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Amyloid diseases are a diverse group of disorders, characterized by the deposition of amyloid protein fibrils in vital organs and tissues. There are approximately 30 different types of amyloidosis, each resulting from the misfolding and aggregation of a specific protein, and they are all severely debilitating, progressive, and often fatal.
Modulating amyloid proteins is a validated target in systemic amyloidosis. Therapies recently approved in ATTR amyloidosis have proven that reducing or stabilizing the pre-cursor protein leads to slowing disease progression. In AL amyloidosis, off-label plasma cell targeting agents including chemotherapy and Autologous Stem Cell Transplant, which both reduce the precursor protein, have also been shown to improve clinical outcomes. Reducing or stabilizing the pre-cursor protein in AL and ATTR amyloidosis results in the reduction of formation of new amyloid, but does not directly address already deposited toxic amyloid.
There is a substantial unmet need to improve the diagnosis of amyloidosis in patients. The majority of systemic amyloidosis patients see more than four specialists and take more than 18 months to get an accurate diagnosis, with 25% of patients taking more than five years to get a correct diagnosis. Unfortunately, due to this prolonged process, a significant number of patients die without a diagnosis. Of the patients that do receive a diagnosis, there are a number of diagnostic procedures required with clear challenges in getting an early and accurate diagnosis. A misdiagnosis can be deadly and delayed diagnosis leads to poorer patient outcomes.
A prompt diagnosis is urgently needed, but for most patients, it takes over 18 months from first symptoms to confirmed diagnosis. For 25% of patients, it takes more than five years.
A significant portion of the long diagnostic timeframes is owed to an initial delay in suspicion of amyloidosis. Patients present with non-specific and seemingly unrelated cluster of symptoms such as fatigue, dyspnea, edema or GI issues. Most patients see more than four specialists before reaching a diagnosis.
The Attralus PET/CT imaging agent AT-01 has
the potential to provide a rapid and accurate diagnosis of
systemic amyloidosis.
Even after amyloid is suspected, the diagnostic pathway can be arduous and require numerous tests, including an invasive biopsy for most patients. Current diagnostic tests only reveal an incomplete picture of the patient’s disease, often with amyloid
only confirmed in one organ.
AT-01 has the potential to comprehensively measure amyloid deposition in organs throughout the whole body, to differentiate between subtypes of amyloidosis, and to monitor disease progression and treatment response.
Attralus is developing novel pan-amyloid targeting agents to directly bind and remove toxic amyloid fibrils from organs and tissues throughout the body, with the potential to reverse disease pathology – going beyond current treatments that reduce the formation of amyloid fibrils and slow disease progression but do no remove amyloid from the body.
When available, current treatment options for AL and ATTR do not directly address already deposited toxic amyloid in organs and tissues. These treatments have limited impact of later stage patients, which represent ~50% of the population.
Attralus’s therapeutics target motifs that are universally and ubiquitously presented on all amyloid fibrils. This pan-amyloid binding profile allows Attralus’s therapeutics to target multiple types of amyloid fibrils including AL, ATTR, and ALECT2.
While there are treatments in two types of
amyloidosis (ATTR & AL), there remains a very high
unmet need with poor median survival & quality of life.
Not only do we have the potential to develop therapeutics to treat patients with any form of systemic amyloidosis, we also can potentially treat those with late-stage disease for whom current therapies have not shown significant impact.
Overview
Attralus, Inc., (formerly Aurora Bio) is a VC funded privately held development stage biotechnology company focused on improving the lives of systemic amyloidosis patients, through the development of novel diagnostics and therapeutics. We are developing pan-amyloid targeting agents that facilitate diagnosis, and the development of novel immunotherapies designed to clear amyloid fibrils in patients with systemic amyloid diseases. We aim to improve the diagnosis and treatment of systemic amyloid diseases, such as light chain (AL), transthyretin (ATTR), and LECT2 amyloidosis, to increase patient survival and quality of life.
Attralus’ technology has broad applications and the potential to address up to 30 systemic amyloid based diseases. Attralus has a diagnostic imaging agent currently in a ph 1/2 trial, positioned to potentially be the first approved diagnostic specifically for amyloidosis. The company also has 2 novel therapeutic fusion proteins, directed at amyloid removal, that are in pre-clinical development
Headquartered in South San Francisco and founded in 2019, Attralus has recently completed a Series A funding with VenBio to carry forward its mission to improve the lives of systemic amyloidosis patients
Description
The AD/Director, Program Management will be responsible for providing both strategic and hands-on program and project management expertise. Initially reporting directly to the CEO, the AD/Director will be responsible for creating the program plan and budget and providing daily coordination and tracking of critical activities, assuring all milestones and deliverables are met. The Director will be responsible for developing the program management processes and procedures for the company, determining appropriate software and other tools, structuring regular meetings and communication within the company and with external collaborators.
Responsibilities
• Collaborate with the management team to provide project management leadership and execution activities within the company and between external partners and Attralus teams.
• Develop and execute integrated cross-functional project plans with established goals, milestones, timelines and budget, with a key focus on bringing pre-clinical therapeutic programs into early clinical development
• Conduct and direct day-to-day program activities to meet milestones; monitoring critical path activities to ensure delivery of program objectives.
• Drive planning for key drug development milestones.
• Maintain effective communication with the management team through oral and written correspondence and ensure adequate documentation of each communication.
• Always use/model/maintain/promote best practices in Program Management, including the use of agendas, minutes, dashboards, maintain document repository, establish and implement templates, tools, and processes to drive efficiency, alignment, communication, and effective planning.
• Create and maintain easily accessible, high level program documents in electronic format.
• Recommend, manage and train on necessary software and tools.
• Identify, develop and/or maintain an appropriate electronic platform (SharePoint, Shared Folders, etc.) for reporting/archiving/documentation of relevant program information, records, etc.
• Conduct risk management, contingency and scenario planning using appropriate program management tools.
• Identify program issues or resource gaps and facilitate resolution.
• Communicate program information and support development of program presentations to senior leadership, board members, investors and other key stakeholders as appropriate.
• Contribute to budgetary planning at the program level.
• Facilitate adherence to Aurora’s governance processes; work with key stakeholders to prepare for those interactions; lead/support as appropriate. Ensure implementation of governance decisions.
Qualifications
• Minimum of a BA/BS in a scientific disciplined is required, Advance degree preferred
• 7+ years of program management or equivalent experience in a pharmaceutical or biotechnology organization.
• Experience with research/pre-clinical and early clinical development project planning required. PM Certification is a plus.
• Rare disease experience a strong plus (not required).
• Desire and ability to work in a start-up, fast paced organization where you will wear many hats.
• Must have excellent verbal and written communication skills as well as exceptional organizational capability.
• Ability to drive program plans and timelines (across multiple functional areas) is essential. Proven success in goal setting, prioritization and time management is required.
• Understanding of FDA and/or EMA quality and regulatory processes. Prior experience with regulatory filings is desirable.
• Experience working with external partners is desirable.
• Ability to work independently in decision-making and resolution of program obstacles and conflicts.
• Familiarity with developing budgets and forecasting is desirable.
• Ability to function autonomously, with an appreciation of detail while being cognizant of “the big picture.”
• Have a patient-first mindset. All decisions made with patients in mind.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Project is required.
Benefits/Equal Opportunity Employer
Attralus, Inc. offers both comprehensive benefits and Paid Time Off (PTO) plans for employees, which begin on the first day of employment.
Attralus, Inc. is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
