Anthony J. Dolisi, Olaregen Therapeutix

Q:

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

A:

I have built a 25+ year career in progressive leadership roles. I consider myself a results-driven executive with a track record of success in driving rapid revenue growth in start-up and/or turnaround business environments. I have extensive experience in pharmaceutical, biotech, and molecular diagnostics markets and medical devices including in wound care. I have several product launches with first-in-class products in cardiology, central nervous system, oncology, virology, wound care, and infectious disease. I tend to leverage experience and best practices in clinical, sales, and commercial operations. I have had unique opportunities to develop peak-performing commercial teams that consistently maximize productivity and revenue generation.

My experience is both broad and deep and includes launch planning, P&L management, licensing and co-promotion, team leadership and motivation, brand/consumer marketing, medical-education/key opinion leader development, creative market segmentation, managed care/contracting, and community/patient advocacy. My industry experience is primarily in executive leadership with Fortune 500 companies including American Home Products, Glaxo SmithKline, Agouron, Pfizer, and Johnson & Johnson. Combining both commercial and clinical expertise has made a significant contribution in both patient care and by building multi-million-dollar businesses. I enjoy igniting growth in business lines, devising innovative differentiated product strategies, and spurring company growth through creative and comprehensive portfolio strategies.

As President & CEO of Olaregen Therapeutix Inc., I am responsible for all the functional sectors of the Olaregen organization, driving the performance and success of the business. I will lead in the efforts to commercialize new products, oversee all facets of the company’s go-to-market strategy, as well as play a vigorous role in pipeline development, acquisitions, and strategic alliances.

Q:

What should readers know about Olaregen Therapeutix’s vision and mission?

A:

Olaregen Therapeutix Inc. is a regenerative medicine company focused on the development, manufacturing, and commercialization of products that fill unmet needs in the current wound healing market. The company was acquired by Generex in 2018, which continues to support the company's mission to provide advanced healing solutions that substantially improve medical outcomes while lowering the overall cost of care. Olaregen’s first product introduction, Excellagen^® (a 3-dimensional wound conforming matrix), is a topically applied product for dermal wounds and other medical conditions.

Olaregen is committed to searching for and developing innovative products that meet unmet medical needs. Based on our unique proprietary products, we will continue to pursue solutions that build on the multiple attributes of these compounds to drive our innovative pipeline.

Patients are always our first priority. Olaregen has pledged to develop regenerative products to advance healing and improve patients’ quality of life. It’s our mission, our vision; it is our purpose.

Olaregen fits in with Generex’s strategy of providing end-to-end solutions for physicians and patients; for example, Excellagen is a great product for the management of diabetic foot ulcers. We are delighted to be working with Generex via the formation of NuGenerex Health, through which we will provide collaborative health services for the diabetes patient population. Because Olaregen is part of the NuGenerex family of companies, we have direct access to the NuGenerex Health physicians and patients who can benefit from Excellagen and our full line of wound care products to improve outcomes and reduce the cost of care.

Q:

What attracted you to Olaregen?

A:

In my late 30s, my blood sugar was out of control. My A1C was 11. It was nothing for my blood sugar to be over 300 mg/dL. My doctor recommended I meet with a diabetes educator, who signed me up to a diabetes self-management education class. I made the appointment, and we started working on my diet and my insulin regimen. She taught me how to correct my blood sugar when it was high, and she reviewed all the potential long-term complications of diabetes, including diabetic foot ulcers. My provider recommended seeing an eye doctor and foot specialist on a regular basis. Patients with diabetes are prone to poor circulation, have a weakened immune system, and impaired nerve function in their feet. These wounds can also develop into serious infections that can lead to amputations, loss of limbs, and even loss of life.

Olaregen afforded me the opportunity to utilize my longtime experience in pharmaceuticals, combined with my passion to help patients suffering from the severe comorbidities of the life-threatening disease diabetes.  

Q:

What do you like most about working for Olaregen?

A:

We are very passionate! We are all highly motivated to impact patients who have these extremely hard-to-heal wounds. Diabetic ulcers, post-Mohs surgical wounds, venous ulcers, and pressure ulcers: these are just devastating wounds for not only patients but for their families.

We know we have a product, Excellagen, that is backed with good clinical data that showed success in one of the most difficult classes of wounds to heal—diabetic foot ulcers. This gives us confidence—a lot of confidence. We overcome commercial hurdles daily but remain focused on getting our message out to the healthcare community so we can make a difference in our patients’ lives.

Last week, we were in a team meeting where we talked about a veteran in a Central Texas VA where Excellagen was applied to his wound that had been open for several years, and it healed in one week. Wow! That is why we come to work. We love these success stories.  

Q:

What are some of the biggest changes you have witnessed in the wound care industry over the course of your career?

A:

Well, it wasn’t that long ago that these hard-to-heal wounds were treated with just gauze, and that was the only tool in the shed. Thankfully, there has been significant investment in developing innovative solutions in advanced wound care in the last 20 years.

I think negative pressure wound therapy (NPWT) was a game changer. I don’t know too many wound care protocols where this technology is not part of the doctor’s or nurse’s toolbox. Also, cellular and tissue-based products (CTPs) are relatively new to the market.

CTPs give a lot of hope to the individuals who have had non-healing wounds for years—yes, years. More than 50 percent of these hard-to-heal wounds will not heal with traditional therapy, including NPWT. It will be exciting to see how these matrices will innovate with next-generation product launches in the next five years. And our plan is to be a part of this, a significant contributor to next-gen CTPs.

Q:

What changes do you expect the industry to experience in the coming years?

A:

The abundance of ongoing preclinical and clinical research suggests that new products and product classes are on the horizon. More and more, we are also seeing utilization of different products and product classes in combination, as opposed to a one-product-at-a-time approach. There is also increased focus on accumulating real-world evidence, in addition to data generated from strictly controlled clinical trials, to better enable treatment strategies and manage outcome expectations. Although not yet mainstream, imaging and biologic diagnostics are being developed to help personalize wound care. And perhaps most important, patients and clinicians alike must remain focused on prevention.

Q:

How does your company intend to impact the improvement of quality wound care research and trials moving forward?

A:

We made a significant investment in a multi-centered randomized controlled clinical study that showed some great results. Many 510(k) products have not done this type of high-quality clinical study. This was not a single-site, 10-patient study. Our primary investigator was out of Yale, and we had more than 10 sites participate in the study. In the last year, we have had multiple KOLs helping us continue to build clinical evidence. So far, we have seen some impressive results.
 

Q:

Is there anything else you would like to add about Olaregen?

A:

I’d know the team is really excited about our future, but we are really excited about today! We believe our Excellagen product can impact our patients, their caregivers, HCPs, and payors today. We are investing in our pipeline to bring other technologies to the market. But we have solutions today.

We are all experienced professionals at Olaregen, and we hope to make significant contributions in healing hard-to-heal wounds.

Q:

What is your life like outside the company?

A:

During my spare time, I enjoy spending time with friends and family. I am one of five children, so my extended family is large. When not traveling for work, I like to stay local, but during the weekend I usually travel to my country house in Pennsylvania for quality time. I enjoy boating and skiing, and I love family games. I have two children in their 20s; my daughter is a third-year dental student at Stony Brook University and my son is in wealth management at AXA Financials. I have been married to my wonderful wife, JoAnn, for more than 29 years. In fact, we will be celebrating our 30-year anniversary on June 23, 2020. I would not have been able to accomplish my life goals without her. Our favorite vacations are on cruise ships; I love the Oasis and Allure. In a couple of months, I have planned to take a ship sailing from New York. I can’t wait.  

I really enjoy cooking—or should I say eating—and antiquing in my spare time. I often watch cooking experts on YouTube to learn new cooking techniques and learn about new dishes to pair with a fine wine. During the weekend, I am often rummaging in the local antique shops looking for unique collectables. My family and friends have encouraged me to set up my own cooking blog and Instagram page where I post a new recipe, along with a photograph or open a restaurant. I may take them up on it in my retirement years when I have free time.