Upcoming Publication in Monitor, Journal of the ACRP


Target Health is pleased to announce that a new publication entitled “21st Century Approaches to QA Oversight of Clinical Trial Performance and Clinical Data Integrity,” will be published in December in Monitor, Journal of the ACRP. The premise of the article is that QA, not just QC, should be a real-time, integral part of the drug and device development processes, and not an “after the fact” phenomenon which is common in clinical research. We need QA to be a trusted and critical “friend.”


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.

How 3D Printers Are Reshaping Medicine


Printing off a kidney or another human 1) ___ may sound like something out of a science fiction novel, but with the advancements in 3D printing technology, the idea may not be so far-fetched. While 3D printing has been successfully used in the health care sector to make prosthetic limbs, custom hearing aids and dental fixtures, the technology is now being used to create more complex structures – particularly 2) ___ tissue.


Organovo, a San Diego-based company that focuses on regenerative medicine, is one company using 3D printers, called bioprinters, to print functional human tissue for 3) ___ research and regenerative therapies. “This is disruptive technology,” said Mike Renard, Organovo’s vice president of commercial operations. “It’s always interesting and fun, but never easy.


Traditional 3D printing, also known as additive manufacturing, is a process of making three dimensional solid objects from a digital model. 3D printing is achieved using additive processes, in which an object is created by laying down successive 4) ___ of material such as plastic, ceramics, glass or metal to print an object. Companies including Boeing, General Electric and Honeywell use this type of 3D printing to manufacture parts. Bioprinters, though, use a “bio-ink” made of living cell mixtures to form human tissue. Basically, the bio-ink is used to build a 3D structure of 5) ___, layer by layer, to form tissue.


Eventually, medical researchers hope to be able to use the printed tissue to make organs for organ replacement. However, growing functional organs is still at least 10 years away, said Shaochen Chen, a professor of nano-engineering at the University of California, San Diego, who uses bioprinting in researching regenerative medicine. But even though developing functional organs may still be a decade off, medical researchers and others are using bioprinting technology to make advancements in other ways.


Researchers in 6) ___ medicine at Wake Forest University in North Carolina partnered with the Armed Forces Institute for Regenerative Medicine to make a 3-D skin printer that deposits cells directly on a wound to help it heal quicker. Researchers at the university have also had success printing off kidney cells. Bioengineers at Cornell University have printed experimental knee 7) ___, heart valves and bone implants. And the non-medical start-up Modern Meadow, which is backed by investor Peter Thiel, is using bioprinting technology to develop a way to print meat.

Bio-printing is also playing a part in how some pharmaceutical companies conduct medical research, and the technology may also have the potential to save the drug companies a lot of money because it could cut drug testing 8) ___, Chen said. Medical researchers in the pharmaceutical industry, until lately, have used two-dimensional cell cultures to test drugs during the early stages of development. However, the 2D cell cultures do not reflect human tissue as accurately as 3D printed tissue, meaning the 2D models can create misleading test results. Testing with 3D tissues, however, provide more precise results, which allows for pharmaceutical companies to determine failed drugs early on before investing more 9) ___ in development. And with clinical trials accounting for the largest percentage of the biopharmaceutical industry’s budget for the research and development at $31.3 billion, according to a report from the President’s Council on Science and Technology, it’s no surprise that drug companies want to use 10) ___ tissues to help avoid wasted costs. “It’s very, very significant and it takes a lot of time and money developing a successful drug,” Chen said. “I think this is a great idea and will save the pharmaceutical industry a lot of troubles and it could also help get drugs to market faster.”


And this is where Organovo sees opportunity, Renard says.


Organovo, with the help of the Australian company, Invetech, was the first company to launch a commercial 3D, 11) ___. The company originally intended to sell its printer, which is called the NovoGen MMX bio-printer, to other companies for use. But after seeing opportunity to cash in on the market for human tissue, the company changed its business model to making tissues for drug companies for medical research and therapeutic applications instead. “Generally, the drug business can benefit significantly from these 3D tissues and there is plenty of evidence that their processes are basically broken.” They are inefficient and highly suspect,” Renard said. “There’s a big problem and they are looking for a better solution.”


Organovo, which trades on the OTC market, wants to be that solution. The company has partnered with Pfizer and United Therapeutics, and while Renard would not disclose the details of their partnership, he did say that the companies have a business arrangement in which funding is provided and some rights are shared. Renard did not disclose any other drug companies that are partnering with Organovo. But Organovo, which has made blood vessels, lung tissue and recreated tumors using bio-printing, is customizing tissue of all types for its current partners’ medical research, Renard said. “We build 12) ___ tissue for them,” Renard said. “They may have specific cell lines, disease areas of interests and they want a proprietary model for them, and we can make it.”


ANSWERS: 1) organ; 2) human; 3) medical; 4) layers; 5) cells; 6) regenerative; 7) cartilage; 8) costs; 9) money; 10) 3D; 11) bioprinter; 12) custom


Chuck Hull: (1939 to present)

Pioneer in Stereolithography and the 3D Printer


Charles “Chuck” W. Hull, the inventor of stereolithography and founder of 3D Systems



A huge and diverse industry has grown out of the development of stereolithography, an additive manufacturing technology also known as optical fabrication or photo solidification, that has been used in 3D printing in the last three decades, not the least of which is regenerative medicine. Chuck Hull, executive vice president, and CTO of 3D Systems, along with Doug Neckers, CEO of Spectra Group Limited, are pioneers of Hull’s patented technology that spawned an age of 3D printing. Today, prototypes of airplane wings, musical instruments, auto parts, and medical prostheses can be created on demand in a matter of hours, and printers capable of producing intricate 3D objects can be had for the price of a high-end TV.


Development of SLA and 3D Systems

SLA is a process of building 3D structures from a computerized design. Multiple thin layers of a liquid UV-curable photopolymer resin are cured, one on top of another, using a UV laser to trace and solidify a pattern and causing each layer to adhere to the layer below. SLA greatly reduced the time it takes for designers and engineers to create a concept design or functional 3D prototype. After patenting the 3D manufacturing process in 1986, Hull founded 3D Systems, which commercialized the first rapid-prototyping system for computer-aided-design software. The company is now a leading provider of commercial and household 3D printers and design-productivity tools for digital manufacturing.


3D Systems’ most recent innovation is a $1,300 Cube printer that makes plastic 3D objects such as toys and jewelry and is marketed to consumers, hobby designers, and garage entrepreneurs. Hull calls this latest advancement a “democratization” of access to 3D printing. 3D Systems has been extremely successful, reporting revenues of $90.5 million in the third quarter of 2012, a 57% increase over the same period in 2011. It announced in October 2012 that it expects about $350 million in revenues by the end of 2012.


Hull has a BS in engineering physics from University of Colorado (USA) and an honorary doctorate in engineering from Loughborough University (UK). He was working to develop UV-curable resins for Ultra Violet Products in California when he made the breakthrough.


In the early 1980s, Dr. Hull wondered if photopolymer chemistry could be imaged to quickly make first-article (prototype) plastic parts, since it took six to eight weeks to get first-article parts from the traditional tool-making and molding processes. And then the design usually had problems, and it had to be done over. Designing in plastic was a very time-consuming and expensive process. At that time, stereolithography created great interest because it solved the first-article problem; it was a rapid prototyping system. Based on that, the company grew rapidly, expanded the range of stereolithography systems, and also developed lower-cost ink-jet-based 3D printers. Since then, quite a few competing companies and technologies emerged, each with their own approach to 3D printing. However, over the years, 3D Systems continued to develop new types of printers, and the company acquired several other companies and technologies in the field.


Cellphone covers, shoes, and other articles can be printed with 3D Systems’ Cube 3D printer. Photo Courtesy 3D Systems


The technology required mastering photochemistry, laser optics, optical scanning, precision mechanical mechanisms, machine-control software, 3D image manipulation software, process engineering, and system integration. Hull created the first stereolithography system by himself in a lab that his employer let me use. This was very basic, but it demonstrated the concept. Based on that, he formed the new company, 3D Systems, and brought in all the special talent to develop commercial systems. There was tremendous interest from the beginning, and the company’s initial customers invested alongside with the company to learn and help evolve the technology to where it is today.


Fortunately, the time was right to deliver an affordable 3D printer. That and working on great 3D content for anyone and everyone to take advantage of, were the main challenges in offering a compelling consumer introduction to 3D printing. According to Hull, production systems using SLA and selective laser sintering (SLS) still demand a premium in the market because their capabilities to suit customers’ requirements is evolving. The real price breakthrough has been in entry-level systems – delivering great value for the cost – and in the ability to deliver increasing levels of functionality from years of experience at the high end to the professional 3D-printer market.


The company is on a mission to place creative tools into the hands of everyone – without regard for their technical abilities. Hull sees a future when everyone can create and make in 3D with true coloring-book simplicity. In the past 25 years, a few hundred thousand people have been able to design with complete freedom of creation. Just imagine what happens when billions of us gain access? The level of innovation and creativity should far surpass anything we know today.


Hull’s favorite is the very first cup that was printed. His wife keeps it with her still today. He also stated that while there are many amazing things have been printed, perhaps the medical model that surgeons used in 2003 to successfully separate the Egyptian twins joined at the head will always remain one of his most important objects.


The U.K. and U.S. governments are among many nations funding programs to accelerate the development and commercialization of laser-based additive manufacturing technologies. The U.K. Technology Strategy Board will invest millions of pounds on 3D printing technologies with its “Inspiring New Design Freedoms in Additive Manufacturing” competition. The United States in 2012 launched a pilot institute to serve as a proof-of-concept for its National Network of Manufacturing Innovation. The pilot institute is located in Ohio and will be focused on additive manufacturing technologies such as 3D printing. Lawrence Livermore National Laboratory (USA) is planning a major push in its research programs devoted to additive manufacturing technologies like stereolithography. In addition, at its Center for Micro and Nano Technology in California (USA), LLNL develops applications for the Departments of Energy, Defense, and Homeland Security. The lab will collaborate with U.S. manufacturers to develop efficient technologies for their manufacturing processes.


Below is an example of LLNL’s printed 3D structures.


Sources: SPIE: (SPIE is the international society for optics and photonics);
Forbes (2013); Business Week (2013); Wikipedia


Interview With Chuck Hull

More history of 3D Printers

Watch Statue Made with 3D Printer

3D Print Show London 2012

Understanding 3D Printers

Dr. Gabor Forgacs- What if we could simply “print” new organs for use in clinical trials? Gabor Forgacs from Organovo tells us about a radical new approach to tissue engineering.

Dr. Anthony Atala

Massachusetts General Hospital – Regenerative Medicine

Printing Human Organs

Tissue Engineering – Columbia University

Stem Cells — Growing New Parts

3D Printer – Biologically Sound Human Ears


History of printing

3D Printing: A Matter of Life and Death


When Kaiba Gionfriddo was born prematurely on 28 October 2011, everything seemed relatively normal. At 35 weeks, his doctors’ main concern was lung development, but Kaiba was breathing just fine. Doctors deemed him healthy enough to send him home within a few days. Six weeks later, Kaiba stopped breathing and turned blue. After 10 days in the hospital and another incident, physicians diagnosed the infant with severe tracheobronchomalacia, a condition where there is a weakened windpipe so that the trachea and left bronchus collapse, preventing crucial airflow from reaching the lungs. Kaiba then underwent a tracheostomy and was put on a ventilator, the typical treatment for this condition. However, it didn’t work. Since the prognosis was not good, his doctors tried something revolutionary: a 3D-printed lung splint that could save his life.


Glenn Green, MD, associate professor of pediatric otolaryngology at the University of Michigan, and colleague Scott Hollister, PhD, professor of biomedical engineering and associate professor of surgery, used 3D printing technology to create a bioresorbable device that instantly helped Kaiba breathe. It’s a prime example of how 3D printing is transforming healthcare as we know it. Green and Hollister had already developed a prototype of the 3D-printed splint, a sort of tubular scaffolding designed to fit around a patient’s airway and inflate his bronchus and trachea.



Scott Hollister, PhD, left, and Glenn Green, MD Image: University of Michigan Health System.



Approximately 1 in 2,200 babies is born with tracheomalacia, a condition in which the tracheal cartilage softens and leads to collapse.


Yet while 3D printing is changing the way consumers think about mass manufacturing, a parallel revolution is only gradually entering the mainstream consciousness. Behind the scenes, doctors and biomedical engineers are experimenting with the technology, already saving and otherwise improving lives in the process. So far, 3D printing has helped produce jaw transplants, skull implants, millions of hearing aids and a wide variety of prosthetics – for both humans and other animals. Some scientists have developed 3D printers (“bioprinters”) that print layers of skin tissue, artificial blood cells, miniature human livers and even bionic ears.


In cases with tracheomalacia, doctors once treated many of these instances with traditional solutions. Technicians handcrafted hearing aids and dental appliances from molds; doctors fitted prosthetics to residual limbs; patients received transplants, albeit slowly, from viable donors. The difference is 3D printing allows for speed, efficiency and customization, three factors that can make a life-altering – hopefully life-saving – difference.


The technology behind conventional 3D printing is fairly simple to explain. After a 3D printer reads the design you’ve created with computer software, it passes over a platform, much like an inkjet printer, and deposits the desired material in layers. The process varies according to the model and the size of the object, but a 3D printer typically sprays, squeezes or otherwise transfers a material onto the platform in a matter of hours.


To create Kaiba’s tracheal splint, Green and Hollister obtained emergency clearance from the FDA and then took a CT scan of his trachea and bronchus to produce a precise image, from which they could design the device. Using computer modeling software and making some modifications, they created a splint that perfectly matched Kaiba’s windpipe and printed it with a biodegradable polyester called polycaprolactone.


The custom splint fits around Kaiba’s airway, and it will dissolve within three years. Image: University of Michigan Health System


The splint goes around the outside of the bronchus, then sutures pass through the splint to tether the trachea through the inside. This expands the bronchus and inflates the trachea. With growth, the splint opens up. Even though Green and Hollister sized the design to Kaiba’s bronchus, they crafted three or four increments of about a half a millimeter above and below the diameter from his scan. Then they made about five copies of each, just to make sure they had enough going into the operating room. When they implanted the splint on 9 February 2012, it established an opening in the bronchus. Kaiba’s lungs immediately started moving. The surgeons expect the device to dissolve completely within three years, when Kaiba’s windpipe will have grown in the correct dimensions, big enough that it won’t further collapse. As a surgeon, Green explains that he can’t match the ability of a computer specifically tailored to a patient’s image. “There are a bunch of things that I hand-carve or hand-make,” he says. “My abilities are down to around a millimeter, maybe. I can get a microscope out for some small applications, but to do that in the operating room, to go sub-millimeter resolution, is not worthwhile. And I can’t do it with a big case like [Kaiba’s]. It’d be impossible to do.”


The splint, in this particular case, was inserted at no cost to the family, since it was considered a research project. Green explains, however, that the initial price for such devices in the future will be relatively high, because of expenses associated with purchasing the 3D printer, the sterilization, etc. That said, the raw material is very inexpensive – the polycaprolactone splint costs less than $10, and it can be fashioned in about 24 hours.


An iconic painting hangs at the Countway Library at Harvard Medical School. The scene shows a gaggle of physicians crowded around two patients on operating tables – one in the front room, another in the back, almost as if mirroring each other. Men in white lab coats stand outside the doorway on the right, hanging slightly past the frame, talking excitedly while pointing to their notepads. Something important is about to happen. The painting depicts the first human organ transplant in history – a kidney, in 1954. Anthony Atala, MD, director and chair of Wake Forest Institute for Regenerative Medicine in North Carolina, projected the painting onto a screen before beginning his October 2009 TED Talk. Wake Forest is one of the largest facilities in the world dedicated to regenerative medicine. Its scientists were the first to engineer lab-grown organs – human bladders – which they successfully implanted into seven patients at Boston Children’s Hospital in 2006.


The biomaterials used in regenerative medicine are essentially materials compatible with the body. They can be natural (like collagen), synthetic or a combination of the two. Biomedical engineers can weave biomaterials together, or they can print them, similar to how Kaiba’s doctors manufactured his splint. As a result of this bioprinting technology, scientists at the Wake Forest Institute 3D-printed a kidney in seven hours, using biomaterial and human cells.


Bioprinting is similar to conventional 3D printing in that it’s a combination of related technologies used to print out living structures, and each one has its own process, limitations and potential achievements.


Autodesk, one of the leaders in computer-aided design software since it was founded in 1982, has worked to push innovation in 3D bioprinting for the past three years. Essentially, the company is trying to look at life as a design space.


Anthony Atala, MD, holds a printed human kidney, with the printer in the background. Image: Flickr, Steve Jurvetson


One of the things that makes bioprinting different from conventional printing is that the design software has to understand biology as well as the mechanical aspects of the designs. With traditional CAD software for a conventionally 3D-printed object, the design and geometry has to be specified. With bioprinting, the CAD software has to understand the biochemistry of it, too – things such as metabolism and nutrient diffusion.


Today, the team at the Wake Forest Institute works to engineer replacement tissues and organs, and to develop cell therapies for more than 30 different areas of the body. It’s currently developing a specialized 3D printer as part of the Armed Forces Institute of Regenerative Medicine, a federally funded initiative to apply regenerative medicine to battlefield injuries. In other words, this printer may be able to print skin grafts directly onto patients’ wounds.


There’s currently no standard software for 3D bioprinting, and therefore, no practical way for the community to exchange designs. Now, Autodesk is developing Project Cyborg, a platform to enable researchers and scientists to develop computational models and receive information in a more open and accessible way. Despite no standard way to create and share designs, 3D printing is filling the holes left behind by traditional medicine.


Kaiba was taken off ventilator support 21 days following the splint procedure, and he hasn’t had any trouble breathing since then. He still has regular and relatively close follow-up appointments at the University of Michigan. He uses a valve to talk. He’s mildly delayed in physical development, which Green says is unsurprising, considering how long Kaiba was paralyzed. But Kaiba still looks and acts like a normal kid, playing with his brother and sister and hanging out with the family dog, Bandit. He even gets himself into trouble, scooting across the floor and “getting into everything,” according to his mom. Source: Sept 2013 http://www.cool3dprinting.com/p/4007226009/3d-printing-is-a-matter-of-life-and-death


3 Ways 3-D Printing Could Revolutionize Healthcare



Originally used to cheaply and quickly make prototypes, 3-D printing has lately gained momentum as a (cheap, quick) manufacturing endpoint in and of itself. The technology redefines the phrase “broadly applicable:” it’s been used for architecture, industrial design, automotive and aerospace engineering, the military, civil engineering, fashion and food. In medicine, it has had most success with prosthetics, dental work and hearing aids, which can all be made from plastic or pliable materials and often need to be tailored to a specific patient. But scientists have also worked out, at least in theory, how to print blood vessels, skin, even embryonic stem cells. “The biggest advantage is that everything is customizable,” said Markus Fromherz, Xerox’s chief innovation officer in healthcare.


There are three categories of healthcare where 3-D printing could be applied, or is already, Fromherz said: for body parts or prosthetics – sometimes called “scaffolding,” medical devices and human tissues.




Printing technology has already revolutionized joint replacements, Fromherz said. “Knee replacement is a very common procedure, there are six or so different types of knees that doctors use,” he said, adding, “with each one you need to cut the bone differently. But with 3-D printing, doctors aren’t limited to those six knees. They can design one specific to each patient. Patients with custom knees don’t have to lose extra inches of bone, instead the surgeon can cut at the optimal point, which could lead to faster recovery times and better functionality. Strong, flexible new knee joints mimicking bone and cartilage can now be printed with nylon. These surgeries are available at top-tier medical facilities like the Mayo Clinic.


Medical Devices


Most hearing aids are already 3-D printed, since these have always been customized to the user, and scanning, modeling and printing saves time over casting a handmade mold of the inner ear. What used to take a week now takes less than a day. Similarly, making crowns and dental implants used to take two weeks, but now can happen while the patient reads a magazine in the waiting room. “Printing medical devices is maybe of lesser value as far as a hospital is concerned,” Fromherz said.


Hospitals buy medical devices in bulk and 3-D printing their own devices, which don’t often need customization, doesn’t offer much advantage. Printing may be best for when doctors need to create a new device on demand for rare, unpredictable conditions. In May 2013, doctors printed a customized splint for a newborn with a collapsing trachea, which saved the boy’s life.


Human Tissue


Scientists have printed artificial meat tissue suitable for eating, but making tissues and organs that maintain life has been much harder. So far, printed bits of functional liver tissue in Petri dishes could be viable for testing drugs, and larger models have been useful for surgeons to practice technique. “Printing functional human tissue will be a game changer, but it’s far out,” Fromherz said.


What the Future Holds


The next step is to build in electronics. Artificial knees could include sensors to measure the pressure and health of the knee, connected wirelessly to an app or provider software. If you’re printing a device, body part or tissue from scratch, it won’t be much more difficult to build electronics into the design, he said. Every printed device or tissue could double as a source of data. But 3-D printing isn’t foolproof, and there are regulatory and use-case questions yet to be answered. “With a regular printer, everyone can create a document,” Fromherz said. “Not everybody will be skilled or knowledgeable enough to create a knee.”


Not a useful one, anyway. And it still takes at least 30 minutes to print anything. The technology may one day be most useful at military field hospitals or at the scene of an accident, where immediately creating splints, body parts or devices could save lives, it’s not quick enough yet to be implemented. “There will be 3-D printers I’m sure in every home and hospital in the future,” Fromherz said. “But right now the tech isn’t fast enough.”

Source: Forbes 2013 BrandVoice

TARGET HEALTH excels in Regulatory Affairs. Each week we highlight new information in this challenging area


FDA and NIH Create First-of-Kind Tobacco Centers of Regulatory Science Research


Despite decades of work to reduce tobacco use in the United States, it continues to be the leading cause of preventable death and disease.


The FDA and the NIH, as part of an on-going interagency partnership, have awarded a total of up to $53 million to fund tobacco-related research in fiscal year 2013 to create 14 Tobacco Centers of Regulatory Science (TCORS). This new, first-of-its-kind regulatory science tobacco program, is designed to generate research to inform the regulation of tobacco products to protect public health. Using designated funds from FDA, TCORS will be coordinated by NIH’s Office of Disease Prevention, directed by David M. Murray, Ph.D., and administered by three NIH institutes — the National Cancer Institute, the National Institute on Drug Abuse, and the National Heart, Lung, and Blood Institute.


The TCORS program brings together investigators from across the country to aid in the development and evaluation of tobacco product regulations. Each TCORS application identified a targeted research goal. Taken together, the TCORS sites will increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists.


Comprised of scientists with expertise in fields including epidemiology, behavior, biology, medicine, economics, chemistry, toxicology, addictions, public health, communications, and marketing, the TCORS program is the centerpiece of the FDA/NIH collaboration to foster research relevant to tobacco regulatory science. New research from TCORS will help inform and assess the impact of FDA’s prior, ongoing and potential future tobacco regulatory activities implemented by CTP. In addition, the TCORS investigators will have the flexibility and capacity to begin new research to address issues raised in today’s rapidly evolving tobacco marketplace.


The TCORS awards represent a significant investment in federal tobacco regulatory science, including $53 million in the first year and a potential total of more than $273 million over the next five years. TCORS funding may not exceed $4 million in total costs per year per center, and an investigator could request a project period of up to five years.


Designed to generate vital research in seven core areas, as well as ensure innovation in the field, the research supported by this initiative will provide scientific evidence within the following seven FDA tobacco-related research interest areas:


1. Diversity of tobacco products
2. Reducing addiction
3. Reducing toxicity and carcinogenicity
4. Adverse health consequences
5. Communications
6. Marketing of tobacco products
7. Economics and policies

Cauliflower Cheese Pie with Pine Nuts and Golden Raisins


This recipe has gone through several incarnations! The first version, I got from friend, colleague and fellow-foodie, Charlie Nuttell MD, on Facebook. I tried his but forgot to include the cheese, so not too good. This is not to say, that his wouldn’t be wonderful (if I had done it right); and I will try it again, soon.


The second adaptation had the cheese and was delicious but I didn’t take a photo of it. This particular (above) third try doesn’t resemble, at all, the original, since I adapted it into a whole new recipe. The photo above shows the cauliflower pie out of the oven, tasted by me, photo taken, last bit of mozzarella added, and ready to go into the oven for a quick melt before my dear husband (and loyal recipe guinea pig) returns from a conference in Boston.


For the pie, you can use what you see, above, a nice pie dish (I got this one from Williams-Sonoma), or use whatever non-stick pan you have, or try an inexpensive disposable aluminum pie pan. It doesn’t even have to be round.


To measure truffle oil, I use a medicine dropper from CVS drugstore. Be sure to rinse it out right after using and after it dries, keep in a small plastic zipper bag, to be used only for the truffle oil. Truffle oil is fragrant but powerful, so trust me, measure it drop by drop.


When I make cauliflower mashed like “mashed potatoes” I add a few drops of truffle oil, which really elevates this dish, in a big way. Or if you’re still making regular mashed potatoes, use a few drops of truffle oil, and expect to be impressed by its deliciousness.




1 large head of cauliflower

2 cloves garlic, juiced

2 large eggs, lightly beaten

4-6 oz. low fat mozzarella cheese (save some for garnish)

1 onion, sliced

Pinch salt (optional)

Pinch black pepper (grind to your taste)

3 drops, black or white truffle oil, (or to your taste)

1 cup golden raisins

1 cup pine nuts, toasted

Olive oil cooking spray




1. Preheat oven to 350-400 degrees.

2. Chop the cauliflower into chunks and place into microwave for about 5 minutes or until soft


Or – steam the whole head of cauliflower and then place into the food processor.


3. Spray a fry pan once with the olive oil, and cook the onion until it’s golden brown. Set aside

4. When you place the cauliflower into a food processor, also put in the cooked onions, then blend until it’s a mashed potato texture

5. In a large bowl, stir together cauliflower/onions, eggs, cheese, truffle oil and seasoning, garlic juice, raisins, pine nuts

6. Spray once, a baking pan (non-stick, if you have it) with spray olive oil (now, oil the whole pan with paper towel) and fill with the cauliflower mixture (about 1/2 inch thick). Use a spatula to get every last bit of it out and onto the baking pan.

7. Bake at 450 degrees for 15-20 minutes or until the top starts to brown. Keep your eye on this pie so it doesn’t burn.

8. Just before serving, add additional cheese to the top, put in oven for a few minutes, until the cheese melts. Serve and enjoy!


This recipe is versatile; it lends itself as an appetizer with some chilled white wine, before dinner; easily a veggie side dish with poached fish or seafood; could be a snack or a delicious addition to any brunch.


AFTERWARDS: (Friday Saturday Sunday)


Worn out, after traveling from a rewarding Boston conference, my loyal spouse, arriving home, poured himself some icy white wine (Orvieto from Umbria), relaxed in his favorite chair, and sank his teeth into this warm cauliflower melting-cheese pie. He loved it and announced he was going to have it for breakfast on Saturday. We slept later Saturday morning so he had it for brunch before leaving for the theater. Now Sunday, we plan to have the remaining pie with wine early this evening, along with other leftover yummy things like sherry mushrooms, garlic broccoli, and scallops.