Let's have a conversation.
We would like to begin by introducing Acutis Biosciences
the research and commercial development arm of Acutis.
Acutis Biosciences is a separate, multidimensional entity through which new tests are developed, selected to validate and brought to market. It is also intended to be much more: a new resource and trusted partner for life sciences-related businesses, including pharmaceutical companies, contract research organizations (CROs), diagnostics manufacturers and other clinical laboratories. What’s more, Acutis Biosciences is a promise built
on the success of Acutis Diagnostics, one of the most respected and innovative specialty labs in the industry.
A lab that built its reputation, year after year after year, by delivering to its clients the fastest turnaround time
and reliably precise results. Licensed by the State of New York’s Department of Health,
Acutis Diagnostics has undergone the most rigorous inspection and vetting processes.
As a company, it has never taken anything for granted.
While Acutis Biosciences is in its early stage, it is already in motion, utilizing state-of-the art technology, establishing partnerships, and developing intellectual property. This is a company that is growing and growing organically.
We have invested heavily in infrastructure—science, operations and marketing—to serve multiple markets simultaneously, and this investment will culminate with the completed build-out of an additional 40,000 square feet of facilities in the New York metropolitan area.
Acutis Biosciences was conceived to act in real time.
Our ambition is to create new and innovative products while providing meaningful service diversification.
Our first step began with Reveal™, our branded molecular diagnostics tests.
Moving with the same sense of urgency, we will soon offer new laboratory-developed tests, including an assay
that will detect the presence of more than two dozen different microbes that are causative agents of urinary tract infection. This assay is currently in the validation stage with regulatory submission set for mid-2019. It is anticipated that the analytical and clinical studies being conducted will exceed in breadth and depth that of any similar products. Early results for our tests are extremely promising.
Also in the pipeline is a portfolio of assays conceived to predict an individual's response to certain drugs,
based on that person’s genetic makeup. These pharmacogenomics tests are being developed and clinically validated in concert with a leading precision-medicine company. In addition, we have developed a number of new custom assays for the study of various active pharmaceutical ingredients, as well as for the identification of a myriad of synthetic analogs for other APIs. These projects, combined with the construction of a new facility—designed to help facilitate our clients’ abuse-liability studies— positions us as a trusted partner to CROs and Pharma companies.
Acutis Biosciences is also developing comprehensive panels for both key viral-based as well as sexually transmitted diseases. At the same time, we are developing assays for infections such as Zika, as well as diagnostic tools to identify bacteria and fungi in wounds caused by chronic conditions such as diabetes.
Our robust molecular capabilities, when coupled with our 21CFR part 11 compliant LIMS and real-world experiential data will allow Acutis Biosciences to be an integral partner in the in vitro diagnostics development process.
Acutis Biosciences will provide genuine product diversification.
While the primary clients of our parent, Acutis Diagnostics, has been physicians and clinicians, Acutis Biosciences
is expanding the communities we serve. The goal is to open new markets with breakthrough products, goods
and services. How will will achieve this ? The pharmacogenomics assays discussed above describe one way.
In addition, our sales and marketing teams will promote these tests to physicians and medical clinics, while we will work with our personal medicine partners to market tests directly to medium and large companies that are currently self-funding their employees’ health insurance. These tests are intended to help companies achieve significant savings by reducing and even preventing adverse drug reactions and by reducing unscheduled absences. Where successful, they will also help lower the costs associated with ineffective prescription medicines.
Moreover, by receiving the approval of New York State, our assays will meet the highest standards for precision, accuracy and reproducibility. This “certification” ensures that our Pharma and CRO partners can have the highest confidence in the data we supply for their drug development projects.
Acutis Biosciences moves into the Pharma market we understand that we need to be a partner that possesses the capabilities to design and perform complex tests to assist during design and discovery.
As study drugs move into the clinical phases, our menu of both FDA-cleared and laboratory developed tests will be
a valued resource to help provide the highest quality bioanalyses to sponsors. In addition, our robust data mining capabilities will allow us to work with clients and payors to provide increased clinical decision support as well
the ability to support key analytics projects in the clinical space.
Privately held and self-financed, our effort is focused on market need.
One example: the development of tests for rapid microbial diagnostics coupled with antibiograms to allow for
proper stewardship of antibiotic usage. Our R&D teams are working on solutions in this area, and we expect
that our approach to this market will yield impressive results. A successful introduction of such technology
would fit in line with our reputation for providing industry-leading turnaround time, which allows clinicians
to make informed and timely treatment decisions.
Our intent is also to help improve antibiotic stewardship, which the market has already put a high premium.
The story is being written
which is why the time to talk is now.
David C. Goldberg
Mr. Goldberg is an accomplished industry professional, having spent more than 35 years in leadership roles in the life sciences and healthcare industry. He had a long career at Enzo Biochem Inc, where he served as President and General Manager of the company’s clinical services and research products divisions, as well as serving as both the Vice President of Business Development and Corporate Development for the parent company. Goldberg also served as Chief Operating Officer at Aeon Global Health, where he oversaw worldwide operations for the publicly traded healthcare organization.
His areas of responsibility have included: strategic planning, marketing and sales, technology assessment, P & L, and compliance. He has presented at numerous investor-and partnering-conferences. Goldberg received an MS in Microbiology from Rutgers University and an MBA in Finance from New York University.
PhD, Director of Research and Development
Dr. Shanmugam is a research scientist in the areas of molecular biology and infectious diseases. He has authored nearly 25 peer-reviewed papers, in such areas as the use of biofilms in the treatment of wounds and the study of protein expression during atrial fibrillation. His research led to the first complete sequence of a key strain of Aggregatibacter actinomycetemcomitans, an important periodontal pathogen.
He served most recently as a research associate in the departments of Oral Biology and Cell Biology, as well as Molecular Medicine at the University of Medicine and Dentistry of New Jersey. A recipient of a Howard Hughes Medical Institute fellowship, Dr. Shanmugam earned his PhD in Genetics and Molecular Biology at Madurai Kamaraj University and completed post-doctoral fellowships at both the Weizmann Institute and Cold Spring Harbor Laboratories.
Ted E. Schutzbank
PhD, D (ABMM), Director of Clinical Microbiology and Genetics
Dr. Schutzbank is an expert in both clinical bacteriology, virology and medical genetics. He has held faculty positions at the University of Cincinnati, George Washington University, and New York Medical College. Dr. Schutzbank has authored nearly 30 peer-reviewed articles, 10 book chapters and has co-authored Clinical Laboratory Standards Institute (CLSI) guidelines in molecular diagnostics techniques and quality easement.
He has also served on a number of corporate scientific boards for such companies as Qiagen, Luminex and IGEN International (now Roche), and has presented both nationally and internationally on such topics as nucleic acid-based technology evaluation, population health, and personalized medicine. Dr. Schutzbank received his PhD from Columbia University and completed a post-doctoral fellowship at the State University of New York at Stony Brook.
DABCC, FAACCC, Director of Biomarker Development and Precision Medicine
Dr. Halim is an internationally recognized thought leader in both biomarker development and pharmacogenomics. He has served as the Vice President of Translation Medicine at Celldex Therapeutics and the Global Head of Biomarker Development for Daiichi Sankyo in Japan. He is one of a select few triple-board certified clinal laboratory professionals in the areas of Molecular Diagnostics, Clinical Chemistry and Toxicology, and has extensive expertise in GCP, GLP, FDA and CAP guidelines and regulations.
Dr. Halim has authored more than 60 peer-reviewed articles on such topics as companion diagnostic development, population pharmacokinetics/pharmacodynamics and the impacts of discordant clinical laboratory results on the drug development process. He received his Doctorates in Pharmacology from Bonn University, and a PhD in Biochemistry for the University of Cairo and completed a post-doctoral fellowship at the University of Tennessee.
Dr. Maddali is a global business leader in the field of precision medicine. She currently serves as the Vice President of Strategy and Business Development for Cancer Genetics, Inc. Maddali had previously held senior management positions with Q2 Solutions, where she was the Global Head of Devices and Business Strategy. She has also served as Associate Director of Biomarkers and Companion Diagnostics at Quintiles IMS.
Dr. Maddali has completed more than 170 biopharma/CRO/IVD commercial partnerships over the past 10 years and has presented on such topics as CAR-T as well as the use of blockchain in precision medicine. She earned her PhD in Physiology and Pharmacology at the University of Missouri and a Doctor of Veterinary Medicine from Sri Venkateswara University in India.