Outside the Lab: Interview With Dr. Greg Stock

In episode one of Outside the Lab, show host Michael Choi interviews Dr. Gregory Stock, CEO of Signum Biosciences. Dr. Stock provides insight into Signum’s business strategy, which is to first focus on the cosmoceutical market and reinvest short term cash flow towards the more lucrative, yet more costly pharmaceutical applications of its discoveries.

Outside the Lab explores the business side of the life sciences industry. We interview CEOs, Venture Capitalists, Consultants and other industry professionals on the dynamic and ever changing lifesciences landscape.

If you know someone who would make an interesting guest on an upcoming show, feel free to contact us.

About Signum Biosciences

Signum Biosciences is a private biotechnology company dedicated to acquiring and developing effective, innovative, economical medicines to prevent and treat diseases of aging. Through research on protein networks that control biological systems, we are developing therapeutic candidates for Alzheimer’s , Parkinson’s, arthritis, cancer, cardiovascular disease and a variety of skin conditions.

All cellular activity is coordinated by cellular communication networks, so when these networks go awry, disease results. In cancer, cells mutate and their growth becomes unregulated. In Alzheimer’s, imbalanced expression of a secreted protein in the brain brings inflammatory responses that lead to memory loss and neuronal cell death. In vascular disease, damage to the vascular endothelium generates inflammation that causes atherosclerotic plaques. In skin, neutrophils aggregate in localized areas and cause damage. Each disease develops from progressively more serious imbalances in regulatory and signal transduction processes.

We have developed a strategy to modulate signal transduction networks globally instead of through specifically targeted receptors and other components. This approach is feasible because cellular networks have their own built-in global regulatory mechanisms that can be tuned to modulate the activities of all components at once with minimal deleterious effects.

More global approaches to regulating human biochemical networks are gaining traction for the treatment of disease, and the cutting-edge biochemistry embodied in our proprietary assays offers an efficient new platform for drug discovery in multi-billion dollar disease markets. Our approach will speed the development and commercialization of innovative new drugs and allow us to spin off validated, well-characterized skin care products during the process.

Nanodrug Delivery

Get up to date on the recent trends in nanodrug delivery by exploring innovative technologies in evolutionary nanomedicines and medical devices. Understand the impact of advances taking place in the laboratory as they apply to the development of viable commercial products.

This specific case study on the use of the nanotechnology as it transforms the pulmonary drug delivery market will provides key insights on the use of these innovative technologies in drugs and devices. It also provides pertinent updates on how the FDA views nanotechnology products and current FDA research in the nanotechnology area.

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Raj Bawa PhD is President of Bawa Biotechnology Consulting LLC, a biotechnology and patent law firm with offices in Ashburn, Virginia and Schenectady, New York. The firm has broad expertise in biotechnology, nanotechnology, drug delivery, medical device technology, HIV/AIDS, and biodefense-related scientific, legal and business issues. In addition, the firm specializes in all aspects of biotechnology and pharmaceutical patent law, including prosecution, application drafting, prior art searching, freedom-to-operate searching and technology research opinions. Dr. Bawa has over fifteen years of patent experience. He has been a researcher for more than twenty years. Since 2002, Dr. Bawa has served as a technology and patent consultant to national and international biotechnology and pharmaceutical companies. Since 1998, as a Visiting or Adjunct Assistant Professor at Rensselaer Polytechnic Institute. Dr. Bawa is a registered patent agent (Registration No. 51,385) licensed to practice before the US Patent and Trademark Office in Washington, DC. Dr. Bawa has previously held various positions at the US Patent and Trademark Office in Washington, DC, including Patent Examiner; Primary Examiner; Supervisory Patent Examiner (acting); and Instructor at the US Patent Academy. At Rensselaer, he also serves as Advisor/Patent Agent to the Office of Technology Commercialization where his principal roles include patent strategy, research opinions and prosecution. He is an Adjunct Professor of Natural and Applied Sciences at Northern Virginia Community College in Annandale, Virginia. Dr. Bawa attended Panjab University in India, earning a B.Sc.in Microbiology (1985). He earned his M.S. and Ph.D. degrees in Biology from Rensselaer Polytechnic Institute in Troy, New York. He is the author of around 40 scientific, legal and business publications in journals and books and presently serves on the editorial boards of the peer-reviewed journals, Nanotechnology Law and Business and International Journal of Nanomedicine. He is an associate editor of the peer-reviewed journal, Nanomedicine: Nanotechnology, Biology and in Medicine. He is co-editor of a new book titled Nanotechnology Law to be published in 2007 by Law Journal Press. Some of Dr. Bawa?s awards include: Talbot Award of the US Biophysical Society (1988); Research Fellowship/Teaching Assistantship from Rensselaer (1985-90); Sigma Xi Travel Award (1988, 1990); Appreciation Award from the Under Secretary of Commerce, US Department of Commerce (2001); Service Recognition from the American Society for Microbiology (2006); Director?s Award (2001) and Key Award (2005) from the Rensselaer?s Office of Alumni Relations.

Polytrauma: The Nervous System & Physiological Systems

With ongoing wars in Iraq and Afghanistan, increasing numbers of civilians and military personnel are being exposed to explosive blasts. The injuries caused by these blasts are devastating, wreaking havoc on many parts of the body at once. The physicians and healthcare specialists treating the victims of these blasts must be aware of the complexity of injuries involved.

In past wars, soldiers with multiple blast wounds were likely to die on the battlefield, but now the chances of being rescued are much higher. Medic teams can safely extract soldiers from battle zones using air transport and deliver immediate medical care. With increasingly sophisticated rescue efforts, more soldiers are surviving massive injuries. And when they return home, they need intensive long term rehabilitation.

Blasts cause polytrauma—multiple complex injuries usually involving both brain and body. Polytrauma manifests itself in unpredictable patterns that are not easily traceable to particular locations or systems in the body. Doctors mistakenly attribute many post-war symptoms—cold intolerance, reduced aerobic capacity, sexual dysfunction—to brain damage alone when in fact the pathology is widespread, involving multiple hormonal pathways. Conversely, symptoms of brain damage are often misdiagnosed as various types of body injury. For instance, a person with a concussion may have seemingly unrelated symptoms such as nausea and vomiting.

The problem is that the brain and body are intimately entangled systems. The brain secretes chemicals that control activity in the tissues, and the tissues secrete chemicals that influence the brain. Regulation is bidirectional, and cause-effect relationships are difficult to decipher.

When a blast-survivor patient visits a doctor for a particular problem, the doctor should look at the brain-body system. If the patient presents a head injury, the doctor should examine the body, and if the patient presents a body injury, the doctor should examine the head. Blast injuries are complex and require a multidisciplinary treatment approach. Neurologists, endocrinologists and other specialists need to work together in treating these patients with polytrauma.

Recently, a group of experts convened to address these issues. Rolland Parker, president and founder of the New York Academy of Traumatic Brain Injury, spoke before the New York Academy of Traumatic Brain Injury Annual Conference.

ROAD TO HOPE documentary

About this Film

Documentary produced by Hope’s Voice and supported by ScribeMedia – Producers of Reporting AIDS.

The 2005 Road to Hope Tour traveled 7,000 miles from Washington, DC to San Francisco, CA visiting 23 schools and thousands of students. The tour featured HIV positive young people and advocates that joined together to educate and bring awareness to students around the country about HIV and AIDS. Hope’s Voice and joined forces with advocacy groups from around the country to put together this exciting tour.

Getting Beyond the Press Release Du Jour

The public relies heavily on media outlets to supply information on health and medicine. As purveyors of news that directly impacts people’s health decisions, journalists have an obligation to report stories that are balanced, accurate, and relevant.

One of the greatest challenges of health reporting is developing stories outside the established framework. Typically, journalists find stories by combing through press releases distributed by universities, public and private research institutions, public relation firms, and government agencies—organizations with their own sets of biases and agendas. When journalists rely too heavily on these sources, they become dependent on someone else to tell them what is newsworthy. There are more objective and creative ways to dig up stories.

Reporting outside of the box requires careful observation and questioning. Challenging the conventional wisdom is often the key to a killer scoop. For example, questioning some of the basic claims tossed around in the stem cell debate led Boston Globe reporter Gareth Cook to a 2005 Pulitzer Prize for explanatory journalism. And probing the seemingly mundane concept of disease definition led Seattle Times reporter Susan Kelleher to create the award-winning series “Suddenly Sick.”

In a recent conference of journalists called Medicine in the Media, veteran health journalists shared strategies for conceiving fresh stories. The panel of speakers included Craig Stoltz, editorial director at Revolution Health, Susan Kelleher, investigative reporter from the Seattle Times, and Gideon Gil, health and science editor for the Boston Globe. The panelists led a brainstorming session for health stories, touching on topics as diverse as restless leg syndrome and FDA submission policies.

Is Screening and Early Detection Always Good?

Screening technologies for diseases such as prostate and breast cancer are constantly improving. The media eagerly reports stories about new tests and the public devours them because the underlying assumption is that screening can only be good. But this premise is flawed.

Screening results can be ambiguous; they do not necessarily lead to better treatments; and, they can change people’s lives for the worse. Earlier detection can lead people to panic, worry, subject themselves to risky medical procedures, and take medications with serious side effects. Early detection may, in fact, have no effect on mortality but can significantly and permanently alter the quality of life. Messages about medical screening promulgated by journalists are often one-sided and fail to convey the complexity of issues involved.

Speaking before an audience of journalists at Medicine in the Media, Barry Kramer, Director, NIH Office of Medical Applications of Research, warns of the negative implications of prostate cancer screening, and urges journalists to weigh the pros and cons of screening when communicating information to the public.

This impromptu dialogue took place during a 3 day course offered to journalists by the National Institute of Health.

The National Institutes of Health’s Office of Medical Applications of Research (OMAR) presents a free annual training opportunity to help develop journalists’ ability to evaluate and report on medical research. Now in its sixth year, the course curriculum builds on the best of prior years’ offerings to create an intensive learning experience with hands-on application. This year’s course will he held at an idyllic, retreat-like setting near Bethesda, Maryland.

The course examines the challenges and opportunities inherent in the process of communicating the results of medical research to the public. Stressing an evidence-based approach and re-examining intuitive beliefs about medicine, the course will prepare participants for the crucial task of interpreting and evaluating research findings including statistics, selecting stories that hold meaningful messages for the public, and placing them in the appropriate context.

Faculty include prominent experts from the fields of medical research and medical journalism. Sessions will be interactive, with hands-on opportunities to apply lessons learned, and will incorporate journalists’ special perspectives on the public’s need for useful medical knowledge.

We invite application by journalists whose primary target audience is the general public. Applicants may produce news stories about health or healthcare for newspapers, magazines, or newsletters; television or radio; or on-line media. Participants should be eager to develop skills and knowledge necessary for good medical science reporting, but need not have specific experience or background in medical journalism.

There is no cost for the course. All meals and lodging are provided. Participants are responsible for their own travel. Learn more…

Medicine in the Media: The Challenge of Reporting Medical Research

In June 2005, the Seattle Times published “Suddenly Sick,” a five-part series by reporters Susan Kelleher and Duff Wilson illustrating the impact of disease definitions on medicine and the power of the pharmaceutical industry in shaping these definitions.

Disease is a relative concept, but medicine often defines it using strict quantitative parameters. For example, a body mass index of 30 or above spells obesity, and blood pressure beyond 140/90 means hypertension. These definitions change with time, as new evidence emerges, changing our understanding of disease. But there are other factors driving these vicissitudes, and they are not always as objective as evidence-based medicine.

According to Kelleher and Wilson’s report, pharmaceutical companies have commandeered the process by which diseases are defined, influencing members of high-profile organizations such as the World Health Organization and prominent medical societies—the people who play a key role in defining disease—through financial donations.

Revisions in disease definitions are not always backed by powerful scientific evidence, and often these revisions have a broadening effect, bringing more people under the disease umbrella. For example, reducing the “normal” blood sugar by a few units pushes thousands of people previously considered non-diabetic into the diabetic category. And this expands the drug market by huge dollar margins, creating millions, if not billions, of dollars in additional profits for the pharmaceutical industry.

Kelleher recently spoke before an audience of health reporters at Medicine in the Media, a conference sponsored by the Department of Health and Human Services and the National Institutes of Health, which convenes every year to addresses the challenges of reporting medical research. Kelleher shared some of the wisdom she has gleaned in reporting “Suddenly Sick” and many other medical stories.

This presentation was part of a 3 day course offered to journalists by the National Institute of Health.

The National Institutes of Health’s Office of Medical Applications of Research (OMAR) presents a free annual training opportunity to help develop journalists’ ability to evaluate and report on medical research. Now in its sixth year, the course curriculum builds on the best of prior years’ offerings to create an intensive learning experience with hands-on application. This year’s course will he held at an idyllic, retreat-like setting near Bethesda, Maryland.

The course examines the challenges and opportunities inherent in the process of communicating the results of medical research to the public. Stressing an evidence-based approach and re-examining intuitive beliefs about medicine, the course will prepare participants for the crucial task of interpreting and evaluating research findings including statistics, selecting stories that hold meaningful messages for the public, and placing them in the appropriate context.

Faculty include prominent experts from the fields of medical research and medical journalism. Sessions will be interactive, with hands-on opportunities to apply lessons learned, and will incorporate journalists’ special perspectives on the public’s need for useful medical knowledge.

We invite application by journalists whose primary target audience is the general public. Applicants may produce news stories about health or healthcare for newspapers, magazines, or newsletters; television or radio; or on-line media. Participants should be eager to develop skills and knowledge necessary for good medical science reporting, but need not have specific experience or background in medical journalism.

There is no cost for the course. All meals and lodging are provided. Participants are responsible for their own travel. Learn more…

Nursing Shortage: A Doctor’s Perspective

Barbara Ficarra, RN, Award-Winning Journalist, Executive Producer and Medical Show Host of Health in 30 and Nurses in Motion recently sat down with Fred Pescatore, M.D., NY Times-Best Selling Author and Practicing Family Physician in NY to continue the discussion on the nursing shortage.

The nursing shortage is a global complex issue, and there are no easy answers. Watch uncensored, passionate dialogue unravel; Barbara Ficarra and Dr. Pescatore speak candidly about how the nursing shortage impacts quality patient care, how vital the role of nurses are in society, how nurses are not being compensated for their work as professionals; and how major manufacturers in essence contribute to the nursing shortage.

Fred Pescatore, MD, is a traditionally trained physician practicing nutritional medicine. Dr. Pescatore is the author of the New York Times best selling book, The Hamptons Diet. This lifestyle program focuses on the use of foods of high nutritional quality, does not exclude any food groups, and unravels the mystery of heart-healthy monounsaturated fats. A former Associate Medical Director at the Atkins Center for five years, Dr. Fred’s other titles include, Thin For Good, The Allergy and Asthma Cure and the number 1 best-selling children’s health book, Feed Your Kids Well.

Major television reporters, radio hosts and print journalists call upon him to be the medical expert on nutrition. He has been featured on such shows as, Health in 30 Radio Show with Barbara Ficarra on WRCR, The View, The Today Show, Deborah Norville, The O’Reilly Factor, and Extra. Recent interviews include Washington Post, InStyle, US magazine, First for Women, Women’s Health and Fitness, Let’s Live, The New York Times, The Wall Street Journal, Fortune, Women’s World and more.
Dr. Pescatore lectures across America, and the world; and is actively involved in clinical research.

He is the author of numerous papers and magazine articles. Dr. Fred is a consultant for many firms and is instrumental in developing and clinical testing many of the leading nutritional products. He is the President of the AHCC Research Association, President of the International and American Association of Clinical Nutritionists, member of the National Association of Medical Communicators.

Nurses in Motion Host
Barbara Ficarra RN, BSN, MPA is an award-winning journalist and the medical/health correspondent and executive producer with ScribeMedia. Barbara is the creator/host/executive producer of Health in 30 and Nurses in Motion for Scribe Media. Nurses in Motion delves into the complex ssues surrounding the nursing profession. Barbara is also on-air in Radio.

Barbara is the creator/executive producer/host of Health in 30™ radio show which airs live every Friday from 5:30 p.m. to 6:00 p.m. EST, broadcasts on WRCR-AM 1300 and streams live online at Healthin30.com – click the WRCR logo to listen live! Health in 30™ is a 30-minute show that brings listeners the latest health and medical news and information with leading guest medical experts. Barbara conducts lively and informative discussions with leaders in their fields to provide vital health information on a broad range of topics, while focusing on education and prevention; and listeners will often call-in with questions.

Barbara Ficarra is also the creator and editor-in-chief of the Healthin30.com website. Healthin30.com is dedicated to the responsible sharing of information from leaders in the healthcare industry. On Healthin30.com, readers can get more in-depth information and tips from these same experts. The highlight of the website is the “Speak Out” logo, this is where all medical communicators can go to sign-up to be a guest on the Health in 30™ show and/or write for the website. Nurses are especially encouraged to sign-up and to use their voice to advocate to the pubic that they are medical experts and communicators.

Barbara is a media consultant, medical communicator and media consultant/co-coach with Media Image Coach and is active on the front lines of the healthcare system, she is an administrative head nurse at a level 2 trauma center and she is multifaceted in her clinical experience from oncology to general med/surg.

Barbara Ficarra has been selected by the American College of Emergency Physicians (ACEP) to receive a prestigious Journalism Award of Excellence for Coverage of Emergency Medicine. The program, “Ins and Outs of the ER” covered what to expect in the ER and the challenges of crowding and waiting on the Health in 30 Radio Show.

“Awards are given for outstanding coverage of an emergency medicine issue, in-depth analysis or investigation that brings clarity to a key emergency medicine issue and educates the public and significant impact that motivates positive change or breaks a new story that generates widespread coverage.” Barbara was honored by ACEP at the Leadership and Advocacy Conference on May 1st at the Hyatt Regency in Washington, D.C.

Barbara was selected to teach at the American Medical Association’s Medical Communications Conference in Tampa, Florida on April 12th.

Barbara is in demand to speak at professional conferences, the next conference is scheduled for June 6th where she will be the keynote speaker at the American Association of Critical Care Nurses in Fairfield, NJ. On April 21st Barbara spoke at the Hudson Valley Chapter of the American Society of Ophthalmic Registered Nurses in Mt. Kisco NY, Barbara was the closing keynote speaker on April 27th at the Nursing Spectrum Career Fair in Teaneck, NJ. and presented “Nurses in the Media” during nurses week at a level II trauma center in NJ. Barbara will also be the Keynote Speaker at two Nursing Spectrum Career Fairs in October. Barbara spoke at the National Primary Care Conference in Boston in Nov.

Barbara was recently elected to the Board of the National Association of Medical Communicators and a member of New York Women in Communications. Barbara has media training featuring teleprompter, anchoring, hosting, broadcasting and interviewing; and she is a published author. Barbara serves on the Academy of Judges for the International Health and Medical Media Awards (the FREDDIE Awards).

Recent Trends in Nanodrug Delivery – Alan Minsk

Recent Trends in Nanodrug Delivery – Innovative Technologies and Commercial Viability…

One of the greatest impacts of nanomedicine is likely to take place in the context of drug delivery, which is poised to deliver to the market both evolutionary and revolutionary nanomedicines and devices. Early forecasts for nanomedicine commercialization are encouraging. However, there are challenges as well – formidable legal, policy, ethical and regulatory questions as well as emerging thickets of overlapping patent claims.

Currently, patent systems are under greater scrutiny and strain, with patent offices around the world continuing to struggle with evaluating the swarm of nanomedicine-related patent applications. Given this backdrop, it is natural to question whether advances in the laboratory will result in viable commercial products that benefit society.

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Alan Minsk JD is a Partner and Chair of the Food & Drug Practice Team of Arnall Golden Gregory LLP, located in Atlanta, Georgia.

Prior to returning home to Atlanta and his association with Arnall Golden, he worked with a Washington, D.C. food and drug law firm.

Mr. Minsk advises pharmaceutical, medical device, and food companies on all legal and regulatory matters relating to the U.S. Food and Drug Administration, and certain matters concerning the U.S. Department of Agriculture, the Federal Trade Commission, the Drug Enforcement Administration, the Bureau of Alcohol, Tobacco and Firearms, and the Consumer Product Safety Commission.

He counsels clients and has spoken and written on a wide variety of FDA-related issues, including regulatory strategies and life cycle management, combination products, FDA enforcement, FDA inspections, corporate compliance, market exclusivity, product promotion and advertising, product liability, clinical trials and imports and exports.

He serves on the editorial advisory boards of the Pharmaceutical Formulation & Quality and the Law Journal Newsletters’ Product Liability Law & Strategy journals and was recently appointed to the University of Georgia College of Pharmacy Regulatory Affairs Advisory Board.

Bionanotechnology II: Drug Delivery – Ola Nerbrink

Recent Trends in Nanodrug Delivery – Innovative Technologies and Commercial ViabilityOne of the greatest impacts of nanomedicine is likely to take place in the context of drug delivery, which is poised to deliver to the market both evolutionary and revolutionary nanomedicines and devices.
Early forecasts for nanomedicine commercialization are encouraging.

However, there are challenges as well – formidable legal, policy, ethical and regulatory questions as well as emerging thickets of overlapping patent claims. Currently, patent systems are under greater scrutiny and strain, with patent offices around the world continuing to struggle with evaluating the swarm of nanomedicine-related patent applications.

Given this backdrop, it is natural to question whether advances in the laboratory will result in viable commercial products that benefit society.

Watch This Presentation (in new window).

Ola Nerbrink PhD obtained a Bachelors degree in chemistry/physics from Lunds University in Sweden in 1981, a Licentiate degree in Occupational Hygiene with emphasis on inhalation topics from Lund University in 1997 and, in 2001, he finalized a PhD in Occupational Medicine from Karolinska Institute in Stockholm.

Dr. Nerbrink has been active in the pharmaceutical field for more than 20 years. He was employed at AstraZeneca R&D Lund in 1985 where he worked with aerosol related development in the pre-clinical and pharmaceutical area as a Laboratory Scientist and later on as a Research Scientist. The emphasis lay on development and characterization of inhalation systems used by humans and in in-vivo animal models used in laboratory applications. These inhalation systems were based on DPIs, nebulizers and pMDIs.

Since 1986, he was employed as an Associate Director and then Principal Scientist where he focused mainly on novel powder and liquid device development at the pharmaceutical department of AstraZeneca, with specific emphasis on current and future liquid aerosolization technology. Since 2002 he is has been at Novo Nordisk Pharmaceuticals in Hillerd as a Principal Scientist where he works with research/development of atomization systems for inhalation purposes.