3rd the leading global event for designing bioequivalence...

Ensure Regulatory Compliance when Demonstrating the Bioequivalence of New Dosage Forms, Delivery Methods and Biosimilars

SUDHAKAR KOUNDINYA Principal Scientist, Pharmacokinetics

DR. REDDY’S

MAGDALENA LESZCZYNIECKA CEO

STC BIOLOGICS

AUDRA STINCHCOMB CSO

F6 PHARMA

September 26-27, 2016 | Hilton Boston Logan Airport | Boston, MA

FEATURED SPEAKERS INCLUDE:

JEROME SCHENTAG CSO

VOLANT PHARMA

AMITAVA MITRA Principal Scientist, Biopharmaceutics

MERCK

Bioequivalence Summit

3rd The leading global event for designing bioequivalence tests for multiple drug delivery systems

DETAILED MASTER CLASS on Bioequivalence Requirements

for Biosimilars! ü Understand Technical and Regulatory Factors

Behind Biosimilar Interchangeability

ü Navigate Requirements for Biosimilar Labeling

ü Compare and Contrast U.S. and International Biosimilar Regulations

ü Pinpoint the Factors Determining Biosimilar Nomenclature

ü Clarify the Manufacturer’s Perspective on Being First-to-Market

SPECIAL FOCUS: Meet Bioequivalence Criteria for

Challenging Drug Delivery Mechanisms! ü Craft Surrogate Testing Methods for Topical Drugs

ü Review the Greatest Challenges for Gel-Based Delivery

ü Spotlight Design-of-Experiment Approaches for Transdermal Patches

ü Optimize Test Designs for Sublingual and Buccal Systems

ü Accommodate Different Regulatory Approaches for Inhaled Products

ORAL INHALED TOPICAL TRANS- DERMAL

SUBLINGUAL INJECTION

TO REGISTER Contact Joel Nunez 917-258-5157 or [email protected]

Dear Colleague,

Every new formulation and generic drug needs to demonstrate bioequivalence to

secure market approval. But each of these required tests can be complicated by

innovations in drug delivery or dosing features, yielding unpredictable challenges

if companies modify delivery techniques to try to improve drug bioavailability.

And as challenging as the test designs can be for small molecule generics, the

rapidly expanding market for biosimilars demands a significant update to your

bioequivalence analysis techniques.

The 3rd Bioequivalence Summit, taking place September 26-27, 2016 in Boston,

MA, is your must-attend event for achieving true interchangeability of small

molecule generics and biosimilars across multiple drug delivery platforms. No

other conference goes into as much scientific detail in order to help broaden the

robustness and market uptake of your generic and biosimilar portfolio.

The expert speaking faculty of the 3rd Bioequivalence Summit will arm you with

the tools and knowledge needed to:

• Analyze the latest regulatory guidelines on bioequivalence

• Review improvements to bioequivalence testing protocols

• Devise strategies for bioequivalence testing across multiple drug delivery methods, including oral, topical, transdermal, sublingual and inhaled

• Understand consumer and physician perceptions of generic drugs

• Improve the performance, regulatory approval and market uptake for biosimilars

We look forward to seeing you in Boston this fall!

Sincerely,

Matt GreenbaumMatt Greenbaum Production Team Leader ExL Events

WHO SHOULD ATTEND: This conference is specifically designed for generic, pharma and biotech professionals responsible for:

ü Bioequivalence

ü Biosimilars

ü Pharmacokinetics/Pharmacodynamics/DMPK

ü Pharmaceutics/Biopharmaceutics

ü Statistics/Biostatistics

ü Regulatory/Technical Affairs

ü Drug Development

ü Formulation/Preformulation

ü Scientific Affairs

ü Drug Delivery

ü Drug Discovery

ü Research and Development

ü Chemistry

This conference is also of interest to:

ü Clinical Research Labs

ü CROs

ü Statistical Service Providers

ü CMOs

ü Regulatory Consultants

ü API Suppliers

Hilton Boston Logan Airport 1 Hotel Drive Boston, MA 02128

To make reservations, please call 1-800-HILTONS and request the negotiated rate for ExL’s September Meetings. You can also make reservations online using the following link: http://bit.ly/24KXVM4. The group rate is available until September 5, 2016. Please book your room early, as rooms available at this rate are limited.

*ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at [email protected]. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

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“Good presentation on the current practices and understanding of biosimilars.” —Principal Scientist, DR. REDDY’S

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

Do you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event or distribute promotional items to attendees. ExL Events will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact Dave Borrok, Senior Business Development Manager, at 212-400-6234 or [email protected].


Day One | Monday, September 26, 2016

8:00 Registration and Continental Breakfast

9:00 Chairperson’s Opening Remarks

Adapting Bioequivalence Tests to a Changing Regulatory Landscape

9:15 Rethink Global Frameworks and Approaches to Assess BE/BA and the Interchangeability of Generic and Branded Drugs

Drug developers are constantly required to perform bioequivalence tests for all new product formulations and delivery methods. By building a strong framework for daily requirements, you can be better prepared for more complex applications.

• Address basic requirements for BE studies• Delve into the quality, safety and efficacy of BE studies• Learn new strategies to clarify BE studies

Jeffery Liu, Director, Global Clinical Development, GLAXOSMITHKLINE

10:00 Reassess the Tolerability Range in Bioequivalence TestingTraditionally, bioequivalence tests have tolerated a very wide margin of 80-120. But challenges facing hormone-based therapeutics can make a case for tightening the range around the mean value.

• Avoid drift over time in terms of drug product• Analyze the tolerance ranges that cause the most trouble for generic

companies• Recognize regulatory preferences for tolerance ranges

John Caminis, R&D Head, Biosimilars, BAXALTA

10:45 Networking Break 11:15 Global Regulatory Approaches to the Bioequivalence of Specific Drugs and Drug Products: Challenges and Opportunities

Establishment of bioequivalence (BE) is a concept globally accepted to be pivotal to generic drug development. However, depending on the type of drug and/or drug product, the approaches for BE — right from selection of reference product to criteria for BE (based on PK/PD/clinical/in vitro endpoint) — differ significantly. Although the currently available regulatory approaches to determine BE of generic products are largely standardized for conventional oral drug products, the approaches for specific drugs (HVD, NTI) and drug products (including topical dermatological products, FDCs, paediatric formulations, orodispersible formulations and orally inhaled drug products) are either evolving or quite different across regulatory jurisdictions.

• Hear an overview of the similarities and differences between global regulatory approaches to establishing bioequivalence for specific drugs and drug products as part of the International Generic Drug Regulators Pilot Project

• Understand the challenges and opportunities in establishing bioequivalence for such drugs and drug products under global product development

• Discuss opportunities for harmonizing regulatory approaches to determine the bioequivalence of generic drug products

Shrinivas Savale, Drug Development, TORRENT PHARMACEUTICALS

Alternative Delivery Methods12:00 The Development and Application of Validated Surrogate Methods to Assess the Bioequivalence of Topical Generic Drugs

Clinical trials for topical dermatology drugs tend to be extremely expensive and time-consuming. There is an urgent need to develop alternative procedures that will more efficiently assess bioequivalence for these products.

• Analyze the status and causes of slow approvals for topical generics in multiple markets

• Review the most likely alternate methods• Accelerate approval and improve market uptake for topical products

Isadore Kanfer, Leslie Dan School of Pharmacy, UNIVERSITY OF TORONTO

12:45 Luncheon

1:45 Review the Bioavailability and Bioequivalence of Topical Drug Products Applied to Skin

Systemic PK-based clinical studies for topical dosage forms are expensive and time-consuming, and may not work if the absorption amount is very small. This can slow the development of generics and burden the healthcare system, necessitating the creation of surrogate in vitro permeation tests.

• Examine the effect of head-on drug absorption of topical dosage forms

• Study the IVIVC of surrogate tests and healthy human subject data• Ensure that surrogate methods are validated and relevant to clinical

application scenarios

Audra Stinchcomb, CSO, F6 PHARMA

2:30 Research and Developments in Sublingual Drug Delivery Systems

Innovations in drug delivery systems — especially those dealing with a drug’s administration and how bodies absorb and tolerate it — have been a growing trend in the scientific industry. In particular, sublingual/buccal drug development has significantly evolved over the last few years.

• Compare bioequivalence with and without water for new and existing formulations

• Determine the need for assessing intraoral absorption contribution• Overlap your bioequivalence test designs with patient-centric data

gathering

Sudhakar Koundinya, Principal Scientist, Pharmacokinetics, DR. REDDY’S LABORATORIES

3:15 Networking Break

3:45 Oral Bioequivalence for Proteins, Peptides and GenesOral is the preferred route of administration for chronic treatment of disease, yet most biological products are not absorbed when given orally. There are new means of avoiding the major reasons for the lack of oral bioavailability, such as the development of a stable encapsulation system that protects from acids, bile, proteases and peptidases. The encapsulated molecules are then absorbed completely by enterocytes. For the first time, oral dosing of macromolecules appears feasible without a change in dosage to compensate for losses in the GI tract.

• Avoid acid degradation in the stomach and the adverse digestive aspects of bile and proteases

• Detect in blood after oral absorption, and calculate oral bioavailability for test compounds

• Explore next steps for macromolecules, including biosimilars

Jerome Schentag, CSO, VOLANT PHARMA

4:30 Bioequivalence Assessment of Transdermal PatchesTransdermal is a route of administration wherein active ingredients are delivered across the skin for systemic distribution. Challenges arise in determining the scale of bioequivalence when conducting these studies.

• Gain insight into the challenges of transdermal bioequivalence studies

• Discuss the natural limits of drug entry imposed by the skin’s impermeability

• Examine the FDA’s expectations of ANDA submissions• Compare the One-Factor-at-a-Time (OFAT) approach versus the

Design of Experiments (DOE) approach to transdermal patches

Meena Venugopal, Vice President, Biopharmaceutics, ALVOGEN

5:15 Day One Concludes


8:00 Registration and Continental Breakfast

8:45 Chairperson’s Recap of Day One

Advances in Bioequivalence TestingTechniques

9:00 The Application of Biopharmaceutics, Modeling and Simulation to Guide Formulation Development for Bioequivalence

It is critical to delve into mechanistic understanding of formulation bioperformance by the application of biopharmaceutics principles and PBPK modeling. Such understanding of formulation performance would enable the robust design of formulations that strengthen the likelihood of their becoming bioequivalent to the reference formulation.

• Rationally design formulations that would have the best probability to be bioequivalent

• Reduce the number of bioequivalence studies• Highlight approaches to potentially waive bioequivalence studies

Amitava Mitra, Principal Scientist, Biopharmaceutics, MERCK

9:45 Alternate Study Sizes and Data Endpoints as Dictated by Drug Performance

The quality and sensitivity of your systems represents a major challenge for lab analysis. Your drug candidate will influence the type of clinical endpoint you must select to determine bioequivalence, which in turn directly impacts the size and expense of your clinical trial population.

• Identify when to focus on PK activity, PK endpoints or PD biomarkers• Preemptively design clinical trials to include enough patients to allow

for PK endpoint analysis• Pinpoint research partners with the capacity to handle the necessary

number of patients, tests and serum samples

10:30 Networking Break

Biosimilars Master Class11:00 Strengthen Your Analytical Comparability Tool Kit for Biosimilars

The FDA ranks biosimilar candidates into four distinct categories, the most desirable of which is “fingerprint biosimilars” — those that are effectively indistinguishable from the original biologic. But can you reach this degree of biosimilarity without the time and financial costs of clinical development?

• Assess how higher levels of analytical comparability would work• Envision a regulatory, analytical and process perspective• Look to and learn from successful cases of developing fingerprint

biosimilars

Magdalena Leszczyniecka, CEO, STC BIOLOGICS

Zahra Shahrokh, Chief Development Officer, STC BIOLOGICS

11:45 Explore the Interchangeability of BiosimilarsAs biosimilar development in the United States gathers momentum, pharmaceutical companies look to other markets for guidance. Europe leads the way in biosimilar development, but both regions are experiencing barriers that affect regulation.

• Delve into biosimilar interchangeability legislation from the U.S. and EU

• Examine the different principles of biosimilar substitution• Discuss legal issues associated with interchangeability

John Caminis, R&D Head, Biosimilars, BAXALTA

12:30 Luncheon

1:30 Survey the U.S. Biosimilars Labeling PathwayThe pharmaceutical industry is pressing for guidance to address biosimilar labeling. The FDA has released several draft guidances for biosimilars, raising many questions about consistent labeling standards.

• Gain insight into the implementation of labeling policy• Understand the proposed guidelines and requirements for labeling

biosimilar products• Navigate the “totality of evidence” approach to biosimilar evaluation• Explore patient-centric prescribing and choice

Jocelyn Ulrich, Assistant Vice President, PHRMA

2:15 Review Prospects for Product Naming, Pricing and Market Uptake of Biosimilars Globally

With biological medicine patents expiring in 2016, several biosimilars are set to hit the market throughout the year. Many stakeholders have voiced concerns about the regulatory framework related to these products.

• Address regulatory concerns regarding biosimilar nomenclature • Analyze biosimilar entry and uptake globally, including in Europe,

Australia and Japan • Discuss multi-stakeholder perspectives on U.S. biosimilar uptake• Identify financial incentives for stakeholders to drive the biosimilar

market • Review the manufacturer’s perspective on being first to market

Joseph Fuhr, Professor of Economics, WIDENER UNIVERSITY

3:00 Chairperson’s Closing Remarks

3:15 Conference Concludes

Day Two | Tuesday, September 27, 2016

“A difficult subject made easier.” —Principal Analytical Scientist, SUNOVION

“Complex mathematical issues were presented simply, and that made them attractive.” —Senior Biostatistician, ORION PHARMA

“Helpful examples of the proper approaches for different formulation types.” —Senior Scientist, UPSHER-SMITH

“Very interesting and informative topics.” —Director, Biopharmaceutics, IMPAX LABS


MEDIA PARTNERS

Questions? Comments? Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please email Production Team Leader Matt Greenbaum at [email protected].

EARLY BIRD PRICING* $1,895 Register By Friday, August 12, 2016

STANDARD PRICING* $2,095

ONSITE PRICING* $2,195

Registration fees for attending ExL’s 3rd Bioequivalence Summit:

*Includes Sales Tax and Service Fees

GROUP DISCOUNT PROGRAMS*Offers may not be combined. Early Bird rates do not apply. To find out more on how

you can take advantage of these group discounts, call 866-207-6528.*

Save 25% For every three simultaneous registrations from your company, you will receive a

fourth complimentary registration to the program (must register four at one time).

Save 15% Can only send three? You can still save 15% off of each registration.

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Bioequivalence Summit

3rd

SUDHAKAR KOUNDINYA DR. REDDY’S

MAGDALENA LESZCZYNIECKA STC BIOLOGICS

AUDRA STINCHCOMB F6 PHARMA

JEROME SCHENTAG VOLANT PHARMA

AMITAVA MITRA MERCK

September 26-27, 2016 | Hilton Boston Logan Airport | Boston, MA

FEATURED SPEAKERS:

Conference Code: C804

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Ensure Regulatory Compliance when Demonstrating the Bioequivalence of New Dosage Forms, Delivery Methods and Biosimilars

The leading global event for designing bioequivalence tests for multiple drug delivery systems

TO REGISTER Contact Joel Nunez [email protected]


3rd the leading global event for designing bioequivalence...

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