FDA Goes Paperless


Target Health provides full Regulatory Affairs services for over 55 companies at FDA, including regulatory strategic planning, regulatory and medical writing, and eCTD publishing. Let us help you make this transition.

Small companies especially need to know that the deadline for the eCTD requirements for submissions to CDER and CBER is approaching for INDs and DMFs. The important dates established by FDA are summarized hereafter:


After the dates listed below, eCTD requirements for submissions to CDER and CBER will go into effect and submissions that do not use eCTD will not be filed or received.


May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs), must be submitted using eCTD format.


May 5, 2018Commercial Investigational New Drug Applications (INDs) and Master Files must be submitted using eCTD format.


Construction in New York City


The view below is of 1 Vanderbilt Place across the street from Grand Central Station. The morning sun reflecting off the I-beams with a golden brilliance, gave rise to a certain urban exuberance!

The early morning sun lights up One Vanderbilt Place. © Jules Mitchel, Target Health Inc.


For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 165). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website.


Joyce Hays, Founder and Editor in Chief of On Target

Jules Mitchel, Editor



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Harvard Scientist Creates Neural Lace That Fuses with Your Brain

The Elman Simple Recurrent Neural Network. The context layer (u1. ul) provides a temporal memory to the network, allowing it to “remember“ previous hidden layer states. Generated in LaTeX via PGF/Tikz.

Graphic credit: Fyedernoggersnodden – Own work, CC BY 3.0, https://commons.wikimedia.org/w/index.php?curid=5837043



Connectionism is a set of approaches in the fields of artificial 1) ___, cognitive psychology, cognitive science, neuroscience, and philosophy of mind, that models mental or behavioral phenomena as the emergent processes of interconnected networks of simple units. The term was introduced by Donald Hebb in the 1940s. There are many forms of connectionism, but the most common forms use neural network models. Connectionism can be traced to ideas more than a century old, which were little more than speculation until the mid-to-late 20th century. Through his work on the structure of the nervous system for which he won the Nobel Prize in 1906, the Spanish physician, Santiago Ramon y Cajal established the basis for studies of neural networks, but it wasn’t until the 1980s that connectionism became a popular perspective.


A neural network (also called an ANN or an artificial neural 2) ___) is a sort of computer software, inspired by biological neurons. Biological brains are capable of solving complex problems, but each individual neuron is only responsible for solving a very small part of the problem. Similarly, a neural network is made up of interconnected cells that work together to produce a desired result, although each individual cell is only responsible for solving a small part of the problem. This is one method for creating artificially intelligent programs. There are two ways to think of a neural network. First is like a human brain. Second is like a mathematical equation. Neural networks are also an example of machine learning, where the output of the program can change as it learns. A 3) ___ network can be trained and improves with each example, but the larger the neural network, the more examples it needs to perform well – often needing millions or billions of examples in the case of deep learning.


In a world where in only a few decades we went from clunky phones to wireless satellite-connected devices that allow us to be anywhere and do anything on the internet, it’s natural that scientists went to the next level – to your 4) ___. A fine nano-mesh (also referred to as neural lace), created by Dr. Charles M. Lieber, fits inside a syringe and unfurls on the brain to monitor its activity, creating a bio-technological interface. A recent paper was published in Nature Nanotechnology where a new ultra-fine mesh that merges with the brain and creates a machine-biological functionality is described. For now, the mice with this electronic 5) ___ are connected by a wire to a computer ? but in the future, this connection could become wireless. Called “mesh electronics,“ the device is so thin that it can be directly injected to the brain, where it attaches to the brain. The technology was already successfully tested on mice, who not only survived the implantation, but seem to have no negative side 6) ___. This could have a lot of potential applications, including monitoring brain activity and delivering treatment for degenerative diseases such as Parkinson’s. It might even be used to artificially boost brain capacity. The mesh was injected into a region of the brain called the lateral ventricle. “This could make some inroads to a brain interface for consumers,“ says Jacob Robinson, who develops technologies that interface with the brain at Rice University. “Plugging your 7) ___ into your brain becomes a lot more palatable if all you need to do is inject something.“


The mesh also gives scientists access to previously inaccessible areas of the brain; when researchers want to study some areas of the brain of a mouse, they have to actually cut a piece from it, but this technology might change that, allowing remote research. Further down the line, delivering treatment directly to the brain could be the way to go. Neural electronics are already a reality for some people. Patients suffering from severe epilepsy or tremors can find relief via electric shocks, which are delivered by long wires threaded deep into the brain. Also, quadriplegics have learned to control prosthetic limbs using chips embedded in the brain. But we’re still far from actually implementing the mesh in 8) ___. For starters, researchers need to ensure a longer mesh lifespan. Previous neural meshes have suffered from stability problems either with the signal they output or their own structure. But the team is optimistic that this time, the mesh will blend in with the brain and quietly fit in the empty gaps.


We are now poised at a time in history when brain-computer interfaces (BCI) are the obvious next step. Now in the automation age, humans face the daunting prospect of 9) ___ intelligence (AI) becoming more capable than ourselves. Now that touchscreens and voice recognition are part of our everyday devices, it’s time for us to be able to control our electronics with our minds. In this electronic age, we are edging closer to the elimination of various diseases, hoping for life without dementia, brain damage, and neurological diseases. The BCI provides us with a way to maintain control of our world and our electronics, to heal ourselves – and maybe even allow humanity itself to level up. Caleb Sharf, director of Astrobiology at Columbia University in New York City, has predicted that we may well witness a “first new origin event“ in the process of 10) ___. Bionics and the brain computer interfaces that are already in development may change the human species forever.


Journal Reference: Jia Liu, Tian-Ming Fu, Zengguang Cheng, Guosong Hong, Tao Zhou, Lihua Jin, Madhavi Duvvuri, Zhe Jiang, Peter Kruskal, Chong Xie, Zhigang Suo, Ying Fang & Charles M. Lieber. Syringe-injectable electronics. Nature Nanotechnology (2015) doi:10.1038/nnano.2015.115

https://www.zmescience.com/science/nanotechnology-science/neural-mesh-brain-17062015/; References: Tech Insider; Aeon; Inverse; DARPA; ScienceDaily: Wikipedia; https://futurism.com/?p=84324&post_type=posthttps://futurism.com/?p=82517&post_type=post


ANSWERS: 1) intelligence; 2) network; 3) neural; 4) brain; 5) mesh; 6) effects; 7) computer; 8) humans; 9) artificial; 10) evolution


Charles M. Lieber PhD (1959 to present)

Charles M. Lieber (Photo Credit: Wikipedia)


Charles M. Lieber (born 1959) is an American chemist and pioneer in the field of nanoscience and nanotechnology. In 2011, Lieber was recognized by Thomson Reuters as the leading chemist in the world for the decade 2000-2010 based on the impact of his scientific publications. Lieber has also published over 390 papers in peer-reviewed scientific journals and has edited and contributed to many books on nanoscience. He is the principal inventor on over fifty issued US patents and applications, and founded the nanotechnology company Nanosys in 2001 and Vista Therapeutics in 2007. He is known for his contributions to the synthesis, assembly and characterization of nanoscale materials and nanodevices, the application of nanoelectronic devices in biology, and as a mentor to numerous leaders in nanoscience.


Lieber “spent much of his childhood building – and breaking – stereos, cars and model airplanes.“ He obtained a B.A. in Chemistry from Franklin & Marshall College, graduating with honors in 1981. He went on to earn his doctorate at Stanford University in Chemistry, carrying out research on surface chemistry in the lab of Nathan Lewis, followed by a two year postdoc at Caltech in the lab of Harry Gray on long-distance electron transfer in metalloproteins. Studying the effects of dimensionality and anisotropy on the properties of quasi-2D planar structures and quasi-1D structures in his early career at Columbia and Harvard led him to become interested in the question of how one could make a one-dimensional wire, and to the epiphany that if a technology were to emerge from nascent work on nanoscale materials “it would require interconnections – exceedingly small, wire-like structures to move information around, move electrons around, and connect devices together. “Lieber was an early proponent of using the fundamental physical advantages of the very small to meld the worlds of optics and electronics and create interfaces between nanoscale materials and biological structures, and “to develop entirely new technologies, technologies we cannot even predict today.”


Lieber joined the Columbia University Department of Chemistry in 1987, where he was Assistant Professor (1987-1990) and Associate Professor (1990-1991) before moving to Harvard as Full Professor (1992). He now holds a joint appointment at Harvard University in the Department of Chemistry and Chemical Biology and the Harvard Paulson School of Engineering and Applied Sciences, as the Joshua and Beth Friedman University Professor. In 2015 he became Chair of the Department of Chemistry and Chemical Biology.


Lieber’s contributions to the rational growth, characterization, and applications of a range of functional nanoscale materials and heterostructures have provided concepts central to the bottom-up paradigm of nanoscience. These include rational synthesis of functional nanowire building blocks, characterization of these materials, and demonstration of their application in areas ranging from electronics, computing, photonics, and energy science to biology and medicine.


Nanomaterials synthesis: In his early work, Lieber articulated the motivation for pursuing designed growth of nanometer-diameter wires in which composition, size, structure and morphology could be controlled over a wide range, and outlined a general method for the first controlled synthesis of free-standing single-crystal semiconductor nanowires, providing the groundwork for predictable growth of nanowires of virtually any elements and compounds in the periodic table. He proposed and demonstrated a general concept for the growth of nanoscale axial heterostructures and the growth of nanowire superlattices with new photonic and electronic properties, the basis of intensive efforts today in nanowire photonics and electronics. In parallel, he proposed and demonstrated the heterojunction concept of radial core-shell nanowire structures and single-crystalline multi-quantum well structures. Lieber also demonstrated a synthetic methodology to introduce controlled stereocenters – kinks – into nanowires, introducing the possibility of increasingly complex and functional nanostructures for three-dimensional nanodevices.


Nanostructure characterization: Lieber developed applications of scanning probe microscopies that could provide direct experimental measurement of the electrical and mechanical properties of individual carbon nanotubes and nanowires. This work showed that semiconductor nanowires with controlled electrical properties can be synthesized, providing electronically tunable functional nanoscale building blocks for device assembly. Additionally, Lieber invented chemical force microscopy to characterize the chemical properties of materials surfaces with nanometer resolution.


Nanoelectronics and nanophotonics: Lieber has used quantum-confined core/shell nanowire heterostructures to demonstrate ballistic transport, the superconducting proximity effect, and quantum transport. Other examples of functional nanoscale electronic and optoelectronic devices include nanoscale electrically driven lasers using single nanowires as active nanoscale cavities, carbon nanotube nano-tweezers, nanotube-based ultrahigh-density electromechanical memory, an all-inorganic fully integrated nanoscale photovoltaic cell and functional logic devices and simple computational circuits using assembled semiconductor nanowires. These concepts led to the integration of nanowires on the Intel roadmap, and their current top-down implementation of these structures.


Nanostructure assembly and computing: Lieber has originated a number of approaches for parallel and scalable of assembly of nanowire and nanotube building blocks. The development of fluidic-directed assembly and subsequent large-scale assembly of electrically addressable parallel and crossed nanowire arrays was cited as one of the Breakthroughs of 2001 by Science. He also developed a lithography-free approach to bridging the macro-to-nano scale gap using modulation-doped semiconductor nanowires. Lieber recently introduced the assembly concept ?nanocombing,’ which can be used to align nanoscale wires in a deterministic manner independent of material. He used this concept to create a programable nanowire logic tile and the first stand-alone nanocomputer.


Nanoelectronics for biology and medicine: Lieber demonstrated the first direct electrical detection of proteins, selective electrical sensing of individual viruses and multiplexed detection of cancer marker proteins and tumor enzyme activity. His approach uses electrical signals for high-sensitivity, label-free detection, for use in wireless/remote medical applications. More recently, Lieber demonstrated a general approach to overcome the Debye screening that makes these measurements challenging in physiological conditions, overcoming the limitations of sensing with silicon nanowire field-effect devices and opening the way to their use in diagnostic healthcare applications. Lieber has also developed nanoelectronic devices for cell/tissue electrophysiology, showing that electrical activity and action potential propagation can be recorded from cultured cardiac cells with high resolution. Most recently, Lieber realized 3D nanoscale transistors in which the active transistor is separated from the connections to the outside world. His nanotechnology-enabled 3D cellular probes have shown point-like resolution in detection of single-molecules, intracellular function and even photons.


Nanoelectronics and brain science: The development of nanoelectronics-enabled cellular tools underpins Lieber’s views on transforming electrical recording and modulation of neuronal activity in brain science. Examples of this work include the integration of arrays of nanowire transistors with neurons at the scale that the brain is wired biologically, mapping functional activity in acute brain slices with high spatiotemporal resolution and a 3D structure capable of interfacing with complex neural networks. He developed macroporous 3D sensor arrays and synthetic tissue scaffold to mimic the structure of natural tissue, and for the first time generated synthetic tissues that can be innervated in 3D, showing that it is possible to produce interpenetrating 3D electronic-neural networks following cell culture.


Lieber’s current work focuses on integrating electronics in a minimally/non-invasive manner within the central nervous system. Most recently, he has demonstrated that this macroporous electronics can be injected by syringe to position devices in a chosen region of the brain. Chronic histology and multiplexed recording studies demonstrate minimal immune response and noninvasive integration of the injectable electronics with neuronal circuitry. Reduced scarring may explain the mesh electronics’ (also referred to as neural lace) demonstrated recording stability on time scales of up to a year. This concept of electronics integration with the brain as a nanotechnological tool potentially capable of treating neurological and neurodegenerative diseases, stroke and traumatic injury has drawn attention from a number of media sources. Scientific American named injectable electronics one of 2015’s top ten world changing ideas. Chemical & Engineering News called it “the most notable chemistry research advance of 2015.“


Lieber is an elected member of the National Academy of Sciences, the American Academy of Arts and Sciences, the National Academy of Medicine, the National Academy of Inventors, and an elected Foreign Member of the Chinese Academy of Sciences (2015). He is an elected Fellow of the Materials Research Society, American Chemical Society (Inaugural Class), Institute of Physics, International Union of Pure and Applied Chemistry (IUPAC), American Association for the Advancement of Science, and World Technology Network, and Honorary Fellow of the Chinese Chemical Society. In addition he belongs to the American Physical Society, Institute of Electrical and Electronics Engineers, International Society for Optical Engineering, Optical Society of America, Biophysical Society and Society for Neuroscience. Lieber is Co-editor of the journal Nano Letters, and serves on the editorial and advisory boards of a number of science and technology journals.


Other Interests: Since 2007 Lieber has grown giant pumpkins in his back yard in Lexington, MA. In 2010 he won the annual weigh-off at Frerich’s Farm in Rhode Island with a 1,610-lb pumpkin, and returned in 2012 with a 1,770-lb pumpkin that won 2nd place in that year’s weigh-off but set a Massachusetts record. His 1,870-lb pumpkin in 2014 was named the largest pumpkin in Massachusetts and ranked 17th largest in the world that year. The discrepancy between the size scales of his day job and hobby has been noted: “on the one hand, Lieber’s chemistry” has had a defining influence on the field of nanoscience and nanotechnology, “according to his CV. On the other, his pumpkin could probably fill an entire Trader Joe’s with pumpkin specialty products for the fall season.”

Sources: Wikipedia, Harvard.edu and NIH.gov


Iodine Deficiency May Reduce Pregnancy Chances


Iodine is a mineral used by the body to regulate metabolism. It also helps regulate bone growth and brain development in children. Iodine is found in seafood, iodized salt, dairy products, and some fruits and vegetables. Severe iodine deficiency has long been known to cause intellectual and developmental delays in infants.


According to an article published in Human Reproduction (11 January 2018), women with moderate to severe iodine deficiency may take longer to achieve a pregnancy, compared to women with normal iodine levels. The study is the first to investigate the potential effects of mild to moderate iodine deficiency — common among women in the United States and the United Kingdom — on the ability to become pregnant.


For the study, the authors, analyzed data collected from 501 U.S. couples who were planning pregnancy from 2005 to 2009. The couples were part of the Longitudinal Investigation of Fertility and the Environment (LIFE) study, which sought to examine the relationship between fertility, lifestyle and environmental exposures. When the women enrolled in the study, they provided a urine sample from which their iodine levels were measured. Each woman was also given a digital, at-home pregnancy test. Baseline results from the 467 women analyzed in the current study, showed that iodine status was sufficient in 260 (55.7%), mildly deficient in 102 (21.8%), moderately deficient in 97 (20.8%) and severely deficient in eight (1.7%).


To estimate a couple’s chances of pregnancy during each menstrual cycle, the authors used a statistical measure called the fecundability odds ratio (FOR). A FOR less than one suggests a longer time to pregnancy, while a FOR greater than one suggests a shorter time to pregnancy. Results showed that women who had moderate-to-severe iodine deficiency had a 46% lower chance of becoming pregnant during each menstrual cycle, compared to women who had sufficient iodine concentrations. Women in the mildly deficient range had a smaller, statistically insignificant increase in the time it took to conceive. Although the study population was not a representative sample of the U.S. population, the authors noted that the percentage of women in the study having insufficient iodine (44.3%) is close to that seen in population-wide studies. For example, a previous study estimated that 30% of U.S. women of childbearing age had insufficient levels of iodine. The authors concluded that if their findings are confirmed, public health officials in countries where iodine deficiency is common may want to consider programs to increase iodine intake in women of child-bearing age.


The authors cautioned that women who are concerned they may not be getting enough iodine may wish to consult their physicians before making dietary changes or taking supplements.


Foods high in iodine include:

  1. Sea Vegetables, including Kelp, Arame, Hiziki, Kombu, and Wakame. Kelp has the highest amount of iodine of any food on the planet and just one serving offers 4 times the daily minimum requirement.
  2. Cranberries: This antioxidant rich fruit is another great source of iodine. About 4 ounces of cranberries contain approximately 400/mcg of iodine. I recommend buying fresh organic berries or juice. If you buy cranberry juice from the store, be aware of how much sugar it contains.
  3. Organic Navy Beans: Many beans are a great food source of iodine and navy beans may top the list. Just 1/2 cup of these beans contain about 32/mcg of iodine.
  4. Organic Strawberries: This tasty red fruit packs up to 10% of your daily iodine needs in just a single serving. One cup of fresh strawberries has approximately 13/mcg of iodine.
  5. Raw, Organic Cheese: One ounce of raw cheddar cheese contains around 10-15 mcg of iodine.
  6. Organic Potatoes: Leave the skin on and one medium-sized baked potato holds 60/mcg of iodine


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Perhaps Why Common Cancer Drug Causes Hearing Loss


Cisplatin and similar platinum-based drugs are prescribed for an estimated 10 to 20% of all cancer patients. The NIH’s National Cancer Institute supported research that led to the 1965 discovery of cisplatin leading to its success as an essential weapon in the battle against cancer. However, the drug causes permanent hearing loss in 40-80% of adult patients and at least half of children who receive the drug. The new findings help explain why cisplatin is so toxic to the inner ear, and why hearing loss gets worse after each treatment, can occur long after treatment, and is more severe in children than adults.


According to the NIH, hearing loss can have a major impact on a person’s life and many adults with hearing loss struggle with social isolation and depression, among other conditions. In addition, children who lose their hearing often have problems with social development and keeping up at school. Helping to preserve hearing in cancer patients who benefit from these drugs would be a major contribution to the quality of their lives.


According to an article published in Nature Communications (21 November 2017), a new way has been found to explain the hearing loss caused by cisplatin. Using a highly sensitive technique to measure and map cisplatin in mouse and human inner ear tissues, the authors found that forms of cisplatin build up in the inner ear. They also found a region in the inner ear that could be targeted for efforts to prevent hearing loss from cisplatin.


Previous studies have reported that In most areas of the body, cisplatin is eliminated within days or weeks after treatment, but in the inner ear, the drug remains much longer. Previous research focused on why the inner ear is more sensitive than other parts of the body to cisplatin-induced damage. The current hypothesis to be tested was: What if the inner ear is not able to get rid of cisplatin, and cells in the inner ear important for hearing die because they are exposed to the drug for a long time?


For the study, the authors developed a mouse model that represents cisplatin-induced hearing loss seen in human patients. By looking at inner ear tissue of mice after the first, second, and third cisplatin treatment, it was observed that cisplatin remained in the mouse inner ear much longer than in most other body tissues, and that it builds up with each successive treatment. The authors also studied inner ear tissue donated by deceased adult patients who had been treated with cisplatin, and observed that cisplatin is retained in the inner ear many months or years after treatment. In addition, when inner ear tissue was examined from one child, it was found that cisplatin buildup that was even higher than seen in adults. These results suggest that the inner ear readily takes up cisplatin, but it has very little ability to remove the drug.


In mice and human tissues, the authors saw the highest buildup of cisplatin in a part of the inner ear called the stria vascularis, which helps maintain the positive electrical charge in inner ear fluid that certain cells need to detect sound. The authors determined that the accumulation of cisplatin in the stria vascularis portion of the inner ear contributed to cisplatin-related hearing loss. The authors concluded the findings suggest that if it is possible to prevent cisplatin from entering the stria vascularis in the inner ear during treatment, it may be possible to protect cancer patients from developing cisplatin-induced hearing loss.


FDA Collaborates with Department of Defense


The U.S. Food and Drug Administration (FDA) and the Department of Defense’s (DoD) Office of Health Affairs announced today the launch of a joint program to prioritize the efficient development of safe and effective medical products intended to save the lives of American military personnel.


The framework for the program was put in place through H.R.4374, which authorized DoD to request, and the FDA to provide, assistance to expedite development and the FDA’s review of products to diagnose, treat, or prevent serious or life-threatening diseases or conditions facing American military personnel. Utilizing this law’s expanded authorities, the FDA will work closely with Health Affairs to better understand the military’s medical needs for deployed personnel; give the highest level of attention to and expedite its review of priority DoD medical products in a manner similar to products under the breakthrough designation program; provide ongoing technical advice to Health Affairs to aid in the rapid development and manufacturing of medical products for use by the military; and, take a closer look at products currently under development to determine opportunities to expedite their availability.


The FDA outlined its approach in an initial work plan the agency developed in close collaboration with DoD. This was done in accordance with H.R.4374, which was enacted in December 2017 along with the National Defense Authorization Act for fiscal year 2018. Because current high-priority DoD product programs include freeze-dried plasma, cold-stored platelets, and cryopreserved platelets, the initial phase of the program will be conducted among the FDA’s Center for Biologics Evaluation and Research (CBER) and Health Affairs. Leadership from the FDA’s CBER will meet with Health Affairs on a regular basis as part of this program, which will help the FDA’s experts efficiently prioritize and expedite availability of biological products that are essential to the urgent care of those involved in national defense.


As part of this program, the FDA and Health Affairs will hold one or more workshops in 2018 to discuss aspects of the scientific and clinical development of products that are important to the health of military personnel. Findings from this workshop will inform an FDA guidance document that will help commercial product developers identify opportunities to fulfill unmet medical needs for battlefield settings and other front-line conditions experienced by men and women of the U.S. armed forces.


While the availability of certain biological products is of the upmost priority, the FDA and Health Affairs recognize that there is need for a broad range of medical products for service members, including preventive vaccines and therapeutics, and that these needs will continue to evolve in the future. Accordingly, the program is just the initial step in building an ongoing partnership between these two federal partners that can extend across the FDA’s capabilities.


Meat Loaf Experiment, Adapted from the NY Times

On the dinner menu this past Friday, snacked on all weekend by Jules. Now, long gone. ©Joyce Hays, Target Health Inc.


My photos are not doing this delicious recipe, justice. I should have spooned more of the juices over the meat. Take my word for it, this meatloaf gets gobbled up by Jules whenever I do another experiment with it. ©Joyce Hays, Target Health Inc. 



1 onion, well chopped

25 fresh garlic cloves, sliced

2 scallions, chopped

1/2 loaf Italian bread, crust removed, torn into small pieces (about 2 cups)

1 cup almond milk

2 teaspoons curry

1 teaspoon turmeric

2 teaspoons dry oregano

1/2 pound ground beef

1/2 pound ground veal

2 large eggs, scrambled

1/2 pound turkey sausage, chopped well

3/4 cup grated Parmesan

1 cup fresh parsley, well chopped

2 teaspoons dry thyme

Zest of 1 lemon

Juice of 1 lemon

1 pinch salt

1 pinch black pepper

1 jalapeno, seeds removed, well chopped

1/4 cup extra-virgin olive oil

1/4 cup butter

1 cup dry white wine


The reason I wanted to experiment with the recipe I saw in the NYTimes, is that I had never soaked bread in milk for a meatloaf, and I had never scrambled the eggs before mixing them in with the other ingredients. Also, I had never gone through the step of searing, before baking. The outcome is a meatloaf that is definitely very moist. I’m not sure exactly what scrambling the eggs does, but the end result is delicious. Besides the soaked bread and scrambled eggs, all of the other ingredients are from my own meatloaf creations. As you know, I especially like to use lots of garlic. For roasts, tagines, meatloaf, baked veggie dishes, 25 garlic cloves is nothing, because they become soft and have a delicious nutty flavor when baked or roasted. I don’t serve meatloaf that often, but will now, try to do more, in order to compare this recipe with my others. ©Joyce Hays, Target Health Inc.



1. Preheat the oven to 375 degrees.

2. Soak the bread in the milk for 10 minutes.

3. Do all cutting, chopping, slicing

4. Scramble the 2 eggs

5. Sautee the onions, garlic, jalapeno and scallions until soft

6. In a large mixing bowl, and with your hands, mix the beef, veal, chopped turkey sausage, scrambled eggs, Parmesan, parsley, lemon zest and lemon juice.

7. Add all herbs, seasonings, spices and mix well again. Get all of the vigorous mixing done before you add the bread. Add the bread last.

8. Squeeze the bread to remove excess milk, then chop the wad of wet bread and add it to the meat. Mix gently until well combined, but DO NOT OVERMIX.

9. Transfer the contents of the bowl, onto a board and shape into a loaf. Make the loaf about 10 to 11 inches long and about 4 inches wide. Loosely cover and refrigerate for 15 minutes.

10. Use A large baking pan. It doesn’t have to be a rectangle shape. a large round white pan will work okay.

11. Heat the oil and butter in the white pan, on the stove, over medium-high heat. Add the meatloaf and sear without moving it until it is browned, about 5 minutes. Carefully slide a spatula under the meatloaf, then gently use another spatula to help turn it and brown the second side, again without moving it for 5 minutes. Transfer to a plate, temporarily.

12. Make the gravy:Return the skillet to the stove and raise the heat. Add the wine and deglaze the pan. Deglaze simply means, stirring in the wine with a wooden spoon, while scraping up the browned bits stuck to the sides and bottom of the pan, which will make a simple sauce. Return the meatloaf to the baking pan, pour the sauce over the loaf and then put into the middle of the oven, basting occasionally with the pan juices, about 25 minutes.

Transfer the meatloaf to a platter and let stand, tented with foil, 10 minutes. Slice, pour the pan juices over the top and serve.


Do all your chopping, cutting, slicing, etc. ©Joyce Hays, Target Health Inc.


Chopping herbs. ©Joyce Hays, Target Health Inc.


Soaked bread in milk, coming out of fridge. ©Joyce Hays, Target Health Inc.


Eggs about to get scrambled. ©Joyce Hays, Target Health Inc.


Chopping up the precooked turkey sausage. ©Joyce Hays, Target Health Inc.


Cooking the onions, garlic, jalapeno, scallions. ©Joyce Hays, Target Health Inc.


About to hand mix meat, eggs, parmesan. ©Joyce Hays, Target Health Inc.


Here, everything added except the lemon and the bread. ©Joyce Hays, Target Health Inc.


Adding lemon zest and lemon juice to the bowl. Finally, the bread. ©Joyce Hays, Target Health Inc.


Ready to be formed into a loaf and refrigerated. ©Joyce Hays, Target Health Inc.


Getting ready to sear both sides of the loaf. ©Joyce Hays, Target Health Inc.


Getting ready to sear both sides of the loaf. ©Joyce Hays, Target Health Inc.


The one possibility for a slip-up, but one that can easily be fixed, in seconds. If the loaf loses its shape when you turn it, never mind, all you do is re-form it with your hands. ©Joyce Hays, Target Health Inc.


After searing both sides, put the loaf into your baking dish. Use a baking dish that goes from oven to table. ©Joyce Hays, Target Health Inc.


Back to the searing pan. Add your wine and deglaze, which simply means scrape all of the little pieces of the loaf that are stuck to the sides and bottom of the pan. This wine, butter, natural juices and little scraps are the ingredients of the delicious warm juice to bake in and to serve over the meat, at the table. ©Joyce Hays, Target Health Inc.


Ready to bake. ©Joyce Hays, Target Health Inc.


Into the oven. ©Joyce Hays, Target Health Inc.


We started our meal, clinking glasses of the delicious Henschke shiraz and a simple crisp garden salad with oil, lemon and mashed garlic dressing, Then came the meatloaf with my saffron rice recipe and another veggie dish, I’m experimenting with; and more Henschke. Dessert was a low calorie jello cake with cool whip on top.


Henschke Shiraz, from Australia, is one of our favorite, rich velvety, smooth finish, reds. ©Joyce Hays, Target Health Inc.


Have a great week everyone!

From Our Table to Yours

Bon Appetit!