Regardless of your role in the organization, there are a number of challenges that you must overcome in order to lead a successful biopharma startup. These challenges include finding the right people and fostering a company culture.

In this post I'll cover how to find the right team, manage execution, and track performance. So let's get started...
 
Finding the right team
 
One of the biggest challenges facing a new biopharma startup is finding the best team. It can be difficult to attract top talent, especially when you're a small startup without a proven track record. To attract top talent, you must offer competitive compensation. Smaller startups often struggle to offer competitive compensation, while larger organizations are often more willing to offer generous benefits packages and equity compensation.
 
While leading a biotech startup is a challenging role, there are some factors that can help you overcome these challenges and build a strong company culture. First of all, it's important to recognize that the corporate culture will affect the work being done. While companies will always have a culture, it's important to intentionally build a positive and productive one. Developing a positive culture means identifying your strengths and leveraging them to make decisions based on core values and knowledge.
 
Your co-founders are an important part of your team. In addition to bringing in valuable experience, it is important to share a vision for the company and identify the core values of each team member. These values could include business acumen, healthcare experience, and technical skills. Using networking platforms to recruit co-founders is a great way to find a team that shares your vision.
 
Creating a team with the right skills is an essential part of a biotech company's success. While the biotech industry is experiencing an incredible time, finding the right talent to translate these innovations to reality is an ongoing challenge. A recent published survey report stated that 51 percent of CEOs in life sciences and pharmaceuticals companies mentioned- Finding the right people is one of their biggest challenges.
 
I have a separate post on ‘Best practices for biotech talent management’. You may check it out here. And here’s a post giving Best practices for talent management in pharma companies.
 
Finding the right team is essential when you're trying to compete with the big players. It's essential to have the right mix of people with relevant experience in sales, marketing, and research and development. It's also crucial to be able to hire people with the right technical skills, such as engineers, statisticians, and data analytics.
 
Managing execution

Managing execution challenges is an important part of leading a new biopharma Startup. As a company grows and its goals change, execution expertise becomes increasingly important to achieve those goals. Fortunately, the biotech community has many resources to help new startups navigate the execution challenges that come with bringing a new biopharmaceutical to market.
 
Tracking performance
 
Tracking performance is critical to the success of any biopharma Startup. It can be challenging to measure the impact of key decisions, especially in the R&D phase of a new biotech. The process may take years; that's why it's crucial to include the right information and discussion in key decisions.
 
Today's biopharma companies are in the midst of a transformation. Digital technologies are driving new processes and reducing time to market. A global pandemic has increased the importance of these next-generation capabilities. These capabilities include more efficient manufacturing, process automations, more effective supply chains, more efficient and flexible networks, and more. They also allow biopharma companies to pursue new value through M&As and patient engagement ventures.
 
Creating a company culture
 
Creating a company culture for a biotech Startup is an important step towards achieving sustainable success. It's crucial to build a cohesive team and ensure that the culture reflects the values of the company. Employees feel more engaged when they feel that the leadership is transparent and demonstrates their commitment to the company mission. It's also important to share goals and objectives with the team.
​

• How to Bring in Organizational Culture Change
• What Role Does Culture Play in Business Transformation?

 
Companies that focus on creating a strong company culture have a greater chance of success than those that ignore it. An unfavorable corporate culture can lead to high turnover and burnout among employees, which in turn leads to a less-productive organization. A positive company culture is marked by a high level of employee satisfaction and a healthy, stimulating environment. Employees who feel valued are more likely to stay with a company, which in turn attracts top talent.
 
It is important to create a company culture that emphasizes innovation. Innovation requires continuous improvement and new ideas. Innovation promotes progress on a company and individual levels. A company culture that encourages experimentation and constant learning is an ideal environment for innovation.
 
In addition to a strong company culture, it's important to hire people with diverse backgrounds and experiences. A well-rounded employee can bring a unique perspective to the company, and their diverse experiences can help them adapt to changing roles. While working in silos in Big Pharma may result in specialized skills, working in diverse parts of the organization can foster humility and a fresh perspective.
 
Creating a company culture is not easy. It requires a commitment by the senior management team to model the mindsets and behaviors they want. They should also provide ongoing coaching and engage teams in capability building. This approach can be highly effective in creating a shared culture and helping the company achieve its goal.
 
Building a biotech company requires a dynamic, ever-growing team. To succeed, the company should be able to attract motivated team members and build shareholder value. Furthermore, the company must be able to implement a business model that encourages growth and is easy to execute.
 

Related Reading:​

1. Kaizen for pharmaceutical, medical device and biotech industries
2. How to cut costs strategically using Kaizen
3. Streamline processes and workflows with Gemba Walk.
4. Top Ten Strategic Decision-Making Tools for Operational Excellence

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Categories:  Biotechnology | Operational Excellence | Leadership 

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One of the keyways to improving operational excellence is to have the right talent at your workplace. While it was easier to hire talent previously, today’s times demand that organizations nurture their employees, give them the means to excel in their jobs and the confidence to stay with the organization for a longer time (and not hop on to the next job opportunity that comes their way).
 
The biotech industry has a unique set of requirements when it comes to talent management. Companies have historically relied on hiring job-ready candidates from their competitors, but with today's tight regulation and accelerated start-ups, biotech firms must make sure to attract and hire top-quality candidates themselves. This requires a strategic approach to hiring that puts a premium on individual potential.
 
An effective biotech talent acquisition strategy should begin with the development of a candidate profile. Executives should describe the ideal candidate and determine the requirements for each position. This process will help them determine whether they're attracting the right candidate. After that, they can invite other firms to conduct searches.
 
Companies should strive to maintain a positive culture for all employees. A toxic work environment can result in high turnover rates and burnout. It can also damage the organization's productivity. A positive company culture will foster high job satisfaction, a stimulating work environment, and clear communication. Top talent will always seek a company that promotes these characteristics.
 
The biotech industry continues to grow, and it's becoming increasingly competitive for the best talent. In addition to industry giants, smaller biotechnology companies are competing for top talent. A recent global CEO survey found that 51 percent of CEOs in the life sciences and pharmaceuticals industries are having trouble attracting top talent.
 
The challenges of hiring top-level employees have forced biotech companies to change their hiring practices. Many are now using data-driven hiring methods to find top candidates. With the help of artificial intelligence (AI), these hiring systems have become the go-to tool for growing biopharmaceutical companies.
 
The importance of talent management cannot be overstated. Investing in top-quality talent acquisition strategies will lead to greater productivity, increased profitability, and more efficient recruitment. Recruiting strategies should be tailored to the needs of the business. Biotech companies are constantly in need of new talent, and this is a key component of the company's growth strategy.

Related Reading:

1. Top Ten Strategic Decision-Making Tools for Operational Excellence
2. ​How to cut costs strategically using Kaizen
3. Top 30 Continuous Improvement Tools
4. Top 10 Change Management models

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Categories:  HR Development | Biotechnology

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​The challenges of biotech businesses are increasing, including aggressive competition, shifting landscapes, and pandemic disruption. 

​To overcome these challenges, firms need to realize the scope of process excellence and redefine the operations roadmap. Here are five tips to help you improve your operations in the biotech industry. - Develop a process map based on the principles of Lean, Lean Six-Sigma. Kaizen or Poka Yoke - Define the metrics that will measure the success of your operations.

- Design processes to reduce waste.
​A well-designed manufacturing process should have operational efficiencies built-in. Many biopharmaceutical companies have found operational excellence (OpEx) in their manufacturing process, but there are still many obstacles to overcome. To succeed, biotech companies must build operational efficiencies into the manufacturing process, beginning with the process design.

- Implementing Kaizen, Lean, Lean Six Sigma, Six Sigma or Poka Yoke, has many benefits for pharma and biotech companies. It improves quality, facilitates compliance, and lowers costs. By applying Lean Six Sigma methodologies, pharmaceutical companies can boost operational efficiency and improve compliance.

- Create a culture of improvement and ownership.
It creates a culture where employees can identify problems and fix them themselves without the need for management intervention. This approach will free up management to focus on strategic growth activities.

You should focus on culture and operational excellence to make sure your organization becomes an operational excellence machine. Once organizational culture changes, your company will grow and flourish. A culture of innovation will benefit everyone, including the scientists who work there.

- Understand the role of communal knowledge and financials.
Kaizen, Lean and Six-Sigma, Poka Yoke methodologies can improve the efficiency of operations across the organization. Embrace a pilot rollout approach and make sure to involve sponsors who are visible and supportive. Operational excellence benefits from external support and communal knowledge, and it's vital to the success of your biotech company.

- Define Operational Excellence.
Operational excellence involves implementing an effective management system to eliminate waste, streamline processes, and boost profitability. For details checkout- Top Ten Strategic Decision-Making Tools for Operational Excellence

​Related Reading:​

1. Kaizen for pharmaceutical, medical device and biotech industries
2. How to cut costs strategically using Kaizen
3. Streamline processes and workflows with Gemba Walk.
4. Top Ten Strategic Decision-Making Tools for Operational Excellence

​Follow Shruti on Twitter, Facebook, YouTube, LinkedIn

Categories:  Biotechnology | Operational Excellence

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​#operationalexcellence #operationalexcellenceforbiotechindustry #strategicdecisionmaking #strategymanagement #decisiontools #decisionmaking #strategicplanning  #challengesofdecisionmaking #strategy #operationalexcellence

As the field of stem cell research and manufacturing continues to evolve, challenges remain. These include unregulated processes, scaling up production, epigenetic analysis etc. These challenges must be addressed to ensure project success and profitability. The challenges also include the ongoing need for better gene delivery at scale. In addition, the manufacturing process must be optimized to minimize waste and increase efficiency.
 
Usually, I write about improving OpEx (operational excellence) via business process improvement. But improving efficiency of technical processes is equally vital for the OpEx mission. In this post, I shall briefly touch upon challenges in stem cell research and its manufacturing; these challenges must be surpassed to improve gains.
 
To start off, stem cells are cells with the potential to develop into many different types of cells in the body. To put it in layperson's language, stem cells serve as a repair system for the body. Therapies involving stem cells are hence known as regenerative medicine therapies. 

​In case you want to know more about what stem cells are and what do they do, I’ve a separate post covering this topic; you may check it out here.
 
So, let’s begin with some of the challenges to overcome with stem cell research and manufacturing … 

1. Unregulated stem cell research-

Stem cell regenerative medicine therapies are expected to be beneficial for patient having spinal cord injuries, type 1 diabetes, Parkinson's disease, amyotrophic lateral sclerosis, Alzheimer's disease, heart disease, stroke, burns, cancer and osteoarthritis.
 
Cord blood and cord tissue stem cells have the special quality of being the purest and youngest tissue-specific stem cells you can collect and function more quickly and effectively than adult stem cells from other sources.

Stem cell research has been extremely intense since the early 2000s, with many clinical trials underway. Efforts have been hampered by regulatory uncertainties and inconsistent controls. 
 
In recent years, stem cell research has become a truly global endeavor. Fundamental research is critical for creating a solid foundation for clinical studies. To meet these challenges, scientists in various countries (where laws permit) could work together.
 
While research on stem cells has spurred investment, industry development, and media coverage, there are very few clinical applications. While some companies are developing treatments with hematopoietic stem cells, they are not regulated and are not suitable for all patients. Moreover, the lack of evidence in these therapies is a significant challenge for legitimate scientists in the field and for regulatory agencies attempting to protect their constituents.

Note: Stem cells work is illegal in several countries across the globe. Hence, I’ll recommend that companies planning on initiating projects involving stem cells must first update themselves on applicable laws around stem cells in order to ensure full legal compliance. 

2. Unregulated stem cell biomanufacturing- 

The current situation in the field of stem cell research and manufacturing is a concern for patients. Despite some progress in recent years, there are still significant challenges to overcome before stem cell therapies are widely available. One major challenge is ‘scale-up’ or the process of manufacturing cells in large enough quantities to treat a large number of patients.
 
There are various sources of stem cells- From brain, bone marrow, blood and blood vessels, skeletal muscles and liver; though blood is the most applied source for stem cell collection.
 
Stem cells from blood are collected with an apheresis machine. Blood flows from a vein through the catheter into the apheresis machine, which separates the stem cells from the rest of the blood and then returns the blood to the patient's body.
 
From non-blood sources, stem cell treatments are mostly produced in petri dishes and are usually used to treat one or two patients. To help people with serious health conditions, the stem cell community will need to develop strategies for producing cells at a large scale.
 
Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells (also known as hematopoietic progenitor cells) that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood (i.e., the 'hematopoietic' system) but they are not approved for other uses.
 
Regulatory control of stem cell production is vital to ensure that the cells are safe and effective. Although many clinical trials are ongoing to investigate the effectiveness of stem cell therapies, this industry is still far from being fully regulated. Many unregulated clinics operate with minimal controls and risk of harm to patients.

The atrocious part is that, unregulated stem cell biomanufacturing challenges have led to unproven therapies and stem cell tourism.
 
3. Epigenetic analysis of stem cells- 

To further explore the multipotency of stem cells, epigenetic analysis is important. Epigenetic modification occurs when chromatin is modified to regulate gene expression. For example, H3K4me3 and H3K27ac are both known to regulate gene expression. However, epigenetic modifications can also be reverted.
 
Recent studies have shown that the behavior of stem cells is influenced by the expression of certain chromatin remodeling factors. These factors regulate the behavior of stem cell subsets during homeostasis of compartments in adulthood. For example, certain types of stem cells can differentiate in different ways and maintain a high-level of functional fitness.
 
Several epigenetic players interact with transcription factors to regulate stem cell homeostasis. For example, the transcription factor p63 is required for epidermal stemness and differentiation. This transcription factor regulates genes such as the cell cycle proteins and early epidermal differentiation markers. Another epigenetic factor that regulates p63 is Setd8, which is necessary for monomethylation of lysine 20 in histone H4. When Setd8 is deleted, p63 expression is impaired and the stratified epidermis fails to form.
 
4. Automated process for tracking and documenting blood products- 

Automated process for tracking and documenting the processing of blood products is essential for safe patient care. Records must be kept concurrently with each significant step of the blood processing process, including entry dates, person performing work, and complete history of work performed. Using a secure electronic solution, companies can store all their compliance records in one place. The process is also vital for reporting any known adverse reactions to blood products.
 
Automated blood supply management software can make the process easier and safer by preventing errors and ensuring a safe and reliable blood supply. It can be set up to automatically track blood products and perform cross-matching to identify incompatible blood products. This can significantly reduce the risk of mistakes or wasteful product.
 
5. Scale-up of stem cell manufacturing- 
​
A successful scale-up of stem cell manufacturing process is crucial for ensuring the quality and integrity of the cells. In order to achieve this, the process must be able to control cell surface and physicochemical parameters, minimize change in cell surface, and be highly reproducible. Moreover, it must meet cGMP standards.
 
One solution is the use of a multiplate bioreactor. This device has a flat surface and can be used to grow and differentiate pluripotent stem cells at high production scales. The multiplate design can be used in the early stages of development as well as in the industrialization of cell therapies. However, future technological developments will be required to make the process more efficient and scalable.
 
Another solution is to use microcarriers and single-use bioreactors. This method allows for easy scalability and high control of product quality. It also reduces labor costs and contamination risks.

Disclaimer: Information presented here is for educational purpose only. Stem cell research, manufacturing thru commercialization is illegal in several countries across the world. Ensure that you are fully complying to the laws before undertaking any activity and/or therapies involving stem cells.

Related Reading:

1. Kaizen for pharmaceutical, medical device and biotech industries​
2. How to cut costs strategically using Kaizen
3. Top 30 Continuous Improvement Tools
4. How to Improve Operational Excellence in the Pharma Industry
5. Top 10 Change Management models
6. Continuous Improvement for Drug Industry: Part 1: Introduction to Digitalization in Pharmaceutical and Medical Device R&D.

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Categories:  Life Sciences | Operational Excellence

Keywords and Tags:
#stemcells #stemcellresearch #continuousimprovementforlifescienceindustry #continuousimprovement #stemcelltherapies #stemcellmanufacturing #regenerativemedicinetherapies 

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

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A few years ago, I was approached by a CEO of a pharmaceutical contract research company to turnaround his sick unit into a profitable enterprise. This company was dealing with the development of solid oral dosage forms. To bring about the necessary change, we initiated several Kaizen campaigns companywide, with 360 degrees focus to overhaul all processes and operational systems. We addressed all key areas across the organization including accounts payable/ receivable, material procurement, order processing, suppliers, R&D, scale-up, production, logistics, product dossiers filings, project management, business development, sales & marketing and PR communication processes.
 
Another key area where Kaizen helped us in a big way was to integrate various client information data sets maintained within different databases on separate systems.​

​At the end of nine months, this company’s books started showing profits, and from there on, it kept going from ‘good to great’. It was an excellent example of a successful transformation.
 
Unfortunately, this contract research company is not alone in the challenges it has faced. Studies indicate that 88% of business owners in North America struggle to maintain consistent cash-flow. Key questions to consider are:

• Can your organization benefit from increased workplace productivity?
• Does your team face challenges with reduced R&D budget?
• Does your organization face challenges because of inconsistent or poor cash-flow?
• Do you need to cut corners as you are forced to do more with less?

 
If you answered ‘yes’ to any of the above questions, then Kaizen should be your mantra…​

​This book is a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device, and biotech companies.
 
It is an invaluable resource, an essential tool for all professionals within the pharmaceutical, medical device, biotech organizations i.e. all life sciences and health care companies, interested in employing Kaizen in their workplaces and their personal lives. This book will also facilitate running Kaizen in a manufacturing company and do it at a world-class level.

​This book doesn’t simply explain Kaizen process features, implementation, and application. The scope of this book is much wide.  

This book is meant for small to medium-size pharmaceutical, medical device and biotech research, manufacturing and contract services companies. This book is to-

• Demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech, and all life sciences organizations, irrespective of their size or workplace culture.
• Apply Kaizen to what really matters, that is, ‘to achieve business expansion along with increased productivity and profits’.  
• Provide practical and useful examples of Kaizen principles that can be executed at various levels: across the organization; within a specific department, business unit or team, as well as for yourself as an individual to further your personal career.
• Improve revenues and create a lasting change using Kaizen principles and techniques.​

Some salient features of this book

• It shows pharmaceutical & biotech scientists, design engineers, operators and everyone involved in product development, how to utilize Kaizen- to create innovations, shorten product development times, improve first-to-file rates, conduct successful scale-up and technology transfer to manufacturing sites.

 

• It shows everyone associated with manufacturing, how to use Kaizen to decrease cycle times, work-in-process & quarantine inventories, the cost of distribution & logistics, improve equipment efficiency, facility capacity utilization and shift output.

 

• It shows everyone in Human Resources how to use Kaizen to minimize employee turnover, hire and retain talent, and motivate employees to create a difference.

  

• It shows the company’s senior management, stakeholders, finance and other supporting business units, how to use Kaizen to increase ROI (return on investment) while complying with cGMP (current Good Manufacturing Practices) and other regulations, address rising competition and counteract fluctuating market economy.

 

• This book presents useful ideas that one can implement immediately, often at no additional cost.

 

• It shows how to transform a business from ‘good- to- great’. True benefits of Kaizen implementation are realized because, it adds value to your products, increases market share, and drives both top line and bottom line of your business.

 
Kaizen has mainly been used in Japan and many other SE Asian companies and in Europe. Up until now, it has not gained enough significance in North America, because of which it has not been utilized to its full potential. The root cause is the difference in work culture and corporate governance styles of companies in eastern and western countries; this book totally eliminates this gap.​

In addition, this book is an excellent resource for Kaizen beginners with a lot of real-life industry examples, case studies and provides several ‘do-it-yourself’ exercises, which is of tremendous value, in absence of a Kaizen coach.


Chapter 1:
 
Pharmaceutical industry growth unlike few other industries viz. retail, banking etc. is not completely determined by ‘value’ it brings to its customer. Frustrated customers can easily walk out of a shop and get their product from some other place. In contrast, pharmaceutical products are unique in the sense, the customer (i.e. patient) doesn’t usually have much say in its purchase. Patients usually buy medicines their doctors prescribe or pharmacist dispense (until such time they don’t experience any adverse effects). For the medicines where adverse effects are well-known or documented on the product label, patients really have no choice but to take bitter medicine (pun intended).
 
Also, a patient on a prescription drug may not always have the option to change medication or brand, because of lack of competing brands due to enforced Exclusivity and Patents laws. Even with the advent of generic medicines which offer price benefits, many patients don’t prefer to change the pill they have been taking over the years.

Moreover, Kano’s model may not strictly apply to Life science industries, because unlike other products, a drug product if not proved safe, efficacious and stable, will just not make it to the market. And this applies to all medicinal products- be it Rx (prescription), OTC (over the counter), medical devices etc.​

Pharmaceutical, medical device, and biotech companies are always under federal drug authorities radar for compliance to standards. The very existence of pharma business is based on meeting compliance- be it cGMP, safety, therapeutic efficacy, quality etc.
 
As federal drug regulations change, companies must upgrade to stay in business. Hence, there is an indirect continuous improvement happening all the time. This is probably one of the reasons why the majority of life science companies have not really attempted formal business process improvement methodologies.
 
However, Kaizen is not simply a business process improvement technique. Kaizen doesn’t just focus on cost-cutting or quality improvement. Kaizen is a way of life; of becoming ‘better’ every day; of becoming better than the best- consistently, and taking your business from being good to great with its products, market share, governance, and most importantly, Good to Great with PROFITS!
 
Let’s begin with what is Kaizen?
 
The name ‘Kaizen’ is an adaptation of the Japanese term that stands for continuous improvement. In Kaizen technique, it is believed that employees need to be empowered to enhance various processes of the company. Kaizen utilizes some of the Lean methodology philosophies to plan, implement and evaluate changes in a variety of roles. Kaizen must be integrated into a company’s daily operations to achieve maximum benefits.
 
Kaizen hails from the words, "Renew the heart and make it good." Therefore, an adaptation of Kaizen concept requires changes in the "heart of the business", corporate culture and structure; since Kaizen enables companies to translate the corporate vision in every aspect of its operational practice.​​

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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