02.04.2024

Biosimilars: Regulatory, Quality, and Manufacturing Excellence

At ADRES, we specialize in guiding companies through the intricate journey of biosimilar development.

Our expertise in Regulatory Affairs (RA), Quality Assurance (QA), and Chemistry, Manufacturing, and Controls (CMC) positions us uniquely to support biosimilar projects.

Regulatory Affairs:

Navigating the complex regulatory landscape is crucial for biosimilar development success.
We provide strategic regulatory planning, dossier preparation, and liaise with regulatory bodies, ensuring compliance with the stringent standards for biosimilars.

Quality Assurance:

Biosimilars development require meticulous QA processes. Our team ensures the highest quality standards are met, from development to market.
We implement robust quality systems, conduct audits, and ensure continuous quality improvement, aligning with global regulatory requirements.

Chemistry, Manufacturing, and Controls:

The manufacturing of biosimilars demands precision. We assist in developing and optimizing manufacturing processes, ensuring scalability and cost-effectiveness.
Our CMC expertise covers process development, validation, and technology transfer, ensuring consistent and high-quality biosimilar production.

For biosimilar developers, partnering with ADRES International means gaining a trusted ally, committed to excellence and success in bringing your biosimilar products to market.

Connect us, Let’s innovate together for a healthier future.

01.04.2024

Unlocking Biotech Valuation: Orphan Drug Impact & Regulatory Compliance

By: Lital Israeli Yagev

Nurexone has recently been granted Orphan Drug Designation by the FDA for their groundbreaking treatment in Spinal Cord Injury (SCI) and is now seeking the same designation in the European Union.

Why does this matter?

Orphan Drug Designation is more than just a regulatory compliance milestone. It’s a gateway to valuable incentives including tax credits, waived fees, and most importantly, exclusive marketing rights for a significant period upon approval. This not only accelerates the path to market but also enhances the commercial potential of innovative treatments.

Reflecting the market’s confidence,

Nurexone’s stock surged an impressive 78%, underscoring the positive impact of Orphan Drug Designation on biotech firms. This trend aligns with recent studies, showing that such designations can lead to substantial increases in company valuations, driven by the promising outlook of their pipeline.

At ADRES, we understand the intricacies and the immense value of Orphan Drug Designations.

Our expert regulatory consulting team has a proven track record in navigating this complex landscape, offering strategic guidance and comprehensive support to secure these designations in the US and EU. Whether it’s crafting compelling applications or articulating a strong scientific rationale, we’re here to turn challenges into opportunities.

Looking to explore how Orphan Drug Designation can transform your biotech venture? Connect us, Let’s innovate together for a healthier future.

28.03.2024

ניווט במבוך הרגולטורי: מדוע סטארט-אפים ביוטכנולוגיים בוחרים במומחיות חיצונית

בתעשיית הביוטק המתפתחת במהירות, חברות סטרטאפ ניצבות בפני אתגרים רבים, החל מהמורכבות של פיתוח מוצרים ועד לניווט במבוך של דרישות רגולטוריות.

בכל הקשור לאתגר הרגולטורי, הדרך סלולה בצמתים, מכשולים והתלבטויות. וכל מפנה מוטעה יכול להוביל לעיכובים משמעותיים בלוחות הזמנים והוצאת תקציבים גדולים יותר מהמתוכנן.

בלא מעט מקרים, ייעוץ רגולטורי לא רק יכול לסלול את הדרך לתהליכי אישור חלקים יותר, אלא גם להבטיח עמידה בתקנים גלובליים, ובסופו של דבר חוסכות זמן ומשאבים.

בכתבה זו נכיר את האתגרים המרכזיים עימם מתמודדים סטארטפים בתחום הביוטק ונתמקד בערך שטמון בייעוץ רגולטורי ממוקדד כפתרון שמייעל, חוסך משאבים ומקצר תהליכים עבור אותן חברות.

האתגרים שעומדים בפני חברות סטארט-אפ ביוטכנולוגיות

חברות סטארט-אפ ביוטכנולוגיות יוצאות למסע מלא פוטנציאל אך גם עמוס מכשולים.

אחד האתגרים הראשונים שהן נתקלות בהם הוא היכולת להפוך קונספט טיפולי למוצר בר-קיימא. טרנספורמציה זו דורשת הבנה מעמיקה לא רק של הרקע המדעי העומד מאחורי הטכנולוגיה אלא גם שליטה בנבכי הרגולציה. הנתיב ממחקרים פרה-קליניים לניסויים קליניים ולבסוף לאישור שיווק ומכירה הוא מורכב ומלא בתקנים רגולטוריים מחמירים שמטרתם להבטיח את בטיחות המוצר ויעילותו ויכולים להיות סבוכים מאד.

יתר על כן, חברות סטארט-אפ מתמודדות לעתים קרובות עם משאבים מוגבלים, הן מבחינת מימון והן מבחינת מומחיות. העלויות הגבוהות הכרוכות במחקר, פיתוח וביצוע התאמות רגולטורית יכולות למתוח את התקציבים עד קצה גבול היכולת. בנוסף, הצורך להישאר מעודכנים בדרישות רגולטוריות המשתנות כל הזמן במדינות שונות מוסיף שכבה נוספת של מורכבות. אתגרים אלה מדגישים את החשיבות של תכנון אסטרטגי, שילוב ייעוץ רגולטורי בשלבים מוקדמים וניהול משאבים כדי לשמור על תהליך הפיתוח על המסלול מבלי להתפשר על התוצאה הסופית.

אז מה היתרון בבחירת ייעוץ רגולטורי?

באילו מצבים רצוי לתעדף ייעוץ רגולטורי חיצוני ומה היתרונות של ייעוץ כזה ?

עלות מול יעילות: שכירת יועץ רגולטורי במשרה מלאה עשוי להיות מהלך יקר, במיוחד עבור סטארטאפים עם תקציב מוגבל. יועצים חיצוניים יכולים להיות חסכוניים יותר, מכיוון שהם נשכרים בדרך כלל על בסיס פרויקט.
מומחיות מותאמת לצרכים: ליועצי רגולציה יש לרוב ידע מיוחד בתחומי רגולציה ספציפיים. סטארטאפים יכולים לבחור יועצים בעלי מומחיות התואמת את הצרכים הספציפיים שלהם, במקום להעסיק עובד במשרה מלאה שאולי אין לו את אותה רמת מומחיות.
גמישות: יועץ חיצוני יכול להצטרף לתקופות הרלוונטיות לפי הצורך, דבר המאפשר לחברה להסתגל לדרישות הרגולטוריות המשתנות ללא התחייבות של עובד במשרה מלאה.
רשת ומשאבים: ליועצים מנוסים יש בדרך כלל רשת של אנשי קשר ומשאבים שיכולים להועיל לסטארט-אפים המנווטים בנוף הרגולטורי ולחסוך לא מעט כאב ראש.

בעוד שהעסקת מומחה רגולטורי במשרה מלאה עשויה להתאים לחברות סטארט-אפ מסוימות, ייעוץ חיצוני יכול להציע פתרון גמיש יותר, חסכוני ומיוחד יותר עבור חברות ביוטק רבות בשלב מוקדם.

ADRES מלווה חברות ביוטק משלב הרעיון ועד ליציאה לשוק

ADRES חברה העוסקת בייעוץ רגולטורי לחברות ביוטכנולוגיות, הוקמה על ידי רבקה זייבל, יועצת רגולטורית עם יותר מ-35 שנות נסיון בתחום. על ידי מתן שירותי ייעוץ מקיפים המכסים כל שלב במחזור הפיתוח, ADRES מבטיחה שחברות סטארט-אפ יקבלו את ההדרכה והמומחיות הדרושות כדי לעבור בהצלחה מהרעיון לשוק. תמיכה זו כוללת התאמות רגולטורית, הבטחת איכות, ניהול תוכנית קלינית ואף ייעוץ לתהליכי ייצור.

בשלבים המוקדמים של הפיתוח, ADRES עוזרת לחברות סטארט-אפ לזהות ולארגן לפי סדר עדיפויות את השלבים הקריטיים כדי להפוך את החזון שלהן למציאות. זה כולל תכנון מחקרים טרום-קליניים שמבטיחים תנאי בטיחות רלוונטיים ועומדים בציפיות הרגולטוריות הגלובליות.

ככל שהמוצרים מתקדמים לעבר ניסויים קליניים, המומחיות של ADRES הופכת לחיונית יותר ויותר. זה כולל ניהול אינטראקציות עם רשויות רגולטוריות גלובליות, הכנת תיעוד להוכחת יעילות ובטיחות של מוצר, והבטחה שכל הנתונים והידע שנצברו תומכים באישור המוצר.

תפקידה של ADRES הוא הרבה מעבר לניווט בדרישות משפטיות ורגולטוריות בלבד; הוא כולל הגנה על חברות מפני עיכובים תוך עמידה בתכנון התקציב. בזכות הנסיון והמומחיות הרבה בתחום, ADRES יוצרת מערכת תמיכה ייעוצית שעוזרת לחברות סטארט-אפ לקצר משמעותית תהליכים רגולטורים סבוכים ומגדילה את הסבירות שחברות סטארט-אפ בתחום הביוטק יגיעו למטרה הסופית שלהן: הבאת מוצרים חדשניים לשוק.

יש לכם שאלה? רוצים להתייעץ? צרו קשר ונחזור אליכם.

17.03.2024

Regulatory Consultation for Global Biotech Expansion

Expanding your biotech venture globally is an exciting journey. However, it comes with its own set of challenges, especially when it comes to navigating international regulations. This is where regulatory consultation becomes crucial. Let’s explore how it can facilitate your global expansion.

Navigating International Biotech Regulations

Each country has its own regulatory landscape, making international expansion a complex process. Understanding these diverse regulations is key to a successful global presence. Regulatory consultants can provide the expertise needed to navigate these complexities. They help ensure that your products meet the standards of each market you enter.

Strategies for Entering New Markets

Entering new markets requires a well-thought-out strategy. Start by researching the regulatory requirements of your target markets. Then, develop a plan that aligns with these regulations while considering cultural and market differences. Regulatory consultants can offer valuable insights into local regulations and help you tailor your approach accordingly.

Case Studies: Successful Global Expansions

Many biotech companies have successfully expanded globally with the help of regulatory consultation. For example, a biotech firm looking to enter the European market might partner with a consultancy like ADRES. With their expertise, the company can navigate the EU’s regulatory landscape, ensuring a smooth market entry and compliance with local standards.

Tips for Working with International Regulatory Bodies

Working with international regulatory bodies can be daunting. Here are some tips to make the process smoother:

Understand the Local Regulatory Framework: Each country has its own set of rules. Make sure you have a clear understanding of these regulations.
Build Relationships: Establishing a good rapport with regulatory bodies can facilitate smoother interactions and negotiations.
Stay Informed: Regulations can change. Keep yourself updated on any changes in the regulatory landscape.
Seek Expert Guidance: Regulatory consultants can provide invaluable support in navigating international regulations and liaising with regulatory bodies.

In conclusion, regulatory consultation is a vital component of global biotech expansion. It provides the expertise needed to navigate the complex landscape of international regulations, ensuring that your venture can successfully enter new markets and thrive on a global scale. By following these tips and leveraging the knowledge of regulatory consultants, you can set your biotech company up for international success.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

29.02.2024

𝐇𝐨𝐰 𝐭𝐡𝐞 𝐅𝐃𝐀’𝐬 𝐍𝐞𝐰 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧 𝐌𝐞𝐚𝐬𝐮𝐫𝐞𝐬 𝐂𝐚𝐧 𝐅𝐚𝐬𝐭-𝐓𝐫𝐚𝐜𝐤 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 – (Biopharma Regulatory Affairs)

Authored by Lital Israeli Yagev

The Food and Drug Administration (FDA) has always been pivotal in drug and biopharmaceutical development. With the enactment of the Prescription Drug User Fee Act (PDUFA) VII for the period 2023-2027, the FDA has introduced innovative measures that promise to revolutionize the way biopharmaceutical developers communicate with the agency, potentially fast-tracking the development process.

One of the main introductions under PDUFA VII is the expansion of the INTERACT meeting program. Originally, this program was designed to offer early advice on various aspects such as toxicology, proof-of-concept, biodistribution study design, Chemistry, Manufacturing, and Controls (more on CMC regulatory affairs) issues, and first-in-human trials, primarily in collaboration with the Center for Biologics Evaluation and Research (CBER). Now, this program has extended its reach to include similar engagements with the Center for Drug Evaluation and Research (CDER). This expansion is a significant boon for developers of complex pharmaceuticals, particularly at stages where clear guideline documents may not be readily available. By engaging with the FDA in these early stages, developers can gain invaluable insights and guidance, smoothing the path for their innovative products and the opportunity for another free consultation with the FDA, as part of the Pre-IND meeting for a later stage.

Adres operates as a regulatory affairs consultancy specializing in regulatory affairs, Medical QA and CMC. Navigating the intricate crossroads of innovation and regulation can be daunting, and securing professional advice is not merely advantageous—it is imperative.
We encourage you to seek assistance without reservation. We are here for you incase you have questions. Come pick our brains!

In addition to the INTERACT meetings, the FDA has introduced a new Type D meeting. This meeting format is designed to accelerate feedback from the agency on a narrow set of issues, limited to two focused topics. The unique aspect of this meeting type is its efficiency and specificity, involving only a few associated questions and the participation of no more than three disciplines within the FDA. What makes Type D meetings particularly appealing is the FDA’s commitment to providing response to meeting request within 14 days and written response within 50 calendar days. This rapid turnaround enables developers to receive timely feedback and make quicker decisions in their development process.

These new communication routes under PDUFA VII represent a significant step forward in the FDA’s approach to supporting drug and biopharmaceutical development. By offering more structured and timely interactions, the FDA acknowledges the complexities of modern pharmaceutical development and actively works to facilitate and expedite these processes.

The FDA’s new communication measures under PDUFA VII mark a pivotal shift in the landscape of biopharmaceutical development. By embracing these opportunities, developers can navigate the regulatory process more efficiently, bringing their groundbreaking treatments to the market faster than ever before.

Don’t hesitate to reach out for support. Remember, in this journey, you’re not alone. Feel free to contact us and pick our minds.

21.02.2024

What about the Third Stage? Continuous Process Validation (CPV)

Authored by Or Degany

In the intricate world of pharmaceutical and biopharmaceutical manufacturing, pharma regulatory consultants emphasize the importance of ensuring consistent quality and regulatory compliance. Continuous Process Validation (CPV) is a critical player in this arena, often recognized as the third stage in the process validation lifecycle. CPV’s primary aim is to demonstrate that a commercial pharmaceutical and biopharmaceutical manufacturing process remains in a state of control post-approval.

Understanding CPV Implementation Challenges

Implementing a CPV program, especially for legacy biopharmaceutical products with a long manufacturing history, poses significant challenges. These products, which have been licensed and manufactured over extended periods, may not initially align with contemporary CPV methodologies. Their process designs may be less rigorous, control strategies less developed, and process parameter classifications not fully accomplished. This gap between older manufacturing processes and current regulatory expectations requires careful navigation.

ADRES: Your Partner in CPV Implementation

At ADRES, we understand the intricacies of implementing CPV in the biopharmaceutical sector. Implementing CPV can be daunting, especially when dealing with legacy products. Understanding the nuances of process control, regulatory compliance, and quality assurance within the CPV framework requires expertise and experience.

If you’re navigating these complex waters, reaching out for expert assistance can make a significant difference.

Whether you are just beginning to explore the world of CPV or want to enhance your existing program, our team at ADRES is here to offer guidance and support. We are committed to helping you understand and implement CPV effectively, ensuring your pharmaceutical and biopharmaceutical manufacturing processes meet the highest quality and control standards.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

18.02.2024

Unraveling the Intricacies of PRIME: Your Pathway to Accelerated Medicine Approval (Biotech Regulatory Affairs)

Authored by Dr. Liron Gibbs-Bar

Embarking on the regulatory affairs journey of bringing a new medicinal product to the market is no small feat. The road is long and filled with regulatory hurdles, especially when aiming to meet the high standards required for regulatory approval and market access. However, there’s a beacon of hope for applicants, particularly those in the academic sector and small to medium-sized enterprises (SMEs): the PRIME scheme by the European Medicines Agency (EMA).

Launched in 2016, the PRIority MEdicines (PRIME) scheme represents a pivotal shift in the EMA’s approach to medicinal regulation. Its primary goal is straightforward yet ambitious: to offer continuous scientific and regulatory guidance, coupled with an accelerated assessment process for new medicines that target unmet medical needs and hold significant public interest.

For researchers and companies working on groundbreaking treatments, PRIME offers a unique opportunity. Early Entry PRIME status can be a game-changer, especially for SMEs and academic applicants. This status is granted when proof of principle is demonstrated, opening doors to invaluable guidance from regulators early in the development process.

The EMA’s recent revision to the PRIME guidelines introduces several key features to enhance the scheme’s effectiveness:

Pre-submission meetings to assist applicants in planning their PRIME application.
Expedited follow-up scientific advice with shortened timelines, providing quicker access to essential guidance.
A submission readiness meeting about a year before the marketing authorization application (MAA) filing date, offering a platform to discuss the development status and readiness of the marketing application dossier.
A revamped approach involving the submission and maintenance of a regulatory roadmap and product development tracker, taking the place of the PRIME annual update.

These enhancements are designed to deepen knowledge, and support accelerated assessments, significantly benefiting those navigating the complex waters of medicinal product development.

At ADRES, we understand the intricacies of the regulatory landscape, including the PRIME designation. Our team has extensive regulatory submissions experience, catering to SME and non-SME companies.

We recognize the challenges and opportunities of seeking PRIME status and are equipped to guide you every step of the way.

Navigating the PRIME pathway can be daunting, but with proper support and guidance, it’s a journey you can embark on with confidence.

You’ve got this!

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

14.02.2024

Phase-appropriate validation – Biotech Regulatory Affairs

By Inbal Apel

Are you a biotech or biopharma company embarking on the challenging journey of clinical trials? The road ahead, particularly in the early stages, is often fraught with complexities and uncertainties. One key area that usually raises questions and concerns is validating testing methods and manufacturing processes. If thoughts about CMC regulatory affairs keep you up at night, you’re not alone.

In the nascent phases of clinical trials, it’s typical for manufacturing methods and processes to be in a state of evolution. They are often still being refined, adjusted, and understood. This fluidity can make full validation not just challenging but sometimes unnecessary and even counterproductive. This is especially true for companies taking their first steps in clinical research and development.

To provide some perspective, let’s consider the guidelines laid out by the European Medicines Agency (EMA). Specifically, their guideline on “strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.” This guideline offers a critical insight: it points out that “the methods used for determination of the strength and/or the potency of the product need to be relevant for the intended mechanism of action, reliable, and qualified.” Note the emphasis on being ‘qualified’ rather than ‘validated.’ This distinction is crucial and underscores a more tailored approach to validation that is phase-appropriate.

Understanding the nuances of these requirements is vital for navigating the regulatory landscape successfully. It’s not just about ticking boxes; it’s about ensuring that your methods are robust, reliable, and appropriate for the stage of development your product is in. This phase-appropriate validation approach allows for a more flexible, adaptive, and ultimately more effective and cheap pathway through the early stages of clinical development.

But how do you translate these guidelines into actionable steps? How do you plan and align your company’s Gantt chart for each stage of clinical development? The task can seem daunting, especially when juggling the myriad other responsibilities that come with running a biotech or biopharma company.

This is where expert guidance on regulatory affairs can make a world of difference. Seeking advice from those who have navigated these waters before can provide clarity and direction. It can transform a confusing maze of regulations and best practices into a clear roadmap towards successful clinical trial progression.

regulatory affairs consulting

Adres is a regulatory affairs consultancy. For those who find themselves at this complex intersection of innovation and regulation, seeking expert guidance is not just helpful – it’s essential. Don’t hesitate to reach out for support. Remember, in this journey, you’re not alone.

Feel free to contact us and pick our minds https://adres.bio/contact-us.

12.02.2024

Implementing the New GCP R3 Guidelines.

Authored by Carmel Dafna

The updated ICH E6 R3 introduces key improvements from Version 2. Here are fundamental changes, focusing on how they directly impact the sponsor role:

Increased focus on Sponsor Oversight:
The update focuses on the responsibility of the sponsors to have a greater level of oversight. ICH E6 Version 3 emphasizes a more robust and proactive approach to ensure that the sponsors will play a critical role in protecting the participant’s safety and the integrity of clinical trials. This includes increasing the highlight on risk management and quality management systems.

Enhanced Sponsor Quality Assurance:
Version 3 emphasizes a proactive approach to quality management for sponsors and suggests tools and strategies to ensure the highest standards of data integrity, compliance, and overall trial success. This includes recommendations for sponsors to adopt Quality Management Systems, indicating that Sponsor Quality Assurance is adapting and evolving with the clinical research.

Risk-Based Monitoring Integration:
Significant change, allowing sponsors to evaluate how to allocate resources where they are most needed. This ensures sponsors can cultivate a more dynamic and responsive approach to managing study conduct and identifying risks.

Data Integrity and Security:
With an increased focus on data integrity and security, sponsors should be able to protect sensitive information throughout the trial. This not only addresses compliance concerns but also improves the reliability of the data generated.

Continuous Improvement Mindset:
ICH E6 Version 3 asks for continuous improvement from sponsors, expecting them to proactively assess and improve their processes to ensure that sponsors will optimize trial conduct and outcomes.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

13.12.2023

𝐀𝐫𝐞 𝐲𝐨𝐮 𝐬𝐭𝐫𝐮𝐠𝐠𝐥𝐢𝐧𝐠 𝐰𝐢𝐭𝐡 𝐭𝐡𝐞 𝐜𝐨𝐦𝐩𝐥𝐞𝐱 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝐬𝐞𝐭 𝐛𝐲 𝐭𝐡𝐞 𝐅𝐃𝐀 𝐚𝐧𝐝 𝐄𝐌𝐀?

ADRES Webinar on Pre-Approval Inspection Readiness

𝐓𝐡𝐢𝐬 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐟𝐨𝐜𝐮𝐬 𝐨𝐧 𝐢𝐧𝐬𝐩𝐞𝐜𝐭𝐢𝐨𝐧 𝐫𝐞𝐚𝐝𝐢𝐧𝐞𝐬𝐬, providing comprehensive insights into the necessary activities and best practices to face regulatory inspections confidently.

This webinar caters explicitly to companies involved in the clinical development of Pharmaceuticals, biologics, and combination products.

We promise to demystify the process and equip you with actionable strategies to transform uncertainty into confidence.

Whether it’s understanding the implications of a Voluntary Action Indicated (VAI) status from a key subcontractor or simply refining your readiness checklist, we’ve got you covered.

If you have any questions or need further assistance, please feel free to reach out to us at https://adres.bio/contact-us.

Join our YouTube channel, where you can find our original videos, with relevant information.