Preface
Since the first approval of a recombinant protein (insulin) in the USA
in the early 1980s, the last two decades have seen the explosion of a new class
of Biotechnology-derived pharmaceutical products, so-called Biopharmaceuticals. The growth rate of biopharmaceutical
products has been exponential with more than fifty such products approved in
the USA and Europe and with projections of up to fifteen percent market share
of pharmaceuticals worldwide within the next few years. Several marketed products developed by the
Pharmaceutical Biotechnology sector already have annual sales in excess of $1
billion! The field has primarily stemmed from astounding progress in genetic
engineering and hybridoma technology for recombinant proteins and (humanized) monoclonal
antibodies, and it has recently expanded to nucleic acid-based therapeutics for
gene therapy.
As Editor-in-Chief, it is my privilege to introduce the first issue of Current Pharmaceutical Biotechnology.
This new bi-monthly Journal intends to provide the reader with reviews
and updates on research and development of biopharmaceutical products from
leaders in pharmaceutical biotechnology.
This first issue sets the tone for the broad scope of the Journal with a
diversity of topics covered by leading scientists in the field of
Biopharmaceuticals. The characteristics
and performance of products such as Rituximad, recombinant human erythropoietin
and growth hormone are described.
Advances in tissue engineering of bone, models to assess the in vivo activity of anti-angiogenic
factors, and the rationale design of new biopharmaceutical products are also
reviewed.
Dr. Grillo-Lopez et al. (IDEC
Pharmaceutical Corporation, USA) review the first monoclonal antibody for the
treatment of relapsed or refractory, CD20-positive, B-cell non-Hodgkin’s
lymphoma, Rituximab, which was approved in late 1997 by the US Food and Drug
Administration and in 1998 by the European Agency. The report summarizes the outcome of several clinical trials with
Rituximab, a genetically engineered monoclonal chimeric antibody, used as
single agent or in combination therapy.
Dr. Jelkmann (Institut fur Physiologie, Medizinische Universitat zu
Lubeck, Germany) reviews the clinical use of the recombinant human
erythropoietin, the largest selling biopharmaceutical product to date. The clinical uses of that glycoprotein
hormone in patients with renal failure and in anemic cancer patients, as well
as the risks associated with erythropoietin for improvement of athletic
performance are described.
Since the approval by the FDA of recombinant human growth hormone in
1985, the product has been used widely in growth hormone deficient and
sufficient children. Dr. Lanes (Unidad
de Endocrinologia Pediatrica, Hospital de Clinicas Caracas, Venezuela) reports
on the growth rate, final height and bone mineral density in short children
treated long-term with the recombinant human growth hormone.
Drs. Ripamonti and Tasker (Bone Research Unit, MRC/University of the
Witwatersrand, South Africa) provide an update on the rapidly growing field of
tissue engineering and the progress of the use of bone morphogenic proteins
(BMPs) in osteogenesis. They discuss
BMPs activity in primates, their tissue localization and use in periodontal
regeneration. They also report on the
synergistic activity of recombinant human BMP with TGF-b proteins in heterotopic
sites of primates and the results of a clinical trial using naturally-derived
BMPs.
Dr. Latchman (Institute of Child Health, University College London, UK)
reviews the recent progress in understanding transcriptional regulation and the
mechanism of drugs that target transcription.
Delineation of this new area opens up the potential to design new drugs
that have the ability to modulate the synthesis of transcription factors, their
protein-protein interaction or DNA binding, and regulate their activity.
The treatment of metabolic disorders associated with type 2 diabetes
through the understanding of the mode of action and rationale design of drugs
that act as ligands for the peroxisome proliferator activated receptors (PPAR)
is summarized by Dr. Boel et al.
(Health Care Discovery, Novo Nordisk A/S, Denmark).
Dr. Ribatti et al. (Institute
of Human Anatomy, University of Bari Medical School, Italy) describe the chick
embryo chorioallantoic membrane (CAM) as an in
vivo assay system to quantify angiogenesis and anti-angiogenesis. They exemplify the applications of that
extra embryonic membrane assay to investigate anti-angiogenic factors.
Dr. Miele et al. (Cardinal
Bernardin Cancer Center, Loyola University Medical Center, USA) investigate the
promise of cell fate modifiers that target the Notch signaling network to
control cell differentiation, proliferation and apoptosis. They review strategies to design novel Notch
agonists and antagonists, such as recombinant proteins, antibodies, synthetic
peptides, antisense oligonucleotides and gene therapy approaches that have been
developed, and their potential therapeutic applications.
The final contribution from Dr. Andres et al. (Unit of Vascular Biology, Instituto de Biomedicina de
Valencia, Spain) illustrates the use of drugs that target and directly or
indirectly inhibit the activity of cyclin-dependent protein kinases (CDKs) to
regulate abnormal cellular proliferation.
The therapeutic applications of these drugs that can suppress cell
growth are reviewed in animal models and clinical trials.
At the beginning of the new Millennium, we can expect the medical
revolution to continue to blossom and to lead to an amazing increase in the
number of biopharmaceuticals that will originate from the Pharmaceutical
Biotechnology industry. I am confident that Current
Pharmaceutical Biotechnology will be an accurate reflection of that new
medical era and will become a respected Journal that provides critical reviews
of current and emerging research on biopharmaceuticals and their clinical
development.
Alain Rolland, Pharm.D., Ph.D.
Vice President R&D
The Woodlands Center
Head
Valentis, Inc.
Biographical
Summary of Dr. Alain Rolland
Dr. Alain Rolland is currently Vice President of Research and
Development, and Head of The Woodlands Center of Valentis, Inc., a biologics
delivery company developing gene medicines and PEGylated proteins. He previously served several positions at GeneMedicine, inc. from June 1993 to
March 1999, ranging from Director of Gene Delivery to Vice President of
Research. From 1989 to 1993, he was the Head of Formulation Research at the
R&D Center of Galderma International (CIRD) in France. From 1987 to 1988, he was at the Advanced
Drug Delivery Research Center of Ciba Geigy Pharmaceuticals in the UK. He received a Pharm.D. degree in 1981, and a
DEA degree in Pharmacokinetics and Biopharmaceutics in 1983 from Rennes
University (France). He obtained his
Ph.D. in Pharmaceutical Sciences in 1987 from Rennes University after inventing
and developing novel polymeric nanoparticles for targeting anticancer drugs to
the liver for the treatment of hepatocellular carcinoma. He has published over fifty scientific
articles and book chapters, edited scientific books and he is the recipient of
several awards. Dr. Rolland holds
numerous patents in the field of drug/gene targeting and formulation. He is a member of several scientific
societies, including the American
Controlled Release Society, the American
Association of Pharmaceutical Scientists and the American Society of Gene Therapy. He is also on the Editorial Board of scientific journals such
as the Journal of Pharmacy and
Pharmacology, Advanced Drug Delivery
Reviews, and the Journal of
Controlled Release.