CANTON, Massachusetts and LONDON, November 16 /PRNewswire/ --
- Conference Focus is Translating Research into Commercially Successful Products
Organogenesis, Inc., the world's most successful regenerative medicine company, has announced that Stephen Farrell, Vice President of Marketing will address the 5th Annual Commercial Translation for Regenerative Medicine conference, taking place this week in London.
Farrell's Friday morning speech, "Assessing Commercial Opportunities and Developing a Business Model Under New ATMP Regulations," will cover the recent European Union regulations concerning advanced therapies, focusing specifically on the commercial implications for cell- and tissue-based products.
The Congress invited Organogenesis to speak to the industry's top scientific and business leaders to discuss EU regulations concerning Advanced Therapy Medicinal Products (ATMP). As the first company to have translated the exciting science of regenerative medicine into a profitable, and scalable, business model, the commercialization pathway that Organogenesis has established is of high interest for companies in the field.
"We are optimistic that the new European Union regulations will provide clarity for companies worldwide to successfully launch novel, cell-based therapeutics in the EU," said Farrell. "However, unique complexities exist for this new field due to the very nature of these therapies, requiring expertise and well executed strategy to address successfully. We want to foster this growing industry by sharing Organogenesis' learnings with emerging companies looking for successes in the field."
In his speech, Farrell will review the regulations as they relate to the creation of a global, scalable model for companies developing cell-based regenerative medicine therapies. In addition, Farrell will address the specific challenges facing regenerative medicine companies with "living technology" products as they look to commercialize in European markets.
"The recent progress in the ATMP regulatory market is lighting the path for EU availability of cell-based therapies," continued Farrell. "The legislation is not likely to have an impact on market potential for such therapies, but rather on the potential to market. This is where Organogenesis' expertise can be helpful, as guidance to this emerging industry."
The field of regenerative medicine has now reached the stage of translating groundbreaking science into viable product offerings. Challenges in the field of living technology include product design, clinical development, mass production, and distribution of a living product safely, reliably, and economically. Unlike traditional medicines, living cells are delicate, have a short lifespan, and thus pose tremendous challenges to deliver in the form of therapies.
Organogenesis is the first company to successfully mass produce living regenerative medicine products -- reaching hundreds of thousands of patients -- and to have reached sustained profitability. Its signature product, Apligraf(R), is the first bio-engineered cell therapy to have received FDA approval, and is used by doctors successfully in treating patients with diabetic foot ulcers and venous leg ulcers in the U.S. and other markets across the world.
Organized by Marcus Evans, one of the world's leading providers and promoters of global summits and strategic conferences, the 5th Annual Commercial Translation for Regenerative Medicine conference is being held in London, England on November 15th and 16th.
The Commercial Translation for Regenerative Medicine annual conference brings together key industry, academic and regulatory leaders in the regenerative medicine industry. The field has grown from its former
research-oriented, cottage-industry past to a primary example of a 21st century, translation focused, healthcare enterprise. This new perspective, along with strong public and political support, has allowed regenerative medicine to enter a second era. The forum will discuss the challenging path ahead for the regenerative medicine industry to produce clinical therapies that perform significantly better than earlier counterparts, and to produce real cost benefit.
About Regenerative Medicine
A new frontier in healthcare, regenerative medicine is an evolving therapeutic approach that utilizes living cells to repair or replace body tissue damaged by injury, disease or the aging process. It is a multidisciplinary field involving biology, medicine and engineering.
Regenerative therapies rely on the body's own natural ability to repair and regenerate, and enable the body to heal itself Regenerative medicine also empowers scientists to grow living cells, tissues and organs in the laboratory, and to safely implant them into the human body for the purposes of healing.
The related terms "Tissue Regeneration," "Tissue Engineering" and "Stem Cell Therapies" are often used to refer to some of the activities under the umbrella of regenerative medicine.
About Organogenesis, Inc.
Massachusetts based Organogenesis, Inc. is the world's most successful regenerative medicine company and is focused in areas of bio-active wound healing, bio-surgery and bio-aesthetics. Organogenesis delivers living tissue "on demand," and its mission is to bring the medical marvel of regenerative medicine products to patients and to standardize their use in everyday medical care. For more information, visit http://www.organogenesis.com.
Web site: http://www.organogenesis.com
Angelyn Lechman of Chase Communications, +1-858-273-1805, firstname.lastname@example.org, for Organogenesis, Inc.