Realizing the digital opportunity is no simple task—it represents an innovation capability for the entire organization- as good as an organizational overhaul. 

​Part 1 of this blogpost series introduced digitalization in pharma and medical device R&D, Part 2 discussed on the need for digitalization, Part 3 mentioned on- How to go for digitalization in R&D, while Part 4 discussed advantages of digitalization.

In this blogpost, I shall elaborate on- Digitalization in various phases of drug research and development.

Experiments and clinical trials carry a huge cost for drug industries, both financially and in terms of human and scientific resources. Advanced simulation, modelling, AI-based analytics, and quantum computing help identify the strongest candidate for new therapies by allowing only the most promising moieties to proceed to the costly experimental phase. 
​
Let’s see how does digitalization impact various phases of drug development…

​Traditionally new drug discovery used mouse models with a hope that findings would translate to humans, leading to high failure rates. Now and going forward new drug moieties are discovered using human genome sequencing technology. Rapid growth in genome sequencing technology allows researchers to not only design therapies based on human biology, but also at reduced costs.

Using digitalization at in silico discovery for target identification maximizes the value of data. The efficient data interoperability implies a clear data strategy, data governance and data management which shrinks drug discovery timelines significantly by 3-5 years! Also, this reduces cost of drug discovery by several million USD.

Further, besides researchers, peers and colleagues from project decision-making to portfolio management & risk optimization functions work more closely together and feel more empowered through increased data visibility and decision transparency.

​Digitalization uses Big Data for formulation prediction. Using digital mode of drug product development shrinks both development cost as well as time enormously.

Just as drug discovery, digitalization impacts how drug products are developed such as-
​
1.      (Drug) Salt- finding study.
2.      Dose-finding study.
3.      Identifying ADME (Absorption Distribution Metabolism Elimination) of the drug.
4.      Route-finding study-

Route finding study identifies the best way to administer the drug or whether the drug can be administered via multiple routes? Should the drug be administered only by per oral route or can it be administered via other mucosal routes such as nasal, inhalation, ophthalmic, parenteral, transdermal etc.

5.      Proof of concept study/ Formulation development & analytical testing-

Digitalization allows machine learning algorithms to review raw material properties such as- drug molecule chemistry, excipient chemistry, powder dynamics, rheology, ADME , patent and regulatory data etc. to build formulation recipes and predict results. Digitalization uses Big Data to suggest formulation compositions.

For instance- in case of targeted drug delivery systems, the choice of carrier is vital. And researchers conduct studies to identify if the carrier-mediated drug transport additive should be- Niosomes, liposomes, methacrylates, ion-exchange resins, cyclodextrins, fullerenes or nanotech-buckyballs, RBC (red blood cells) or something else.

Another customary study is to find out if the formulation requires a therapeutic platform for delivery.

Needless to say, huge number of experiments get done to arrive at the ‘best’ carrier for drug delivery. Obviously, this involves huge R&D cost and time which can be saved by digitalization in product development.

Moreover, data visualization helps researchers to identify the product with best profile. Both in vitro and in vivo data can be visualized. Researchers can skip pilot BE studies if a product shows superimposable data graphics with RLD (reference listed drug). Imagine the costs saved!

Additionally, quantum computing also immensely helps product development via 505 (b) (2) pathway.

Hence, I would say if a company aims to develop products via 505 (b)(2) pathway then digitalization is the way to go. For such companies, digitalization shall save millions of dollars of R&D budget and in addition provides first-mover advantage.

​Digitalization makes clinical research more efficient. Even though electronic data records are standard since long and digital regulatory submissions are being accepted for over two decades, clinical development still has significant untapped efficiency reserves. Discovery and clinical trials making up the largest share of costs to get a drug to commercialization, efficacy gains in these areas therefore have a direct measurable impact not only with time to market but also in real savings.

AI has many potential applications in clinical trials both near- and long-term. These range from automating routine study data entry functions, to analyzing electronic health record data to find suitable candidates & clinical trial sites, to monitoring and encouraging patient compliance with study protocols, to adaptive dose finding, to discovering and modelling potential new molecules and therapies. 

Big Data and real-world data (RWD) are becoming increasingly prevalent as digital devices become more adept at capturing myriad signals from patients in a variety of settings.

For example, combining historical information from EHRs (electronic data records) with imaging, genetic and molecular test data is driving the development of highly targeted oncology treatments, such as CAR-T and other cell therapies, giving hope to patients resistant to more conventional treatment approaches .
 
If Big Data is the raw material of digital transformation, then AI is the engine that sponsors rely on.

AI powered capabilities viz pattern recognition, evolutionary modelling etc. are essential to gather, normalize, analyze and harness large data sets that are fundamental to modern therapeutic development. Also, these models are especially useful for conducting smaller studies that are gaining importance in targeted smaller patient populations.

Additionally, applying advanced statistical models to the new data also improves pharma R&D productivity.

One of the main hurdles in clinical operations is the disconnect between clinical development plans and clinical trial protocols. In other words, between strategy and the operations.

Digitalization defines the ideal trial avatar and guides researchers on patient-centric clinical development,  feasibility of the study to help them better plan the duration of recruitment and trial length, collaborate with patients in the research process, ease patient access, reduce the burden of trial participation and transform patientcare during clinical trials.

Such gained efficiencies, optimize time and cost, expedite patient enrolments, improve retention & increase study diversity, improve investigator productivity, reduce manual effort on repetitive tasks and transform patientcare during a clinical trial by paper-less tracking.

A published case study (Reference- https://www2.deloitte.com/us/en/blog/health-care-blog/2018/how-a-digital-rd-strategy-can-improve-clinical-trial-innovation-and-execution.html) indicated how digital transformation of a standard neurological test reduced clinician burden- in neurological assessment, a commonly used symbol-digit modalities test asks a participant to match basic numerals to geometric shapes according to a reference key. The lower the number of correct connections within the allotted time, the higher the level of cognitive impairment. A biopharma company made this test available to patients on an iPad at the point of care and fed test results directly into the patient’s EHRs. This eliminated the need for clinicians to spend time on conducting the test and entering data and also enabled more standardized test administration.
 
From understanding disease onset and progression to identifying early safety signals or food and drug interactions to engaging with patients for clinical trial participation and awareness to virtual augmented reality to conduct virtual clinical trials, digitalization enables researchers to better predict the properties of a material, the performance of an active molecule and/ or its toxicological effect.
 
In addition, digitalization improves efficiency of post-marketing pharmacovigilance and patient safety.
 
In fact, from now on in the coming decade, adopting digital technology at scale viz patient reported outcomes captured using mobile devices, digital assistants and voice recognition to virtual augmented reality (AR) to conduct virtual clinical trials and digital biomarkers as primary endpoints might just be the norm!

Digitalization will be a necessity in pharma R&Ds in years to come regardless of whether it is an innovator company or a generic player. The extent and magnitude of digitalization needed of course shall be different for the two.

Pharma, medical device R&D digitalization surely involves a huge cost. But it is the need of business to stay relevant and stay competitive. Hence companies must strategically plan its digitalization journey. One of the critical aspects of R&D digitalization is selecting the right digitalization platform.

Coming up in next part of this series- Selecting the right R&D digitalization platform!

​Meanwhile, note that there are fifteen different Continuous Improvement pathways for pharmaceutical and medical device R&Ds. Are you planning a Continuous Improvement initiative for your R&D division?

​Part 6:  Selecting the right R&D digitalization platform.
Part 7:  Six building blocks for digital transformation in pharmaceutical and medical devices R&Ds.
Part 8:  How to transform existing R&D setup to a digitalized R&D.
Part 9:  Tips and Quick wins of digitalization in pharmaceutical and medical device R&D.

​Biopharmaceutical R&D involves a series of high-risk and high-investment decisions. In addition, the industry faces considerable productivity challenge in terms of identifying, testing, and bringing new drugs to market, especially in the context of the highly innovative therapies we seek today.

In previous parts of this series, I discussed Introduction to digitalization in pharma and medical device R&D (Part 1), the need for digitalization (Part 2) and how to go for digitalization in pharma and medical device R&D (Part 3).
​
In this blogpost, I shall highlight some of the salient advantages of digitalization in pharma and medical device R&Ds.

​Digital transformation via digitization and digitalization in R&D allows researchers to automate time-consuming manual processes and open new exploration skylines in prickly issues that have failed to evoke breakthroughs.

Artificial intelligence (AI), advanced analytics and automation are changing ways of working in scientific research. The umbrella category of AI and advanced analytics of digital technology has the maximum potential to improve R&D productivity.

Close behind are identification of biomarkers, use of EHRs (Electronic Health Records) and Clinical Registries.

A significant advantage of digitalization in drug development is creation of targeting biomarkers as the therapeutic approach, followed closely by gene therapies and customized therapies targeting specific disease stages & comorbidities.

Digitalization opens pharma R&D horizons in areas such as genomics which further leads to breakthroughs in precision medicine. It also creates opportunities for decentralized clinical trials, unleashing future innovation in digi-ceuticals and healthcare wearables.

In the allied chemicals sector too, R&D digitalization facilitates designing and modeling new materials and composites. Digitalized chemical innovation is the foundation for everyday products from smartphones and fiberoptic network cables to autonomous vehicles. Digitalization enables researchers to better predict the properties of a material, the performance of an active molecule or its toxicological effect.

As quantum computing- an element of digitalization, allows deeper molecular modeling, medical device research and development specialists expect quantum computing to open new material prospects in specialties such as batteries, semiconductors, superconductors, composites and opto-electronic gadgets.

Further, quantum computing-based molecular modelling helps researchers to identify the most effective molecular designs or structures before having to synthesize molecules in laboratory settings. AI helps glean the best compound in the early stage, so researchers can skip over the very long discovery processes. For example- using AI to select or optimize the antibodies and evaluate efficacy or toxicity in the preclinical stage.

Digitalization explores the space of interest for discovery, guides researchers to do more focused experiments and generate data to refine the experimentation process further.

As therapies are designed as targeted dosage forms, the efforts to identify those patients who may benefit most from a drug takes considerable amount of time and effort. Digitalization helps these efforts by leveraging digital technology to help find the right people set for the right trials.

For example- AI improves patient-trial matching by crunching large datasets like electronic health records, genomic data, medical literature, trial databases, inadequate enrollment of patients in trials—too small a sample, too high a drop-off rate, or suboptimal cohort selection. Failing to exclude individuals using another medicine that could interfere with the tested one—is a major cause of trial failure.

Once underway, advanced analytics can enable adaptive clinical trials, where researchers modify a live trial, such as by refining the sample size, changing the allocation of patients to ‘control’ versus ‘trial’ arms, and stopping a trial early based on likely success or failure.

A significant value driver within clinical R&D is reinventing how companies engage physicians, patients, and investigators at a granular level. Through digitalization, the medical affairs teams can understand the requirements of individual physicians (as well as other stakeholders) and to deliver precise information on-demand.

Lowering the costs of trials and improving experimental data are worthy ends in themselves, but companies can also use digital technology to identify new lines of therapy.

For instance, in health care, the quality of data available to researchers helps in the development of therapeutic areas like immunotherapy, which alters the human immune system to better fight diseases like cancer. This is a far cry from current therapies like radiotherapy and chemotherapy which bring debilitating side effects and are often palliative rather than curative. Digital technologies like wearables, implants, and digestible can show how a therapy is working in richer detail via digital biomarkers.

An overarching benefit of digitalization in pharma R&D is improving the quality of new products before they enter the experiment and clinical trial process. Digital innovation can improve the quality of experiments from optimizing design and protocols to generating better data about the drug candidate’s effectiveness.

Big data and AI enabled modelling processes allow researchers to move from static processes to more fluid and adaptable working procedures for drug discovery and R&D pipeline portfolio management.

Moreover, analytics, simulation, prediction, and modeling show researchers more about how an innovation might fare in the real world. This eliminates drug candidates that might once have incurred costs in a failed pilot or pivotal trial due to shortcomings that researchers were unable to spot in an earlier phase.

Further, in a digitalized formulation R&D, with super imposable information from recipe builder on bio-chemical properties of active(s) and additives, enforced patent and regulatory data, with a click of a mouse key, formulators can checkout series of formulation suggestions. These formulation suggestions can be further evaluated by digital experimentation.
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On an average, post digitalization in drug development, the time from drug discovery thru product commercialization can be decreased by as much as 6 years! 

​A Japanese pharma company (Reference- https://www.bbc.com/news/technology-51315462) put a new drug molecule invented entirely by artificial intelligence into human clinical trials. This new compound is designed to help patients with obsessive-compulsive disorder (OCD). It reached human clinical trials in just 12 months – now, compare that with the four to six years that it traditionally takes for drug candidates to reach that stage! Cool, isn’t it?
​
In the next part of this series, I shall elaborate on- Digitalization in various phases of drug research and development.

​Meanwhile, note that there are fifteen different Continuous Improvement pathways for pharmaceutical and medical device R&Ds. Are you planning a Continuous Improvement initiative for your R&D division?

​Part 5:  Digitalization in various phases of drug research and development.
Part 6:  Selecting the right R&D digitalization platform.
Part 7:  Six building blocks for digital transformation in pharmaceutical and medical device R&Ds.
Part 8:  How to transform existing R&D setup to a digitalized R&D.
Part 9:  Tips and Quick wins of digitalization in pharmaceutical and medical device R&D.

​Keywords and Tags:

#businessprocessimprovement #continuousimprovement #digitalization #digitization #digitaltransformation #digitaltransformationinR&D  #digitalizationinR&D #continuousimprovementinR&D #advantagesofdigitalization

As per media reports, the company also has had recent issues with debris in its other products i.e. 787 Dreamliners and KC-46A military refueling tankers, which led to two suspensions of deliveries of KC-46As to the US air force.

Foreign object debris, an industrial term for rags, tools, metal shavings and other materials left behind by workers during the assembly line aircraft production process, can raise the risk of electrical short-circuiting and fires.

This typically results from poor employee training coupled with near non-existent in-process quality control systems!

A culture of Kaizen helps bigtime in such cases. Kaizen-based installation of quality systems are extremely effective for all types of workplaces be it- production, assembly-line or service functions. Moreover, combining Kaizen with mistake-proofing tools such as Poka Yoke, the product’s quality as well as safety are further augmented.

To learn more about how Shruti can help your organization achieve new heights or to book a Workshop, Contact Dr. Shruti Bhat via Form or WhatsApp

Follow Shruti on Twitter, Facebook, YouTube, LinkedIn
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Keywords and Tags:
​#Boeing  #737max #kaizen #mistakeproofing

Part 1 of this blog post asked two questions-

1. Are you choosing your doctor correctly?
2. Are you choosing your prescription/ OTC medicines correctly? 

In order to take an informed decision, one needs to obtain background information about your potential doctor, clinic, hospital, medicine (and pharmaceutical company that makes them).

Here are few quick tips -

1. Check if the doctor's degrees are authentic: With so many cases of degrees being forged and quacks running the hospital show, one needs to be sure, that the doctor who would potentially treat you is at least the medical expert he/she claims. An easy way is to check with medical colleges, city medical registry etc.

2. Surf internet about the doctor, clinic, hospital. Much information will be available (of course you need to screen wisely). Patients, caretakers, relatives post their experiences for the benefit of others. Try to source maximum information (in public domain) that will help you to decide.

3. Get a detailed quote about doctor’s fees, surgical procedures involved, time taken, hospital stay, approximate cost of medicines etc. Compare quotes and if there are major discrepancies, investigate deeper. 

4. In cases where a clinic or hospital expect patients to consume medicines and/or medical devices provided by the healthcare facility (and not buy from an outside pharmacy), doubly ensure authenticity of such medicines/ devices. It might seem gory but I’m aware of incidences where, stents picked up from the ashes of cremated angioplasty patients have been re-used by hospitals! Unbelievable and horrifying isn’t it? 

5. Take a second opinion about the diagnosis before embarking on the therapy. And severe the ailment, more important it is to take an independent second or third opinion regarding diagnosis and prescribed line of therapy, medicines to be taken. (I do understand this costs money. But then it’s better be safe than sorry). I’m aware of cases where patients were diagnosed with breast cancer and underwent surgery for breast removal. After several years they got to know that their diagnosis was wrong. It had happened because of a medical error by the radiologist.  

6. Before buying the prescribed drug products check if this medicine needs to be taken for life time. For example, blood pressure, diabetes medicines are to be taken lifelong. Check immediate and long-term side effects of drugs.

Importance reference points are- 

Physician’s drug reference (PDR) available in your library or online.

US FDA –Adverse events reporting website 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/

Independent free internet sites:  

http://www.rxlist.com/script/main/hp.asp  ; 

http://www.drugs.com/   ;   

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm196029.htm ;

http://www.medbroadcast.com/drug_info.asp

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php

http://www.nlm.nih.gov/medlineplus/druginformation.html

http://www.cancerresearchuk.org/about-cancer/cancers-in-general/treatment/cancer-drugs/side-effects/

http://www.cancer.org/treatment/treatmentsandsideeffects/treatmenttypes/targetedtherapy/targeted-therapy-side-effects

Please note I am not associated with any of the above-mentioned internet sites, so I cannot vouch for them. It is therefore recommended to do good due-diligence before accepting information provided online by any website. 

Also, check if there are any reported interactions of the prescribed drugs with other drugs or food that you might be taking. For example, patients taking anti-malarial drugs such as Choloroquine, must abstain from taking tea and coffee (for the time they are on the medicine) to prevent eye damage.

7. Check who is the innovator company for this drug. Also, check which other companies are making and selling this drug in your country. Do price comparisons. 

The innovator company as the name implies, is the one who invented this drug and introduced in the market for the first time. Other companies sell generic versions of the drug. Both innovator and generic medicines are supposed to be equally safe and effective (scientifically termed Bio equivalent or therapeutically equivalent) in patients. Whether to buy a drug product from an innovator or a generic is left to the patient’s discretion.

8.  Check about the pharmaceutical company that manufactures and sells your medicine. 
Some companies don’t manufacture drug products they sell. These companies have them contract manufactured at other places. The rules surrounding contract manufacturing and labeling vary in different countries. In certain cases, this information is printed on the product label as “Manufactured by (name of the company) and marketed by (name of the company)”. In any event, this information is available for public reference at every country’s local FDA office. 

Do an internet surf and check published reports, reviews about the company. An important point to note is whether the company has received 483 notices (i.e. notice of non-compliance to prescribed regulations) from FDA. This link gives free information about USFDA inspection reports, observations and 483 notices to pharmaceuticals, medical devices and food companies http://www.fda.gov/ICECI/Inspections/ucm250720.htm#

Check if at any point of time the company was de-barred from importing/ exporting into your country. Also, check what steps did the company take to amend the matter before their marketing permission got re-approved. 

9. Check with your pharmacy if they have received complaints about the product from other customers. 

10. Check if the medicine has been dis-approved or discontinued in any country, yet available and prescribed in your country.

My experience is that, good doctors usually appreciate when a patient takes interest in his/her well-being. Patient’s motivation certainly gives a big boost to a doctor’s therapy.

Good doctors are happy to see their patient’s cured. So please discuss your drug research findings with them. Help them to help (treat) you. Your updates will also help other patients (with similar ailment). 

Hope this information benefits you and your loved ones. I’ll sign-off on this note-

Yes, YOU as the patient have a right to choose both your doctor and the medicines you take.
Don’t be a meek patient and accept whatever is handed out to you. Be vigilant and decisive.  
Get well soon… stay healthy and happy.



Disclaimer- In addition to terms and conditions, readers are advised to please note that, the information contained in this article is NOT a substitute for medical advice. It is intended to empower general public to understand the pharmaceutical world and consider ideas and alternatives while discussing their specific health scenario with medical and pharmaceutical professionals. Please discuss your specific scenario with a qualified Medical Doctor and ONLY follow health advice given by a qualified medical professional. Also, please note that each country has its own health care related regulation(s), readers are therefore expected to over-ride any information presented here to adhere to rules of their land.

#Healthcare  #DontSuccumbToMedicalFrauds 

For past few days, I’ve been blasted with news articles dropping in my email inbox, about allegedly corrupt medical practices affecting patient’s health and finances. Some of the articles were indeed interesting reads. With a disclaimer of not being sure about the authenticity of their content, I share them here for your quick review-

Big Pharma is America’s new mafia- 
http://www.thedailybeast.com/articles/2015/02/21/big-pharma-is-america-s-new-mafia.html

How pharma is taking you for a ride?
http://dissidentvoice.org/2015/02/how-pharma-is-taking-you-for-a-ride/

The drug that is bankrupting America-
http://www.huffingtonpost.com/jeffrey-sachs/the-drug-that-is-bankrupt_b_6692340.html

Why are so many toddlers taking Psychiatric drugs ?
http://blogs.wsj.com/experts/2015/02/19/why-are-so-many-toddlers-taking-psychiatric-drugs/

These articles describe Pharmaceutical industry’s influence on doctor’s prescribing habits; fraud’s in clinical drug trials; falsified data published in prestigious medical journals and submitted to FDA etc. Worse still the published data doesn’t get corrected after true facts are known; nobody ever finds out which data is bogus, which experiments are/were tainted and which drugs might be on the market under false pretenses.

Over the years, many prescription drugs have been recalled after serious side effects and even deaths were reported in patient population who consumed those drugs. 

This is deeply troubling !

Patients go to the doctor with a hope that they would get the best of medical advice they deserve and be cured of their ailments. Instead they get conned, duped, misguided. I’m sure this is not the case with all patients or all doctors, but still, my question is- Why should a medical doctor misguide patients or prescribe unnecessary medicines to patients?

This is absolutely unacceptable !

But there is little an individual patient can do to change this alleged doctor- fraud hoopla, especially at the time he/she are ailing. At that time their first concern is to get well. I do realize that if a person ails, they need doctors and medicines, but gone are the days when you could trust your doctors, hospitals and medical care advisors to decide for you. The practical scene today is, YOU 'alone' are responsible for your life and health.

That said, I’ve two quick questions-

1. Are you choosing your doctor correctly?
2. Are you choosing your prescription/ OTC medicines correctly? 

Think about it- When you're job hunting, you research about the company (or potential employer). When companies hire employees, they do a thorough background check. So, when you choose a doctor, should you not do a background check of your doctor (along with clinic, hospital, drugs and the company that makes them)?

Most certainly the answer is affirmative !

To be continued in Part 2 …

Part 2 describes few ways, one can find background information about a doctor, clinic, hospital, medicines and pharmaceutical company that make them.


​
Disclaimer- In addition to Terms and Conditions of this website, readers are advised to please note that, the information contained in this article is NOT a substitute for medical advice. It is intended to empower general public to understand the pharmaceutical world and consider ideas and alternatives while discussing their specific health scenario with medical and pharmaceutical professionals. Please discuss your specific scenario with a qualified Medical Doctor and ONLY follow health advice given by a qualified medical professional. Also, please note that each country has its own health care related regulation(s), readers are therefore expected to over-ride any information presented here to adhere to rules of their land.

​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

#Healthcare #Dontsuccumbtomedicalfrauds

Reports have been rising consistently about seizure of counterfeit packaged products- more so for pharmaceuticals and cosmetic products. Few probable reasons for pharma/ cosmetic products being soft targets could be- ease of counterfeiting, very high profits / gains to the counterfeiters, relaxed laws world-wide dealing with this issue.

My thoughts on anti-counterfeit measures on pharma products were re-produced by Express Pharma in their August 2013 issue. Picture and link provided for details http://pharma.financialexpress.com/specials/pharma-technology-review/2531-pro-tech-ting-the-brand

While, the crime seems to continue, it's encouraging to note that counterfeiting of medicines has been recognized as very grim. 29 pharmaceutical majors globally have come together with Interpol to devise ways for checking such crimes from happening and/ or catch the counterfeiters and penalize them appropriately under the frame work of law.

​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

​#ContinuousImprovement   #Innovation

Innovation Forum :  Heard of Pacemaker hacks? It's true... implanted pacemakers are being used to transmit data digitally...so now, your heartbeat is the password !
 
Read NBC news link -

http://www.nbcnews.com/technology/your-heartbeat-password-medical-implants-could-get-new-security-feature-4B11181764