An Inside Look At Organogenesis, Inc.

Today’s Wound Clinic interviewed Geoff MacKay, President and CEO of Organogenesis (Canton, Mass), in this Q&A style interview. MacKay, has held the position since December 2003.

Today’s Wound Clinic (TWC): How long have you personally been in the wound care section of healthcare and how did you get into this area of specialty?
Geoff MacKay (GM): I have worked in wound care and regenerative medicine since 1996. I was the head of Sales and Marketing for Novartis Biotech Europe, head of Global Sales of Novartis Transplantation and Immunology, and Vice President of Sales and Marketing for Novartis Tissue Engineering in the US. Novartis was initially a partner of Organogenesis, and through this connection in the 1990s, I became committed to the potential of regenerative medicine in wound healing.

TWC: What do you find most rewarding about providing products to medical directors and wound care clinicians?
GM: The tremendous impact on patient’s lives. Over the past 10 years, living cell-based regenerative medicine products have begun to transform our field, dramatically altering patient outcomes. The leading role that Organogenesis is playing in bringing this field into the mainstream and getting regenerative medicine treatments to patients who need them is a source of great pride for my fellow employees and me.

TWC: How many different types/series of products do you make? Please list all of them.
GM: We have three product areas: Bio-Active Wound Healing, Bio-Surgery and Oral Regeneration.
Under Bio-Active Wound Healing, our bi-layered, living cell-based product Apligraf® is indicated for venous leg and diabetic foot ulcers. Apligraf is a 44 square centimeter circular bio-engineered cell construct, whose two layers make it effective in speeding up wound healing and achieving healing in wounds previously unresponsive to treatment. At this point in time, the product is the leading regenerative medicine brand in the world with more than 350,000 patient applications. Currently, 90% of the top 1,000 wound centers in the U.S. use Apligraf, which is applied on average once every 2 minutes. VCT01™ is our next generation of bio-engineered cell based technology, which is in clinical development.
Within the Bio-Surgery arena, Organogenesis has developed and commercialized FortaFlex® bioengineered collagen matrices, a line of natural biomaterials and the foundation for an entire family of FDA-cleared products that are used for heart and tendon repair surgery.
CelTx™, a living bi-layered cell therapy for Oral Regeneration, is an alternative to palate graft for gum repair and the first living-cell therapy designed for oral soft tissue. We have completed a successful Phase III trial and submitted to the FDA.

TWC: What would you say makes your company unique?
GM: Apligraf makes us unique. Organogenesis was the first company to receive FDA approval for an allogenaeic living cell-based therapy — Apligraf, which is indicated for venous leg and diabetic foot ulcers. It is the leading regenerative medicine brand in the world.

TWC: Please tell our readers something about your company that they may not know?
GM: Most people even in our business are not aware of the complexity of our process for manufacturing Apligraf. Our cell banks are the foundation for Apligraf and our other cell-based technologies. Donor tissue from infant circumcisions is subjected to an extensive series of tests performed to maximize the safety profile of the donated tissue.
The donated tissue is dissociated at our manufacturing facility into either human keratinocytes or human fibroblasts. Both cell types are expanded over the course of several weeks, eventually becoming master and working cell banks.
During a 20–day growing process for the product, a complex, differentiated epidermis is formed that contains multiple layers of living cells. The product undergoes rigorous quality control throughout the growing process before being prepared in a temperature-controlled packaging environment for shipping to physicians and customers throughout the world.

TWC: Please describe the mission/vision of your company in wound care and any of your goals that you would like to highlight.
GM: Organogenesis’ mission is to bring regenerative medicine to patients and standardize its use in everyday medical care. Since joining the company, I’ve led the effort to make Apligraf available to more and more patients with non-healing chronic wounds. I often receive thank you cards from grateful patients who have suffered from chronic wounds for years and finally received Apligraf and saw their wounds heal within weeks. This type of gratitude is one of the most satisfying parts of working in this field.

TWC: Looking ahead, what is Organogenesis currently working on for 2011 and beyond?
GM: Organogenesis has grown dramatically throughout these tough economic times, both in terms of the number of patients treated and the size of our company. We’ve opened new facilities, tripling the total square footage of our facility and adding staff across all departments. We have grown from 12 employees in 2003 to more than 400 employees today, primarily due to the increased adoption of Apligraf.
I’ve been fortunate to play a leadership role in what I believe is the most exciting emerging field in medicine. I believe this field has the potential to reset treatment paradigms for disease, injuries and aging.

TWC: Are there any trends in wound care that you and your executives are monitoring closely?
GM: The dramatic shift towards taking action: If a wound is not closing at an acceptable rate after 3-4 weeks of good passive approaches, the next step is to go directly to a bioactive approach such as Apligraf or Regranex. This is definitely in both the patient’s and the payer’s interests.

TWC: How will the rising number of wound care patients affect how your company operates its business in the future?
GM: We are continuing to build the infrastructure and skill set to help clinicians properly integrate Apligraf into their care protocols. We are very proud that the top U.S. wound centers use Apligraf, but we believe that our job—to ensure this advanced modality is used appropriately and to its best advantage—is just getting started.

TWC: Do you have any advice for clinicians who are unsure about what products are best for their wound care clinic?
GM: The best way to cut through the clutter of the hundreds of wound care options is to focus primarily on the few options which have randomized, controlled, multi-centered clinical data.