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Replies to post #212738 on Avid Bioservices Inc (CDMO)
Scott Antonia, Dmitry Gabrilovich, Sunil Chada and Kerstin Menander and guess what?...
Abstract
Molecular Therapy (2006) 13, S364|[ndash]|S364; doi: 10.1016/j.ymthe.2006.08.1034
943. Prognostic Determinants Associated with Efficacy of Adenoviral p53 Gene Therapy in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck
John Nemunaitis 1, Carol Bier-Laning 2, Gary L. Clayman 3, David Van Echo 4, L. Guertin 5, J. Hamm 6, Robert Dreicer 7, George H. Yoo 8, H. Minn 9, M. Bekradda 10, W. Sutherland 10, Kerstin B. Menander 11, Robert E. Sobol 11 and Jerry Goodwin 12
1Mary Crowley Medical Research Center, Dallas, TX
2Loyola University, Chicago, IL
3M.D. Anderson Cancer Center, The University of Texas, Houston, TX
4School of Medicine, University of Maryland, Baltimore, MD
5CHUM, Pavillon Notre-Dame, Montreal, QC, Canada
6University of Louisville, Louisville, KY
7Cleveland Clinic, Cleveland, OH
8Wayne State University, Detroit, MI
9Turku University Central Hospital, Turku, Finland
10CAC, Le Kremlin-Bicetre, Le Kremlin, France
11Introgen Therapeutics, Houston, TX
12Sylvester Cancer Center, University of Miami, Miami, FL
http://www.nature.com/mt/journal/v13/n1s/full/mt20061084a.html
Management & Advisors
Robert E. Sobol, MD - Chief Executive Officer
Dr. Sobol has over 25 years of biotechnology entrepreneur and management experience. He has pioneered the development of novel biological cancer therapies and is an internationally renowned physician-scientist in the fields of molecular cancer treatments and biomarkers. He has founded, held senior management positions and served on the Board of Directors of numerous biotechnology companies.
He was a co-founder of Biogen-Idec which is one of the world’s largest biotechnology companies and pioneered the use of monoclonal antibodies for cancer therapy. Dr. Sobol led the research teams responsible for the first experimental gene therapies for the treatment of brain tumors and colon carcinoma. Dr. Sobol is a past President of the International Society of Cell and Gene Therapy for Cancer and has served on the Clinical Program Review Committee of the National Cancer Institute.
Dr. Sobol received a B.A. in Philosophy from Boston University and a M.D. from The Chicago Medical School. He subsequently trained at the University of Southern California Medical Center and at the University of California, San Diego and received Board Certifications in Internal Medicine and Medical Oncology.
Kerstin B. Menander, PhD - Vice President Clinical Affairs
Dr. Menander has had over three decades of experience in clinical and translational research, as well as regulatory strategy. The breadth of her experience includes both academic and corporate appointments. She has held senior management positions at Abbott and Syntex (now merged with Roche). Dr. Menander has overseen over 150 clinical trials, most involving novel biologic or targeted agents, and has a highly successful record of collaborations with laboratory/translational research programs throughout the United States and internationally.
Dr. Menander has served as member and as chairman for the Scientific Affairs Committee of the National Pharmaceutical Council. She was a participant in the World Health Organization group for bladder and prostate cancer. She is an invited lecturer at the Scientific Conferences conducted at the Karolinska Hospital in Stockholm, Sweden.
Dr. Menander received a Ph.D. in Histopathology and an M.D. from the University of Lund in Sweden.
Max W. Talbott, PhD - Vice President Regulatory Affairs
Dr. Talbott has over 30 years of experience as a government and pharmaceutical/biotechnology executive. Dr. Talbott has participated in over 500 drug, biotech and device development programs. He has held senior management positions in regulatory affairs for major pharmaceutical companies including Dupont, Bristol-Myers-Squibb, Sanofi-Aventis and Eli-Lilly. The breadth of his collaborations span the U.S., North, Central, and South America, Eastern and Western Europe, India and Asia.
During his government service with the Food and Drug Administration (FDA), he managed and was responsible for the oversight of hundreds of clinical trials and for organizing numerous FDA advisory committee meetings. While at the FDA, Dr. Talbott was also one of the key participants in the creation and implementation of the 510k, IDE, and PMA regulations.
Dr. Talbott received a B.S. in Biology and an M.A. in Physiology from Ball State University and a Ph.D. from Rutgers University in Immunology and Pharmacology.
Mary Ellen Rybak, MD - Vice President Gastrointestinal Cancer Programs
Dr. Rybak has extensive experience in drug development and marketing authorizations for oncology products. This experience includes the clinical development of recombinant adenoviral vectors for intra-arterial, intra-tumoral and intra-peritoneal administration for head and neck, colorectal, hepatocellular and ovarian cancer.
She has held senior management positions in oncology and hematology drug development at Schering-Plough and at Johnson & Johnson where she was Vice President of Oncology.
Dr. Rybak received an M.D. from Harvard Medical School.
Dora Wiederhold, PhD - Director Regulatory Affairs
Dr. Wiederhold has previously served as the Manager for Clinical Protocols in the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center. In that capacity, she coordinated all aspects of protocol administration for clinical studies from inception through completion. She was responsible for the development and authoring of Phase I and Phase II clinical protocols, and providing clinical site management for multicenter clinical studies. In addition she has prepared numerous reports for regulatory agencies.
She has also held research positions in the pharmaceutical industry including Amgen. She is also experienced in the conduct of pre-clinical studies and participated in the pre-clinical development program of p53 Inc’s Ad-mda7 tumor suppressor product.
Dr. Wiederhold received a B.S. in Biology from the University of Houston and a Ph.D. in Molecular Biology from the University of Texas.
Loretta L. Nielsen, PhD - Director Pre-Clinical Studies
Dr. Nielsen has significant experience in directing pre-clinical drug development programs. Previously at the Schering-Plough Research Institute, Dr. Nielsen was extensively involved in pre-clinical studies of adenoviral tumor suppressor p53 gene therapy. Her expertise includes drug development studies employing state-of-the-art animal tumor models as well as cell-based assays and the derivation of new tumor cell lines. She has developed novel cancer models derived from genetically modified mice and from human tumor samples.
She is experienced in preparing the preclinical pharmacology sections of regulatory filings. Dr. Nielsen is co-inventor on 3 cancer therapy patents, including one pertaining to tumor suppressor gene therapy and chemotherapy in the treatment of malignancies. She is co-author on more than 90 clinical and preclinical articles, book chapters, and abstracts.
Dr. Nielsen received a B.S. in Biology from Albright College and a Ph.D. in Medical Sciences-Physiology from Harvard University.
http://p53inc.com/Management-Advisors.html
MultiVir : BOARD OF DIRECTORS
Robert E. Sobol, MD - Chief Executive Officer
Mr. McCandless has served on our board of directors since March 2012. Since 2003, Mr. McCandless has served as Vice President of Pope Asset Management, LLC. From 1998 to 2001, Mr. McCandless worked in the mutual fund accounting division of Putnam Investments. He received a B.B.A. in Finance from the University of Michigan and an M.B.A. from the Amos Tuck Business School at Dartmouth College.
William Wells - Chairman of the Board
Mr. Wells has served as Chairman since December 2014 and on our board of directors since November 2009. Since 2000, Mr. Wells has served as President of Pope Asset Management, LLC, a registered investment advisor offering financial asset management services to high net worth investors. Mr. Wells is the founder and primary portfolio manager for Pope Asset Management, LLC. Mr. Wells previously worked in the private wealth management division of Goldman Sachs & Co. from 1985 to 2000. Mr. Wells received a B.A. in Economics from the University of Mississippi and an M.B.A. from the Amos Tuck Business School at Dartmouth College.
Charles J. Beech:
Mr. Beech has served as a member of our board of directors since February 2015. Mr. Beech has been the Chairman and Chief Executive Officer of Peregrine Enterprises, an investment holding company, since 1991. Mr. Beech was one of the founders Trivantis, an eLearning and internet publishing company in 1999, served as its Chairman from 1999 to 2007, and has served as Chairman and Chief Executive Officer since 2007. Mr. Beech was the Managing Partner of MARCO, a merchant banking firm from 1988 to 1991, and the President and Chief Executive Officer of CheckRobot from 1988 to 1991. Mr. Beech has also served as an executive for a number of other organizations, including as the President of Maybelline Sales Corporation, and a number of sales, management and marketing positions related to over-the-counter products at Proctor & Gamble. Mr. Beech holds a B.A. in History and Political Science from Southeast Missouri State University.
We believe that Mr. Beech possesses specific attributes that qualify him to serve as a member of our board of directors, including his extensive experience analyzing, investing in, and serving as an executive for various companies.
Charles Beech...:
http://www.linkedin.com/pub/robert-beech/17/662/266/en
http://cincytechusa.com/about/staff/robert-beech/
Suneel L. Mahajan, M.D
Dr. Mahajan has served as a member of our board of directors since February 2015. Dr. Mahajan retired from active medical practice in June 2014 has been consulting with Marvel Hospitals since 2014 on projects involving oncology centers in India. Dr. Mahajan was a Hematology and Oncology physician and participated in clinical research at the Cancer Specialists of North Florida from September 1983 to June 2014. Dr. Mahajan received his Doctor of Medicine from the B.J. Medical School in Poona, India. He completed clinical training at the Sassoon General Hospital in Poona, India and the Muhlenberg Hospital in Plainfield, New Jersey. Dr. Mahajan was a fellow in Clinical Hematology at Brown University, Pawtucket Memorial Hospital, a fellow in Developmental Therapeutics at the MD Anderson Hospital and Tumor Institute and received Board Certifications in Medical Oncology, Hematology and Internal Medicine.
We believe that Dr. Mahajan possesses specific attributes that qualify him to serve as a member of our board of directors, including his extensive experience as a physician and researcher in the fields of hematology and oncology.
Casey S. McCandless, MBA
Mr. McCandless has served on our board of directors since March 2012. Since 2003, Mr. McCandless has served as Vice President of Pope Asset Management, LLC. From 1998 to 2001, Mr. McCandless worked in the mutual fund accounting division of Putnam Investments. He received a B.B.A. in Finance from the University of Michigan and an M.B.A. from the Amos Tuck Business School at Dartmouth College.
http://www.linkedin.com/pub/casey-mccandless/55/262/8a0/en
Paul D. Quadros
Mr. Quadros has served as a member of our board of directors since February 2015. Mr. Quadros has also served as a director of VirRx, our 50%-owned, non-consolidated subsidiary, since March 2013. Mr. Quadros served as Managing Partner of Tenex Greenhouse Ventures, a life science venture fund, from January 2001 to December 2012. Mr. Quadros co-founded Corautus Genetics in 2003 and served as its Chairman from 2003 to 2004, he also co-founded Cardiac Science in 1993 and served as a director from 1993 to 2003, including two years as non-executive chairman. Mr. Quadros held various roles, including Executive Chairman, President, Chief Executive Officer and Chief Financial Officer, at GenStar Therapeutics from 1995 to 2004. He was a General Partner of Technology Funding, a venture capital fund from 1985 to 1995. Mr. Quadros is a member of the Band of Angels seed funding organization, and has served as both Chairman or Co-Chairman on its Life Science Special Industry Group since 2008. Mr. Quadros holds a B.A. in Finance from California State University at Fullerton and an M.B.A. from the UCLA Anderson School of Management.
We believe that Mr. Quadros possesses specific attributes that qualify him to serve as a member of our board of directors, including his extensive experience as an investor and executive in the healthcare industry, as well as his perspective as a director of VirRx
Victor Schmitt
Mr. Schmitt has served on our board of directors since February 2015. Mr. Schmitt currently serves as an Advisor to Bay City Capital, which he has done since April 2007. Mr. Schmitt was President, Venture Management for Baxter Healthcare Corporation from 1992 to 2007 and previously held a number of positions with Baxter Healthcare Corporation, including as President of Baxter Biotech Europe and Vice President of Business Development and Finance for Baxter Healthcare Corporations’ Blood Therapy Group. Mr. Schmitt received a B.S. in Commerce from the University of Virginia and an M.B.A. from the University of Maryland.
http://www.linkedin.com/pub/victor-schmitt/5/165/207/en
http://www.multivir.com/#!board-of-directors/c1i5l
MANAGEMENT:
Robert E. Sobol, MD - Chief Executive Officer
Nicholas Puro – Chief Operating Officer and Chief Financial Officer
http://www.linkedin.com/pub/nicholas-puro/2a/954/ba4/en
Max W. Talbott, PhD - Vice President Regulatory Affairs
After a 30 year career as a government official and pharmaceutical/biotechnology executive, in 2002, Max Talbott established MAX TALBOTT LLC for the purpose of healthcare industry consulting with a specialty focus in regulatory affairs.
During his industrial career, Max participated in over 500 drug, biotech, and medical device development programs, leading to the approval of over 30 major drugs and devices. In his government service in FDA's medical device organization, he managed the oversight of hundreds of clinical trials as well as supervising dozens of FDA advisory committee meetings. While at FDA, Max was one of the key participants in the creation and implementation of the 510k, IDE, and PMA regulations.
To utilize this industry and government expertise, MAX TALBOTT LLC has established a global network of associate experts who support Max in his domestic and international consulting efforts. MAX TALBOTT LLC can provide on-the-ground tactical and strategic support in the U.S. as well as in North and South America, Eastern and Western Europe, India and Asia. The range of global healthcare product regulatory capabilities provided by MAX TALBOTT LLC extends from the preclinical, "pre-IND/IDE" stage through registration and into the post-marketing environment. In addition to these regualtory services, MAX TALBOTT LLC can also provide the following healthcare product services:
Advisory Committee/Board of Directors Expertise
Due Diligence/Investment Evaluation and Referral
Business/Product Transaction Assessment
Arbitration and Litigation Support
Expert Witness Testimony..
..
http://www.linkedin.com/in/maxtalbottllc/en
Sunil Chada, PhD – Chief Scientific Officerhttp://www.linkedin.com/pub/sunil-chada/31/bb/467/en
Dr. Chada has served as our Vice President and Chief Scientific Officer since July 2011. From 2008 to 2011, Dr. Chada was the Vice President of Translational Medicine at Intrexon Corporation. From 1997 to 2008, Dr. Chada served in several positions at Introgen Therapeutics, Inc. (which filed a petition for bankruptcy in 2008 and liquidated in 2010), including Vice President of Clinical Research and Vice President of Research for the Introgen Research Institute. From 2002 to 2006, Dr. Chada served as adjunct faculty at the M.D. Anderson Cancer Center of the University of Texas. Dr. Chada was also involved in discovery and preclinical research at Chiron Corporation and Viagene Inc. Dr. Chada received a B.S. from the Department of Cell and Molecular Biology at Kings’ College, University of London, an M.S. in Molecular Biology from the University of California at Los Angeles, and a Ph.D. in Molecular Genetics and Microbiology from the University of Massachusetts Medical School.
http://www.multivir.com/#!management/ckjs
