Home General Biotechnology

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Susan Kling FinstonIn the “Mystery of Capital,” Peruvian economist Hernando de Soto famously writes about the need to convert assets into capital for creation of social and economic value in developing countries and economies in transition, noting:  “Any asset whose economic and social aspects are not fixed in a formal property system is extremely hard to move in the market.”  While de Soto is describing the need to legalize informal property systems, this is equally true with respect to BRICS and other countries seeking to unlock capital resources for R&D intensive start-ups, also known as Micro, Small and Medium Enterprises (MSMEs).

The importance of creating incentives for Angel investors has been recognized as a critical factor for development of biotechnology.  As articulated by Life Sciences policy expert Michael Tremblay, PhD in describing the needs of smaller (or less developed) biotech markets:  “you’ll need to consider the economic developments that come with building a life sciences sector as you’ll need to energise high net worth individuals as angel investors to help start and run the small businesses ….”

The United States provides investment tax credits at the state and federal level that create an immediate benefit to High Net Worth Individuals (HNWIs), also known as Angel Investors, from the moment of investment in a biotechnology start-up or other high-risk technology company.  These Angels have made a huge difference for biotech entrepreneurs in recent years, pitching in where VCs increasingly fear to tread.

In contrast, the challenge of private financing for innovation remains a continuing challenge for the BRICS, in part due to the absence of similar tax credit programs to provide immediate investment incentives for HNWIs:

Angel investors are virtually absent and there remain concerns relating to tax and exchange control regulations that may impact on the risk management strategies of local fund managers.

To take the case of India, for example, the government seeks to provide incentives for R&D investment both through grant / soft loan programs (with matching requirements) and by allowing deduction of R&D expenses against revenues.  Both of these policies provide significant benefits for larger companies with established product lines, however these are not the companies that generally create market disturbing bio-pharma innovation.

Conversely, these policies do not provide as much benefit for R&D intensive MSMES, both due to the challenge of meeting stringent matching requirements, and the absence of incentives for HNWIs to invest in high-risk / high-reward start-up companies. This may be one important reason why India’s life sciences sector has been described as “Biotech without Startups,” something that sounds paradoxical to Western ears, accustomed to how biotechnology evolved from start-ups to global operations, as in recent years with Celgene and Alexion, and in the early days of the biotechnology revolution with Biogen-Idec, Genentech and Amgen.

Amgen began as a biotech start-up more than 30 years ago, with a focus on commercialization of  innovative cancer therapies that save and improve people’s lives.  including oncology therapies are effective against blood cancers, solid tumors, supportive care and more in the pipeline. In financial terms, Amgen ’s valuation exceeds $100 billion –  more than India’s pharmaceutical and biotechnology sectors combined.

With the right incentives for High Net Worth Individuals, imagine the how much social and economic value could be created in any of the BRICS by just one home-grown Amgen!

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

EU Financial accounts reports

Go to paper

ABSTRACT: Presents updates on the 2000 financial results of several biotechnology and pharmaceutical firms in Europe. Celltech Group Plc; ML Laboratories plc; Pharmagene plc.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Drug Patent Expirations for November 2014

TradenameApplicantGeneric NamePatent NumberPatent Expiration
ATROVENT HFABoehringer Ingelheimipratropium bromide5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride6,335,033Nov 4, 2014
QVAR 80Teva Branded Pharmbeclomethasone dipropionate5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride5,958,452Nov 4, 2014
ZETONNATakeda Gmbhciclesonide5,683,677Nov 4, 2014
ALVESCOTakeda Gmbhciclesonide5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride5,965,161Nov 4, 2014
QVAR 40Teva Branded Pharmbeclomethasone dipropionate5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride6,706,281Nov 4, 2014
QNASLTeva Branded Pharmbeclomethasone dipropionate5,683,677Nov 4, 2014
PALLADONEPurdue Pharma Lphydromorphone hydrochloride6,743,442Nov 4, 2014
NOVOLOG PENFILLNovo Nordisk Incinsulin aspart recombinant5,626,566*PEDNov 6, 2014
APTIVUSBoehringer Ingelheimtipranavir6,169,181*PEDNov 6, 2014
INTEGRILINScheringeptifibatide5,686,570Nov 11, 2014
INTEGRILINScheringeptifibatide5,756,451Nov 11, 2014
DICLOFENAC SODIUMFalcon Pharmsdiclofenac sodium5,653,972Nov 16, 2014
DICLOFENAC SODIUMFalcon Pharmsdiclofenac sodium5,603,929Nov 16, 2014
FOSAMAXMerckalendronate sodium5,462,932*PEDNov 17, 2014
SURFAXINDiscovery Labslucinactant5,407,914Nov 17, 2014
FUZEONRocheenfuvirtide6,133,418Nov 17, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONSanofi Aventis Usfexofenadine hydrochloride; pseudoephedrine hydrochloride7,135,571*PEDNov 18, 2014
CHILDREN'S ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONSanofi Aventis Usfexofenadine hydrochloride; pseudoephedrine hydrochloride7,138,524*PEDNov 18, 2014
CELLCEPTRoche Palomycophenolate mofetil5,688,529Nov 18, 2014
ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
ALLEGRASanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
CHILDREN'S ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
CHILDREN'S ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,135,571*PEDNov 18, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONSanofi Aventis Usfexofenadine hydrochloride; pseudoephedrine hydrochloride7,138,524*PEDNov 18, 2014
CHILDREN'S ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRA ALLERGYSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRASanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
ALLEGRA HIVESSanofi Aventis Usfexofenadine hydrochloride7,138,524*PEDNov 18, 2014
PRILOSECAstrazenecaomeprazole magnesium5,690,960Nov 25, 2014
VELTINStiefel Gskclindamycin phosphate; tretinoin5,690,923Nov 25, 2014
PRILOSEC OTCAstrazenecaomeprazole magnesium5,690,960Nov 25, 2014
NEXIUM 24HRAstrazeneca Lpesomeprazole magnesium5,690,960Nov 25, 2014
NEXIUM IVAstrazenecaesomeprazole sodium5,877,192*PEDNov 27, 2014
NEXIUMAstrazenecaesomeprazole magnesium6,875,872*PEDNov 27, 2014
VIMOVOHorizon Pharmaesomeprazole magnesium; naproxen6,875,872*PEDNov 27, 2014
NEXIUMAstrazenecaesomeprazole magnesium5,877,192*PEDNov 27, 2014
SULARShionogi Incnisoldipine5,626,874Nov 30, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
Contact Us with any questions.

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Conflict of interest in academic research

Go to paper

ABSTRACT: The potential for conflict of interest in research can occur whenever a faculty member's financial interest in an industrial sponsor is sufficient to affect his or her impartiality in interpreting the results of the sponsored project. Owing, in large part, to the role of public funding of research, the appearance of a conflict of interest can be as damaging to the reputation of the investigator and/or university as an actual conflict...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

A new season for biotechnology in Europe

Go to paper

ABSTRACT: Comments on the status of the biotechnology industry in Europe as of March 2002. Research system for life sciences in Europe; Changes in the European Union's (EU) policy toward biotechnology; Plans of EU for the biotechnology industry.

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Welcome to Biotech Nation

Go to paper

ABSTRACT: Welcome to Biotech NationMoira A. Gunn, PhDAMACOM, New York, NY;ISBN: 978 0814409237; 2007; 258pp; hardback

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Drug Patent Expirations for October 2014

TradenameApplicantGeneric NamePatent NumberPatent Expiration
DENAVIRDenco Assetpenciclovir sodium5,866,581Oct 4, 2014
DENAVIRDenco Assetpenciclovir sodium6,124,304Oct 4, 2014
REMODULINUnited Theraptreprostinil5,153,222Oct 6, 2014
SYMBICORTAstrazenecabudesonide; formoterol fumarate dihydrate5,674,860Oct 7, 2014
SUPRANEBaxter Hlthcaredesflurane5,617,906*PEDOct 8, 2014
CHIROCAINEPurdue Pharma Lplevobupivacaine hydrochloride5,708,011Oct 13, 2014
COARTEMNovartisartemether; lumefantrine5,677,331Oct 14, 2014
CLIMARA PROBayer Hlthcareestradiol; levonorgestrel5,676,968Oct 14, 2014
VARITHENAProvensispolidocanolRE38919Oct 14, 2014
ATROVENT HFABoehringer Ingelheimipratropium bromide5,676,930Oct 14, 2014
VARITHENAProvensispolidocanolRE40640Oct 14, 2014
TYVASOUnited Theraptreprostinil5,153,222Oct 16, 2014
ORENITRAMUnited Theraptreprostinil diolamine5,153,222Oct 16, 2014
TOBINovartis Pharmstobramycin5,508,269Oct 19, 2014
BACTROBANGlaxosmithklinemupirocin calcium6,025,389Oct 20, 2014
AUBAGIOSanofi Aventis Usteriflunomide5,679,709Oct 21, 2014
CYCLOSETVerosciencebromocriptine mesylate5,679,685Oct 21, 2014
IMODIUM MULTI-SYMPTOM RELIEFMcneilloperamide hydrochloride; simethicone5,679,376Oct 21, 2014
PRAVIGARD PAC (COPACKAGED)Bristol Myers Squibbaspirin; pravastatin sodium5,622,985*PEDOct 22, 2014
PRAVACHOLBristol Myers Squibbpravastatin sodium5,622,985*PEDOct 22, 2014
VELCADEMillennium Pharmsbortezomib6,083,903Oct 28, 2014
VELCADEMillennium Pharmsbortezomib7,119,080Oct 28, 2014
VELCADEMillennium Pharmsbortezomib6,617,317Oct 28, 2014
IPLEXInsmedmecasermin rinfabate recombinant5,681,818Oct 28, 2014
VELCADEMillennium Pharmsbortezomib6,297,217Oct 28, 2014
RYTHMOL SRGlaxosmithkline Llcpropafenone hydrochloride5,681,588Oct 28, 2014
VELCADEMillennium Pharmsbortezomib6,747,150Oct 28, 2014
WELCHOLDaiichi Sankyocolesevelam hydrochloride7,101,960*PEDOct 29, 2014
WELCHOLDaiichi Sankyocolesevelam hydrochloride6,066,678*PEDOct 29, 2014
WELCHOLDaiichi Sankyocolesevelam hydrochloride5,679,717*PEDOct 29, 2014
WELCHOLDaiichi Sankyocolesevelam hydrochloride6,784,254*PEDOct 29, 2014
WELCHOLDaiichi Sankyocolesevelam hydrochloride5,919,832*PEDOct 29, 2014
WELCHOLDaiichi Sankyocolesevelam hydrochloride6,433,026*PEDOct 29, 2014
WELCHOLDaiichi Sankyocolesevelam hydrochloride5,917,007*PEDOct 29, 2014
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
  • Sales data (top 200 drugs)
  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
See the Database Preview and Plan Comparison.
Contact Us with any questions.

This is a guest post from Steve McLaughlin, Managing Partner and Founder of US BioSearch. Do you have a response to Steve’s post? Respond in the comments section below.

Stephen McLaughlin a (4)Effective succession plans involve a combination of many choices and decisions that are distinctive to each, specific company. Bioscience companies also present their own, unique challenges, as I have learned with my 28 years of leadership experience as a U.S. Marine Officer, Foreign Service Officer, founder of a medium sized European consultancy company, and bioscience recruiter.

The first crucial point is that a solid plan does not center solely on the president and founder of the company. A strong succession plan will focus on the entire company. A succession plan for the president and founder undoubtedly needs to be addressed, but not at the expense of the larger organization.  The following points address this issue.

I strongly believe a good succession plans begins with a company’s target market and not on the structure of the organization, i.e. the good plan focuses on the products or services that the market demands, and this will tailor the other needs of the company accordingly.

A successful company exists to service the market. While this fact is well known it can easily be forgotten as a company reaches a certain size. As organizations grow, the focus often tends to become more “internal” — on structure, internal policy, personnel issues, and the like. At this stage, businesses often forget and focus less on the reason the company exists in the first place, which is to service an outside need, and to do this as best they can.

Some organizations are able to handle change better than others. This was evident to me with the Marine Corps when I served as an Officer in the 1980’s. The Marines never lost sight of their ultimate goal—an effective combat organization in a changing world–and utilized the best skill sets and technology available to achieve it. However, when I was employed with the State Department, I saw that the organization did not understand how to adapt in a changing world. I found this institution struggled with many issues, one being the rapid growth and importance of the Internet, and was not able to define a core function.

How does focusing on the target market relate to good succession planning? A company which does not understand the reason it exists – what service it provides to its market – cannot possibly comprehend which staff positions are essential. For example, a drug company subsists to provide drugs to the marketplace. It’s therefore critical to understand the key skill sets involved in creating these new drugs, which brings us back to the company’s succession plan. Will the business lose some of its key members to retirement? Does it have the right scientific skills and technology to develop these new products? These are some of the key questions to ask.

A good succession plan also involves having a solid understanding of the intricate needs of the current and future structure of the company. Businesses require different types of organization depending on their revenue model. A company that grows past a certain threshold of revenue, for instance, will require different skill sets from its employees and need more experienced leaders. A good succession plan will include this important concept.

A related example is a succession plan that includes a strategy for when the business needs to have certain Human Resource functions internal to the company. If the company anticipates growing to this point, and has a general idea of when that point might be, it can create a plan for internally grooming the right individual to take on that position at the appropriate time.

A solid succession plan will also take into account the various skill sets available to and required for the business to be successful. Employee talent and technical skill sets are required to produce quality products or services and determine the overall success of the company. The plan should estimate the training, experience, and skill sets required for each function. It should be dictate where or how these skill sets can be acquired, and it should include a logical career progression in the market for each position. The plan needs to additionally include the market value of each skill set and any potential shortages that may exist. For example, good bioscience companies know that bioinformatics individuals are in high demand by companies outside bioscience, and therefore, they must plan for this accordingly.

In addition, a strategic succession plan will include several levels of staff promotion opportunities, and in particular, prepare for the next two or three levels of promotion for each key skill set within the company. This would include plans for employee training to gain the skills needed for individual advancement. The plan should also project potential deficits in staff numbers caused by retirements, attrition, or other events typically beyond the control of the business.

I have seen this balancing act successfully applied in the corporate world and in the bioscience sector. Well led companies understand this balance. It is the reason such businesses can exist and thrive long-term, supporting the needs of individuals who will rise in the organization.  I also believe the right external expert, who has years of experience dealing with leadership and talent challenges, can aide companies with the issue. He or she can correctly guide an organization and company to create a strong succession plan, without endangering revenue.

About the author:

Prior to starting US BioSearch, Steve was a Managing Partner at Beckett McLaughlin International, LLC. He was responsible for the firm’s Global Life Sciences practice as well as international business development in Latin America and Europe. In this role he was responsible for developing Executive Recruiting and Market Research business in the Energy, Life Sciences, Information Technology, Banking and Finance Industries.  Steve was also a senior executive for a risk analysis firm which advised a major financial house on private equity, venture capital, and hedge fund investments. Previously, he started and ran a successful European consultancy advising U.S. clients on penetrating emerging European markets.  Earlier in his career Steve worked as a U.S. Foreign Service Officer, conducting risk analysis and geopolitical reporting in Chile, Peru, and Mexico.  Steve served as a U.S. Marine Corps Officer with four years service. Steve was born in the Middle East and lived in Israel, Italy, Nigeria, Somalia, Mexico, Barbados, and the Dominican Republic. He is a graduate of Rice University with a B.A. in History, where he was student body president. He also completed graduate studies in International Trade Theory at the Universidad Mayor in Santiago, Chile. Steve speaks native Spanish and English, and fluent French.

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

The legal and ethical considerations relating to the supply and use of human tissue for biomedical research: A UK perpective

Go to paper

ABSTRACT: Alder Hey Children's Hospital supplied parts of the thymus gland removed from young children during heart surgery to a pharmaceutical company. The circumstances raised a number of very serious issues to the medical research community and have led to a consideration of the legal and ethical framework in which human tissue is used for medical research...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website