Expanded Access Policy
Athersys, Inc. is committed to addressing areas of significant unmet medical need through the development of innovative drugs and/or biologics that extend and enhance the quality of human life. We are conducting clinical trials to assess the safety and efficacy of our investigational drugs or biologics, which if proven, will allow us to obtain the approvals from regulatory authorities necessary to provide the broader patient community with full access to these therapies.
We recognize that there are patients with these disease indications (or related conditions) for whom clinical trial enrollment is not an option. These patients may be interested in seeking to utilize our investigational drugs or biologics prior to regulatory approval through expanded access authorization (i.e., compassionate use).
Athersys, Inc. has ethical responsibilities to ensure the quality and integrity of clinical trials and to minimize risks to current research participants and future patients. These ethical responsibilities required careful consideration in evaluation of the appropriateness of providing expanded access to our investigational drugs or biologics (i.e., compassionate use). We have concluded that sustainable, long-term availability of our investigational drugs or biologics can be best achieved by demonstrating safety, tolerability, and effectiveness through the conduct of controlled clinical trials designed to address the requirements of regulatory agencies for approval. Offering expanded access outside of a controlled clinical trial at this time could jeopardize the conduct of our ongoing or planned clinical trials and thus prevent or delay access for other patients in need. Accordingly, we have reached the difficult decision that it is not appropriate to provide expanded access to our investigational drugs or biologics outside of our clinical trials at this time.
Athersys, Inc. reserves the right to review and amend this policy in the future. If we do amend this policy in the future to provide such expanded access, we are under no obligation to continue to provide such access and may cease at any time.
For additional information about this policy, please contact firstname.lastname@example.org. Responses will be provided within approximately one business week.
Policy Adopted: April 2017
Athersys is committed to protecting your privacy and using technology that gives you the most powerful and safe online experience. This Statement of Privacy applies to the Athersys Web site and governs data collection and usage. By using the Athersys website, you consent to the data practices described in this statement.
Collection of your Personal Information
Athersys collects personally identifiable information, such as your e-mail address, name, home or work address or telephone number. Athersys may also collect anonymous demographic information, which is not unique to you, such as your ZIP code, age, gender, preferences, interests and favorites.
There is also information about your computer hardware and software that is automatically collected by Athersys. This information can include: your IP address, browser type, domain names, access times and referring Web site addresses. This information is used by Athersys for the operation of the service, to maintain quality of the service, and to provide general statistics regarding use of the Athersys Web site.
Please keep in mind that if you directly disclose personally identifiable information or personally sensitive data through Athersys public message boards, this information may be collected and used by others. Note: Athersys does not read any of your private online communications.
Athersys encourages you to review the privacy statements of Web sites you choose to link to from Athersys so that you can understand how those Web sites collect, use and share your information. Athersys is not responsible for the privacy statements or other content on Web sites outside of the Athersys and Athersys family of Web sites.
Use of your Personal Information
Athersys collects and uses your personal information to operate the Athersys Web site. Athersys may also use your personally identifiable information to provide you information from Athersys and its affiliates.
Athersys does not sell, rent or lease its user lists to third parties. Athersys may share data with trusted partners to help us perform statistical analysis, send you email or postal mail, or provide user support. All such third parties are prohibited from using your personal information except to provide these services to Athersys, and they are required to maintain the confidentiality of your information.
Athersys keeps track of the Web sites and pages our customers visit within Athersys. This data is used to deliver better and customized content to users.
Athersys collects the personal information that you provide on the Employment Application when you apply for a position with us online through the Employment Opportunities page of our Web site. The Employment Application allows you to send us information about your capabilities and the kind of position that you are looking for. We keep this information in our database so that the next time a position opens up, we can keep you in mind. Submitting information via the Employment Application is purely voluntary, and is not a requirement for you to use any other features of this Web site. Athersys only uses this Employment Application information to determine your eligibility for the position that you have applied for, and does not disclose it to any third parties.
Athersys Web sites will disclose your personal information, without notice, only if required to do so by law or in the good faith belief that such action is necessary to: (a) conform to the edicts of the law or comply with legal process served on Athersys or the site; (b) protect and defend the rights or property of Athersys; and, (c) act under exigent circumstances to protect the personal safety of users of Athersys, or the public.
Security of your Personal Information
Athersys secures your personal information from unauthorized access, use or disclosure. Athersys secures the personally identifiable information you provide on computer servers in a controlled, secure environment, protected from unauthorized access, use or disclosure.
The Athersys Web site may use "cookies" to help you personalize your online experience. A cookie is a text file that is placed on your hard disk by a Web page server. Cookies cannot be used to run programs or deliver viruses to your computer. Cookies are uniquely assigned to you, and can only be read by a web server in the domain that issued the cookie to you.
One of the primary purposes of cookies is to provide a convenience feature to save you time. The purpose of a cookie is to tell the Web server that you have returned to a specific page. For example, if you personalize Athersys pages, or register with Athersys site or services, a cookie helps Athersys to recall your specific information on subsequent visits. This simplifies the process of recording your personal information, such as billing addresses, shipping addresses, and so on. When you return to the same Athersys Web site, the information you previously provided can be retrieved, so you can easily use the Athersys features that you customized.
You have the ability to accept or decline cookies. Most Web browsers automatically accept cookies, but you can usually modify your browser setting to decline cookies if you prefer. If you choose to decline cookies, you may not be able to fully experience the interactive features of the Athersys services or Web sites you visit.
Changes to this Statement
Athersys will occasionally update this Statement of Privacy to reflect company and user feedback. Athersys encourages you to periodically review this Statement to be informed of how Athersys is protecting your information.
Athersys welcomes your comments regarding this Statement of Privacy. If you believe that Athersys has not adhered to this Statement, please contact Athersys at email@example.com. We will use commercially reasonable efforts to promptly determine and remedy the problem.