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THURSDAY, FEBRUARY 26 

7:20am Plenary Keynote Introduction 

7:30 TRI-CONFERENCE PLENARY KEYNOTE 2
Tissue Engineering Strategies for Musculoskeletal Regenerative Medicine in Civilian and Military Applications
Michael J. Yaszemski, M.D., Ph.D., Brigadier General, United States Air Force Reserves; Professor, Orthopedic Surgery and Biomedical Engineering, College of Medicine, Mayo Clinic
Tissue regeneration via tissue engineering strategies requires some combination of cells, a scaffold upon which the cells can attach and express their phenotypic function, and signaling molecules to direct the cells down the desired differentiation path. This cellular component often includes stem cells. This lecture will present current concepts regarding musculoskeletal tissue regeneration and the issues to be considered for its translation to clinical practice, as well as the unique reconstructive challenges encountered in combat injuries. 

8:25 Executive Summit Chairperson’s Remarks 

EXPANDING R&D EFFICIENCIES

8:30 Case Study: Cost-risk-value Optimization – A New Model that Leads to Greater R&D Efficiency
Stephen A. Williams, M.D., Ph.D., Decisionability LLC
For many years, Pharma has recognized the importance of cost, risk and value enhancement. Unfortunately, focusing on any one domain causes collateral damage to the others. Cost reduction strategies have the obvious intent of lowering costs and improving efficiency, but they can lead to a lack of resourcing to the investigation of risk, and smaller, narrower programs of lower value. “De-risking” strategies that systematically evaluate drug candidates against thresholds for all historically important causes of failure do indeed reduce risk, but increase costs and potentially reduce value by wrongly terminating drugs with higher than average benefits where the threshold should be raised. Value enhancement strategies can increase costs through expansion of programs, and increase risks as there is a disincentive to pursue any activity that might harm the value.  Sophisticated computer models can be built that take into account all of these domains, but they are resource-intensive, tend not to be trusted by the human scientists and governance bodies, and are difficult to adapt to the specifics of each project.  We describe a simple method of characterizing and monetizing risk within individual drug programs that enables the teams to identify, communicate and pursue activities that create the most value through liberating the greatest amount of risk at the least cost: cost-risk-value optimization.

DEVELOPING NEW PARTNER/ALLIANCE/COLLABORATION MODELS

9:00 Leveraging Web2.0 Social Networks for Collaborative Drug Discovery
Barry A. Bunin, Ph.D., CEO & President, Collaborative Drug Discovery, Inc.
Collaborative Drug Discovery (CD) will present a platform for more cost-effective, simultaneous global collaborations working with Industry and Foundations. CDD has created a community based platform that combines traditional drug discovery informatics with Web2.0 features to provide the best of both worlds. Four case studies will be used to highlight how community based drug discovery informatics capabilities are transforming academic, and increasingly industrial science in today’s more collaborative pharmaceutical research environment.

9:30 Deploying Enterprise 2.0 Solutions: Case Studies & Business Challenges
William Mattes, Ph.D., DABT, Director of Toxicology, The Critical Path Institute
Deploying Enterprise 2.0 and search capability into a large life sciences company presents many challenges. Although much of the technology exists already, and results from social network based business models on the internet are compelling, ensuring a positive ROI in the corporate environment can be difficult. Unclear incentives and lack of focus on change management processes account in large part for the barriers of adoption. This talk will present case studies to illustrate the provision of workspaces for team collaboration, the use of idea management software for innovation, and the prototype of a guided navigation system for domain -based search.

10:00 Innovative Collaboration Models to Achieve Competitive Advantage
Christine J. Cioffe, Ph.D., Vice President, R&D Portfolio Management, Merck & Co., Inc. 

10:30 Poster Competition, Refreshment Break & Raffles in the Exhibit Hall

INTERNATIONAL PARTNERSHIPS

11:30 Case Study: USA Company Partnerings with Companies outside the USA
David Zarling, Ph.D., M.B.A., Chief Executive Officer, Colby Pharmaceuticals
Life sciences international partnership formation and management between organizations with aligned strategic goals can find and achieve synergy to significantly reduce costs, manage risks, and to maximize resource allocation and rewards.  Life science international partnering is increasing due to the current necessity to rapidly achieve proof of principal, external validation and entry to global sales and marketing and to creatively finance product research and development. Life sciences business executives are now evaluating and working with the best and cleverest international  partner candidates willing to share and manage risk, resources or financing, but who may not necessarily be the highest bidders or the partnering candidates with the most prestige or visibility. Partnership management, especially shared expectations, communication, respect, trust and timely achievement of co-development milestones following the partnering agreement is as important as it is in the introductory, preparation and negotiation phases. International partnering and financing is increasingly for life science company product development, testing and distribution. Product candidate research and developed with international partners requires close communication, continued trust, earned respect and genuine compromise, sharing of resources, expectations, and managed risk and nearer term reward. Business models for life science businesses are currently evolving and life science companies are interacting and creatively financing product development in new ways that require international collaboration and, can require multiple international partners.

12:00pm Case Study: Building Sustainable Value Through International Partnerships
Villoo Morawala-Patel, Ph.D., Founder, Chairperson & Managing Director, Avesthagen Ltd. (Invited)

12:30 Luncheon Hosted by CHI 

1:30 Plenary Keynote Introduction

1:40 TRI-CONFERENCE PLENARY KEYNOTE 3 
Engineering Cells to Death 
James A. Wells, Ph.D., Chair, Department of Pharmaceutical Chemistry; Professor of Pharmaceutical Sciences, Departments of Pharmaceutical Chemistry and Cellular & Mole-cular Pharmacology; and Director of the Small Molecule Discovery Center, University of California, San Francisco
Apoptosis, or programmed cell death, represents an ultimate fate decision in cell biology. This process is critical for cellular differentiation and remodeling of tissues, and for anti-viral and anti-tumor defense. The study of apoptotic pathways has important ramifications for determining what is critical for cellular homeostasis, and for the development of potential anti-cancer therapeutics. A distinct molecular feature of apoptosis is the widespread but controlled cellular proteolysis, that is predominantly mediated by eight members of the caspase family of cysteine proteases. These enzymes are like demolition experts that cleave protein targets critical for cellular life. We have designed new enzymes, and antibodies, and small molecules to study and activate individual caspases and the proteins they cleave. For example, a robust proteomic method for global profiling of proteolysis ("degradomics") in cells has been developed. Key to this is an engineered enzyme, subtiligase, that permits selective labeling and enrichment for the protein N-termini created as a result of proteolysis. Using this approach we have already identified >300 caspase substrates from Jurkat cells that were induced to undergo apoptosis by treatment with the chemotherapeutic agent etoposide. The proteins fall into a wide range of functional classes, and reveal much about the molecular components, logic, and timed sequence of events that drive a cell from life to death. We believe these engineered enzymes and proteomic approaches will be useful for characterizing the proteolysis of apoptosis induced by various agents or in different cell types, and will be generally useful for dissecting protease signaling pathways

2:25 TRI-CONFERENCE PLENARY KEYNOTE 4
The Brave New World of Personalized Medicine: The Experimental Man Project, One Man Takes the Ultimate High-Tech Exam
David Ewing Duncan, Chief Correspondent, NPR Talk’s “Biotech Nation” and Best Selling Author “Masterminds”
This focus of this presentation will be on "Creative Disruptions", and will demonstrate the walking scientific response to the question: "Can they really do that?" The most important and controversial topics of today’s scientific research will be discussed, from stem cells and synthetic biology, to rising drug prices and reforming the FDA. Recently, there has been attention on science’s most significant story: a species’ potential to self-evolve. As the founder of the independent BioAgenda Institute for Life Science Studies and, more recently, as the founder of the new Center for Life Science Policy at UC Berkeley, the passion for what comes next after new technologies appear will be explored -- what happens in business, politics, science, philosophy, the media, the arts, and to society as a whole.

3:05 Networking Refreshment Break in the Tri-Conference Exhibit Hall with BEST NEW PRODUCT AWARDS
(last chance for viewing posters and exhibits) 

IMPLEMENTING NOVEL APPROACHES TOWARDS PRODUCT COMMERCIALIZATION

3:55 Executive Summit Chairperson’s Remarks

4:00 Critical Path Program - Current Status
William Mattes, Ph.D., DABT, Director of Toxicology, The Critical Path Institute
The Critical Path Initiative is the U.S. Food and Drug Administration’s (FDA) effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured. Participants will learn how the FDA is making progress to build on its unique position to work with other federal agencies, patient groups, academic researchers, industry, and other stakeholders to identify areas ripe for improvement and to coordinate, develop, and/or disseminate solutions to scientific hurdles that are impairing the efficiency of developing and evaluating FDA regulated products.

4:30 Case Study: Strategies and Novel Approaches toward Product Line Extension
Dongzhou J. Liu, Ph.D., MSc, M.B.A., Assistant Director, New Products R&D, GlaxoSmithKline
With the increasingly tough challenges in the industry, developing a new drug remains a costly and risky venture. More companies have been trying to diversify the business units, create amalgam of many smaller disease-based units, and/or extend variation of existing products to stay profitable and provide returns for shareholders. This presentation focuses on how to apply line extension strategy and novel approaches to increase productivity, economic development cycles, support innovations, and successful product launches.

5:00 Case Study: Improving Pharmaceutical R&D Productivity to Sustain Value for Stakeholders
Aditya R. Das, Ph.D., M.B.A., Director, Business Development, AAIPharma, Inc.
AAIPharma, Inc. is a global full service Contract Research and Development Organization focused on both CMC and Clinical Services. They have four novel drug delivery platforms for oral delivery that include strategies for formulating poorly soluble actives and targeted delivery to specific regions of the GI tract using qualified excipients. These platforms are offered free of any royalty or milestone payments. Attendees will learn how early stage clients can utilize these platforms to accelerate product development and reduce time to market. 

5:30 Executive Summit De-brief
Program Chair will lead an interactive discussion with participants on the knowledge and ideas they have gleaned throughout the day and how they can be applied to your working environment.

6:00 Close of Executive Summit
Participants who wish to extend their education may attend any of the Tri-Conference Sessions on Friday, February 27.
Please visit www.Tri-Conference.com for Summit updates and presenter 
biographical profiles.

Overview | Day 1 | Day 2 | Download Brochure

For questions or suggestions about the meeting, please contact:
Cindy Crowninshield
Cambridge Healthtech Institute
Tel: 781-354-0120
email: ccrowninshield@healthtech.com

For sponsorship and exhibit sales information, please contact:
Arnold Wolfson
Cambridge Healthtech Institute
Phone: 781-972-5431
Email: awolfson@healthtech.com