Thus, more than 30 years ago, I found myself immersed in the fascinating world of radiopharmaceuticals.

During this time, we were working on FDA approval for a radiopharmaceutical, “Strontium-89”, which is used for relieving metastatic bone pain in breast, lung, and prostate cancer patients.

As part of our efforts to gather clinical data for FDA approval, we conducted clinical trials primarily in Asian countries. I would spend nights calling our colleagues to discuss clinical protocols and clinical trial data. Eventually, we succeeded in obtaining regulatory approval for the drug, and we partnered with Cardinal Health for its distribution.

At that time, I was one of the first women to hold a management position in the nuclear medicine space. Over the years, the presence of women in this field has significantly increased. Receiving FDA approval for a true generic radiopharmaceutical was a significant achievement. Not only did we obtain FDA approval, but I also achieved another first by having the FDA inspect a Russian facility and approve our active pharmaceutical ingredient—an unprecedented feat.

It wasn’t an easy journey, especially considering the market was relatively flat in radiopharmaceuticals as compared to today’s market. The largest revenue-generating drug at the time was Cardiolite, distributed by Syncor, which later merged with Cardinal Health. After receiving FDA approval for our drug.

My responsibilities extended beyond regulatory work. I oversaw our GMP and GLP manufacturing lab, which included chemistry, microbiology, and quality control facilities. I managed the entire lab operations, from manufacturing to shipping the drug worldwide.

One of the most rewarding experiences of my career was receiving a personal call from the daughter of a cancer patient who was treated with our radiopharmaceutical. She expressed her heartfelt gratitude, as her father had been in extreme pain. The drug provided him with relief, and I couldn’t have asked for a more inspiring moment. It reaffirmed the importance of the work we were doing and the positive impact we could have on people’s lives.

As for how we arrived at Advanced Innovative Partners today, after facing challenges with both of my parents becoming ill simultaneously I was forced to sell our previous company and took on a variety of consulting roles to rebuild our resources. I collaborated with a regulatory attorney and several other companies like Johnson and Johnson.  In 2017, I decided to become an entrepreneur again and founded Advanced Innovative Partners (AIP) with a focus on radiopharmaceuticals.

The foundation of AIP was built on a unique peptide molecule developed in collaboration with the National Institutes of Health (NIH). This enabled us to create a comprehensive portfolio that encompasses both diagnostics and therapeutics, with a particular emphasis on breast cancer, lung cancer, and solid tumors.

We also recognized the challenges in developing drugs for orphan diseases, and this led us to establish a division within AIP dedicated to rare pediatric cancers for which we received several orphan drug designations.

While we continue to fund the company, the radiopharmaceutical market has witnessed significant growth in recent years, demonstrated by notable acquisitions made by Novartis in the field of nuclear medicine and we are building on this momentum to expand our portfolio further.

Disrupting the Field of Oncology with Nuclear Medicine

[Dex Marco]: Nuclear medicine has been used to treat cancer for decades, and radioligand therapy itself is not new. The therapy has previously been used to treat cancers like lymphoma, but it was not always widely accepted or used by members of the medical community. What do you think are the major challenges that hindered the swift adoption of radioligand’s utility in medical practice and how does Advanced Innovative Partners leverage its clinical-stage biotechnology expertise in this regard?

[Ms. Roseanne]: The adoption of radionuclide therapy has not always been widely accepted. It’s true that nuclear medicine and radiopharmaceuticals have been used to treat cancer for decades, but the utilization of radioligand therapy has faced its share of challenges.

SPECT and MRI were the more conventional imaging technologies for cancer detection, while PET imaging, the one closely tied to radiopharmaceuticals, had a slower adoption rate. However, we have witnessed a significant shift in recent years with the increasing number of PET cameras and the FDA approvals obtained by companies like Novartis and others. These advancements have sparked greater interest and confidence among physicians, leading to a renewed focus on precision medicine using theranostics.

Additionally, another challenge we faced was the traditional order of medical consultations for cancer patients. Typically, after a cancer diagnosis, patients would first consult a general practitioner, then an endocrinologist, followed by an oncologist, and finally, a nuclear medicine physician. Nuclear medicine was often seen as a last resort rather than an early consideration.

At Advanced Innovative Partners (AIP), we strive to be a disruptor by emphasizing the need for companion diagnostics and theranostics for the use in Peptide Receptor Radionuclide Therapy. This can greatly enhance treatment plans for patients with cancer.

By combining our technologies to manage cancer with a personalized approach, we aim to bridge the gap and overcome the challenges with cancer treatment. Our goal is to improve patient outcomes and provide innovative solutions for physicians to treat patients.

A Broader Portfolio for Greater Competitive Advantage

[Dex Marco]: AIP’s lead technology platform is an integrin antagonist peptidomimetic, a small chain protein-like molecule that binds with high affinity to cancer cells proving its strong antineoplastic potential. With AIP as the exclusive licensee of the patent and with the company’s growing intellectual property portfolio, what strategies are set in place to ensure that the momentum is maintained and that AIP maintains its competitive advantage in the field of precision medicine?

[Ms. Roseanne]: Thank you for recognizing the strength of AIP’s lead technology platform and our growing intellectual property portfolio. At AIP, we understand the importance of maintaining momentum and ensuring a competitive advantage in the field of precision medicine.

To achieve this, we have implemented several strategies to diversify our portfolio and reduce dependence on a single platform or technology. We have dedicated groups within AIP that focus on specialized domains, allowing us to explore various avenues for innovation. Our oncology portfolio offers a wide range of theranostics that enable accurate cancer detection and treatment. By enhancing early detection and providing precise treatment options, our technologies will significantly improve patient outcomes.

In addition to oncology, we have a rare pediatric disease portfolio that offers clinical management for several malignancies and disorders. We also develop radiopharmaceuticals for the diagnosis of rare and devastating childhood conditions. This commitment to orphan diseases reflects our dedication to making a positive impact on the lives of children and their families.

Furthermore, we are developing diagnostic and therapeutic drugs within our infectious disease portfolio. These advancements allow for rapid and reliable identification of various infectious disorders, which is crucial in addressing infectious diseases and managing sepsis effectively.

Another important aspect of our work at AIP is the treatment of biomedical countermeasures. We focus on symptom management and assisting the body’s healing process to mitigate the damaging effects of radiation. Our goal is to help people, healthcare professionals, and emergency responders in safeguarding individuals from radiation-related risks. Prevention plays a pivotal role in reducing the likelihood of acute radiation syndrome (ARS), and we prioritize raising awareness and providing effective solutions.

Driving these endeavors forward and ensuring their viability and success is our Chairman and Co-Founder, Stanley Satz, Ph.D. As AIP’s Chief Scientific Officer, Dr. Satz brings over three decades of expertise as a radiation physicist. His leadership and immense knowledge in the creation of radiopharmaceuticals for targeted radiation therapy make him an authority in this field. Dr. Satz’s dedication to research and innovation has resulted in multiple U.S. patents and numerous journal publications, cementing his reputation as a visionary in precision medicine.

At AIP, we are committed to advancing the field of precision medicine and maintaining our competitive edge through ongoing research, strategic partnerships, and the development of cutting-edge technologies. Our ultimate goal is to make a lasting difference in patient care and contribute to the future of healthcare.

Navigating Regulatory Affairs for Optimal Patient Safety

[Dex Marco]: Radioligand therapy is administered through an intravenous infusion, and though it does help limit damage to healthy tissue, patients can experience some side effects. From a regulatory standpoint, what steps or protocols in the clinical research process at AIP are present to ensure dose optimization and guarantee the significant reduction of side effects?

[Miss Roseanne]: As a regulatory expert who has successfully navigated through the regulatory approval process for pharmaceuticals, I have an understanding of the challenges involved, especially when it comes to radiopharmaceuticals. Particularly, injectable drugs are an extremely challenging process due to stringent regulatory requirements.

When collaborating with partners for drug development, our priority at AIP is to ensure the safety of our drugs. This is crucial for any collaborator we associate with during clinical studies, following rigorous protocols to demonstrate the efficacy and safety of our pharmaceuticals.

To ensure the highest level of monitoring, we engage with CROs that play a vital role in overseeing the study and monitoring the patients. Patient safety is of utmost importance to us, and we closely monitor their well-being throughout the study. It is important to note that the patients we treat with our drugs are often in the second or third line of treatment, meaning they have already undergone chemotherapy or other forms of treatment.

Leveraging Partnerships Streamlines Radiopharmaceutical Supply Chain

[Dex Marco]: As demand for radioligand therapy increases, AIP is well-positioned to take up the challenge to scale up its accessibility and increase awareness about this type of medication. How would AIP address the concern about supply chain optimization and the prohibitive cost of the drug in the long term?

[Miss Roseanne]: We have witnessed significant progress in the supply chain for radiopharmaceuticals, which is truly encouraging. The availability of isotopes from multiple manufacturers has improved, making radiopharmaceuticals more accessible to patients in need.

It’s heartening to see the supply chain adapting to meet the growing demand for radiopharmaceuticals. As a virtual company, AIP has established partnerships that allow us to seamlessly handle logistics and ensure that our products reach those who need them.

While challenges may have existed in the past, the industry is evolving rapidly to overcome them. From commercial to government setting up new facilities, contributing greatly to manufacturing efforts promising a well-supported supply chain in the future.

At AIP, we are confident that the optimization of the supply chain and the logistics required for radionuclide therapy will not be prohibitive. The industry’s response to the increasing demand, coupled with the availability of both established and emerging manufacturers, showcases a positive outlook for the long-term sustainability of the supply chain.

Precision Medicine, the Future of Healthcare

[Dex Marco]: The progress in diagnostic nuclear medicine over the years since the discovery of 99mTc is indeed phenomenal. And while we started with purely a diagnostic end goal, we have a growing radiopharmaceutical therapy revolution for precision medicine. Where do you see AIP in the years to come in the field of oncotheranostics?

[Miss Roseanne]: Thank you for giving me the opportunity to share Advanced Innovative Partners’ breakthroughs that drive our developments in radiopharmaceuticals for diagnosis and therapy. Breast cancer and lung cancer are particularly driving forces, as my own grandmother passed away from cancer. We are determined to make a difference in developing effective treatment options and improving outcomes for patients in need. In the ever-evolving field of healthcare, AIP is committed to making a significant impact as we recognize the tremendous potential that lies within the booming radiopharmaceutical market. We firmly believe that by diagnosing, treating, and precisely targeting cancer with precision medicine, we can achieve truly successful outcomes and transform the lives of patients. Thank you once again for allowing me to share our story.

[Dex Marco]: This is Ms. Roseanne Satz of AIP – expediting radiopharmaceutical market adoption, changing patients’ lives.

Engr. Dex Marco Tiu Guibelondo, B.Sc. Pharm, R.Ph., B.Sc. CpE

Editor-in-Chief, PharmaFEATURES

Join Proventa International’s 10th Annual Medicinal Chemistry Strategy Meeting at Le Meridien Boston Cambridge, Massachusetts this 8th of November 2023 to learn more about Innovative and Emerging Modalities (Track 2) in advancing the field of medicine and improving patients’ quality of life. Click on the photo below to download the brochure and register for the event.