Biotechnology Whitepapers

The 3W Gaurrantee: What you Really Saved when you invest in Outsourced Talent

Sat, 24 Dec 2011 04:09:08 -0500

This paper is written to help 3W partners learn the real value of Outsourcing. It will give executives a background of the global economy. At the same time, it gives a clear picture of how business can accommodate the need to serve the global market. Through this paper, you will find just how outsourcing can be utilized to adapt this evolution.
Outsourcing is a cost efficient way of maintaining business procedures and quality output while cutting back on CAPEX and OPEX.

The FDA Review Process: a Technical Look

Rebecca Friend — Thu, 01 Sep 2011 12:01:27 -0400

Navigating eCTD regulations is easier said than done. Same goes for assembling and reviewing applications. This white paper covers the full FDA review process to help you create an application that is technically sound, structured correctly, and most importantly, is ready for agency review. Download.

Pharma is Moving to Digital & Social Media. Wake up!

Thu, 28 Jul 2011 19:14:02 -0400

It's happening right now, all around us. Some of it is under the radar, some of it right out in the open. In spite of the cries for FDA guidance, which seems like it will never come, or fears of being the first to jump off the proverbial cliff, big Pharma is slowly making the move that mainstream consumer brands took years ago. The likes of Lilly, Pfizer, J&J, and Sanofi-Aventis are moving more and more marketing dollars to digital media and away from traditional DTC.

There are many factors moving brand managers in this direction. These forces have been pushing and shoving at them for years now, and in many cases it comes down to simple physics - you simply cannot resist market forces forever, something has to give. Consumers are on a mass move from traditional media consumption to multi-platform digital and social media - or what some will simply call "new media."

The Cutting Edge of Chemistry

Rebecca Friend — Thu, 07 Jul 2011 14:12:42 -0400

The Cutting Edge of Chemistry is a free report from Thomson Reuters, delivering an action-packed review of the latest synthesis schemes, scaffolds, mechanisms of action, and new structures shaping today's drug discovery and development pipeline. Extensively researched, these reports give you a deeper insight into the latest chemistry news that matters to you.

In this issue, we look at the first total synthesis of lomaiviticin aglycon, which according to recent research opens the door to biological testing of the lomaiviticins and their derivatives as putative anticancer drugs. We also review new oral treatments for multiple sclerosis that reached their first markets in 2010 in The Finishing Line, in addition to fascinating molecular mechanisms of action and new molecular entities ready to progress into the R&D area.

Subscribe here to download your free report

The Cutting Edge of Chemistry draws on the expert insight and strategic data from Thomson Reuters IntegritySM, a unique scientific database designed to empower your drug discovery and development activities by seamlessly connecting you to the latest biology, chemistry, and pharmacology data.

To ensure you never miss an issue of The Cutting Edge of Chemistry, subscribe here.

Find out more about Integrity: go.thomsonreuters.com/chemistry

Central Nervous System (CNS) Compound Library from OTAVA

Thu, 30 Jun 2011 05:04:32 -0400

There are many different drug targets expressed in brain tissue. The delivery of drugs to central nervous system (CNS) is complicated by blood brain barrier (BBB) which controls entry of drugs into CNS. BBB is one of the most important factors limiting the development of drugs that specifically target brain disorders. Nowadays BBB remains a bottleneck in brain drug discovery. From the time of high-throughput screening introduction many approaches for finding of compounds with good BBB permeability based on their physicochemical properties were proposed. The state of the art data were used to prepare OTAVA's CNS compound library.
OTAVA Ltd. offers CNS compound library which currently contains about 2 000 compounds. All the selected compounds possess physicochemical properties preferable for BBB penetration and they are simultaneously suitable for oral administration. Molecular weight of compounds selected ranges from 160 to 450, sum of oxygen and nitrogen atoms ≤ 5, number of rotatable bonds ≤ 8, CLogP > 0 and CLogD between 1 and 3. Parameter filters of CLogD and number of rotatable bonds restriction have the main influence on oral bioavailability. Biologically unstable compounds and compounds containing carboxyl groups, reactive groups or unwanted atoms were removed from this library.
CNS Targeted Library from OTAVA is designed as a special screening library containing compounds with high probability to penetrate blood brain barrier thus additional CNS permeability optimization for found inhibitors generally is not required. More information about this library you can find on our website www.otavachemicals.com.

Otava Lead-Like Library

Thu, 30 Jun 2011 05:00:46 -0400

The preclinical drug-discovery process requires the screening of millions of small organic molecules to find a suitable lead compound for one ultimately successful outcome. A lead compound in drug discovery is a substance that displays pharmacological and/or biological activity and whose chemical structure is used as a starting point for chemical modifications in order to improve potency, selectivity or pharmacokinetic parameters.
Based on current data, effective lead compounds have lower molecular complexity when compared with drugs. They also have a smaller number of rings and rotatable bonds, lower molecular weight and they are more polar. The concept of leadlikeness is already having a significant impact on the design of chemical libraries.
Lead-like library, which is available from OTAVA Ltd., is a universal screening library containing about 57,000 compounds. This library is an integral part of the OTAVA chemical libraries and it can be used for high-throughput screening in addition to OTAVA's Drug-like Green Collection and Fragment Library. Comparing to Drug-like Green Collection, this Lead-like library has lower molecular weights (MW 160-400), smaller number of rotatable bonds (≤ 8) and number of hydrogen bond donors (≤ 4) and acceptors (≤ 8). It is done to extend potential chemical space for further lead optimization.
Any biologically unstable compounds and compounds comprising any reactive groups or atoms different to O, N, C, H, Br, I, Cl, F, or S were removed from the library.
This Lead-like library from OTAVA is of great help for medicinal chemists in achieving positive drug discovery outcome in a timely and cost-effective manner.

Otava Ltd.
P.O. Box 88
Kyiv 187, 03187
Ukraine
Phone/Fax : +380 44 522 24 58
E-mail: info@otavachemicals.com

Tar Heel Biotech: The Policies, Trends, and Investments That Continue to Promote Growth in North Carolina's Biotechnology Sector

Tue, 12 Apr 2011 10:16:37 -0400

In the midst of a struggling national economy, North Carolina has emerged as biotechnology powerhouse, boasting over 500 biotech companies and nearly 57,000 biotech jobs. This paper analyzes the pragmatic policies, strategic investments, and industry trends behind the state's unmatched success.

Biologically Active Molecules: Chemical Research, Development and Scale-up

Fri, 25 Mar 2011 07:06:23 -0400

The increasing demand for different biologically active molecules has posed challenges to the scientists to get the desired substances in large amounts either from natural sources or to produce synthetically through efficient and economically viable routes.

Our company, OTAVA Ltd., provides a wide range of biologically active compounds modulating activity of distinct targets.

Protein kinases are popular targets in oncology drug development. These proteins are upregulated in tumor cells making them ideal targets for selective tumor therapy. Currently kinase inhibitors are among the most preferred drugs in development by many pharmaceutical companies. Our company offers a variety of inhibitors including CDK4, DNA-PK, EGFR, CK2, CDK2, IKK-ε, GSK-3 and JNK3 inhibitors. We also propose sets of compounds that inhibit Histone Deacetylase (HDAC), Cyclooxygenase-1, CFTR Chloride Channel, Hypoxia-Inducible Factor-1, STAT3 Transcription Factor, NAD-Dependent Deacetylases SIRT1 and SIRT2.

Protein-protein interactions have a key role in most biological processes and offer attractive opportunities for therapeutic intervention. Developing small molecules that modulate protein-protein interactions is difficult. There has been important progress in this endeavour in recent years. A recently developed inhibitior of interaction between the translation initiation factors eIF4E and eIF4G is commercially available from our company.

In addition to these highly valuable products, OTAVA offers compounds which were evaluated in vitro on 60 human tumor cell lines.

Our biologically active compounds can also be used in experimental biology for understanding the functions of biological molecules in vivo and some compounds could further be used in drug design.

Avoiding Post-Acquisition Product Sales Failures

Wed, 16 Mar 2011 15:45:21 -0400

When Post-Acquisition Product Sales Fail To Meet Expectations

While mergers and acquisitions stalled in the wake of the global financial crisis and concerns over healthcare reform, activity has begun to resurge in recent months. M&A supplements the product pipeline of mature healthcare companies and is an important aspect of continued revenue growth. Healthcare companies represent medical device, diagnostics, pharmaceuticals, consumables, capital equipment, information technology and services.

In seeking to diversify, risk-averse healthcare companies are looking for acquisitions with successfully commercialized technologies and demonstrated revenue as the most attractive targets for potential M&A. Yet because of venture capital constraint and other economic factors, many smaller public or privately held companies, although ripe for M&A and with excellent products in their pipeline, have been unable to prove the market acceptance and commercialization potential of their innovations.

This places the burden of proof of commercialization on the acquiring healthcare company, and places it during a time when the industry is expecting healthcare companies to provide more comprehensive solutions than the piecemeal ones of the past. Not only that, the healthcare industry increasingly expects quantifiable financial justification for these comprehensive solutions.

In this complex environment, the possibility of failure looms large. After a merger or acquisition, it is not at all unusual for post-acquisition product sales to fail to meet expectations.

The National Provider Identifier (NPI) and its Impact on the Pharmaceutical and Medical Device Industries

Thu, 10 Mar 2011 11:49:07 -0500

As detailed in the Physician Payments Sunshine Provisions (PPSP), all vendors within the healthcare industry that interact with providers must disclose all transfers of monetary value annually to the federal government by name, address, specialty, and NPI. Companies that fail to report are responsible for any fines applicable. To date, NPI has not been a mandate and now pharmas must make a full tranistion to their use by 2012 as no other identifies, including ME numbers, will be sanctioned. This whitepaper details the history of the NPI, why it's now important, and what pharmas will need to know to incorporate their use.

Can a R&D Tax Credit Expand Investment in Product Development for Global Health?

Fri, 04 Mar 2011 09:33:20 -0500

Tax credits are used throughout the world to encourage investment in R&D, but are tax credits a good tool to stimulate more R&D for diseases of the poor? The Center for Global Health R&D Policy Assessment’s draft report, “Can a R&D Tax Credit Expand Investment in Product Development for Global Health?” starts to answer this question by considering whether a tax credit would encourage large biotechnology and pharmaceutical firms in the United States to increase expenditure for global health.

This report describes the experience of previous tax credits to spur pharmaceutical R&D like the Orphan Drug Clinical Research Credit, the UK’s Vaccine Research Relief Programme and others. The paper also explores implications for the effectiveness of recently proposed US legislation for neglected disease R&D.

The Center welcomes your insights on this draft report. Comments can either be posted on this website or if you would like to provide more extensive feedback, can be emailed directly to the author, Aarthi Rao. Comments will be accepted until March 11, 2011.

WHITE PAPER: Four Strategies for Cost-Effective Pharmacovigilance

Jocelyn Zobitz — Wed, 23 Feb 2011 15:32:50 -0500

Developing drug safety and pharmacovigilance programs has become increasingly complex amid challenging economic conditions. This paper presents four key areas in which pharmaceutical and biotech companies of all sizes can take steps to maintain quality and safety while making ever dollar count.

Best Practices: ERP Vendor Reference-Checking

Mon, 03 Jan 2011 12:11:51 -0500

Selecting an ERP solution can be a formidable challenge
Especially for a medtech manufacturing business.That's because you've got so much on the line: the wrong ERP selection can impact compliance, time-to-market and profitability. How do you know you've got the information you need to make the best decision for your company?

Effective reference-checking is essential
Most companies focus on functionality requirements, technology issues and the total cost of ownership. Too often, they overlook critical factors that are essential to making the best selection for their business. These factors can be explored only through diligent reference checking that will help you:

Identify hidden shortcomings
Reduce the risk of a bad decision
Understand the intangible factors

Learn how to check ERP vendor references
This important practice is often neglected or inadequately performed, but it is critical to making the right selection for your company. For over twenty years Expandable Software has worked with fast-growing medical device manufacturing companies implementing, validating and launching ERP systems as part of their core regulated quality systems. We've identified the top ERP success factors and produced a paper with tips for conducting the reference check.

Launching a Medical Device, Healthcare or Life Science Product: Fail Fast, Marginal or Worth Pursuing?

Fri, 17 Dec 2010 13:54:17 -0500

The speed to market, accelerated sales growth and risk mitigation for a medical device, life science or healthcare product is critical to the success of a business. Whether you are planning to launch a new product, a non-progressing asset, or a product acquired into your portfolio due to recent merger or acquisition, there are critical considerations vital to a successful launch.

The old model of sales outsourcing no longer provides answers to today's ever-changing economic climate and is incomplete. Healthcare reform has altered market dynamics. Both Medicare and Medicaid have put forth new pay-for-performance initiatives. And medical institutions are demanding that new products show economic value in addition to clinical benefit. A new paradigm is desperately needed. Many leading companies are looking for new and innovative "shared risk-shared reward" partnerships, with a focus on customizable and scalable sales solutions.

This white paper discuss some of the most common mistakes made when bringing a new product to market and a proven four step process for launching your product successfully.

The Adverse Impact of the US Reimbursement System on the Development and Adoption of Personalized Medicine Diagnostics

Wed, 08 Dec 2010 12:58:28 -0500

CONTACT

Gwen Gordon

Phone: (202) 589-1770

ggordon@PersonalizedMedicineCoalition.org

Michal Taton

Phone: (617) 912-5119

mtaton@bostonhealthcare.com

Personalized Medicine Coalition Workgroup Issue Brief Highlights Need for Updates to Diagnostics

Reimbursement System

Current Reimbursement Framework Hinders Development and Adoption of Personalized Medicine

Washington, DC and Boston, MA (December 8, 2010) - The Personalized Medicine Coalition (PMC) and Boston Healthcare Associates today announced the release of an issue brief that outlines the scope and nature of problems with the U.S. reimbursement system for personalized medicine diagnostic tests and proposes points to consider for policymakers at the Centers for Medicare and Medicaid Services (CMS) and on Capitol Hill.

"PMC has recognized that the reimbursement framework created decades ago is ill-equipped for an era of personalized medicine," said Edward Abrahams, PMC President.

"Reimbursement and coding policies should be redesigned to facilitate the further development and adoption of innovative diagnostic tests that can improve patient outcomes and we believe, lower long-term health care costs," added Amy Miller, PMC Public Policy Director and the report's study director.

The issue brief discusses the implications for personalized medicine of problems with diagnostic test coding, coverage and evidence standards for reimbursement, and payment for personalized medicine diagnostics.

Written by David Parker, Ph.D., Vice President of Boston Healthcare Associates, the issue brief is the product of a working group that met during the summer of 2010 to focus on Medicare reimbursement issues. The working group, co-chaired by Scott Allocco of BioMarker Strategies and Steve Phillips of Johnson & Johnson, included representatives from more than 30 diverse PMC member organizations ranging from development stage diagnostic test companies, to large multinational biopharmaceutical companies, to industry trade associations.

"The reimbursement system for advanced personalized medicine diagnostics - including the way tests are coded and the evidence currently needed to obtain coverage - does not recognize the clinical utility or economic value of these tests, or the realities of the niche markets they serve," said David Parker, the study author. "As a result, patient access to these tests is obstructed, and innovation in personalized medicine is stifled."

"This report clearly shows that the current reimbursement system for personalized medicine diagnostics is broken," said task force co-chair Scott Allocco. "We must now find ways to fix the system in a way that promotes, rather than hinders, the development of personalized medicine."

The report is available for download here.

About the Personalized Medicine Coalition

The Personalized Medicine Coalition (PMC), representing a broad spectrum of academic, industrial, patient, provider, and payer communities, seeks to advance the understanding and adoption of personalized medicine concepts and products for the benefit of patients. For more information on the Personalized Medicine Coalition, please visit www.PersonalizedMedicineCoalition.org.

About Boston Healthcare Associates

Boston Healthcare assists emerging and established biopharmaceutical, medical device, and diagnostic companies worldwide in gaining a competitive advantage in the health care marketplace by helping them unlock the value of their innovations. These companies rely on Boston Healthcare to create opportunities, navigate complexity, grow their businesses, and achieve objectives through reimbursement and market access strategy services, health economics and outcomes research, market analytics and pricing strategy, and business development support services. Clients draw on Boston Healthcare's unique approach to gain a real-world edge in a highly competitive health care environment. For more information, visit www.bostonhealthcare.com.