Bioequivalence Innovations for Generic Oral Products: Biowaivers, Bridging, and Development for Oncology and Discontinued Products

The field of generic oral drug products continues to evolve leading to innovative bioequivalence (BE) approaches when conventional in vivo bioequivalence study designs may not be feasible. In response to these evolving complexities, this workshop is designed to address the latest advancements and regulatory challenges in the field, offering a unique platform to engage with all relevant parties, share knowledge, and contribute to the evolution of generic oral product development and regulatory assessment.

Attendees will gain valuable insights into the intricacies of developing generic oral products across diverse areas, including oncology drugs, unavailable reference listed drugs or reference standards, and drug products that are reformulated to mitigate nitrosamine risks. In addition to a series of expert-led presentations and panel discussions, in-person attendees will interact directly with experts from industry, consulting groups, academia and FDA in small group working sessions to deepen their understanding of current practices and challenges, regulatory expectations, and emerging trends. Specifically, the 2-day workshop will cover critical areas such as bioequivalence approaches for oral oncology products, risk assessment and regulatory decision making for nitrosamine-driven reformulation, demonstration of bioequivalence when a reference listed drug or reference standard is unavailable, biopredictive dissolution, and regulatory acceptance of innovative and alternative bioequivalence approaches for generic oral products. These topics reflect the most pressing challenges facing generic oral drug development today and the scientific innovations being deployed to overcome them.

Choose your experience:

Virtual Attendees will have free access to all sessions of the workshop except the small group (in-person only) working sessions. Virtual attendees will be able to:

• Attend all presentations and panel discussions
• Participate in all Q&A panel discussions by submitting questions online in real time to the speakers and panelists
• Access a session summarizing the in-person only discussions
• Enjoy free access to workshop recordings of presentations and panel discussions (not including the in-person only sessions)

In-person Attendees will enjoy all the benefits of virtual attendance as well as interactive experiences featuring:

• Interactive Small Group Working Sessions with on key topics related to bioequivalence approaches for oral oncology products, risk assessment and regulatory decision making for nitrosamine-driven reformulation, demonstration of bioequivalence when a reference listed drug or reference standard is unavailable, biopredictive dissolution, regulatory acceptance of innovative and alternative bioequivalence approaches for oral products.
• Collaborative Problem-Solving Exercises, including real-world case studies and consensus mapping to identify priorities and actionable outcomes.
• Direct Interactions with experts from industry, consulting groups, academia and FDA for clarifying regulatory expectations and exploring insights into regulatory standards.
• Networking Opportunities designed to foster collaboration and advance regulatory science supporting bioequivalence innovations for generic oral products.

Workshop Topics

• Regulatory pathways and insights for innovative and alternative bioequivalence approaches for generic oral drugs when conventional in vivo BE studies are not feasible
• Oral oncology products and BCS Class IV drugs, where ethical, scientific, and feasibility constraints are most prominent
• Biowaiver and alternative BE strategies supported by biopredictive dissolution, absorption and PBPK modeling, and model-integrated evidence
• Bridging challenges for discontinued products, including unavailable reference standards
• BE implications of nitrosamine-driven reformulation, emphasizing risk-based regulatory approaches

Audience

The workshop is designed for professionals interested in advancing their understanding of regulatory science relating to innovative and alternative bioequivalence strategies for oral drug products. It is ideal for individuals involved with the product development, bioequivalence demonstration, and regulatory assessment of oral drug products. It provides an opportunity to address challenges and questions related to biowaivers, alternative BE strategies for oncology and BCS IV drug products and developing generics when a reference standard is unavailable, and to discuss the BE implications of nitrosamine-driven reformulation. This workshop is relevant to formulation scientists, analytical scientists, regulatory affairs specialists, quality control experts, biopharmaceutics, clinical pharmacology and R&D professionals from industry, consulting groups, academia, and FDA.

• Virtual Attendance is ideal for those who wish to access expert presentations and panel discussions remotely, eliminate travel requirements, and have the flexibility to engage with content in real time or on demand.
• In-Person Attendance is best for participants seeking high-level engagement through collaborative small group working sessions, direct interaction with experts from industry, consulting groups, academia and FDA, and immersive learning focused on real-world challenges and problem-solving.

Registration Fees:

• This workshop is FREE for virtual attendees.
• The combined cost for the two-day workshop in-person attendance and activities is:
  • $350, in-person attendees – general
  • $150, in-person attendees – government (must have an email ending in “.gov” to register at this rate)

For faculty and students from the University of Maryland, Baltimore, The Universities at Shady Grove, and University of Michigan, please contact CRCG (info@complexgenerics.org) regarding registration.

Continuing education (CE) credits will not be provided for attending this workshop.  A certificate of attendance will only be provided to individuals attending in-person, when requested.

For in-person attendees, beverages and food for breaks will be provided; lunch is not included.  Please see the tab Ordering Lunch to order lunch each day.  You can go to Dawson’s Market as well, located in Building III, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch, as well.

Introduction to the Workshop

This two-day workshop will highlight bioequivalence (BE) approaches for generic oral drug products when conventional in vivo BE studies may not be feasible. The workshop will explore biowaiver pathways supported by bio-predictive dissolution, absorption modeling, and model-integrated evidence. The program will address BE strategies for oral oncology products, for bridging BE when designated reference listed drugs (RLDs) or reference standards are unavailable for discontinued products and when surrogate comparators are needed, and for the reformulation of nitrosamine-impacted drug products. Sessions will highlight scientific justifications and regulatory considerations for implementing these alternative BE strategies. Data integrity, reproducibility, model credibility, and well-defined criteria will be emphasized for establishing BE in complex and challenging generic oral drug development scenarios.

Participants will gain critical insights into the BE approaches described above as well as other related topics including biopredictive dissolution and strategies for regulatory acceptance of innovative and alternative BE approaches within the scope of generic oral products. Sessions will feature expert presentations, case studies, and interactive panel discussions.

In-person attendees will benefit from small-group working sessions focused on real-world challenges, best practices, and actionable solutions, offering a unique opportunity for direct engagement with regulators and thought leaders from industry and academia.

DAY 1:

Session 1: Bioequivalence Approaches for Oral Oncology Products 

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• This session will highlight how FDA and industry approach bioequivalence decision-making for oral oncology products when ethical constraints, patient feasibility, and limited study options require the use of alternative evidence and clearly defined decision thresholds.

Session 2: Nitrosamine-Driven Reformulation and Bioequivalence: Risk Assessment and Regulatory Decision-Making

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• This session examines how nitrosamine-driven reformulation should be evaluated within BE frameworks, emphasizing scientific justifications, risk-based assessment, and when alternative BE evidence is appropriate, particularly for BCS IV immediate release and modified release products.

Session 3: Discontinued RLDs and Unavailable Reference Standards: A Structural Barrier to Generic Access

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• This session frames discontinued RLDs and unavailable reference standards as a barrier to generic access, highlighting the public-health impact, regulatory constraints, and alternative approaches to resolve the problems.

Session 4: Small-Group Working Sessions

Format: Interactive Working Session (In-Person Attendees Only)

• In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, consulting groups and academic experts. In-Person Attendees will engage in discussions related to challenges and opportunities of bioequivalence approaches for oral oncology products, nitrosamine-driven reformulation and bioequivalence, and developing generic products when a reference standard is unavailable. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable research or policy recommendations. Direct interactions with experts from FDA, industry, consulting groups and academia will be fostered.

DAY 2:

Session 5: When Is Dissolution Truly Biopredictive? 

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• This session highlights when dissolution data can credibly transition from a quality control tool to regulatory evidence for bioequivalence, focusing on biorelevant/predictive dissolution, discriminating capabilities of the testing media/method, integration with modeling, evidence sufficiency, and common dissolution-based BE arguments.

Session 6: Regulatory Acceptance of Alternative Approaches  

Format: Presentations and Panel Discussion (Virtual and In-Person Attendees)

• This session explores strategies for achieving regulatory acceptance when using alternative approaches to establish bioequivalence in challenging scenarios.

Session 7: Small-Group Working Sessions

Format: Interactive Working Session (In-Person Attendees Only)

• In this collaborative session, participants will join small-group discussion tables facilitated by FDA, industry, consulting groups and academic experts. In-Person Attendees will engage in discussions related to the solutions (e.g., biopredictive dissolution and regulatory acceptance of alternative approaches) to address the challenges discussed on Day 1. Attendees will engage in guided discussions, consensus mapping, and reporting of actionable next steps. This session will foster direct interactions with experts from FDA, industry, consulting groups and academia.

For the May 5-6 workshop, you will need to pre-order your lunch for each day; lunch is not provided.  Lunch will be delivered to the main building where the workshop will be held (Building II, Ballroom) and labeled with your name.  You will pick up your ordered food at the registration desk, each day. 

You can go to Dawson’s Market as well, located in Building III, first floor.  Hours are 9 AM-5 PM ET.  The cafe has additional food and beverage options there.  You are welcome to bring your lunch, as well.

The link for placing your order for Day 1 (May 5) is: https://square.link/u/v9xMwlxI

The link for placing your order for Day 2 (May 6) is: https://square.link/u/tRQgNkZk

Make your selection and Add to Order.  Once you have made your selection, you will then click on the shopping cart icon to check out.  If you want to purchase more than one item for the same day, you will need to place two separate orders.  You will Continue to Payment, where you can pay with Google Pay, Credit Card, or Cash App Pay.  Then hit Place Order.

During checkout, there is a spot for Note to Seller, to use when placing your order, if needed for modifications to your order.

The deadline for ordering lunch is Monday, April 27^th by 5 PM ET.

Coffee, water, and pop will be available throughout each day in the conference room (Ballroom). 

Food will be provided in the morning, and AM and PM breaks each day.

USG Lunch (Dawson’s Market)

 Chicken Caesar Wrap $14.99 Includes chips, cookie, and choice of beverage

Turkey & Swiss Wrap $14.99 Includes chips, cookie, and choice of beverage

Tuna Salad Wrap $14.99 Includes chips, cookie, and choice of beverage

Grilled Vegetables & Hummus Wrap $14.99 Includes chips, cookie, and choice of beverage

Eggless Egg Salad Wrap (VEGAN) $14.99 Includes chips, cookie, and choice of beverage

You will have the option to remove tomatoes and/or cheese, if needed

Greek Salad $14.99 Includes romaine lettuce, tomatoes, onion, kalamata olives, bell peppers, feta cheese, pepperoncini peppers served with Dijon vinaigrette. Includes chips, cookie, and choice of beverage

Grilled Salmon Caesar Salad $15.99 Includes chopped romaine, house made croutons, shredded parmesan & Caesar dressing. Includes chips, cookie, and choice of beverage

Goat & Greens $14.99 Includes spinach, cranberries, pecans, tomatoes, goat cheese served with balsamic vinaigrette. Includes chips, cookie, and choice of beverage

Hot Items

Tomato Basil Soup  $6.99

Taco Bowl  $15.99 Your choice of [fajita chicken, ground beef, or vegetables] on a bed of rice with mixed greens, fajita vegetables, black beans, shredded cheese, and toppings on the side (guacamole, sour cream, and salsa)

Beverage Choice

Coke

Diet Coke

Sprite

Water

Just Tea-Mango White (additional $1.00)

Just Tea-Original Green (additional $1.00)

Just Tea-Half & Half (additional $1.00)

Dr. Browns-Cream

Dr. Browns-Black Cherry

Dr. Browns-Root Beer

Olipop-Grape (additional $1.00)

Olipop-Ginger Lemon (additional $1.00)

Olipop-Cherry Cola (additional $1.00)