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.

India’s recent election has brought a decisive majority to the right-of-center BJP Party, carrying BJP leader Narendra Modi to the Prime Minister’s office. What will the decisive BJP Victory mean for the future of innovative life sciences in India? Will Prime Minister Modi re-invigorate commercial biotechnology in Delhi?

The State of Gujarat has long been a been a manufacturing and export powerhouse for generic pharmaceuticals, where “Gujarat contributes nearly 28 per cent to national pharmaceutical exports.” In contrast to the broader challenges facing bio-pharma growth in India, Gujarat has continued as a bright spot for pharmaceutical exports, enjoying double-digit growth over the last fiscal year. Long recognized as a manufacturing powerhouse, Gujarat has captured an outsize share – now exceeding 40% of India’s total generics turnover. 

During his 12-year tenure as Chief Minister of the State of Gujarat, Minister Modi identified the innovative life sciences as having great development potential, having seen the benefits to India’s southern states of Karnataka and Andhra Pradesh from the Information and Communications Technology (ICT) revolution. Then-Chief Minister Modi set out to to attract highly innovative life sciences companies to the State through seed funding programs as well as promotion of the sector at Vibrant Gujarat – a bi-annual pan-industrial congress attracting industry leaders from across India and abroad.

Established under the jurisdiction of the Gujarat State Biotechnology Mission (GSBTM) and administered by the Gujarat Venture Fund Limited (GVFL), the Gujarat Biotech Venture Fund (GBVF) provides seed funding to innovative companies registered in Gujarat. (Full disclosure: my biotech start-up, Amrita Therapeutics Public Limited, received initial seed funding under the GBVF that enabled the company to initiate R&D at the depths of the global economic crisis in early 2009.) I met Minister Modi at the 2009 Vibrant Gujarat  in Gandhinagar, and witnessed first hand the intensive efforts underway to support growth of Gujarat’s innovative biotech sector.

Now Prime Minister-elect Modi has the opportunity to ‘green light’ incentives to encourage home-grown biotech start-ups across the country, including:

• Investment Tax Credits to encourage investment by VCs and Angel Investors in ‘high risk, high reward’ biotech discovery companies that require a substantial commitment of funds for a decade or more before commercial launch
• Expansion of current Department of Biotechnology (DBT) industry partnership programs, with an orientation to support for cutting-edge, biotech ventures vs. established pharma manufacturers
• Focus on regulatory excellence: Indian industry – and Indian’s own citizens – can only thrive in an environment with unquestionable Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)
• Collaborate closely with the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) to ensure that Indian clinical trials fully meet international standards and that Indian patients gain access to clinical research for indigenous innovative therapies and cures for cancer and other high priority public health threats

Beyond increasing access to early capital, the Indian Government also could do more specifically to promote innovative oncology research to address the growing public health threat of colorectal and other cancers for Indian nationals. In the U.S. and in India alike, biotechnology companies historically take root and multiply in clusters in close proximity with other biotech companies, research institutes, and incubation facilities that provide access to wet-labs and high-cost, sensitive equipment and other supplies — Establishment of focused research clusters for oncology R&D would bring long-term benefits.

The Indian electorate voted decisively for change and economic reforms to encourage the assimilation of new technologies for broader social and economic benefits. Time will tell whether Prime Minister-elect Modi will again focus efforts on biotechnology – beyond Gujarat’s borders – for the benefit of India and the world.

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.

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Stem cells are a rapidly developing technology area. The pace of scientific and clinical progress is accompanied by new patents, which can secure technology for innovators, and require careful observation by others to avoid infringement.

After discussions with Christian Walker, a colleague and entrepreneur in the stem cell space, I have launched StemCellPatentWatch to help track new IP developments in the stem cell space.

StemCellPatentWatch delivers on a simple premise: It scans new patent grants for those covering stem cell technologies. Complete details on inventorship, patent ownership, and claims are included. You can also use the search form to find patents of interest, and there is a weekly newsletter featuring the patent updates.

I look forward to your feedback on this new site, and for suggestions for further improvement.

Drug Patent Expirations for May 2014

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

Strategic alliances as a mechanism for wealth creation in the biopharmaceutical industry: An empirical analysis of the Spanish case

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ABSTRACT: The paper studies strategic alliances signed between traditional pharmaceutical companies (TPCs) and new biotechnology firms (NBFs) in Spain, on the initial basis that a firm's rate of new product development is a positive function of the number of strategic alliances that it has entered into. Nevertheless, we believe, as do others, that although strategic alliances may initially have positive effects on that rate, this relationship may exhibit diminishing returns...

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

Cell therapy: European legal and regulatory implications

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ABSTRACT: This paper reviews some of the legal and regulatory considerations that may arise in connection with the use in Europe of cell therapy approaches for the treatment of disease.

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

Bioterrorism and bioethics: Challenges for industry, government and society

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ABSTRACT: The emerging threat of bioterrorism raises important challenges for the biotechnology industry. Not only do new ethical issues arise for companies seeking to take advantage of opportunities for product development; so too must industry continue to grapple with longstanding issues that arise from advances in human genetics and 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

This is a guest post by Gerry Langeler, Managing Director with OVP Venture Partners. Do you have a response to Gerry’s post? Respond in the comments section below.

Many scientists conduct research they believe can have commercial value, and so they fancy themselves as budding entrepreneurs. But a remarkable number stumble over predictable hurdles when they try to make the switch from researcher to start-up founder.

Between academic research and commercial success lie a set of challenges that I discuss in my book “The Success Matrix – Winning in Business and in Life.” It turns out all business endeavors (and for that matter all personal endeavors) consist of three basic elements:

Vision – Process – Output

You have to know where you want to go.
You have to have the skills and resources to get there.
And then you have to execute.

It sounds so simple.
But history shows getting it right is very, very hard.

As a scientist and researcher, you have undoubtedly run this drill many times. The problem is the context changes when you go from academic activities to commercial ones. Regardless of your responsibilities, there are eight possible combinations of presence or absence of Vision, Process and Output, and we can name those combinations as “characters” with predictable strengths and weaknesses.

If you have Vision, but no Process or Output, you are a Dreamer.
If you have Vision and Process, but no Output, you’re an Academic.
If you have Vision, no Process, but Output, you’re a Brute.
If you have no Vision, have Process, but no Output, you’re a Bureaucrat.
If you have no Vision, have Process and have Output, you’re a Merchant.
If you have no Vision, no Process, but have Output, you’re a Grunt.
If you have none of the above, you’re a Loser.
And if you have them all, you’re a Success!

When you change from academia to business the definitions change, too

What makes this difficult for scientists is that the definitions of what makes good Vision, Process and Output are different when you change your objective from accepted peer-reviewed research papers to customer accepted commercial products.

Bulletproof experimental results may be required to pass muster with your peers before you can get published in Nature. But, in the world of commerce, you’ll need to blend scientific integrity with effective cost and time-to-market progress toward commercial stages that keep companies afloat.

Now, that doesn’t mean you can trot off to the FDA with just a smile and shoeshine. But it does mean that you’ll need a different Vision, a different Process, and be measuring yourself against different Output if you want to be considered a Success as an entrepreneur or a member of an entrepreneurial team. That presents for you a required change from what made you successful as a researcher. What got you here won’t get you there.

As a board member of biotech companies, I’ve seen this struggle up close. By definition, we only want to invest in world-class researchers who we believe are on the cusp of scientific breakthroughs. But, then we have to get them accept that our money is not infinite, nor our patience, and so they need to “invent to a schedule.” Yet, as we all know, no one can actually schedule inventions, or breakthroughs.

So, what is needed is an appreciation by the scientists that “the perfect is the enemy of the good” and that “good” is often good enough to move forward, even if that feels uncomfortable to those for whom “perfect” (or nearly so) has been their standard.

It is still publish or perish, but with different rules

To be fair, in some ways the commercial world mirrors the academic when one considers the “publish or perish” doctrine. You can’t go on forever doing research without Output (what you publish) or your source of grant funding will dry up, or your tenure will never be approved. The difference is in the commercial world, the “time to publish” is more constrained. And in the commercial world, “publishing” means demonstrating enough progress, to whoever is your audience, so that checks continue to get written.

But those demonstrations of progress are not nearly as constrained as a peer reviewed research report. Those of us who invest in biotech for a living understand that sometimes your research results are preliminary, or even sketchy, but we need to make informed judgments on imperfect information. What we require from you is your best efforts within the time before we have to make another financial commitment.

And above all, we need the candor that comes from scientific inquiry. Many times your first experiment won’t yield the results you expect. That’s OK. Let’s try to find out why. Is your (and our) hypothesis wrong, or were the experimental conditions wrong, or did you learn something that opens a new avenue of investigation?

Unlike polished documents at the end of the research process, our Process is quite comfortable with the uncertainty that comes with the path to discovery.

So, that might mean for a while you look like a Brute to us. Great Vision and some interesting Output, albeit without a validated, repeatable Process yet. Essentially every start-up we’ve ever backed, not just in biotech but in all technology sectors, has been a Brute when they started out. They understood that to continue to get funding from venture capitalists, and ultimately get products to customers, brute-force was necessary.

Heroes are the stuff of legend, but not of longevity

Heroic efforts are often the difference between success and failure. But what we know is long-term heroes (and Brutes) don’t scale. Long-term, polished, repeatable processes need to be in place for the commercial enterprise to succeed.

Similar things can be said of the other “less than Success-ful” characters. For example, at times you just have to crank out stuff, even if it doesn’t seem to align with the grand Vision, or match up with a sophisticated Process. Welcome the “Grunt.”

Sometimes in a commercial enterprise, some Output is better than none. It keeps the wolf away from the door. Just as with the Brute, you don’t want to rely on Grunt behavior very long. But in the short-term, it can be all you need to fight another day.

What you need to avoid at all costs is to revert into “Academic” behavior, at least as defined in commercial company terms. All Vision and Process with no Output will not keep the lights on.

This is one of the reasons we like to pair up fantastic researchers with others who have already made the leap into commercial companies. Nothing can replace the breakthrough science. But those pragmatists who understand the differences between the two domains can be remarkably helpful in getting the scientists new to the corporate world to understand the different rules of the game.

And instead of failed scientist, the result can be a successful enterprise.

What do you think? Do you know people (or organizations) that fall into the character groups described in the Matrix? How do you deal with them? Sound off in comments below.

For over 20 years, Gerry Langeler has served as a Managing Director with OVP Venture Partners (OVP), the most experienced venture capital firm in the Pacific Northwest. OVP was formed in 1983, and raised seven venture capital funds, the most recent at $250 million. The firm focused on early stage companies in clean tech, digital biology, and information technology. OVP backed over 125 startups and saw over 50 major liquidity events, including 25 IPOs and more than 30 acquisitions by public companies.

I have been struggling to understand the utility of Google Glass in most of the presented use cases.

The Google Glass homepage features largely recreational consumer-driven uses, such as taping a ballet concert, performing Google searches, and navigation. A regular cellphone or GoPro can readily serve these needs, which leads me to question where the killer app for Google Glass may lie. Just as the Segway was supposed to change the world, its uses now are primarily saving security guards and tourists from too much walking.

Why is Google pushing a bunch of soft ‘wants’ instead of painful ‘needs’?

The life sciences, along with many other technical disciplines, face a substantial challenge both in visualization, and in real-time information delivery. Consider the cases of surgeons using Google Glass here and here, or the US military’s use of augmented reality to speed vehicle repair. Surgeons can use Google Glass to beam images and obtain remote guidance in real-time, and students can gain a first-hand view and ask questions in real-time. Augmented reality can permit fewer mechanics to repair vehicles faster and more effectively, reducing the number of personnel and equipment needed to be stationed in warzones or other dangerous areas.  These applications represent currently pressing, painful, unmet needs.

Google Glass needs to take a lesson from the Segway debacle. Instead of pushing trivial or contrived applications on consumers (which may kill the technology), they would be better served by focusing on strong unmet needs, and letting consumers and hackers develop their own derivatives.

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

ATMP in practice: Towards a new industry landscape in tissue engineering

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ABSTRACT: Regulatory divergences and market fragmentation across member states have hampered the development of the tissue engineering industry in the EU. Addressing this situation by providing a harmonised and more predictable regulatory regime, the regulation on advanced therapy medicinal products (ATMPs) is based on a regulatory strategy that aims to consolidate the increased activity in the domain of regenerative medicine while maintaining the pace of technical development and innovation in this area...

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