Cambrooke Celebrates 20 Years with Lynn and David Paolella!

What an incredible 20 years it has been. On day one of starting the company, could you ever have imagined that it would have grown to what it is today?

While we did not know specifically that someday we would be acquired by Ajinomoto, from the beginning we planned to build a world class clinical nutrition therapy company beginning with PKU.  As parents of 2 PKU children, we struggled for 8 years feeding our children and speaking with both patients and parents regarding the shortcomings of the diet.  Our initial target to improve the quality, variety and cost of the low protein food diet was merely a first step.  We could not understand the lack of development seen in the protein substitutes then available in the US and EU.  We deliberately sought to build a company that would have a global impact and not be only a family “lifestyle” business.  This means always putting the company’s mission, the customers, and the employees ahead of our personal or private interests.  The Cambrooke brand is now part of a global company that will bring Cambrooke’s vision to inborn errors of metabolism and many other clinical nutrition applications to come.

Our personal vison does not end with nutrition. We look forward to  safe and effective treatment alternatives for PKU in the years ahead.

What were the most important milestones for you over the last 20 years and how did they help to shape Cambrooke today?

During the first 4 years, Cambrooke developed its product specifications in-house and relied on food manufacturers with excess capacity to produce to our standards.  Overtime, it was clear this approach was not sustainable for such a specialized low volume food business.

Moving our food production to a 20,000 SF manufacturing facility dedicated to low protein food greatly expanded the number of products and quality control we could exert over production. By 2004 we had a team focused on the “craft” of making a range of bread without flour, cheese without milk, and “meat analogues” Camburgers™ and Chicken flavored “Nuggets” without animal or vegetable proteins.  We became the first company to create a low protein hot-dog, the Brookelyn Dog ™ specially designed for inborn-errors of protein metabolism.  In total, Cambrooke produced more than 120 low protein food products for distribution in North America. Many of them fresh-frozen.

Additionally there were other key milestones in the history of the business.  Primary among these was an early opportunity to license and commercialize the Glycomacropeptide technologies from the University of Wisconsin.  While there were several large companies active in the PKU taskforce organized by Sally Gleason, MS RD, Cambrooke moved quickly to license the patents before they were granted by the patent office (USPTO).  We made the decision following a review of the preclinical data (PKU mouse) that showed a GMP medical food diet was superior to the AA medical food diet for both the PKU and non-PKU (wild-type) mice!  Both the brain Phe and blood Phe were lower on the GMP-Medical Food diet for the PKU mice.  We were convinced GMP was important to lifelong physiology and health in the PKU diet. The good taste of GMP was just a by-product of this intact protein.  Cambrooke was the first company to launch a GMP-medical food in 2009. Our children, Cameron and Brooke, were the first beneficiaries. It remains the cornerstone of their treatment today.

Although profitable prior to 2011, raising millions of dollars of private-equity became necessary to support the working capital requirements for developing the GMP formula business globally.  We built a state of the art aseptic beverage manufacturing plant to make the highest quality ready to drink medical foods available anywhere in 2012.

Our growth in the past 8 years into Australia, Europe, and now Asia has enabled our vision to serve patients around the globe. We are fortunate to have a great number of caring staff and distribution partners who extend our mission worldwide.

What has been the most fulfilling part of your 20 year journey?

Nothing is more satisfying than seeing a young child who is struggling with their formula, sample Cambrooke’s GMP product for the first time — often they don’t believe it is formula and that they can be relieved of drinking their usual formula forever.  Secondly, knowing that the company we formed twenty years ago is providing gainful employment and supporting families on three continents is very gratifying.  Many of our staff have been with Cambrooke for more than a decade — we personally, and Ajinomoto at the corporate level, value the mutual dedication of company to employees.

It all started with Cameron and Brooke, two of your children diagnosed with PKU. How has treatment and low protein foods changed since they were just children?

Of course it all started with the reality of feeding our children. The good news for us: Cameron was diagnosed in the first week of life and began a low protein diet immediately.  The bad news we came to find: there was almost nothing he could eat. What he could eat, pure fat or pure sugar and carbohydrates was not a balanced or healthy diet.  Normal bread, pasta, and many vegetables, are too high in protein to be consumed regularly or in any quantity.  His daily natural protein intake (4g/day) is less than the 5g protein found in a single slice of white bread.

The low protein food we could buy in 1992 was extremely limited and not something we could offer our children without guilt.  Many of the low protein mail order baked goods would dissolve into a pasty glue before you could chew it.  The starch based bread made from scratch often made a paper white gooey mess in the center of even our best loaves.  The one other product, low protein pasta, was available at the end of the decade, though expensive, was the best product we could feed without guilt.

PKU adults who grew up in the 60s and 70s have told us numerous times what a difference Cambrooke has made by bringing quality and variety to the low protein diet for PKU.  Our third metric, lower cost, has been more elusive.  After building this business, we learned that the small batch sizes, laboratory analysis on nearly every batch, and high cost of distribution have made the cost of each product much higher than their main-stream counterparts.  To offset the high cost for families, we established the first of its kind medical insurance assignment in 2002 for PKU low protein foods in the US.  We continue that program today under the Cambrooke Cares™ program to eliminate out of pocket costs for eligible PKU patients.

What do you predict is in store for the community in the next 20 years?

We remain excited by the research undertaken by university and bio-tech companies in the area of PKU treatment.  From the initial approval of Kuvan, and recently Palynziq — we have seen two treatments that did not work for our classical PKU children — yet remain hopeful that new treatments will be developed with a safety profile equal to the medical food diet that is now the frontline treatment for PKU.  In the interim we are likely to see a home blood Phe monitor approved that will help us fine tune the diet and management of PKU.  In addition, more frequent monitoring will provide new insight into the nature of transient Phe levels and their impact on health and well-being.

Any final words of advice for new parents of PKU children?

New parents will benefit by engaging their families with their local or national advocacy groups and let your children be proud of their PKU. My family knows this first hand as we are among the proud founding members of the New England Connection for PKU & Allied Disorders (NECPAD) organization. Keep vigilant with diet today to stay healthy for a better treatment/cure available in the coming years.

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