Donald Kay Riker, Ph.D., Founder & President
Donald Riker, former Vice President of Research & Development & Chief Scientific Officer, Chattem, Inc. and Procter & Gamble Associate Director & Research Fellow in OTC Healthcare brings a wide experience to bear on how science-based consumer businesses use consumer insight and technology to grow revenues and how risks are assumed and managed. Don’s career of over two decades in the consumer health & beauty care sector reflects both operating and technology roles including management of all of R&D, product development, clinical and claims development, technology assessment, and licensing & business development. During his five years at Chattem, an over-the-counter health & beauty leader, its stock price increased over 8-fold. Don completed his post-doctoral training at the Yale University School of Medicine after receiving a Ph.D. from Cornell.
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We understand that gaining deeper insight into OTC companies and their products may be difficult. At On Point we use our operating experience, intuition and networks to provide you with a sophisticated view on: product introductions, company operating risk, patent issues, product liability, new technology, product superiority, advertising claims, safety and FDA issues, recalls, assumed operating risk, etc.
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Discovering the next product breakthrough requires inviting your consumers to participate in a process that leads to an actionable, breakthrough product concept. Our SpencerHall partners can provide: concept development, proprietary qualitative consumer techniques, new product use testing, brand technology review, and a standing innovator panel for product ideation.
Donald Riker, President & Founder, On Point Advisors, LLC, has worked closely with SpencerHall while at P&G and Chattem and has worked with other clients to provide technical creativity and medical/technical perspectives to new concept development and testing.
Nancy Spencer, Managing Partner and co-founder of SpencerHall, a leading consumer research and innovation firm, is an expert in consumer understanding, strategic positioning and idea generation. She has pioneered new research techniques to uncover new, deep consumer insights and behavior discontinuity, leading to successful competitive product positioning. Prior to co-founding SpencerHall in 1996, Nancy was Group Vice President, Account Director/New Products, at Northlich Stolley LaWarre, agency of record for Procter & Gamble’s idea generation and new product strategic development, where she helped create several major new brands for P&G including FemStat, Dryel and Fit Produce Rinse.
Jon Hall, Managing Partner and co-founder of SpencerHall, has a proven track record in creating innovative concepts and breakthrough business strategies. Prior to co-founding SpencerHall, Jon was Procter & Gamble's Director of New Ventures for the Beauty Care sector. In this capacity, he led the creation and development of new products, including creating entirely new product categories such as Olay Daily Facials. Jon's concept development work established new Beauty Care records in pre-market testing and his framework for consumer understanding was deployed worldwide. Jon's 14 years with Procter & Gamble in Beauty Care Marketing included leadership of Sure and Secret deodorants and the Old Spice acquisition/turnaround.
SpencerHall specializes in uncovering consumer insights and creating new brands/products. Their approach utilizes inventive research techniques to uncover the real roots of consumer behavior. This deeper insight is then leveraged to create product concepts and positionings that drive consumer action. Specific services include Consumer Research and Ethnography Studies with techniques designed by Consumer Psychologists; Strategic Consulting; Product Innovation –a unique ideation and creativity process that leverages company’s technology competencies to create breakthrough new concepts grounded in consumer insight; and Sounding Boards—providing quick, cost effective reactions to a variety of learning needs, where timing and efficiency are important. SpencerHall’s experience spans packaged goods, financial services, pharmaceuticals, technology, appliances and business-to-business for clients such as Alberto-Culver, Cardinal Health, Coca-Cola, Cyberonics, Fidelity, Frito-Lay, Gillette, GlaxoSmithKline, Hanes, Johnson & Johnson, Procter & Gamble, Reckitt Benckiser, and Wrigley.
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Regulatory Support: Regulatory compliance is key to avoiding risk. Our LBR Regulatory partner can conduct all regulatory support activities, including: claims and labeling review, advertising review and approval, as well as filing regulatory submissions or responding to challenges.
Clinical Support: On Point Advisors’ staff has managed development and execution of hundred's of OTC clinical trials. Clinical trials of OTC products are both an art and a science. We provide proven skill in OTC trial design, execution, placement, and analysis and interpretation of results. We can also supply our point of view of competitor’s trials or claims support.
Legal Support: Product liability actions, claims challenges, patent defense, and M&A can often require technical support of counsel. On Point can provide integrated opinion on multi-functional technical issues for you.
Donald Riker, Ph.D., President & Founder, On Point Advisors, LLC, managed a clinical development unit producing over 125 trials in support of OTC products. Further, he has worked closely with counsel on OTC technical insights, product liability, patent validity/infringement, and due diligence. Dr. Riker is a member of the Regulatory Affairs Professional Society and American Society of Clinical Pharmacology & Therapeutics.
Lois B. Rosenberger, M.S., Ph.D., Partner is the Founder and President of her own established consulting firm, LBR Regulatory. Lois brings 24 years of experience in the pharmaceutical industry at several Rx, CRO, and OTC companies, including Procter & Gamble, Roche Pharma, Stolle and Kendle, where she was Vice President of Global Regulatory Affairs.
Stephen M. Rosenberger, B.S., J.D., Partner has 12 years of pharmaceutical experience in toxicology, GLP, preclinical and clinical writing, regulatory affairs, and project management. In addition Steve practiced law for 8 years in defense of product liability litigations of drugs and medical devices. Steve can provide clients with advice regarding FDA regulation, consumer safety and product exposure.
LBR Regulatory manages preclinical regulatory affairs including IND and NDA submissions, medical writing, and whitepaper defense in response to regulatory agencies. LBR also provides quality assurance, regulatory compliance, regulatory filings, clinical development oversight, submission appraisal and evaluation.
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Building a brand portfolio often means searching for technology or brands to acquire. We can help that search and provide a deeper understanding of product superiority and performance. At On Point we can also provide an unbiased, third-party view of product potential by conducting due diligence for hidden risk and technical liabilities to aid selection or valuation.
Donald Riker, President & Founder, On Point Advisors, LLC has supported due diligence of brand acquisitions, evaluated new technology, supported intellectual property, and managed line extensions in a variety of OTC categories. He is a member of the Licensing Executives Society.
Kirk Hodgdon, Principal Growth Catalyst, Bolin Marketing has helped Presidents and CEO’s identify business growth opportunities and then build programs to capture them. Clients include: 3M Film, Breathe Right Nasal Strips, Little Remedies Pediatrics, Carmex Lip Balm, American MedCenters, CNS, Inc., Vetco, Inc., American Medical Systems, and Restore Medical.
Bolin offers critical third-party vantage points that help identify and evaluate the merit of potential partners, brands and opportunities. Once that happens, we facilitate a win-win relationship to create lift-off. Our track record speaks volumes because it drives volume: Radisson & Sleep Number Beds, Caribou and National Geographic, Cold Stone Creamery & Aquafina are examples of successful partnerships we have cultivated.
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For companies who do not have in-house product development, pilot facilities, or manufacturing our Sterling Pharmaceutical partner can provide these services as an out-sourced service, or as on-site oversight.
Robert G Flynn, M.S., R.Ph., Partner, Sterling Pharmaceutical Services
Bob has worked at leading drug companies as Vice President, Scientific Affairs and R&D, including: Perrigo, Warner Lambert, Sterling, and Smith Kline-Beecham. He has developed 350 products and 36 ANDA in the OTC, generic, nutritional and personal care industries. Bob has managed research & development, regulatory affairs, analytical, process, quality control and compliance. Bob has an acknowledged reputation for converting marketing strategies into reality, communicating technical issues, acquiring new technologies and providing outsourcing services that deliver competitive advantage. He knows how to produce products and evaluate operating capabilities, risks, and documentation.
Robert T. Flynn, Partner, Sterling Pharmaceutical Services
Robert T. Flynn has 20 yrs experience in line Operations management at Glaxo-SmithKline, KV Pharma, and Impax Labs as Supervisor, Manager, and Director of Manufacturing. Bob has extensive experience managing both solid and liquid manufacturing and continuous improvement projects. He has been involved with the development and launch of 40 aNDA’s. He has investigated many manufacturing problems and has been party to 17 FDA inspections. Bob brings a practical knowledge of manufacturing pitfalls, risks, and capabilities.
Sterling Pharmaceutical Services is a full service provider of products for the health and beauty care industry. They provide operational expertise for commercialization from product development to final manufacturing. For our investor clients they offer deep experience at assessing operational capabilities and risks, cost control & capital ex spending, manufacturing compliance, operating controls, and (pre-) launch risks. As managers they have developed and launched a combined 400 products, including those with OTC NDA’s, aNDA’s as well as nutritionals.
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