James (Jim) Lynn Hill was born in Cleveland, Ohio in 1951. His father, Ronald Hill, moved his family to South Florida in 1958 without ever having visited the area because he knew that a better life was waiting in the southern sunny climate near Miami, Florida. Mr. Hill’s father took a big risk to move his family (3 children) to South Florida without a secure job transfer. Ronald Hill eventually became a very successful State Farm Agent, having set up his own business and subsequently moving his family several times to more desirable locations. As the first born and only son, Jim learned to adapt quickly to new environments.
Growing up in South Florida, Jim quickly adapted to the sub-tropical climate and grew to appreciate the wonderful natural features of S. Fla. in the 60’s. In 1969, after graduating from Nova High School, in Ft. Lauderdale, Mr. Hill went to the Florida Institute of Technology (FIT), in Melbourne, Florida where he majored in Ocean Engineering as a freshman. At the time there were only 5 female students and 2000 men. FIT In 1972 opened up a Pre-Professional Biology Department to which Jim switched to after 2 years of math and physics courses.
Working part time as a golf course grounds keeper, house construction laborer and finally as a gardener, Jim made his way through FIT to obtain a degree as a Pre-Professional Biology Major in 1974. Married in 1972, and with a child on the way, Jim took a job with Dade Reagents (American Dade) in Miami Fla in Sept 1974.
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After all the hard work and studying it seemed like a tough time to look for a job in Sept 1974. Graduating in May 1974 and having a well deserved “vacation” to travel, Jim went to the northern NY mountains (Adirondacks) where his wife’s grandparents had a cabin on a lake (Seventh Lake) for 4 weeks, then back to the Florida Keys at his parents weekend retreat (Riptide Mile marker 97.5 Key Largo). There he spent another 2 months living the good life of an unemployed youth thankful for his parents place to stay free of charge.
It was a great life. But Jim had to adapt in order to provide good food for his wife, Cindi. He would eventually figure out how to bicycle to the local bait shop and beg for a few dead shrimp which died over the last night or two, and take these dead shrimp to a rock pit another couple miles down the highway and use this bait to catch live fish. These fish were used to bait lobster traps which Jim’s father owned and was allowed to put out for Florida Spiny Lobster. This procedure worked well and when the Hill family came to the Riptide, they all had fresh lobster on the weekends.
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Dade Reagents, in 1974 was a respected coagulation diagnostics company known worldwide. Mr. Hill entered the workforce as a Coagulation Quality Assurance technician with a salary of less than $10,000/year. Learning all he could at the bench from experienced technicians and the Coag gurus , he worked his way up to a promotion to Coagulation R&D in 1977. At this time Mr. Hill volunteered to help retrofit the newly introduced Auto-Fi instrument that Dade tried to market as their own instrument (having successfully marketed nearly all the diagnostic products necessary for a complete coagulation line of products). It was the first traveling trip for Jim and it went quite well. Understanding and appreciating instrumentation development (math and physics from FIT), it was a good fit for Jim to support the instrument team, one biologist, one engineer and one marketing rep, visiting several hospitals in different cities.
Once in Dade R&D, Mr. Hill went on to co-develop several products with Lucy Abernathy as his senior partner. Ms. Abernathy later married George Darnel (President of Dade) and Mr. Hill soon after decided that he needed a new opportunity to further develop his skills and energy. Before leaving Dade in May of 1985, Jim had contributed to successful products such as Latex Agglutination Fibrinogen Degredation Products Kit where he co- developed a kit similar to the state of art kit from North Carolina. Jim was introduced to purification of human fibrinogen as an antigen in order to inject to rabbits on site at Dade to make antibodies. Jim learned how to kill the rabbits and remove the blood in order to make serum for the development of the test.
After this experience, Mr. Hill co-developed a platelet aggregation kit still on the market as of 2012. Collagen, ADP and Epinephrine were the 3 platelet agonists. Back in 1980 they had to use chart recorders. But the product evidently did well enough that it is still found on the list of available platelet aggregation products from Dade Behring (2012).
Mr. Hill was asked to help transfer the Dade Fresh Cell Hemotology Calibrator product to manufacturing which entailed clean room production standards and interfacing with production employees. Most importantly, Jim learned about manipulating fresh and old blood blood cells. At one point in the transfer project, large volumes of washed and resuspended blood cells were continuously contaminated with gram neg bacteria which rendered the bulk product useless. Mr. Hill went over his supervisor to the VP of R&D to gain support for a consultant to help with the contamination problem. Although the supervisor was not happy, the end result was a successful transition from R&D to production for the product.
Mr. Hill was told he was too “determined” and should calm down. He was given a 1 week leave of absence with pay to figure out why he was so determined to make progress in a project that was not so important. (Mr. Hill found out that an important hematology instrument was actually present on site but he was told it was not there and had to go to Jacksonville, FLA to run samples. Jim was upset and let it be known to a certain PhD in charge of the department that was “hiding” the instrument).
After a year of developing a P&P thromboplastin, combination of rabbit thromboplastin and adsorbed bovine plasma, which involved frequent visits to a slaughter house for obtaining bovine blood, Mr. Hill heard that a company in Silicon Valley (Sunnyvale, California) was looking for a scientist willing to take a risk to help them develop a fingerstick PT system. They wanted a PhD but instead they settled on Jim Hill.
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Biotrak 1985 – 1989 To be asked to be a part of a Silicon Valley start-up was a big deal in 1985, as it is still a big deal today. The agreement was finalized on the Santa Cruz roller coaster after interviewing with 8 of the 11 employees. Jim was brought in at a time when the current chemistry leader (Laura) was on holiday due to her honeymoon. Mike and Jim (VP R&D and VP Operations) knew they needed an expert to make the first ever fingerstick PT/INR rapid point of care system work. Laura hoped she had a good PhD to do the job (Linda). When Laura left for her honeymoon the guys brought Mr. Hill out for an interview. Early May 1985. They sealed the deal on the roller coster. Minimum 50 hrs / week and it is expected Mr. Hill would do everything possible to keep the little company going. He was the 12th person hired. Laura and Linda (both PhD’s) recognized that Jim Hill was a real Coag guru. It worked- Biotrak was sold to Ciba Corning and then to Boehringer Mannheim. Many people made a lot of money. Mr. Hill did not.
Jim Hill relocated from Miramar Florida to San Jose California and dedicated himself to Point of Care Anticoagulation Diagnostics. Mr. Hill worked with the cartridge and instrument team to make success. INTEGRATED SYTEM DEVELOPMENT
PT and aPTT systems were developed with Jim Hill responsible for chemistry and controls.
First Patent for Jim Hill was the PT control. Heparin as the anticoagulant and water as the reconstitution liquid. Necessary red cells were fixed and resuspended in the plasma before being quick frozen in lyophilization vials before settling. “Whole Blood Control sample” US473133OA filing date July 1, 1986.
MOST IMPORTANT DISCOVERY – In 1985, the most important discovery for Jim Hill was that one could take fresh venous blood out of a donor and preserve it without use of anticoagulant, in order to simulate fresh venous blood, for the sake of developing a fingerstick PT/INR test. Although not a patented procedure, before 1985, there was no cited literature indicating that one could perform hundreds of tests with fresh blood without the use of anticoagulant. Mr. Hill used his knowledge of materials, temperature and pipetting to initiate a new procedure used by many companies today.
ONE STEP APTT – This was another achievement for Jim Hill. Never before 1988 was there a commercial fingerstick aPTT on the market. Mr. Hill worked many hours, including weekends, to help formulate a chemistry utilizing bovine sulfatides as the activator and soy bean phosphitides as the activator. Realizing a 1 step aPTT was difficult with a fingerstick or drop of venous blood, Mr. Hill experimented with many forms of cephalins (phospholipids) and activators. A 2 step conventional aPTT reagent for hospital use would be well within the expertise of QCDC.
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Boehringer Mannheim 1989-1999 After nearly 5 years at Biotrak it was time to accept a position at a large company to utilize skills and experience to make a real difference in anticoagulation diagnostics. Mr. Hill accepted a position at Boehringer Mannheim for responsibility of PT chemistry, INR calibration and controls necessary for a large project to do fingerstick PT/INR testing. Mr. Hill was given a lab and office and several scientists to carry out these tasks. In 1993 the CoaguChek System was launched and with great success. Continued quality development was necessary to keep up with the popular demand. Mr. Hill developed the QC testing requirements as well as the overall INR accuracy requirements for the system.
In addition Mr. Hill was responsible and provided hands on guidance for the user controls as well as the hospital QC controls. Mr. Hill visited world experts several times in order to be an accomplished and experienced manual tilt tuber for the sake of accurate INR calibration. Trips to London (UK), Aruss (Denmark) and Vienna (Austria) were made with water bath and world standard manual tilt tube standards to prove the accuracy of the CoaguChek system with Mr. Hill providing the hands on testing as well as the data analysis to provide conclusive evidence of the accuracy of the CoaguChek system throughout the 1990’s.
1999-2003 Roche Diagnostics In 1999 Roche Diagnostics purchased the privately owned Boehringer Mannheim company and Coagulation R&D was shut down in Indianapoilis. Mr. Hill was transferred to Mannheim, Germany to help a new center of excellence for Coag point of care diagnostics. Although the position was for 1 year and maybe 2, Jim was the last of the transferred US scientists to leave Mannheim after 4 years. Instead of accepting a full time position with Roche, Mr. Hill left to help a smaller company trying to develop a newer fingerstick PT/INR system in the United Kingdom (Inverness Inovation, Unipath). The last scientific experiments were directed towards a patent which outlined the way to monitor PT from a meter which was operating at Room Temperature (18-32C) with the same accuracy as if the test was heated to 37C. “System and method for measuring coagulation time without thermostatic control”. EP 1588161 B1 Pub date Oct 24th, 2007 Filing date Jan 24th, 2004 and the text is available from WO2004068138A1 which includes graphs of real data.
2003-2007 Inverness Medical Innovations (Unipath) After relocating to the UK in May of 2003, Mr. Hill helped research and develop the SmartChek system which was the primary R&D project for the company at the time. For several years a variety of detection schemes, disposable reagent carriers and on board controls were tested using PT chemistry and INR calibration technology already proven, to come up with a slick new competitor to the CoaguChek System. Unfortunately these efforts eventually were abandoned although the company prospered throughout the project’s developmental phase (stock price rose steadily from 2003-2007 and many acquisitions were realized). In June of 2007, Mr. Hill resigned from IMI and moved back to Germany to reside full time with his wife in Feldafing, Germany.
2007-2013 Clotter@jimhill.de Consulting After networking friends and associates via the internet, it was not long after landing in Bavaria that Jim was contacted by a prospective client, Dr. Andreas Calitzis. After a brief interview, Dr. Calatzis asked Mr. Hill to help him with his company, Multiplate, in Munich. The first job was to help a company in Switzerland (Pentapharm) and the work included 16 hours working at Enzyme Research labs, in South Bend Indiana. The first bill from Clotter@jimhill.de was submitted August 2008. This work was completed at the request of Dr. Calatzis.
The next job was to consult for a day with Microvisk technologies in Wales, UK as an independent consultant separate from Multiplate. This work was completed in September 2008. Although it was a good experience, the result was an unfavorable forecast for the young start-up in the opinion of Jim Hill. Microvisk has long since disappeared.
Since these 2 initial jobs, Mr. Hill has worked exclusively for Dr. Calatzis and Multiplate, helping to set up the current Reagents/Controls developmental wet lab and commercializing 3 key platelet aggregation reagents for the Multiplate System, ADP, TRAP and Arachadonic Acid. These 3 reagents were formerly purchased from the UK (Hart Biologicals). Working as a consultant 1 day a week, Jim was able to help Multiplate bring in-house these strategic reagent products. In January 2012, Multiplate, having since changed it’s name to Verum Diagnostics, was sold to Roche Diagnostics for $ 11 Million. (Roche trade)
It has been a slow transition from the original startup company (Multiplate) to an acquired company (Verum Roche Diagnostics). Since 2012, Mr. Hill has consulted and performed in lab developmental experiments to bring to Verum the knowledge of acquiring, handling, and developing human plasmas in a lyophilized product form in addition to initiating R&D work relating to reagents like sourcing and purifying rabbit brain acetone dried powder from Hungary rabbits, rabbit brain powder cephalin for aPTT reagents, and the associated additives and preservatives necessary for commercialization into high quality hospital based diagnostic products capable of delivering precise and accurrate results second to no other similar products on the current market.
In addition to the above products, Mr. Hill also worked on formulating Collagen as a platelet aggregation reagent with gold standard status as well as an Ecarin Clotting Time test derived from Pentapharm (first customer) snake venom.
The last consulting project for Clotter@jimhill.de was involving the development of aPTT point of care controls for hospital use. This work has been completed as of the end of 2013 and no further consulting has been done with regards to Verum Roche Diagnostics.
2014- ? The year of 2014 is an exciting new year for Clotter@jimhill.de. First of all the name was changed to Quality Cardiovascular Diagnostics Consulting. QCDC. Web site – QCDC.EU Mr. Paul Weigert has agreed to join Jim in expanding the possibilities for a specialized consulting company, geared towards providing guidance and hands on help in developing cardiovascular diagnostic products of the highest quality. See Paul Weigert’s page for more details on his experience. Together, QCDC should be able to provide help to small and large companies with a real mission of developing high quality diagnostic products for their future portfolio.
Mission of QCDC for the future is that “There are so many pharmaceutical products available for such a wide variety of conditions, that there will be a need for more precise and accurate diagnostic tests to ensure that the newer and more expensive drugs are really necessary. When this time comes, it is in the belief of QCDC, that the desire to market more precise and accurate diagnostic tests will be commonplace.”
QCDC can help deliver guidance and hands on help to ensure that companies wanting to develop high quality diagnostic products to monitor drugs, whether in trials or after release to the public, are able to take advantage of QCDC’s 85 years experience in this area of expertise.