Shruti Bhat PhD, MBA, Operations Excellence Expert
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R&D Leadership:

R&D leadership involves two key aspects. Firstly, providing able leadership to R&D divisions and secondly, creating products that become market leaders. I was fortunate to have on the ground experience with both of these aspects.

Here, I share some of my real- world applications, insights and thoughts about how to effectively lead R&Ds to get the maximum productivity and ROI. In addition, create exceptional products and services that would capture market share and become ace brands.
​​To know more about how R&D leadership can help your company expand its product offerings, increase profit and earnings per share for investors, checkout my thoughts and insights below.
​
Here you will find articles on Design Thinking, product development methodologies such as DFSS, TRIZ, QbD etc., Experimental designs, building R&D capabilities, Research management, R&D leadership, Continuous improvement for R&Ds etc. 

Popular Articles on ​Research Management and R&D Leadership:​

From Chaos to Control: How One Manufacturer Centralized Its Patent Workflow and Cut Filing Time by 58%

Most companies protect ideas the way they invented them: haphazardly. But when innovation is treated like a product line — measured, structured, and refined — patent chaos becomes a competitive advantage. Read More

Top Strategies to Improve Operational Excellence in the Patenting Process for Faster and Smarter IP Management

Is your patenting process slow, expensive, or inconsistent?
Operational excellence isn't just for manufacturing — it is critical for IP too. Read More

​Kaizen for CDMOs & CROs: How Continuous Improvement Drives Operational Excellence in Pharma and Biotech

​Is your CDMO or CRO stuck in a cycle of inefficiency, delays, and rising costs? Here's how Kaizen can help you break through. Read More

Enhancing R&D Efficiency in Biotech with TQM

Struggling with delays and high costs in R&D? This case study details how a biotech company transformed inefficiencies into streamlined success using TQM principles. By integrating development, quality planning, fostering cross-departmental collaboration... Read More

Continuous Improvement for Pharmaceutical R&D

ROI from pharmaceutical R&D investment is steadily dropping over the past decade. This data needs a serious investigation into- How to  increase the ROI? Read More

Top 10 Proven Strategies to Enhance Operational Excellence in R&D

Are you struggling to balance creativity and efficiency in your R&D operations? Achieving operational excellence in R&D isn't just about innovation—it's about optimizing processes, reducing costs, and accelerating time-to-market. Read More

R&D Productivity Improvement Plan Checklist

The R&D Productivity Improvement Plan Checklist is a strategic framework to enhance research and development efficiency, aligning innovation with business goals. It covers key areas like strategy alignment, market intelligence, process optimization... Read More

What is Scrum? Scrum, a dependable R&D productivity improvement tool.

Today, R&D's productivity in addition to research skills, is based on the process efficiency of the R&D department. Read More

Driving Operational Excellence in Pharma R&D: Strategic Levers for Faster Drug Development

​80% of delays in drug development are operational, not scientific. That’s where operational excellence becomes a game-changer... Read More

How a Pharma R&D team used Lean Agile principles to accelerate product development and reduce errors.

Can Agile work in Pharma R&D? This company slashed development timelines by 20%—here’s how! Read More

Boosting Employee Productivity in SMEs Through Continuous Improvement Workshops

Do you want to SKYROCKET employee productivity in your business? Most small and mid-sized enterprises (SMEs) struggle with productivity bottlenecks ...
Read More

Continuous Improvement for Drug Industry: Part 1: Introduction to Digitalization in Pharmaceutical and Medical Device R&D.

There are 15 different continuous improvement pathways for pharmaceutical and medical device R&Ds; I shall discuss one such pathway- Digital transformation in Pharmaceutical and Medical Device R&Ds. Read More

​New Age Product Development to Reduce Supply Chain Costs

Reducing procurement, supply chain logistics is an omnipresent to-do issue for business leaders, pandemic or otherwise, but more so in today’s Read More

Launching and growing a start-up R&D unit- A case study

A SE Asian bio-pharma company that sold white labeled products wanted to start indigenous research facility. They also wanted to improve product quality and logistics as most of their products had customer complaints. Read More

Kaizen For Cost Reduction - A Continuous Improvement Case Study

​Learn how to use Kaizen to manage intellectual property and reduce patent filing costs by 20% or more. Read More

Organoids As Models of the Human Brain

The successful transplantation of human brain cells into a rodent's brain has made it possible for scientists to study the complex brain circuits and psychiatric disorders. Read More

​Kaizen For Innovation Management & Productivity Improvement Of A Hospital In France: A Healthcare Continuous Improvement Case Study

​Healthcare is a service-based industry sector. Unlike other industries, healthcare has a lot of human angle to it, since it deals with patients Read More

Business Turnaround and Innovation Management in a Global Contract Research Organization- A Case Study

A Global Contract Research Organization (CRO) was sick and on the verge of being sold out. The management wanted to give a final shot for its revival prior to potential sell off. Read More

Innovation Management, Just-in-time and Kaizen Case Study in a Multi-National Pharmaceutical Company Working on ANDA Para III and IV Drug Products

An multi-national pharmaceutical company had an ambitious goal of new product introductions Read More

How to identify 505 (b)(2) drug product development opportunities- An Innovation Management Case Study

A Global Pharmaceutical Contract Research Organization (CRO) wanted to start a new division that could develop products via the 505 (b)(2) pathway. Read More

Developing ANDA Para II and III Drug Products via QbD (Quality by Design) : Innovation Management Case Study

A multi-national bio-pharma company wanted to develop Three new products via QbD methodology for US (ANDA para II and III) and Canada markets. Read More

8 Steps to Becoming a Customer- Centric Organization.

Customer-centric approach comprises of sequential and collaborative efforts at understanding the voice of the customer (VoC). Read More

​9 Key areas for businesses to bring new products fast to market.

First-mover advantage is the ultimate aim behind any new product development. Unlike popular belief, new product development is Read More

Nanotechnology – A drug delivery promise for scar-less wound healing.

Nanotechnology represents an ‘Innovative direction’. It’s not the future as it’s already present in the pharmaceuticals, natural products realm and it’s expected to grow with time. Read More

Role of Benchmarking in Business Process Improvement/ Business Process Redesign

Benchmarking is a business term that defines the comparison of a business against others in terms of understanding where the business stands Read More

​3D Printed drones for distribution- supply chain logistics process improvement.

3D Printing is revolutionizing distribution and supply chain logistics processes. Besides saving zillions of dollars, Read More

New avenues available for smoking cessation: E cigarettes  !

Currently there are several options available for people interested in smoking cessation- tablets, capsules, patches, mouth dissolve films, chewing gums Read More

FDA Approves First-Ever Human Test Of Embryonic Stem Cell-Based Therapy.

The USFDA has approved "the world's first authorized test in people of a therapy derived from human embryonic stem cells. Read More

FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients.

The Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD). Read More  

FDA Approves Novel Asthma Treatment.

USFDA recently approved the "first non-drug asthma treatment- Alair." According to the developer the procedure known as "bronchial thermoplasty" ​Read More

​What is the Future of medicine ? What are the lessons from 60 years of pharmaceutical innovation?

If the NME (New Molecular Entity) output is constant, the only way to grow Read More

How to transform businesses via portfolio management- Part 1

Product mix or product portfolio is one of the important parameters impacting successful business transformation. ​Read More

 How to transform businesses via portfolio management - Part 2

Portfolio project management technique plays the role of a gear in the overall portfolio management. Its function starts right from identifying new products for the portfolio, thru Read More​

How to transform businesses via portfolio management- Part 3

 Broadly, new product development can happen via three development pathways namely Read More

​How to transform businesses via portfolio management- Part 4

The fourth important parameter of building a profitable portfolio is introspecting and assessing your marketing and sales process(es) efficiency and effectiveness. Read More

Gefapixant can become a 'game changer' in treating people with persistent cough, reveals study

A new drug Gefapixant 45 mg twice per day is the first treatment to show efficacy with an acceptable safety profile in phase 3 clinical trials for refractory chronic cough ​Read More

​Healthcare process efficiency improvement with blood bank robot

This fully automated system can take over manual tasks such as sorting by blood Read More

Design Thinking for Service Industries

Design Thinking and rapid prototyping is not just for the Manufacturing industries … Service industries also stand to benefit from it. Here’s how Read More

Research and development in the 21st century: Web-enabled innovation comes of age.

High-tech organizations that live and die by new product development have exploited the Web to speed communications and share information. Read More

New Zealand: Prior Art Searching: The Importance Of Due Diligence In R&D Processes

Time and costs spent searching existing scientific publications and patent registers can avoid costly mistakes when acquiring or licensing technology from a third party or before undertaking Read More

​Big pharma kisses its blockbuster years goodbye

Industry giants are facing major new challenges as patents run out on many of the drugs that have kept them in clover.  ​Read More

Is ‘hybrid model ' a good long-term strategy for drug-makers?

Innovator drug companies have been actively wooing generic drug-makers, to have a foot in the innovative and generic segments of the pharmaceutical landscape. ​Read More

Mexican Supreme Court Decides on Broad Interpretation of Linkage Regulations.

Mexico enacted linkage regulations to avoid the granting of marketing authorizations in violation of patent rights. The system created by these regulations is far less elaborate than Read More

Federal court of appeals upholds data protection laws...

The Federal Court of Appeal dismissed the appeals brought by Apotex Inc. and the Canadian Generic Pharma Association challenging the validity of the Data Protection Regulations Read More

Life cycle management and Intellectual property management for pharmaceutical generics.

Brand Teams Protect Their Products With an Average of Five Distinct Strategies, According to Cutting Edge Information Read More

​China clarifies patent law rules...

New legislation was promulgated recently following the recent revision of the PRC Patent Law ("New Patent Law"). "Matching rules" will affect the initiative of patent Read More

Importance of prior art search in product development - A Case study

Time and costs spent searching existing scientific publications and patent registers can avoid costly mistakes when acquiring or licensing technology Read More

Kaizen For Innovation And Product Development: A Continuous Improvement Case Study

​In this case study, Kaizen-ing helped in improving eyedrop dropper design and its process of making. Read More

 Launching and growing a start-up R&D unit- A case study

A SE Asian bio-pharma company that sold white labeled products wanted to start indigenous research facility. They also wanted to improve Read More

​What are stem cells and what do they do?

Stem cells are cells that are found in many different places in the human body. They can be found in the bone marrow Read More

Pharmaceutical patent cliff ...

In today’s global economy, there is an increasing convergence of intellectual property and finance. Wall Street is grappling with how, exactly, to recognize the true value of a firm’s intellectual property, Read More

Top 15 drug patent losses for 2013

Pharmaceutical researcher Evaluate Pharma estimates there are $290 billion of sales at risk from patent  expirations between this year and 2018. Read More

Mistake-Proofing Pharmaceutical Product Development, Manufacturing and Logistics, Cost Savings via Poka Yoke ​

Do you have any of the following complaints such as - R&D is slow, doesn’t give ... Read More

Modernize regulatory information management to improve operational excellence in life science organizations

One of the many ways to improve operational excellence in life science organizations is ...
Read More

Stem Cell Research and Manufacturing Challenges

As the field of stem cell research and manufacturing continues to evolve, challenges remain. These include unregulated processes, scaling up production, epigenetic analysis etc. ​Read More
valsartan losartan irbesartan product recalls- what are the lessons for pharmaceutical industry? dr shruti bhat

Valsartan, Irbesartan, Losartan Product Recalls- What are the Lessons for Pharmaceutical Industry?​

Since September last year, news of *SARTAN drug recalls are doing the rounds Read More
nanotechnology in mucosal drug delivery systems by dr shruti bhat

​Nanotechnology in Mucosal Drug Delivery Systems

​A new generation of drug delivery systems is being created as a result of the ability to design nano particles and their matrixes. Nano particles are very small molecules Read More
Innovative Strategies and models for r and D success by dr shruti bhat

​Innovative Strategies and Models for R&D Success.

​Over the last quarter of the twentieth century, medical research made substantial advances in defining our understanding of diseases, their etiologies, and the biochemical pathways through which they were mediated. Read More
lean innovation, hoshin kanrii and six sigma for product design, development and manufacture via 3D printing

​Lean Innovation, Hoshin Kanrii and Six Sigma (as DFSS) for Product Design, Development and Manufacture via 3D Printing; a Case Study

Lean Innovation, Hoshin Kanrii and Six Sigma (DFSS- design for six sigma) for product design, development Read More​
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USFDA Unveils Two Draft Guidelines For Generic Development Of Transdermal And Topical Dosage Forms

​The United States Food and Drug Administration (USFDA) today 9th October 2018, Read More
intranasal administration route for protein and peptide mucosal delivery by dr shruti bhat

Intranasal administration route for protein & peptide mucosal delivery. ​

Due to its unique physiology and ready accessibility, the nasal cavity is an attractive delivery site for the systemic administration of therapeutics. The nasal membrane or mucosa Read More ​
carriers used in drug targeting by dr shruti bhat

Carriers used in Drug Targeting- ​

Niosomes non-ionic surfactant vesicles are similar to liposomes and can be prepared with cholesterol, a surfactant such as polysorbates (tweens) or sorbitanesters of fatty acids (spans) and water. Read More ​
continuous i,provement in cancer therapy and healthcare system services

Continuous Improvement in Cancer Therapy & Healthcare System Services ​

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. ​Read More
buccal delivery of peptides- I by dr shruti bhat

BUCCAL DELIVERY OF PEPTIDES- I ​

The presence of a smooth and relatively immobile surface for placement of a bioadhesive dosage form, the buccal region appears to be more suitable Read more
use of nanotechnology as therapeutic platforms for disease management by dr shruti bhat

​Advances in pharmaceutical research- use of nanotechnology as therapeutic platforms for disease management.

New nanoparticles deliver bigger drug payload. Read More 
Pulmonary Route For Mucosal drug Delivery- 1 by dr shruti bhat

Pulmonary route for mucosal drug delivery- I ​

​Choosing the lungs to deliver drugs beyond airways is not new. Nicotine and other anesthetics have been delivered to the blood stream this way for many years. Read More 
pulmonary route for mucosal drug delivery by dr shruti bhat

​Pulmonary route for mucosal drug delivery- II

​Dry powder inhalers (DPIs) are breath-actuated devices, by virtue of the fact that the kinetic energy imparted to the drug comes from the patient inhaling Read More
medical robots market is expected to reach usd 11.4 billion by 2020 at ACRG 22.2%, dr shruti bhat

Medical robots market is expected to reach USD 11.4 Billion by 2020 at CARG of 22.2% ​

​Medical robots, an emerging field in healthcare is causing a paradigm shift in healthcare as it improves Read More
usfda approves first-ever test of embroynic stem cell based therapy by dr shruti bhat

FDA Approves First-Ever Human Test Of Embryonic Stem Cell-Based Therapy.

The USFDA has approved "the world's first authorized test in people of a therapy... Read More​
Novel oral controlled release drug delivery systems by dr shruti bhat

​Novel Oral Controlled Drug Delivery Systems

Technology in the field of controlled delivery has gone forward at a rapidly accelerating pace and promises many new and exciting developments. Read More
Mucosal drug delivery systems- formulation considerations- 1 by dr shruti bhat

Mucosal Drug Delivery Systems- Part 1: Formulation Considerations ​

​Mucoadhesive drug delivery systems utilize the property of bioadhesion.. Read More
mucosal drug delivery systems formulation considerations-2 by dr shruti bhat

Formulation considerations in mucosal drug delivery-II ​

The rational approach for developing innovative polypeptide delivery system must therefore initially address two basic questions Read More
mucosal drug delivery systems formulation considerations- 3 by dr shruti bhat

​Formulation Considerations In Mucosal Drug Delivery Systems - III

Several test methods have been reported for studying mucoadhesives. These tests are necessary not only to screen a large number of candidate mucoadhesives Read More
mucosal drug delivery systems formulation considerations - 4 by dr shruti bhat

Formulation considerations in mucosal drug delivery- IV​

​To ensure efficacy and safety of a drug product, the active compound and its degraded product(s) must be quantified to determine the expiry period Read More
Controlled release dosage forms by dr shruti bhat

​Controlled Release Drug Delivery Systems.

​The deployment of drugs within the body is becoming more precise with the advent of rate-controlled dosage forms Read More
Analytical Considerations of Mucosal Drug Delivery Systems by dr shruti bhat

​Analytical considerations of mucosal drug delivery systems

As is the case with classical chemical substances, drug and diagnostic products ​Read More
mistake proofing pharmaceutical products- what can we learn from valsartan, losartan, irbesartan recalls

Mistake-Proofing Pharmaceutical Products: What can we learn from Valsartan, Losartan and Irbesartan recalls? ​

First Valsartan, now Irbesartan formulations are going thru a recall. Read More
gambia cough syrup tragedy_ how can we stop such catastrophe

Gambia cough syrup tragedy: How can we stop such catastrophe?

Dozens of child deaths have been reported recently in African country The Gambia. The deaths are allegedly linked to cough syrups ... Read More
how to boost manufacturing capability in life science organizations

How to Boost Manufacturing Capability in Life Sciences Organizations

One of the biggest challenges facing life sciences organizations today is the need to scale their operations... Read More

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