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Catalyst Biologics Presentation

Transcript: ADVANTAGES AUTOMATED WORKFLOWS COMPLIANCE OUR STORY WOUND KITS The lessons learned on the journey to get where we are today helped us acquire the knowledge and perspective that shaped the foundation of our company: THE ACE UP OUR SLEEVE MARKET REACH CATALYST ANCILLARY SOLUTIONS STREAMLINED PROCESSES DESIGN ELEMENTS: 5 Hospital Systems Benefit Verification Pre-authorization Coding & Dictation Guidance Recoupment Protection & Denial Defense OFFICE APPLICATIONS ENTRY OPPORTUNITIES SUBTITLE PROGRESSIVE WOUND CARE PLATFORM "Be a yard stick of quality; some people aren't used to working in an environment where excellence is expected." PREPARATION & PROCESS 12 Surgery Centers ACCESS TO HMS WOUND CARE DATA STRATEGIC SALES STRATEGY 2 Wound Care Centers 1 Cancer Center We help medical practices thrive by improving continuity of care and growing practice revenue "Tact is the ability to tell someone to go to hell in such a way that they look forward to the trip" - Churchill INTEGRITY SUPPORT Easily integrated and adopted "If opprtunity doesn't knock, build a door" DIRECT ACCESS TO PHYSICIANS, ADMINISTRATORS, AND C-LEVEL EXECS THROUGHOUT THE REGION "Give me six hours to cut down a tree and I'll spend the first four sharpening the axe." WOUND KITS EXPERIENCE & CAPABILITY SURGICAL APPLICATIONS Using technology to ensure efficiency REIMBURSEMENT Personal Development & Constant Learning ESTABLISHED CREDIBILITY PATHOLOGY "Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum" COMBINED 14 YEARS OF EXPERIENCE IN MEDICAL SALES WHAT SETS US APART GROWTH & STABILITY THROUGH DIVIRSITY OUR VALUE "The illiterate of the 21st century will not be those who cannot read and write, but those who can't learn, unlearn, and relearn" - Alvin Toffle OUR SOLUTIONS HEADLINE 300+ Physician Contacts Finding the need behind the need OUR METHOD REIMBURSEMENT SUPPORT dme/ccm diagnostics ADD COLORS 500+ ICONS wound care biologics


Transcript: November, 30, 2017 How Biologic Medicines are Made What Are Biologics Biologics are proteins derived from living sources. They are not new medicines, because it has been used for years and extracted from our bodies cells which are living sources. What Are Biologics First 3 steps Step1: The process starts with the insertion of genetic material into “chinese hamster ovarian cells” or C.H.O. They keep them frozen in liquid nitrogen. Step2: Then in the seed lab, a technician thaws the cells in warm water. Then it is transferred to a glass flask that contains growth media.---It’s a recipe of nutrients and vitamins to help the cells multiply. Step3: The team injects the mixture into a five gallon capacity bioreactor. First 3 steps Step 4: Inside, a propeller agitates the mixture to stimulate growth. Over a 3 week period, the number of cells increase exponentially. After the cells are done growing, each new cell is programmed to produce the target protein. Step 5: Next, a technician measures salts and other dry ingredients. They preparing the recipe to purify the protein liquid once it’s been separated from the cells. The guy labels the bag and records the information separately. Step 6: He adds the ingredients to a purifying mixing tank. After separating the cellular materials from the protein mixture, The amp pumps it through steel and glass columns. There the purification solution works with resin beads to separate the protein from the impurities. Next 3 Steps The technician takes a sample and conducts a test to ensure the medicine is sterile and then it’s sent to hospitals. It’s sent from the factories that make the medicines and to the hospitals and they are given to the doctor and then given to patients. Where Does it Go? What is the consumer classification of this product - Convenience goods, shopping goods or specialty goods? I guess it’s specialty goods since it comes from cells and it’s not often that medicine is made from the cells in our bodies. How is this product used? It is used to “save People’s lives” and patients in need of this medicine. Where is this product sold? I don’t think there’s a specific place that it is sold since it is a medicine and it’s usually for patients in absolute need so maybe a business that is tied with hospitals are buying it and then it’s sent to hospitals. Six Steps of Production Six Steps of Production Planning- The scientist gather their tools tio prepare for the long process of making bilogical medicine Purchasing- They don't purchase anything because these are products used from human biology. Production Process- There is a process pof about six things to do to make the medicine. Schedule- They have to find places to ship the medicine at a certain amount of time to know how much to send. Dispatching- The medicine is then sent out to the hospitals that have purchased the product. Follow Up- They do the process all ovee again after the medicine is sent out. The six steps: The six steps:

Drugs and Biologics Presentation

Transcript: Pharmacokinetics Current Pricing (as of 2017) Reported AE's (performed on a much larger population): Those on Prozac: 2869 most common AE's at 20mg were nausea, headache, and insomnia (inability to fall/stay asleep) Those on Placebo: 1673 most common AE's were headache, insomnia, and nausea ADME: 1st pass-extensively metabolized in the liver excreted in the urine the primary route of elimination appears to be hepatic (liver) metabolism to inactive metabolites excreted by the kidney. The long elimination half-life of fluoxetine (even when dosing is stopped) will persist in the body for weeks. this drug specifically selects for the neurotransmitter serotonin, which controls mood in an individual serotonin travels from one neuron through a channel, attaches to its receptor on another neuron and the signal enters the body (bear in mind, these neurotransmitters can detach from the receptor and go back to the original channel it came from, reentering the neuron); this is a reversible channel/reaction In a person with depression, serotonin is mainly entering the neuron and not sending signals to enter the body, resulting in an individual being "unhappy" the drug aids in blocking the channels so that serotonin can bind to the receptor and the signal is transmitted to the body and cause the individual to be happy over time, serotonin will build up in the body and the individual's mood will increase to a positive, healthy state Prozac (Fluoxetine Hydrochloride) IUPAC Name: N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine Molecular Formula: C17H18F3NO White to off-white crystalline solid with a solubility of 14 mg/mL in water Molecular Weight: 345.79 g/mol Drug Substance: 10 or 20 mg fluoxetine (depending on dosage) Excipients: starch, gelatin, silicone, titanium dioxide, iron oxide, and other inactive ingredients Antidepressant Pharmacokinetics (cont'd) PD: Mechanism of Action Prozac (Fluoxetine Hydrochloride)-Boxed Warning Label *H-Cl Michelle Ijeoma Drug Development Spring 2017 Summary: being on this drug can cause suicidal thoughts and actions. If such should occur, seek your physician ASAP. Drug Formulations Capsule taken orally: Children: 10 mg, 20 mg Adults: 20 mg, 40 mg, 60 mg Brand: Generic: PD: Mechanism of Action Although exact MOA is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin Brand Name: 10mg, 30 tablets: $229.23 20mg, 30 tablets: $235.10 40mg, 30 tablets: $464.4 Generic: 10 mg, 30 tablets: $14.19-$19.74 20 mg, 30 tablets: $14.21 40 mg, 30 tablets: $16.59 Phase 3 Clinical Trials of Fluoxetine FDA Prozac Filing Information: FDA Prozac General Information: Prozac Dosage Details: Prozac Chemical Structure: Prozac Worth: Price of Brand Name: Price of Generic: Pharmacokinetics (cont'd) Eli Lilly and Co. (Indianapolis, IN) Classified as an SSRI (selective serotonin reuptake inhibitor) antidepressant drug Is used to treat the following: depression (MDD) anxiety (panic attacks) other related disorders (ie: OCD, bulimia) Intended Population: 20 mg/day for adults > 17 years of age 10-20 mg/day for pediatrics </= 17 years of age (no younger than 7 years old) References Phase 3 Clinical Trials of Fluoxetine PD: Mechanism of Action Chemistry! Toxicity Studies: Chronic toxicity studies-phospholipids are increased in some tissues of mice, rats, and dogs given fluoxetine chronically Genotoxicity studies- no genotoxic effects were observed Reproductive toxicity studies-no adverse effects on fertility. However, adverse effects on fertility were seen when young rats were treated with fluoxetine Carcinogenicity studies- no evidence of carcinogenicity was observed Administered to adult and pediatric (total of 2869) subjects who exhibited symptoms of depression Received 20 mg Prozac once daily in double blind, placebo controlled trials (lasting 12 weeks): reported significant improvement Most commonly reported adverse events: Asthenia (lack of energy or abnormal physical weakness): 11% Prozac, 6% Placebo Flu Syndrome: 5% Prozac, 4% Placebo Regulatory History First filed IND: because this is an older drug, the IND could not be found. 20 mg Oral Capsule was approved on December 29, 1987 (NDA # 018936) Chemical Type: 1 New Molecular Entity (NME) Review Classification: Standard Review Drug August 2001: Eli Lilly loses patent on Prozac a few months later, generics come out, tanking


Transcript: Genesis BIOLOGICS GENESIS Dayton Orthopaedic Surgery Sports Medicine Center Office Locations Far Hills North Dayton Springfield West Chester Troy Meet the Team MOVE TO END Jennifer Leibold, PA-C 250 years Jonathan Paley, M.D. over 25 Skippy, PA-C Education: GED Total joint Replacement Shoulder Reconstruction Sports Medicine Stem Cell Biologics and Joint Restoration Services Provided MOVE TO END Carpal Tunnel Foot and Ankle Neck and Back Workers Compensation BIOLOGICS Orthobiologics involves the field of stem cell research. This typically involves the harvest of stem cells from either adipose tissue, bone marrow cells and from the actual blood itself. These stem cells, are able to differentiate into tissue that resemble normal cartilage or tedon. Orthobiologics is used to excel the healing process of joint repair, broken bones or tendons and ligaments that have been injured. ORTHOBIOLOGICS A global medical device company and leader in new product development and medical education in orthopedics Over 11,000 innovative products and surgical procedures more than 90% of all products made within the US BIOLOGICS *ASK ABOUT VIDEO AT END OF PRESENTATION* What We Need What We Offer How does Dayton Orthopaedics utilize Biologics? PRP BMA Angel PRP Platelet Rich Plasma Two types of PRP Rich Leukocyte- Tendons 1 shot seires Results seen as quick as 3-5 days Poor Leukocyte- Joints 3 shot series Results seen as quick as 1-2 weeks The use of a portion of the patient's own blood having a platelet concentration to promote quicker healing of injured tendons, ligaments, muscles, and joints. *ASK ABOUT VIDEO AT END OF PRESENTATION* BMA Bone Marrow Aspirate One shot seires for BOTH joints and tendons Marrow taken from Pelvic bone Numb the Periosteum Extract Marrow Re-injected to the troubled area of the body Involves taking a sample from the soft tissue inside of the bone. Bone marrow is the spongy tissue found and contains cells that produce white blood cells, red blood cells, and platelets. Results as quick as 6 days Angel System The Angel System How it's Done The Angel System utilizes a proprietary platelet sensor and one button automation to prepare customized platelet-rich plasma formulations -Reduce invasive surgical procedures - Products are naturally found within the patient body -Reduces chance of infection or rejection -Outpatient procedure that is more rapid in recovery time than surgery -Minimizing impact of degenerative disease and more BENEFITS QUESTIONS? REMEMBER. IF IT'S NOT GREAT, WHY BOTHER? Arthrex Introduction


Transcript: Biologics or Immunizing biologicals - derivatives of animals (serums, antitoxins, globulins) or microorganisms (vaccines, toxins, toxoids, tuberculins) confer a state of protection against pathogenic microorganisms. Classification of Immunity I. Natural (Innate) Immunity - endowed at birth and is retained because of race and other factors. II. Acquired Immunity - developed or acquired during the lifetime. Subdivided into two classes. 1. Active Immunity a. Naturally acquired active b. Artificially acquired active 2. Passive Immunity a. Naturally acquired passive b. Artificially acquired passive A. Viral Vaccines 1. Measles (Attenuvax), Live, attenuated Rubeola virus, grown on avian or human cell tissue culture. 2. German Measles (Meruvax II) Live Rubella virus, grown on human diploid cell tissue culture. 3. Mumps (Mumpsvax) Live Mumps virus, Chicken embryo tissue. 4. Smallpox or Vaccinia (not available commercially) Live vaccinia-cowpox- virus, skin of bovine calf 5. Poliovirus (TOPV)- Trivalent oral polio vaccine live - Only under special conditions due to vaccine associated paralytic polio- Guillain-Barre Syndrome. 6. Poliomyelitis (IPV) Inactivated polio vaccine trivalent, Rhesus monkey kidney tissue culture 7. Rabies (Imovax, RabAvert) Inactived rabies virus, Imovax - human diploid cell (HDC) & RabAvert - chicken fibroblasts tissue culture. 8. Influenza (Fluzone, FluShield, Fluvirin) Inactivated Influenza virus, seasonally selected types 9. Yellow Fever (YF-Vax) Live, attenuated yellow fever virus, domestic fowl embryo. 10. Hepatitis A, Inactivated(Havrix, Vaqata) Inactivated surface antigen particles obtain from the plasma of healthy chronic hepatitis B antigen carrier by plasmapheresis. 11. Hepatitis B, Recombinant (Recombivax HB, Engerix-B) Recombinant HB surface antigen 12. Chickenpox or Varicella (Varivax) Live, attenuated varicella virus human diploid cell culture 13. Japanese Encephalitis (JE-Vax) Inactivated JE virus, prepared from infected mouse brain. B. Bacterial Vaccines 1. Typhoid (Typhim-inj, Vivotif Berna- oral) Salmonella typhi, killed bacelli 2. Cholera (CDC source) Vibrio cholera, killed bacteria 3. Plague (CDC source) Yersinia pestis, killed bacilli 4. Tuberculosis - BCG Vaccine (Tice BCG) Mycobacterium tuberculosis, living culture of bacillus Calmette-Guerin strain. 5. Pneumococcal polyvalent (Pneumovax 23, Pnu-Imune 23) Streptococcus pneumoniae, capsular polysaccharide from serotypes listed 6. Meningococcal Polysaccharide (Menomune A/C/Y/W-135) Niesseria meningitidis, capsular polysaccharide from different serotypes 7. Hemophilus b Polysaccharide (HibTITer, ActHIB) Heamophilus influenzae, capsular polysaccharide. 8. Pertussis (CDC source) Bordetella pertussis, killed bacteria, both fluid and adsorbed forms 9. Lyme Disease (CDC source) Borrelia burgdorferi, outer cell surface protein by recombinant technology C. Rickettsial vaccines These can only be obtained from CDC 1. Typhus - Rickettsia prowazeki - inactivated, chicken embryo origin 2. Rocky Mountain Spotted Fever - Rickettsia rickettsii, - Killed, chicken embryo origin 3. Rickettsial pox- Rickettsia akari - Killed, chicken embryo origin 4. Typhus- Scrub aka Tsutsugamushi Disease - Rickettsia Tsutsugamushi, Killed, chicken embryo origin 5. Q Fever - Coxiella burnette, whole cell culture 6. Trench Fever - Rickettsia quintana, whole cell culture A number of antigen-containing preparations are employed in diagnostic aids to determine whether an individual has developed hypersensitivity to certain types of organism Small quantity preparation usually injected intradermally developing reaction usually read at 48 hours Commonly available in : tubeculin,histoplasmin,coccidiodin,diptheria toxin, and mump skin test Preparation obtain from human and bovine strains of the tubercle strains It is applied as a diagnostic agent to determine whether the person animal is or has been infected with Mycobacterium Applied intracutaneous injection, by rubbing into the scarified skin, dropping into the eye is another method A sterile solution of concentrated, soluble products of growth of the tubercle bacillus (Mycobacterium tuberculosis) Used to test patient suspected with tuberculosis Usual dose 5 units ,administered intradermally The test is read after 48 to 72 hours after administration Sterile, standardized liquid concentrate of the soluble growth products by the fungus(Histoplasma capsulatum ) No value of treating disease Used in determining whether patient is harbouring fugal organism Stored between 2 to 8˚C The expiration is two years after date of manufacture or date issue 0.2 ml,intradermally into the flexor surface of the forearm Steril solution containing antigens from by products of the mycelial growth or form the spherules of the fungus (Cocciodis immitis) Used for detecring coccidomycosis Usual dose,intradermally is 0.1 ml of a 1:100 dilution Diptheria toxin Sterile solution of the diluted, standardzed products of growth of diptheria


Transcript: Compare and contrast the types biologics for active immunity and their mechanism of action List sources of biologics for passive immunity Describe possible adverse drug reactions for biologics based on their mechanism of action, administration, and/or excipients Describe the childhood and adult immunization schedules Biologics must meet specified standards as administered by the Center for Biologics Evaluation and Research of FDA Typically, these are injected intradermally and the site for development of a hypersensitivity reaction. A positive reaction is determined by the extent of induration and degree of reaction, from slight induration to vesiculation and necrosis. BIOLOGICS Administered primarily for prophylactic action, to develop acquired active immunity. May contain living attenuated or killed microorganisms Vaccines The vaccine for influenza is made from inactivated viruses and experts consider flu shots safe during any stage of pregnancy. Racial Immunity The number one killer among vaccine-preventable diseases. Common in the elderly. Non-smokers are 4 times less likely to get this compared to smokers. A specific immunity that may be active or passive Pharmacists can encourage immunization the following: formulary management administrative measures (participation on infection committees, policy and procedures development, and advocating standing orders in institutions participation in administration programs patient history and screening counseling and documentation public administration and advocacy Due to the importance of disease caused by S. pneumoniae several vaccines have been developed to protect against invasive infection. The World Health Organization recommend routine childhood pneumococcal vaccination it is incorporated into the childhood immunization schedule in a number of countries Pneumococcal disease is a leading cause of serious illness throughout the world. It is caused by a common type of bacteria, the pneumococcus, which can attack different parts of the body. Illnesses caused by pneumococcus include pneumonia, meningitis, middle ear and sinus infections, and a condition called sepsis, which is an infection of the bloodstream. Pharmacists must have contact information for patients with special needs as it relates to immunization information, where to find information programs, and issues of travel and safety, among others Antigen - a toxin or other foreign substance that induces an immune response in the body, especially the production of antibodies. Influenza, commonly known as "the flu", is an infectious disease caused by an influenza virus. Symptoms can be mild to severe. The most common symptoms include: a high fever, runny nose, sore throat, muscle pains, headache, coughing, and feeling tired. IndividualImmunity Varicella zoster virus (VZV) is one of eight herpesviruses known to infect humans. VZV infections are species-specific to humans. It causes chickenpox (varicella), a disease most commonly affecting children, teens and young adults and herpes zoster (shingles) in older adults; shingles is rare in children. VZV is known by many names, including chickenpox virus, varicella virus, zoster virus, and human herpesvirus type 3 (HHV-3). BIOLOGICS BIOLOGICS It is thought to be associated with smoking-induced damage to tissue which allows bacteria to infiltrate into the lungs and windpipe. Pharmacists and allied health professionals are asked to report any indication of suspicious symptoms to local and state health departments Define, compare, and contrast the different types of immunity List the standards and control requirements needed for the production of biologics List various sources of valuable information for the proper use, storage, and administration of biologics Develops in response to antigenic substances in the body Immunity Biologicals for Passive Immunity Pharmacists are encouraged to participate in their community's disaster preparedness efforts Food and Drug Administration the ability of an organism to resist a particular infection or toxin by the action of specific antibodies or sensitized white blood cells Each lot must meet the specific control requirements for that product. These include tests for: potency general safety sterility purity water (residual moisture) pyrogens identity constituent materials (preservatives, diluents, adjuvants) Responding to Bioterrorism The measles virus causes an acute infection characterized by fever, cough, coryza, conjunctivitis, rash, and enanthem that may be followed by severe complications including encephalitis. Pharmacists must also be attuned to the cost of vaccinations and its implications substances produced by a living source, including antibiotics, hormones, and vitamins, among others Objectives Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open the mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

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