World renowned faculty and leading industry experts will impart the knowledge and insights gained through current research, ventures and best practices. Selected faculty have unparalleled experience in bringing innovation to market in the life science industry.
Faculty Leaders
» Martin Babler
President & CEO, Talima Therapeutics, Inc.
Martin Babler was until recently VP of Immunology Sales and Marketing at Genentech with responsibility for Xolair, Rituxan Immunology and the late stage Immunology pipeline.
Prior to this, Martin was Senior Director and head of Commercial Development in charge of marketing and strategic input for all products in Genentech's pipeline across the different therapeutic areas. His team was focused on creating high value assets in close collaboration with Research and Development and introduced several new tools and systems to the organization that help optimize product launches.
Martin joined Genentech several years ago as Director of Marketing in the Cardiovascular Franchise.
Prior to joining Genentech, Martin held various roles of increasing responsibility in sales, sales management, marketing and business development on a global as well as affiliate level with Eli Lilly and Company.
Martin Babler holds a degree in Pharmacy/Pharmacology from the ETH in Zurich, Switzerland and has attended the Executive Development Program at Kellogg Graduate School of Management.
» Ashraf Hanna, M.D., Ph.D.
Vice President, Alliance Management and Pipeline Strategy Support, Genentech
Ashraf Hanna, 38, will join Genentech in a newly created position as vice president, Alliance Management and Pipeline Strategy Support, reporting to Susan Desmond-Hellmann, M.D., M.P.H., president, Product Development. Working with Business Development, the Project Portfolio Management Group, and Research and Development, Hanna will be responsible for establishing, implementing and evaluating alliance management strategy and process.
Prior to joining Genentech, Hanna was vice president at Tanox, with responsibilities for strategic planning and business development. Prior to that, Hanna worked for McKinsey and Company and was a medical resident at Metrowest Medical Center.
Hanna holds a Bachelor of Arts degree in Physics from the University of Chicago, a doctorate in Physics from Harvard University and a medical degree from the University of Massachusetts Medical School.
» Judith A. Hasko
Partner, Latham & Watkins
Judith A. Hasko is a partner in the Silicon Valley office of Latham & Watkins. Ms. Hasko is a member of the Technology Transactions and the Health Care and Life Sciences practice groups. She also currently serves as a member of the firm's Global Recruiting Committee.
Ms. Hasko's practice focuses on representing biotechnology, pharmaceutical, medical device and other companies and investors in a wide range of technology-based commercial transactions. She works with both private and public companies in domestic and international transactions, counseling such companies with respect to corporate partnering, joint venture, asset purchase, spin-out, licensing, distribution, manufacturing, co-development, profit-sharing and co-promotion matters. She also advises investors with respect to licensing and intellectual property matters arising in private and public offerings by life sciences companies.
Ms. Hasko's representative transactions include advising Corgentech in its co-development, co-promotion and profit-sharing agreement with Bristol-Myers relating to a phase 3 clinical stage product, potentially worth more than $550 million; representing Tularik in its collaborations and licenses with companies such as Eli Lilly & Co, Japan Tobacco and Amgen; advising Nektar Therapeutics in its largest and most comprehensive deal to date -- an agreement with Bayer HealthCare to develop and commercialize NKTR-061, an inhaled amikacin for the treatment of pneumonias, which may yield up to $175 million in payments to Nektar; and working with clients such as Abgenix and Gilead in various strategic licensing and IP matters, including collaborations with domestic and international pharmaceutical companies. She joins Latham & Watkins from the Palo Alto office of Cooley Godward LLP, where she was a partner in the firm's life sciences practice since 2001.
Ms. Hasko received her J.D. degree cum laude in 1994 from the University of Wisconsin Law.
» Abhay Joshi, Ph.D.
President & CEO, Alvine Pharmaceuticals
Dr. Abhay Joshi is the President, CEO and Director of Alvine Pharmaceuticals, Inc. He has over eighteen years of global operations and research and development experience in biologic, pharmaceutical and medical device industries in the United States, Europe, Latin America and Asia Pacific. Prior to Alvine, Dr. Joshi served as an Executive Vice President, Chief Technical Officer and member of Executive Committee at CoTherix, Inc., now Actelion Ltd. Dr Joshi held various senior management positions at Allergan. He was the Vice President of Global Technical Operations, Specialty Pharmaceuticals at Allergan where he was responsible for the company's global biologics manufacturing operations for BOTOX® and its Latin America and Asia Pacific pharmaceutical operations. Dr. Joshi received his BTech in Chemical Engineering from the Indian Institute of Technology, New Delhi, an MSE and a Ph.D. in Chemical Engineering from the University of Michigan, Ann Arbor, and an MBA from the University of California, Irvine. Dr. Joshi holds an adjunct faculty appointment at the University of Southern California School of Pharmaceutical Sciences.
» Eric J. Patzer, Ph.D.
President and CEO, Aridis Pharmaceuticals, LLC
Dr. Patzer has 22 years experience in product development beginning his career at Genentech in 1981. Dr. Patzer played a key role in the development of Activase®, Protropin®, Herceptin® and Xolair®. As Vice President, Product Development, Dr. Patzer's responsibilities included analytical development, hybridoma development, preclinical animal testing, QA/QC and project and portfolio management. Dr. Patzer played a key role in developing the product development and management process at Genentech.
In 1996 Dr. Patzer joined Aviron (now MedImmune Vaccines) as Vice President, Development. Under his leadership, the Development organization was expanded to support the development of the intranasal influenza vaccine (FluMist®) through preclinical and clinical development and resulting in U.S. regulatory approval (FDA). The organization consisted of the following departments: analytical development, clinical QC testing, process and formulation development, clinical manufacturing, clinical laboratory testing and project management. Dr. Patzer was the project team leader of the intranasal influenza vaccine, FluMist®, during preclinical and clinical development.
In 2003, Dr. Patzer founded Aridis Pharmaceuticals, LLC to develop convenient and cost effective therapeutics for infectious diseases focused on live attenuated vaccines and antibody therapies that can be delivered in simple oral or pulmonary dosage forms and that can be stored outside the cold chain (i.e., are stable at room temperature and above). Aridis is currently developing two temperature stable oral vaccines against rotavirus gastroenteritis in infants and shigellosis in adults and children and a temperature stable antibody therapeutic against pulmonary infections with Pseudomonas aeruginosa.
» Janet L. "Lucy" Rose
Managing Director, Life Sciences Regulatory & Capital Markets Consulting, Deloitte & Touche LLP
Former Director of the Office of Training and Communications and DDMAC, CDER, FDA
Lucy Rose is uniquely qualified to provide regulatory training and consulting to the pharmaceutical industry and its service support providers, such as public relations firms, advertising agencies and CME providers. Her combination of education and experience, coupled with her extensive experience as a trainer and educator, provides the depth of knowledge and expertise necessary to equip companies to face a promotional environment changing at warp speed.
From 1995-97, Lucy served as the Director of Office of Training and Communications for the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration. There she designed and implemented programs to improve external communications with consumers, patients, the pharmaceutical industry and health care professionals. Additionally, she designed and implemented programs to improve employee performance, including leadership and management development. Examples of programs introduced during Lucy?s leadership include: design and implementation of CDER's World Wide Web Site, Live Satellite Educational TV programs with the pharmaceutical industry, comprehensive introductory training programs for new reviewers, and design and implementation of CDER's crisis communication program.
Lucy led CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) from 1993 to 1995. In this capacity, she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. health care professionals and consumers. Under Lucy?s leadership, the division intiated a philosophy of transparency and educational outreach, in addition to setting clear review priorities and timeliness goals for industry-requested comments, such as voluntary submissions of launch campaigns. Special challenges encountered during her tenure included the FDA Industry Supported Scientific and Education Guidance and the evolution of Direct-to-Consumer Broadcast advertising, among others.
Prior to joining FDA, Lucy was associated for seven years with Mead Johnson Pharmaceuticals, a division of Bristol-Myers Squibb Pharmaceuticals. She began her career as a sales representative, served as a regional sales trainer, and for four years was the District Sales Manager in Washington, DC. Lucy earned a B.S. degree in biology from Salem College in Winston-Salem, NC and an M.B.A. from Averett College. In addition, Lucy practiced as a board-certified Physician Assistant, having graduated from the Wake Forest School of Medicine.
Lucy has been honored with a number of awards. The FDA twice selected her for their highest leadership accolade, the Award of Merit, for her work at DDMAC and at Office of Training and Communication. In 2004, Phame, an award organiation that evaluates Direct-to-Consumer promotion, elected her to its DTC Hall of Fame for her many years of leadership in the DTC arena. Additionally, Lucy speaks extensively at professional conferences on the regulatory and compliance issues surrounding the promotion of prescription drugs. She is an active member of the Drug Information Association and the Food and Drug Law Institute.
Session Leaders
» John T. Bigalke
Vice Chairman and U.S. Managing Partner, Health Sciences & Government
Deloitte & Touche LLP
John Bigalke is Vice Chairman and a member of the Board of Directors of Deloitte & Touche USA LLP. He is the Managing Partner of our Health Sciences & Government practice. John's work in public accounting began in 1977, and he has many years of experience in the life sciences and health care industry, including participation in fraud investigation and litigation defense projects; expert witness testimony; due diligence and deal structuring for mergers and acquisitions transactions; SEC filings and tax-exempt bond financing; operation efficiency reviews; strategic planning; and performance improvement projects.
The life sciences and health care industry has recognized John's know-how and commitment through appointments to various industry and professional leadership positions, including the National Board of Directors of the Healthcare Financial Management Association, where he has served on the Executive and Governance Committees and the Principles and Practices Board. John also has served as a member of the American Institute of CPAs' Healthcare Committee and as chairman of their Healthcare Conference Committee. Internally, John serves on the Finance & Audit Committee of the Board of Directors. He has served on a variety of internal committees and task forces.
John is a recent graduate of Columbia University Graduate School of Business Leadership Development Program. Additionally, he has been recognized as a Distinguished Alumni of Clemson University.
He is a co-author of Med Inc. and Financing Technology's Frontier and author of numerous articles. He is a member of the American Institute of CPAs, the Florida Institute of CPAs and is licensed as a certified public accountant in seven states.
» Keith Donnermeyer
National Life Sciences Industry Leader, Deloitte & Touche LLP
Keith has over 30 years serving the Life Sciences and Health Care industry in a variety of capacities. He leads the industry practice for Deloitte on the West Coast and serves on the firm's National Life Sciences Management committee. In his capacity he overseas the Deloitte services provided to virtually all of its West Coast biotech and pharmaceutical clients, regardless of the nature of those services. In addition, to his leadership role he also serves as the lead partner serving some of the firm's largest clients in the biotech industry. As a senior partner for Deloitte, Keith has assisted many public companies, international clients and early-stage companies with mergers & acquisitions, IPO services, regulatory matters, capital financing and strategic and operational matters. He has also assisted numerous companies with Sarbanes-Oxley Section 404 readiness and attestation engagements.
He is an active member of a variety of industry associations including BIO, BayBio, Biocom and CHI. Keith is also a member of the Board of Directors for BayBio. He participated in the 2005 UC Berkeley BioExec Institute. He is a frequent speaker and presenter for industry matters at Deloitte presented programs. He is a CPA and a 1975 graduate of the University of Wisconsin - Eau Claire.
» R.T. (Terry) Hisey
Vice Chairman, U.S. Life Sciences Leader, Deloitte & Touche USA LLP
Terry Hisey serves the Life Sciences industry in bringing Tax, Audit, Consulting, and Financial Advisory Services to assist clients in achieving sustainable competitive advantage through strategic change. The Life Science activities span the entire value chain including Drug Discovery & Development, Commercial Operations, Production & Distribution, and Regulatory Compliance. In addition to Life Sciences, his responsibilities also include linking the Life Science effort with those in Health Providers, Health Plans, and Government to identify and capitalize on the unique capabilities that Deloitte could offer based on our depth in all aspects of the value chain. Terry is Chairman of the Life Sciences Advisory Board for Deloitte Research and is a Steering Committee member for the Deloitte Center for Health Solutions in Washington, DC working with The Honorable Tommy Thompson, Former U.S. Secretary of Health and Human Services.
Terry was previously the Vice President and National Leader of the Life Science Practice of a major global consulting & integration firm and was a global leader in their efforts regarding Life Science thought leadership in strategy, transformation, and operations. He has personal client service experience with a number of Pharmaceutical and Biotechnology firms that includes Amgen, Merck, Abbott, Genentech, Pfizer, GlaxoSmithKline, Wyeth Biopharmaceuticals as well as other major and mid-size Life Science companies.
In addition to his client work, Terry is a noted industry authority, a frequent speaker, the Strategy Advisor to Pharmaceutical Executive Magazine and a guest lecturer at several schools including the University of Pennsylvania and Drexel University. In addition, Terry is a member of several industry associations and advisory boards and he is the Deloitte sponsor for the William and Phyllis Mack Center for Innovation at the Wharton School of the University of Pennsylvania. Terry has a BS in Engineering from Penn State and a MS in Business & Organizational Management from the University of Pennsylvania.
» Matthew K. Hudes
U.S. Managing Principal, Biotechnology, Deloitte Consulting LLP
As national managing partner, biotechnology, for Deloitte & Touche USA LLP's Life Sciences & Health Care practice, Matthew Hudes is a seasoned professional with more than 17 years of experience in a broad array of biotechnology arenas. As practice leader in this dynamic sector, Matthew directs strategic professional services for leading biotechnology and pharmaceutical companies.
Before joining the Life Sciences & Health Care practice, Matthew worked extensively within the biotechnology arena, including being chief executive officer of a software company that developed a system to find patients (and investigators) for clinical trials to improve researchers' access to information typically "trapped" in laboratory and medical systems. He has directed the management teams of three successfully acquired biotech start-ups and has worked with many leading-edge companies in life sciences and high technology.
He speaks frequently about the use of technology for innovating clinical research, manufacturing and quality, regulatory compliance, supply chain and other topics. He also has written extensively about the business of biotechnology.
» Paul H. Keckley, Ph.D.
Executive Director, Deloitte Center for Health Solutions
Dr. Keckley, is Executive Director for the Deloitte Center for Health Solutions ("the Center"), a part of Deloitte & Touche USA LLP. In this role, Dr. Keckley provides strategic guidance on the development of Center research and thought leadership. Dr. Keckley brings to Deloitte 30 years of experience in academic medicine and the private sector. He is regarded as a primary expert in health care economics, health policy and trend analysis.
Prior to joining Deloitte, Dr. Keckley served in several key roles at Vanderbilt University. He was the Executive Director of the Vanderbilt Center for Evidence-based Medicine (VCEBM), Associate Professor at Vanderbilt University School of Medicine, and an Associate Professor of Health Management at the Owen Graduate School of Business. He continues to teach in the Schools of Medicine and Business on an adjunct basis.
In the Center for Evidence-based Medicine, he conducted research evaluating how consumer adherence to evidence-based treatment directives might be achieved, how health insurers incorporate evidence in their coverage and pay for performance programs, and methods for integrating evidence-based practices in provider organizations.
Dr. Keckley led efforts by the Vanderbilt Medical Group to develop, integrate and measure adherence to evidence-based pathways and order sets. He led Vanderbilt joint ventures involving clinical outsourcing in domestic and international settings and spearheaded Vanderbilt's entry into integrative health, with the anticipated opening of the Vanderbilt Center for Integrative Health scheduled for November 2006.
Before joining Vanderbilt, Dr. Keckley served as Chairman of the Board of Interdent, a California dental practice management company; Chief Executive Officer of EBM Solutions, a developer of evidence-based guideline software; Chief Executive Officer of Aveta (formerly the IPA Management subsidiary of PhyCor Inc.), and Principal of The Keckley Group, a strategic planning consulting practice that served 1,200 U.S. provider organizations and health plans.
Dr. Keckley is an active member of several societies and editorial boards, and has authored numerous articles and three books. He has been profiled by ABC's 20/20, CBS's 60 Minutes, Fox News, CNN, The Wall Street Journal, and has been featured as a keynote speaker at several national industry meetings. Dr. Keckley has also testified for state Medicaid Review Committees in Utah and Tennessee about the potential impact of evidence-based standards on benefits for enrollees.
Dr. Keckley received a B.A. from Lipscomb University, his MA/PhD from Ohio State University, and completed a fellowship in economic policy at Oxford University.
2008 Invited & Confirmed Key Industry Speakers
» Jack Anthony
CEO, Osprey Pharmaceuticals
Mr. Anthony most recently was chief executive officer at Pharmix Corp., a San Francisco-based computational design drug company. Prior to Pharmix, Mr. Anthony was responsible for creating many successful in-licensing and out- licensing partnerships, as senior vice president of business development at Saegis Pharmaceuticals, now part of Lundbeck of Denmark. Mr. Anthony also was senior vice president of business development at Tularik, where he played an instrumental role in the acquisition of Tularik by Amgen in 2004. Mr. Anthony has served in senior business development and marketing positions at such innovative biotechnology firms as FibroGen, Cell Therapeutics, and Inhale (now Nektar) Therapeutics, negotiating research, development and commercialization deals with numerous universities, and global biotechnology and pharmaceutical companies. Mr. Anthony began his career in life sciences with Baxter Healthcare Corporation, where he spent more than 15 years, ultimately serving as a vice president of Baxter's Blood Therapy Group. He earned a Bachelor of Science degree in biology from Allegheny College.
» Steve Buckanavage
Vice President, Global Marketing, Oncology & Infection Therapy Area
AstraZeneca Pharmaceuticals
- Over 22 years of pharmaceutical sales and marketing experience
- Led two oncology product launches in the US
- Oversaw three product line extension launches in Europe and Japan
- Led a phase III clinical development team in Europe
- Sits on the global Oncology and Infection Therapy Area Team as the commercial leader
- Currently responsible for strategic commercial view on internal and external projects impacting the AstraZeneca Oncology and Infection portfolio
» G. Steve Burrill
CEO, Burrill & Company
G. Steven Burrill has been involved in the growth and prosperity of the biotechnology industry for over 40 years. An early pioneer, Mr. Burrill is one of the original architects of the industry and one of its most avid and sustained developers. He currently serves as Chairman of the Board of Pharmasset (NASDAQ: VRUS) and is a member of the Boards of Directors of Catalyst Biosciences, DepoMed (NASDAQ: DEPO), Intranasal, Phytomedics, Proteogenix, Proventys, Targacept (NASDAQ: TRGT) and XDx. Prior to founding Burrill & Company in 1994, he spent 28 years with Ernst & Young, directing and coordinating the firm's services to clients in the biotechnology/life sciences/high technology/manufacturing industries worldwide. In 2002, Mr. Burrill was recognized as the biotech investment visionary by the prestigious Scientific American magazine (The Scientific American 50).
Mr. Burrill is a founder and currently serves as the Chairman of the Board of the Foundation for the National Medals of Science and Technology. Additionally, he serves as Chairman of the Board on Campaign for Medical Research as well as Chairman of the San Francisco Mayor’s Biotech Advisory Committee (MAYBAC). Other not-for-profit activities include serving on the Boards of Directors for the Bay Area Science Infrastructure Consortium, BayBio, California Healthcare Institute, The Exploratorium, Genetics Policy Institute, The Kellogg Center for Biotechnology, Kramden Institute, The National Health Museum, and Research!America. He also serves as an advisor on the MIT Center for Biomedical Innovation.
» Jennifer E. Cook
Vice President, Product Portfolio Managment, Genentech, Inc.
Bio coming shortly.
» Simon Gisby
Managing Director, Deloitte & Touche Corporate Finance LLC
Simon Gisby leads the US Healthcare practice at Deloitte & Touche Corporate Finance. He has experience in all aspects of healthcare corporate finance raising over $3 billion for his clients in debt and equity, advising on over $1 billion of M&A transactions and over $5 billion of restructuring assignments.
Prior to joining Deloitte & Touche Corporate Finance, Simon was a Director at Houlihan Lokey Howard and Zukin and UBS Warburg, and a Vice President at PaineWebber. He started his career in finance at Chase Manhattan Bank.
» Chris Horan
Vice President, Planning, Distribution and Logistics, Genentech, Inc.
Chris Horan is currently vice president, Planning, Distribution and Logistics at Genentech. In this role, Chris is responsible for product and materials planning for Genentech's entire supply chain. Chris joined Genentech in 2004 and was charged with creating and building operational excellence capabilities for Product Operations. Prior to Genentech, Chris was with Merck & Company, Inc. for 16 years. During his tenure with Merck, Chris was responsible for leading international manufacturing projects in 9 countries, including ex-pat assignments in Australia, China, and Korea. Chris played a key role in shaping Merck's Global Operational Excellence organization by providing OE leadership to its marketing and sales division, focusing on the Japan market. Chris graduated from the Stevens Institute of Technology in Hoboken, New Jersey with a Bachelor of Engineering degree.
» David A. Kessler, MD
Former Commissioner of the US Food and Drug Administration
David A. Kessler, MD, was until recently the dean and vice chancellor for medical affairs at UCSF School of Medicine. Before joining UCSF in the fall of 2003, Dr. Kessler had been Dean of the Yale University School of Medicine since July 1997. Dr. Kessler, who served as Commissioner of the United States Food and Drug Administration from November 1990 until March 1997, was appointed by President Bush and reappointed by President Clinton.
As commissioner of the FDA, he acted to speed approval of new drugs and placed high priority on getting promising therapies for serious and life-threatening diseases to patients as quickly as possible. He introduced changes in the device approval process to make it more efficient and ensure that it meets high standards. Under his direction, the FDA announced a number of new programs, including: the regulation of the marketing and sale of tobacco products to children; nutrition labeling for food; user fees for drugs and biologics; preventive controls to improve food safety; measures to strengthen the nation's blood supply; and the MEDWatch program for reporting adverse events and product problems. He emphasized strong law enforcement and created an Office of Criminal Investigation within the agency. According to The New York Times (11/27/96), David Kessler " revitalized a beleaguered agency that had become mired in bureaucratic disarray." The Los Angeles Times (11/27/96) praised him for " restor[ing] the Food and Drug Administration to what it was meant to be - an aggressive advocate for the public's health." With his departure, "[t]he American people lost one of their most effective champions" (New York Daily News, 11/28/96).
Dr. Kessler has a wide range of experience in research, clinical medicine, education, administration, and the law. He is a 1973 magna cum laude, Phi Beta Kappa graduate of Amherst College. He received his J.D. degree from The University of Chicago Law School, where he was a member of the Law Review, in 1978, and his M.D. degree from Harvard Medical School in 1979. He did his internship and residency in pediatrics at the Johns Hopkins Hospital. In 1986, he earned an Advanced Professional Certificate from the New York University Graduate School of Business Administration.
» Henk Kocken, Ph.D.
Vice President of Quality and Regulatory Affairs, Alvine Pharmaceuticals
Dr. Henk Kocken joined Alvine Pharmaceuticals as Vice President of Quality and Regulatory Affairs in June of 2007. Dr. Kocken has held various academic and industry positions for over twenty years with increasing responsibility in quality management and compliance, and specializes in building company-wide quality systems compliant with cGMP, FDA and worldwide regulations and ISO-9000. Prior to joining Alvine Pharmaceuticals, Dr. Kocken served as Head of Quality at KaloBios, Inc. and Vice President, Quality Systems at VaxGen, Inc. In addition, he has held leadership positions at CoTherix, InterMune, FibroGen, BioRad and Clontech. Before relocating to the United States, Dr. Kocken was Assistant Professor Molecular Biology at Eindhoven University of Technology in The Netherlands. Dr. Kocken holds a Bachelors degree in Biochemistry and a Masters degree in Molecular Biology, both from Nijmegen University, The Netherlands and received his Ph.D. in Chemical Technology from Eindhoven University of Technology, The Netherlands.
» Gareth Morgan
Executive Director, Central Clinical Operations, Bristol-Myers Squibb
Gareth Morgan is Head of Central Clinical Operations at Bristol-Myers Squib. He leads a department responsible for operational implementation of BMS clinical development programs executed globally. Gareth started his pharmaceutical career with Hoechst-Roussel Pharmaceuticals Inc. (now Sanofi-Aventis) in Clinical Operations and Project Management. As a Project Manager he successfully led research and development teams, including submission and approval of an NDA and several s-NDAs. In the mid-90s he joined Genentech Inc. where he was responsible for Portfolio Planning and Analysis, providing senior management with guidance regarding development cost and risk. In 1998 he was recruited by Bayer Pharmaceuticals where he was appointed Director of US Project Management and later Vice President of Global Clinical Project Management. In both roles he operated across all therapeutic areas, providing management and leadership for team leaders responsible for multiple regulatory submissions and product approvals
The BMS Central Clinical Operations department consists of Operations Leads, Protocol Managers, and Clinical Trial Associates and totals more than 200 personnel. Operations Leads are each responsible for running one global clinical program from an operational perspective. Protocol Managers lead the planning and execution of specific clinical studies. Clinical Trial Associates support the Operations Leads and Protocol Managers as needed. In a recent KMR benchmarking analysis of thirteen major pharmaceutical companies, BMS received the highest composite score for development performance, driven by excellence in operational cycle time and cost.
Gareth holds an MS in Biological Science and an MBA. Gareth and his family reside in Princeton, NJ. He splits his time between BMS facilities in Lawrenceville, NJ, Wallingford, CT, and Brussels, Belgium.
» Barbara Ryan
Managing Director, Deutsche Bank Securities Inc.
Barbara Ryan is a Managing Director at Deutsche Bank Securities Inc., and joined the firm (formerly Alex Brown & Sons), in April 1992 as a senior analyst covering the Large Cap U.S. Pharmaceutical Industry. Barbara has been covering the US Pharma sector for 25 years (since 1982), and while at Alex Brown, also covered the PBM industry, healthcare distributors, as well as the drug wholesalers, and some specialty pharma companies. In 2005, she extended her coverage to include the U.S. drug distributors. Barbara has been recognized by the Wall Street Journal All-Star Analyst survey, and is a four-time member of the Institutional Investor All-America Research Team Prior to joining Deutsche Bank, Barbara was a senior analyst at Prudential Securities, for two years, and began her sell-side career at Bear Stearns, in 1981. Barbara studied at the University of Massachusetts, and majored in Finance. Barbara lives with her husband, Al Filippone, and their two sons in Connecticut, and participates in USTA league tennis competition.
» Kuo Bianchini Tong
Founder & President, Quorum Consulting
Mr. Tong works with his clients to understand how economic, financial, and reimbursement forces can be managed and how to influence product acceptance and utilization. His consulting engagements focus on strategic planning and implementation in early phases of product development, during clinical evaluation, and following regulatory approval. Mr. Tong has worked across a number of different clinical specialties and therapeutic categories including: hematology and oncology; solid organ and bone marrow transplantation; infectious diseases like HIV/AIDS and hepatitis; cardiovascular diagnostics and therapeutics; dermatology; orthopedic surgery; and anesthesiology/pain medicine.
Mr. Tong is an active member of numerous professional organizations and societies including: the Academy of Managed Care Pharmacy; American Public Health Association; American Society for Blood and Marrow Transplantation; American Society of Clinical Oncology; Infectious Disease Society of America; International Society for Heart and Lung Transplantation; International Society for Pharmacoeconomics and Outcomes Research; and Society for Investigative Dermatology.
Prior to founding Quorum Consulting, Mr. Tong was a senior associate with Corning HTA (now known as Covance), a Washington, DC health care consulting firm. Prior to entering the consulting field, Mr. Tong was active in clinical and health services research at the University of California at Los Angeles Neuropsychiatric Institute and the University of Pennsylvania Department of Medicine. He holds a MS Business and Management, Johns Hopkins University and a BA, University of Pennsylvania
» Mervyn Turner, Ph.D
Senior Vice President Worldwide Licensing and External Research, Merck & Co
Dr. Turner joined Merck Research Laboratories in 1985. Since then he has held many positions of increasing seniority at the company. In 1999 he was appointed Senior Vice President, Merck Frosst Centre for Therapeutic Research in Montreal, Canada. In 2002 he returned from Montreal to take up his current position as Senior Vice President, Worldwide Licensing and External Research. Dr. Turner oversees all of Merck's licensing activities and the management of academic relations. Through his multiple and diverse experiences in the Merck Research Laboratories, he has acquired a broad perspective on drug discovery and development. During Merv's tenure in Licensing, there has been a sizeable increase in deal activity for Merck, with over 230 significant transactions completed since 2003. Under Dr. Turner's leadership, Merck has also been active in mergers and acquisitions with companies such as Aton, Abmaxis, GlycoFi, Sirna and NovaCardia. Dr. Turner sees partnerships and M & A as a logical product of the cultural shift within Merck towards a more outward-facing and partner-friendly organization. Dr. Turner has authored over 80 articles in peer reviewed journals and has served on the editorial boards of many of them. Dr. Turner trained as a chemist at the University of Sheffield in the UK. After completing postdoctoral research at Harvard University, he returned to the UK and pursued an academic career in molecular parasitology until joining Merck in 1985.
» Barbara Yanni
Vice President & Chief Licensing Officer, Merck & Co
Barbara Yanni Barbara Yanni leads the Corporate Licensing group, which is responsible for negotiating agreements to acquire compounds, programs and new technologies to complement Merck's research programs and pipeline. She works closely with her scientific colleagues at Merck to ensure that the company has access to discoveries that will enhance Merck's ability to bring new medicines to the market. Ms. Yanni and her team have played a major role in the significant increase in Merck's external relationships. In the past four years, Merck has executed almost 200 significant licensing transactions in all stages, from technologies and early research collaborations to Phase III development candidates.
Before joining Corporate Licensing, Ms. Yanni was Executive Director of Corporate Development at Merck where she negotiated acquisitions, divestitures and other business arrangements. She has also worked in other positions in Merck's Finance area including Financial Evaluation and Analysis, Treasury and Tax. She joined Merck in 1985 as Domestic Tax Counsel after working as a tax lawyer for several years at Bristol-Myers and in private practice.
2007 Key Industry Speakers
» Gregg Alton, J.D.
Senior Vice President and General Counsel, Gilead Sciences
Gregg Alton is Senior Vice President and General Counsel for Gilead Sciences, Inc. Mr. Alton joined Gilead in 1999 and is currently responsible for legal affairs, government affairs and health policy and Gilead's access program. Prior to joining Gilead, Mr. Alton was an attorney at the law firm of Cooley Godward LLP where he focused on mergers and acquisitions, corporate partnership and corporate finance transactions for healthcare and information technology companies. Mr. Alton is a member of the board and treasurer of the AIDS Healthcare Foundation. He received his J.D. from Stanford Law School and his bachelor's degree from the University of California at Berkeley.
» Christopher S. Boerner
Group Product Manager, Xolair Marketing, Genentech, Inc.
Chris Boerner (pronounced Burner) is currently a Group Product Marketing Manager for Xolair covering promotions. In this role Chris manages a team responsible for all direct to physician and patient promotional activities for Xolair, including physician marketing, direct to patient programs, advocacy group activities and conventions / medical meeting programs. Prior to this role, Chris was responsible for strategy development for Xolair. In addition to his role on Xolair, Chris has worked in Genentech's Market Development Group. Most recently he was Associate Director of Oncology Market Planning. In this role, Chris managed teams responsible for all commercial analytics for Genentech's in-line and pipeline oncology products.
Prior to joining Genentech, Chris worked at McKinsey & Company. He is Graduate of the Business and Public Policy Ph.D. Program at the Hass School of Business at UC Berkeley, where specialized in Economics. His dissertation focused on firm strategy in the pharmaceutical industry.
» Kathryn Bowsher
Principal, Act One Marketing
Ms. Bowsher is a seasoned strategic marketing executive with a specialty in bringing new products to market. She has over 20 years of experience and a proven track record of bottom line results in both large and small companies. Kathryn's extensive background in moving new products from idea through launch includes launching 7 products and working with over 25 development teams. Act One Marketing serves life science companies and investors. Principal services included New Product Opportunity Assessment, Commercialization Strategies for development stage products, and Corporate/Clinical Business Planning. Prior to founding Act One Marketing, Kathryn was VP of Marketing at Somnus Medical Technologies and has directed global marketing and product development strategy for a $725 million drug line at Baxter International. Other clients and employers have included Goldman Sachs & Co., BiPar Sciences, Perlegen, Alza, Corus Pharma and PhotoThera. Kathryn holds an MBA from Stanford and an AB from Princeton.
» Felissa H. Cagan
Vice President, Intellectual Property, Jazz Pharmaceuticals
Felissa Cagan joined Jazz Pharmaceuticals as its Vice President, Intellectual Property in March 2004. Prior to joining Jazz, she was Senior Director, Intellectual Property, at Nektar Therapeutics (formerly Inhale Therapeutic Systems) beginning in March 1997. Ms. Cagan was patent counsel at ALZA Corporation from 1994 to 1997. Prior to joining ALZA, she was an associate with the law firm of Morrison & Foerster. Ms. Cagan received her J.D. from the Santa Clara University School of Law and a B.S. in Chemical Engineering from Northwestern University. She is a registered Professional Engineer in the State of California and was a practicing Chemical Engineer for seven years prior to attending law school.
» Grace Colon
Senior Director, Commercial Strategy, Gilead Sciences
Grace Colon joined Gilead Sciences in 2005 as Senior Director, Commercial Strategy. In that role, she was responsible for supporting global franchise planning and analysis, including market research, competitive intelligence and financial modeling and forecasting, and new therapeutic area product planning. Currently, she is Senior Director, Corporate Strategy, and is responsible for implementing a new Alliance Management function.
Previously, she was VP of Corporate Planning at Affymetrix where she was responsible for strategic planning, business intelligence, and project management. Prior to Affymetrix, Grace was with McKinsey & Co. where she served clients in health care, high tech and venture capital.
She was also Acting COO for the International Genomics Consortium, a non-profit medical research organization focused on cancer genomics. Grace holds a BS degree in chemical engineering from the University of Pennsylvania and a Ph.D. in chemical and biochemical engineering from the Massachusetts Institute of Technology. She also was a postdoc at MIT in the Department of Biology. She has written numerous peer-reviewed scientific and business publications, been an invited speaker at a number of conferences and has licensed two industrial biotechnology inventions.
She is a member of the Board of the Professional Women's Healthcare Alliance and serves on the Outstanding Corporate Innovator Selection Committee of the Product Development and Management Association.
» Casper De Clercq
Venture Partner, US Venture Partners
A twenty-year veteran of the medical and life sciences industry, Casper de Clercq observes that innovation in the biotech sector runs in cycles. In the past five years, for instance, there has been extensive adoption of high throughput cell screening assays in the industry. "Over the next five to ten years we will see an emphasis on the integration of those tools and significant acceleration of lead compounds arising out of their application," he says. Because FDA approval and public financing exert a defining influence on the biotech sector, Casper notes, medical device companies have recently been favored while biotech remains a longer term game. USVP has a long track record in biotechnology — founding partner Bill Bowes founded Amgen in the late 1970s — which attracted Casper to the firm. "USVP takes the long term approach. They really stick with companies, using seasoned judgment with regard to risk while supporting the management team in building long term value." Another strength of USVP is the operating experience of its team, Casper notes. "The emphasis here is on deep management experience. We don't get in the way of our companies, but we do get involved with respect to clinical, regulatory and commercialization strategy."
Having joined USVP in 2004, Casper has extensive experience with device innovations in the cardiovascular arena, drug delivery and diagnostics. Given changing conditions in the drug development area, oncology and other therapeutics with an abbreviated regulatory path are of particular interest to Casper. Prior to 2004, Casper was heavily involved in several rounds of financing and the IPO process at Aerogen (AEGN), a specialty pharmaceutical company, where he served as Vice President of Business Development, Sales and Marketing. In 1999 he co-founded Epicor, which was acquired in 2004 by St. Jude Medical at a valuation of more than $200 million. Casper also held senior sales and marketing positions with Heartport (minimally invasive heart surgery) and Diagnostic Products Corporation (immunodiagnostics). At these companies, Casper worked closely with the scientific and engineering teams to define customer requirements and lead product commercialization.
Casper has been through venture financing from the company side many times, and advises: "It's important to get substantial investors early in the process. Yes, you want strategic guidance and good counsel, but it's also important to find VCs that have the financial resources to support several rounds. The commitment to long-term funding can be more important than initial financing terms. Medical investing is an endurance sport." Early in his career Casper worked as a strategy consultant for Bain & Company, working in Boston, Johannesburg and London. Casper holds a B.A. in Biochemistry from Dartmouth and an M.B.A. and M.A. in Biology/Immunology from Stanford University. A fan of aquatic sports, Casper has sailed competitively on the San Francisco Bay and in Europe and windsurfs when the wind gets above 20 knots. He rowed competitively at Dartmouth for four years. He is active with environmental organizations, especially around issues concerned with health and human impact. "The advances in health care have allowed us to live longer—the other half of the equation is how we can minimize human impact on the ecosystems that sustain us."
» Anton Gueth
Managing Director, Burrill & Company
Anton Gueth has over 20 years experience in the healthcare industry. Prior to joining Burrill & Company, Mr. Gueth was President of Gueth Consulting, a firm specializing in business development and alliance management in the life sciences industry. A recognized expert in alliance management, he collaborates with Vantage Partners to provide clients access to world class expertise in orchestrating strategic alliances for pharmaceutical and biotech companies. As a business development consultant he supported early stage companies with an outsourced business development model and also held the position of Chief Operating Officer for a start-up software company, Collaborative Drug Discovery (CDD).
Prior to establishing his own consulting firm in 2003, Mr. Gueth worked with Eli Lilly and Company for 20 years holding a number of operational positions in corporate and business development, general and financial management, sales and marketing. Most notably, as Director of Alliance Management, he led Eli Lilly's efforts to become the "pharmaceutical partner of choice."
Mr. Gueth is a member of the Board of Directors of Antares Pharma, a specialty pharmaceutical company with an emphasis on delivery technology, and a member of the Board of Directors of the American Liver Foundation, California Chapter.
» Laurel S. Hacche, Ph.D.
Director, Worldwide Quality Assurance, Allergan, Inc.
Dr. Laurel Hacche is a Director of Worldwide Quality Assurance for Allergan, Inc. She currently has QA oversight for the corporate audit program, annual product reviews, government agency communication records, third party manufacturers, the global stability program, complaint management, and R&D technology transfer. In addition to the above activities, she serves as the lead corporate QA liaison for FDA and alternate regulatory agencies. Dr. Hacche has been with Allergan, Inc. for 18 years. Prior to Allergan, Inc., she served as a Postdoctoral Researcher in the Dept. of Biological Chemistry at the California College of Medicine at U.C. Irvine. She has held an Associate Faculty position at the Math, Science, and Engineering Department at Saddleback College and served as an Assistant Professor at the Joint Science Department for The Claremont Colleges. Dr. Hacche holds a Ph.D. in Physical Polymer Chemistry from U.C. Irvine and an A.B. in Chemistry from Occidental College.
R.T. (Terry) Hisey
Vice Chairman, U.S. Life Sciences Leader, Deloitte & Touche USA LLP
Terry Hisey serves the Life Sciences industry in bringing Tax, Audit, Consulting, and Financial Advisory Services to assist clients in achieving sustainable competitive advantage through strategic change. The Life Science activities span the entire value chain including Drug Discovery & Development, Commercial Operations, Production & Distribution, and Regulatory Compliance. In addition to Life Sciences, his responsibilities also include linking the Life Science effort with those in Health Providers, Health Plans, and Government to identify and capitalize on the unique capabilities that Deloitte could offer based on our depth in all aspects of the value chain. Terry is Chairman of the Life Sciences Advisory Board for Deloitte Research and is a Steering Committee member for the Deloitte Center for Health Solutions in Washington, DC working with The Honorable Tommy Thompson, Former U.S. Secretary of Health and Human Services.
Terry was previously the Vice President and National Leader of the Life Science Practice of a major global consulting & integration firm and was a global leader in their efforts regarding Life Science thought leadership in strategy, transformation, and operations. He has personal client service experience with a number of Pharmaceutical and Biotechnology firms that includes Amgen, Merck, Abbott, Genentech, Pfizer, GlaxoSmithKline, Wyeth Biopharmaceuticals as well as other major and mid-size Life Science companies.
In addition to his client work, Terry is a noted industry authority, a frequent speaker, the Strategy Advisor to Pharmaceutical Executive Magazine and a guest lecturer at several schools including the University of Pennsylvania and Drexel University. In addition, Terry is a member of several industry associations and advisory boards and he is the Deloitte sponsor for the William and Phyllis Mack Center for Innovation at the Wharton School of the University of Pennsylvania. Terry has a BS in Engineering from Penn State and a MS in Business & Organizational Management from the University of Pennsylvania.
» Philip J. Honerkamp
Deputy General Counsel, Jazz Pharmaceuticals, Inc.
P.J. Honerkamp is Deputy General Counsel for Jazz Pharmaceuticals, Inc. Mr. Honerkamp joined Jazz Pharmaceuticals in 2004 and is responsible for corporate legal matters including licensing and acquisitions, clinical trials, commercial contracts and debt and equity offerings. Prior to joining Jazz Pharmaceuticals, P.J. was an attorney at the law firm of Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP where he focused on corporate and securities law; private, public and commercial financings; mergers and acquisitions; licensing and strategic transactions; and venture fund formations. He received his J.D., cum laude, from Harvard Law School and his bachelor's degree, magna cum laude, from Davidson College.
» Chris Horan
Vice President, Planning, Distribution and Logistics, Genentech, Inc.
Chris Horan is currently vice president, Planning, Distribution and Logistics at Genentech. In this role, Chris is responsible for product and materials planning for Genentech's entire supply chain. Chris joined Genentech in 2004 and was charged with creating and building operational excellence capabilities for Product Operations. Prior to Genentech, Chris was with Merck & Company, Inc. for 16 years. During his tenure with Merck, Chris was responsible for leading international manufacturing projects in 9 countries, including ex-pat assignments in Australia, China, and Korea. Chris played a key role in shaping Merck's Global Operational Excellence organization by providing OE leadership to its marketing and sales division, focusing on the Japan market. Chris graduated from the Stevens Institute of Technology in Hoboken, New Jersey with a Bachelor of Engineering degree.
» Mohan S. Iyer
Managing Director, Merchant Banking Group, Burrill & Company
Mohan brings a broad life sciences background in a range of functions including business development, strategic planning, marketing, product development, engineering and manufacturing. Prior to joining Burrill & Company, he was Executive VP of Corporate Development at diaDexus, Inc. where he was responsible for sourcing and executing various types of transactions during a seven year period, including in-licensing, out-licensing, and a successfully executed spin-out of the therapeutics division. While at diaDexus, he played a key role in two major private financings, managed R&D operations for a transition year, and headed the marketing launch of a novel cardiovascular diagnostic product. Prior to diaDexus, Mohan was a healthcare consultant at The Wilkerson Group where he managed several strategic engagements across the pharmaceutical, biotech, diagnostics and medical device industries. Mohan began his biotech career as a biochemical process engineer at Genentech, where he spent 7 years in positions ranging from biopharmaceutical manufacturing to capital projects management. He holds a BS in Chemical Engineering (Tennessee), an MS in Biomedical Engineering (Duke), and an MBA (Yale).
» Suzy Jones
Senior Director, Business Development, Genentech, Inc.
Suzy Jones is Senior Director of Business Development at Genentech, Inc. As a member of the Business Development team, Suzy heads-up a group of licensing professionals responsible for building out Genentech's pipleline outside of the area of Oncology. Her group is responsible for identifying new opportunities that will support the company's short- and long-term strategic objectives and negotiating and structuring collaboration agreements to support the newly formed strategic alliances. Suzy's career includes 18 years of biotech experience. She spent 7 years conducting basic Immunology Research evaluating the role of adhesion molecules in inflammation, 4 years in Product Development where she managed several pipeline products at various stages of their lifecycles, including Rituxan, Avastin, and Raptiva, and 7 years in business development overseeing Genentech's licensing efforts in Immunology, Tissue Growth and Repair, New Therapeutic Areas and Technology Licensing.
» Harris Kaplan
CEO, Healogix, LLC, Founder, Migliari-Kaplan
Harris Kaplan is currently President and Chief Executive Officer of Healogix, a consultancy that advises companies on how to create and maximize the value of new products in development.
Harris has extensive experience in the pharmaceutical industry both on the client and consulting side of the business. Harris co-founded Migliara-Kaplan Associates which became the world?s largest custom marketing research company serving 19 of the top 20 pharmaceutical companies. Migliara-Kaplan Associates specialized in helping companies identify new product opportunities and then maximizing the commercial potential of new products in development. Migliara-Kaplan was acquired by NFO in 1996 and is now part of TNS Healthcare.
Harris was also cofounder of Cozint Interactive which was acquired by GFK, the German based research company. Harris serves as an advisor to several venture capital funds and is on the Board of Directors of Informed Medical Communications, Informedix, and the Kernan Orthopedic Hospital.
» Daniel P. Maher
Vice President, Product Development, BioMarin
Mr. Maher joined BioMarin as vice president, program management in August 2003, bringing with him over 20 years of biotechnology industry experience. He is currently responsible for program management and research. From 1998 to 2003, Mr. Maher worked at Aradigm Corporation serving as vice president, program management. Prior to Aradigm, he served as director of clinical operations at Covance, Inc., and as vice president of operations at Spectra BioMedical, Inc. Prior to Spectra, Mr. Maher acted as director, therapeutics project management, at Chiron Corporation. Mr. Maher started his career at Genentech, Inc. in 1981, serving in several capacities in operations, and as Manager of Product Development. Mr. Maher received an M.B.A. in health services management from Golden Gate University and a B.A. in biology from San Francisco State University.
» David A. Kessler, MD
Former Dean and Vice Chancellor for Medical Affairs, UCSF School of Medicine
Former Commissioner of the US Food and Drug Administration
David A. Kessler, MD, is the dean and vice chancellor for medical affairs at UCSF School of Medicine. Before joining UCSF in the fall of 2003, Dr. Kessler had been Dean of the Yale University School of Medicine since July 1997. Dr. Kessler, who served as Commissioner of the United States Food and Drug Administration from November 1990 until March 1997, was appointed by President Bush and reappointed by President Clinton.
As commissioner of the FDA, he acted to speed approval of new drugs and placed high priority on getting promising therapies for serious and life-threatening diseases to patients as quickly as possible. He introduced changes in the device approval process to make it more efficient and ensure that it meets high standards. Under his direction, the FDA announced a number of new programs, including: the regulation of the marketing and sale of tobacco products to children; nutrition labeling for food; user fees for drugs and biologics; preventive controls to improve food safety; measures to strengthen the nation's blood supply; and the MEDWatch program for reporting adverse events and product problems. He emphasized strong law enforcement and created an Office of Criminal Investigation within the agency. According to The New York Times (11/27/96), David Kessler " revitalized a beleaguered agency that had become mired in bureaucratic disarray." The Los Angeles Times (11/27/96) praised him for " restor[ing] the Food and Drug Administration to what it was meant to be - an aggressive advocate for the public's health." With his departure, "[t]he American people lost one of their most effective champions" (New York Daily News, 11/28/96).
Dr. Kessler has a wide range of experience in research, clinical medicine, education, administration, and the law. He is a 1973 magna cum laude, Phi Beta Kappa graduate of Amherst College. He received his J.D. degree from The University of Chicago Law School, where he was a member of the Law Review, in 1978, and his M.D. degree from Harvard Medical School in 1979. He did his internship and residency in pediatrics at the Johns Hopkins Hospital. In 1986, he earned an Advanced Professional Certificate from the New York University Graduate School of Business Administration.
» Peter McWilliams, Ph.D.
Principal, Sanderling Ventures
Peter McWilliams is a Principal with Sanderling Ventures and has more than 15 years experience in biomedical research and management. He works with several Sanderling portfolio companies in the role of Chairman, Director, CEO and member of the management team. Portfolio companies include Trinity Biosystems, Artielle Immunotherapeutics, Actimis Pharmaceuticals, Harkness Pharmaceuticals, Cylene Pharmaceuticals and others.
Prior to joining Sanderling, Dr. McWilliams worked at Genentech (NYSE: DNA) where, as a Product Manager in Oncology Commercial Development, he managed a pipeline of oncology products in clinical and pre-clinical development and was the Commercial Team Leader for Avastin®. Prior to that he was an Associate with Booz.Allen & Hamilton in San Francisco where he focused on projects for major US and International life science companies. From 1991 to 1994 he worked for Oxford Molecular, one of the first companies in the field of rational drug design and bio-informatics where, as a Product Manager and Applications Specialist, he helped to set up and establish their US operations prior to their successful IPO on the London Stock Exchange in 1994.
Dr. McWilliams received an M.B.A. from Columbia Business School in 1996, where he was an R.C. Kopf Fellow and was elected to Beta Gamma Sigma. He received a Ph.D. in 1991 and an M.A. in 1990 in Chemistry from Princeton University where he received a Hugh Scott Taylor fellowship. He received a B.A. in Natural Sciences from Cambridge University in 1987.
» Thomas A. Moore
Chief Executive Officer and Chairman of the Board of Directors, Advaxis
Effective December 15, 2006, Thomas Moore was named our Chairman and Chief Executive Officer. He is currently also Director at Alteon, Inc., a publicly traded developer of pharmaceuticals for the treatment of diabetes and age-related diseases, El Dorado Inc., a targeted marketer to unassimilated Hispanics, Medmeme, which measures medical education effectiveness, MD Offices, an electronic medical records provider, and Opt-e-scrip, Inc., which markets a clinical system to compare multiple drugs in the same patient. He also serves as Chairman of the Board of Directors of Mayan Pigments, Inc., which has developed and patented Mayan pigment technology. Previously, from June 2002 to June 2004 Mr. Moore was President and Chief Executive Officer of Biopure Corporation, a developer of oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues. From 1996 to November 2000 he was President and Chief Executive Officer of Nelson Communications. Previously, Mr. Moore had a 23-year career with the Procter & Gamble Company in multiple managerial positions, including President of Health Care Products where he was responsible for prescription and over-the-counter medications worldwide, and group vice president of the Procter & Gamble Company.
» Theresa Musser
Executive Director of Development Operations, Rigel Pharmaceuticals
Theresa Kane Musser is Executive Director of Development Operations at Rigel Pharmaceuticals in South San Francisco, CA. She is responsible for the project management, clinical operations and regulatory submission departments for the company. Prior to her current position, Theresa worked at Genentech, Inc. for 11 years where she held a variety of positions including heading the departments Project Management, Clinical Operations for the Pulmonary Therapeutic Unit and Business Operations (for the Clinical Department). She worked at SmithKline for 8 years where she did international clinical development of cardiovascular drugs and project management in a variety of therapeutic areas. Theresa started her career in the pharmaceutical industry as a Clinical Research Associate for Ayerst. She received a BA in Biology from UC Santa Cruz. Theresa is an active member of several industry organizations including the Project Management Institute and is Immediate Past President of the Drug Information Association.
» Catherine M. Polizzi, Ph.D.
Partner, Morrison & Foerster
Catherine M. Polizzi is a partner in the Palo Alto office and Co-Chair of the firmwide Intellectual Property group of Morrison & Foerster LLP. Dr. Polizzi focuses her intellectual property practice on patent law and biotechnology.
Dr. Polizzi has a wide range of experience in patent law and technology, working with small, medium and large companies as well as universities. Dr. Polizzi provides patent portfolio strategic counseling and comprehensive portfolio management for emerging as well as mature life science companies. She is involved in all aspects of patent prosecution and procurement. Dr. Polizzi's practice also includes due diligence evaluation and counseling. Dr. Polizzi provides counseling for intellectual property strategy and implications during all stages of product and project development. Her practice also includes patentability, freedom of operation, infringement, and validity evaluations and opinions. Dr. Polizzi has significant experience in technology transactions, as well as patent litigation and interference.
Dr. Polizzi holds a Ph.D. in Molecular Biology and Biochemistry from the University of California, an M.A. in Chemistry from the University of California, and a B.A. with distinction in Chemistry from the University of Mississippi. Dr. Polizzi received a J.D. from Stanford Law School, where she was awarded the Hilmer Oehlmann, Jr. Award for Legal Research and Writing.
» Michael E. Raynor
Author, The Strategy Paradox & The Innovator's Solution
Distinguished Fellow with Deloitte Research, Deloitte Consulting LLP
Michael was born in Brantford, Ontario, the same town as Wayne Gretzky, but he can't play hockey nearly as well. He holds an undergraduate degree in Philosophy from Harvard College (1990) in Cambridge, MA, where he graduated Magna cum Laude. His thesis on the metaphysics of personal identity has left him absolutely sure he has no idea who he is. During the course of his undergraduate career he was a Detur Prize winner for first-year academic excellence and a John Harvard Scholar for continued academic excellence. He has an MBA (1994) from the Richard Ivey School of Business in London, Ontario, where he was awarded the Nelson M. Davis Memorial Scholarship. He earned his Doctorate in Business Administration from the Harvard Business School (2000) with a dissertation on the sources of corporate value-added in diversified firms. He also earned the Dively Award for research excellence.
At Deloitte Consulting LLP, Michael is the Distinguished Fellow with Deloitte Research. He works with senior executives in the world's leading corporations across a wide range of industries, including telecommunications, media and entertainment, pharmaceuticals, medical devices, energy, and manufacturing. His client work, research, writing, as well as his speaking engagements focus on generating returns — competitive strategy — and reducing risk ? corporate strategy.
Michael's first book, co-authored with Clayton M. Christensen, The Innovator's Solution, was published in 2003, and became a bestseller. The focus of the book was on creating and sustaining successful growth. Michael?s second book, The Strategy Paradox, was published by Doubleday in February 2007. This book is about how to reduce risk without sacrificing returns.
» Janet L. "Lucy" Rose
Former Director of the Office of Training and Communications and DDMAC, CDER, FDA
President, Lucy Rose and Associates, LLC
Lucy Rose is uniquely qualified to provide regulatory training and consulting to the pharmaceutical industry and its service support providers, such as public relations firms, advertising agencies and CME providers. Her combination of education and experience, coupled with her extensive experience as a trainer and educator, provides the depth of knowledge and expertise necessary to equip companies to face a promotional environment changing at warp speed.
From 1995-97, Lucy served as the Director of Office of Training and Communications for the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration. There she designed and implemented programs to improve external communications with consumers, patients, the pharmaceutical industry and health care professionals. Additionally, she designed and implemented programs to improve employee performance, including leadership and management development. Examples of programs introduced during Lucy?s leadership include: design and implementation of CDER's World Wide Web Site, Live Satellite Educational TV programs with the pharmaceutical industry, comprehensive introductory training programs for new reviewers, and design and implementation of CDER's crisis communication program.
Lucy led CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) from 1993 to 1995. In this capacity, she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. health care professionals and consumers. Under Lucy?s leadership, the division intiated a philosophy of transparency and educational outreach, in addition to setting clear review priorities and timeliness goals for industry-requested comments, such as voluntary submissions of launch campaigns. Special challenges encountered during her tenure included the FDA Industry Supported Scientific and Education Guidance and the evolution of Direct-to-Consumer Broadcast advertising, among others.
Prior to joining FDA, Lucy was associated for seven years with Mead Johnson Pharmaceuticals, a division of Bristol-Myers Squibb Pharmaceuticals. She began her career as a sales representative, served as a regional sales trainer, and for four years was the District Sales Manager in Washington, DC. Lucy earned a B.S. degree in biology from Salem College in Winston-Salem, NC and an M.B.A. from Averett College. In addition, Lucy practiced as a board-certified Physician Assistant, having graduated from the Wake Forest School of Medicine.
Lucy has been honored with a number of awards. The FDA twice selected her for their highest leadership accolade, the Award of Merit, for her work at DDMAC and at Office of Training and Communication. In 2004, Phame, an award organiation that evaluates Direct-to-Consumer promotion, elected her to its DTC Hall of Fame for her many years of leadership in the DTC arena. Additionally, Lucy speaks extensively at professional conferences on the regulatory and compliance issues surrounding the promotion of prescription drugs. She is an active member of the Drug Information Association and the Food and Drug Law Institute.
» Peter Van Vlasselaer, Ph.D.
President and CEO, Arresto BioSciences
Dr. Van Vlasselaer is the President and CEO of Arresto BioSciences. Before that, he was CEO of Avidia, a venture-financed biotechnology company, until it was sold to Amgen in October 2006. Prior to joining Avidia, he was Senior Vice President of Technical Operations at InterMune, Inc. (NASDAQ: ITMN) and Vice President of Product Development at Dendreon, Inc. (NASDAQ: DNDN). Before that, Peter was Staff Scientist at the Center for Nuclear Research in Mol, Belgium, where he managed research in Hematology, Immunology and Bone Biology. He was at DNAX Research Institute (Schering-Plough), where he conducted research in human B cell biology. Peter holds a B.S. in Zoology and a Ph.D. In Cellular Immunology from the University of Leuven, Belgium, and he was a Post-Doctoral Fellow at the Immunology and Rheumatology Division of the Stanford Medical School. He is inventor and author on multiple patents and publications in different fields, and was awarded the King Boudewijn Award for young entrepreneurs in Belgium.
