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Bioequivalence: Intersection Between Science & Regulatory

November 5th6th, 2014 -
Westin San Diego
, San Diego, CA

Event Summary

The Industry’s Only Scientific & Regulatory-Focused Event For Uncovering Novel Bioequivalence Approaches To Ensure A Safer, Regulatory-Compliant & Faster Time-To-Market On Future Branded & Generic Drug Products

** Please note, there is limited remaining room availability at the Westin San Diego. We advise attendees to register ASAP to secure the Curtis & Coulter reduced rate before October 22nd. **

CLICK HERE FOR SAMPLE 2014 ATTENDEE LIST

In order for generic drugs to be approved, the FDA requires bioequivalence studies to make sure the generic drug, when administered will have the same effect as the branded drug. However, ensuring the safety of a drug can be a very complex and costly process with a high failure rate. A challenge that often creates a bottleneck between the scientific community and regulatory agencies.

What can be done to bridge the gap between the scientific community and the regulatory agencies in safely bringing a new drug to market? The must-attend Bioequivalence: Intersection between Science and Regulatory Conference will share and address specific case studies and take-home examples on how we can clarify, simplify and unify the bioequivalence testing process, and ensure a faster time to market on future drug products.

Over the course of 2 days, you will hear from a number of the drug development industry’s leading bioequivalence innovators who will share multiple unique, take-home strategies, examples and best practices from scientific, practical and regulatory standpoints.

This must-attend event is co-located with Curtis & Coulter’s Oral Drug Formulation Innovations Summit. Conveniently hosted in San Diego, attendees have access to both events in the same location.

Get Registered


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Sponsors

  • gateway_analytical (2)
  • quest
  • logo

Event Partners

  • Bentham
  • Contract-pharma
  • dissolution-technologies
  • farmavitanet_logo
  • iptechex_pharmalicensing_logo
  • mnt_logo
  • OnDrugDelivery
  • pharmaphorum
  • PharmaVoice
  • pm360_logo
  • technology-networks

Interested in becoming an event or media partner?

For a full list of event partnership opportunities, please visit here and email info@curtiscoulter.com or call +1 (781) 499-2685

Agenda at a Glance

Click Here For Basic Program Agenda

Conference Topics include:

  • Emerging Bioequivalence Studies
  • Bioanalytical Methodology
  • Contemporary Challenges of Drug Design, Discovery and Development
  • Managing BA/BE Studies
  • Drug Design, Discovery, and Development
  • PK/PD Models, Biowaivers, and Biosimilars
  • Advances in Assessment of Bioequivalence
  • Bioequivalence and Drug Product Selection
  • Relevance of Genetics to BA/BE in Drug Development
  • Regulatory Policies, Procedures and Prerequisites
  • IVIVC Correlation
  • Quality Guidance for Amorphous Drugs and Crystalline Measurement Systems

Benefits of Attending:

  • 45+ industry-led speaker faculty over 2 full days sharing innovative drug development take-home strategies
  • 120+ senior participants spanning pharma, biotech, and specialty technology companies
  • 5+ hours of networking and breakout sessions, including evening cocktail reception
  • Exhibit hall with multiple leading formulation and bioequivalence providers

Speakers

  • Jan Neuhauser, PhD, Medical Assessor, Department for Medical Assessment, AGES, Austria
  • Wenlei Jiang, PhD, Reviewer, Officer of Generic Drugs, FDA
  • Alexander Pontius, PhD, Lab Head Dissolution Testing, Bayer Pharma AG
  • Arijit Chakravarty, PhD, Director, Modeling & Simulation (DMPK), Takeda
  • Anthony Lucas, PhD, Vice President, R&D, Putney, Inc.
  • Han Chao, PhD, Scientific Director, Janssen, Johnson & Johnson
  • Shefali Kakar, PhD, Senior Director, Clinical Pharmacology, Novartis
  • Ding Ding, PhD, Director, Regulatory Affairs, Zhejiang Hisun Pharmaceuticals
    (China)
  • Vit Perlik, PhD, Senior Clinical Development Manager,, Zentiva
  • Anthony Lucas, PhD, Vice President, R&D, Putney, Inc
  • Adnan Sabir, M.S., RPh, QA-CMC , Kowa Pharmaceuticals, America, Inc.
  • SImmanuel Freedman, PhD, Manager, Clinical Pharmacology Modeling & Simulation, GlaxoSmithKline
  • Anjali Joshi, PhD, Scientist I, Forest Laboratories Inc
  • Oksana Olkhovyk, PhD, Senior Scientest, Gateway Analytical
  • Marta Bellini, PhD, Senior Analytical and Formulation Scientist, Chiesi Group
  • Piyush Jain, PhD, Formulation Scientist, GlaxoSmithKline
  • Elizabeth Hewitt, PhD, Senior Scientist, Analytical Development, Small Molecules, Takeda
  • Pavel Farkas, Pharm.Dr., Senior Director, Biopharmaceutics R&D Zagreb, Teva
  • Binfeng Xia, PhD, Senior Scientist, Preclinical Dev. Biopharmaceutics, Merck & Co.

Interested in presenting at this focused event? Our speaker programs are carefully researched each year to ensure that delegates are exposed to the highest level of expertise. However, delegates not only benefit from the experience of our speakers, but also gain an insight into the experiences of other attendees.
Q&A sessions and panel discussions are utilized to enable sharing of knowledge and facilitate idea exchange.

If you have a cutting edge case study or relevant presentation and are interested in joining the speaker faculty at one of our events, please email info@curtiscoulter.com. Q&A sessions and panel discussions are also utilized to enable sharing of knowledge and facilitate idea exchange.

Please note that due to the high volume of submissions we receive, places on the speaking faculty are extremely limited and subject to approval via our conference advisory committee. Solution providers submissions should contact Mark Coulter at mark@curtiscoulter.com.

Who Should Attend

Pharmaceutical, biotech, CRO, diagnostic and academic professionals specializing in:

  • Bioequivalence
  • Pharmaceutical R & D
  • Formulation
  • Clinical Develpoment
  • Pre-formulation
  • PK / PD
  • Drug Delivery
  • Regulatory Affairs
  • Product Development
  • Biostatistics
  • Medical Affairs
  • Project Management
  • In-Licensing
  • Life-cycle Management

gateway_analytical (2)
Gateway Analytical is a full service FDA registered and inspected, cGMP-compliant laboratory that provides analytical testing services focused on delivering detailed information to generic pharmaceutical manufacturers to help them establish drug bioavailability and prove bioequivalence. Gateways patented method of chemically specific particle sizing using Raman Chemical Imaging provides visual and spectral identification of the active pharmaceutical ingredient and excipients in a drug formulation, in addition to the chemical differentiation of agglomerates, aggregates and polymorphs. Gateway works closely with pharmaceutical manufacturers to help guide them through FDA regulatory requirements which include: addressing drug formulation, manufacturing quality concerns, consulting and product submission support.
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Quest Life Sciences is a decade old CRO pioneering in the conduct of BA/BE studies and clinical trials. We are a 5 time USFDA approved center and have submitted over 500 studies including regulated and ROW markets. We are fully operational in Thailand and Russia etc, markets which mandate BE studies on local population. Handling regulated markets like US, UK, EU, TGA etc has been our prime focus including para IV submissions, patient based onco/derma studies as well.

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Chemech offers innovative contract FR&D including 505(b)(2), tech transfer, contract manufacturing and BA/BE studies (at Quest Life Sciences). We have over 20 years experience in developing:
1. Topical – Ointment, creams, gels, lotions, foams, solutions
2. Transdermal patches – Matrix-type, reservoir, active delivery systems
3. Ophthalmic solutions, semi-solids, suspensions
4. Solid orals – IR, MR, tablets, capsules
5. Liquid orals – solutions, suspensions
Both Quest and Chemech offer other independent services like bio-analytical services, regulatory support and selected clinical trial services based on client’s requirements.

Curtis & Coulter have limited sponsorship opportunities available to help showcase your solutions and services in front of the event delegation. Whether it is showing industry leadership through a speaking engagement, promoting your brand in creative ways throughout the event, hosting a networking reception, or exhibiting your products / services, please feel free to contact Mark Coulter at mark@curtiscoulter.com or call +1 (781) 499-2685 to arrange a needs assessment.*

* Please note that sponsorship opportunities are limited due to the educational-led focus of this event. Please enquire for availability.

dissolution-technologies
Dissolution Technologies is a peer reviewed quarterly publication reporting ongoing, useful information on dissolution testing. It provides an international forum for dissolution analysts to receive and exchange information on various dissolution topics.
technology-networks
Technology Networks were established over 10 years ago with the aim of providing informative websites for life science professionals. From our UK headquarters near Sudbury, in Suffolk, we run, update and provide an outstanding web-based information solution for those working within the Life Science and Drug Discovery community. Since its humble beginnings running just one website based on Combinatorial Chemistry, Technology Networks has expanded its portfolio to include over 30 communities. All of which are available through
Screenshot 2014-09-04 00.55.20
The Information Source for the Pharmaceutical Manufacturing Industry. Welcome to Pharmaceutical Online, the premier sourcing site for the pharmaceutical manufacturing industry, find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our supplier directory, product showcase, and offline search service to expedite your discovery of new products and services. Our goal is to help buyers, like you, identify and select suppliers. Over the years, Pharmaceutical Online has achieved an unparalleled reputation for the development, organization, and presentation of information for the  pharmaceutical industry. Visitors are enriched with valuable information that can improve your business and make it more profitable. Please take a moment to join our community and discover the benefits of your free membership.
Bentham
Bentham Science Publishers have gained a longstanding international reputation for their excellent standards and top quality scientific publications. Many journals published by Bentham Science have received high impact factors in their respective fields. For the current list of print, online, and open access publications, please visit www.benthamscience.com.

A Bentham Science online newsletter, BenSci, gives news and updates in all fields of social and natural sciences, technology and medicine.

pharmaphorum (3)
pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.
Contract-pharma
Every week, thousands of pharma and biopharma outsourcing professionals go to www.contractpharma.com to read current features, find stories in the archives, get breaking news and online exclusives, download surveys, Top Companies reports and whitepapers, search the Contract Services Directory and find useful links to other important content. These users are a highly targeted audience that comes back time and again for insights into this marketplace and into your products and services.
pm360_logo

PM360 is the premier, must-read monthly magazine for marketing decision makers in the pharmaceutical, biotech, and medical device industries. PM360 is the only journal that delivers practical how-to marketing information necessary for product managers/pharma marketing professionals to succeed in the complex and regulated healthcare environment. For more information, please visit: www.pm360online.com.

iptechex_pharmalicensing_logo
Pharmalicensing is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.
mnt_logo
Media News Today is the largest independent medical and health news site on the web – with over 8,000,000 monthly unique users it is ranked number one for medical news on all major search engines. Medical News Today is used by pharmaceutical, biotech and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted disease/condition and general health campaigns. For more information contact peter@medicalnewstoday.com or visit www.medicalnewstoday.com.
PharmaVoice
PharmaVOICE.com is a Website for life-sciences executives and other healthcare-service related professionals. PharmaVOICE.com is produced by PharmaLinx LLC, publishers of PharmaVOICE magazine and the VIEWs.The primary audience is made up of executive and corporate management from pharmaceutical, biotechnology, drug delivery, marketing communications, clinical services, contract research, drug development, and information technology companies.PharmaVOICE.com provides access to all of the articles that have appeared in the print publications of PharmaVOICE and the VIEWs. PharmaVOICE.com also provides an online calendar of industry events, an online discussion forum, a monthly interactive opinion poll, and other online content, supported by a robust search engine.

farmavitanet_logo
Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.

Event Pricing

Standard Pricing
Conference Only: $2195
On-Site Pricing
Conference Only: $2295

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Event Venue and Details

Venue

Westin San Diego
400 West Broadway, San Diego, CA 92101 United States
+ Google Map
Phone:
+1 (619) 239-4500
Website:
https://www.starwoodmeeting.com/Book/CurtisCoulter