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[av_heading heading='Kris Newhart' tag='h2' style='' subheading_active='' show_icon='' icon='ue800' font='entypo-fontello' size='' av-medium-font-size-title='' av-small-font-size-title='' av-mini-font-size-title='' subheading_size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' icon_size='' av-medium-font-size-1='' av-small-font-size-1='' av-mini-font-size-1='' color='custom-color-heading' custom_font='#318e12' icon_color='' margin='' margin_sync='true' padding='10' icon_padding='10' link='' link_target='' id='' custom_class='' template_class='' av_uid='' sc_version='1.0' admin_preview_bg=''][/av_heading]

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<h4><em>Executive Assistant & Office Administrator</em></h4>
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<h3><strong>How long have you been with Acumen?</strong></h3>
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I started with Acumen as a contractor in June 2020 and converted to an Acumen employee in January 2021.
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<h3>What initially drew you to Acumen and our company's mission?</h3>
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When I joined Acumen, the Company had only about 8 individuals propelling the company forward.  In conversations with these people, it was immediately noticeable how passionate and dedicated each and every one of them was about moving sabirnetug (ACU193) forward.
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<h3>What excites you most about the work you do at Acumen?</h3>
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The satisfaction and excitement of knowing that I am able to help others in moving their work forward. Contributing toward the goal of improving the lives of those suffering from Alzheimer's and their families.
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<h3>Which of Acumen's four values <em>(People, Integrity, Innovation, and Perseverance)</em> resonates most with your work and role?</h3>
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<strong>PEOPLE</strong> for sure. In an EA role, you get to interact with every single employee. These interactions offer me the opportunity to gain insights into the important work that each department is doing.
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<h3>From your perspective, what sets our company apart in the field of Alzheimer's research?</h3>
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Acumen’s novel approach of sabirnetug (ACU193) to selectively target amyloid beta oligomers and the focus early-on to assemble an experienced and dedicated team who had the scientific understanding and belief in sabirnetug (ACU193).
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<h3>Outside of work, what are some of your hobbies or interests that you enjoy in your free time?</h3>
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Spending time with my family, boating and water sports, and vacationing at the beach
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<h3>What is a quote that is meaningful to you and why?</h3>
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<em>“Do the best you can until you know better. Then when you know better, do better.”</em> ~Maya Angelou.

For me, this speaks to always doing your best, but understanding that your best can evolve and grow over time as circumstances change
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President & Chief Executive Officer
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Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis et quasi architecto beatae vitae dicta sunt explicabo. Nemo enim ipsam voluptatem quia voluptas sit aspernatur aut odit aut fugit, sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt. Neque porro quisquam est, qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit, sed quia non numquam eius modi tempora incidunt ut labore et dolore magnam aliquam quaerat voluptatem. Ut enim ad minima veniam, quis nostrum exercitationem ullam corporis suscipit laboriosam, nisi ut aliquid ex ea commodi consequatur? Quis autem vel eum iure reprehenderit qui in ea voluptate velit esse quam nihil molestiae consequatur, vel illum qui dolorem eum fugiat quo voluptas nulla pariatur
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At Acumen, we are focused on developing novel targeted therapies for Alzheimer’s disease. We are currently testing ACU193, an investigational drug designed to bind to and remove toxic protein aggregates called amyloid-beta oligomers (AβOs) that build up in the brains of people with Alzheimer’s disease.
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Backed by a pharma-quality team with a pharma-quality asset, at Acumen, we are driven to develop a targeted treatment that can fundamentally shift how we treat Alzheimer’s disease.
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<strong>POSITION TITLE:</strong>
Quality Assurance Manager
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<p style="text-align: right;"><em>To apply, send cover letter and CV to Kris Newhart:</em></p>
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<strong>POSITION DESCRIPTION:</strong>
The Quality Assurance (QA) Manager will oversee the activity of the quality assurance department and staff, developing, implementing, and maintaining quality systems supporting the organization’s products and/or development processes.

The QA Manager will initially work under the direction of the current QA Director, who is a consultant to Acumen. The QA Manager will assume responsibilities for the management of QA activities over time, and Acumen’s intention is that the QA Manager will be a leadership track position.

The QA Manager will work closely with peers in CMC, Clinical, Non-clinical, Non-clinical, Project Management and Research functions and will be jointly responsible for effective QA support of cross-functional activities.

Travel within the US will be required. Travel outside of the US may be required in the future.

Location: Carmel, IN with potential to work remote during 2021. (relocation possible for qualified candidates)

<strong>ROLE AND RESPONSIBILITIES:</strong>

<strong>Role:</strong> The Manager of Quality Assurance (QA) is responsible for working with the current QA Consultant Director in providing quality oversight for product manufacturing activities including review of executed batch records, batch release and change control processes associated with manufacturing activities, as well as for implementing and monitoring the effectiveness of Quality Systems throughout our organization. The QA Manager should possess a working understanding of cGMP requirements as well as ICH, FDA and other relevant pharmaceutical industry regulatory guidelines. The Manager of QA will also be involved in investigations related to drug substance/product manufacturing activities, product complaints and ensures closure in a timely manner. The individual in this role will report to the Chief Operating Officer but be provided specific position direction from the current QA Consultant Director. This individual is expected to excel at working in a collaborative cross-functional environment with team members from manufacturing (CMC), analytical development, Clinical, regulatory, and contract manufacturing organizations (CMOs) and other service providers.

<strong>Responsibilities:</strong>
<ul>
 	<li>Provide support in quality oversight for drug substance/product manufacturing activities including review of executed batch records and subsequent batch release/disposition.</li>
 	<li>Develops and maintains a phase-appropriate Quality Management System</li>
 	<li>Identifies and establishes appropriate quality standards, specifications and parameters for products.</li>
 	<li>Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.</li>
 	<li>Assist in ensuring investigations related to deviations during drug substance and product manufacturing are completed appropriately and in a timely manner.</li>
 	<li>Interface with manufacturing, analytical development, clinical, nonclinical, and regulatory team members regarding change controls, protocols, quality requirements, and reports.</li>
 	<li>Write and revise standard operating procedures for the Company, as necessary.</li>
 	<li>Support document control functions, including initiating, tracking, processing, reviewing, distributing, releasing and archiving of documents.</li>
 	<li>Identifies and investigates non-compliances, particularly when problems recur in multiple products; recommends and facilitates corrective and preventive actions.</li>
 	<li>Reviews client, customer, and user feedback and takes appropriate action, as needed.</li>
 	<li>Maintains compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies.</li>
 	<li>Prepare and/or support the preparation and review of Quality Agreements with CMOs.</li>
 	<li>Perform and support audits of CMOs and CROs and other GxP vendors.</li>
 	<li>Support the collections and evaluation of metrics to measure the health and effectiveness of the quality system that promote the identification and implementation of quality system improvements.</li>
 	<li>Support FDA and other health authority GMP inspections or Sponsor Audits, including assisting in pre-approval inspection activities (preparation, conduct, and responses).</li>
 	<li>Perform other assigned tasks as needed.</li>
</ul>
<strong>QUALIFICATIONS AND EDUCATION REQUIREMENTS:</strong>
<ul>
 	<li>Three to five years of experience in GMP related field required with supervisory experience a plus working knowledge and understanding of GxPs for drugs in development.</li>
 	<li>Understanding of standards of practice for the manufacture of monoclonal antibodies is a plus.</li>
 	<li>Ability to maintain attention to detail, prioritize work and handle multiple assignments in a fast-paced environment.</li>
 	<li>Ability to critically evaluate and troubleshoot complex problems, while offering timely and informed options for resolution.</li>
 	<li>Ability to adapt the work schedule to participate in teleconferences with CMOs in different time zones.</li>
 	<li>Must have excellent verbal, written and organizational skills.</li>
 	<li>Must have excellent leadership and interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management.</li>
</ul>
<strong>PHYSICAL REQUIREMENTS:</strong>

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

<strong>COMPENSATION AND BENEFITS:</strong>
Competitive base salary, annual incentive bonus and company stock options. Package details based on qualifications and track record of performance.

Competitive benefits package including health, dental, vision, life insurance and 401K.

<strong>About Acumen Pharmaceuticals, Inc.</strong>
Acumen Pharmaceuticals, Inc., is a privately held company with offices in Charlottesville, VA and Carmel, IN. Acumen is developing targeted therapies for the safe and effective treatment of Alzheimer’s Disease and related neurodegenerative diseases. Acumen’s lead program, ACU193, is a monoclonal antibody which binds to amyloid beta oligomers which are widely acknowledged to be major mediators of Alzheimer’s Disease pathology. Acumen plans to initiate human clinical studies of ACU193 in 2021 and is seeking to add key contributors to support the development of ACU193 and the growth of the company.

<strong>EEO Statement</strong>
Acumen Pharmaceuticals, Inc., is an equal opportunity employer. In accordance with anti-discrimination law, it is the purpose of this policy to effectuate these principles and mandates. Acumen prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Acumen conforms to the spirit as well as to the letter of all applicable laws and regulations.
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Who is <strong>Acumen</strong>

<em>Acumen </em>means keenness and depth of perception. That’s exactly who we are: an experienced, tenacious team singularly focused on developing targeted therapies for a condition that has remained untreatable for far too long.

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If you are living with AD, you know how this disease can impact your life and the lives of your loved ones, from managing day-to-day living, to understanding your long-term outlook. You and your family understand the need for new treatment options better than anyone.

Clinical trials are an important part of bringing new medicines to patients. A clinical trial is a research study designed to evaluate whether an investigational medicine is effective at addressing a particular disease, as well as the effect that potential treatment has on the patient. Data from clinical trials allow for regulators to determine if a drug is ready to be made available to patients broadly.

Patients are important partners in the journey toward developing new medicines, and their participation in clinical trials is invaluable.

People who choose to participate in a clinical trial may do so for a number of reasons:
<ul>
 	<li>They may gain access to specialized diagnostic tests, investigational medicines, and excellent trial-related medical care at no additional cost to them.</li>
 	<li>They hope to contribute to a better understanding of the disease and how AD affects the brain.</li>
 	<li>They altruistically hope their contribution to advancing science and medicine will help future patients have better treatment options.</li>
</ul>
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You may qualify for the INTERCEPT-AD study if:
<ul>
 	<li>If you have mild cognitive impairment due to AD or mild AD</li>
 	<li>You are aged 55-85 and weight at least 90 lbs and no more than 250 lbs</li>
 	<li>If you are female, you are post-menopausal or have been surgically sterilized</li>
 	<li>If you are male with a female partner of child-bearing potential, you must use contraception</li>
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Leveraging our deep understanding of amyloid-beta oligomers to usher in a medical breakthrough for Alzheimer’s disease.
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[av_heading heading='Acumen Welcomes New Members to its Advisory Board' tag='h3' style='blockquote modern-quote' subheading_active='subheading_above' show_icon='' icon='ue800' font='entypo-fontello' size='' av-medium-font-size-title='' av-small-font-size-title='' av-mini-font-size-title='' subheading_size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' icon_size='' av-medium-font-size-1='' av-small-font-size-1='' av-mini-font-size-1='' color='' custom_font='' icon_color='' margin='' margin_sync='true' padding='10' icon_padding='10' link='' link_target='' id='' custom_class='' template_class='' av_uid='' sc_version='1.0' admin_preview_bg='']
July 17, 2020
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Acumen Pharmaceuticals, Inc. has engaged three new members as part of its world-class Advisory Board. 

Cynthia Lemere, Ph.D., Michael Weiner, M.D. and Reisa Sperling, M.D. will join the board alongside current advisors Colin Masters, M.D., Jeffrey Cummings, M.D., Sc.D., Jeffrey Sevigny, M.D., Stephen Salloway, M.D., and M.S., Steven DeKosky, M.D. 

Acumen Chief Medical Officer Eric Siemers commented, “We are delighted to have Drs. Sperling, Lemere and Weiner join our Advisory Board.  We believe the combined expertise of this group as an Alzheimer’s therapy development advisory board is unsurpassed.”
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It is important that clinical trial participants understand the journey they are embarking on. That is why clinical researchers will go through a process with them called informed consent. Informed consent ensures that potential trial participants are provided sufficient information about the clinical trial so they can understand the potential benefits, risks and possible alternatives to clinical trial participation. Informed consent is an important part of conducting ethical research and is there to protect participants. Your trial site coordinator will go through the informed consent process with you.
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Who is <strong>Acumen</strong>

<em>Acumen </em>means keenness and depth of perception. That’s exactly who we are: an experienced, tenacious team singularly focused on developing targeted therapies for a condition that has remained untreatable for far too long.

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[av_heading heading='Jeffrey Cummings, MD, ScD' tag='h3' style='blockquote modern-quote modern-centered' subheading_active='subheading_below' show_icon='' icon='ue800' font='entypo-fontello' size='' av-medium-font-size-title='' av-small-font-size-title='' av-mini-font-size-title='' subheading_size='' av-medium-font-size='' av-small-font-size='' av-mini-font-size='' icon_size='' av-medium-font-size-1='' av-small-font-size-1='' av-mini-font-size-1='' color='' custom_font='' icon_color='' margin='' margin_sync='true' padding='10' icon_padding='10' link='' link_target='' id='' custom_class='' template_class='' av_uid='' sc_version='1.0' admin_preview_bg='']
Cleveland Clinic; University of Nevada, Las Vegas
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Jeffrey Cummings, MD, ScD is Director Emeritus of the Cleveland Clinic Lou Ruvo Center for Brain Health, Vice Chair of the department of brain health at the University of Nevada, Las Vegas, Professor of Medicine (Neurology) at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, and a Principal Investigator/Director of the NIH/NIGMS-funded Center for Neurodegeneration and Translational Neuroscience.

Dr. Cummings is a world-renowned Alzheimer’s researcher and leader of clinical trials. He has been recognized for his research and leadership contributions in the field of Alzheimer’s disease through the Henderson Award of the American Geriatrics Society (2006), the Ronald and Nancy Reagan Research Award of the national Alzheimer’s Association (2008), and the Lifetime Achievement Award of the Society for Behavioral and Cognitive Neurology (2017). In 2010, he was honored by the American Association of Geriatric Psychiatry with their Distinguished Scientist Award. In 2018, he was honored with the Leadership and Achievement Award by the International Society of CNS Drug Development, and he received the Bengt Winblad Lifetime Achievement Award from the national Alzheimer’s Association.

Dr. Cummings’ interests embrace clinical trials, developing new therapies for brain diseases, and the interface of neuroscience and society, and he has authored or edited 43 books and published over 725 peer-reviewed papers.
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ACU193 is designed to address an underlying cause of Alzheimer’s disease by binding to a toxic form of protein aggregates called amyloid-β-oligomers, or AβOs. Evidence indicates that AβOs are a primary trigger and persistent driver of Alzheimer’s associated pathology and neurodegeneration. The accumulation of AβOs is associated with deterioration and loss of the connections between nerves, as well as inflammation. There is evidence that this leads to memory impairment, cognitive decline and progressive neurodegeneration that are seen in Alzheimer’s disease.

By binding to AβOs, ACU193 prevents them from binding to specialized parts of nerves called dendritic spines. By binding to AβOs, ACU193 may help to preserve nerve function and protect cells from neurodegeneration.
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To find the nearest trial site, you can visit the trial descriptor on <a href="https://clinicaltrials.gov/ct2/show/NCT04931459" target="_blank" rel="noopener">clinicaltrials.gov</a>. An investigator or trial site manage can help determine if you’re eligible for the study, explain how the study works, what is required of you, and what the risks and possible benefits may be.
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Acumen acquires exclusive licenses to Northwestern University and USC Aβ-derived diffusible ligands intellectual property
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Acumen and Merck & Co. enter exclusive license and research collaboration
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Acumen-Merck select ACU193 as pre-clinical candidate
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Acumen receives ACU193 program exclusivity
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National Institute of Aging awards $3.6 million U01 grant for development of ACU193
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Former Lilly Alzheimer’s disease development team engaged

Acumen closes on a $15 million Series A-1 round
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Acumen closes on a $75 million Series B round
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A first-in-human, Phase 1 clinical trial of ACU193 in early Alzheimer’s patients expected to initiate
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<em>Acumen</em> means keenness and depth of perception. That’s exactly who we are: an experienced, tenacious team singularly focused on developing targeted therapies for a condition that has remained untreatable for far too long.
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