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Quality Control Medical

Location:
Dix Hills, NY
Posted:
October 27, 2016

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Resume:

SAMUEL O. S COKER, Ph.D.

* ***** *****

Dix Hills

New York 11746

Home Phone Number: 631-***-****

Mobile Phone: 631-***-****

Citizenship: USA

.

SUMMARY OF QUALIFICATION

Results oriented, high energy hands on professional with 20 years of experience in blood transfusion medicine, blood filtration technology, filter development, cryopreservation, lyophilization technology, biochemistry, hematology, medical research and product development with a very successful record of accomplishments. As a principal investigator, I successfully managed a highly successful research and development group of top scientists and I was able to successfully apply for and obtained funding from the USA Federal Government Department of Defense for new product development to assist in the treatment of combat causalities by providing life saving blood products. Successfully generated and developed original ideas that have resulted in significant financial benefits to Pall Corporation.

Major strengths include strong scientific leadership, strong and exceptional problem solving skills that have been recognized both in academic and medical device industries, excellent communication skills, competent, strong team player, attention to detail, computer and internet literate as they relate to scientific research, advance knowledge of statistical tools that are needed for successful analysis and interpretation of complex scientific data that are needed to provide sound advice to CEOs and presidents of major biotech companies.

Excellent reputation for writing clear and concise explanations for senior managements (CEOs, Presidents, Chairmen etc.) on complex scientific and medical subjects that will allow them to make sound judgment and investments in new biotechnologies. Dutiful respect for compliance in all regulated environment, as well as supervisory skills including hiring, termination, scheduling, training of research scientists,and other scientific and technical tasks.

Thorough knowledge of current research tools covering extensive multidisciplinary topics in haematology, blood banking, blood chemistry, transfusion medicine, biochemistry, chemistry, immunology, biophysics, manufacturing practices and a very clear vision to accomplish the company goals and objectives that will advance the interest and financial survival of a company. More recently, my scientific efforts have focused on the creation and development of a system that will reduce or prevent Transfusion Related Acute Lung Injury, the current leading cause of the morbidity and mortality associated with blood transfusion. By all accounts the results of this creative idea on a new product for TRALI have been excellent and recognized by experts in the field of Transfusion Medicine as having the potential to significantly reduce TRALI-related mortality and morbidity that are associated with the transfusion of red cell concentrates. In overview, I am responsible for strategic scientific and technical leadership and management of the basic science research program in blood for biomedical application.

PRESENT POSITION

Senior Principal Scientist – 2012 to present

Medical Research and Development

Haemonetics Corporation

Some of my responsibilities include the following:

1.Carry out basic research in emerging areas of blood transfusion, hematology, blood filtration and biotechnology and to foster the growth of the biotechnology within the blood and biomaterials group through transitional research and technology transfer.

2.Provide scientific and technology leadership in developing new filtration media, or materials for filtering whole blood and blood component to remove leukocytes, pathogens and infectious prions from blood and blood components

3.Establish the scientific basis for the mechanisms that are responsible for the interactions of blood and blood components (red blood cells, platelets, leukocytes and plasma) with various chemistries and media (polyester fibers, polyurethane, nylon etc)

4.Provide scientific and technical leadership, technology transfer and interaction with other research centers in academia, biotechnology companies and other relevant medical product driven companies.

5.Multidisciplinary approach to research in hematology, blood transfusion, Cellular Therapy and development of new and innovative devices to different applications in the medical field.

6.Improving quality of basic and applied research in blood and medical fields

7.To develop and deliver a program of research on blood/haematology affecting the delivery of safe therapeutic products to patients with special reference to blood products.

8. To provide scientific and technical leadership and coordinate the company’s research into the development of new products for medical application.

9.Develop appropriate assays for the purpose of high throughput screening of materials for biomedical application and optimization of lead products.

10.Provide scientific and technical leadership, technology transfer and interaction with other research centers in academia, biotechnology companies and other relevant medical product driven companies.

11.Responsible for the oversight and direction of high-throughput new materials or product discovery as part of a strategic effort to develop and identify new products for biomedical application especially in blood banking, blood transfusion safety.

PROFESSIONAL ACCOMPLISHMENTS

Over the past several years I have achieved several professional accomplishments. The following list provides a broad spectrum of accomplishments covering all aspects of blood transfusion from basic science, applied science in developing devices for reducing the adverse effects of blood transfusions, to improvement in the safety of the blood supply by developing pathogen inactivation and removal technologies and whatever the needs or problem I have the ability and creativity to come up with a solution.

1.Development of a PseudoDisposable System for the Capture and Recovery of Immunoglobulins (IgG) from plasma. I developed a a sytem for removing therapeutic immunoglobulins from whole blood and plasma during “Chairside” plasma and whole blood donation. This process significantly improved the recovery of therapeutic immunoglobulins from the current 50% to about 90% This increase in efficiency of the recovery of therapeutic immunoglobulins has the potential to significantly improve the profit margins by as much as 40%.

2.Development of a Platelet Standard for Quality Control: I developed a process for long term storage of platelet. Currently platelets can only be stored for 5 to 7 days after which they lose their functionality. I have developed a process that allows the platelets to be stored for 60 days. These platelets can be used for quality controls of analyzers that are designed for testing the functionality of platelets prior to transfusion.

3.Successfully created and developed a prototype of leukocyte-reducing filter to reduce the incidence of morbidity and mortality in transfusion medicine. The potential market opportunity for Pall Corporation is more than $20,000,000 and it will usher in a new generation of leukocyte reducing filters that will help maintain Pall Corporation as the technology leaders for developing innovative filtration technologies for improving the safety of the blood supply.

4.Developed preservative solution for leukocyte reduced blood and blood products. This development allows stabilization of residual white blood cells in leukocyte reduced blood and blood products for extended period of time so that these samples can be analyzed at anytime with 30 days which significantly improves the efficiency and logistics of quality controls of these products. This simply invention allowed Pall Corporation to manage and provide important and critical quality control of Pall leukocyte-reducing filters with accounts in excess of $30,000,000. Currently, this simple solution also provides revenue or profit in excess of $250,000 annually for Pall Life Science’s group in Japan.

5.Successfully created and developed flow cytometric method for accurate counting of residual leukocytes in leukocyte reduced blood products. This was a seminal development at Pall Corporation, Scientific Laboratory services by replacing the highly labor-intensive manual counting of residual leukocytes. For about 11 years this flow cytometric method was employed solely by the SLS for counting residual leukocytes and for quality control of all leukocyte reduced product and for addressing customer issues relating to filter efficiency. This development saved SLS and Pall Corporation more than $200,000 annually over the 11 year period.

6.Created and developed a unique system for harvesting platelets using Pall’s filtration technology. This technology allows the recovery of platelets from whole blood for the production of growth factors for wound healing. This technology has been licensed to Smith and Nephew with annual revenue of about $600,000. The same system is now being sold for about $200-300 per filter set for application in wound healing in vertinary medicine with a potential market in excess of millions of dollars.

7.Successfully created and developed systems for capturing and recovery of stem cells from human umbilical cord using Pall’s filtration technology. I created and developed this idea into a prototype which now forms the basis for the new product for Cell Therapy application. Currently, this cell recovery system is being marketed by Pall Life Science’s group with a potential market for millions of dollars in the emerging stem cell market.

8.The first scientist to successfully created and developed filtration device for successful removal of infectious prions from red cell concentrates based on a simple mechanism which involves the interaction of the negatively charged prions at physiologic pH with positively charged quaternary ammonium polyester fibrous material. This idea of the use of Mustang E anion exchange chemistry has to date remained the main chemistry in the new filter that has now been developed into a product with a potential market opportunity in excess of $10,000,000. The creative process in developing this technology to address a very serious and fatal adverse effect of transfusion of blood products contaminated with infectious prions, responsible for a variant of human Creutzfeldt - Jakob disease (vCJD).

9.The first scientist to successfully demonstrate the phenotypic distribution of different white blood cells in leukocyte reduced platelet concentrates for transfusion. This development was used to demonstrate that not all leukocyte reduced blood products are the same and, most importantly, that some of the adverse effects associated with the transfusion of blood products may be due too the presence of different residual leukocyte populations.

10.Successfully created and developed the first ever technology in the world for freeze-drying and reconstitution of human red blood cells with maintenance of normal physiologic properties. This development resulted in the award of advanced technology grant of about $6,000,000 from the US Department of Defense.

11.The first scientist to identify the presence of apoptotic leukocytes in leukocyte-reduced blood products. These apoptotic cells are not stained or detected by flow cytometric methods for quality control of leukocyte reduced blood products. This discovery was made about 10 years ago and it has significant implications on some of the adverse effects of blood transfusion. Since these cells are not counted by conventional flow cytometric methods which were very popular for quality control of leukoreduced products, lack of their enumeration may lead to underestimation of residual leukocytes and potential transfusion of blood products with residual leukocyte content that is higher than the minimum recommended by FDA with potential increase in leukocyte-associated adverse effects of transfusion. More recently, this phenomenon has now been recognized by other scientists in Europe (United Kingdom, Germany, Netherlands etc.).

12.Created and developed preservative solution for long term storage of human red blood cells at freezing temperature of -20 C using standard house hold refrigerator.

13.Remained for over 11 years as the chief SLS point contact for Pall’s customers and top research scientist both in academia and in biotechnology companies or industries as an expert on blood, red cell haemolysis and biomaterial interaction as it relates specifically to diagnosing and complaints on filtration devices, problem solving and on the interaction of blood components with Pall’s filtration devices for leukoreducing blood and blood products.

14.Established Pall Haematology Reference Laboratory about 11 years ago and was solely responsible developing the infrastructure and for putting in place all the necessary requirements that were needed to obtained license from the New York State Department of Health as a CLIA licensed laboratory. This was a very significant development for Pall Corporation because several of our customers with annual business of more than $30,000,000 require CLIA certification before they can use any laboratory for quality control of leukocyte-reduced blood products that are produced with Pall’s filtration technologies. This is the first and only laboratory at Pall Corporation with CLIA certification. Currently, I am the only NYS DoH licensed Director of the laboratory which is responsible for processing all the samples from Pall’s customers.

EDUCATION

Ph.D., Clinical Pharmacology, St. Bartholomew’s Hospital Medical College, University of London, London, England, United Kingdom.

M.Sc; Physiology and Pharmacology, University of Strathclyde, Glasgow, Scotland, United Kingdom

EMPLOYMENT EXPERIENCE

Senior Technical Director - 2005

Pall Medical Research and Development,

Pall Corporation, Port Washington, NY

Technical Director - 1997

Pall Medical Research and Development,

Pall Corporation, Port Washington, NY

Senior Principal Scientist and Project Manager, Department of Basic Blood Research and Development. Cryopharm Corporation, Pasadena, California.-1995. Biological research and development of technologies to remove pathogens from blood and blood products to improve the safety of the blood supply; Development of lyophilization technologies for long term preservation of blood and blood products; Development of preservatives for long term storage of human red blood cells for use by both the Civilian Population and the US Department of Defense.

Assistant Professor of Research, Physiology and Biophysics: 1990

Department of Physiology and Biophysics

University of Southern California School of Medicine,

Los Angeles, California.

Postgraduate training in Haematology, Immunology, Blood Transfusion, Physiology, Biophysics, Biochemistry

Department of Physiology and Biophysics

University of Southern California School of Medicine,

Los Angeles, California.

PUBLICATION RECORD

Over 60 -Peer -Reviewed Publications/Chapters in scientific books/abstracts. Examples of publications are listed below. Full list of publications and book chapters are available on request.

1.Sowemimo-Coker SO. Evaluation of an experimental filter designed for improving the quality of red blood cells (RBCs) during storage by simultaneously removing white blood cells and immunomodulators and improving RBC viscoelasticity and Band 3 proteins. Transfusion. 2014 Mar; 54(3):592-601.

2.Silliman CC, Kelher MR, Khan SY, LaSarre M, West FB, Land KJ, Mish B, Ceriano L, Sowemimo-Coker S. Experimental prestorage filtration removes antibodies and decreases lipids in RBC supernatants mitigating TRALI in vivo. Blood. 2014 May 29; 123(22):3488-95.

3. Silliman CC, Bercovitz RS, Khan SY, Kelher MR, LaSarre M, Land KJ, Sowemimo-Coker S. Antibodies to the HLA-A2 antigen prime neutrophils and serve as the second event in an in vitro model of transfusion-related acute lung injury.Vox Sang. 2014 Jul; 107(1):76-82.

4.Cardone F, Sowemimo-Coker S, Abdel-Haq H, Sbriccoli M, Graziano S, Valanzano A, Berardi VA, Galeno R, Puopolo M, Pocchiari M. Assessment of prion reduction filters in decreasing infectivity of ultracentrifuged 263K scrapie-infected brain homogenates in "spiked" human blood and red blood cells. Transfusion. 2014 Apr; 54(4):990-5.

5.Sowemimo-Coker S O; Andrade F; Kim A; Pesci S

A simple filtration system for red blood cell depletion and volume reduction in routine processing of human umbilical cord blood.

Vox Sanguinis 2009; 96(2):138-45.

6.Sowemimo-Coker S O; Pesci S; Andrade F; Kim A; Kascsak R B; Kascsak R J; Meeker C; Carp R

Pall leukotrap affinity prion-reduction filter removes exogenous infectious prions and endogenous infectivity from red cell concentrates.

Vox Sanguinis 2006; 90(4):265-75.

7.Sowemimo-Coker Samuel; Kascsak Regina; Kim Anzi; Andrade Fabiola; Pesci Susan; Kascsak Richard; Meeker Clifford; Carp Richard; Brown Paul

Removal of exogenous (spiked) and endogenous prion infectivity from red cells with a new prototype of leukoreduction filter.

Transfusion 2005; 45(12):1839-44.

8.Sowemimo-Coker Samuel O

Red blood cell hemolysis during processing.

Transfusion medicine reviews 2002; 16(1):46-60.

9.Sowemimo-Coker S O; Kim A; Tribble E; Brandwein H J; Wenz B

White cell subsets in apheresis and filtered platelet concentrates.

Transfusion 1998; 38(7):650-7.

10.Sowemimo-Coker S O; Goodrich R P; Zerez C R; Tanaka K R

Refrigerated storage of lyophilized and rehydrated, lyophilized human red cells.

Transfusion 1993; 33(4):322-9.

11. Sowemimo-Coker S O; Haywood L J; Meiselman H J; Francis R B

Effects of normal and sickle erythrocytes on prostacyclin release by perfused human umbilical cord veins.

American journal of hematology 1992; 40(4):276-82.

12.Sowemimo-Coker S O; Meiselman H J

Effect of procaine hydrochloride on the electrophoretic mobility of human red blood cells.

Cell biophysics 1989; 15(3):235-48.

13.Sowemimo-Coker S O; Meiselman H J; Francis R B

Increased circulating endothelial cells in sickle cell crisis.

American journal of hematology 1989; 31(4):263-5.

14.Sowemimo-Coker S O; Yardin G; Meiselman H J

Effect of procaine hydrochloride on the aggregation behavior and suspension viscoelasticity of human red blood cells.

Biorheology 1989; 26(5):951-72.

15.Moroff Gary; Sowemimo-Coker Samuel O; Finch Stephen; Murphy Scott; Brandwein Harvey; Whitbread John; Wenz Barry

The influence of various hematology analyzers on component platelet counts.

Transfusion medicine reviews 2005; 19(2):155-66.

16. Gyongyossy-Issa M I C; Weiss S L; Sowemimo-Coker S O; Garcez R B; Devine D V

Prestorage leukoreduction and low-temperature filtration reduce hemolysis of stored red cell concentrates.

Transfusion 2005; 45(1):90-6.

17.Gregori Luisa; McCombie Nancy; Palmer Douglas; Birch Paul; Sowemimo-Coker Samuel O; Giulivi Antonio; Rohwer Robert G

Effectiveness of leucoreduction for removal of infectivity of transmissible spongiform encephalopathies from blood.

Lancet 2004; 364(9433):529-31.

18. Neu Björn; Sowemimo-Coker Samuel O; Meiselman Herbert J

Cell-cell affinity of senescent human erythrocytes.

Biophysical journal 2003; 85(1):75-84.

19.Meiselman H J; Baskurt O K; Sowemimo-Coker S O; Wenby R B

Cell electrophoresis studies relevant to red blood cell aggregation.

Biorheology 1999; 36(5-6):427-32.

20.Weinstein R; Sowemimo-Coker S O; Goodrich R P

Survival of lyophilized and reconstituted human red blood cells in vivo.

Transfusion clinique et biologique : journal de la Société française de transfusion sanguine 1995;2(6):427-32.

21.Goodrich RP; Sowemimo-Coker SO. Freeze-Drying of red blood cells. In Advances in Low-Temperature Biology 1992, vol 2, pp 53-99

22.Sowemimo-Coker S O; Turner P

The effect of pentoxifylline on filterability of normal red blood cells and their adhesiveness to cultured endothelial cells.

European journal of clinical pharmacology 1985; 29(1):55-9.

23. Kovacs I B; Sowemimo-Coker S O; Kirby J D; Turner P

Altered behaviour of erythrocytes in scleroderma.

Clinical science (London, England) 1983; 65(5):515-9.

24. Rustin M H; Kovacs I B; Sowemimo-Coker S O; Maddison P J; Kirby J D

Differences in red cell behaviour between patients with Raynaud's phenomenon and systemic sclerosis and patients with Raynaud's disease.

The British journal of dermatology 1985; 113(3):265-72.

25.Cervia JS, Sowemimo-Coker SO, Ortolano GA, Wilkins K, Schaffer J, Wortham ST. An overview of prion biology and the role of blood filtration in reducing the risk of transfusion-transmitted variant Creutzfeldt-Jakob disease.Transfus Med Rev. 2006 Jul;20(3):190-206.

INVENTION RECORDS, PATENTS AND PATENT APPLICATIONS

Over 20 patents, patent applications and records of inventions. Examples of patents are listed below. Full list of patents, patent applications and records of inventions are available on request.

1.Method of harvesting rare cells from blood products – US Patent Number EP1690930

2.Preparation of a cell concentrate from a physiological solution US Patent Number 7,291,450

3.Method of freezing cells and cell-like materials. US Patent Number 5958670

4. Biological fluid filter (WO/2004/039474

5.Preparation of a nucleated cell and /or platelet suspension (WO/2005/094914)

6.Freeze dried red blood cells - US Patent Number 5690963

7.U.S. Patent Number 4,874,690

8.Prion Procesing - Patent Application WO/2008/005960

9.Method for inactivating non-enveloped viral contaminants with a photosensitizer by increasing viral permeability to the photosensitizer. US Patent Number 6,251,644

10.Method of inactivation of viral and bacterial blood contaminants. US Patent Number 6,235,508

11.Method of inactivation of viral and bacterial blood contaminants. US Patent Number 5,955,256

12.Photoinactivation of viral and bacterial blood contaminants using halogenated coumarins. US Patent Number 5,516,629.

13.Removal of immunoglobulins and leukocytes from biological fluids. US Patent Application Number20120219633



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