Sonodynamic therapy (SDT) is a minimally invasive treatment that uses ultrasound waves to activate a chemical agent called a sonosensitizer. The sonosensitizer produces reactive oxygen species (ROS), which damage and kill target cells.

Understanding Sonodynamic Therapy

The science behind SDT is based on the principle that ultrasound waves can create acoustic cavitation bubbles in tissues. Acoustic cavitation is the formation of bubbles in a liquid when subjected to high-intensity sound waves. These bubbles can collapse violently, generating high energy levels estimated to be ~100 microjoules per bubble. That energy is sufficient to break a chemical bond or damage cellular tissue. It is important to note that not all of this energy is released in a single burst. The energy is released over a short time, and it can be spread out over a large area.

When a sonosensitizer is present in the tissue, it can be activated by the acoustic cavitation bubbles. This activation produces ROS, highly reactive molecules that can damage DNA and other cellular components. Examples of ROS include:

• Superoxide anion (O2•-)
• Hydrogen peroxide (H2O2)
• Hydroxyl radical (•OH)
• Singlet oxygen (1O2)
• Nitric oxide (NO)
• Peroxynitrite (ONOO-)

Several sonosensitizers have been developed. Many are based on porphyrin molecules, the basic structure of the oxygen-carrying component of the red blood cell in humans. A brief list of sonosensitizers that are being evaluated are:

1. Hematoporphyrin derivative (HPD): This is a naturally occurring porphyrin consisting of a complex mixture of porphyrins derived from hematoporphyrin, a compound found in blood. HPD is taken up by tumor cells more than by normal cells. When HPD is exposed to ultrasound, it produces free radicals, which can damage tumor cells. HPD is injected into the bloodstream and is then distributed throughout the body. It takes about 48 hours for HPD to reach its maximum concentration in the tumor cells.
2. Photofrin II: Photofrin is a chemically modified form of HPD. It is more photostable and water-soluble, allowing it to be more effectively distributed when administered. Like HPD, Photofrin II is injected into the bloodstream and distributed throughout the body. It takes about 24 hours for Photofrin II to reach its maximum concentration in the tumor cells. The tumor cells are then exposed to ultrasound. This activates the Photofrin II, causing it to produce free radicals, which damage the tumor cells, leading to their death.
3. ATX-70: Although no longer in development, ATX-70 is an example of a class of compounds being investigated for SDT. They are gallium porphyrin complexes. Essentially, the iron atom in the HPD complex is replaced by gallium. It is more photostable and water-soluble than HPD itself or Photofrin II. ATX-70 is injected into the bloodstream and is then distributed throughout the body. It takes about 24 hours for ATX-70 to reach its maximum concentration in the tumor cells. The tumor cells are then exposed to ultrasound waves. The ultrasound waves activate the ATX-70, causing it to produce free radicals. The free radicals damage the tumor cells, leading to their death.
4. A7X–S10: This is a molecule under development by Avicenna Medical for the treatment of liver cancer and breast cancer. A7X-S10 is a chlorin derivative. It is more photostable and water-soluble than HPD and Photofrin II. Early studies show it effectively kills cancer cells in vitro and in vivo. They also indicate the compound to be safe and well-tolerated by patients. However, A7X-S10 is in early Phase 1/2 recruitment for multiple indications. Additional data is needed to determine its overall efficacy.
5. DCPH-P-Na (I): DCPP-P-Na (I) was developed by a team of researchers at the University of Tokyo in Japan. It has been studied primarily in animal models and has exhibited in vitro and in vivo activity against cancer cells. The safety profile in animal studies is good, but this does not always translate well into human models. The compound can be selectively targeted to tumor cells, which minimizes the risk to healthy tissue. Although promising, additional studies are needed to determine long-term safety and efficacy in humans.

Use of SDT in Medical Applications

SDT is a relatively new treatment. There are distinct advantages to SDT. It is a minimally invasive treatment that has minimal side effects itself. Sound waves can treat deep-seated cancers, infections, and surface afflictions such as acne or psoriasis.

Limitations of the therapy are targeted delivery of the sonosensitizer and specific targeting of the ultrasound energy. Some minor side effects are reported, including pain and swelling in the treatment area. The therapy is also limited to facilities that have targeted ultrasound devices.

Listed below is a summary of studies evaluating SDT in a variety of therapeutic areas:

1. Cancer treatment: One of the most promising areas of investigation is SDT in treating various cancers. Specifically:
   • Breast cancer (NCT04918553, UCSF)
   • Liver cancer (NCT05142903, University of Pennsylvania)
   • Pancreatic cancer (NCT04853743, University of Pittsburgh)
   • Head/neck cancer (NCT04956757, University of Texas)
   • Glioblastoma (NCT05370508, SonALAsense (a GreenField Partner).
2. Infection treatment: SDT is being investigated for the treatment of infections a variety of infection types:
   • Bacterial infections (NCT05179648, UC San Diego) and (NCT05503602, UCLA)
   • Fungal infections (NCT05320734, University of Pittsburgh)
   • Viral infections (NCT05390967, University of Texas)
   • Acne vulgaris (NCT05546310, UC, Davis)
3. Tissue repair: SDT is being investigated for treating tissue damage, such as burns and wounds.
   • Diabetic foot ulcers (NCT04714036, UC, Irvine)
   • Psoriasis (NCT04778645, UCSF)
   • Osteoarthritis (NCT04806164, UC, San Diego)
   • Dupuytren’s contracture, a condition that causes the fingers to contract (NCT04905853, University of Pittsburgh)

SDT is a promising new treatment that can improve the lives of many patients across many therapeutic areas. As research continues, SDT will likely become a more widely used treatment.

Greenfield is proud to be a part of developing this promising new therapy!

(NOTE: If you want to participate in a clinical trial using SDT, you can talk to your doctor. They can help you find a clinical trial that is right for you. It is important to note that clinical trials are research studies and do not guarantee treatment. Before participating in a clinical trial, it is important to talk to a medical professional about the risks and benefits of the study.)

Many of my colleagues in this forum know that bringing a new drug to market is an exhaustive journey in terms of time and finances. We are all well-versed on how pharmaceutical companies venture into the unknown, hoping the investments yield a safe, effective, and marketable product.

Phases of Drug Development

Drug development generally follows a linear and predictable trajectory:

1. Discovery and Preclinical Testing: Potential compounds are identified and tested. This can typically take 1 – 6 years.
2. Clinical Trials: Divided into three phases, these trials evaluate the drug’s safety and efficacy. In total, clinical trials average 6 – 7 years.
3. FDA Review: Post trials, an application is submitted for regulatory approval. Depending on the submission type, this can take 0.5 – 2 years.
4. Post-Market Surveillance: The drug is continually monitored in real-world scenarios once approved.

The process from ideation to market introduction takes about 10 to 15 years. Currently, only five advance to clinical trials for every 5,000 compounds entering the preclinical phase. Out of these, one might receive approval. In 2022, CDER approved 37 novel drugs either as new molecular entities under NDAs or as new therapeutic biological products under BLAs.  That equates to 185,000 compounds entering the pre-clinical phase the 10 to 15 years prior.

The Cost

Historically, the estimated cost of drug development has spiraled. Research from the Tufts Center for the Study of Drug Development estimates the cost at $2.6 billion as of 2021, a <3-fold increase from $802 million in 2003 (adjusted for inflation). A Deloitte report this year showed the development cost for biopharmaceuticals at $2.3 billion.

Here’s a dissection of these figures:

1. Preclinical Phase: Costs here, primarily due to laboratory studies and animal testing, can range from $15 million to $100 million.
2. Clinical Trials: The most expensive chunk. Breakdown:
   • Phase I: Approximately $25 million.
   • Phase II: Can vary widely but averages around $60 million.
   • Phase III: The most expensive, averaging at $350 million. However, considering the vast patient base and extensive monitoring, costs can shoot up to $1 billion for certain drugs.
3. FDA Review: Submitting an application to regulatory bodies requires $2-3 million. Yet, if the regulatory body has concerns, addressing those can escalate costs considerably.
4. Post-Marketing and Surveillance: Monitoring a drug post-release can add $20 million to $300 million to the development tab, dependent on the nature of the drug and the length of the surveillance.

Deciphering the High Cost

1. Failure is Expensive: Most drugs never see the light of day. Statistically, the attrition rate is staggering. About 90% of drugs that enter clinical trials fail for several reasons. For every success, there are numerous expensive failures.

2. Prolonged Development Cycle: Drug development isn’t a sprint; it’s a marathon. The decade-long journey involves consistent funding, irrespective of the outcomes.

3. Strict Regulations: Regulatory bodies impose stringent standards to safeguard public health. Meeting these standards necessitates expansive and expensive testing.

4. Inflation: The Tufts Center report indicates that the annual average cost of drug development has risen 7.4% above inflation. This rise is attributed to more complex trial designs, higher costs for trial participants, and an increasing focus on chronic and degenerative diseases.

A Worthwhile Investment?

Given these staggering costs, one might wonder if it’s all worth it. From a humanitarian perspective, the answer is a resounding “yes.” Every successful drug holds the potential to save or enhance countless lives. Financially, a successful blockbuster drug can generate billions in revenue for pharmaceutical companies, offsetting the costs of its development and that of other unsuccessful candidates.

However, these immense costs directly impact drug pricing, which is often a bone of contention. High prices can make essential drugs inaccessible for vast population swaths. Hence, balancing R&D costs with affordability remains a challenge.

According to the Deloitte report, the ROI from pipeline products is falling. The average peak forecast of annual sales in 2022 fell 22% vs. the prior year ($500 million down to $389 million). The decline is attributed to the higher cost of advancing pipeline products to market.

The Future – Streamlining Costs

There’s active research and debate on streamlining drug development to make it more efficient and cost-effective:

1. Technology: Artificial intelligence and machine learning are expected to play pivotal roles in shortening drug development cycles and predicting which drugs have higher chances of success. One positive from the COVID-19 pandemic was the advancement of new capabilities that, before 2020, were only being discussed. If the industry can continue to utilize, or better, accelerate their use, then more efficient drug design and development is possible.
2. Collaboration: Increased collaboration between pharmaceutical companies can share costs and risks. Big Pharma has the horsepower to drive the development of pharmaceutical products. However, boutique/virtual companies are faster at innovation. Working together can create vast and less siloed pipelines for drug development. Further integrating supply chain management of downstream suppliers earlier in the process gives a greater opportunity for success on the manufacturing side of the business.
3. Regulatory reforms: Simplifying the drug approval process without compromising on safety can also help reduce costs. Additionally, more and earlier cooperation between industry and regulatory bodies helps coordinate strategies to navigate the approval pathway.

Conclusion

The development of a drug product, from its conception in a laboratory to its journey to the patient’s bedside, is riddled with scientific and economic challenges. While development costs are extraordinarily high, the potential societal benefits and financial returns can be profound. The adage is true:  time is money. It’s crucial, moving forward, to find ways to expedite the drug development process. This has to be done as we improve patient safety and provide efficacious therapies, ensuring that the marvels of modern medicine are accessible to all.

The Cost of Overwork

The consequences of a relentless work culture

Overwork costs us personally, physically, professionally, and mentally. Studies and anecdotes suggest that overworking, or ‘burnout,’ can lead to various adverse outcomes, including decreased productivity, increased stress levels, and even physical health problems like heart disease. This continuous grind can lead to emotional exhaustion, a reduced sense of personal accomplishment, and depersonalization – treating people as objects rather than human beings.

The Vital Need for Rest and Recuperation

Acknowledging the human need for downtime

The human body and mind are not machines; we can’t expect them to function optimally without rest and recuperation. Yet, we often neglect this basic need to pursue success, achievement, and recognition. Never underestimate ‘The Power of Pause.’ Taking time off allows our bodies and minds to recharge. It allows us to step back from our daily routines and replenish our energy. The hiatus doesn’t need to be an exotic vacation; it can be as simple as a day spent in a park, a weekend hobby class, or a ‘staycation’ at home. What’s vital is breaking the monotonous routine and giving our minds the space to wander and rejuvenate.

Unlocking Creativity Through Time Off

Fostering innovation and fresh perspectives

One of the most significant benefits of taking time off is boosting creativity. Our brains are not linear processors; they thrive in diverse, stimulating environments. Constant work can stifle our creative thinking, leaving us feeling stuck or uninspired. When we step away from our tasks, we allow our minds to make connections between disparate ideas, sparking creativity and innovation. Have you ever wondered why some of the best ideas come when we are in the shower or just about to fall asleep? It’s because, during these times, our minds are relaxed and free from immediate tasks. These moments of relaxation can be extended through intentional periods of time off, allowing our brains to explore new territories of thought.

Reconnecting with Ourselves and Our Passions

Rediscovering our dreams and core values

Downtime is also an opportunity to reconnect with ourselves, our dreams, and our passions. In the constant rush of deadlines and commitments, we often lose touch with who we are and what we truly want. Taking time off offers a chance to recalibrate and align ourselves with our core values and desires, to ensure we are moving in the right direction.

Strengthening Relationships Through Time Off

Cultivating meaningful connections with loved ones

Moreover, time off provides a platform for us to strengthen our relationships. It allows us to devote undivided attention to our loved ones, creating stronger bonds and lasting memories. These connections are a significant component of our happiness and emotional well-being.

Gaining Valuable Insights and Perspective

A shift in viewpoint leads to breakthroughs.

Stepping outside our daily routines through time off allows us to look at our lives differently. This shift in viewpoint can lead to valuable insights, helping us solve problems or make decisions that seemed daunting before. A break can provide us with the distance needed to view our lives and work with fresh eyes. We may discover new approaches, understand the significance of overlooked aspects, or realize the importance of taking a break sometimes.

Prioritizing Time Off for Well-Being and Productivity

Making intentional choices and planning for rest

Recognize the need to prioritize time off. While understanding the importance of time off is one thing, incorporating it into our lives is another. It requires intentionality and planning. Some may find it beneficial to schedule regular time off, while others prefer a more spontaneous approach. Regardless, it’s essential to prioritize this time, just as we would any other critical task or appointment.

Challenging the Culture of Busyness

Rethinking success and embracing a balanced life

If we take the time to recognize the value of rest, we will start seeing time off not as an indulgence but as a necessity for our overall well-being and productivity. Taking time off can be a revolutionary act in a culture that often equates busyness with worth. It’s about reclaiming our time, health, and ourselves. We’ve been conditioned to view taking time off as a sign of laziness or a lack of ambition. However, it’s crucial to realize that relaxation and recreation are not the antithesis of productivity; they’re vital companions. By integrating regular periods of rest into our lives, we can improve not just the quality of our work but also the quality of our lives.

Embracing the Power of Time Off

Taking a stand for your time, health, and happiness

Let us redefine success not by how busy our schedules are but by how balanced our lives feel. By embracing time off, we can live fuller, happier, and more fulfilling lives. So, step away from the desk and the computer (after reading this blog, of course), and hit the beach, hike in the woods, or walk the dog. You deserve it.

We at GreenField work primarily in the pharmaceutical industry. This industry is among the most highly regulated in the United States and the world. The responsibility of every member of this industry, from bench-top discovery through to distribution of the product to the end-user, is bound to the ethos of delivering both safety and efficacy to the patients who need our products. We are not alone.

In today’s dynamic business environment, numerous industries face the challenges of operating within highly regulated frameworks. Whether it’s finance, healthcare, energy, or technology, businesses must navigate complex regulatory landscapes to ensure compliance and success. However, amidst these challenges lies immense opportunity. By understanding the intricacies of regulatory environments and proactively adapting to changes, businesses can meet compliance obligations and position themselves to thrive in their respective industries. In this blog, we will explore effective strategies for achieving success in a highly regulated business and staying ahead of the curve. These include, in no preferential order:

1. Embracing a Culture of Compliance
2. Staying Informed and Anticipating Changes
3. Building Strong Relationships with Regulators
4. Investing in Regulatory Technology
5. Establishing Robust Risk Management Practices
6. Fostering a Culture of Innovation
7. Engaging Legal and Compliance Experts

Building a strong foundation for success in highly regulated businesses begins with establishing a culture of compliance. Compliance should not be seen as a burden but as a strategic advantage. Companies can create a proactive and compliant workforce by fostering an environment where all employees understand the importance of adhering to regulations. Regular training and awareness programs can keep employees updated with the latest regulatory developments, ensuring compliance becomes ingrained in the company’s DNA. Compliance must be an “all-in” culture. There’s no halfway.

Regulations are continually evolving, making it crucial for businesses to stay informed about upcoming changes. Proactively monitoring regulatory updates relevant to your industry is essential. Engage with industry associations, regulatory bodies, and legal experts to gain insights into potential future changes. By staying ahead of regulatory shifts, businesses can proactively adjust their practices, policies, and processes to ensure compliance well in advance. This approach mitigates risks and enables companies to seize new opportunities and gain a competitive edge. Forewarned is forearmed. Don’t let the change take you by surprise. That strategy didn’t work well for the dinosaurs and won’t work well for your company.

Developing strong relationships with regulatory authorities is another key aspect of success in a highly regulated business. Open and transparent communication with regulators can yield several advantages. Seek clarification when needed, participate in industry consultations, and actively engage in discussions with regulators. By demonstrating a commitment to compliance and building trust, businesses may have a greater influence on shaping regulations that align with their strategic goals. Additionally, maintaining positive relationships with regulators can lead to improved cooperation, timely information sharing, and a better understanding of regulatory expectations. Ask questions. Seek guidance. Make Regulatory compliance a two-way discussion.

Technology can be a powerful tool in managing compliance obligations efficiently. The emergence of regulatory technology (RegTech) solutions allows businesses to automate processes such as monitoring, reporting, and risk management. Utilizing artificial intelligence, machine learning, and data analytics can streamline compliance efforts, reduce costs, and enhance decision-making capabilities. By implementing RegTech solutions, businesses can stay ahead of the regulatory curve, improve compliance effectiveness, and allocate resources more strategically. It is important to assess and invest in technology that aligns with specific regulatory requirements and addresses the unique challenges faced by the business. Bring all the available tools to the table to ensure your company complies.

Effective risk management is paramount in highly regulated businesses. Developing comprehensive risk management practices that identify, assess, and mitigate potential compliance risks is crucial. Risk assessments should be conducted regularly to identify vulnerabilities and implement controls to address them. By proactively managing risks, businesses can minimize the likelihood of regulatory non-compliance and its associated consequences. Creating a risk management framework that aligns with the regulatory landscape and supports the organization’s strategic object is essential. Regular monitoring and evaluation of risk management practices ensure they remain effective and adaptable to evolving regulatory requirements. Risk management begins at the product design phase and never ends.

Successful businesses in highly regulated industries find innovative ways to meet compliance requirements while driving growth. Encouraging a culture of innovation empowers employees to think creatively and find efficient solutions to regulatory challenges. Embracing emerging technologies, exploring alternative business models, and continuously seeking opportunities for improvement within the boundaries of regulatory frameworks are key. By fostering a culture that rewards innovation and encourages collaboration, businesses can stay ahead of the curve and identify new avenues for growth and competitive differentiation. It is crucial to balance compliance and innovation, ensuring that all changes are aligned with regulatory guidelines. Reward the behavior you want to keep: reward employees and teams that bring innovative ideas to the table and foster compliance.

Navigating complex regulatory landscapes requires expertise. Engaging legal and compliance experts specializing in your industry can provide invaluable guidance. These professionals can interpret regulations, assist in designing compliance programs, and ensure that your business remains current with regulatory changes. Legal and compliance experts can also help identify potential risks and advise on mitigation strategies. Collaborating with knowledgeable professionals allows firms to tap into their experience and leverage their understanding of the regulatory landscape. Engaging with experts ensures that the business remains proactive in addressing regulatory challenges and stays ahead of any emerging compliance requirements.

Achieving success in highly regulated businesses demands a proactive approach and a commitment to compliance. Companies can position themselves as industry leaders by embracing a culture of compliance, staying informed about regulatory changes, building strong relationships with regulators, investing in regulatory technology, establishing robust risk management practices, fostering innovation, and engaging legal and compliance experts. Staying ahead of the regulatory curve ensures compliance and unlocks opportunities for growth, reputation enhancement, and long-term success in highly regulated industries.

In the competitive business landscape, small companies often face numerous challenges in scaling their operations, optimizing processes, and making strategic decisions. While larger organizations may have the resources to hire extensive consulting firms, small companies may need help navigating the complex world of business consulting. However, there is a hidden gem that can deliver immense value to small businesses – small, mighty consulting teams. This blog post will explore how these agile and specialized teams can be critical to small companies.

One of the significant advantages of small consulting teams is their ability to offer tailored expertise. Unlike larger consulting firms that may have a broad focus, small groups often specialize in specific industries or functional areas. This specialization allows them to possess deep knowledge and insights into small companies’ unique challenges. Whether it’s marketing, finance, operations, or technology, these teams can provide targeted advice and solutions aligned with small businesses’ specific needs.

For small companies, budget constraints are an everyday reality. There may be more feasible options than engaging a large consulting firm with high fees. This is where small, mighty consulting teams shine. They offer cost-effective solutions that provide a high return on investment. With lower overhead costs and a lean team structure, these consultants can provide competitive pricing while delivering impactful results. Small companies can benefit from their expertise without breaking the bank, making it a win-win situation.

Small consulting teams are nimble and agile, allowing them to adapt quickly to the evolving needs of small companies. They can provide on-demand support, acting as an extension of the internal team when necessary. Unlike larger firms, small groups can quickly assess the challenges, develop actionable strategies, and implement them without layers of bureaucracy. Their flexibility enables them to work closely with small companies, fostering strong relationships and ensuring a personalized approach that addresses specific pain points effectively.

Despite their size, small, mighty consulting teams are equipped to offer a holistic approach to problem-solving. They understand that small businesses require comprehensive solutions considering various interconnected aspects of the company. These teams can analyze the business from different angles, uncovering hidden opportunities and identifying potential risks. Their holistic approach ensures that small companies receive well-rounded advice, encompassing immediate challenges and long-term strategies for growth and sustainability.

Building strong relationships is crucial for the success of any business endeavor. Small, mighty consulting teams excel in this area. They prioritize personalized interactions, taking the time to truly understand the unique characteristics and goals of the small company they are working with. This fosters trust and collaboration, creating a partnership rather than a mere client-consultant relationship. As a result, small companies can rely on their consulting team as trusted advisors who have their best interests at heart.

In business consulting, size only sometimes equates to value. Small, mighty consulting teams offer specialized expertise, cost-effectiveness, agility, and a holistic approach that caters to the specific needs of small companies. By leveraging their strengths, small businesses can access the guidance and support required to overcome challenges, drive growth, and achieve their goals. So, if you’re a small company seeking valuable insights and practical solutions, take notice of the power of small, mighty consulting teams. They may be the missing piece in your journey toward success.

Introduction:

In today’s fast-paced and demanding work environment, maintaining inspiration and motivation can be a challenge. However, it is essential for personal growth, job satisfaction, and overall success. This blog will explore practical strategies to cultivate inspiration and thrive professionally. Let’s dive in!

Define Your Purpose:

Understanding your purpose and what drives you is crucial to staying inspired in your job. Take time to reflect on why you chose this career path and the impact you want to make. By aligning your work with your values and passions, you’ll fuel your motivation and inspiration.

Set Meaningful Goals:

Setting clear and meaningful goals provides a sense of direction and purpose. Break down your long-term objectives into achievable milestones. Celebrate your accomplishments along the way and use them as reminders of your progress and capability. Goals will keep you focused and motivated, driving your inspiration forward.

Seek Continuous Learning:

Never stop expanding your knowledge and learning. Embrace new challenges and seek professional growth opportunities. Attend workshops, conferences, or online courses relevant to your field. Engage in discussions with colleagues, join professional networks, and stay updated with industry trends. Actively pursuing knowledge will keep you inspired by the constant flow of fresh insights.

Embrace Creativity and Innovation:

Creativity and innovation are powerful sources of inspiration. Find ways to infuse creativity into your work, whether through brainstorming new ideas, experimenting with different approaches, or finding innovative solutions to problems. Embracing creativity will unlock your potential, ignite your passion, and inspire you to think outside the box.

Cultivate a Supportive Environment:

Surround yourself with positive and supportive colleagues and mentors who encourage your growth. Collaborate with like-minded individuals who share your enthusiasm and inspire you to reach higher. Engage in constructive conversations and seek feedback to enhance your skills and knowledge. Building a supportive network will create an environment that nurtures inspiration.

Practice Self-Care:

Taking care of your physical and mental well-being is crucial for staying inspired. Adopt healthy habits like regular exercise, sufficient sleep, and a balanced diet. Allow yourself to take breaks and recharge. Engage in activities you enjoy outside of work, as they provide a sense of fulfillment and contribute to your overall inspiration.

Find Meaning in Your Work:

Reflect on the impact of your work and connect with its purpose. Understand how your tasks and projects contribute to the bigger picture. Identify the positive outcomes of your efforts, no matter how small, and appreciate the value you bring to your organization and beyond. Finding meaning in your work will fuel your inspiration and sense of fulfillment.

Conclusion:

Cultivating inspiration in your job is an ongoing process that requires self-reflection, goal-setting, and a supportive environment. By aligning your purpose, setting meaningful goals, embracing creativity, and practicing self-care, you can maintain a fulfilling professional life. Remember, inspiration is not a fleeting emotion but a mindset that can be nurtured and sustained. Embrace these strategies and let your inspiration guide you towards continued success.

All drug development programs hit snags! No amount of planning or money will make everything flow perfectly. It helps to understand some of the big hurdles so you can avoid them and be ready to navigate.

GreenField works to help our clients understand these factors. We bring the discussion to the table so our clients can better plan and shorten the development timeline.

(These are in order of our own personal bias)          

1. ASSUMING (we all know what happens when we assume)

Assuming that suppliers have the item(s) you desperately need sitting on a shelf waiting for you to buy it

In the highly regulated world of pharmaceutical development, a random supplier will rarely have your drug substance, excipient, or component sitting on a shelf waiting for you to buy it. This point was driven home over the last two years when COVID-19 trashed the concept of JIT delivery.

Even for companies developing a generic or 505b2 product, it’s essential to understand that many suppliers manufacture their goods based on a forecast. Standing commercial customers get priority, and offering money rarely moves you up the list. 

If you have to manufacture a novel drug substance, excipient, or component, leave sufficient time in your clinical timeline for suppliers to develop and manufacture what you need. If you’re bringing synthetic technology to the table, that can shorten the development timeline, but your CROs need time to run through that synthesis before taking it into a kilo-lab or plant.

A good rule of thumb is to allow two weeks of development time per step and an additional 1- 2 weeks to manufacture in the plant, longer if the technology is unique or requires extreme conditions.

Include analytical methodology development timing. It can run parallel to chemical development but inevitably lags behind the wet-chemistry synthetic work. Labs need samples to develop their efforts. Once those methods are in place, in-process and release testing takes more time. We recommend that our clients allow for a minimum of 6 – 8 weeks for release testing on their drug substance or drug product.

Most importantly, we get people to understand that there are very few idle labs and plants. New customers need to queue with a CDMO’s existing customers and workload. Trust the CDMO when they tell you what their schedule will allow.

2. CONCEALMENT (know when to show your cards)

Too much secrecy

We understand the need to protect intellectual property. We urge our clients to ensure non-disclosure agreements (NDAs) are in place, regardless of the discussion stage or what information will be disclosed. However, when a CDMO asks questions about the project, the answers are critical to properly planning your program. Many clients want to keep information private such as regulatory status, delivery forecasts, realistic commercial forecasts, and clinical indications.

Trust the agreements you have in place. It is rare for a service provider to risk their reputation by misusing or abusing confidential information from a client. The more you help the service providers plan for you, the more dependable your development timelines are.

AND, remember, those NDAs work both ways. Ask your CDMO questions. They’ll answer them to the best of their ability without infringing on their other client’s confidentiality.

3. PROCRASTINATION (don’t be like the grasshopper)

Putting off critical supportive work until the last minute

To get drug product delivered to the clinic and conserve spending, many clients tend to put off supportive development work until the last minute. It’s essential to keep those submission-supportive studies in mind early in development. A simple, turnkey-type study may end up being more difficult than expected or yield an unexpected result. Getting these studies done earlier rather than later leaves time to understand the results and make any adjustments to your development plan design.

4. MISSED MESSAGES (who’s on first?)

Poor communication

Communication is a crucial element for smooth project flow. Efficient top-to-bottom and lateral communications help the team function in stride. The same applies to external communication. Ensure all of your supporting partners know the company’s goals. Let them know what part they play in achieving those goals. Be honest about timing and whether you include room for errors. Make sure information is updated promptly.

Lastly, document your meetings and conversations. Publish minutes that detail assigned tasks and due dates. The most common cause for delays in a project are situations where everyone on the team thinks someone else is performing a specific task when no one is.

Your experiences may highlight others. When we work with our clients, we build this into our project plans and advise our clients accordingly. Connect with us to consult about your project. We would love to hear from you. CONNECT WITH US HERE

Crawl, Walk, Skip, Run, Fly, Soar…

From the time we first hear the fable about the ant and the grasshopper, we are constantly reminded of the value of preparation and organization. This applies to every part of our lives. Our whole education system is built on it.  Learning our ABC’s and phonetics is the first step in teaching a common language enabling our ability to pass on information from person to person and across generations.  Learning “1+1=2” established the foundation of understanding the science of the world around us and the universe unfolding above us.  Learning our history teaches us the successes and failures of our past allowing us to build forward from a platform of knowledge and experience.

As our lives unfold all of these lessons build a upon one another and overlap, providing the framework that allows us to evolve from crawling, to walking, to running, to floating in hot air balloons, to the first controlled flight at Kitty Hawk, to walking on the moon, landing rovers on Mars, and more.

A Philosophy of Preparedness

Learning, being prepared, and taking advantage of the experiences of those that came before us allows us to step off from a foundation of knowledge.  That’s the philosophy we live by here at GreenField.  Within our experience, we’ve contributed to hundreds of pharmaceutical products on the market today.  Our time at a large, multinational, Fortune-500 pharmaceutical company gave us insights that are hard to come by. 

Mistakes Are Where We Learn (That’s What We Bring to the Table)

I’d be lying if I didn’t point out that we made our share of mistakes.  To be honest, making mistakes is where we learn.  Nothing drives home the value of being prepared like having to explain to an EVP that his product is going to be delayed because of a mistake, expected or not (think Cersei and the walk of shame).  The good news is, we learned from the mistakes and we bring all that experience to the table.

The Value of 100+ Years of Knowledge

Ultimately, that’s the value of hiring experienced professionals to help with your programs. We know the value of preparation, planning, and knowing what to expect as you go through the development process. Together our success and learning opportunities equal more than 100+ years of experience. That’s a value that you can’t put a price on.

“There are no secrets to success.  It is the result of preparation, hard work, and learning from failure.” – Colin Powell

FIND YOUR WAY (over and over again)

When my kids were growing up, they asked me why I became a chemist.  The question grew much more intense when they found out I had to know a lot of math in order to actually be a chemist.

In my opinion Math gets a rep. It’s fun!  You start off memorizing your multiplication tables, then you’re solving quadratic equations, then geometry proofs, and boom-you’re deriving wave equations. It doesn’t get much better than that, does it?

“WHEN” IS A LOT OF THE “WHY”

I’m not 100% sure what got me moving down the science path, but I believe a lot of it was the “when” of when I lived.  I was born in the 60’s and grew up in the 70’s. The inventions and leaps that were made in technology throughout my “when” are unreal. Here’s a short list:

Neil Armstrong walked on the moon.

Skylab launched.

North American Rockwell started the shuttle program (my dad was there).

Catalytic converters improved the air we breathe.

Cell phones came to be.

And…this is a big one…

Computers went from being megalithic room-sized contraptions that could add and subtract to desktop units that could be programed to solve those pesky wave equations!

All this happened in my life before I was 25. That’s an incredible time and I’m lucky for my “when”.

SEEING SCIENCE CHANGE THE WORLD

I saw how science changed the world and I wanted to be a part of it. I studied chemistry in college.  I added biology and physics classes to round it out.  And more math (naturally). None of it was easy. It was really, really hard. But I loved the challenge.

After college, I went to graduate school and I was lucky. I landed a brilliant advisor and a good research project.  After grad school, I had a post-doctoral stint with a leading researcher and saw more challenges and higher expectations.  These challenges kept me excited, and sometimes frustrated. Every obstacle was a chance to flex new muscles, meet people, learn things and better myself.

PRACTICE MAKES PASSION MAKES PURPOSE

From grad school, I got the opportunity to enter pharmaceutical research.  I learned about the business I’m in right now.  In that first job, I learned how to take a small scale, totally impractical bench-top synthesis, and turn it into a process we could run in swimming pool sized reactors. For the first time, all that stuff I learned had a practical purpose.  The team I was on was taking molecules discovered in a research lab and producing them for clinical trials.  We were actually making something that could make people’s lives better.  We could alleviate pain and suffering.  We could improve quantity or quality of life, and sometimes both.

EVOLVING PASSION

I was able to take that experience and learn more about the business of pharmaceuticals.  It’s a highly regulated industry and it’s the responsibility of the pharmaceutical developer to prove to all those agencies that the products we make are safe for the patient and that they actually do the things we claim they can do.  Those products have to be made safely, without contaminating the environment. We have to control the side reactions that lead to impurities that could hurt the patient which means we have to know every possible aspect of the chemistry.  We have to be able to detect those impurities and quantify them accurately.  We even have to be pro-active in what we do in case something arises later.  I was blessed to work with some of the best regulatory and quality people in this business.

And yet all that work doesn’t mean anything if you can’t produce it cost effectively.  I learned about supply chains and strategic sourcing.  I learned who made the raw materials needed to feed the manufacture of those products and the intricacies of buying them on a commercial scale, and making sure they arrive where they need to be, when they need to be there.

THE ONE THAT MAKES ALL THE DIFFERENCE

Finding a way to make all of that happen was my passion.  Seeing a product make its way through the clinical development process to commercialization may seem trivial, but it’s a very complicated path filled with challenges and pitfalls.  I’ve seen so many projects come down that path.  The majority of them fail for any number of reasons.  But getting that ONE that makes it through, that feeds the passion of a lifetime.  Knowing you helped someone.

That’s my passion and purpose.  That’s why I became a chemist.

Despite all the math.