Schedule for GEN Theater Presentations at BIO
Tuesday, May 19 and Wednesday, May 20 from 10:30 am to 5:00 pm — Booth #5807
Your participation in this year's BIO International Conference would not be complete without visiting the GEN Theater. With over 25 presentations from some of the industry's top leaders, the GEN Theater offers visitors a great opportunity to learn—at no cost—about the latest developments in life science research and the biotechnology industry.
The presentations, which run throughout Tuesday and Wednesday, span clinical development, diagnostics, bio-based therapeutics, and numerous industry topics. So review the presentations' dates and times below and don’t forget to bring a colleague!
Also, please remember to drop in at the GEN Booth #5924 to meet with a member of the GEN staff and preview our career center . We will also be allowing visitors to play our Lab Product Matching Game for a chance to win a free Flip video camera!
We look forward to seeing you then!
As media partner to the BIO convention, John Sterling, editor in chief of GEN, picked his top 10 sessions. You can also hear his podcasts on April 16 about biotech in Georgia and on April 30 on trends in the industry by clicking on Podcasts from our homepage.
Tuesday, May 19 |
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| Time | Speaker/Organization | Presentation Title | View presentation online |
|---|---|---|---|
| 10:30 am | Stephanie C. Finnegan Former CEO Goodwin Biotechnology, Inc. Tom Lytle CEO Neogenix |
Bench to Clinic - Working with a CMO |  |
| 11:00 am | Robert M. Hoffman, Ph.D. President & CEO AntiCancer, Inc. |
Hair Follicle Stem Cells for Nerve and Spinal Cord Repair | |
| 11:30 am | Tim Kelly, Ph.D Vice President, Biopharmaceutical Development KBI Biopharma, Inc |
A Platform Approach to Preformulation Development for Antibody Products | |
| 1:45 pm | Greg Adams, Ph.D. Diosynth Biotechnology |
Analytical Considerations During the Development of a Biosimilar mAb | |
| 2:15 pm | Marian Hajduch, M.D., Ph.D. Senior Scientist Palacky University |
Implementation of e-Health Principles in Czech Cancer Care and Research: Unique Opportunities for Biopharmaceutical Industry and Health Care Sector | |
| 2:45 pm | Jeff Odum Principal Consultant O'Brien & Gere |
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500 | |
| 3:15 pm | Grant Merrill Director of Project Development AES Clean Technology Inc Michael Meagher, Ph.D. Professor University of Nebraska, Lincoln, NE |
Partnering with a Design/Builder to Develop a Biotech Pilot Plant | |
| 3:45 pm | Ian Sellick Director of Marketing Pall Life Sciences |
Mechanisms of particle, microorganism and soluble contaminant removal | |
| 4:15 pm | Frank Feller Business Development Manager Fresenius Kabi Deutschland GmbH |
HESylation - Modification of Biopharmaceuticals for Superior Second-Generation Drugs | |
| 4:45 pm | Gary Pekoe, PhD President and CEO Arkios BioDevelopment Int’l. |
Strategic Regulatory Development Planning for Emerging Technology Companies | |
|
Wednesday, May 20 |
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| Time | Speaker/Organization | Presentation Title | View presentation online |
| 10:30 am | Judith Farrés, Ph.D. Business Developer ANAXOMICS Biotech |
Drug Discovery and Innovative Technologies. ANAXOMICS application of Interaction Networks to Drug Discovery | |
| 11:00 am | John M. Littleton, MD, PhD Chief Scientific Officer Naprogenix, Inc. |
Reinventing plant-based drug discovery to unblock the pharmaceutical pipeline | |
| 11:30 am | Mehdi M Yazdanpanah, Ph.D. CEO NaugaNeedles |
Self-assembled nanoneedles for in situ measurement and manipulation of soft biomaterials | |
| 12:00 pm | Stefan Schmidt, PhD, MBA Vice-President of Technology ERA Biotech S.A |
Enhancing eukaryotic protein production with the technology Zera® | |
| 1:00 pm | Killian O'Driscoll Director of Projects National Institute of Bioprocessing Research and Training (NIBRT) |
Addressing research and training challenges in the bioprocessing industry | |
| 1:30 pm | Jeremy Caudill Vice President, Sales & Business Development DSM Biologics |
Next Generation Processes – How to meet the challenges of the future? | |
| 2:00 pm | Thaddeus Prusik, PhD Senior Vice President Temptime |
From Manufacturing Facility to Patient Treatment – Preventing the Administration of Biopharmaceuticals That May Be Heat Damaged | |
| 2:30 pm | David Hughes General Manager BioPharmaceuticals Australia |
Scale-up and Manufacturing Challenges and Solutions for Biologics in Asia-Pacific | |
| 3:00 pm | Daniel Shelly, Ph.D., MBA, Director, Business Development Meridian Life Science, Inc. |
Development of a recombinant Human Parvovirus B19 vaccine to prevent Transient Aplastic Crisis | |
| 3:30 pm | Stuart Newman, Ph.D. Executive Team Business Manager Eskitis Institute for Cell and Molecular Therapies |
Back to Nature: Drug Development at the Eskitis Institute | |
| 4:00 pm | Jeremy Barker, Ph.D. CEO Queensland Facility for Advanced Bioinformatics |
Supporting biomarker discovery using integrated bioinformatics | |
| 4:30 pm | Richard Richieri Senior Vice President of BioProcess Development and Manufacturing Avid Biosciences |
The Importance of CMO Partnership for Bio-Similar Production: Market Exclusivity | |
| 5:00 pm | Sarah Gili Development Associate, Dalos BioPharma |
The Role of Botanical Products as New Infectious Disease Therapies | |
ABSTRACTS and CONTACT INFORMATION
Tuesday, May 19, 2009 10:30
Bench to Clinic - Working with a CMO
Abstract:
This talk presents a case study of a client which presented Goodwin Biotechnology, a CMO, with a novel antibody. Numerous obstacles were encountered in the manufacture of this product but eventually all were overcome. Key to our success was a high level of teamwork between the CMO and the client to ensure success, especially at this early stage of development during which so many products fail.
Speaker information:
Stephanie C. Finnegan
Former CEO
Goodwin Biotechnology, Inc.
1850 NW 69th Ave., Plantation, Florida 33313
Tom Lytle
CEO
Neogenix
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Tuesday, May 19, 2009 11:00 am
Hair Follicle Stem Cells for Nerve and Spinal Cord Repair
Abstract:
Our laboratory discovered that the hair follicle has pluripotent as well as monopotent stem cells. The pluripotent hair follicle stem cells express the stem cell marker nestin and can differentiate into neurons, glia, keratinocytes, smooth muscle cells and melanocytes in vitro. Hair follicle stem cells implanted into the gap region of severed nerves or spinal cords of mice greatly enhance the rate of nerve and spinal cord regeneration and the restoration of nerve function. Hair follicle stem cells provide an easily accessible and safe source for potential treatment of peripheral nerve and spinal cord injury.
Speaker information:
Robert M. Hoffman, Ph.D.
President & CEO
AntiCancer, Inc.
7917 Ostrow Street, San Diego, CA 92111
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Tuesday, May 19, 2009 11:30 am
A Platform Approach to Preformulation Development for Antibody Products
Abstract:
Many companies wish to simplify the preformulation development process by applying a standardized "platform approach". This constitutes a significant challenge, given the unique biophysical, thermal, and chemical properties of protein therapeutics. This challenge is perhaps even greater for a contract development organization due to the diverse nature of the protein products being developed. In this workshop, we describe techniques consistently employed across a range of antibody products to characterize the optimal base formulation conditions and define a preliminary design space.
Speaker information:
Tim Kelly, Ph.D
Vice President, Biopharmaceutical Development
KBI Biopharma, Inc.
1101 Hamlin Road, PO Box 15579, Durham, NC 27704
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Tuesday, May 19, 2009 1:45 pm
Analytical Considerations During the Development of a Biosimilar mAb
Abstract:
European guidelines for the development of biosimilars and the impending patent expiry of many leading biotherapeutic products have created highly attractive opportunities for biosimilar monoclonal antibodies (mAb). The obstacles facing the development of a biosimilar monoclonal antibody are generally considered to be more challenging than for simpler proteins (e.g., growth hormone) that can be produced in bacterial systems. This presentation discusses findings from a study conducted by Diosynth Biotechnology on how to approach biosimilar process development program on a CMO basis.s
Speaker information:
Greg Adams, Ph.D.
Diosynth Biotechnology
101 J. Morris Commons Lane, Morrisville, NC 27560
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Tuesday, May 19, 2009 2:15 pm
Implementation of e-Health Principles in Czech Cancer Care and Research: Unique Opportunities for Biopharmaceutical Industry and Health Care Sector
Abstract:
The main strategic goal of the Czech Society for Oncology (www.linkos.cz) is to establish a uniform platform for information and analytic support, equally available to all Comprehensive Cancer Centers in the Czech Republic within the National Oncology Program (www.onconet.cz). This activity was primarily established to focus on the processing of available data sources and on the collection of needed clinical data. In addition to this, the we have managed effective promotion of national research activities, namely in the field of predictive modeling of the health care consumption and costs using cancer data. Expert teams working in the Society are incorporated in many projects closely related to informatics and data analysis: 1. Processing of epidemiological data from the National Oncology Registry (www.svod.cz), 2. Evaluation of cancer prevention programs (www.mamo.cz), 3. Clinical trials data collection and 4. Research drug registries which monitor efficacy and toxicity of new drugs (www.herceptin.registry.cz, www.avastin.registry.cz, www.tarceva.registry.cz, www.renis.registry.cz, etc.). The talk will specifically addresses, how those data are routinely used in prospective planning of health care, evaluation of predictive biomarkers, efficacy and/or toxicity of novel therapies and cancer prevention programs in real clinical practice.
Speaker information:
Marian Hajduch, M.D., Ph.D.
Senior Scientist
Palacky University
Puskinova 6, 775 20 Olomouc, Czech Republic
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Tuesday, May 19, 2009 2:45
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
Abstract:
The new FDA Guidance for Industry on Process Validation states that "activities undertaken to demonstrate that utilities and pieces of equipment are suitable for their intended use and perform properly is referred to as qualification." Today's regulatory expectations for delivering facilities under a risk-based approach must focus on the intended use of the facility related to the product(s) being manufactured. This session will discuss the concepts of GEP and QbD and also identify synergies with the new ASTM E2500 standard "Standard Guide for the Design, Specification, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment." These new approaches on working under a risk-focused Quality Management System will introduce new concepts to project teams and change the way proven engineering/management systems are implemented and reviewed by FDA.
Speaker information:
Jeff Odum
Principal Consultant
O'Brien & Gere
512 East Township Line Road, Two Valley Squ., Suite 120, Blue Bell, PA 19422
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Tuesday, May 19, 2009 3:15 pm
Partnering with a Design/Builder to Develop a Biotech Pilot Plant
Abstract:
If you are preparing to enter the world of biotechnology manufacturing, join us for a short program focused on the value that a design/build partnership can provide. We will utilize a lessons-learned format to review the techniques that minimized time to market and optimized the investment made by the University of Nebraska in its Biological Process Development Facility. This world class pilot plant was built on the university's campus in Lincoln, Nebraska to develop vaccines and therapies from recombinant yeast and bacteria.
Speaker information:
Grant Merrill
Director of Project Development
AES Clean Technology Inc
422 Stump Road, Montgomeryville, PA 18936
Michael Meagher, Ph.D.
Professor
University of Nebraska, Lincoln, NE
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Tuesday, May 19, 2009 3:45 pm
Mechanisms of particle, microorganism and soluble contaminant removal
Abstract:
"Filtration" and "Purification" are terms used across a broad spectrum of industries, especially in industrial, pharmaceutical, nutritional and energy-based biotechnology but the words belie a multitude of mechanisms of action. This presentation discusses different methods for the capture for removal and capture for further processing of wanted and unwanted (contaminating) materials in fluid and gas streams, and how understanding these mechanisms can inform product choice.
Speaker information:
Ian Sellick
Director of Marketing
Pall Life Sciences
2200 Northern Blvd., East Hills, NY 11548
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Tuesday, May 19, 2009 4:15 pm
HESylation - Modification of Biopharmaceuticals for Superior Second-Generation Drugs
Abstract:
HESylation represents the technology of coupling drug substances with hydroxyethyl starch (“HES”) derivatives in order to modify the drug pharmacokinetics or solubility. The starch moiety is highly degradable, and by introducing hydroxyethyl groups we can accurately steer the pharmacokinetic and -dynamic behaviour. HES has a stellar safety record, e.g. up to 210g/day can be administered intraveniously without side effects.
Speaker information:
Frank Feller
Business Development Manager
Fresenius Kabi Deutschland GmbH
Kabi Innovation Centre, Else-Kröner-Straße 1, D-61352 Bad Homburg, Germany
[ back ]
Tuesday, May 19, 2009 4:45 pm
Strategic Regulatory Development Planning for Emerging Technology Companies
Abstract:
Small Emerging Technology companies face numerous challenges when developing a strategy for product development. Many of the challenges are unique to these companies due to their size, cost constraints, and in some cases the lack of precedent for their technology, among others. Characterizing a strategic regulatory development plan is often a neglected part of early product development, but should occur simultaneously with other early-stage tasks. Choosing a consulting partner experienced in working with small Emerging Technology companies is also very important.
Speaker information:
Gary Pekoe, PhD
President and CEO
Arkios BioDevelopment Int'[l.
421 S. Lynnhaven Road, Suite 101, Virginia Beach, VA 23452
[ back ]
Wednesday, May 20, 2009 10:30 am
Drug Discovery and Innovative Technologies. ANAXOMICS application of Interaction Networks to Drug Discovery
Abstract:
ANAXOMICS extensive systems biology experience, computational and bioinformatics tools have enabled us to effectively perform systems biology studies adapted to drug discovery. Connecting molecular events to physiological responses, training, reading and perturbing the maps, provides the ability to: identify or validate targets for therapeutic interventions, report about the possibility of a target to produce an adverse event or identify new indications for an existing drug; are some of the possible applications.
Speaker information:
Judith Farrés, Ph.D.
Business Developer
ANAXOMICS Biotech
c/ Balmes, 89 3° 7a, 08008 Barcelona, Spain
[ back ]
Wednesday, May 20, 2009 11:00 am
Reinventing plant-based drug discovery to unblock the pharmaceutical pipeline
Abstract:
The flow of synthetic drugs from conventional R & D is slowing, eroding investor confidence in the pharmaceutical and agrochemical industries. Leveraging the extraordinary diversity of bioactive metabolites from plants could reverse the trend, but current approaches to plant-based drug discovery are slow and expensive. Applying functional genomics technology to the production of biologically active metabolites by plants could facilitate the discovery and optimization of active compounds in plants, and may challenge synthetic chemistry as a source of novel molecules in the future.
Speaker information:
John M. Littleton, MD, PhD
Chief Scientific Officer
Naprogenix, Inc.
1401 University Drive, Lexington, KY 40545-0236
[ back ]
Wednesday, May 20, 2009 11:30 am
Self-assembled nanoneedles for in situ measurement and manipulation of soft biomaterials
Abstract:
A unique nano-fabrication technology has been developed for growing individual nanoneedles of silver-gallium at a selected location and orientation. These electrically conductive nanoneedles provide stiffness that is well-matched to the viscoelastic properties of complex fluids and biological materials. The technology is being integrated into platforms for combined electrochemical and viscoelastic probing of live cells and subcellular organelles within live cells. Specific progress towards this system includes recent demonstrations of using silver-gallium nanoneedle-tipped probes to (1) make precise AFM measurements of the rheological properties of polymeric liquids, and (2) puncture individual live cells and measure viscoelastic response.
Speaker information:
Mehdi M Yazdanpanah, Ph.D.
CEO
NaugaNeedles
11300 Decimal Dr., Louisville KY, 40220
[ back ]
Wednesday, May 20, 2009 12:00 pm
Enhancing eukaryotic protein production with the technology Zera®
Abstract:
Zera® improves the productivity of most eukaryotic cell lines by in vivo encapsulation of recombinant proteins into de novo synthesized storage organelles. Zera® is compatible with the majority of proteins and peptides and enables various classes of difficult to express proteins. The presentation will first illustrate the time and cost savings of the Zera® process in two cell-lines, and second describe how Zera® enriches the traditional Protein Expression. Various examples of targets and recombinant product-candidates will be drawn from ERA's own Screening program.
Speaker information:
Stefan Schmidt, PhD, MBA
Vice-President of Technology
ERA Biotech S.A
Parc Científic de Barcelona, Baldiri i Reixac, 15-21, 08028 Barcelona, Spain
[ back ]
Wednesday, May 20, 2009 1:00 pm
Addressing research and training challenges in the bioprocessing industry
Abstract:
This talk will focus on real case studies which highlight the technical solutions implemented to resolve common research and training challenges faced by the bioprocessing industry. The case studies featured include: What’s in your media? The optimization of cell culture media. Sugar and spice. Ensuring quality and efficacy of biopharmaceuticals via glycoprofiling. Can you teach an old dog new tricks? Biopharma training for the pharma industry.
Speaker information:
Killian O'Driscoll
Director of Projects
National Institute of Bioprocessing Research and Training (NIBRT)
Room 125 Engineering Building, UCD, Dublin 4, Ireland
[ back ]
Wednesday, May 20, 2009 1:30 pm
Next Generation Processes – How to meet the challenges of the future?
Abstract:
The current economic situation is requiring new solutions for the Biotech industry. Next generation processes are needed to lower CAPEX, cost of goods and reduce time to market. Examples of new technologies will be presented during the talk. The combination of HTS for downstream process development and the XD™ process from DSM show that it's possible to achieve these goals in a shorter time.
Speaker information:
Jeremy Caudill
Vice President, Sales & Business Development
DSM Biologics
45 Waterview Boulevard, Parsippany, NJ 07054
[ back ]
Wednesday, May 20, 2009 2:00 pm
From Manufacturing Facility to Patient Treatment – Preventing the Administration of Biopharmaceuticals That May Be Heat Damaged
Abstract:
Manufacturers’ strict control over heat-sensitive biopharmaceuticals is lost as products move along the cold chain through to patient administration. Physicians have concerns about their ability to know, for sure, if products are heat damaged which could negatively affect patient treatment. As biopharmaceutical companies expand distribution globally, the risk of administering undetected heat-altered product is amplified. Ted Prusik, PhD shares research on the topic and introduces a device that uses polymerization technology to accumulate all temperature conditions to which a biopharmaceutical product is exposed. This device is correlated to the heat stability of the specific product and visually indicates whether product quality may have been altered by over exposure to heat.
Speaker Information:
Senior Vice President
Temptime
116 American Road, Morris Plains, NJ 07950
[ back ]
Wednesday, May 20, 2009 2:30 pm
Scale-up and Manufacturing Challenges and Solutions for Biologics in Asia-Pacific
Abstract:
The sourcing strategies and decision-making logic which businesses need to consider in relation to production of clinical trial materials or commercial batches and the nature of the product have taken a new turn with the maturing contract manufacturing capabilities for cellular therapies, vaccines, antibodies and other biological products in the Asia-Pacific region. This session will outline the current status and will address the pros and cons for outsourcing manufacturing in new regions using Australia as a case in point.
Speaker information:
David Hughes
General Manager
BioPharmaceuticals Australia
PO Box 15168, Brisbane, Queensland 4002, Australia
[ back ]
Wednesday, May 20, 2009 3:00 pm
Development of a recombinant Human Parvovirus B19 vaccine to prevent Transient Aplastic Crisis
Abstract:
Human Parvovirus B19 (HPVB19) is a member of the family parvoviridae and genus parvovirus. These small DNA viruses replicate autonomously and destroy principally human erythrocyte precursors. HPVB19 has been shown to be the causative agent of a variety of conditions, ranging from asymptomatic infection, erythema infectiosum (EI; also “fifths disease”) in children, arthritis in adults, transient aplastic crisis (TAC) in patients with hemolytic anemia, chronic anemia in immunodeficient patients, and hydrops fetalis leading to spontaneous abortion in infected pregnant women. Immunization is a promising strategy to prevent serious parvovirus infection in high-risk groups. A recombinant HPVB19 vaccine invented by Dr. Neal Young and investigators at the National Heart, Lung, and Blood Institute (NHLBI). Initial clinical development with the vaccine showed development of neutralizing antibodies in healthy adults. Meridian Life Science, Inc. subsequently licensed the rHPVB19 vaccine technology from the NIH and is assisting the NIH with manufacturing of the vaccine and aspects of clinical development. The vaccine is a virus-like particle vaccine consisting of two viral proteins (VP1 and VP2) in separate baculovirus vectors that are co-infected at the correct MOIs into Spodoptera frugiperda (Sf9) cells and that, upon expression, self assemble at the appropriate ratio into immunogenic but non-infectious virus-like particles. The clinical development plan will be discussed along with estimates of the global disease burden caused by the HPVB19 virus.
Speaker information:
Daniel Shelly, Ph.D., MBA
Director, Business Development
Meridian Life Science, Inc.
3471 River Hills Drive, Cincinnati, OH 45244
[ back ]
Wednesday, May 20, 2009 3:30 pm
Back to Nature: Drug Development at the Eskitis Institute
Abstract:
The development of high-throughput screens has led to the development of large, synthetically-derived libraries that had little if any synergy with biological space. Eskitis has developed an enviable program of natural product drug discovery based on the unique flora and fauna of Australia, Papua New Guinea and China. Our biota collection is derived from over 40,000 specimens of plants and marine invertebrates. Using this collection as a basis, we have developed Nature Bank, a unique set of optimized, pre-fractionated natural product extracts. We offer screening of Nature Bank against partners’ drug targets using our industry-standard high throughput screening facility.
Speaker information:
Stuart Newman, Ph.D.
Executive Team Business Manager
Eskitis Institute for Cell and Molecular Therapies
Eskitis 2 Building (N75), Griffith University, Brisbane Innovation Park, Don Young Rd., Nathan, Brisbane, Queensland 4111, Australia
[ back ]
Wednesday, May 20, 2009 4:00 pm
Supporting biomarker discovery using integrated bioinformatics
Abstract:
The Queensland Facility for Advanced Bioinformatics (QFAB) is arguably Australia's largest bioinformatics service provider based in Brisbane, Australia. QFAB is a leader in supporting the bioinformatics requirements of research-intensive universities, institutions and companies including secure access to very large databases, specialist software, high-performance computing, terabyte storage, data integration technologies and expert services beyond the capability of any single institution or company in Australia or the Asia-Pacific region. These capabilities will be illustrated using case-studies involving childhood obesity and breast cancer.
Speaker information:
Jeremy Barker, Ph.D.
CEO
Queensland Facility for Advanced Bioinformatics
Queensland Bioscience Precinct, The University of Queensland, Brisbane, Queensland 4072, Australia
[ back ]
Wednesday, May 20, 2009 4:30 pm
The Importance of CMO Partnership for Bio-Similar Production: Market Exclusivity
Abstract:
The "Promoting Innovation and Access to Life-Saving Medicine Act" was proposed in March '09 which aims to reduce costs of biological therapeutics through biosimilar production. Once patents expire on name brand drugs, a race will ensue to be the first to submit an ABLA which demonstrates interchangeability, in turn earning 6 months of market exclusivity as a "biosimilar". Selection of an experienced CMO partner will be critical in order to produce quickly the data a company will require to file.
Speaker information:
Richard Richieri
Senior Vice President of BioProcess Development and Manufacturing
Avid Biosciences
14282 Franklin Ave. Tustin, CA 92780
[ back ]
Wednesday, May 20, 2009 5:00 pm
The Role of Botanical Products as New Infectious Disease Therapies
Abstract:
While medicinal therapy originated with the administration of plant-derived or obtained substances, modern pharmaceutical product development and treatment has concentrated on the discovery and synthesis of synthetic active pharmaceutical ingredients (APIs) to be used alone or in combination with other APIs. The increase in microbial resistance coupled with the increasing cost of product discovery provides the opportunity for the re-emergence of more traditional botanically-derived therapies with their own unique synergist activity and lack of microbial resistance.
Speaker Information:
Sarah Gili
Development Associate
Dalos BioPharma
421 S. Lynnhaven Road, Suite 101, Virginia Beach, VA 23452
[ back ]