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​A detailed root cause analysis shall of course open avenues of true ‘problem areas i.e. disjointed business processes’ which need correction, followed by a neat process improvement strategy and its flawless execution.​

​There are over eighteen different continuous improvement methodologies to choose from.

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How to Employ Kaizen in Pharmaceutical Operations?

Though a combination of nine types of Kaizen would be most suited; for starters, Gemba Kaizen can provide maximum help.

Gemba Kaizen is a method of continuous improvement that involves real time action. It is commonly used to add valuable activities to an organization, which help to add to the quality of customer satisfaction. When a problem arises, Gemba Kaizen pinpoints the issue as promptly as possible. The solution to the problem is then used to deal with the same problem, if it should reoccur, but ideally stops the problem from reoccurring in the first place. 
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This method also implements ideas used in lean manufacturing, which help to reduce waste and unnecessary procedures.

One of the main goals of Gemba Kaizen is to eliminate anything that is not valuable, or adds value, to an organization, whether it is systems, procedures, employees, business verticals, machinery, facility and others. 
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1. Reduced Variations in Eye Drop Dosage; a Continuous Improvement Case Study: Kaizen in Pharmaceutical Product Development
2. Kaizen Improved Patenting and Patent Filing Process ~ 20% drop in Patenting Cost; a Continuous Improvement Case Study
3. How to Speed-up Pharmaceutical Generic Product Development?: Continuous Improvement Case Study

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Today I read a report in Stat News about the first ‘digital pill’ that has been rolled out at a Cancer Treatment center in Minnesota US. The report mentions how chemotherapy pills taken by cancer patients are packaged with a sensor that can alert a physician, pharmacist, or caregiver after the pill has been swallowed.

The report highlights that seven patients — all of whom have colorectal cancer in stage 3 or stage 4 and are being treated in Minnesota — have been provided with this treatment. The idea is that, by tracking when patients take their drugs, health care providers will be better able to ensure medication adherence and to provide treatment guidance, with the goal of improving health outcomes.

How does digital pill work?:

After patients swallow a chemo capsule, the sensor gets activated once capsule gets damp in the stomach fluids. The sensor then pings a signal to a patch worn by patients on their torso; which transmits data on the time of day, the size of the dose, and the type of medication taken to an online portal that the patient can view. If patients choose to allow it, their support team can access this database portal too.

This program in Minnesota appears to be the first one in which a digital pill has been used in oncology. So far, neither patients nor insurers pay anything beyond the typical cost of the medication for this high-tech upgrade.

This news sparked my interest for several reasons-

1. As there is high proliferation of cancer disease world-wide, such digitization of cancer therapy will hopefully bring benefits to a wider population of cancer patients.
2. Despite advances in Oncology, not everything about cancer is understood by researchers, doctors, patients and care givers. The resulting effect is that there is no cure for cancer, especially once cancer has metastasized or is beyond stage 2. Another peculiarity of cancer is that no two types of cancer are same, hence medications and their dosages administered to cancer patients are different. For example, dosage of Tarceva tablets prescribed for a lung cancer patient is different from what is prescribed for a patient with pancreatic cancer. However, the digitization platform done for chemotherapy of colo-rectal cancer can be researched further to extend to other cancer types, which can yield better patient compliance, superior therapeutic modeling and better treatment outcomes to a wider patient population.
3. Additionally, this concept of  'digital pill' can be extended to other disease types too, where patient compliance has always been a problem; for example Tuberculosis, Schizophrenia, hypertension etc. Drug-resistant tuberculosis is worse to treat than regular TB. Hence, a digital TB pill will be  a boon for patients and doctors alike. Similarly, patients forgetting to take their blood pressure pill is usual, especially among older folks. Such non-compliance issues can hopefully be nipped in the bud with digital pharmaceuticals for hypertension.  
4. Such digital pills can substitute the health system services which invest in phone calls and other reminders to patients to help them stay on track with their medications.

'Digital' pill is not only an impressive step in Continuous Improvement for Cancer Therapy, it is a significant step in Continuous Improvement for Health System services too! and, hopefully pave way for Continual Improvement in TB care, hypertension management and patient-centric drug product design.

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About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

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The United States Food and Drug Administration (USFDA) today 9th October 2018, unveiled one revised draft guidance and another new draft guidance to help advance the development of generic Transdermal/Topical Delivery Systems (TDS). Here's a snapshot:

When applied to a patient’s skin, Transdermal/ Topical products are expected to deliver the correct dose of the medication consistently and for the expected length of time, while adhering consistently and uniformly to the skin, even when the skin is exposed to water, humid environment and/or body movement.

Because of the inherent complexity of delivering a drug through a transdermal/ topical system, making generic copies of these branded (reference listed) transdermal/ topical drug products is hard; and the two draft guidance documents aim to mitigate this problem.

ANDA Guidance document for assessing Irritation and Sensitization:

This 12-page guidance provides recommendations for Abbreviated New Drug Application (ANDA) sponsors on the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system.

Applicants must perform a comparative assessment of the generic and reference listed transdermal/topical drug products using an appropriately designed skin I/S study with human subjects. The draft document demonstrates that the potential for a skin irritation or sensitization reaction with the Test-TDS is no worse than the reaction observed with the Reference-TDS.

Study design and conduct, considerations for statistical analysis, overall assessment of adverse event data and format of data submissions are outlined in the draft guidance. (Note: The recommendations relating to the design and conduct of I/S studies described in this guidance replace the recommendations related to I/S studies provided in product-specific guidances published before this guidance. This set the stage for revisions in bioequivalence (BE) study guidelines for 23 TDS products).

ANDA Guidance document for Assessing Adhesion

This revised 9-page draft guidance supersedes a draft from June 2016 and provides recommendations for the design and conduct of studies evaluating the adhesive performance of a TDS.

Apropos the guidance document, depending on the objective(s) of a transdermal/ topical dosage form product development program, applicants may choose to evaluate transdermal /topical adhesion in clinical studies performed to evaluate adhesion only or in clinical studies performed with a combined purpose (example- for simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints).

Additional topics covered in the revised draft include the study design and conduct, considerations for statistical analysis, as well as recommendations on the combined evaluation of adhesion and bioequivalence.

About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

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​Recent data has shown that in some cases, low concentrations of insoluble drugs in a nanoparticle form can be more active than previously thought, offering the potential to administer drugs in low dosages without reducing the effectiveness of the treatment. The new technology is allowing the scientists to develop new medicines by converting currently available drugs into a nanoparticle form. Antiparastitic drugs to treat malaria are also being developed in collaboration with the Liverpool School of Tropical Medicine.

Professor Steve Rannard, from the Department of Chemistry who is also co-founder and current Chief Scientific Officer of IOTA NanoSolutions, said: "Already our technology has shown the potential to improve a range of current medicines and may lead to treatments that prevent drug resistance. If our approach can deliver new antimalarial treatments, it may help to prevent millions of deaths per year and improve the lives of hundreds of millions of current malaria sufferers."

Nanoparticle program delivers anti-cancer therapy.
A research team at Washington University in St. Louis has combined a nanoparticle platform used in imaging growing blood vessels and combined it with the fungal drug fumagillin to create a new weapon to fight the growth of tumors. Fumagillin has long been known as a potent anti-cancer therapy, but its neurotoxic side effects are too harsh for patients. To circumvent the side effects, the scientists adapted nanoparticles designed to dock on a protein carpeted on endothelial cells clustered on the walls of new blood vessels and loaded them with fumagillin. By targeting the therapy directly at the new blood vessels, the therapy can stop angiogenesis, a key target in oncology research.

"It basically becomes a vehicle to dump off a truckload of cargo," Joseph DeSimone of the University of North Carolina tells MIT Technology Review. "It's sort of like a Trojan horse."

There are a number of research programs underway relying on animal studies to determine the effect of new nanoparticle technologies that can interrupt angiogenesis. First-generation nanoparticle therapies rely on passive delivery methods while this second generation round of research is working on new technology aimed at more precise targeting of disease.


Nanomaterials used to fix neuron damage.
Northwestern University researcher Samuel Stupp has presented the results of a study in which he injected nanomaterials into the severed spinal cords of mice, allowing them to walk again after several weeks of therapy. The nanomaterials he used were designed to self-assemble into nanofibers which repaired damaged neurons. The research offers new insights into the near-term research potential of nanotechnology and offers hope for patients with Alzheimer's and Parkinson's who suffer from severe neuron damage.

"Regenerating bone and cartilage are our first targets," Stupp told the Chicago Tribune. "That would be very important to Baby Boomers who value their quality of life. We are also working with regenerating blood vessels to address damage from heart attacks. (Nanotechnology) will first aid in diagnosing illness, but it also will provide therapies to alleviate or cure." 
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Nanoparticles offer ovarian cancer treatment approach.
Magnetic nanoparticles have been used to ‘drag' cancer cells out of the bodies of mice. Scientists at Georgia Tech coated the nanoparticles with a targeting molecule that caused them to bond to the cancer cells. And the researchers say the approach could be used to treat metastatic ovarian cancer. During metastasis, the cancer cells drift in the abdominal area, offering a target for the nanoparticles. They believe that a patient's abdominal fluid could be drained, cancer cells filtered out, and then infused back into the abdominal cavity.

"It's possible that the particles may not ever have to go into the patient's body," says John McDonald, the chief scientific officer of the Ovarian Cancer Institute at Georgia Tech. "That would be preferable, because then you don't have to worry about any potential toxicity."


About the Author: Shruti Bhat PhD, MBA
 
Dr. Shruti Bhat is an award-winning Business Excellence Leader, Global Continuous Improvement Mastermind, Best-selling Author and Speaker. She is Continuous Improvement Advisor to several start-ups, mid-size and growing firms in Canada, USA, India, Africa and Emerging markets. She has authored eight business books and is an invited speaker at several national and international conferences, symposia and workshops.

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#ShrutiBhat  #ContinuousImprovementAcademy  #Manufacturing #Lean #ContinuousImprovement #Kaizen  #QualityImprovement  #Innoworks  #Innovation  #Quality  #eLearning  #Business  #BusinessProcessManagement  #ServiceIndustry  #ManufacturingManagement  #LeanInnovation  #Pharmaceutical  #LifeScience  #Food  #Beverage  #Biotechnology  #Retail  #Cosmetics  #PersonalProducts  #Chemicals  #Drugs #Engineering #ShiftingParadigms #BPM  #LeanManagement  #KaizenLeaderMasterclass  #LeanSixSigma  #Kanban  #FMEA  #RiskManagement