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

The regulatory system in the EU and further afield

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ABSTRACT: The regulation of modern biotechnology began almost as soon as the potential benefits and risks became clear. In some countries a decision was made to use current law to address the new technologies, arguing that the changes that are able to be introduced into new products are not substantially different from those introduced by other techniques...

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

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

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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

Tradename Applicant Generic Name Patent Number Patent Expiration
ATROVENT HFA Boehringer Ingelheim ipratropium bromide 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 6,335,033 Nov 4, 2014
QVAR 80 Teva Branded Pharm beclomethasone dipropionate 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 5,958,452 Nov 4, 2014
ZETONNA Takeda Gmbh ciclesonide 5,683,677 Nov 4, 2014
ALVESCO Takeda Gmbh ciclesonide 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 5,965,161 Nov 4, 2014
QVAR 40 Teva Branded Pharm beclomethasone dipropionate 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 6,706,281 Nov 4, 2014
QNASL Teva Branded Pharm beclomethasone dipropionate 5,683,677 Nov 4, 2014
PALLADONE Purdue Pharma Lp hydromorphone hydrochloride 6,743,442 Nov 4, 2014
NOVOLOG PENFILL Novo Nordisk Inc insulin aspart recombinant 5,626,566*PED Nov 6, 2014
APTIVUS Boehringer Ingelheim tipranavir 6,169,181*PED Nov 6, 2014
INTEGRILIN Schering eptifibatide 5,686,570 Nov 11, 2014
INTEGRILIN Schering eptifibatide 5,756,451 Nov 11, 2014
DICLOFENAC SODIUM Falcon Pharms diclofenac sodium 5,653,972 Nov 16, 2014
DICLOFENAC SODIUM Falcon Pharms diclofenac sodium 5,603,929 Nov 16, 2014
FOSAMAX Merck alendronate sodium 5,462,932*PED Nov 17, 2014
SURFAXIN Discovery Labs lucinactant 5,407,914 Nov 17, 2014
FUZEON Roche enfuvirtide 6,133,418 Nov 17, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 7,135,571*PED Nov 18, 2014
CHILDREN'S ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 7,138,524*PED Nov 18, 2014
CELLCEPT Roche Palo mycophenolate mofetil 5,688,529 Nov 18, 2014
ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
ALLEGRA Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
CHILDREN'S ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
CHILDREN'S ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,135,571*PED Nov 18, 2014
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION Sanofi Aventis Us fexofenadine hydrochloride; pseudoephedrine hydrochloride 7,138,524*PED Nov 18, 2014
CHILDREN'S ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA ALLERGY Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
ALLEGRA HIVES Sanofi Aventis Us fexofenadine hydrochloride 7,138,524*PED Nov 18, 2014
PRILOSEC Astrazeneca omeprazole magnesium 5,690,960 Nov 25, 2014
VELTIN Stiefel Gsk clindamycin phosphate; tretinoin 5,690,923 Nov 25, 2014
PRILOSEC OTC Astrazeneca omeprazole magnesium 5,690,960 Nov 25, 2014
NEXIUM 24HR Astrazeneca Lp esomeprazole magnesium 5,690,960 Nov 25, 2014
NEXIUM IV Astrazeneca esomeprazole sodium 5,877,192*PED Nov 27, 2014
NEXIUM Astrazeneca esomeprazole magnesium 6,875,872*PED Nov 27, 2014
VIMOVO Horizon Pharma esomeprazole magnesium; naproxen 6,875,872*PED Nov 27, 2014
NEXIUM Astrazeneca esomeprazole magnesium 5,877,192*PED Nov 27, 2014
SULAR Shionogi Inc nisoldipine 5,626,874 Nov 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:

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  • 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
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See the Database Preview and Plan Comparison.
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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

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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

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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

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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

Gerry Langeler, author of The Success Matrix and Managing Director with OVP Venture Partners recently spoke at a breakfast event and was kind enough to record the video.

Gerry’s thoughts on ‘Why scientists fail as entrepreneurs‘ was previously featured on the BiotechBlog, and his video is posted below. For more, you can also visit Gerry’s website at www.thesuccessmatrix.com.

 

Drug Patent Expirations for October 2014

Tradename Applicant Generic Name Patent Number Patent Expiration
DENAVIR Denco Asset penciclovir sodium 5,866,581 Oct 4, 2014
DENAVIR Denco Asset penciclovir sodium 6,124,304 Oct 4, 2014
REMODULIN United Therap treprostinil 5,153,222 Oct 6, 2014
SYMBICORT Astrazeneca budesonide; formoterol fumarate dihydrate 5,674,860 Oct 7, 2014
SUPRANE Baxter Hlthcare desflurane 5,617,906*PED Oct 8, 2014
CHIROCAINE Purdue Pharma Lp levobupivacaine hydrochloride 5,708,011 Oct 13, 2014
COARTEM Novartis artemether; lumefantrine 5,677,331 Oct 14, 2014
CLIMARA PRO Bayer Hlthcare estradiol; levonorgestrel 5,676,968 Oct 14, 2014
VARITHENA Provensis polidocanol RE38919 Oct 14, 2014
ATROVENT HFA Boehringer Ingelheim ipratropium bromide 5,676,930 Oct 14, 2014
VARITHENA Provensis polidocanol RE40640 Oct 14, 2014
TYVASO United Therap treprostinil 5,153,222 Oct 16, 2014
ORENITRAM United Therap treprostinil diolamine 5,153,222 Oct 16, 2014
TOBI Novartis Pharms tobramycin 5,508,269 Oct 19, 2014
BACTROBAN Glaxosmithkline mupirocin calcium 6,025,389 Oct 20, 2014
AUBAGIO Sanofi Aventis Us teriflunomide 5,679,709 Oct 21, 2014
CYCLOSET Veroscience bromocriptine mesylate 5,679,685 Oct 21, 2014
IMODIUM MULTI-SYMPTOM RELIEF Mcneil loperamide hydrochloride; simethicone 5,679,376 Oct 21, 2014
PRAVIGARD PAC (COPACKAGED) Bristol Myers Squibb aspirin; pravastatin sodium 5,622,985*PED Oct 22, 2014
PRAVACHOL Bristol Myers Squibb pravastatin sodium 5,622,985*PED Oct 22, 2014
VELCADE Millennium Pharms bortezomib 6,083,903 Oct 28, 2014
VELCADE Millennium Pharms bortezomib 7,119,080 Oct 28, 2014
VELCADE Millennium Pharms bortezomib 6,617,317 Oct 28, 2014
IPLEX Insmed mecasermin rinfabate recombinant 5,681,818 Oct 28, 2014
VELCADE Millennium Pharms bortezomib 6,297,217 Oct 28, 2014
RYTHMOL SR Glaxosmithkline Llc propafenone hydrochloride 5,681,588 Oct 28, 2014
VELCADE Millennium Pharms bortezomib 6,747,150 Oct 28, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 7,101,960*PED Oct 29, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 6,066,678*PED Oct 29, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 5,679,717*PED Oct 29, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 6,784,254*PED Oct 29, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 5,919,832*PED Oct 29, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 6,433,026*PED Oct 29, 2014
WELCHOL Daiichi Sankyo colesevelam hydrochloride 5,917,007*PED Oct 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.