Biotech 2008

Innovation Corridor

2008-11-11T10:59:00.000-08:00

This year's Innovation Cooridor at Biotech 2008 was bigger (45 posters) and better. Universities and early stage start up companies showcased technologies that could be the basis of licensing opportunities or new start up companies. Each participant also received feedback on the commercialization potential of their inventions. The top poster presenter from each session also had the opportunity to meet one on one with the judging panel of scientific, legal and business experts.

This is a wonderful opportunity to connect innovation in the region with the commercialization infrastructure.

The 3rd group of posters is currently being presented so you still have the chance to speak with the investigators.

Thanks to everyone on the Innovation Corridor planning committee , my co-chair Chris Yochim from AstraZeneca and the great support from BIONJ and Pennsylvania BIO for making Innovation Corrridor a success.

Judith Sheft
Associate Vice President
Technology Development
New Jersey Institute of Technology
Biotech 2008 Innovation Corridor Co-Chair

Tuesday Luncheon & Keynote Address

2008-11-11T08:19:00.000-08:00

Senator Arlen Specter, R-PA spoke about the successes of the biotech industry from his perspective as both a Senator and as a Hodgkin's Disease patient.

Sen. Specter said he wants to bring more money for research funding to Pennsylvania and the nation, and is hopeful that he may become appropriations chairman, though it all depends on party control. As appropriations chair, he said, he would enact a top-to-bottom reform of how money is disbursed, something he says that Congress has never attempted.

Sen. Specter would like to add $5.2 billion in funding to NIH - a move that would return the NIH's level of funding back to where it was before budget cuts. He thinks the Obama administration will be friendlier to health care funding

"It is repugnant that an opportunity for scientific advancement was rejected due to idealogical reasons," said Sen. Specter, who is sure that Congress will authorize the use of federal funds for research on embryonic stem cells. With President-elect Obama's support, he said, they'll pass it a third time and it will be signed instead of vetoed as in the current administration.

Jeff Libson, Corporate and Securities Partner, Pepper Hamilton LLP, said he is confident that the scientific community will make great strides in defeating disease. The Pennsylvania-New Jersey area is a vital part of the life sciences industry that helps fuel the region - and the country's - economy.

Keynote speaker Frank Baldino, Jr., Ph.D., Chairman & CEO, Cephalon, Inc. spoke about America's healthcare policies are about to undergo tremendous change, said Baldino, who believes the time for action has arrived. These changes will affect every aspect of the biotech industry, which he believes will be impacted heavily by the first 100 days of the new administration. There are currently 1300 pieces of legislation circulating among America's state capitals that would change the way the biotech industry does business.

How did the biotech industry become a target for change? Baldino thinks it's because the companies have lost their connection with the patients - even his own mother criticizes him for the high prices of prescription drugs. The biggest problem, he believes, is one of access, with fewer and fewer people with the means to afford drugs - and he recommends that Pharma reconnects with patients in ways other than direct-to-consumer advertising.

"We need to become a trusted health care resource rather than a product manufacturer," said Baldino. "Products need to be practical and address the needs of patients...and it's our responsibility to do this."

The pressures of the payor system are also contributing to the squeeze on patients. The payors and pharma need to work together to reduce health care expenditures for patients. Ten percent of every health care dollar is spent on pharmaceuticals - which most Americans view as too much. Pharma needs to prove that these expenditures vastly improve the quality of life for patients.

Pharma, says Baldino, needs to become more transparent to gain the trust of patients, health care providers, and policymakers. Change must be imparted on to the pharmaceutical business model. With a system in place where most drugs have 12-year path to the market with a 2% chance that the drug will be approved, pharma must change direction and revolutionize the approach to business. Emerging markets will be key to any pharma success.

Pharma, he said, must move from mere marketers of drugs to the purveyors of healthcare solutions.

By Danielle Kozich on behalf of Pennsylvania Bio

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Antibacterial Drug Resistance: Challenges and Advances

2008-11-11T07:35:00.000-08:00

Chris Cashman, President and CEO of Protez Pharmaceuticals, stated "how will we practice medicine is we have antibiotic resistent bugs?" He's right, how will we? Have you thought about it?

I just attended this great session and found it very interesting because the panel laid out the truth - we will have problem in the near future. Having resistance to any treatment is not what anybody wants to hear but sometimes as we know, the truth is not always good. BUT in our industry's case it means potential, collaboration and a challenges which we all live for in Biotech. The overall theme of this panel is sharing and collaborating which will be key for solving this future problem.

By: Leslie Orischak
Puresyn, Inc.

Finance Session II

2008-11-11T05:55:00.000-08:00

The Evolution of Capital: Traditional and Non-Traditional Funding

Moderator: Walter Greenblatt, Managing Director, Walter Greenblatt & Associates
Zev Scherl, General Partner, NewSpring Capital
Mel Billingsley, Ph.D., President & CEO, Life Sciences Greenhouse of Central Pennsylvania
Anne VanLent, President, AMV Advisors
Gary Sender, CFO and Vice President of Finance & Administration, Tengion Inc.
Chris Schnittker, CPA, Vice President & CFO, VioQuest Pharmaceuticals, Inc.

Greenblatt: Opened with a discussion about the demand side of financing - biotech is hungry for cash. 35% of small biotechs have less than 12 months' cash. Nearly 100 of 330 public biotech companies have less than 6 months' cash on hand.

Scherl: Over the past five years, payments increased across all stages of development. Medtech M&A activity has slowed down dramatically this year, with Pharma and private equity emerging as buyers. There are some positive facts about the market: Many VC firms have raised substantial funds and are positioned to put significant capital to work. Pharma and medical device companies are desperate to fill product pipeline gaps with new products. He believes the recession will eventually have dramatic impact on health care and pharma/medtech spending, and that companies should consider all financing alternatives and vehicles.

Billingsley: Talked about non-dilutive funding. Non-dilutive funding preserves the current status of equity/cap table. If via peer review grant, it offers 3rd party vetting. It provides a limited scope of funding $100k-$200M, and some firms may convert to equity stake at a later stage. However, the timing may be difficult.
There are many types:

Federal SBIR/STTR grants - must meet SBA criteria
Contracts (federal and private) - federal contracts have considerable paperwork & required deliverables
Venture philanthropy/foundation funding - often target specific diseases; may be derivative from main corporate mission.
Convertible debt (may be paid back w/interest or converted to equity at a later point)
Venture debt (non-convertible)
Business development resources

VanLent: Spoke about alternative financing options:

Royalty financing - takes on several forms

a royalty interest - an asset purchase of pre-existing royalty resulting from an existing license agreement or cash flow stream
a synthetic royalty financing is the creation of a royalty around a single product or a basket of product revenues
a hybrid financing may combine royalty-based financing with structured debt and equity investments

Collaborative development (R&D) funding

ex: Symphony
on a successful product, the biotech company can go out and buy back all the product rights
primarily has been done with private companies

Priority review vouchers

available to sponsor of newly-approved drug or biological for neglected tropical disease
approved itself under Priority Review
voucher is transferable or saleable
applicable to any NDA/PLA submission
NPV value of acceleration est. between $50-$500M

Sender: Gave an overview of the venture debt market

Enterprise financing, pure working capital or combo
Size ranges from $1M to $20M
Maturity from 2-4 years
Interest rate spread to LIBOR or other index. 11-13%
Warrants struck at last financing round
2-5% of total debt facility equicy participation often attached.

Benefits:

Near term non dilutive finacing.
Reduced cost of capital vs. equity
Capital-intenstive co-allow equity to finance R&D
Runaway extension
Equipment draws can often exactly match the timing of expenditure

Risks

Payback timing has to be carefully managed
Triggering of Material Adverse Change clause can be burdensome
In a liquidation, debt holders get paid back first
Will debt providers have money if draws are staggered?

Schnittker: Addressed M&A Considerations
Make sure you are considering yourself as a target for M&A. Most lately have been pharma-biotech, but expect an uptick in biotech-biotech. Valuations are challenging in this environment. It's not a speedy process - 6 months at best. Therefore, it's not a last resort strategy. Don't forget to consider spin-outs and carve-outs.

Reverse Mergers are an alternative to the IPO route. There are 2 types:
1. Company that's lead product has failed but they have excess cash to deploy.
2. Publicly listed shell company with no assets.

Benefits of reverse mergers:

Access to capital markets and public listing.
Often less dilutions vs. IPO or other capital raise.
Change in investor base and board membership.

Hidden Costs:

External perception of a "short cut" to the market
Reduced debt marketing and later trading volume issues
Analyst coverage and other Wall Street sponsorship
May need to consider a concurrent cash raise
Shaking the "baggage" of the acquired company can be difficult.

By Danielle Kozich on behalf of Pennsylvania Bio

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Finance Session I

2008-11-11T05:51:00.000-08:00

Collaboration: The Current State of Funding

Moderator: Thomas Hess, CPA, Senior Vice President of Finance & CFO, Yaupon Therapeutics, Inc.
Panelists: Jim Dentzer, CFO, Amicus Therapeutics
Kevin Taylor, Vice President, Business Development, Adolor Corporation
P. Sherrill Neff, Managing Partner, Quaker BioVentures
Christian Schade, Senior Vice President, Finance & Administration and CFO, Medarex, Inc.

Hess: M&As are becoming an attractive exit strategy. Partnering/collaboration activity is growing. A trend is emerging: Existing collaborations are converted into successful M&A deals.

Neff: Recommends for companies to spend every nickel like it's their last. VCs are more preoccupied right now with their problems than with the companies seeking capital-a major problem. The IPO market is dead for the foreseeable future and in their absence, biotech has to look to the acquisitions market. M&A numbers are misleading; they include much smaller numbers and there have only been 40-60 deals over $50B per year. Everything is slowing down. (Neff interjected here with "I hate to be an optimist today.") Interesting things are taking longer to get funded, there are problems in the portfolio, and it's hard to get those first and second meetings. It's harder to get projects across the finish line. To avoid internal drams, it's really critical to have a team in place that can deal with each other in stressful times and face reality quickly. Expect the worst, but intelligent corporate collaboration can enable survival until another dawn.

Taylor:Spoke about M&As from a target perspective. His advice? Focus on what potential acquirers will want to know. Assemble the team to address each of the key diligence areas. Expect tougher, diligence than financing diligence, with an IP focus. Ensure existing collaborations don't hinder the deal. ID material agreements and review key terms such as assignment provisions, termination triggers and consequences. Beware of ambiguities in contracts and take a hard look at IP with realistic filings and protection. Never make M&A your sole strategy.

Dentzer: Spoke about structuring a collaboration. There are several considerations:

Territory scope: Global deal vs. ROW-only
Co-Development: Joint development vs. go-it-alone
Co-Promotion: Profit split vs. Royalty
Unique diligence
Revenue recognition
Tax issues
Financing structure
Asset/product characteristics
Regulatory pathway: US and ROW
Market dynamics: US and ROW
Reimbursement: US and ROW

Four key reasons for entering into a collaboration:

Source of financing
Validation of science
Increases probability of success
Launch in multiple countries simultaneously

The NPV of the company should increase when a product/opportunity is partnered.

Schade: Addressed the "back end" of deals - profit split or royalty? On the biotech end of the deal, there are some considerations. Most profit splits have a cost-sharing component on the front end as well as the back. The definition of "net sales" and calculation of "profit" must be determined as well as launch costs early on in the commercialization. The company also must determine the ability to opt-in or opt-out during development and commercialization. Most development programs are global. Must have a defined transition point in development. Product manufacturing, sales and distribution all need to be hammered out. Accountants must be involved early in the agreement process. Pricing strategy and marketing and selling obligations must be considered.

Dentzer: Discussed alternative funding components in upfront or as options after closure. Equity components: Increase incoming cash in upfront. There's a potential for further equity option after the deal closes. Recent examples: Icagen/Pfizer - Aug.2007, Schering-Plough/Novacea - June 2007, ChemoCentryx/GSK - Aug. 2006.

For development loan from Pharma, consider interest bearing notes. Recent examples: ARIAD/Merck - July 2007, Shire/Renovo - June 2007.

By Danielle Kozich on behalf of Pennsylvania Bio

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Monday's Dinner and Keynote Address

2008-11-10T18:56:00.000-08:00

Jerry Zaro, Chief of Economic Growth for New Jersey, opened his remarks by extolling the many virtues of the Garden State: the state has a large labor pool, excellent public and private schools – and unlike many other states, New Jersey has a “brain GAIN.”

The state also has a program that will return between 10 – 80% of payroll taxes back to companies doing business in NJ. Other state programs include an angel fund to encourage venture capital in the state – and businesses receiving money from the fun d can keep their profits without paying New Jersey state tax.

Celgene , said Zaro, is a great examples of a business that benefited from New Jersey’s programs and policies.

Our keynote speaker was the President & COO of Celgene, Robert Hugin. Hugin served the US as a Marine. Tomorrow is Veterans’ Day – I’d like to thank Hugin and every other veteran of our country’s armed services for his or her service.

10 years ago, when Hugin joined Celgene, the company had 6 weeks of operating cash on hand. Today, Celgene has operations in 40 countries, multiple cancer drugs, a deep and diverse pipeline for future drugs, and have invested nearly 40% of their revenue back into R&D. This year, Celgene will have $2-2.25 B in revenue. The Celgene story is about survival.

The company changed course many times before it got to where it is today. Hugin’s advice to other biotech companies is to:

Constantly challenge your business model and make sure you’re going in the direction you want.
Guard your IP and share it at your own peril – partner at the last minute. Celgene has succeeded because they own their products worldwide.
Recruit exceptional people and set aspirational goals. No matter how big or how diverse you get, you have to maintain the feeling of individual ownership and entrepreneurship.
You have to take and manage risk for every aspect of the company. Great things don’t happen to companies who don’t take great risks. You’ve got to take risks if you want great returns.
Size matters. We believe there are tremendous disadvantages to large organizations. When you get too big, you don’t get great results.

Hugin believes the biotech industry must make strides to reform the health care system. The US spends over $2 trillion a year in healthcare, a number that accounts for nearly 20% of GDP – these numbers are not sustainable. The pharmaceutical industry can’t allow others to shape the debate – it must get involved. 95% of Americans want their country to be the global leader in medical research. The cancer death rate has decreased by 2% per year this decade – double the rate for the previous decade. If we invested in better diagnostics, we could reduce cancer treatment costs by 40%.

Employees must be ambassadors for improvements in healthcare. If they don’t believe we can cut cost and improve care, it will never work and we will never succeed.

By Danielle Kozich on behalf of Pennsylvania Bio

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Monday Afternoon Plenary Session

2008-11-10T15:00:00.000-08:00

Overview of the Industry: Past, Present & Future

Keith Brownlie, Partner, Ernst & Young, opened the discussion.

In 2007, the bio industry had record deals, booming financing, and improved profitability. In 2007, public company net loss of .5% of revenues - the lowest ever. However, the year was not without challenges, including: safety concerns (several black box warnings,) emerging regulatory challenges, and the cooling of public equity markets.

The acquisitions and black box warnings dented revenue growth in 2007. It was a year for record-breaking mergers & acquisitions. US financing reached the second-highest total on record (2000.) The uncertainty of the financial markets makes predicting the 2008 numbers difficult; they will certainly be lower. Most companies are planning on M&As or dual tracking for exits. Many are operating with less than 1 year's cash on hand and more than 100 have less than 6 months' cash on hand.

Rules of the road going forward: the deal space will still be very active, but bargaining power is critical. Raising capital in public markets in the year ahead will be very difficult. Companies will have to reduce the burn rate and spend capital more effectively.

A pattern is growing: the drug industry is being reinvented by three sweeping trends:
-increasing r&d productivity
-personalized medicine
-globalization

Doug Long, Vice President of Industry Relations, IMS Health, provided 2009 market estimates. Global pharma market will grow to over $820m in 2009 - the US market growing at about 1-2%. The strongest markets are the emerging markets - they'll grow from 14-15%. The oncology market will grow, too, at 15-16%, and biotech as a whole will grow 11-12%.

The generic market will mature with another $24bn in products due to expire, creating what Long calls "The Golden Age of Generics." At the same time, NCE's launch performance in the first half of 20008 is the weakest of the past 10 years.

Safety issues are increasing and having a real impact on the total market. Products that would have been approved 5 years ago aren't getting approved today. The FDA has more power than ever, and black box warnings are going up.

Mike Erickson, Ph.D., Associate Partner, McKinsey & Company

opened with a shot of "The Scream" to describe the current state of mind of a biopharma executive. He said Pharma has a broken innovation model - developing costs are increasing while productivity is shrinking.

Competition is getting tougher and stakeholder influence is shifting. New influencers come from a new array of outlets, including social media, reshaping the stereotype of what opinion leaders should be.

However, not all is bleak; some opportunities are coming. Specialty care biopharmaceuticals represent a place of hope and growth. Specialty care represents an increasing share of value from launched products. Demographics are also encouraging - the aging population will increase demand for pharmaceuticals. In the US today, there are over 50m folks over 50 - in 2025, there will be 75m over 50. This group accounts for 75% of prescriptions.

By Danielle Kozich on behalf of Pennsylvania Bio

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Hot Topics in Business Session III

2008-11-10T14:37:00.000-08:00

Dealmaking and Strategic Partnerships that Create Value

Steve Elek II, Partner, Transaction Services, PricewaterhouseCoopers, moderated the session.

Panelists were:
Barbara Deptula, Executive Vice President, Business Development, Shire Pharmaceuticals

Russ Gantt, Vice President, Corporate Development, North America, AstraZenica

Elizabeth Anderson, Worldwide Vice President for Immunology and Respiratory, Global Strategic Marketing, Johnson & Johnson
Tamar Howson, Executive Vice President, Business Development, Lexicon Pharmaceuticals
Perry Karsen, Senior Vice President, Business Development, Celgene Corporation

Elek: What's the view of the panel on the current state of the markets and industry?

Deptula: There's not been an IPO since 11/07; lifescience companies are decreasing in value as we speak. There are a lot of distressed assets out there.

Karsen: We are undergoing a very Darwinian period here. I can't recollect a time when so many companies were in distress.

Howson: It depends on your perspective. This is not a good time, but for companies that have assets which deserve to be developed, the marketing is going to be more rational.

Anderson: From a J&J perspective, with the right deal, we are very competitive. We have a sense that biotechnology, from a technology perspective, has been heavily de-risked. We are looking at what makes that asset a value asset in a marketplace that will be completely different in 10-15 years.

Gantt: The pressure is not just on the biotech companies. The big pharmas haven't performed very well over the past 12 months either. The partner companies being prepared to envision what the market will look like 5, 10 years from now - we really believe that it will be dramatically different.

Elek: It's a great time to be a cash-rich company. Instead of dealing with licensing issues, you can just buy the company outright.

Elek: Everyone's trying to get an edge on transactions. How do you go by sourcing opportunities?

Gantt: Opportunities come up and we start the dialogue. Sometimes it takes 2 years before we start a partnering dialogue. Very therapeutic and commercial-driven.

Karsen: These are long-term processes.

Deptula : One of the new sources we're seeing is the venture capital space. We make sure we have contacts with all the major VCs. The world is changing.

Elek: For those in the office looking to raise money or sell a business, what can they do to make their situation look more attractive?

Anderson: The ability to gain worldwide rights to a product is very important. We look for good management and we are always assessing transparency.

Deptula: Keep it focused on one thing - one core therapeutic thing - that you think is going to make it. Even in licensing, what is your clinical program like and who's running it?

By Danielle Kozich
on behalf of Pennsylvania Bio
kozich@thebravogroup.com

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Chris Matthews Plays Hardball at Lunch

2008-11-10T13:45:00.000-08:00

Biotech 2008 members were treated to lunch with Chris Matthews, who hosted a panel focusing on access, innovation and cost in our national health system. The panel included Representative Allyson Schwartz (D-PA District 13) and fellow Pennsylvanian Jim Greenwood, President and CEO of the Biotechnology Industry Organization (BIO).

Mr. Matthews introduced the discussion by addressing the historic moment we all lived through on November 4th. He dispelled any cynicism by stating that this election and its result was a major historic event. Mr. Matthews said he would be rooting for the new president the same way he was rooting for Jackie Robinson.

All panelists agreed that in order to meet the healthcare challenges facing the new administration and Congress, biotechnology and pharmaceutical companies will need to be an integral partner in finding solutions. Rep. Schwartz praised the industry for having a favorable image with Congress and called on companies to leverage the goodwill that exists among her colleagues.

Some key points included a call to reverse the Bush Adminstration's ban on stem cell research and emphasizing the importance for the NIH to support this research. Comparative effectiveness and evidence based medicine are priorities that President Obama and his administration strongly support, and creating this function within government will play an integral part in making decisions about how healthcare resources are allocated. Mr. Greenwood pointed out the importance of encouraging innovation and warned against too much regulation stifling industry's ability to develop cutting edge treatments. Rep. Schwartz called for improvements in medical information systems nationwide and said that this was one way to improve cost effectiveness.

Innovation was at the top of the debate, with Mr. Greenwood saying that in the post-Vioxx era, excessive pressure on the FDA on safety issues is creating an overly conservative agency. This benefits nobody said Mr. Greenwood--especially not patients who die waiting for potentially life saving treatments to be approved.

All panelists agreed that in the US, one of the wealthiest countries in the world, children should have health insurance. The Children's Health Insurance Program (CHIP), which has been a success in Pennsylvania and other states, should be properly funded and expanded nationally so that all children in the US can have access to quality healthcare.

Posted by David Avitabile, JFK Communications and Ron Schmid, R.E. Schmid & Associates

Growth Strategies for Bioscience Companies II

2008-11-10T12:12:00.000-08:00

"Developing Your Pipeline While Minimizing Risk and Managing a Great Exit"

Jane Hollingsworth, CEO, NuPathe Inc., moderated the session in a question and answer format.
Panelists were:
Michael Bozik, M.D., President and CEO, Knopp Neurosciences, Inc.
Frank LaSaracina, Founder, South Point Associates LLC
Mel Sorensen, M.D., President and CEO, Ascenta Therapeutics, Inc.
Paul Thomas, Former Chairman, President & CEO, LifeCell Corporation

One of the perennial questions for early stage companies developing their business model is, "Is it better to develop one product, or a portfolio of products?"
Sorensen: There is no one answer. It is all relative to your timeline, and whether you are looking at the short-term or long-term. It's much easier to see a single product result in an acquisition. When you have a single product, you have more flexibility managing your cash, and the high cost of pharmaceutical trials means you have less costs to worry about. In a portfolio approach, you have to be much more cautious about your cash flow and keeping your business going.

LaSaracina: A lot of it depends on who you are - management versus investors versus the board. If you are the management or the entrepreneur, if you have nurtured your product, you can want to stay focused. If not, you want to be careful where you're focusing your energies.
As the investors or the board, you might want to take a risk-management approach - as in, do you want all of your eggs in one basket? My perspective is that it's always better to manage your risk the best you can, and focus your activity on what will create the most value for your shareholders, while having an under layer of activities that will help cushion your risk.

Thomas: I don't think there's one answer. If you're a technology company, pursuing other technologies makes sense. You reach a point in a company's evolution where you have to take a risk. Ideally, that's a point where we'd all like to reach: you feel it, you smell it, you taste it and you really think it's going to work. It's a higher risk, but if you're successful, it really plays dividends. If you place your chips on single products, you can pursue multiple applications and hedge your bets a bit.

Bozik: Focus is very important. At the end of the day, you have to be willing to take the leap. The experience that we've had is very similar; we've placed our bet on our lead compound. But you shouldn't exclude an investment in the underlying technology because it creates credibility and a story, and when your product goes, that platform becomes a very rich source of 2nd generation activity. Stay focused, it is about product, but you have to build a foundation underneath.

LaSaracina: The finance situation right now is as bad as I've ever seen it, but Big Pharma has never been more desperate for products. They are looking at a patent cliff that's unprecedented.
Hollingsworth: Do you think the buyers in larger biotech pharma companies are more interested in buying diagnostics than they used to be?

Bozik: I've heard that's the case - there is still interest in diagnostics. Everyone's looking for what's the early test that you can determine whether a product's active or not.

Sorensen: The payors should be interested too, not just big pharma. Big Pharma doesn't always make the best decisions, or pay attention to compounds that don't have huge market sizes.

LaSaracina: As we go in the direction towards personalized medicine, there will be a resurgence of the diagnostic market that will gain importance as we start trying to treat smaller groups of patients that will respond better to therapies. If you can develop a product to monetize before selling your business, that's excellent. In this environment you have to demonstrate that you can move forward.

Bozik: There's an enormous amount of money available from the government. In PA, there's a big effort to shift policy to make small business more competitive for these Phase I Phase II SBIRs. We've had a number of discussions with NIH and NCI. the NIH recognizes they need to make a shift to be more like business - NCI is demonstrating this already. It's easier for them to fund platform technology because it's not as expensive, and shouldn't be disregarded as a source of income.

Thomas: The only drawback is that the money takes a long time.

By Danielle Kozich
on behalf of Pennsylvania Bio
kozich@thebravogroup.com

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Drug Delivery, Device and Diagnostics I

2008-11-10T10:27:00.000-08:00

"Drug Delivery Technologies: What's Old is New (and Better) through Drug Delivery"
Gwilym Atwell, Principal, Fish & Richardson P.C., moderated the session.

Unfortunately, I arrived in the session late and missed the first speaker, Troy Harmon, Vice President, Business Development for Eurand, entirely.

Second was Dr. James Gilligan, Vice President of Development for Unigene, who addressed Drug Delivery of Polypeptides.

He detailed the advancement of drug delivery systems, in order of increasing convenience and patient compliance:
1. Injectables
2. Depot
3. Transdermal
4. Pulmonary
5. Nasal
6. Buccal
7. Oral

However, several hurdles exist that hamper the development of oral delivery for polypeptides.
1. Cost of active pharmaceutical ingredients
2. The supply of the inactive ingredients
3. The gastric environment
4. Intestinal protease activity
5. Intestinal permeability barrier

Third on deck was Shawn O'Brien, President & CEO of Profectus BioSciences, Inc, who discussed how drug delivery platforms can create value:

1. able to achieve TPP of a NCE or Biologic
-Symbicort Inhaler Technologies
2. extend patent life with new formulations
-Seroquel SR: However, difficulty exists in having to repeat all of the trials all over again
3. enter new indications, LCM
4. Improve existing profile with existing indications
-Effexor
5. re-purpose off patents drugs with new formulations and different delivery systems.

Successful product development/TPP must answer "Yes" to 3 questions
1. That the clinical/performance outcome is better than the competition now and in the future
2.That the payors will pay for this improved outcome
3.That the patients/caregivers will be compliant to the therapy. (ex. cholesterol drugs have about 6 mo compliance, but they're designed for a lifetime of use.)

Technology has evolved to improve the original product - electophoration - sending electric charges through the cells in conjunction with drug administration, for example, has greatly increased the efficacy profile of DNA as a vaccine.
BUT will patients be willing to volunteer for electric shock to undergo this treatment for a preventative vaccine? Probably not, but if it's ever implemented in conjunction with therapeutic vaccines, compliance would most likely be higher.

Some interesting drug deliveries in development include
Phase Bio - developing the ELP biopolymer platform
This brings polymers and proteins together - They are liquid at room temp. but becomes a solid at body temp. to deliver a drug over time.

Dr. Joachim Kohn from the New Jersey Center for Biomaterials at Rutgers, the State University of New Jersey wrapped up the session with a discussion, "What is old, new and better in drug delivery to the eye."

The old: eye drops, which date back to 2000 B.C. and today is used mostly for minor irritations.
As a pharmaceutical dosage form, eye drops have serious limitations - dexterity, hard to get used to, and the majority of dose is washed from the eye. They're also particularly difficult for elderly or the handicapped. Also, the structure of the eye makes the eye drop ineffective for delivery to many of its' parts.

The new: modern eye drops include agents to increase viscosity - in gels or films. They are better, but still not ideal for anything other than superficial eye diseases.

Some eye diseases have no pharmaceutical treatment options, for example, keratoconus- a disease of the cornea that can only be treated with corrective lenses, corneal implants or surgery.

Some major eye diseases require better treatment options, retinal diseases, inflammatory and autoimmune diseases. The treatment of these diseases can be onerous, and patients are quick to drop out of compliance.

Retisert for treatment of uveitis is first intra-vitreal implant approved by FDA, but it's non-biodegradable and must be surgically removed. Dr. Kohn is working on a Lux-Rutgers research project that will develop an implant for vocolosporin. This is ideal - it reaches are of the eye that were previously inaccessible while increasing compliance at the same time.

By Danielle Kozich
on behalf of Pennsylvania Bio
kozich@thebravogroup.com

I apologize if there are any errors in this post; I am a layperson and many of these terms are out of my field of expertise.

Biotech 2008 – What to Expect

2008-11-04T10:19:00.000-08:00

Biotech 2008 has become one of the preeminent bioscience conferences in the Mid-Atlantic region. Attendees come to network, learn new ideas, and share their insights on the industry.

As a new feature this year, we will be blogging from some of the session tracks, plenary panels, keynote addresses, and other sessions.

Keep checking out the Biotech 2008 Blog to see what is happening at the conference. We look forward to seeing you next week in Philadelphia.

Amber van Niekerk
Pennsylvania Bio