Archive for the ‘Member Press Releases’ Category

BIO Releases First-Ever Industry Principles on Value of Biopharmaceuticals

February 5, 2016

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News Release

1201 Maryland Avenue, SW l Ste. 900

Washington, D.C. l 20024 l 202-962-9200



Twitter: @IAmBiotech

For Immediate Release

Contact:Daniel Seaton

BIO Releases First-Ever Industry Principles on Value of Biopharmaceuticals

Innovative biopharmaceutical industry focused on value, advocating for needed reforms

Washington, D.C. (February 3, 2016) – The Biotechnology Innovation Organization (BIO) today released new Principles on the Value of Biopharmaceuticals. These voluntary Principles represent the first-ever systemic, industry-endorsed set of commitments by research-based biopharmaceutical companies to support comprehensive and sustainable solutions to improve patient access to and affordability of innovative medicines that are transforming how we treat and cure patients with once-devastating diseases.

The following statement may be attributed to BIO President and CEO Jim Greenwood:

“America’s innovative biopharmaceutical companies exist to advance the health and well-being of patients by tackling head-on the unrelenting scientific challenges inherent in the discovery, development and delivery of new, high-value cures and treatments. These Principles represent a commitment by our industry to do our part to improve the ability of patients to access those medicines on a sustainable and affordable basis, while also continuing to take the big risks and make the enormous investments required to fulfill the promise of the next generation of cures.”

Among other principles, BIO members are committed to open dialogue with patients, healthcare providers, and payers on the value of their biopharmaceutical innovations and to take these stakeholders’ views into account in the development and delivery of such cures and treatments.  In addition, BIO and its members will work with such stakeholders, as well as policymakers, to explore a broad range of novel delivery approaches to maximize the value of these innovations for patients and the overall healthcare system, including by seeking to remove legal barriers that currently limit the ability to engage in value-based contracting and communications.

“As evidenced by these Principles, the research-based biopharmaceutical industry welcomes the vigorous public debate about the cost and value of our medical innovations,” Greenwood said.  “BIO members already are doing their part to find sustainable patient-centered solutions, and as an industry we are committed to doing even more.  To effectively accomplish these goals, it is essential that other stakeholders in the healthcare system do their part, as well. To that end, we call upon payers, healthcare providers and policymakers to join with us in designing and implementing comprehensive solutions that will ensure patients continue to benefit from the tremendous medical advances biotechnology has made possible.”

The full Principles on the Value of Biopharmaceuticals are available here. To learn more about the value of innovation, please visit here.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

IHIF Welcomes Johnson Co. EDC as new Member!!

January 26, 2016

jcdc logo

A non-profit public/private partnership that provides economic development services to municipalities and companies throughout Johnson County.


Learn more at

Pearl Pathways participates in program to drive second-stage growth

January 11, 2016

January 7, 2016

Contact: Diana Caldwell
Pearl Pathways
Business: (317) 899-9341
Cell: (317) 490-0511

Life sciences consulting company selected for prestigious Purdue Economic Gardening Program

INDIANAPOLIS, INDIANA – January 7, 2016 — Pearl Pathways, a comprehensive life science product development services company, is excited to announce its’ participation in the Purdue Economic Gardening Program.

The Economic Gardening program is managed by the Purdue Center for Regional Development with funding provided from a gift from the Lilly Endowment Inc.

Using an entrepreneurial approach to promote business growth, the Purdue Economic Gardening Program provides tailored assistance to second-stage companies. The program states that economic gardening “is about leveraging information using sophisticated business intelligence tools and databases that growth companies either aren’t aware of or cannot afford.”1 Four focus areas of the program include providing information that helps companies define core business strategies, delivering market intelligence, assisting in efforts to identify qualified leads, and contributing to the company’s leadership development. Purdue collaborates with the businesses to work through barriers and develop new methods.

Purdue and Pearl Pathways will focus on market intelligence analysis, geographical mapping, search engine optimization, and analyzing key industry trends. Diana Caldwell, CEO & President, states, “We are thrilled to have been selected for the program. This will allow us access to data and experts that can provide great insights into our business and the marketplace. The highly-skilled Economic Gardening team has been a pleasure to work with, and we are confident that the information they can provide will impact our business planning priorities and day to day efforts with our clients.”PearlPathways

BioStorage Technologies:Innovative Sample Management Partnership is Advancing Precision Medicine to Find Cure for IBD

November 19, 2015

INDIANAPOLIS – As the global leader in comprehensive sample management solutions, BioStorage Technologies has entered into a strategic partnership with the Crohn’s & Colitis Foundation of America (CCFA) to provide innovative sample management and transformative technology servicers across the entire sample lifecycle including logistics, kitting, bioprocessing, storage and distribution of samples for its new IBD Plexus initiative.


Earlier this year, CCFA was awarded a grant from The Leona M. and Harry B. Helmsley Charitable Trust to establish an integrated knowledge platform designed to centralize and aggregate patient information – with linked biosamples – across multiple research efforts. The new initiative, called IBD Plexus, is designed to speed progress toward precision medicine through novel research, leading to better diagnostics, treatments and, ultimately cures for Crohn’s disease and ulcerative colitis, also known as inflammatory bowel diseases (IBD).


IBD Plexus will enable academic and industry researchers, clinicians, and other healthcare providers to study IBD in patients of all ages. The initiative will nurture collaboration among stakeholders and is powered by a common goal of supporting better care, improving treatments, and finding a cure.


The IBD Plexus research project includes a biobank; registries to capture clinical, patient-reported, and biosample data (genetic, genomic, microbiomic, etc.); and a large data management platform to house, organize, aggregate, and disseminate data to support research decisions. Within three years, databases will be combined or built with clinical information on more than 40,000 Crohn’s and colitis patients, along with genomic and microbial profiles from 7,000 patients who will be followed over time.


IBD Plexus’s sample management and technology services platform will be provided by BioStorage Technologies. In addition, BioStorage will be relocating a sample collection and performing DNA extraction through its BioProcessing Solutions Alliance with RUCDR Infinite Biologics.


“We are honored to collaborate with CCFA’s IBD Plexus to support their delivery of personalized medicine to patients with IBD and the advancement of the search for the cure,” said Greg Swanberg, CEO, BioStorage Technologies.


“IBD Plexus will provide the infrastructure and capacities to dramatically shift the paradigm and accelerate IBD research. We are pleased to be working with BioStorage Technologies as a partner in this important initiative,” said Dr. Caren Heller, Chief Scientific Officer for CCFA.


“This project embodies the Helmsley Charitable Trust’s commitment to establishing close and productive partnerships with the organizations that offer the greatest potential to impact the areas that we support,” said Helmsley Charitable Trust trustee Sandor Frankel. “We are thrilled at the prospects of what this important new research platform can achieve in advancing therapies, care and the path to a cure for those with IBD with the support of best-in-class partners.”


About Biostorage Technologies 

BioStorage BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering flexible onsite, offsite and hybrid models for the smartsourcing of research assets, BioStorage Technologies provides a complete life-cycle of sample management solutions. With an expert team of global sample consultants, industry-leading temperature-controlled storage facilities, innovative bioprocessing solutions and state-of-the-art technology solutions to support sample inventory and data virtualization, the company supports its customers in maximizing opportunities, minimizing risk and reducing costs. BioStorage Technologies, Inc. is a privately held, global corporation. For more information, visit or call +1 866 697 2675 for North America, +49 6155 898 1011 for Europe or +65 31576199 for Singapore or +86 10 8587 2390 for China.


About CCFA

The Crohn’s & Colitis Foundation of America (CCFA) is the largest non-profit voluntary health agency dedicated to finding cures for inflammatory bowel diseases (IBD). CCFA’s mission is to cure Crohn’s disease and ulcerative colitis, and to improve the quality of life of children and adults who suffer from these diseases. The Foundation works to fulfill its mission by funding research, providing educational resources for patients and their families, medical professionals, and the public, and furnishing supportive services for those afflicted with IBD. For more information, visit or call 888-694-8872.


About CCFA

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional nonprofits and other mission-aligned organizations in the U.S. and around the world in health, selected place-based initiatives, and education and human services. Through its IBD and Crohn’s Disease Program, the Trust has allocated nearly $160 million to institutions in the United States, Canada, Europe, and Israel. Across the program, nearly 100 Helmsley-funded investigators are working to understand both how human genetics and the gut microbiome can cause and exacerbate IBD and bring those insights into the development of new treatments and a cure. For more information, please visit


Acquisition expands Novo Nordisk’s portfolio of projects within diabetes and obesity

August 27, 2015

Bagsværd, Denmark, 27 August 2015 – Novo Nordisk today announced that it has entered into a definitive agreement under which Novo Nordisk will acquire Calibrium LLC and MB2 LLC, two privately held biopharmaceutical research companies based in Indiana, US.


Formed in 2013 and 2014, respectively, Calibrium and MB2 are focused on developing a portfolio of novel drug candidates for the treatment of diabetes and related metabolic diseases. The acquisition will expand Novo Nordisk’s portfolio of projects and intellectual property rights within diabetes and obesity and provide a basis for expanding Novo Nordisk’s research presence in the US.


Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk says: “We are always on the lookout for ways to strengthen our leadership position within therapeutic proteins. This research team has demonstrated world-class capabilities in protein design and created a project portfolio of innovative product leads that fit very well with our aspirations within diabetes and obesity.”


Dr Richard DiMarchi, chief scientific officer and co-founder of Calibrium and MB2 says: “It’s an honour to join the global Novo Nordisk research community. Their intense focus on metabolic diseases, which over the years has led to numerous breakthrough protein-based medicines, aligns perfectly with my career-long priorities. I’m optimistic that together we can create novel, transformative therapies in the fight against the global epidemic of diabetes and obesity.”


The parties have agreed not to disclose the financial details of the transactions.


The closing of the transaction is subject to US regulatory approval and is expected to occur during the third quarter of 2015.


About Calibrium and MB2

Calibrium is an emerging biopharmaceutical company focused on the discovery and early development of novel peptides for the treatment of diabetes and related metabolic diseases. Calibrium was co-founded by Fritz French, chief executive officer, and Richard DiMarchi, PhD, chief scientific officer.


MB2 is a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class, mixed agonist drugs for the treatment of diabetes and obesity. MB2 was co-founded by Kent Hawryluk, chief executive officer and Richard DiMarchi, PhD, chief scientific officer.


Both companies are privately held and located in Carmel, IN, US.



Further information

Katrine Sperling +45 3079 6718
Ken Inchausti (US) +1 609 514 8316


Peter Hugreffe Ankersen +45 3075 7085
Daniel Bohsen +45 3079 6376
Melanie Raouzeos +45 3075 3479
Frank Daniel Mersebach (US) +1 609 235 8567


Pearl IRB Granted AAHRPP Accreditation

March 1, 2015

February 17, 2015

Contact: Diana Caldwell
Pearl IRB
Business: (317) 899-9341
Cell: (317) 490-0511

Pearl IRB Granted AAHRPP Accreditation
Further distinguishing the uniqueness of Pearl IRB

INDIANAPOLIS, INDIANA – February 17, 2015 — Pearl IRB, LLC a provider of superior central IRB review services, is proud to announce its recent accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

Pearl IRB now joins an elite group of 23 commercial-independent IRB’s who hold this prestigious designation. Additionally, Pearl IRB joins Indiana University as just the second AAHRPP accredited organization in the state of Indiana.1

“We are extremely proud to have earned AAHRPP accreditation. This accreditation validates our commitment to high quality research processes and organizational excellence,” shares Pearl IRB’s President and CEO, Diana Caldwell. Pearl IRB is further differentiated by being one of only five AAHRPP accredited, commercial-independent IRB’s to also receive WBENC (Women’s Business Enterprise National Council) certification as a Women’s Business Enterprise (WBE). Caldwell highlights, “Our clients want to work first and foremost with an IRB that demonstrates excellence, but many also have the business objective of engaging with diverse suppliers in the clinical research space. With Pearl IRB, they get both.”

To date, there are more than 200 AAHRPP accredited organizations in 46 states and 10 different countries. 1 AAHRPP promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs). To earn AAHRPP accreditation Pearl IRB completed a voluntary, peer-driven process and provided tangible evidence through policies, procedures, and practices of its commitment to scientifically and ethically sound research and to continuous improvement. Historically, this process can take years to complete – Pearl IRB moved from Phase 1 submission to accredited in just 6 months.

As the “gold seal,” AAHRPP accreditation offers assurances that Pearl IRB demonstrates its value in providing excellence and following high standards for quality, ethics, and protection to research participants, researchers, sponsors, government regulators, and the general public.

To learn more about Pearl IRB, visit or email

About Pearl IRB
Pearl IRB was founded in 2010 by Diana Caldwell and Gretchen Miller Bowker, who have both been involved in drug, device or diagnostic research, development, and commercialization for over 45 years. Pearl IRB’s team is comprised of experts in the fields of medical practice, science, ethics and clinical research and understands the need for efficient and high quality reviews for human subject research. Protecting human subjects and driving improved value and efficiency in protocol reviews and implementation shapes the behaviors of Pearl IRB’s team.

Pearl IRB is part of a family of life science companies. Learn more about Pearl Pathways.
Pearl Pathways is a comprehensive life science product development services company. Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three business units to serve you:
Pearl IRB is a full service commercial Independent Review Board that provides human research IRB reviews, IRB exemptions and waivers, and also offers support for research protocol/ICF medical writing, site assessments, and monitoring services.
Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GMP/GLP/GCP auditing services.Pearl IDEAS provides strategic product development assistance, third party vendor selection and management strategies, due diligence services, and sales and marketing services for drug, biologic and device companies.

To learn more, please visit us at, call us at 317.899.9341, or email Pearl IRB is located in Indianapolis, Indiana, and is a WBENC certified woman owned business. For media inquiries, contact Diana Caldwell at

Pearl Pathways to partner with regulatory and quality services firm Brandwood Biomedical

December 8, 2014

INDIANAPOLIS, INDIANA – December 5, 2014 – Pearl Pathways today announced a partnership with Brandwood Biomedical, an Australia-headquartered regulatory and quality services company with offices throughout Asia.

This collaboration allows both companies to provide on-the-ground support to clients and better adapt to the changes and complexities associated with global markets.

“For Brandwood Biomedical, the partnership provides a seamless way to serve its clients across multiple continents,” said Brandwood Founder and CEO, Arthur Brandwood. “Pearl Pathways has a stellar reputation and we’re delighted to share their strong presence in the United States.”

“Brandwood Biomedical fits our philosophy, shares our customer service values and, like us, serves a diverse mix of small startups to large multinationals,” explains Diana Caldwell, president and CEO of Pearl Pathways. “Pearl Pathways will continue to lead our client engagement and Brandwood’s expert staff will provide local support throughout the Asia-Pacific region.”

The Asia-Pacific Summit for Medical Devices (San Diego, March 2015)

Pearl Pathways and Brandwood Biomedical are hosting The Asia-Pacific Summit for Medical Devices, a two-day intensive seminar on medical device regulations featuring a variety of local experts from Asia-Pacific.

The event will be held on March 5 and 6 at the beautiful Hilton San Diego Mission Valley Hotel. Register before December 31 to enjoy the lowest early bird pricing.​

Safis Clients Receive Two More FDA Market Clearances!

October 9, 2014

October 7, 2014 – Indianapolis, IN. Safis Solutions is announcing more marketing clearances for its clients – Stereotaxis, Inc. (Nasdaq: STXS), headquartered in St. Louis and Biomedix, Inc. located in Bloomington, Indiana that have received recent 510k clearances from the Food and Drug Administration (FDA).


Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. It was announced earlier this month that the company received approval for its Vdrive™ Robotic Navigation System with V-Loop™ Variable Loop Catheter Manipulator. This is the second FDA clearance for the Vdrive family of products, the first of which came in July of 2013 and was for the Vdrive with V-Sono™ system. Karen Duros, Stereotaxis Senior Vice President & General Counsel said, “This is another important step for Stereotaxis in bringing our Vdrive products to market in the U.S. We have a great deal of confidence in Safis’ ability to deliver and we are pleased that our regulatory program is in good hands.”


Early in 2014, Safis was hired by Biomedix, Inc. of Bloomington, IN to help with an important regulatory submission. On Friday August 8, 2014 Biomedix received a Special 510(k) clearance from the FDA for its SELEC-3® I.V. Administration Set. Biomedix manufactures IV fluid delivery sets for hospitals and emergency first-responders. After the submission was cleared, Biomedix President Myra Bender said she “felt relieved” and that a “huge weight was lifted.” She went on to say, “We couldn’t have done it without Safis’ team. I can’t tell you how pleased I am that everything worked out. I do feel that I hired the right company. Biomedix is eager to resume distribution of all the unique designs of our SELEC-3® I.V. Administration Sets.”


John Nadelin, Vice President of Regulatory & Compliance at Safis, leads the service delivery teams and expressed, “We have a lot of gratitude for our role with companies like Biomedix and Stereotaxis. When approvals like this happen, we are reminded of how our work plays a crucial role in patients’ lives.”


Safis Solutions is a regulatory and quality compliance consulting firm for life science clients worldwide, and the regulatory submission success rate has been 100%. Services successfully executed by Safis have helped more than 150 clients over the past 12 years, meeting regulatory compliance and GxP quality standards and gaining government agency approvals for medical products, manufacturing systems, clinical and laboratory systems.


Ping Poulsen, President and CEO of Safis Solutions, was very pleased with the high quality performance by Safis’ teams. When congratulated on Safis’ success, she commented “it was not me, it was the team work. I am very fortunate to be surrounded by more successful professionals.”


Safis originated from the Indiana University Emerging Technologies Center (IUETC) and has been certified as WBE by WBENC, MBE by MSDC, both MBE and WBE by the state of Indiana and the city of Indianapolis. For more information, contact Thomas (Tom) Stergar II at 317-777-6203.


October 1, 2014

CAI good


Media Contact(s): Jackie Weichman, Manager, Global Marketing


Richard Tree takes the reins as CAI Director of Maintenance and Reliability.


INDIANAPOLIS, IN – 01 October 2014 – Commissioning Agents, Inc. announces the addition of Richard Tree to our senior leadership. As Director of Maintenance and Reliability, Richard will be responsible for growing the CAI Maintenance and Reliability business area and administering global quality standards. This leadership includes developing business direction and agenda, strategic planning, tactical guidance, and management.


Robert Chew, President and CEO of Commissioning Agents, Inc. stated, “Richard has three decades of operations and maintenance experience – spanning nuclear submarines to temporary construction office modules. Richard brings both a discipline and pragmatism to how maintenance and reliability programs should be designed and implemented. He understands all aspects of maintenance as a means to an operational end – from making the business case to the deployment of a culture of performance and reliability. We look forward to furthering this dimension of our services.”


Of his new role, Richard stated, “I’m thrilled to be given the opportunity to work for such a great company where I can contribute my expertise to an already highly talented and well regarded team. There has never been a better time to help companies across all industries around the globe realize the benefits of a formal strategy for managing their assets. Firms continually find themselves in some stage of planning, acquiring, operating, maintaining, rehabilitating, replacing, and disposing of assets. The key is to do all of these activities in the most cost effective manner, without sacrificing quality, safety, and sustainability. It is this core principle that forms the substance of what our M&R teams bring to customers.”


Richard has 31 years of experience: 22 years of submarine naval nuclear power operations, and 9 years overseeing manufacturing operations in the private sector. He is a recognized for operations excellence and has held leadership roles as VP of Operations and Chief Operating Officer where he was responsible for multi-site manufacturing plants and their supply chains. He is Lean Six Sigma Certified and has authored multiple articles for industry publications. Some of Richard’s most impactful work was in the area of Enterprise Asset Management involving asset and system design, sourcing, life cycle management, and reliability. His approach to asset life cycle management is one that develops a framework for continuous improvement based on the business’ objectives for their value added needs. His efforts led to dramatic gains in operating equipment effectiveness (OEE) from as low as 40% to as high as 90% as a result of improved reliability. Richard holds an MBA from Southern Methodist University and is currently working on his PhD dissertation in the field of Operations Management from the University of Texas Arlington.


Commissioning Agents Inc. is an employee-owned company headquartered in Indianapolis, Indiana, USA. We provide technical and consulting services that promote the delivery, reliability and efficiency of equipment, facilities, and production operations. Visit our website at for additional information.


Partnership Re-Launches SBIR/STTR Matching Program and Provides No-Cost Technical Assistance for SBIR Proposals

July 30, 2014

Indiana Office of Small Business and Entrepreneurship

Jacob Schpok, Executive Director


INDIANAPOLIS (July 30, 2014) – Lt. Governor Sue Ellspermann announced today a partnership between the Indiana Economic Development Corporation (IEDC) and the Office of Small Business and Entrepreneurship (OSBE) which will provide technical writing assistance to Hoosier entrepreneurs for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) proposals. The same initiative will also re-launch Indiana’s Phase I matching program.


Lt. Governor Ellspermann noted, “Hoosier entrepreneurs and small business owners are keys to the continued economic growth and vitality of our State.  Providing technical support to access funding for innovation and technology transfer is another type of assistance that moves businesses forward.”


“The next great business idea is developing in the mind of a Hoosier,” said Eric Doden, president of the IEDC. “It is our priority to make sure that idea is brought to life in Indiana, with the right support system in place to help our entrepreneurs grow their ideas into high-performing businesses. The entrepreneurial spirit thrives in Indiana, with a business climate built on innovation here in a state that works.”


Through this partnership, Indiana companies can receive up to $5,000 in proposal writing or market research assistance from SBIR writing experts up to two times per SBIR/STTR agency. Indiana companies may also receive up to $500 in proposal review services. To learn more about this service, visit


Companies interested in Phase I matching can access up to an additional 50 cents for every federal dollar, up to $50,000 per award, subject to funding availability and eligibility determination. To apply for matching funds, please contact Elevate Ventures (


The highly competitive SBIR program encourages domestic small businesses to engage in Federal Research and Development that has potential for commercialization. This enables small businesses to explore new technologies by providing the incentive of profit from commercialization.


About IEDC

Created in 2005 to replace the former Department of commerce, the Indiana Economic Development Corporation is governed by a 12-member board chaired by Governor Mike Pence. Victor Smith serves as the Indiana Secretary of Commerce and Eric Doden is the president of the IEDC.


The goal of Indiana’s 21st Century Research & Technology Fund is to support the resolution of next-stage capital formation issues by co-investing with institutional investors in order to further build innovative, high-impact, high-growth companies. Indiana’s 21 Fund is managed by Elevate Ventures.


About OSBE

Under the leadership of Lt. Governor Sue Ellspermann, the Indiana Office of Small Business and Entrepreneurship (OSBE) oversees the Indiana Small Business Development Center (ISBDC), the Procurement Technical Assistance Center (PTAC), and the Indiana Small Business Ombudsman. The OSBE staff helps grow the Indiana economy by assisting entrepreneurs and small businesses through programs and personal consultation. For more information on OSBE and to see how Indiana is “the state that works” for entrepreneurs visit




Media Contacts:

Erik Scheub (OSBE) – 317.232.5679 or

Office of the Lieutenant Governor – 1 North Capitol, Suite 600, Indianapolis, IN 46204, (317) 234-2082


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