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Recents Thoughts of Biotech Innovation: 2015 2016

From WorldofDTCMarketing

Can’t innovate ? Buy small biotech companies that can

cloud-innovationOn a week where a lot of people are taking their final summer vacations the news is that Amgen is buying Onyx and AstraZeneca Plc took a further step to bolster its pipeline of new cancer drugs on Monday by agreeing to acquire privately held U.S. biotech company Amplimmune for up to $500 million.  On paper it’s a good business move but as big pharma companies gobble up small biotech companies they bring with then antiquated processes and business people who are thinking about the bottom line rather than patients.  The results ?  Innovation that led these smaller biotech companies to develop new drugs will be stymied by a bureaucratic business model.

There is a reason why, after being acquired, that so many employees of smaller biotech companies leave.  Either they don’t want to work for big a big pharma bureaucracy or the acquiring company determines that these people are not needed and shows them the door.  Behind all this are people who provided the start-up funding and want to cash in without awaiting the lengthy process of developing new drugs.  In the end however it’s patients who loose.

bureaucracy

Last week Steve Ballmer, the CEO of Microsoft, announced his resignation.  There is a correlation between what happened at Microsoft and the challenges for big pharma.  Steve was forced out because Microsoft became a huge bureaucracy and could not innovate fast enough.  Those of us who have worked in pharma know of the endless 9-5 meetings to move even small projects forward.  Amgen’s culture revolves around back-to-back meetings with executives from other big pharma companies who are trying to put their power on display.  It’s only a matter of time before people from Onyx leave because of Amgen’s prohibitive culture.

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Until the costs of developing and launching new drugs is lower more and more innovative biotech firms are going to have a for sale sign hanging in the window hoping big pharma can help investors cash in.

And in a Commentary on CNBC

This is biotech’s real problem

Robert J. Mulroy, president and CEO of Merrimack

Thursday, 1 Oct 2015 | 9:38 AM ET

1

COMMENTJoin the Discussion

Here’s a challenge — name a biotech that’s not a small company with one potential blockbuster in the works or an industry giant that’s acquiring the hottest new technologies. Got one? Great! Now try to name four more.

Biotech

Jian Wan | Vetta | Getty Images

The fact is, midsize biotechs (Ironwood Pharmaceuticals andMedivation are couple of examples) are a rarity these days, and that’s a problem for patients, doctors and investors. Start-ups that are in the process of developing and drawing from a foundation of knowledge are often acquired once they have a promising candidate in the pipeline. If the associated research teams aren’t immediately jettisoned (just when their potential for broader breakthroughs is surging), the top innovators go off to launch another venture that doesn’t build on their current research.

There’s also enormous pressure to focus on that “next big thing” that can crowd out other innovations for patients, while blocking valuable, in-depth examination of existing treatments. In oncology, drug combinations (like Genentech’s combination of Herceptin, pertuzumab and docetaxel to treat HER-2 breast cancer) are making huge strides in prolonging patients’ lives. Such combinations require understanding how specific tumors grow, and designing diagnostics that tell doctors whether a patient’s tumor fits that profile. The problem? Not enough small biotechs have the luxury of developing that understanding before they’re acquired so that big biotechs can gain another drug candidate.

As the CEO of a cancer-focused biotech that’s spent the last 15 years building a diverse product pipeline — the lead candidate is under FDA review with a decision expected next month — my view is that pursuing individual drug targets will bring limited success. Cancer is the ultimate engineering challenge, and effective treatments need to address more than a single facet of the problem.

The real winners in the industry will be the companies that understand how their therapies work in combinations with their own and competing therapies, and help physicians make sense of the explosion of new treatments via companion diagnostics. In fact, regulators could potentially require a more integrated approach to manage the ever-increasing influx of new drugs and data. In August, the American Society of Clinical Oncology issued guidelines for doctors on interpreting multi-gene tests for cancer susceptibility, acknowledging the need for more education and regulation.

Most oncology biotech start-ups dream of developing such an integrated approach. But it takes time and money, and an environment that prioritizes in-depth scientific research.

Doing well by patients, doctors and investors means pursuing sustainable innovation, not just one-offs or single-use purchases. Innovation drives value and can build on itself to address complex challenges. And while innovation takes time and entails risk, it mitigates that risk in the long term.

For example, if you have a deep understanding of how your drug works — say, the tumor-growth mechanisms it disrupts — you can determine whether there are signs that the mechanism it targets is present in a particular patient and then enroll only those patients in clinical trials. That allows for smaller, less expensive trials — and a higher chance of success.

An integrated approach across the industry would allow drug developers to identify responders, and then eliminate the non-responders from clinical trials and from the target population post-approval, ensuring patients only receive treatments likely to benefit them and don’t waste their time enrolling in irrelevant trials.

The current cycle of big pharma acquiring start-ups and dismantling the research teams while divesting in their own R&D appears self-perpetuating, but cracks are showing in the high cost — now in the billions — of bringing a single drug to market.

These companies are dealing with outside pressures that stymie progress. Less than 10 percent of experimental oncology drugs ever get approved. A tactical approach to the pipeline makes sense from a risk-aversion perspective. But sustainable growth requires strategy and investments in the fundamental science work that drives innovation.

Commentary by Robert J. Mulroy, president and CEO of Merrimack, a biotech company focused on cancer treatments. Prior to joining Merrimack, Mr. Mulroy worked as a management consultant in the pharmaceutical and health-care industries. He has served as an advisor to multiple start-up companies in the biotechnology industry.

The New Biotechnology Innovation Organization

Jim's CornerAt BIO, new discoveries in research and development are constantly being made by our members. We take pride in the contributions they have made across a diverse range of biotechnology industries, including: healthcare, agricultural, industrial and environmental.

As one of the world’s strongest catalysts for innovation, our role within the biotechnology community requires us to reflect on who we are, what we do and how we can better serve our members in future.

Biotechnology scientists and entrepreneurs are not just industrious – they are revolutionary, imaginative, inspired, creative, ingenious and inventive. It is these traits that produce innovation.

BIO Logo Vertical RGBAs you may already know, starting today, the Biotechnology Industry Organization will become the Biotechnology Innovation Organization. It’s a one-word name change – from industry to innovation – but the implications are substantial.

Today is a time of tremendous innovation. So much so that our current name no longer best describes our members and our role as one of the world’s leading innovators.

BIO’s members are on the cutting-edge of science and we believe our new name will allow us to build upon our relationships, create new ones and provide our members with better educational and research opportunities.

Our members are discovering scientific breakthroughs and bringing new and innovative therapies to the marketplace. With the help of biotechnology, people are living longer and healthier lives. Our industry embodies innovation and made the world a better place for people everywhere.

Our meaningful innovations also provide the tools to help feed more people, develop new sustainable fuels and products to help protect the planet and devise unique clean technologies to make our environment safer.

In the more than 22 years since its founding, BIO has united scientists, policymakers and the public in a partnership to drive our remarkable progress even further.

It’s important to note that we are not becoming a different organization. We are not altering our mission or the value we deliver to our members.

We will, however, continue to blaze the trail to accelerate cures – connecting thought leaders, building a stronger, more advanced economy and creating jobs to raise the world’s standard of living.

In the coming years, BIO’s diverse membership – from promising startups to global companies in a wide array of biotechnology and related fields – will drive health, life expectancy and improve quality of life for millions of people.

The Biotechnology Innovation Organization will be there to support our members in their tireless effort to make the world a better place to live.

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