Linda Palczuk, President & CEO, Osiris Therapeutics, Inc

Please provide a short description of your background, training, and experience.

I have an undergraduate degree in Biology as well as a graduate degree in Business Administration and have worked in the life sciences industry for over 30 years. I began my career in pharmaceutical sales and was fortunate enough to work with major market-leading brands. My background is mostly on the commercial side of the business, where I held large functional roles as well as general management/profit and loss executive leadership positions with a Fortune 500 biopharmaceutical company.

Why did you choose to lead this particular company?

I was attracted to Osiris for 3 key reasons. First, the scientific technology that underpins the company’s products is extremely compelling, and I was accustomed to innovative science from my previous work experience. As the company that launched the first approved stem cell product in Canada and New Zealand, Osiris has a rich history in cutting-edge science and continues to focus on advances in the field of regenerative medicine. Second, the people of Osiris are extremely committed to our products and the patients we serve; that kind of patient-centricity aligns well with my own personal values. Third, Osiris has great potential for growth and I am excited to be a part of a growing organization.

What differentiates your company from competitors?

I think the biggest differentiation from our competitors is Osiris’s unique technology platform that enables us to produce viable tissue products. With nearly 25 years of research and development, Osiris has acquired a deep understanding of cell biology and key principles of regenerative medicine. This knowledge has helped us develop cell and tissue preservation technologies that maintain both the structural and functional integrity of biological matrices.

What are some of the company’s biggest accomplishments thus far?

The company has had a number of significant accomplishments during its 25-year history:

• In 2005, Osiris created the world’s first cellular bone allograft.
• The company launched the Grafix^® product line in 2010. Grafix^® is a viable, cryopreserved placental membrane product for hard-to-treat acute and chronic wounds. In 2013, Osiris announced the results of a randomized trial where Grafix^® demonstrated overwhelming superiority over standard of care (OWM. 2013;59[12]:38-43.). 
• Since the launch of Grafix^®, Osiris has also achieved commercial success with products in orthopedics, sports medicine, and wound care, including BIO^4®, a viable bone matrix for bone repair and regeneration (available exclusively through Stryker); Cartiform^®, a viable osteochondral allograft (available exclusively through Arthrex); and Stravix^®, a cryopreserved placental tissue used as a surgical covering or wrap.
• In 2012, Osiris received approval in Canada and New Zealand for the world’s first stem cell drug for the treatment of graft-versus-host disease.

Most recently, Osiris has developed Prestige™ Lyotechnology. Unlike all other known lyophilization methods, Prestige™ Lyotechnology enables the preservation of living cells within tissues stored at ambient temperatures. The manufacturing of lyopreserved living tissues with Prestige™ Lyotechnology may be applied to many different cell and tissue types. Placental products will be the focus of the company's first application of Prestige™ Lyotechnology. The ability to apply this new technology to our existing products will continue to differentiate Osiris from our competition.

What is the biggest challenge you face working in the realm of wound care?

What one may see as challenges in the wound care market are also opportunities. As more competitors enter the wound care space, today’s physicians have an increased number of products to choose from over just standard of care. Osiris produces innovative tissue products that retain all the native components of the tissue, which includes viable cells, growth factors, and an extracellular matrix, and we remain diligent in educating physicians on how our unique products could benefit their patient population. With our next generation of products, Osiris is working to make our products on-demand and even easier for the physician to use.

The aging population in the United States means potentially more patients to treat, especially with an increasing prevalence of diabetes. However, the changing demographics are also putting more pressure on the health care system in the United States, leading to more pricing pressures and reimbursement restrictions. Both Grafix^® and Stravix^® are available in multiple sizes to help reduce waste and cost in wound management. 

These are just a couple of the challenges that we face working in the wound care realm.